Dive Brief: Orchard Therapeutics on Monday won Food and Drug Administration approval for the first gene therapy to treat a deadly and devastating rare disease in children called metachromatic leukodystrophy. The condition is caused by a faulty gene that robs the body of the ability to make enough of a crucial enzyme called arylsulfatase…
Dive Brief: Bayer on Tuesday said it plans to seek regulatory approval of a drug for symptoms of menopause following positive results from a third Phase 3 trial. The drug, dubbed elinzanetant, has already succeeded in two late-stage studies testing its ability to reduce the frequency of hot flashes and improve sleep in menopausal women…
Ask a healthcare professional (HCP), and chances are good that they’d like an easy way to reach out to biopharma field reps. In-person meetings are still the gold standard, but adding a digital inbound channel—such as compliant chat or text—fits busy schedules and supports HCPs when they need it most. Veeva Pulse data shows that…
Gene therapy developer Bluebird bio has raised a large debt financing in a bid to extend its cash runway for another year. The company on Monday announced that it’s secured up to $175 million through a five-year term loan with Hercules Capital. Bluebird has drawn the first $75 million immediately, but will only get access…
Dive Brief: Tubulis, a German biotechnology startup developing antibody-drug conjugates, brought in €128 million, or about $140 million, to bring its first prospects into clinical testing. The startup, which is backed by more than a dozen investors, uses a suite of technologies to fine-tune each component of the complex medicines. Its two most advanced drugs,…
Asgard Therapeutics has become the latest emerging developer of “in vivo” cell therapies to attract the attention of large drugmakers. The Swedish biotechnology startup on Thursday raised 30 million euros, or about $33 million, in a Series A round that included participation from three pharmaceutical companies. An investment arm of Johnson & Johnson co-led the…
Dive Brief: The Biotechnology Innovation Organization on Wednesday backed legislation aiming to limit the industry’s association with Chinese life sciences companies that have alleged ties to the Chinese government, including the widely-used contract research and manufacturing company WuXi-AppTec. BIO is also “taking steps to separate from WuXi-AppTec,” a member of the organization, said in a…
Dive Brief: For the first time, the Food and Drug Administration has approved a cell therapy for hard-to-treat forms of two blood cancers. Sold as Breyanzi, the therapy is now cleared for use in certain adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines…
Advisers to the Food and Drug Administration have endorsed the use of two cellular medicines for multiple myeloma earlier in a patient’s disease, overlooking safety concerns raised by agency reviewers earlier this week. The advisory committee on Friday voted unanimously, 11-0, that the benefits of Johnson & Johnson and Legend Biotech’s Carvykti outweighed the risks…
The first drug for metabolic dysfunction-associated steatohepatitis will cost $47,400 per year, its developer, Madrigal Pharmaceuticals, said Thursday. Madrigal revealed the price and launch plan for Rezdiffra on a conference call discussing the decision by the Food and Drug Administration to approve the medicine. Rezdiffra is the first available therapy for MASH, a disease caused…
The Food and Drug Administration has approved the first medicine for a common liver disease that’s been a top target of drugmakers over the last decade. The drug, known as Rezdiffra and developed by biotechnology company Madrigal Pharmaceuticals, was given an accelerated clearance on Thursday for use in adults with metabolic dysfunction-associated steatohepatitis, or MASH. The…
Dive Brief: AstraZeneca is bolstering its rare disease division with the purchase of Amolyt Pharma, an endocrine disease specialist backed by Novo Holdings. Under the deal announced Thursday, AstraZeneca will pay Amolyt shareholders $800 million in cash up front, with the potential for another $250 million for reaching a specific regulatory milestone. The companies expect…
Two cellular medicines for multiple myeloma were associated with an increased risk of early death in clinical testing, raising questions about whether they should be earlier in a patient’s disease, Food and Drug Administration scientists wrote in a briefing document published on Wednesday. On Friday, the FDA will convene a panel of experts to discuss…
Dive Brief: IFM Therapeutics, a biotechnology startup developing drugs that target a part of the immune system, said Wednesday Novartis exercised an option to buy its IFM Due subsidiary for $90 million upfront and as much as $745 million in milestone payments. The deal caps a partnership formed in 2019, when Novartis agreed to fund…
Allogene Therapeutics is turning to gene editing startup Arbor Biotechnologies for help developing “off-the-shelf” cell therapies for autoimmune diseases, the companies said Tuesday. Allogene has been a longtime leader in the push to make cellular medicines known as “allogeneic” CAR-T therapies. These treatments are derived from the cells of donors and seen as more convenient…
Boehringer Ingelheim has formed a partnership with Sosei Heptares in a deal aimed at developing a new type of schizophrenia medicine, the companies announced Monday. Through the partnership, the two companies will work together to advance a portfolio of medicines that focus on GPR52, a protein receptor that’s surfaced as a potential drug target in…
Dive Brief: Roche’s experimental Alzheimer’s disease drug trontinemab showed “best-in-class” potential based on its ability to quickly clear clumps of amyloid protein from the brains of patients enrolled in a small clinical trial, the company said Monday. A majority of patients receiving the highest dose of the drug, which is specially designed to penetrate brain…
Rare diseases, once a miniscule chapter in the pharma playbook, have become a major focus for even the biggest companies in the world. From 5% of new drugs in the late 1980s to 43% in 2023, rare disease treatments comprise a rapidly growing sector of the overall pipeline. Dr. Katie Abouzahr, vice president, autoantibody portfolio…
Dive Brief: President Biden is taking on a bipartisan bogeyman ahead of a critical State of the Union speech, targeting the pharmaceutical industry and saying he will work to expand the government’s power to lower drug prices. In a fact sheet released Wednesday, the White House said Medicare should be allowed to negotiate prices for…
Dive Brief: An experimental pill developed by Novo Nordisk helped obese people lose 13% of their body weight after three months of treatment in a small clinical trial, the company said Thursday, in a result one analyst described as among the best of any weight loss drug tested so far. The drug, called amycretin, is…
Cigna is moving to limit how much health insurance providers and employers have to pay for pricey and in-demand obesity medications. The insurer plans to cap annual price increases for the drugs, called GLP-1 receptor agonists, at 15% for employers and plans participating in a weight loss management program offered by its pharmacy benefit manager….
