FDA approves first reversible BTK inhibitor
The FDA granted Eli Lilly’s Jaypirca (pirtobrutinib) accelerated approval for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL), the company announced Friday.
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Amgen downsizes by 300 amid industry constriction
/in Business, R&D, TherapeuticsAmgen is implementing organizational changes that include laying off approximately 300 team members to “better manage against industry headwinds,” a company spokesperson confirmed to BioSpace via email Monday.
Moderna’s RSV vaccine snags FDA Breakthrough Therapy nod
/in Business, Clinical Trials, R&D, TherapeuticsThe FDA granted Moderna’s RSV vaccine candidate Breakthrough Therapy Designation Monday.
Phase III trial fails to confirm efficacy of Novartis’ SCD therapeutic
/in Business, R&D, TherapeuticsNovartis’ sickle cell disease therapeutic Adakveo (crizanlizumab) is under review by the European Medicines Agency’s Committee for Medicinal Products for Human Use after failing to replicate previous efficacy results in a Phase III trial.
Exclusive: Sanofi to let go of staff at vaccine plants in India as part of review
/in Business, R&D, TherapeuticsFrench drugmaker Sanofi SA is reviewing operations at two of its vaccine making facilities in India and plans to let go of all employees at the plants, the company told Reuters, after it failed to win a UNICEF contract.
WHO maintains highest alert over COVID, but sees hope ahead
/in Health, R&DThe World Health Organization (WHO) said on Monday that COVID-19 continues to constitute a public health emergency of international concern, its highest form of alert.
Indonesia finds local trader forged ingredient label in probe of cough syrup deaths
/in Health, TherapeuticsIndonesian police said on Monday a local trader of industrial-grade chemicals sold them as pharmaceutical-grade, leading to their use in medicated syrups that authorities suspect may have caused deaths of more than 200 children across the country.
Philips to cut 13% of jobs in safety and profitability drive
/in Business, Health, TherapeuticsDutch health technology company Philips will scrap another 6,000 jobs worldwide as it tries to restore its profitability and improve the safety of its products following a recall of respiratory devices that knocked off 70% of its market value.
Celularity warns of potential layoffs in strategic review
/in Therapeutics“As we invest to scale production of our commercial biomaterial products to meet expected demand in the United States and the Middle East, we are prioritizing our most promising cell therapy product candidates and programs and are rebalancing our workforce and identifying targeted expense reductions to support these priorities,” said CEO Robert J. Hariri.
New York Festivals Health Announces 2023 Executive Jury: 14 Healthcare Creative Leaders Will Judge Health Awards in NYC
/in Marketing & Advertising“2023’s NYF Health Executive Jury are recognized for their exceptional reputation and world-renowned award-winning work,” said Scott Rose, President, New York Festivals Advertising Awards Competitions.