The Latest
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Adeline Kon/BioPharma Dive
Deep DiveAfter a record run, fewer biotechs are going public. Here’s how they’re performing.
Adlai Nortye’s IPO is the 16th for a biotechnology company this year, and raised a smaller amount than it had pitched in early August.
Updated Sept. 11, 2023 -
Anthony Musmanno
Sponsored by ViatrisDriving innovation to benefit people living with MS
A holistic approach to R&D is key to support MS patients throughout their treatment journey.
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Ozankutsal via Getty Images
PTC to lay off more staff following drug setback in Europe
The biotech is expanding cuts it announced a few months ago after the EMA decided against renewing a conditional clearance for its drug Translarna.
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Permission granted by Karuna Therapeutics
Karuna submits schizophrenia drug for US approval
The drug’s success in two late-stage clinical trials has buoyed Karuna to a market valuation exceeding $6 billion.
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National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Gritstone wins ‘Project NextGen’ funding to run head-to-head COVID vaccine study
In a note to clients, Evercore ISI analyst Jonathan Miller described the Project NextGen contract for Gritstone as “certainly a nice signal of continued government support for COVID research.”
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Dmitry Belyaev via Getty Images
Harbinger Health raises $140M to study blood-based cancer screening test
The test developer will use the Series B funding to complete a 10,000-person clinical trial ahead of a planned launch in 2025.
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Adeline Kon/BioPharma Dive
Deep DiveBiotech M&A is picking back up. Here are the latest deals.
While Alfasigma’s bid for Intercept comes at an 82% premium to Monday’s close, the proposed $19 per share price is well below what the stock was worth a few years ago.
Updated Sept. 26, 2023 -
Courtesy of Roche
Roche bets on Ionis RNA medicines with neuroscience deal
The Swiss drugmaker is restocking its pipeline by buying into preclinical Ionis medicines for Alzheimer’s and Huntington’s diseases.
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Mario Tama / Getty via Getty Images
Q&AInside Bavarian Nordic’s late-stage stumbles — and drive to become a vaccine giant
Despite the company's recent Phase 3 setbacks in RSV and COVID, CEO Paul Chaplin sees a path forward for the Danish biotech in the travel vaccine market.
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ProQR sale of eye drugs comes undone over employment contracts
Laboratoires Théa terminated its planned purchase of ProQR’s sepofarsen after certain ProQR personnel opted against working for the French company.
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Permission granted by John Tsai
Former Novartis executive Tsai to lead UK heart drug startup
John Tsai, previously Novartis’ chief medical officer, has been named CEO of Forcefield Therapeutics, an 18-month-old biotech that recently licensed AAV technology from Freeline Therapeutics.
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Elizabeth Regan / Industry Dive
Immunovant data show potential for autoimmune disease drug
Much anticipated clinical trial data for Immunovant’s experimental FcRn inhibitor could catalyze business development decisions for its parent, Roivant Sciences.
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Novo Nordisk
Novo Nordisk, Evotec partner in metabolic disease drug discovery pact
Hunting for more metabolic disease drugs, Novo plans to work with Evotec to shape early academic research into new development programs.
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Novartis
Novartis radiopharmaceutical drug succeeds in first-line gut cancer study
Novartis has made a large investment in targeted radiotherapies, sparking competition from fellow pharma companies and young biotechs.
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Courtesy of U.S. Food and Drug Administration
ALS drug developmentFDA staff hold ‘major concerns’ with Brainstorm ALS therapy, documents show
A panel of expert FDA advisers is meeting today to discuss the treatment, and whether Brainstorm’s data provide “substantial evidence” of its effectiveness.
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Courtesy of Eisai
New Alzheimer's drugsEisai’s Alzheimer’s drug Leqembi approved in Japan
Eisai and Biogen’s anti-amyloid drug is still undergoing regulatory reviews in the EU, U.K. and elsewhere.
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Permission granted by Bristol-Myers Squibb
Latest trial win supports expanded use of Bristol Myers’ Opdivo in lung cancer
The drug, which is already cleared as a neoadjuvant lung cancer treatment, could better compete with Merck’s Keytruda if it gains approval in the adjuvant setting for non-small cell tumors.
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Permission granted by Seagen
Seagen’s cancer drug succeeds in ‘must-win’ trial
Compared to chemotherapy, a combination of Seagen’s Padcev and Merck’s Keytruda was significantly better at keeping bladder cancer patients alive longer and their disease from progressing.
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Jacob Bell / BioPharma Dive
AstraZeneca and Daiichi’s next cancer medicine scores in breast tumors
Results show that the medicine helped patients who progressed on earlier-line treatments live longer than those receiving chemotherapy without their disease getting worse, according to a Friday announcement.
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Sarah Silbiger via Getty Images
Intarcia’s diabetes drug-device combo voted down again by FDA panel
The 19-member advisory committee unanimously voted against Intarcia in the review, citing cardiovascular and kidney safety concerns.
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selvanegra via Getty Images
Cell therapy developer closes funding round to support diabetes program
More than $50 million in venture funding has now gone into Seraxis, which is among a series of biotechs trying to fundamentally alter diabetes treatment.
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metamorworks via Getty Images
Novo Nordisk parent backs cell therapy manufacturing facility
The Novo Nordisk Foundation’s planned manufacturing facility will help both private companies and academic researchers develop new cell therapies.
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Justin Sullivan via Getty Images
Genentech takes up a deal to make ‘molecular glue’ drugs
Targeted protein degradation has emerged as one of the more competitive areas of pharmaceutical research in recent years as scientists develop new ways to reach difficult-to-drug targets.
Updated Sept. 20, 2023 -
MadamLead via Getty Images
Roche’s Genentech bets on radiopharmaceuticals in partnership with PeptiDream
The new deal expands on a yearslong partnership between the two drug developers to advance targeted radioisotopes for certain cancers.
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Sarah Silbiger via Getty Images
Taysha drops lead gene therapy following FDA feedback
Additional studies proposed by the FDA would be too challenging, according to Taysha, which simultaneously announced that its partner Astellas has declined to pick up an option for the therapy, called TSHA-120.
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Courtesy of U.S. Food and Drug Administration
Alvotech gets new FDA review for Humira biosimilar
The regulator has twice rejected Alvotech’s copycat drug due to manufacturing issues with a plant in Europe.
