SUBSCRIBE
SUBSCRIBE

Brandon May

Policy
Concerns Over Open-Door Policy for COVID-19 Tests Cited in New FDA Letter
In an editorial letter in The New England Journal of Medicine, Jeff Shuren, M.D., the FDA’s device center director, and the agency’s in vitro diagnostics chief Timothy Stenzel, M.D., Ph.D., wrote that the agency planned to revisit their policy on antibody testing after it had authorized several serology tests.
February 17, 2021
 · 
2 min read
 · 
Brandon May
Drug Development
Should Employers Require COVID-19 Vaccination Before Returning to the Office?
As COVID-19 vaccine rollouts intensify across the country, employers across all industries are trying to decide whether they should implement a mandatory vaccine policy before they let employees back into the office.
February 16, 2021
 · 
2 min read
 · 
Brandon May
Drug Development
FDA Places Partial Clinical Hold on Trial of Alzheimer’s Drug Atuzaginstat
According to a statement made by Cortexyme, the partial hold was placed on the development program for atuzaginstat after an FDA review of the trial data identified hepatic adverse events.
February 16, 2021
 · 
2 min read
 · 
Brandon May
Pictured: Regeneron logo on a light brown building
Regeneron and Sanofi’s Libtayo Improves Survival in Advanced, Metastatic NSCLC
Findings from a pivotal trial published in The Lancet show Libtayo® (cemiplimab), a PD-1 inhibitor jointly developed and commercialized by Regeneron Pharmaceuticals and Sanofi, was superior to platinum-doublet chemotherapy for improving overall survival in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression in tumor cells.
February 12, 2021
 · 
3 min read
 · 
Brandon May
Genetown
Study: Exhaled COVID-19 Aerosol Droplets Dictated by Age, Infection and Body Mass Index
An observational study published in the Proceedings of the National Academy of Sciences suggests there is a strong positive association between the number of coronavirus disease 2019 (COVID-19) aerosol droplets an individual breathes out with age, infection and body weight.
February 11, 2021
 · 
3 min read
 · 
Brandon May
Genetown
Adicet Bio Prices Public Offering of Common Stock at $135 Million
Adicet Bio announced pricing of an underwritten public offering of 9,230,770 shares of its common stock, marking it at a public offering per-share price of $13.00.
February 10, 2021
 · 
2 min read
 · 
Brandon May
FDA
FDA Gives Thumbs Up to Sanofi-Regeneron Advanced BCC Treatment
The U.S. FDA has approved Regeneron and Sanofi’s PD-1 inhibitor Libtayo® for the treatment of patients with advanced basal cell carcinoma with a history of treatment with a hedgehog pathway inhibitor or in patients with advanced BCC who are considered ineligible for an HHI.
February 10, 2021
 · 
2 min read
 · 
Brandon May
Courtesy Niels Wenstedt/BSR Agency via Getty Image
Drug Development
Janssen Shows 35% Drop in Mortality with Prostate Cancer Drug
A final analysis of the Phase III TITAN study shows that Janssen’s ERLEADA®, when added to androgen deprivation therapy, significantly improved overall survival in patients with metastatic castration-sensitive prostate cancer (mCSPC) compared with placebo.
February 9, 2021
 · 
3 min read
 · 
Brandon May
Business
Former Biogen CEO Takes the Helm at Editas Medicine
James C. Mullen succeeds Cynthia Collins as Editas’ CEO, effective on February 15, 2021.
February 8, 2021
 · 
2 min read
 · 
Brandon May
Policy
SEC Slaps Biotech Consultant Mark Ahn with Insider Trading Charges
A Portland, Oregon biotech consultant is facing two counts of insider trading charges, with federal prosecutors and securities regulators claiming the defendant made profitable stock trades using confidential information he learned during his time consulting for Abeona Therapeutics.
February 8, 2021
 · 
2 min read
 · 
Brandon May
Pharm Country
New Study Shows How SARS-CoV-2 Evolves Into New, Antibody-Evading Variants
A new study report in Science suggests SARS-CoV-2 and its mutated new variants can evade immune responses via the selective deletion of small sections of the virus’s genetic sequence.
February 5, 2021
 · 
2 min read
 · 
Brandon May
Drug Development
Gilead’s Inhaled COVID-19 Treatment, Remdesivir, Requires More Adequate Testing Before Regulatory Approval
Foster City-based Gilead Sciences says its inhaled version of remdesivir, which has been increasingly used in research and practice to combat COVID-19 in hospitalized patients, won’t be available any time soon as it needs more testing in clinical research.
February 5, 2021
 · 
2 min read
 · 
Brandon May
Finasteride is accused of causing suicidal thought
Pharm Country
Investigation Finds Merck’s Anti-Baldness Drug Finasteride Long Linked to Suicide Reports
A new report shows Merck’s anti-baldness drug Propecia (finasteride) has been linked to more than 700 incidences of suicide and suicidal thoughts, side effects that both Merck and U.S. regulators allegedly knew about since 2011.
February 4, 2021
 · 
2 min read
 · 
Brandon May
Michael Vi/Shutterstock
Business
Amgen’s Sales Team Faces Layoffs, Hundreds of Jobs Cut at Headquarters
Amgen is in the process of eliminating hundreds of U.S. jobs, the majority of which are centered on the company’s sales team, according to a recent sales call.
February 4, 2021
 · 
3 min read
 · 
Brandon May
Biogen is planning to cut its Alzheimer's drug Adu
Drug Development
Biogen Ditches Parkinson’s Drug After Phase II Study Fails to Show Benefit
As the therapy “did not achieve proof-of-concept” and failed to provide benefit in this study, the development of the drug has been discontinued.
February 3, 2021
 · 
3 min read
 · 
Brandon May
Load More