Policy
Nader Pourhassan, who led CytoDyn for nearly 10 years, was convicted in December 2024 of misleading investors regarding the biotech’s investigational COVID-19 and HIV drug, which artificially inflated its share price.
FEATURED STORIES
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former U.S. Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
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-- Golodirsen has been studied for the treatment of exon 53 amenable patients, approximately eight percent of patients with Duchenne --
The FDA has been looking for ways to increase access to naloxone, an opioid overdose reversal drug, and the new guidelines are part of that effort.
Merck & Co. found itself with two new approvals this week. The FDA approved Lynparza (codeveloped by AstraZeneca and Merck) and also approved Merck’s Keytruda. Both of these drugs were approved for new indications.
InflaRx N.V. today announced the approval of an Investigational Medicinal Product Dossier (IMPD) from the European regulatory authorities, allowing InflaRx to initiate a phase II study with IFX-1, a first-in-class anti-human complement factor C5a antibody, in patients with ANCA-associated vasculitis (AAV).
With the holidays upon us, along with the end of 2018 and the beginning of 2019, the FDA squeezed some target action dates into the last weeks and beginning of the new year. As it turned out, these appear to be a mixed bag of extensions, resubmissions and supplemental applications, some of which are still pending while others have been approved earlier. Here’s a look.
As news continues about Johnson & Johnson’s talcum powder containing carcinogenic asbestos, more than 100 drug inspectors in India are seizing samples, characterized The Times of India. The company, however, downplays that description, suggesting that the samples are fairly routine.
Company to supply a six months’ stock of ready-to-use medicines in the event of an emergency
Amy Abernethy, the chief medical officer of Roche-owned Flatiron Health, has been named the Principal Deputy Commissioner of Food and Drugs at the U.S. Food and Drug Administration.
The Ministry of Health and Prevention organized a seminar on women’s heart health titled ‘Oxygen Plus for your Heart.’ Dr. Muna Al-Kuwari, Director of the Specialized Care Department, and Vice Chair of the Executive committee on Cardiovascular Index, attended the seminar along with representatives from Dubai Media Incorporated, the Ministry of Education, the UAE University, and the National Ambulance.
Generally speaking, the Orphan Drug Act has worked. More companies are willing to invest the millions of dollars needed to develop a drug that has a very small market.