Recent FDA staff cuts to delay drug hearing decision by months, agency tells...
For the first time since the Trump administration's major staff cuts at the FDA this month, the agency publicly announced that the firings will lead to a long delay for what would otherwise be a ...
View ArticleAstraZeneca rejoins PhRMA, two years after leaving lobby group
British drugmaker AstraZeneca is rejoining the drug industry's major US lobbying group, PhRMA, roughly two years after quitting the organization. As part of its membership, AstraZeneca CEO Pascal...
View ArticleVaccine biotechs get stop-work orders for their next-gen Covid work
At least three biotech companies say they’ve received orders to stop their work related to a Biden administration initiative to advance new Covid-19 vaccines. GeoVax, CastleVax and Vaxart told...
View ArticleBristol Myers' schizophrenia drug fails Phase 3 trial for adjunctive treatment
Bristol Myers Squibb’s attempt to turn Cobenfy into a megablockbuster neuroscience drug ran into a stumbling block Tuesday afternoon. The company said Cobenfy, approved last year for schizophrenia, did...
View ArticleBoehringer taps Tessellate Bio for ALT positive cancer pact exceeding $573M...
Boehringer Ingelheim has inked a research collaboration with Tessellate Bio to develop precision medicines for cancers that maintain telomere length to survive and grow. The Amsterdam-based biotech...
View ArticleEli Lilly sues four telehealth companies selling compounded tirzepatide
Just a few weeks after Eli Lilly sued two large compounding pharmacies, the pharma giant on Thursday filed lawsuits against four telehealth companies over their sale of compounded versions of the GLP ...
View ArticleExclusive: Chicago startup Grove Biopharma nabs $30M Series A
A small Northwestern University spinout attempting to develop a twist on biologics has pulled together a $30 million Series A. The startup, named Grove Biopharma, weathered the pandemic and, after more...
View ArticleRepertoire inks autoimmune deal with Genentech as it eyes a return to the clinic
Every few years, Repertoire Immune Medicines makes a major announcement in April. And this year is no different. The Flagship Pioneering-incubated startup on Wednesday unveiled a tie-up with Roche's...
View ArticleAkeso reports another Phase 3 win for PD-1xVEGF approach in lung cancer
Akeso said its PD-1xVEGF bispecific antibody ivonescimab beat BeiGene’s PD-1 blocker Tevimbra in a Phase 3 study in lung cancer patients in China. The readout marks the third late-stage win for...
View ArticleAscletis posts puzzling Phase 1 update on obesity pill
Ascletis Pharma’s obesity pill was less effective at its high dose than at lower doses in an early-stage trial, the biotech said Tuesday. While this doesn’t preclude further development of ASC30 ...
View ArticleGenentech vet launches ADC startup with $20M
A Bay Area protein design startup wants to build more potent antibody-drug conjugates, and is starting with $20 million in seed funding. The company, Synthetic Design Lab, was founded by former...
View ArticleTelenutrition startup Nourish raises $70M
Telenutrition platform Nourish has raised $70 million and reached profitability a little more than a year after its last raise as food medicine startups get a boost under the Trump administration....
View ArticleFDA asks Novavax for post-marketing data of its Covid vaccine, delaying approval
The FDA has asked Novavax to commit to producing post-marketing data of its Covid vaccine, the clearest example yet that the goalposts have changed for vaccine makers under HHS Secretary Robert F....
View ArticleWith aims to become a 'generational biotech,' Zealand Pharma hires Lilly...
Fresh off a splashy obesity deal, Zealand Pharma is doubling down on its R&D ambitions with a new chief scientific officer. The Copenhagen-based biotech, which is partnered with Roche and...
View ArticleChina’s biotech market is staging a comeback that US biotech can only wish for
China’s biopharmaceutical sector is showing signs of revival from its post-pandemic slump, even as its US counterpart remains in a rut. Buoyed by licensing deals, improving company fundamentals and...
View ArticleVeraxa makes a SPAC deal; Illumina discloses layoffs
Plus, news about Innate Pharma, Sanofi, Claris Ventures and Rezolute: A rare SPAC deal: At a time when public markets are challenging for IPOs, a Swiss biotech plans to merge with ...
View ArticleTop pharma companies increased lobbying spend at start of 2025
Pfizer, Novartis, Amgen, Eli Lilly and Johnson & Johnson were the top congressional lobbying spenders among the major biopharma companies, as the industry faces a tumultuous environment in which...
View ArticleVaccine makers stand by their investments despite US headwinds
WASHINGTON — Representatives from large vaccine makers say they are committed to their pipelines, despite a new wave of scrutiny in the US that risks diminishing a major market. On a panel at the World...
View ArticleEurope 'falling behind' on drug R&D and manufacturing investments:...
AstraZeneca CEO Pascal Soriot called on Europe to step up investments and “protect its health sovereignty" as it falls behind the US on spending. His comments echo calls from other pharma CEOs who are...
View ArticleRoche Q1 earnings: CEO warns that tariffs could impact dealmaking
Roche said that its future dealmaking could be impacted by potential tariffs on pharmaceuticals. “If there are questions around tariffs, it will be more difficult to make financial sense of any M&A...
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