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Nurix says protein degrader shows potential in Waldenstrom’s patients in...

Nurix Therapeutics’ BTK degrader has elicited responses in a small group of patients with certain cancers, supporting the biotech’s claim that the drug could potentially offer a better alternative to...

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Regenxbio shares new mid-stage data for its wet AMD gene therapy

Regenxbio released positive new data from a Phase 2 trial investigating its experimental one-time gene therapy for bilateral wet age-related macular degeneration (wet AMD). In the sub-study, the...

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Gilead, Merck's experimental long-acting HIV treatment heads to Phase 3

Gilead and Merck said their once-weekly pill to treat HIV resulted in a comparable level of viral suppression compared to a daily regimen in a 48-week study. In a rare partnership between large...

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AstraZeneca-backed CDMO Nucleus RadioPharma to boost commercial capacity

As the radiopharma space heats up, CDMO Nucleus RadioPharma is expanding its commercial manufacturing with two new facilities to cater to potential clients outside North America. The CDMO has started...

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FDA pilot to give more transparency on generic drug delays

BETHESDA, MD — The FDA is rolling out a new six-month pilot program to provide more transparency to generic drug applicants on complicated regulatory issues, Office of Generic Drugs Director Iilun...

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Starboard takes activist stake in J&J consumer spinout Kenvue

Less than 14 months after becoming a standalone company, Johnson & Johnson’s consumer healthcare spinout Kenvue is staring down an activist investor. The investor, Starboard Value, has built a...

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Lilly files more lawsuits over sales of copycat Zepbound

Eli Lilly has sued three more companies that claim to be selling versions of tirzepatide, the main ingredient in the drugmaker’s weight loss treatment Zepbound. The companies sued by Lilly include an...

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Biden administration calls for expanded contraception coverage

New rules that would require most insurers to cover over-the-counter contraceptives at no cost and without a prescription were proposed by the Biden administration on Monday. The move comes just weeks...

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AvenCell gets $112M to build switchable CAR-T therapies for ‘the last...

AvenCell Therapeutics on Tuesday said it collected $112 million to continue clinical studies of two experimental acute myeloid leukemia CAR-T cell therapies. The Series B raise comes despite cold...

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Roche, Genentech end anti-tau Alzheimer’s drug collaboration with UCB

UCB will advance its anti-tau antibody for Alzheimer’s disease solo after Roche and Genentech walked away from the asset known as bepranemab. In 2020, Roche and Genentech spent $120 million upfront and...

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FDA hits Camurus with CRL for acromegaly therapy over manufacturing issues 

The FDA handed a CRL to the Swedish biotech Camurus for its hormone disorder therapy over “facility-related deficiencies” at a third-party manufacturer. The therapy, dubbed CAM2029, had a PDUFA date of...

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#HLTH24: Former Amazon leader is betting the future of healthcare will blend...

LAS VEGAS — The future of how healthcare is delivered will be a hybrid mix of online and in-person care, much like how people shop both online and in-person. That’s according to Nworah Ayogu, head of...

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#HLTH24: Experts debate the way AI can transform mental healthcare

LAS VEGAS — AI may have a part to play in delivering mental healthcare, despite the empathetic and human nature of the specialty, but experts differ on what is considered safe. Leslie Witt Instead of...

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Pfizer activist Starboard says company must be held 'accountable' for R&D

Activist investor Starboard Value said Pfizer’s executives haven’t delivered on what they once called one of the best pipelines in the industry, and need to be held accountable by the company’s board...

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#HLTH24: 'It’s not right.' Califf slams pharma over weight loss drug prices

LAS VEGAS — FDA Commissioner Robert Califf criticized pharma companies on Monday for charging high prices for weight loss drugs. Califf called the profit margin in the US for the drugs “outrageous.”...

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Ahead of Novo’s CagriSema readout, Lilly returns to a promising new class of...

In its quest to stay at the top of the obesity drug market, Eli Lilly is following in Novo Nordisk’s footsteps by pursuing a new class of weight loss drugs. The Indianapolis drug giant said this month...

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MacroGenics sells rights to breast cancer drug; Rice’s new biotech accelerator

Plus, news about Annexon, Passkey Therapeutics, XOMA Royalty and Twist Bioscience: MacroGenics sells breast cancer drug rights for up to $75 million: The company is handing over Margenza’s rights to...

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Otsuka’s cytokine-targeting drug for IgAN clears Phase 3 hurdle

Otsuka Pharmaceutical’s 2018 purchase of Visterra seems to be paying off after its anti-APRIL antibody passed a registrational test in a rare kidney disease. The IgA nephropathy (IgAN) antibody, named...

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Editas pivots away from ex vivo sickle cell therapy in favor of in vivo approach

Editas Medicine is ousting its ex vivo sickle cell and beta thalassemia gene therapy to instead focus on an in vivo treatment for the diseases. The company announced Tuesday that it’s seeking to...

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Samsung Bio inks largest deal yet worth $1.24B with unnamed Asian pharma 

Samsung Biologics has so far secured at least five major contracts this year, and its latest with an unnamed Asia-based pharmaceutical company is its largest ever, worth $1.24 billion. The new contract...

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