Biotechnology, Drug, Pharmaceutical drug, Pharmacology, Drug development, Therapy
Flagship's Foghorn, partnered with Merck and Eli Lilly, gets a partial FDA hold after patient death
The FDA is tapping the brakes on a Flagship-backed biotech’s R&D efforts to develop a new treatment for blood cancers after a patient died in an early-stage study. Regulators issued a partial clinical hold to Foghorn Therapeutics, the biotech announced Thursday, pressing pause on a Phase ...
Flagship's Foghorn, partnered with Merck and Eli Lilly, gets a partial FDA hold after patient death
The FDA is tapping the brakes on a Flagship-backed biotech’s R&D efforts to develop a new treatment for blood cancers after a patient died in an early-stage study. Regulators issued a ...
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Bayer sounds retreat from a $670 million CAR-T pact in the wake of a patient death
Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma ...
Biotech Roundup: FDA Culpa, Tricida Trips, Freenome’s Funding & More
Among the casualties of the COVID-19 pandemic: the credibility of government agencies entrusted with protecting public health. The FDA this week granted
Foresight is 2020: A look at what’s ahead for biopharma
Executives from biopharma companies and an academic expert weigh in on what's in store for areas like cell and gene therapy, precision medicine and drug pricing.
12 burning questions for Stephen Hahn, Trump’s pick to lead FDA
Stephen Hahn, Trump’s nominee to helm the FDA, could face questions on any aspect of the agency's sprawling portfolio at today's confirmation hearing.
Seven Biopharma Trends to Watch in 2021
It’s not all COVID-19! Check out gene editing, gene and cell therapy, and other areas.
Public biopharmaceutical companies post strong gains in second quarter
The share prices of blue-chip biopharmaceutical companies closed out the month on a high note to contribute to their stellar collective performance during the second quarter, with the ...
Biogen’s Anuhelm Win Has Potential to Reinvigorate Alzheimer’s Investment
Despite controversy over the drug’s effectiveness, it appears to have spiked interest in investing in Alzheimer’s drug companies, something that had been on the decline for several years.
2018 New Drugs Approvals: An All-Time Record, And A Watershed
2018 stands out not only for the sheer volume of new drug approvals, but also for their quality, and the affirmation of several important trends that make it a watershed. There is every ...
Albumedix Announces CBER FDA Drug Master File Acceptance for Recombumin® Elite and Appointment of Director of Regulatory Affairs
Regulatory Assurances for Product Development Using Highest Quality Animal Origin-free rAlb Product Commercially AvailableAlbumedix Ltd. (‘Albumedix’), the world leader in ...