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It was based on data from the APOLLO trial showing the drug significantly decreased the risk of progression or death by 37% compared to dexamethasone alone.
The company said that it values the FDA’s feedback and is happy that the agency has accepted its request to provide insights on its Hepatitis B development program.
The first nonsteroidal mineralocorticoid receptor antagonist (MRA) is approved for adults with chronic kidney disease associated with type 2 diabetes.
HHS issued their announcement, saying, “Americans who have been fully vaccinated do not need a booster shot at this time.”
Adulhelm’s proposed price tag of $56,000 per patient per year is hardly the most expensive drug on the market, but controversy regarding packaging and pricing continues.
A former CEO of Vyera and other activist investors are pushing a slate of new company directors who would steer control of Phoenixus and Vyera away from Shkreli.
Morgan had determined that adding one dose of the Moderna or Pfizer-BioNTech mRNA vaccine to one of Oxford-AstraZeneca’s viral vector technology would equal stronger immunity.
While the drug showed significant improvement in patients on a 200mg daily dose of filgotinib, it may not be promoted in the states any time soon.
Pharmaceutical Continuous Manufacturing Market: Rising to be New Trend With its Magnificent Features
The pharmaceutical continuous manufacturing market is expected to reach US$ 3,064.38 million by 2027 from US$ 1,459.53 million in 2019. The market is estimated to grow at a CAGR of 9.8% from 2020 to 2027.
Acting commissioner of the U.S. FDA asked the independent Office of the Inspector General to investigate how the FDA and representatives of Biogen interacted prior to the FDA’s approval of the company’s Aduhelm (aducanumab) for Alzheimer’s disease.
The company launches with the new funding to advance its focus on first-in-class small molecule therapies for neurodegenerative diseases.
Sana Biotechnology, a gene and cell therapy hybrid whose mission is to create and deliver engineered cells as medicines for patients, puts the “I” first in Inclusion, Diversity and Equity (IDE).
PRESS RELEASES
· Supporting the development of its proprietary MIC-Lx Modified Immune Cells technology as a novel approach to reduce lifelong systemic immunosuppression and improve long-term outcomes for transplant recipients · Strengthening MIC-Lx’s regulatory and commercial positioning in Europe
- EUR ~8M grant supports the late-stage clinical development of Omnix’s antimicrobial OMN6 - Leading European partners join forces to advance OMN6 for the treatment of life-threatening hospital-acquired infections