Dive Brief: The Food and Drug Administration is delaying an approval decision on Eli Lilly’s experimental medicine for Alzheimer’s disease so it can hold an advisory committee meeting to more closely scrutinize the drug’s safety and effectiveness, the company said Friday. According to Lilly, the FDA wants more input on the “unique” design of the…
The Food and Drug Administration has expanded the label for Novo Nordisk’s fast-selling weight loss drug Wegovy following study results that proved the medicine can protect heart health. The agency on Friday approved use of Wegovy to reduce the risk of heart attacks, strokes or death in people with cardiovascular disease and who are either…
A large clinical trial meant to confirm the benefits of a new ALS medication has instead failed, dealing a major blow to the therapy’s developer as well as patients who had hung their hopes on it. Amylyx Pharmaceuticals disclosed Friday morning that the drug, known as Relyvrio in the U.S., didn’t meet the trial’s main…
A Boston-based biotechnology company on Thursday said its most advanced drug showed positive effects in a clinical trial of Parkinson’s disease patients, results that at least one analyst believes could help validate another, similar therapy. The company, NodThera, said that over the course of four weeks, patients given its drug experienced reductions in “key” biological…
Boundless Bio, an oncology startup backed by Bayer and Arch Venture Partners, on Wednesday became the first biotechnology company to file for an initial public offering since late January. The San Diego biotech, which has raised $254 million across three private fundraising rounds, aims to use the proceeds to advance a pipeline of medicines for…
Dive Brief: Barcelona-based venture capital firm Invivo Partners is preparing to close an expected fund of 100 million euros, or $109 million, the third since its formation. In a LinkedIn post on Tuesday, managing partner Luis Pareras said the firm anticipates closing the new fund, which has a hard cap of 120 million euros, “in…
Dive Brief: Sionna Therapeutics, a Waltham, Massachusetts biotechnology startup, announced Wednesday it raised a $182 million Series C round to advance a group of experimental drugs for cystic fibrosis. Founded in 2019 and incubated by investment firm RA Capital, the company aims to challenge Vertex Pharmaceuticals’ market-leading cystic fibrosis business. The company has five drugs…
Dive Brief: An experimental RNA-based medicine developed by Alnylam Pharmaceuticals, when added to standard drugs, helped lower blood pressure significantly more than a placebo in a Phase 2 trial of people with uncontrolled hypertension, the company said Tuesday. The drug, zilebesiran, succeeded in an earlier mid-stage trial last year evaluating multiple doses of the therapy….
After more than two years in the doldrums, initial public offerings, an important indicator of the biotechnology industry’s health, have shown signs of life. A run of offerings in the first six weeks of 2024, most worth around $100 million or more, has put the sector on its strongest pace since 2021. Those IPOs, combined…
Investors have poured $62 million into a biotechnology startup developing a drug to treat chronic cough. Nocion Therapeutics, headquartered in Watertown, Massachusetts, announced Monday it completed a Series B fundraise that was co-led by Arkin Bio Capital and Monograph Capital and included participation from Canaan Partners, F-Prime Capital and others. The company has now raised…
Dive Brief: BridgeBio Pharma is licensing some of the rights to a closely watched experimental medicine for a rare heart condition, agreeing on Monday to a partnership with German pharmaceutical giant Bayer. Per deal terms, BridgeBio will receive $310 million in upfront and near-term payments for rights in Europe to the drug, which is known…
Dive Brief: Abingworth, a venture capital group owned by Carlyle, will invest as much as $210 million to help Gilead Sciences further expand the approved usage of the cancer drug Trodelvy. Trodelvy has been approved in the U.S. since April 2020 to treat breast cancer. Gilead acquired the therapy as part of its $21 billion takeover…
A good track record can be valuable in the uncertain and risky world of drug development. For a group of life sciences investors, it’s worth at least some part of the $100 million they’ve invested in biotechnology startup BlossomHill Therapeutics. BlossomHill, which announced the Series B funding on Thursday, was started by J. Jean Cui…
Advisers to the Centers for Disease Control and Prevention are weighing updates to their recommendation older adults get vaccinated for respiratory syncytial virus, discussing changes at a meeting Thursday that would more forcefully encourage some individuals receive a shot. At the meeting, the Advisory Committee on Immunization Practices reviewed safety and efficacy data on RSV…
Dive Brief: Cancer drug developer FogPharma has raised $145 million in fresh funding, the company revealed Friday, announcing a Series E round that will give a financial boost to the nearly decade-old biotechnology company. The funding will support development of FOG-001, FogPharma’s most advanced drug candidate, which is designed to target a protein known as…
Pfizer believes the answer to its sliding valuation lies in oncology. The company, which is coming off one of the worst years in its history, unveiled on Thursday a new business unit dedicated to cancer research. The division, created in the wake of Pfizer’s $43 billion buyout of Seagen last year, houses a sprawling portfolio…
Gritstone Bio will lay off about 40% of its workforce after missing out on funding it expected to receive this quarter, the company said Thursday. Gritstone, a maker of vaccines for cancer and infectious diseases, is developing a COVID-19 shot with the help of the U.S. government. In September, the Biomedical Advanced Research and Development…
Kenai Therapeutics, a San Diego-based biotechnology company, has raised $82 million to support its work developing cell therapies for nervous system disorders. Cure Ventures, a new venture capital firm founded by three longtime biotech investors, co-led the Series A round announced Thursday, alongside Alaska Permanent Fund Corporation and The Column Group. The investment is the…
Dive Brief: ObsEva, a women’s health drug developer, on Wednesday said it plans to wind down its business and let go of all its employees. The company notified the Swiss stock exchange that it might not have the resources to put together its financial statements for 2023, nor maintain its listing. In January, the company…
An Australian-based biotechnology company says a mid-stage clinical trial has shown that psilocybin, a psychedelic compound found in many mushroom species, helped people with generalized anxiety disorder. The trial recruited 73 participants, giving some psilocybin and others placebos, though they all received psychotherapy. According to Incannex Healthcare, whose work focuses on cannabinoid and psychedelic medicine,…
Ginkgo Bioworks has acquired a biotechnology startup co-founded by gene editing pioneer Feng Zhang, part of the cell engineering company’s plan to build up technologies that can help other companies make genetic medicines. Through the deal announced Wednesday, Ginkgo will acquire Proof Diagnostics, a biotech Zhang formed in 2020 to develop a fast- low-cost test…
Dive Brief: An experimental weight loss drug developed by Viking Therapeutics helped overweight and obese people lose up to 15% of their body weight after 13 weeks of treatment in a mid-stage trial, the company said Tuesday. The drug, a potential rival to Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy, led to greater weight loss…
Dive Brief: GSK said Monday that its oral antibiotic succeeded in a late-stage trial in gonorrhea, proving to be as effective as an existing treatment for the infection. According to GSK, the drug, known as gepotidacin, was non-inferior to a commonly used regimen consisting of the injectable drug ceftriaxone and the pill azithromycin. The summary results…
Dive Brief: The Food and Drug Administration on Saturday approved Alvotech and Teva Pharmaceuticals’ Simlandi, a biosimilar of the most popular version of AbbVie’s rheumatoid arthritis drug Humira. The drug, which can be directly substituted by a pharmacist, was rejected by the FDA twice before due to manufacturing issues at a plant in Iceland. The…
The creativity and expertise of the researchers, technicians and assistants working in healthcare and biopharmaceutical laboratories are critical for every investigation’s success. If a lab is to generate groundbreaking results, principal investigators (PIs) and lab managers must find, hire and retain the right people. To do this, they’ll need to transform their laboratories into innovative…
ORI Capital, the China- and U.S.-based venture investor behind the biotechnology sector’s largest initial public offering this year, has raised a new life sciences fund, the firm said Thursday. The $260 million fund is the second for ORI since the firm was launched in 2015 by Simone Song, formerly the head of health banking for…
Dive Brief: Novavax will pay as much as $475 million to settle a dispute with Gavi, the Vaccine Alliance over an advance purchase agreement for COVID-19 vaccines. The Gaithersburg, Maryland-based biotech paid Gavi $75 million upfront and is on the hook for an additional $80 million a year for five years, according to the deal…
