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Italy’s Angelini Pharma announced plans to purchase Swiss drugmaker Arvelle Therapeutics in a deal worth up to $960 million, gaining access to the epileptic seizure drug cenobamate which it plans to market in Europe. Read More
Amerisource Bergen, the second largest U.S. wholesale drug distributor, announced that it is acquiring the Walgreens Boots Alliance European distribution unit, Alliance Healthcare, in a deal valued at $6.5 billion. Read More
The long-time director of the FDA’s Center for Drug Evaluation and Research (CDER), Janet Woodcock, who stepped aside last year to head the therapeutics arm of the U.S. government’s Operation Warp Speed (OWS) initiative, is taking up a new role as principal medical adviser to FDA Commissioner Stephen Hahn. Read More
The European Commission granted conditional marketing authorization for Moderna’s highly effective COVID-19 vaccine Wednesday, adding a second messenger RNA-based vaccine to its arsenal against the pandemic. Read More
The U.S. government is moving ahead of schedule on a vaccine partnership with pharmacies across the country to speed up inoculations with the Pfizer/BioNTech and Moderna vaccines and it will start the program this week, HHS Secretary Alex Azar announced yesterday. Read More
Wholesale price increases for brand-name drugs analyzed by the research group 46Brooklyn outpaced inflation for the past two years with a median increase of 5 percent in both years. Read More
Sponsors of human gene therapy (GT) products for neurodegenerative diseases affecting adults and children should initiate first-in-human clinical trials in adults before undertaking pediatric trials, according to new draft guidance the FDA released last week. When pediatric trials must be conducted first, sponsors should provide a rationale for why adult studies are not ethical or feasible, the guidance says. Read More
Effective Jan. 1, drugmakers can now seek accelerated drug approvals in the UK using the newly launched Innovative Licensing and Access Pathway (ILAP). Read More
HHS has made it known that pharma companies are required to offer 340B discounts for covered drugs even when they’re distributed by contract pharmacies, speaking out after several big drugmakers began withholding them. Read More