Latest News & Analysis
Bayer shares results from a consulting firm's assessment of its operations, procedures and testing at the root of Coppertone SPF claims and other labeling aspects. The firm could get in front of a conversation that tends to arise this time of year regarding sunscreen safety, effectiveness and truthfulness in marketing.
The EMA’s main scientific committee, the CHMP, has rejected AB Science’s potential mastocytosis drug masitinib, but the company has asked for a re-examination of the decision on a number of grounds, including the fact that it has implemented GCP corrective actions and that updated information shows the product to have “acceptable” long-term safety.
Amid an escalating tussle with the health ministry over the level of South Korean drug prices, foreign pharma firms operating in the country are now proposing the launch of a new joint study on the issue with the incoming government.
US FDA received several applications for new molecular entities last week, including a BLA for Alphaeon's Botulinum toxin that came just three years after number trails began.
Keeping track of US FDA approvals last week included watching the creative and the familiar.
If US FDA Commissioner Gottlieb allows use of in-dwelling ports in ESSENCE study, Office of Pediatric Therapeutics will assess whether the determination could serve as precedent for placebo-controlled trials of other exon-skipping compounds in Duchenne muscular dystrophy.
Hoping to hold off a biosimilar to Remicade, Janssen challenges Samsung's decision not to participate in patent dance as it claims infringement of three manufacturing patents.
Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.
One tier could provide two-year exclusivity, should FDA request clinical trials for new conditions or ingredients, under a US Senate discussion draft. Essentially stalled monograph process would be replaced by deadlines for FDA action in under two years.
FDA's “Wayback” archive; EMA's whistleblower policy; IPRF's drug ID plan; reprieve for DMF holders; investigational compounding; PK/PD for kids; ISPE on quality culture; PDA on quality risks.
Pharmaceutical firms face more flak in India for allegedly flouting pricing norms – this time more than 200 formulations were allegedly launched in the country without seeking price approvals, though some companies claim they are fully compliant with the norms.
The sponsors of two products in the European Medicines Agency’s popular PRIME scheme for speeding patient access to drugs for unmet medical needs appear to be close to filing their applications for marketing authorization. Five more products were accepted on the scheme this week.
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