Dive Brief: Moderna shares rose by as much as 10% Thursday morning after the COVID-19 vaccine developer reported fourth quarter profit that beat Wall Street expectations of a net loss during the final three months of 2023. Full-year sales of $6.7 billion matched estimated numbers Moderna disclosed in January, but were down by about two-thirds…
Dive Brief: BioMarin Pharmaceutical is struggling to sell the first marketed gene therapy for the most common form of hemophilia, announcing on Thursday minimal revenue from the treatment, called Roctavian. In its latest earnings report, BioMarin said Roctavian generated $2.7 million in sales during the fourth quarter and $3.5 million in all of 2023, as…
Dive Brief: The European Medicine Agency’s main drug review committee on Friday supported expanding the approval of Johnson & Johnson and Legend Biotech’s cell therapy Carvykti for earlier treatment of multiple myeloma. The Committee for Medicinal Products for Human Use recommended Carvykti be used in people with relapsed and refractory multiple myeloma who have received at…
The Biden Administration, through the Advanced Research Projects Agency for Health, has committed to invest $100 million into women’s health research, First Lady Jill Biden announced Wednesday. The investment is part of the White House Initiative on Women’s Health Research, launched by Jill Biden last year to draw forth more funding to women’s health research…
Biotechnology startup Frontier Medicines has pulled in $80 million in new funding to support a targeted cancer drug the company thinks might address some of the limitations of medicines from Amgen and Mirati Therapeutics. The company on Thursday announced a Series C round co-led by Deerfield Management and Droia Ventures and that included “significant” participation…
Infectious disease drug developer Vir Biotechnology on Tuesday disclosed that chief medical officer Phil Pang is stepping down from his role to spend more time with his family. Pang will leave at the end of March, and Vir is now looking for his successor. “Phil has served as a formidable leader at Vir, where he…
A new research paper offers the most thorough look yet at a study that sparked the drug industry’s recent experimentation with cell therapy for autoimmune diseases. The paper, which was published in The New England Journal of Medicine on Wednesday, comes from a team of scientists at the Friedrich Alexander University, Erlangen-Nurnberg in Germany. They…
Dive Brief: AstraZeneca’s targeted cancer therapy Tagrisso can now be used alongside chemotherapy to treat a common type of locally advanced or metastatic lung tumor, following a Food and Drug Administration approval Friday. The FDA cleared Tagrisso together with chemotherapy based on results showing the combination reduced the risk of disease progression or death versus…
Dive Brief: Shares of Rapt Therapeutics fell sharply Tuesday after the company disclosed U.S. regulators ordered a halt of two studies testing a drug the biotechnology company is developing for eczema and asthma. The clinical hold is due to a serious adverse event of liver failure in one of the trial participants. While the cause…
Lisa Benincosa is senior vice president of clinical pharmacology strategy at the specialized Clinical Research Organization (CRO), Allucent. Here she discusses how she and her team leverage the power of data to help sponsors optimize decision-making and create efficiencies across the drug development continuum – to drive value for their small and mid-sized biotech partners,…
Quercetina: Flavonoidul puternic cu beneficii Quercetina, un flavonoid natural care se găsește din abundență în diferite fructe, legume, cereale și frunze, a apărut ca un superstar în domeniul științei nutriționale și al medicinei alternative. Acest compus bioactiv puternic se mândrește cu o gamă largă de beneficii pentru sănătate, variind de la proprietăți antioxidante și antiinflamatorii…
Dive Brief: Firefly Bio, a startup working to develop a new kind of cancer medicine, announced Thursday it had raised $94 million in venture funding. The California-based company is putting a spin on antibody-drug conjugates, or ADCs, by merging them with technology that can degrade proteins. Essentially, Firefly aims to marry the targeting strengths of…
Dive Brief: Aurinia Pharmaceuticals will restructure its operations and give money back to shareholders after failing to find a buyer willing to take over the company. Investors can expect a buyback of as much as $150 million worth of stock, Aurinia said Thursday. The company is also planning to downsize, resulting in what it expects…
Astellas Pharma is delving deeper into cell therapies for cancer, announcing Thursday a research deal to develop a pair of treatments with the help of Boston-based biotechnology startup Kelonia Therapeutics. Through the deal, the two companies will combine their respective technologies to develop medicines that introduce a gene to immune cells, modifying them inside the…
Gilead Sciences is evaluating the future of a cancer drug acquired in a multibillion-dollar deal following a new setback the company reported late Thursday. In a statement, Gilead said it paused enrollment in four mid-stage trials of the drug, known as magrolimab, in different types of solid tumors. The Food and Drug Administration subsequently ordered…
Dive Brief: The Food and Drug Administration will decide by June 21 whether to loosen the restrictions surrounding use of Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy, the company said Friday Sarepta’s gene therapy, Elevidys, was granted a conditional OK last June for children between 4 and 5 years of age who have Duchenne…
Dive Brief: An experimental drug being developed by Denali Therapeutics and partner Sanofi for ALS failed to meet its goal in a Phase 2 trial, the biotechnology company disclosed Thursday via a regulatory filing. The trial, dubbed Himalaya, tested the companies’ drug on a rating scale known as the ALSFRS-R, which measures physical functions like…
Intellia Therapeutics will work with a private biotechnology company to develop genetic medicines for cystic fibrosis, with an initial focus on people who have limited or no available treatment options. The collaboration pairs Intellia’s gene editing platform, which is based on Nobel Prize-winning CRISPR technology, with ReCode Therapeutics’ method for delivering genetic medicines to specific…
Dive Brief: Alnylam Pharmaceuticals is delaying the readout of a closely watched Phase 3 trial in the heart disease transthyretin amyloidosis with cardiomyopathy, revealing Thursday changes to the study’s plan. In a quarterly earnings report, Alnylam said it updated the primary and secondary goals of the trial, called HELIOS-B, and extended it by three months….
Dive Brief: The Food and Drug Administration has approved a new regimen for pancreatic cancer, clearing Ipsen’s Onivyde to be used with chemotherapy in treating recently diagnosed metastatic tumors, the company announced Tuesday. Onivyde, which Ipsen bought from Merrimack Pharmaceuticals seven years ago, has been available for second-line use in pancreatic cancer, after tumor progression….
Sage Therapeutics said its new medicine, the first oral treatment for postpartum depression, is off to an encouraging start, with signs of demand from prescribing doctors. Sage and partner Biogen began selling the drug, Zurzuvae, in mid-December and on Wednesday Sage shared the first data from an estimated 10 days when doctors’ offices were open…
A little over four years ago, biotechnology giant Amgen retreated from neuroscience research, halting much of its work developing treatments for diseases of the brain and trimming associated staff. Amgen’s pivot proved a boon for a small startup that was then just getting started in the big drugmaker’s backyard. Latigo Biotherapeutics, which, like Amgen, is…
Dive Brief: Biotechnology startup BioAge Labs has raised $170 million to support an experimental pill it plans to test alongside popular weight-loss drugs like Wegovy and Zepbound, the company announced Tuesday. The Series D funding was led by Sofinnova Investments and includes participation from the venture arms of Amgen and Eli Lilly, both of which…
Dive Brief: An experimental pill developed by KalVista Pharmaceuticals succeeded in a Phase 3 trial, giving the drug a chance to become the first oral “on-demand” treatment for people with the rare swelling disorder hereditary angioedema. In a statement Tuesday, KalVista said the drug, sebetralstat, met the study’s main and secondary goals, reducing the severity…
Six biotechnology startups are merging into a new skin drug developer called Alys Pharmaceuticals, which launched on Monday with $100 million from European life sciences investment firm Medicxi. Alys was formed out of the merger of a group of biotechs hatched in recent years by Medicxi: Granular Therapeutics, Aldena Therapeutics, Nira Biosciences, Graegis Pharmaceuticals and…
As life sciences and pharma services companies forge ahead in 2024, they find themselves at a critical juncture―realizing unparalleled opportunities while managing market challenges. Many leaders have or are asking themselves, “Should we cut costs in our commercial teams? Will we cut too deep and miss the next wave of profitable growth?” The challenge is…
Amgen is a global pharmaceutical company worth more than $160 billion. Nine of its marketed medicines are blockbuster products by annual sales. Yet, on a Tuesday conference call discussing Amgen’s fourth quarter earnings, all Wall Street analysts wanted to talk about was an experimental drug that only just cleared the first stage of human testing….
