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The FDA has issued a warning letter to a Lake Forest, Calif.-based biologics company, Invitrx Therapeutics, for selling unapproved allogenic cellular-derived drugs, including a human umbilical cord-derived product. Read More
Three union pension funds have filed a class action antitrust suit against Bristol Myers Squibb (BMS) and several generic drugmakers claiming the companies conspired to restrict competition on blockbuster blood cancer drug Revlimid (lenalidomide) and share in the profits, thus creating a monopoly. Read More
Newly proposed bipartisan legislation would require the Drug Enforcement Administration (DEA) to reclassify psilocybin and MDMA (“Ecstasy”) from Schedule I to Schedule II drugs, relaxing some of the federal laws that have so far complicated research on strictly controlled psychoactive drugs. Read More
Two years after its blood cancer treatment Blenrep (belantamab mafodotin) won accelerated approval from the FDA, GSK has removed the drug from the market in the U.S. at the FDA’s request. Read More
In response to the nationwide shortage of the antibiotic amoxicillin, the FDA yesterday released guidance that allows compounders to produce beta-lactam antibiotic liquid suspensions to help satisfy the increased demand. Read More
In a win for Pfizer, the Patent Trial and Appeal Board (PTAB) has declared that EtranaDez (etranacogene dezaparvovec), CSL Behring’s investigational gene therapy developed by uniQure for hemophilia B, isn’t unique at all, but merely a tweak of Pfizer’s patented method to increase clotting factor IX with adenovirus-delivered genetic codes. Read More
Regeneron Pharmaceuticals and CytomX Therapeutics have partnered to develop bispecific cancer drugs in a deal whose value could exceed $2 billion. Read More