Capricor to begin filing DMD drug with FDA next month; Surrozen’s $10M milestone
Plus, news about Adaptimmune, Roche, LIfT BioSciences, VerImmune, and Revance Therapeutics: Capricor Therapeutics to file Duchenne cardiomyopathy treatment with the FDA: The San Diego-based biotech in...
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Wave rides new Phase 2 DMD data as it sets sights on accelerated approval
Wave Life Sciences said new Phase 2 biomarker data for its exon-skipping therapy are promising for certain patients with Duchenne muscular dystrophy, and it plans to discuss accelerated approval plans...
View ArticleRegeneron hits setback in Eylea patent battle with Amgen
Regeneron’s stock $REGN dipped about 4% on Tuesday following a loss in its legal battle with Amgen over competitors to its blockbuster eye treatment Eylea. While Regeneron previously defended itself in...
View ArticleSIGA fires former NYC Covid advisor after secret recordings detail...
Biotech company SIGA Technologies has fired chief medical officer Jay Varma, days after the publication of secret recordings of the former New York City public health advisor talking about how he...
View ArticleNovo Nordisk CEO skeptical of PBM promises in Senate hearing on weight loss...
Sen. Bernie Sanders (I-VT) told Novo Nordisk CEO Lars Fruergaard Jørgensen that three major pharmacy benefit managers have agreed not to penalize the company for lowering the list prices of its popular...
View ArticleFDA adcomm will reexamine approval of checkpoint inhibitors in two cancers...
The FDA’s Oncologic Drugs Advisory Committee will meet Thursday to discuss whether several immune checkpoint inhibitor drugs should come with narrower indications in two cancers, based on emerging data...
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Amgen reports dual Phase 3 wins in atopic dermatitis and myasthenia gravis
Amgen released data from two pivotal trials on Tuesday that showed its experimental drug rocatinlimab succeeded in a Phase 3 test in atopic dermatitis, while its approved drug Uplizna also yielded...
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Italian gene therapy startup nabs $52M for rare genetic disease that Moderna...
Genespire patched together a €46.6 million (about $52 million) funding round to get its lead gene therapy into the clinic in a few years. The Milan-based biotech, which employs nine people, said...
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2seventy bio, Bristol Myers end late-stage Abecma study in multiple myeloma
2seventy bio and its partner Bristol Myers Squibb said Wednesday that they are discontinuing enrollment in the Phase 3 KarMMa-9 study investigating Abecma in patients with newly diagnosed multiple...
View ArticleFDA OKs IntraBio's drug less than a week after rare disease's first-ever...
Within the span of a week, the FDA gave the green light to another drug for the rare condition Niemann-Pick disease type C in the form of IntraBio’s levacetylleucine. On Friday, the FDA approved Zevra...
View ArticleMerck's LAG-3 plus Keytruda combo fails Phase 3 in colorectal cancer
Merck’s efforts to combine its PD-1 blockbuster Keytruda with an experimental LAG-3 inhibitor hit a stumbling block Wednesday morning. The company said a Phase 3 study testing the LAG-3 program...
View ArticleSanofi inks deal with I-Mab; Wave discloses $175M offering on heels of DMD data
Plus, news about BioAge, Fulcrum Therapeutics and Arcutis Biotherapeutics: Sanofi snags Greater China rights to CD73 antibody: The French pharma will pay TJ Biopharma €32 million (or about $35 million)...
View Article#EADV24: Novo's semaglutide shows potential in chronic skin condition in...
A small study conducted by researchers at St. Vincent’s University Hospital in Dublin suggests that Novo Nordisk’s GLP-1 semaglutide could treat a common and chronic skin condition called hidradenitis...
View ArticleCelldex reveals Phase 2 responses for chronic hives drug and higher rates of...
Celldex Therapeutics has unveiled 52-week results from a mid-stage study of its anti-KIT drug in chronic hives, raising anticipation for ongoing registrational studies. But the company’s shares $CLDX...
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Emergent says it has $400M in orders related to mpox outbreak
Emergent BioSolutions has secured around $400 million worth of orders for its smallpox and monkeypox products, including its vaccine being used to help protect against a mpox outbreak in Africa. The...
View ArticleBaltimore sues Biogen, saying the company colluded with PBMs to minimize...
Baltimore’s mayor and city council have sued Biogen, alleging that the Boston-based drug developer worked with pharmacy benefit managers to suppress generic versions of a popular multiple sclerosis...
View ArticleEMA to discuss Pfizer's sickle cell drug Oxbryta after patient deaths
The European Medicines Agency will meet on Thursday to discuss Oxbryta — the sickle cell treatment Pfizer inherited in its $5.4 billion acquisition of Global Blood Therapeutics — following patient...
View ArticleUK watchdog criticizes Moderna for Covid-19 trial's use of WhatsApp to dangle...
The UK’s pharma marketing watchdog, the Prescription Medicines Code of Practice Authority, is taking issue with the way Moderna allegedly sought to increase participation in a Covid-19 vaccine trial...
View ArticleJ&J folds cardiovascular and metabolic drug unit
Johnson & Johnson is winding down its pharma division’s cardiovascular and metabolic unit, Endpoints News has learned. The decision primarily impacts the sales, marketing and medical affairs teams,...
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Pfizer pulls sickle cell drug from all markets after data review showed rise...
Pfizer said it will withdraw its sickle cell disease treatment Oxbryta from all markets worldwide, after data showed an “imbalance” of fatalities and complications common to the disease. The surprise...
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