BioNTech will pay $50 million and make a $200 million investment in Autolus Therapeutics as the company most famous for its COVID-19 vaccine boosts its cell therapy capabilities. Per deal terms, BioNTech will receive royalties on sales of Autolus’ obe-cel, a CAR-T therapy for leukemia that the Food and Drug Administration could approve by Nov….
Dive Brief: Neurona Therapeutics, a San Francisco-based biotechnology company, has raised another $120 million to fuel its research into cell therapies for brain diseases. Neurona plans to use the money to continue developing a slate of experimental, “off-the-shelf” cell therapies. The company’s most advanced medicine is in an small, open-label study evaluating it as a…
Biotechnology initial public offerings are showing sustained signs of life for the first time in two years, and Kyverna Therapeutics’ larger-than-expected raise on Wednesday is the latest example. The company, a developer of “CAR-T” cell therapies for autoimmune diseases, brought in $319 million, beating its initial projections. The offering is the sector’s fourth richest IPO…
Takeda Pharmaceutical plans to quickly begin late-stage testing of an experimental drug for narcolepsy, which, if successful, could help the company enter what Wall Street analysts see as a multibillion-dollar market. There are two kinds of narcolepsy, with a key difference being that “Type 1” can involve a sudden loss of muscle control. Takeda has…
Dive Brief: Metagenomi, a gene editing startup spun out of research at the University of California, Berkeley, brought in about $93.8 million in the biotechnology sector’s sixth initial public offering of the year. The company on Thursday sold 6.25 million shares at $15 apiece, matching the estimates it set earlier this week. The offering will fund…
The CEOs of three major drugmakers defended the prices they charge U.S. patients in a Senate committee hearing Thursday, claiming Americans gain access to cutting-edge medicines months or years earlier than people in countries that pay a fraction of the U.S. costs. Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders, I-Vt., and his…
Dive Brief: Kyverna Therapeutics raised $319 million in a larger-than-expected initial public offering Thursday, adding to an early, but notable, upturn in investor demand for new biotech stock issuances. The company, a developer of cell therapies for autoimmune diseases, sold 14.5 million shares at $22 apiece, significantly beating projections it set earlier this week. The…
Dive Brief: BridgeBio Pharma is selling partial rights to an experimental drug for a common form of dwarfism to Japanese pharmaceutical company Kyowa Kirin, the companies announced Wednesday. Per deal terms, BridgeBio affiliate QED Therapeutics will grant Kyowa Kirin rights in Japan to a therapy known as infigratinib that is in Phase 3 testing. BridgeBio…
Dive Brief: Scion Life Sciences on Wednesday made its debut as a venture firm, announcing the close of a $310 million fund to invest in new biotechnology startups. Led by a trio of biotech veterans with experience at firms like Apple Tree Partners and Medicxi, Scion plans to focus initially on backing a half-dozen life…
Sales of Eli Lilly’s diabetes drug Mounjaro exceeded $5 billion in 2023, its first full year on the market, the company said Tuesday, in the latest sign of surging demand for the therapy and other medicines of its kind. Mounjaro’s fast launch helped drive Lilly’s revenue last year to $34 billion, a 20% increase over…
To hear venture capitalist Alex Morgan tell it, investors shouldn’t be in the business of predicting trends. “There’s often a public perception that we’re in the prediction game,” said Morgan, a partner at Khosla Ventures who oversees the firm’s biotechnology investments. “We’re not trying to be. As an early-stage venture investor, we’re trying to imagine…
Novo Holdings, the controlling shareholder of Danish drugmaker Novo Nordisk, will buy contract manufacturer Catalent for $16.5 billion in a take-private deal the companies announced Monday. In a related transaction, Novo Nordisk has agreed pay its parent company $11 billion to take over three Catalent plants in Italy, Belgium and Indiana to help expand production…
In 2021, the Food and Drug Administration for the first time approved a medicine meant to slow the progression of Alzheimer’s disease. Developed by partners Biogen and Eisai, the medicine, called Aduhelm, was viewed initially as a needed new treatment option by patients and a potential blockbuster product by Wall Street analysts. Now, less than…
Dive Brief: The gene therapy company Avrobio agreed to a reverse merger with startup Tectonic Therapeutic after years of struggling with clinical setbacks and a tough financing market for the biotechnology industry. Avrobio investors will likely end up with about 22% of the combined company, while pre-merger Tectonic stockholders will own about 40%, according to…
Roche is reshaping its early-stage pipeline of experimental drugs, jettisoning eight drug candidates in neurological conditions and oncology as it makes room for a set of obesity treatments it gained with its $2.7 billion acquisition of Carmot Therapeutics. The Swiss drugmaker is dropping two Alzheimer’s drugs, including the longtime asset crenezumab; a drug it had tested…
Dive Brief: Protagonist Therapeutics, a biotechnology company focused on peptide drugs, is teaming up with Takeda Pharmaceutical on an experimental, injectable medicine for a rare blood disorder. Per terms of the deal announced Wednesday, Takeda will pay Protagonist $300 million upfront as well as royalties and extra cash for reaching certain milestones. In exchange, the…
Merck & Co. plans to continue seeking out multibillion-dollar biotechnology deals to supplement its own drug research as it prepares for its dominant cancer immunotherapy Keytruda to lose patent protection later this decade. Merck, which earns about half of its pharmaceutical sales from Keytruda, has struck several notable acquisitions in recent years, including an $11…
Arch Venture Partners, one of the biotechnology sector’s most prolific company creators, is raising a new $3 billion fund, according to a regulatory filing. The fund, which would be Arch’s 13th, is being put together less than two years after the firm closed a similar-sized $3 billion raise that was its largest to date. Plans…
Another biotechnology company has hit Wall Street via an initial public offering, the third to do so this year in an uptick of IPO activity that suggests rebounding investor interest in life sciences stocks. Alto Neuroscience raised about $129 million on Thursday, selling 8,040,000 shares at $16 apiece. The company’s stock will trade on the…
Nestlé veteran François-Xavier Roger will succeed Sanofi chief financial officer Jean-Baptiste Chasseloup de Chatillon on April 1, the French pharmaceutical company said Thursday alongside fourth quarter earnings. Chatillon will be step down from his post to become head of Apprentis d’Auteuil, a foundation that supports adolescents with education and training programs. Chatillon has been Sanofi’s…
The U.S. government will test whether centrally coordinating insurance coverage can help people with sickle cell disease access expensive new gene therapies for the inherited blood condition. Two such treatments were recently approved by the Food and Drug Administration after testing showed they can eliminate the crises of pain people with severe sickle cell often…
