European Commission to work more closely with European Medicines Agency
The European Commission said Friday that it has officially adopted a new regulation explaining how it will cooperate more closely with the European Medicines Agency on health technology assessments...
View ArticleEMA again recommends against Duchenne muscular dystrophy drug Translarna
The European Medicines Agency’s human medicines committee again decided not to recommend the renewal of the conditional marketing authorization for PTC Therapeutics’ Duchenne muscular dystrophy drug...
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Apertura and Atalanta reduce headcount en route toward the clinic
Two central nervous system disorder biotechs laid off employees recently. New York gene therapy startup Apertura and Boston RNAi biotech Atalanta Therapeutics have trimmed their workforces, the two...
View ArticleFDA approves Astellas' gastric cancer drug Vyloy ahead of schedule
The FDA on Friday approved Astellas’ treatment for a type of gastric cancer, marketed as Vyloy (zolbetuximab). The approval came three weeks ahead of its scheduled PDUFA date of Nov. 9. Vyloy targets a...
View ArticleGLP-1 drugs from compounders won't be targeted by FDA, for now
The FDA clarified Thursday that it won’t take action against GLP-1 compounders for certain violations while it reevaluates Eli Lilly’s weight loss and diabetes drug tirzepatide’s removal from its...
View ArticleLykos is optimistic about MDMA treatment after meeting with FDA
Lykos Therapeutics said it had a “productive” meeting with the FDA to discuss a path forward for its recently rejected PTSD treatment, in the first public statement from the company since a tumultuous...
View ArticleNJ judge tosses Novartis' IRA lawsuit in another win for government
Novartis has lost its legal challenge against the Inflation Reduction Act on Friday, making it the sixth drugmaker rejected in federal court. New Jersey Judge Zahid Quraishi on Friday granted a summary...
View ArticleA Q&A with a Nobel Prize winner; Pfizer meets with Starboard; J&J reports Q3...
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View ArticleVertex shares full pivotal non-opioid pain data, showing better safety than...
Vertex detailed Phase 3 data for its non-opioid treatment that could mark a drastic shift in pain management. The company expanded on its interim readout on Sunday at the American Society of...
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Former Karuna crew quickly assembles $225M for next neuro bet at Seaport
The team at Seaport Therapeutics, a Boston neuropsychiatry biotech, is having a good fall season. Seaport said Monday it has pieced together $225 million from hefty crossover names and some of the...
View ArticleCatalent acts to reassure customers amid questions about antitrust
The contract manufacturer Catalent sent a letter to its customers Monday seeking to reassure them that little will change after the company’s deal with Novo Holdings, a transaction that will send...
View ArticleSepterna outlines $157M IPO after entering the clinic with GPCR pipeline
GPCR drug developer Septerna plans to raise about $157 million in net proceeds from its proposed initial public offering, according to a new securities filing Monday morning. The Nasdaq debut would...
View ArticleNovo says oral GLP-1 reduces heart events in Phase 3 diabetes trial
Novo Nordisk’s oral semaglutide lowered the risk of certain heart events in a late-phase study in people with type 2 diabetes and related metabolic conditions, sparking plans to file for a label...
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Q3 biotech roundup: The 2024 turnaround sputters into a critical Q4 finale
Some, though certainly not all, chief indicators of biotech business activity are pointed shakily north as we head into a critical Q4. But biotech shows signs of taking another step in the long, slow...
View ArticleGSK to put £50M into Cambridge University partnership; Angelini’s new deal
Plus, news about Takeda, Foresee Pharmaceuticals and Capricor Therapeutics: GSK, Cambridge University team up on immune diseases: The UK drugmaker is pouring £50 million ($65 million) into a five-year...
View ArticleNurix 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...
View ArticleRegenxbio 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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