Cassava and its former execs settle SEC charges for ‘misleading’ Alzheimer’s...
Cassava Sciences and two of its former executives have reached a resolution with the SEC over charges of “misleading” investors about the strength of data from a mid-stage Alzheimer’s disease study....
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Travere halts Phase 3 inherited disease trial due to manufacturing scale-up...
Travere Therapeutics said there is a “voluntary pause” in recruitment to its Phase 3 study in a rare, inherited disorder due to issues in scaling up its production process. The company said enrollment...
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FDA approves Dupixent in COPD, opening ‘next chapter’ for Sanofi and...
The biggest drug driving Sanofi’s and Regeneron’s businesses is about to get a bit bigger. On Friday, the FDA approved Dupixent as an add-on to typical inhaled medicines for patients with inadequately...
View ArticleWeightWatchers replaces CEO who spearheaded its push into prescription weight...
WeightWatchers said Friday that its CEO Sima Sistani, who shifted the weight loss giant’s strategy to prescribing obesity drugs, is stepping down from her role, effective immediately. The company...
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Novo Nordisk to decrease some insulin pen manufacturing, transition supply
Novo Nordisk has told government and global nonprofits that it plans to significantly downsize its manufacturing of some of its insulin pens, according to one of the groups, and will transition a...
View ArticleUS government renews threats over J&J's proposed 340B rebate model
The federal government renewed its threats to Johnson & Johnson on Friday over the company’s proposal to change how some hospitals receive drug price discounts under the 340B program. The company...
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For some multiple myeloma patients, Carvykti cut risk of death by 45%
Johnson & Johnson and Legend Biotech’s CAR-T cell therapy Carvykti reduced the risk of death by 45% compared to standard of care at almost three years for a portion of multiple myeloma patients,...
View ArticleMeet this year’s Endpoints 11; J&J winds down cardiovascular and metabolic...
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...
View ArticleUpdated: Pfizer to further decrease stake in consumer health company Haleon
Pfizer has continued shrinking its ownership in the British consumer health company Haleon. The New York drugmaker sold 640 million shares, raising about $3.26 billion in gross proceeds, according to...
View ArticleJ&J pulls the plug on 340B rebate model changes opposed by government
Johnson & Johnson has called off plans to implement a new rebate model for 340B drug price discounts following threats from the federal government. While continuing to defend the legality of the...
View ArticleCalifornia's Gavin Newsom vetoes bipartisan PBM reform bill
California Gov. Gavin Newsom vetoed bipartisan legislation on Saturday that would have reformed pharmacy benefit managers in the state, prompting the bill’s author to call the decision “a massive...
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FDA pledges to take next steps on advisory committee changes
As the potential end of Robert Califf’s time as FDA commissioner nears, he and a key deputy are continuing to push forward with changes to the advisory committee process. In a Nature commentary...
View ArticleAppeals court rules in favor of FDA regulating certain stem cell clinics more...
A court ruling Friday will open the door to the FDA more tightly regulating stem cell clinics and a commonly-used stem cell mixture known as stromal vascular fraction (SVF) treatments. The ruling, made...
View ArticleFederal judge dismisses longstanding suit over Bristol Myers' $74B Celgene...
A New York federal judge dismissed allegations on Monday that Bristol Myers Squibb purposely delayed Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights. Judge Jesse Furman...
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IGM scraps oncology work to focus on autoimmune, loses three executives
IGM Biosciences will stop working in cancer and shrink its T cell engager pipeline to focus on autoimmune diseases, the California biotech said late Monday. Fred Schwarzer The company’s CEO, Fred...
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Metsera partners with Amneal to manufacture obesity drugs, and Clive Meanwell...
Obesity startup Metsera is getting a new manufacturing partner and a new CEO. On Tuesday, the well-funded startup announced that it would bring on specialty pharmaceutical and generics manufacturer...
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Ron Renaud's new obesity biotech, Kailera, has $400M to go straight to Phase 3
There’s major money behind efforts to speed the next significant obesity company to the market. First, it was Metsera, which launched in April with $290 million and a busy pipeline. Now it’s Kailera...
View ArticleShattuck Labs cuts CD47 program and 40% of workforce as it focuses on IBD drug
Shattuck Labs is laying off 40% of its workforce and discontinuing its CD47 program in acute myeloid leukemia and higher-risk myelodysplastic syndromes following disappointing early-stage data. The...
View Article23andMe CEO says she is no longer open to outside takeover offers
23andMe CEO Anne Wojcicki has said she is no longer open to considering other buyers for the company in a securities filing Monday, the latest in her monthslong attempt to take the turbulent genetics...
View ArticleCVS considers breaking up the company as investors urge turnaround — reports
Struggling healthcare giant CVS Health is considering breaking up the company, including separating its pharmacy and insurance businesses, as part of a strategic review, Reuters first reported late...
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