GSK on Wednesday reported higher-than-expected sales of its RSV vaccine Arexvy, providing further evidence of the product’s strong uptake. The shot brought in 1.2 billion pounds, or about $1.5 billion, last year, notably higher than the range of 900,000 to 1 billion pounds GSK previously forecast. The company’s fourth quarter earnings report showed its vaccine…
Dive Brief: Biotechnology startup Cour Pharmaceuticals has raised $105 million to advance a portfolio of medicines for autoimmune diseases. The startup’s funding was co-led by Alpha Wave Ventures and Lumira Ventures and involved large drugmakers Roche, Pfizer and Bristol Myers Squibb. The cash will support Cour’s plans to develop nanoparticle drugs that can “reprogram” the…
Dive Brief: Gilead has bought a bigger stake in cancer drug developer Arcus Biosciences, announcing Monday it will spend $320 million to own 33% of the company and help speed development of an experimental immunotherapy. With the transaction, the two companies committed to accelerating two trials of Arcus’ drug domvanalimab, which targets a protein called…
The clue came, as they often do, from an unexpected source. Some sixteen months ago, a small study of five people in Germany pointed to a new direction for the high-profile field of cell therapy. The study showed a cellular medicine could drive a tough-to-treat form of lupus into remission. While early, the finding suggested…
Dive Brief: An experimental, under-the-skin shot of Bristol Myers Squibb’s immunotherapy Opdivo appeared to work similarly to the approved, intravenous version of the drug, shrinking kidney tumors at an equivalent rate, the company said Saturday. The subcutaneous shot also had a similar side effect profile, with about 7% of patients receiving either version experiencing a…
Johnson & Johnson CEO Joaquin Duato sold 2023 as a “remarkable year” on an earnings call with investors Tuesday. But the pharmaceutical giant faces looming difficulties that hang over its performance, including incoming biosimilar competition to its blockbuster immune drug Stelara and a $700 million settlement over claims the company’s talc product caused cancer. As…
Dive Brief: Novo Nordisk is adding yet another prospect to its obesity drug pipeline, this time from a biotech company spun out of Harvard University and Zurich University. · EraCal Therapeutics tests compounds in larval zebrafish in a bid to trigger behavioral changes related to appetite while minimizing other effects in the body. The Swiss…
After a rocky year that featured a restructuring, job cuts and the resignation of its CFO, BenevolentAI is looking to the future by tapping a Bayer veteran as its new CEO. Joerg Moeller, most recently the research and development chief at Leo Pharma, spent about 20 years at Bayer earlier in his career, finishing his…
Radiopharmaceutical drugmaker RayzeBio drew interest from two other large drugmakers before agreeing to a $4.1 billion buyout by Bristol Myers Squibb, newly published documents show. The companies, which were not identified in the documents RayzeBio filed with regulators Thursday, both submitted proposals to acquire RayzeBio, but were outbid by Bristol Myers. The new details are…
European authorities are set to rescind the approval of a Duchenne muscular dystrophy drug that’s been on the market there for nearly a decade following evidence the medicine, Translarna, doesn’t appear to help people with the condition. In a statement Friday, the European Medicines Agency’s drugs committee recommended for the second time against renewing the…
Dive Brief: Bristol Myers Squibb’s cell therapy for multiple myeloma, Abecma, should be approved for use in patients whose disease has progressed following two standard treatments, the European Medicines Agency’s drugs committee said Thursday. Once the European Commission ratifies the decision, Abecma would be cleared for earlier use. The treatment is currently only available after…
Dive Brief: ArriVent Biopharma is the second biotechnology company to go public this year, raising $175 million in an initial public offering Thursday that will support development of an experimental lung cancer drug. The company sold 9,722,222 shares at $18 apiece, surpassing projections set earlier this week. The bulk of that cash will go towards…
The Food and Drug Administration this week convened a group of experts to discuss ways to develop new drugs for preventing spontaneous early births, a major health concern for which there are no good treatments. At the two-day workshop led by the FDA and and the Duke-Margolis Center for Health Policy, experts in maternal and…
Cancer drug developer CG Oncology has raised $380 million in an initial public offering than was larger than it expected, a positive sign for a sector that’s struggled to generate demand from Wall Street investors recently. The company on Wednesday sold 20 million shares in its offering — eight million more than it had expected — at…
An 11-year-old boy who was born deaf can hear after receiving an experimental gene therapy, developer Eli Lilly reported on Tuesday. The boy, identified as Aissam Dam by The New York Times, was the first participant treated in a small study Lilly is running to test the therapy, which is designed to correct a particular…
Sanofi on Tuesday said it will acquire San Diego biotechnology company Inhibrx in a complex deal that could be worth up to $2.2 billion. The focus of the deal is an experimental drug Inhibrx is developing for a rare lung disease known as alpha-1 antitrypsin deficiency. Sanofi will acquire the drug via a buyout of…
Dive Brief: The makers of CAR-T cell therapies will need to warn about the risk of new blood cancer, the Food and Drug Administration said, following a review of reports involving so-called T cell malignancies following their use. In Jan. 19 letters to the manufacturers of six CAR-T therapies, the FDA said the prescribing information…
Dive Brief: Coherus Biosciences on Monday said it has agreed to sell its approved biosimilar Cimerli, along with supporting staff, to Sandoz for $170 million in cash. The deal will send to Sandoz, which in October spun out of Novartis as a standalone generic drugmaker, Cimerli’s license and product inventory as well as sales and…
Dive Brief: Gilead Sciences on Monday said its cancer drug Trodelvy missed the main goal of a Phase 3 trial in lung cancer, failing to help keep patients alive longer than chemotherapy after their disease had progressed on earlier lines of treatment. In a statement, Gilead said Trodelvy-treated patients had a “numerical improvement” in survival…
As part of a makeover promised last year, Bayer is beginning a process of staff reductions that aims to slice through the bureaucracy CEO Bill Anderson blames for the company’s sluggish performance. The German conglomerate said it can’t give a figure for the total reduction in headcount but made clear that the layoffs will be…
BridgeBio Pharma has agreed to sell future royalties on an experimental rare disease drug in exchange for $500 million if the medicine, called acoramidis, receives Food and Drug Administration approval. The financing was extended by asset manager Blue Owl Capital and the investment board that manages the Canada Pension Plan, which together would receive 5%…
Five years ago this month, Takeda Pharmaceuticals completed a $62 billion acquisition of Shire — one of the largest deals in pharmaceutical industry history. The anniversary has resurfaced scrutiny over the buyout’s value and mixed results. The addition of Shire grew the footprint of Japan’s largest pharma, helping it expand into European and U.S. markets….
