FDA's Peter Marks single-handedly approved Sarepta’s gene therapy — what does...
Is Sarepta special? Or has the FDA set a new precedent for how it approaches treatments for devastating diseases with few options? On Thursday, the FDA announced it was expanding the allowed use of...
View ArticleArgenx wins second FDA approval for Vyvgart in another autoimmune nerve disease
After a string of clinical failures, the Dutch biotech argenx landed a much-needed win on Friday when the FDA approved its autoimmune disease drug, Vyvgart, for a second rare condition. The disease,...
View ArticleSarepta's big gene therapy expansion; Inside Iambic's AI cycle; Vertex, Lilly...
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 ArticleSchizophrenia biotech LB Pharmaceuticals eyes near-term IPO filing — source
New York-based LB Pharmaceuticals is preparing to file for an initial public offering as investor and pharma enthusiasm grows for the neuroscience space, a source familiar with the company’s plans told...
View ArticleBlood cancer biotech Ascentage Pharma files for US dual listing
Ascentage Pharma, a Hong Kong-listed blood cancer biotech, is planning a dual listing in the US as it prepares for additional drug launches, it said Sunday evening. The biotech, which has offices in...
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Lykos’ pain is others’ gain as psychedelic biotechs take notes from adcomm vote
Lykos’ near-unanimous rejection from an FDA advisory panel earlier this month jolted a psychedelics industry that seemed to be finally hitting its stride. But the race to market is far from over. “Our...
View ArticleUK taps Pfizer over hometown GSK to supply RSV vaccine doses
The UK government has selected Pfizer to supply millions of respiratory syncytial virus (RSV) vaccine doses, snubbing local pharma company GSK and its competing product. The New York-based pharma...
View ArticleCorrected: Entrada raises $100M for Duchenne development; eFFECTOR winds down
Plus, news about NeuroBo, Vico Therapeutics, Takeda, Checkpoint Therapeutics, CombiGene, Spark Therapeutics, ANI, Alimera Sciences and OSE Immunotherapeutics: Entrada Therapeutics raises $100M from...
View Article#ADA24: Gilead, Viking and Biohaven detail promising preclinical research in...
In a twist, preclinical research in metabolic disease is peaking more investor interest at the American Diabetes Association’s annual meeting than in past years. As the GLP-1 and weight loss market...
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Novo reveals more hemophilia A data showing superiority in annualized...
Ahead of an FDA filing later this year, Novo Nordisk on Sunday offered up more detailed hemophilia A data from its Phase 3a trial investigating Mim8, a factor VIIIa mimetic bispecific antibody. The...
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Phase 3 breast cancer failure leads to staff cuts, stock drop at G1 Therapeutics
G1 Therapeutics said its lung cancer drug Cosela didn’t fare better than a placebo in extending the lives of breast cancer patients. In the Phase 3 trial of metastatic triple-negative breast cancer...
View ArticleNovo Nordisk budgets $4.1B for new US manufacturing site as it abandons plans...
Novo Nordisk is further boosting manufacturing in the US for its obesity drugs as it injects $4.1 billion for a second fill-finish facility in Clayton, NC. But the Danish company is pulling back...
View ArticleMerck KGaA's bet on head and neck cancer drug from Debiopharm ends in Phase 3...
Merck KGaA’s Phase 3 trials of xevinapant, the cancer drug it licensed from Debiopharm in 2021, are winding down after the drug showed that it wouldn’t hit the primary endpoint in one of the trials....
View ArticleHouse committee presses FDA on signs of inconsistent inspections in China and...
Republican leaders on the House Energy and Commerce Committee are raising more questions about the FDA’s inspections in India and China after finding inconsistencies in the way some inspectors have...
View ArticleKorea-based Bridge Biotherapeutics closes Boston office
Bridge Biotherapeutics has closed its Boston-area discovery wing, according to sources familiar with the decision by the South Korean drug developer. The closure came in the last few weeks, about four...
View ArticleGrail prepares for public debut, and challenges of going independent, after...
Grail has burned cash to pioneer an emerging field that screens for multiple cancers in a blood sample. But now the company faces questions about whether it can reshape cancer screening without...
View ArticleExsilio Therapeutics raises $82M for mRNA-based gene therapy, led by Tal Zaks
Exsilio Therapeutics has raised $82 million in hopes of using mRNA to surmount the limitations of current gene therapies. mRNA is a medium that the biotech’s chairman and interim CEO Tal Zaks is...
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Ex-Meta scientists launch EvolutionaryScale with $142M seed round, unveiling...
Evolution is very powerful and very slow. A new startup thinks it can harness its might — without the millennia of waiting around. The startup EvolutionaryScale launched Tuesday with a $142 million...
View ArticleNew cancer biotech emerges from Stanford research, with help of Nobel...
A new solid tumor biotech based on research out of Stanford University is targeting the red-hot fields of cancer immunotherapy and antibody-drug conjugates. TwoStep Therapeutics unveiled itself on...
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AstraZeneca’s Imfinzi aces Phase 3 test in bladder cancer, fails another in...
You win some, you lose some: AstraZeneca’s blockbuster cancer medicine Imfinzi has succeeded in a late-stage bladder cancer trial, but disappointed in a separate Phase 3 lung cancer study. The...
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