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BiomX’s phage therapy BX211 succeeds in Phase 2 diabetic bone infection study

BiomX’s antibacterial virus candidate has reduced the size of foot ulcers in patients with diabetic bone infection enrolled in a mid-stage trial. The finding could strengthen the company’s case for an...

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Transcend's neuroplastogen notches Phase 2 win to treat PTSD

Transcend Therapeutics’ PTSD treatment succeeded in a mid-stage study, propelling the scrappy company of less than 20 people toward a Phase 3 trial that could begin at the start of next year. The...

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Alphabet’s Isomorphic Labs raises $600M in biotech’s largest round of 2025 

Google’s bet on AI in drug discovery just got a lot bigger. Isomorphic Labs said Monday it raised $600 million from Thrive Capital, GV and Alphabet in its first external financing. The raise is the ...

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Inspirna, which was preparing for a Phase 3 cancer trial, has folded

A New York City drug developer led by well-known executives and backed by some of the top names in biotech investing is shutting down, a blow to a company that was prepping for a pivotal ...

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LifeMine’s restructuring; Europe won’t renew authorization for PTC’s Duchenne...

Plus, news about ​​Opthea, Apollomics, LaunXP and AstraZeneca: LifeMine reduces headcount: The Boston biotech went through a “company-wide restructuring,” according to employees’ LinkedIn posts. The...

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Lilly's heart drug study shows potential for once-a-year dosing

Phase 2 results on Eli Lilly’s experimental heart disease drug showed it could be dosed far less frequently than competing treatments in development from Novartis and Amgen, giving Lilly a way into an...

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Biotech markets fall as industry takes stock of Marks' exit at FDA

The departure of one of the FDA’s highest-profile regulators, whose career was defined by advancing new technologies to patients, rattled investors and companies who were already feeling insecure....

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AstraZeneca’s cholesterol pill is set for Phase 3, but lags behind Merck rival

AstraZeneca has great ambitions for its mid-stage oral cholesterol drug, believing that it could reach peak sales of more than $5 billion. Positive data presented Monday at the American College of...

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Merck’s PAH drug slashed risk of serious events in halted trial

New data unveiled Monday showed that Merck’s Winrevair can significantly cut the risk of death, lung transplantation and hospitalization in patients with a rare form of high blood pressure in the ...

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Corcept shares soar after Phase 3 win in ovarian cancer

Corcept Therapeutics’ oral glucocorticoid receptor antagonist has improved survival outcomes in a late-stage test in patients with a challenging form of ovarian cancer, sending its shares up 76% at...

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Vaxcyte's Phase 2 pneumococcal vaccine data disappoint investors

Vaxcyte’s stock price {$PCVX} dropped by 50% on Monday after the company reported new Phase 2 data from a study evaluating an experimental pneumococcal vaccine in infants. The company said VAX-24 was...

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FDA reschedules opioid-focused advisory meeting

A meeting of outside experts to discuss the FDA’s post-marketing requirements for opioid medications is now slated for May 5 after being postponed earlier this year. The meeting — originally scheduled...

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Heart gene therapy company Tenaya to lay off 30% to 40% of staff

Heart gene therapy maker Tenaya Therapeutics is laying off 30% to 40% of its staff by the end of the year, the company’s CEO Faraz Ali told Endpoints News by email. Tenaya had 97 employees ...

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FDA changes may not be over after Marks exit, with more cuts and departures

A top official pushed out over vaccines. Senior staff heading for the exit. Thousands of workers targeted for firing. A new commissioner who has yet to visibly take charge ...

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DC court sides with HHS in Vertex's fertility program fight

Vertex lost a legal battle against the federal government on Monday over its proposed fertility support program that would have offered up to $70,000 in services for certain gene therapy patients. A DC...

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Federal judge nixes FDA's lab-developed test rule

The FDA overstepped its authority when it issued a rule last May to bring laboratory-developed tests under the agency’s regulation, a Texas federal court held on Monday. The decision is a ...

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J&J’s third talc bankruptcy bid is stopped by Texas federal judge 

A federal judge on Monday dismissed a Johnson & Johnson subsidiary’s third attempt to settle tens of thousands of talc cases through bankruptcy. Judge Christopher Lopez cited multiple issues with...

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Sanofi continues its bet on R&D by poaching GSK’s head of development

Sanofi is boosting its research and development team by hiring GSK’s former head of development Chris Corsico, according to an internal company communication obtained by Endpoints News. Corsico will...

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Lilly claims Phase 2 win for siRNA approach to mixed dyslipidemia

Eli Lilly’s RNA candidate has reduced levels of a protein linked with cardiovascular disease risk in a mid-stage trial in patients with high cholesterol. Solbinsiran, a small interfering RNA,...

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RNA editing startup AIRNA raises $155M for liver and lung disease therapy

When the transatlantic startup AIRNA launched in 2023, it was already years behind other companies that were trying to bring a new form of genetic medicine known as RNA editing into the clinic. But...

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