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BioPharma Dive
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Washington,District of Columbia 14,880 位关注者
We provide business journalism and in-depth insight into the most impactful news and trends shaping biotech and pharma
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BioPharma Dive provides in-depth journalism and insight into the most impactful news and trends shaping biotech and pharma. The newsletter and website cover topics ranging from clinical readouts to FDA approvals, gene therapy to drug pricing and M&A to research partnerships. BioPharma Dive is a leading industry publication operated by Industry Dive. Our business journalists spark ideas and shape agendas for 13+ million decision-makers in the most competitive industries.
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https://www.biopharmadive.com
BioPharma Dive的外部链接
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- 在线音视频媒体
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- Washington,District of Columbia
动态
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Trace Neuroscience, which launched this week with $101 million, benefited from last year’s approval of Qalsody. Its CEO spoke with BioPharma Dive about how the company came together.
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At an event hosted by BioPharma Dive, drugmaker executives and investors discussed the importance of focus, smart spending and maintaining lines of sight to the clinic. #biopharma
Surviving in biotech’s new normal: 5 tips from industry VCs and CEOs
biopharmadive.com
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How do you build and fund a biotech startup in the aftermath of the downturn — especially one based on a broad drugmaking technology? And how have companies and their investors adapted to what many executives have described as the sector’s “new normal”? This week, BioPharma Dive hosted a trio of panels exploring the tough decisions drug startups currently face in the early stages of their journeys, and offered some advice on how to navigate them. Thanks to everyone who tuned in as well as our speakers — among them Michael Gilman, Abbie Celniker, Ken Song, Nina Kjellson, David K. Yang and Kevin Marks — for all of their great insights. Here’s a sneak peek: #biotechnology #pharmaceuticals #venturecapital #startups #drugdiscovery #drugdevelopment
Surviving in biotech’s new normal: 5 tips from industry VCs and CEOs
biopharmadive.com
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In an unusual reversal, key drug regulators are now saying Leqembi, a high-profile medicine for Alzheimer’s disease, should be approved in Europe, though only for patients less likely to experience a certain kind of concerning side effect. This summer, the European Medicines agency concluded that Leqembi's safety risks outweigh its potential benefits. Chief among those risks was the “frequent occurrence” of a side effect known as "ARIA," which can present as brain swelling and small-scale bleeding. Leqembi's primary developer, Eisai Co., Ltd., appealed the EMA’s so-called negative opinion. The appeal process is rarely successful for drugmakers. Analysts at the investment firm RBC Capital Markets crunched the numbers and found that, over the past decade, the EMA’s main drug review committee has changed its mind only 20% of the time. But Leqembi beat the odds. The committee said Thursday it supports approval for Alzheimer's patients who have mild disease and either one or no copies of a gene believed to increase the risk of ARIA. According to Jefferies analyst Michael Yee, around 60% to 80% of the Alzheimer’s population in Europe fits that genetic profile. Eisai and its partner Biogen work together commercializing Leqembi, and initially hoped European regulators would clear the drug for a broader group of Alzheimer’s patients. Yet, even a narrower approval could significantly boost sales. RBC analyst Brian Abrahams has estimated that peak annual Leqembi sales could reach $8.3 billion, with 20% coming from the European market. #biotech #neuroscience #marketing #commercialization https://lnkd.in/eusXDVMG
Eisai wins over European regulators on Alzheimer’s drug Leqembi
biopharmadive.com
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Kebilidi is the first approved #genetherapy that can be directly administered to the brain. Its OK secures a priority review voucher for PTC.
PTC wins US approval of gene therapy for fatal enzyme disorder
biopharmadive.com
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Merck is buying a new kind of cancer #immunotherapy. The company is paying China-based biotech LaNova Medicines $588 million for the same type of bispecific antibody drug that recently bested Keytruda in a clinical trial.?#Pharma
Merck, facing threat to Keytruda, buys into new kind of cancer immunotherapy
biopharmadive.com
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#Biotech Metsera raised $215 million to fuel obesity drug development. With promising Phase 1 results in hand, Metsera hopes to develop a longer-lasting GLP-1 injection along with other types of obesity treatments.
Metsera raises $215M to accelerate obesity drug plans
biopharmadive.com
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#Biotech company BioNTech SE is buying out Biotheus, gaining control of a cancer bispecific. Biotheus’ antibody drug targets PD-L1 and VEGF, a design that’s high on drugmakers’ radars after the success of Summit Therapeutics’ ivonescimab.
BioNTech to buy Biotheus, gaining control of cancer bispecific
biopharmadive.com
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AbbVie had a tough start this week. The Illinois-based pharmaceutical giant lost tens of billions of dollars in market value Monday after revealing that one of its most closely watched experimental drugs failed two key clinical trials. Among big pharma companies, it’s one of the larger single-day stock price dips of at least the past several quarters. AbbVie had recently spent almost $9 billion acquiring the drug's developer, Cerevel Therapeutics. Now, that deal “just went up in flames,” according to Olivia Brayer, an analyst at the investment firm Cantor Fitzgerald. Brayer covers Bristol Myers Squibb, which sells a medicine, Cobenfy, that would have competed against AbbVie's. Shares of Bristol Myers rose around 12% on Monday's news. In a note to clients, Stifel Financial Corp. analyst Paul Matteis wrote that AbbVie's failure is “outright surprising” and will “significantly bolster” Bristol Myers’ leading position with Cobenfy. Both drugs are part of a new class of antipsychotic medications that Wall Street expects to become huge sellers. Looking ahead, Brian Abrahams, an analyst at RBC Capital Markets, posited that AbbVie may need to consider additional external deals to “make up for” the Cerevel acquisition. Analysts also believe the results could have implications on schizophrenia drug development more broadly. My latest for BioPharma Dive: https://lnkd.in/ejGa3rHD #biotech #neuroscience #stocks
On Wall Street, ‘flat out’ failure of AbbVie schizophrenia drug leaves analysts stunned
biopharmadive.com