Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amryt, Cansino, Incyte, Insmed, JCR, Merck, Protagonist, RDIF, Zealand.
With the December PDUFA date already blown, Pfizer Inc. is headed into a day-and-a-half FDA advisory committee meeting this week to make the case for 2.5-mg tanezumab, a potential first-in-class treatment in the U.S., partnered with Eli Lilly and Co. Inc., for chronic pain due to moderate to severe osteoarthritis.
“We’re launching at the right time,” said Frank Sanders, president of Zealand Pharma A/S’s business in the U.S., in the wake of clearance granted by the FDA for the Copenhagen, Denmark-based firm’s glucagon analogue Zegalogue (dasiglucagon) in severe hypoglycemia.
The latest global regulatory news, changes and updates affecting biopharma, including: MHRA resumes some onsite inspections; Kyprolis discount opens door to U.K. coverage; HHS delays Trump ‘Sunset’ rule.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chiasma, Clarus, Crinetics, Lumos, Neurocrine, Strongbridge, Rezolute, Rhythm, Theratechnologies.
Barely five and a half years since the company was founded, Kiniksa Pharmaceuticals Ltd. has moved its first drug over the finish line, winning FDA approval for interleukin-1 blocker (IL-1) rilonacept to treat recurrent pericarditis and reduce the risk of recurrence in adults and children 12 and older.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Idorsia, J&J, Kiniksa, RDIF.
Now that Johnson & Johnson (J&J), through its Janssen Pharmaceuticals unit, has won the FDA’s nod for Ponvory (ponesimod), market factors will decide how the once-daily oral selective sphingosine-1-phosphate receptor 1 modulator fares against several others already approved in the class.
Although U.S. President Joe Biden has yet to nominate his choice to lead the FDA, his nomination of Xavier Becerra as the next Health and Human Services (HHS) secretary – and Becerra’s Senate confirmation March 18 – could signal a shift to a more conservative approach at the FDA when it comes to approving new drugs and devices.
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