Biotechnology company Ikena Oncology on Thursday said it would lay off staff and reallocate resources toward two experimental cancer drugs. The oncology company is prioritizing the two candidates, dubbed IK-930 and IK-595, over its drug discovery work. As a result, it will trim 35% of its workforce, or about 20 employees, by the end of…
A Congressional committee may subpoena the CEOs of Johnson & Johnson and Merck & Co. to testify about the differences between the costs of their drugs in the U.S. compared to other countries. The statement from Sen. Bernie Sanders, I-VT, the chair of the Senate Health, Education, Labor and Pensions Committee, follows a vote to invite…
A radiopharmaceutical drug from Novartis kept a rare type of neuroendocrine cancer at bay for longer than did standard therapy, according to detailed clinical trial results unveiled by the Swiss drugmaker on Friday. Adding the drug, sold by Novartis as Lutathera, to a high-dose hormonal therapy called octreotide cut the risk of disease progression or…
Jaguar Gene Therapy is spinning out part of its business to handle the specialized work of manufacturing cell and gene therapies, launching Wednesday a new company called Advanced Medicine Partners. The spinout, which is backed by investors Deerfield Management, Arch Venture Partners and others, will provide manufacturing support to Jaguar as well as Deerfield-backed companies….
Mirae Asset Capital Life Science, a new venture capital fund, launched on Thursday, joining several other new firms that have recently emerged with plans to invest in drug startups. The fund is a spinout of Mirae Asset Financial Group, a global investment firm headquartered in South Korea that has previously backed young biotechnology companies such…
Dive Brief: Kyverna Therapeutics on Tuesday revealed plans to go public, testing the waters in a biotechnology market that hasn’t fully recovered from a downturn that started in 2021. The offering would fund Kyverna’s cell therapy work, which is led by an experimental lupus treatment that the company licensed from the National Institutes of Health…
Dive Brief: Massachusetts-based startup Comanche BioPharma has raised $75 million in new venture funding to advance an experimental treatment targeting a cause of the pregnancy-related condition preeclampsia. Preeclampsia involves sudden blood pressure spikes that can lead to serious complications for both the mother and fetus. Comanche’s RNA-based drug is designed to mute overproduction of a…
The Food and Drug Administration on Tuesday approved Vertex Pharmaceuticals’ CRISPR-based medicine Casgevy for the inherited blood condition beta thalassemia, expanding its use six weeks after issuing a landmark clearance in sickle cell disease. The agency’s decision makes Casgevy, which in December became the first CRISPR gene editing therapy to reach the U.S. market, available for…
Guarded optimism seems to be the mood of the biopharmaceutical industry to start 2024. Last year brought a stock market slide and layoffs for more than 150 drug companies. Financial and regulatory headwinds, like the March collapse of Silicon Valley Bank and a more strident Federal Trade Commission, further weighed on the sector. There are…
Over the span of five months, biotechnology startup Aiolos Bio launched, raised initial funding from venture investors and negotiated a $1 billion buyout by GSK. The acquisition, announced by GSK on Tuesday, marks a rapid return on investment for Aiolos’ blue-chip backers, which included Atlas Venture and Bain Capital Life Sciences. They could receive up…
The J.P. Morgan Healthcare Conference, a yearly temperature taker for the biotechnology industry, had a different feel in 2024. For the first time in awhile, young drugmakers and their backers were optimistic the sector’s downturn might finally be over. An improving macroeconomic picture, combined with a recent run of dealmaking, has led many to hope…
Dive Brief: The use of GLP-1-based drugs to treat obesity and diabetes has no “clear relationship” with the risk of suicidal thoughts or actions, the Food and Drug Administration said Thursday after completing a review of reports in its adverse events reporting system and clinical trial data. Regulators plan on continuing to evaluate suicide risk…
Chris Gibson, the CEO of Recursion Pharmaceuticals, thinks the future of drug discovery lies within a ChatGPT-like interface. At a J.P. Morgan Healthcare Conference reception co-hosted with Nvidia, the tech giant now making inroads with biotechnology investment, the Salt Lake City-based company set out to pitch biotechs small and large on its artificial intelligence software….
A group of high-profile scientists and billionaire financiers are building a new biomedical research institute that they claim will offer a new model for studying disease biology and developing new drugs. Arena BioWorks, which publicly launched Friday, is led by Stuart Schreiber, a co-founder of the Broad Institute of MIT and Harvard who’s helped start…
European regulators will seek outside advice before making a decision on approval of Eisai and Biogen’s Leqembi medicine for Alzheimer’s disease. The Committee for Medicinal Products for Human Use opted to convene a meeting of a scientific advisory group, which should take place before the end of March, the Japanese drugmaker said Thursday. Much like…
Dive Brief: The number and amount of biotechnology financings dipped in 2023, with venture firms investing 25% fewer dollars in companies compared to the year prior, according to new quarterly data released Thursday from Pitchbook and the National Venture Capital Association. Venture capital firms are increasingly investing in later-stage drug companies, which accounted for about…
The mood shifts on the third day of the J.P. Morgan Healthcare Conference. Deals have been announced and news peters out. The most closely-watched companies have already presented. Investors and executives are worn down from two frenzied days of meetings. Many fly back home, thinning the previously packed sidewalks of Union Square. But every minute…
The arrival of powerful new drugs for obesity has reshaped the pharmaceutical industry, transforming Eli Lilly and Novo Nordisk into the sector’s most valuable companies and sending others scrambling to catch up. Analysts predict that so-called GLP-1 drugs like Lilly’s Zepbound and Novo’s Ozempic will become some of the most lucrative products ever sold. Their…
Biotechnology’s embrace of artificial intelligence was never more literal than Tuesday at the J.P. Morgan Healthcare Conference, when AI drug discovery specialist Recursion handed out umbrellas in front the Westin St. Francis to combat the inevitable San Francisco rain. AI, and its role in drug development, has been a major topic of discussion at the…
For the first time, the Food and Drug Administration has authorized a U.S. state to import prescription drugs from Canada, granting Florida preliminary clearance to bulk purchase medicines from wholesalers there. The decision is a major policy shift for the agency, which has long resisted drug importation efforts on grounds that it couldn’t ensure the…
A California-based company has raised tens of millions of dollars to support its mission of bringing an ecstasy-based therapy to patients with post-traumatic stress disorder. MAPS Public Benefit Corp. formed a decade ago as a subsidiary of the Multidisciplinary Association for Psychedelic Studies, a nonprofit that both researches and promotes the use of psychedelics for…
Dive Brief: Allogene Therapeutics, a leading developer of “off-the-shelf” cell therapies for cancer, will deprioritize two of its most advanced clinical trials as part of a new plan to improve on other cell-based medicines. The biotechnology company is dialing back work on a pair of studies that were designed to support approval of its therapy,…
CRISPR specialist Intellia Therapeutics on Thursday said it will lay off about 15% of its workforce as it pauses some early-stage research. The cuts come a little over three months after Intellia, one of the first companies founded to turn the gene editing technology into medicines, received a green light from U.S. regulators to begin…
Biotechnology is often described as an “innovation” industry, dependent on companies’ ability to invent and develop new medicines. By that metric, 2023 was a good year. The FDA’s main review office approved 55 novel drugs, the most since 2018, while the agency’s biologics division cleared 15 more. The clearances offer some counterbalance to a prolonged…
Dive Brief: Canada’s health regulators have approved Pfizer’s gene therapy for hemophilia B, the company said Wednesday, making it the first time the drugmaker has received regulatory clearance for such a genetic medicine. The gene therapy, which Pfizer licensed nine years ago from Spark Therapeutics, will compete with CSL’s Hemgenix, a similar treatment that gained…
The Food and Drug Administration closed out 2023 with rejections of three drugmaker applications for first approval or expanded use, handing Amgen, Zealand Pharma and Merck & Co. complete response letters for medicines to treat cancer, low blood sugar and chronic cough. The rejections came at the end of a year in which the regulator’s…
Dive Brief: Swiss pharmaceutical company Novartis has formed a new collaboration with partner Voyager Therapeutics, agreeing Tuesday to license one experimental gene therapy and the tools to develop another. Novartis will pay the biotechnology company $100 million in cash upfront, including $20 million in stock, in a deal that could be worth as much as…
A non-addictive pain pill faces its definitive test, while study results in ALS, a rare heart disease and lung cancer could have far-reaching implications.
