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Channel: Endpoints News

Sionna seeks $135M IPO to fuel tests of cystic fibrosis drug candidates

Cystic fibrosis drug developer Sionna Therapeutics hopes to join the IPO wave started by Metsera and Maze Therapeutics last week. Sionna, which snagged some of its programs from AbbVie last year, hopes...

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Drugmakers seize on biomarkers to test the FDA's rare disease shift

For the first time, the FDA will consider whether to approve a trio of drugs for tiny patient populations based on trials that are using new biological signals as outcomes, rather than a placebo...

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GH Research reports Phase 2b triumph for short-acting psychedelic drug in...

GH Research has shared compelling data in people with a traditionally challenging form of depression who were dosed with its psychedelic candidate, despite the drug being under a clinical hold in the...

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Thermo Fisher to lay off 300 workers at two viral vector factories  

Thermo Fisher Scientific is cutting 300 employees across two viral vector manufacturing facilities in Massachusetts, marking the second round of layoffs at those factories in the past few months. The...

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Senate Democrats criticize RFK Jr.'s divestment plans ahead of Tuesday vote

Democrats in the Senate Finance Committee are calling Robert F. Kennedy Jr.'s new divestment plans to his son "plainly inadequate" ahead of a Tuesday vote on whether to advance his nomination to lead...

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Charles River to shut down North Carolina pathology facility

Charles River Laboratories is permanently closing its pathology facility in Durham, NC, after determining it is no longer “a strategic fit,” a company spokesperson told Endpoints News in an email....

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Biogen's research chief talks China, neuropsychiatry and pipeline plan

Fresh off a reorganization, Biogen’s research leader Jane Grogan says the biotech has to “look outside the walls of the company” to avoid being left behind. In her first interview since then, she told ...

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Noom cuts coaches, staff as fewer sign up

Noom has laid off employees in coaching and customer service after its bet on prescribing GLP-1 drugs wasn't enough to offset losses from its original program, Endpoints News has learned. The job cuts...

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US biosimilar 'void' spells trouble as biologic patent expirations loom,...

While 118 biologics are expected to lose patent protection in the US over the next decade, that $234 billion opportunity for biosimilar developers may not materialize because of several challenges,...

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Gene-edited pig kidneys will be tested in more humans soon

The FDA has cleared two new requests to test gene-edited pig kidney transplantation, including a first clinical trial of the technology. United Therapeutics announced Monday that it received the...

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Omega Therapeutics nears bankruptcy filing, lays off workers

Omega Therapeutics anticipates filing for bankruptcy within the next week, the epigenomic medicines company said in a filing, a sudden end for a company that just a year ago signed an obesity...

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Merck pauses Gardasil shipments to China

Merck is pausing HPV vaccine shipments to China “until at least mid-year” as it grapples with lower demand for the shot. The company also withdrew its $11 billion sales target for Gardasil by 2030 as ...

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Astellas shakes up management despite impressive nine-month earnings

Astellas is reorganizing its management team, and while it doesn't involve a change at the top as Daiichi Sankyo announced last week, it could still have major repercussions for drug development at ...

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Regeneron will start delivering quarterly dividends 37 years into its existence

Regeneron Pharmaceuticals, one of the original and longest-standing biotech companies, is entering the dividends arena for the first time. The Tarrytown, NY-based drugmaker surprised the market Tuesday...

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Updated: Pfizer sticks to 2025 projections as Covid sales stabilize, R&D...

Pfizer’s high-profile, high-volatility Covid-19 franchise stabilized at the end of 2024, as the New York drugmaker pursues a revamp of its R&D operations and continues to cut costs. Pfizer’s Covid...

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Bavarian Nordic’s stock sinks after 2024 revenues underwhelm

Bavarian Nordic’s stock dropped around 10% on the Danish stock exchange Tuesday after reporting disappointing 2024 sales despite a rise of demand for its mpox vaccines. Decreased orders for its public ...

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Study using experimental Eli Lilly drug will try to stop Alzheimer’s decades...

Alzheimer’s disease has afflicted Hannah Richardson’s family for generations. A rare genetic mutation, passed down from her great-grandmother, has struck her relatives with the first signs of memory...

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How opioid addiction treatment startup Bicycle Health reached a profit

Bicycle Health, a provider of telehealth treatment for opioid use disorder, has hit a major milestone that’s eluded many health tech startups: It turned a profit. The company, based in Boston and...

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FDA approves Supernus’ Parkinson’s drug-device after two rejections

At long last, the FDA approved Supernus Pharmaceuticals’ Parkinson’s disease treatment, which will be marketed as Onapgo. Onapgo is now approved to treat motor fluctuations in adults with advanced...

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Updated: RFK Jr. advances out of Senate committee with Cassidy’s support

Sen. Bill Cassidy (R-LA) voted to advance Robert F. Kennedy Jr.’s nomination for HHS secretary to the full Senate, a key show of support from one of the nominee's most vocal critics on the Republican ...

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Turnstone stops TIL studies; GH Research’s $150M offering

Plus, news about Auron Therapeutics, Akribion Therapeutics, Enveric Biosciences and Valerio Therapeutics: Turnstone Biologics to discontinue TIL studies, “review strategic alternatives”: The company...

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Illumina added to China's blacklist following Biosecure Act, tariffs

China added DNA sequencing giant Illumina to a list of blacklisted entities after proposed US legislation targeted two Chinese rivals to Illumina and President Donald Trump imposed a 10% tax on all...

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Trump undercuts RFK Jr. assurances on vaccines, autism

Robert F. Kennedy Jr. is headed for Senate confirmation following Tuesday’s committee vote and a statement of support from the GOP’s biggest skeptic. But it’s still very, very unclear which Kennedy...

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Merck CEO says he’s confident in growth despite Gardasil ‘headwind’

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