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Roche wins FDA OK for Alecensa in early lung cancer
Alecensa is the first targeted drug available after surgery for people with ALK-positive lung tumors, who are at high risk for brain metastases.
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Cerevel, in ‘major surprise,’ finds success in late-stage Parkinson’s study
Analysts had low expectations for Cerevel’s drug tavapadon, which was something of an afterthought in AbbVie’s proposed buyout of the biotech.
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Emerging biotech
Metsera, a well-funded obesity drug startup, sees chance to challenge Lilly, Novo
It’s “early innings” in the obesity drug race, said Metsera CEO Clive Meanwell, whose company acquired a portfolio of medicines it aims to test in combination.
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Vertex begins bid for US approval of non-opioid painkiller
The biotech has begun a rolling submission of a closely watched drug that’s important to its future, but faces questions of sales potential.
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23andMe CEO plans to take company private
Company head Anne Wojcicki is considering buying all outstanding shares of the DNA testing firm, which has seen its stock slump in recent years.
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Obesity drugs
Lilly obesity drug shows benefit in sleep disorder study, pointing to new use
Positive data for Lilly’s medicine tirzepatide in sleep apnea are the latest signal the benefits of GLP-1 agonists could extend beyond diabetes and weight loss.
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Sage’s cognition drug fails in Parkinson’s study
Following negative results, the company doesn’t plan to further test SAGE-718 in Parkinson’s. Other studies in Huntington’s and Alzheimer’s remain ongoing.
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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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Q&A // Emerging biotech
Biotech landlord Alexandria on research clusters and the sector’s recovery
Joel Marcus, the longtime head of Alexandria Real Estate Equities, sees few near-term challengers to the established biotech hubs of Boston, San Diego and San Francisco.
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Ukraine was pharma’s clinical trial ‘darling.’ As war drags on, will the industry return?
While some new drug studies are getting underway, activity is still far below bustling pre-war levels.
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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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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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Deep Dive
New postpartum depression drugs are here. Diagnosis, treatment hurdles still stand in the way.
The first medicine approved for PPD, Sage’s Zulresso, never gained traction. The company is in the midst of launching its second, but long-standing challenges could slow uptake.