Merit Cudkowicz has spent her career treating some of the most unforgiving illnesses. She’s watched Alzheimer’s disease steal memories and Huntington’s disease take control of muscles. But the cruelest may be ALS, or amyotrophic lateral sclerosis, a rare, fatal condition that leaves patients unable to walk, talk and breathe as their nerve cells rapidly break…
Dive Brief: Sanofi will stop developing one of its top cancer drug prospects after the experimental treatment fell short in a late-stage study in advanced lung cancer, the company said Thursday. Trial monitors found the drug, dubbed tusamitamab ravtansine, missed both of its main study goals, failing to significantly delay tumor progression or extend patients’…
Dive Brief: Weeks after installing a new CEO, BioMarin Pharmaceutical is overhauling oversight of the company at the board level. Facing pressure from activist investor Elliott Investment Management, BioMarin’s board named three new independent directors and set up a Strategic and Operating Review Committee to evaluate the company’s operations and priorities. Two of the new…
Dive Brief: The Food and Drug Administration on Thursday approved a new medicine for a form of the rare disease transthyretin amyloidosis, clearing AstraZeneca and Ionis Pharmaceuticals’ Wainua for adults with the condition. The drug, formerly known as eplontersen, has been approved for use in transthyretin amyloidosis polyneuropathy, the variety of the disease that affects…
Bristol Myers Squibb has agreed to acquire Karuna Therapeutics for $14 billion, betting that the biotechnology company’s experimental schizophrenia drug will become a top-selling medicine. Per deal terms announced Friday, Bristol Myers will pay $330 a share for Karuna, a roughly 53% premium to its closing price on Dec. 21. Net of the cash that…
Sarepta Therapeutics has asked the Food and Drug Administration to expand approval of its gene therapy for Duchenne muscular dystrophy, banking on the regulator’s flexibility in reviewing conflicting clinical trial data. The biotechnology company is requesting the FDA clear its treatment, called Elevidys, for people with Duchenne and a confirmed mutation in the relevant gene….
Dive Brief: Gene therapy developer MeiraGTx is selling its remaining financial interest in an eye-disease treatment partnered with Johnson & Johnson, announcing Thursday it is receiving $65 million up front and potentially another $65 million next year in exchange for foregoing future sales royalties. Per deal terms, MeiraGTx could receive up to $285 million more…
Dive Brief: Clene Nanomedicine on Thursday said the Food and Drug Administration doesn’t believe the company has gathered enough evidence to support an accelerated approval of its experimental drug for ALS, or amytrophic lateral sclerosis. A solution of gold nanoparticles, Clene’s drug is meant to protect neurons by promoting cell energy production. In ALS, it’s…
Dive Brief: Argenx lost a quarter of its value Wednesday after reporting the second research setback in two months for its bid to expand use of its only approved drug. The latest study, called Address, showed no significant benefit for Argenx’s Vyvgart Hytrulo in people with two forms of an autoimmune skin disease called pemphigus….
Dive Brief: GSK is deepening its investment in cancer treatments called antibody-drug conjugates, announcing Wednesday plans to pay $185 million to China-based Hansoh Pharma to license an experimental drug that has shown promise in lung, bone and soft tissue cancers. Per deal terms, GSK could owe up to $1.5 billion in additional fees based on…
Dive Brief: The European Commission has revoked the approvals for five generic versions of Biogen’s multiple sclerosis medicine Tecfidera, ensuring the once top-selling drug’s market position there is maintained through early 2025. The EC’s decision follows a judgment by the Court of Justice of the European Union earlier this year that favored Biogen, and the…
Dive Brief: Shares of UniQure dipped more than 10% Tuesday morning after the biotechnology company released more data from a small study testing an experimental gene therapy for Huntington’s disease. The new results include up to 30 months of follow-up from 39 patients enrolled in the study, which is evaluating two doses of UniQure’s therapy,…
Dive Brief: The Novo Nordisk Foundation, which owns a controlling stake in drugmaker Novo Nordisk, said Monday it will invest 1.8 billion Danish kroner, or about $260 million, to fund development of new vaccines for respiratory diseases. The new initiative will study ways to build immunity at the site of infection inside airways for diseases…
Dive Brief: DNA sequencing company Illumina said Sunday it will divest Grail, the liquid biopsy maker it fought to hang onto after purchasing the business for $8 billion more than two years ago over the objections of U.S. and European regulators. The divestiture will take the form of a capital markets transaction or sale of…
Dive Brief: A new type of pain medication from Vertex Pharmaceuticals succeeded in a Phase 2 study of patients with diabetic peripheral neuropathy, boosting the company’s shares on Wednesday. Researchers tested three doses of the drug, dubbed VX-548, along with an approved treatment known as pregabalin that’s sold under the brand name Lyrica. Patients in…
European drug reviewers appear likely to recommend against clearing a new medicine from Apellis Pharmaceuticals in another stumble for a first-of-its-kind treatment the Food and Drug Administration approved earlier this year. In a statement Thursday, Apellis said it’s been informed of a “negative trend” vote on its application for the drug, sold in the U.S….
