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Otsuka Pharmaceuticals announced Wednesday it is ending development of drug candidate AVP-786 after failing to improve agitation associated with dementia due to Alzheimer’s disease.
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Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.
As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.
This year has seen the approval of several first-in-class therapies for HAE, but in a fragmented space, experts question whether they will be enough to net their developers a significant share of the entrenched market.
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Amgen announced the groundbreaking of its newest biomanufacturing facility, located in Holly Springs, North Carolina.
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Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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Monitoring rebates from drugmakers will be critical as provisions of the Inflation Reduction Act are implemented, including drug price negotiations, the Government Accountability Office contends.
Biotech Beam Therapeutics has dosed the first patient in a Phase I/II study of its base-edited CAR-T therapy in relapsed or refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma.
With several of the first 10 selected drugs facing patent expirations and generic competition, the drug price negotiations dictated by the IRA may not greatly affect revenues. But that could change quickly.
Former Agilent Technologies executive Jacob Thaysen will take the reins later this month replacing CEO Francis deSouza, who stepped down in June following a proxy fight with activist investor Carl Icahn.
The company Tuesday posted Sandoz’s financial performance for the first half of 2023, as it looks to secure the approval of shareholders this month for the generics and biosimilars spin-off.
The Swiss pharmaceutical company filed a suit Friday joining a growing group of legal complaints by Big Pharma seeking to block the Inflation Reduction Act’s Drug Price Negotiation Program.
The companies are moving closer to traditional approval for the antibody-drug conjugate Tivdak, which met its primary endpoint for overall survival in an interim analysis.
$27.8B Amgen-Horizon deal gets FTC clearance with restrictions; the White House names first 10 drugs subject to Medicare price negotiations; Sage Therapeutics axes 40% of staff.
The vaccine was effective against previous COVID-19 variants but lacked efficacy against new ones, the company announced Thursday, leaving the booster no commercially viable options.
Under a consent order agreement announced Friday, Amgen is prohibited from bundling any of its products with Horizon’s Tepezza or Krystexxa, allaying the FTC’s primary concerns.