The Latest
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Deep Dive
Biotech IPOs are the industry’s lifeblood. Track how they’re performing.
Including Contineum’s IPO, biotechs have now raised about $1.43 billion in new stock offerings this year, nearly quadrupling last year’s total by this point.
Updated April 5, 2024 -
Sponsored by Sysmex Inostics
The growing role for cfHPV-DNA testing in OPSCC therapeutic development
Learn about why access to robust biomarkers such as cfHPV-DNA is pivotal in determining eligibility, assessing treatment response and detecting recurrence early to improve patient outcomes.
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Stelara biosimilar from Alvotech, Teva approved by FDA
The companies plan to launch their copycat version of the blockbuster immune disease drug early next year, per a legal settlement with J&J.
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Canaan hires Pfizer executive, reels in $100M for biotech investing
The firm has brought in as venture partner Uwe Schoenbeck, who most recently was the top scientist for Pfizer’s emerging science and innovation unit.
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J&J sees mixed performance from new multiple myeloma drugs
Tecvayli sales, which J&J broke out for the first time, surpassed Wall Street forecasts and offset underperformance from Carvykti, which J&J attributed to the "phasing and timing of orders."
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Intra-Cellular builds case for depression drug with late-stage trial win
Shares of the biotech rose 25% after a large trial found adding its drug Caplyta onto antidepressant therapy significantly helped people with major depression.
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Deep Dive
Biotech M&A is on the upswing. Track the latest deals here.
Vertex’s proposed buyout of Alpine Immune Sciences is the largest biotech acquisition to be announced so far this year.
Updated April 10, 2024 -
Cullinan changes name, pivots to autoimmune disease
The biotech says a dual-pronged antibody it’s developing could become an “off-the-shelf” alternative to cell therapies in development for lupus and other inflammatory conditions.
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Regeneron commits $500M to new venture capital fund
While corporate venture arms are commonplace among pharmaceutical companies, the new fund announced Monday is Regeneron’s first.
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Neumora’s schizophrenia drug hit with clinical hold
Shares of the biotech dipped by double digits following disclosure the FDA had paused an early-stage study of Neumora’s muscarinic-targeting drug.
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Roche reports survival data for new dual-acting lymphoma drug
The results could give Roche’s Columvi an edge over a rival medicine from AbbVie and Genmab, while Regeneron awaits an approval of its own therapy.
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Ultragenyx says Angelman therapy is working, but safety questions remain
Treatment appeared to result in functional and cognitive gains in people with the neurological disorder. Three participants experienced lower extremity weakness, however.
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Biotech IPOs bounced back in first quarter, but backlog remains
Proceeds from biotech IPOs during the first three months of 2024 matched levels seen in the first quarters of 2019 and 2020, BioPharma Dive data show.
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European regulator concludes no suicide link to obesity drugs
The decision clears a concern hanging over GLP-1 medicines like Ozempic since reports of suicidal ideation and self-harm among people taking the drugs surfaced in July.
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Roche, Adaptimmune part ways on cell therapy research
The two companies have ended a collaboration that was struck in 2021 and focused on “off-the-shelf” cell therapies for cancer.
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US sues Regeneron, alleging false price reporting on Eylea
The lawsuit claims the drugmaker didn’t disclose reimbursement to drug distributors for credit card fees, artificially inflating the reported price of the blockbuster eye drug.
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Vertex to buy kidney disease drugmaker Alpine for $4.9B
A proposed $4.9 billion buyout of Alpine Immune Sciences would be the largest ever acquisition for Vertex and align with its "toolkit of technologies" approach to dealmaking.
Updated April 11, 2024 -
Emerging biotech
Century buys a startup, raises funding in cell therapy expansion
The biotech is acquiring Clade Therapeutics and its stem cell technology at a discount price, while adding $60 million via a private placement led by Bain Capital.
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J&J, Rallybio partner on drug development for rare fetal condition
The biotech is working on a preventive therapy for the immune disorder, known as FNAIT for short, while J&J is studying its drug nipocalimab as a treatment.
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Novartis pauses enrollment in some Kisqali trials to fix manufacturing
The company said the pause is necessary to meet regulatory limits on nitrosamine, but added it will not affect commercial supply nor regulatory review of the drug in early breast cancer.
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RSV vaccines
Pfizer, with new study results, seeks to bring RSV shot to adults aged 18-59
The company plans to submit the trial data to regulators in a bid to win approval of its vaccine Abrysvo in adults as young as 18 years old.
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Emerging biotech
PureTech launches Seaport, hoping to create Karuna 2.0
The startup is taking aim at anxiety with $100 million from high-profile biotech backers like ARCH, Sofinnova and Third Rock.
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Private biotech funding rises as venture firms deploy cash
Twenty-six drugmakers closed fundraising rounds worth more than $100 million in the first quarter, according to HSBC data shared with BioPharma Dive.
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Obesity drugs
Trial shows Wegovy can ease heart failure symptoms
The results were the second time Novo has shown its weight loss treatment can help with the condition, and may help it secure broader use of the drug.
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Women want to participate in clinical trials. Lack of flexibility is still a problem.
Underrepresentation of women in clinical trials affects the resulting drugs that become available later. Even small changes could boost participation.
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FDA approves CAR-T therapies from J&J, Bristol Myers for earlier myeloma use
The FDA quickly followed last week’s clearance of Bristol Myers’ Abecma with an OK for J&J’s Carvykti, but gave the rival treatments different labels.
Updated April 8, 2024