Dive Brief: Days after winning U.S. approval of the first CRISPR gene-editing medicine, Vertex Pharmaceuticals is clearing up potential intellectual property questions about the sickle cell disease therapy by signing a deal with Editas Medicine. In return for a non-exclusive license to use the gene editing technology in the treatment, Editas will receive $50 million…
Amgen has a new top scientist, announcing Thursday the appointment of Novartis veteran and prolific biotechnology startup founder Jay Bradner alongside another change to its leadership team. Bradner led the Novartis Institutes of BioMedical Research — the Swiss pharmaceutical giant’s Cambridge, Massachusetts-based research hub — from 2016 until last year. Now at Amgen, he’s serving…
The committee that recommends whether drugs should be approved in Europe has thrown its support behind the first medicine based on CRISPR gene editing technology, issuing on Friday a positive opinion of the treatment, known as Casgvey. The committee’s decision positions Casgevy, a blood disease therapy developed by Vertex Pharmaceuticals and CRISPR Therapeutics, to likely…
Dive Brief: The Food and Drug Administration on Thursday broadened use of a drug Merck & Co. acquired in a $1 billion buyout four years ago, clearing Welireg for use in people whose kidney tumors have progressed following treatment with two other types of medicines. Approval was based on a trial that compared Welireg to an…
Dive Brief: An experimental cancer vaccine from Moderna and Merck & Co. continued to show promise in treating melanoma, with newly released evidence showing that a combination of the shot and the immunotherapy Keytruda kept more people alive and disease-free three years after surgery than Keytruda alone, the companies said Thursday. The updated data, from…
Dive Brief: Vir Biotechnology on Thursday announced a restructuring that will result in a 12% reduction in its workforce as well as the closure of some of its research and development facilities. The company said the restructuring will help prioritize investments in key drugs in development for chronic hepatitis delta and hepatitis B. Data from…
The U.S. Supreme Court announced Wednesday it will review a lower-court ruling that would restrict access to the widely used abortion pill mifepristone, bringing a high-profile battle over reproductive rights back to the same court that overturned Roe v. Wade last year. The court will hear appeals from the Biden Administration and mifepristone developer Danco Laboratories…
Pfizer on Wednesday upped the target for its cost-cutting program, revealing the additional spending cuts alongside a sales forecast for 2024 that disappointed Wall Street analysts and sent shares down to their lowest levels in more than a decade. Pfizer said it now aims to save $4 billion by the end of next year, $500…
Dive Brief: AstraZeneca on Tuesday reached a deal to acquire vaccine developer Icosavax in a deal worth up to $1.1 billion. Per deal terms, AstraZeneca will acquire Icosavax’s shares at $15 apiece, and could add another $5 per share to the buyout if certain milestones and sales targets are met. The upfront payment from AstraZeneca represents an…
Dive Brief: Sanofi terminated a licensing deal with biotechnology company Maze Therapeutics Monday after the Federal Trade Commission filed a lawsuit alleging that the collaboration was designed to extend the French drugmaker’s monopoly in treating a rare disorder known as Pompe disease. The scuttled deal came on the same day that the regulator gave final clearance…
SAN DIEGO — At the American Society of Hematology’s annual meeting, pharmaceutical branding is inescapable. Johnson & Johnson’s and GSK’s new logos are splashed across the side of phone charging stations. Sanofi, among others, let attendees know via hand sanitizer stands that it was proud to keep those fingers and palms germ-free. A few, AbbVie…
The life sciences industry is evolving rapidly in response to macroeconomic shifts, regulatory changes, cost pressures, large data volumes and increasing competition. Leading organizations are investing in process mining technology to optimize their business processes, according to Everest Research Group’s recent report, “Accelerating Digital Transformation and Driving Business Success: The Crucial Role of Process Mining…
The last line of this century’s most important biomedical research paper contained a hint of the scientific revolution to come. An ancient bacterial defense system, the researchers wrote in 2012, could be adapted to offer “considerable potential for gene targeting and genome editing applications.” The past decade has proven those words a dramatic understatement. The…
SAN DIEGO — The vast majority of the people who received Bluebird bio’s newly approved sickle cell disease medicine in a clinical trial remained free of the frequent pain crises typical of their condition, some for as long as five years, new study results show. The therapy, now branded as Lyfgenia but previously known as…
SAN DIEGO —The 65th annual meeting of the American Society of Hematology got a dramatic introduction. On Friday, as researchers and doctors arrived here, the Food and Drug Administration approved two gene therapies for sickle cell disease, an inherited condition that for several years now has been a regular focus on the conference. “ASH 2023…
Dive Brief: Spyre Therapeutics, a biotechnology spinout working on antibody drugs for diseases of the gut, announced Friday a $180 million fundraising from a group of blue-chip investors. In June, Spyre launched as a publicly traded company when it entered a reverse merger agreement with Aeglea BioTherapeutics in a stock-for-stock deal. The company was known…
The first gene therapies for sickle cell disease may treat the inherited blood condition for many years, if not a lifetime. They will also cost several million dollars. On Friday, Vertex Pharmaceuticals set the list price of Casgevy, the first CRISPR-based therapy approved by the Food and Drug Administration, at $2.2 million dollars. Bluebird bio,…
Dive Brief: Biotechnology startup Artbio said Thursday it raised $90 million in a Series A financing that highlighted investors’ appetite for an emerging class of cancer medicines known as radiopharmaceuticals. Third Rock Ventures and an undisclosed healthcare fund led the round, which drew participation from seed investors F-Prime Capital and Omega Funds. Artbio previously announced…
The White House on Thursday took steps to pressure pharmaceutical companies to lower the price of drugs developed with federal funding, backing a plan that would enable the government to sidestep patent protections for those medicines. New draft guidelines published by the National Institutes of Standards and Technology permit government agencies to consider “reasonableness of…
Dive Brief: Venture capital activity in biotechnology is undergoing a “recalibration towards pre-pandemic investment norms,” according to a new quarterly report from Pitchbook that tracks global funding and dealmaking in the sector. Pitchbook projects there will be about 840 venture deals totaling $24 billion by the end of the year, a steep decline from the…
AbbVie is restocking its drug pipeline in a big way, announcing Wednesday an $8.7 billion deal to buy neuroscience-focused Cerevel Therapeutics, just days after agreeing to a similar sized acquisition of the cancer biotechnology company ImmunoGen. Per the deal, AbbVie will pay $45 per share of Cerevel, which is developing medicines for schizophrenia, dementia and…
Dive Brief: Pfizer and partner Valneva announced Monday that they have finished enrolling participants in a Phase 3 trial evaluating their experimental vaccine for Lyme disease. The announcement ends a lengthy delay that began in February, when the two companies said they were removing half of trial participants due to concerns of study misconduct by an…
The Biotech Innovation Organization on Tuesday named Amicus Therapeutics co-founder and longtime leader John Crowley as its new CEO, taking over a spot interim chief Rachel King has held for the past 14 months. BIO’s decision to name Crowley, who will assume the role effective March 4, as permanent CEO comes just over a year…
Dive Brief: Seattle Children’s Hospital is spinning out a biotechnology startup named BrainChild Bio to develop new cancer drugs for central nervous system tumors, the hospital announced Tuesday. The company is licensing CAR-T technology from Seattle Children’s, and has also received equity funding from the health care provider. Financial terms of the deal were not…
Dive Brief: The Food and Drug Administration granted conditional approval to Eli Lilly’s oral cancer drug Jaypirca in two types of blood cancer, expanding its use from a rare type of lymphoma to people with leukemia and lymphoma patients who have previously received two other treatments, the company said Friday. Jaypirca is the fourth of…
Europe’s drug regulator has more questions about the safety and potential risks of a new, widely popular class of medicines. Known as GLP-1 agonists, the class includes Novo Nordisk’s Ozempic, Wegovy, Rybelsus and Saxenda, as well as Eli Lilly’s Trulicity. These medicines prompt the body to produce insulin, making them effective treatments for diabetes or…
Researchers have massive amounts of real-world healthcare data at our fingertips and when approaching a real-world evidence (RWE) deep analytics task, electronic health records are typically the first stop in terms of data gathering. However, there are a number of other important data sources, including structured data like healthcare claims and unstructured data such as…
With clinical trials becoming more complex, finding ways to streamline and automate laboratory processes is vital when analyzing bioanalytical samples. As the chief scientific officer of large-molecule bioanalysis, Dr. Tom Zhang leverages his expertise to promote ever-evolving automation technologies. He also maintains Worldwide’s knowledge of large-molecule bioanalytical methodologies. He explains that today’s bioanalytical labs are…
