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Merck finally has subcutaneous Keytruda results, and it's going to regulators

A decade after Keytruda hit the market, Merck has now said a subcutaneous version of the immunotherapy passed a Phase 3. That means Merck will discuss the ...

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Jupiter Bioventures raises $70M fund for 'super-early' science

They've got $70 million, two guys named Ned, and plans to go after early-stage science where other venture capital firms "would fear to tread." On Tuesday, Jupiter Bioventures revealed itself as a new...

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Pharma’s global access efforts have stalled, new report finds

Efforts by the pharmaceutical industry to expand access to low- and middle-income countries need to be “vastly accelerated” and in some cases have fallen behind, according to a new report. The Access...

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Pharma telehealth programs are catching on and raising questions

A new way of selling medications has landed pharmaceutical companies in lawmakers’ crosshairs. Earlier this year, Eli Lilly unveiled a service called LillyDirect to connect patients seeking its...

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Bayer, Cytokinetics make a deal in Japan; Ex-Carmot CEO to run LB...

Plus, news about Spyre, Tongrui Biotech, ATB Therapeutics, Freya Biosciences, Intas and Xbrane: Bayer, Cytokinetics ink deal for heart drug in Japan: The German drugmaker is paying €50 million upfront,...

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#ACR24: Bristol Myers takes on autoimmune diseases with cell therapy; New...

Bristol Myers Squibb recently presented data for the first time from its clinical trial of a cell therapy for autoimmune diseases, which has quickly become one of the most crowded fields in biopharma....

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J&J, Protagonist reveal two Phase 3 wins for oral IL-23 drug that's expected...

Johnson & Johnson and Protagonist Therapeutics announced two Phase 3 successes for their oral IL-23 drug, showcasing the first results out of an expansive pivotal trial program in plaque psoriasis....

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Lilly’s oral lipid drug passes mid-stage test

Eli Lilly reported positive data for its drug candidate for elevated lipids, marking a key milestone for a potential oral option in a space dominated by injectable candidates. Lilly’s muvalaplin met...

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BeiGene settles final suit over future Brukinsa generics

BeiGene has settled a lawsuit with generics manufacturer MSN Pharmaceuticals, resolving all cases associated with the entry of Brukinsa alternatives in the US. The pharma said Tuesday that MSN agreed...

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Chinese drugmaker receives FDA warning letter after management hindered...

The FDA handed Chinese pharmaceutical company Tianjin Darentang Jingwanhong Pharmaceutical a warning letter after it removed information from translated manufacturing records and refused to let agency...

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FDA raises safety questions on AstraZeneca's bleeding reversal agent

The FDA on Thursday will convene an advisory committee to discuss the safety and efficacy of AstraZeneca’s Andexxa, which won accelerated approval in 2018 to reverse the anticoagulation effects of...

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FDA rejects Astellas' effort to support longer use of Izervay 

The FDA has denied Astellas’ attempt to bolster the label for its vision loss treatment Izervay with additional two-year data. Izervay, the centerpiece of Astellas’ $5.9 billion acquisition of Iveric...

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NICE has 'done all we can' to negotiate for Enhertu coverage

The UK's drug pricing body has affirmed its earlier decision not to recommend coverage of AstraZeneca and Daiichi Sankyo’s breast cancer treatment Enhertu. “As we’ve always made clear, the fastest and...

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GSK plots regulatory filings for PBC itch after positive Phase 3 readout

GSK’s linerixibat helped reduce itch in patients with a rare bile duct disease, meeting its primary endpoint in a late-stage trial. If approved, linerixibat would be the first drug on the US market to...

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Pfizer partners with two more Flagship biotechs on obesity, cancer

Pfizer is enlisting another Flagship startup to help it create new obesity medicines. After June's ProFound Therapeutics tie-up, Pfizer will work with the incubator's Ampersand Biomedicines in the hunt...

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Exclusive: Former Pfizer commercial chief Angela Hwang to join Flagship

Former Pfizer exec Angela Hwang is joining Flagship Pioneering as a CEO-partner and chief executive of its startup Metaphore Biotechnologies on Jan. 1, the incubator exclusively told Endpoints News....

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Carolyn Bertozzi’s new biotech debuts with $30M for immunotherapy work

Valora Therapeutics has $30 million to jump-start research on immunotherapies based on sugars — the kind that dots cell surfaces and helps devastating cancers evade immune system attacks. The San Diego...

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Pfizer taps oncology head Boshoff as Dolsten's chief scientific officer...

Chris Boshoff, the head of Pfizer's cancer R&D unit, will become the pharma giant's new chief scientific officer and president of R&D on Jan. 1, the drugmaker said Wednesday morning. ...

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Updated: Sage reports Phase 2 failure in Huntington's disease, ends drug's...

Sage’s final hope to turn its business around has failed, leaving the future of the once high-flying company and its postpartum depression drug uncertain. The company announced Wednesday morning that a...

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23andMe inks new research partnership as it winds down internal drug...

23andMe has notched a research partnership with Mirador Therapeutics to provide the biotech company with access to its trove of genetic data. Mirador, which launched with more than $400 million in...

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