Despite success in other parts of the world, Opko Health Inc. and Pfizer Inc. are still struggling to gain U.S. FDA approval for the recombinant human growth hormone somatrogon in treating pediatric patients, drawing a complete response letter (CRL) with their BLA. The delay caused by the setback gives Skytrofa (lonapegsomatropin) from Ascendis Pharma A/S a chance to charge even further ahead in the pediatric market.
Merck & Co Inc. has had a setback with its chronic cough drug gefapixant after the FDA rejected its NDA, a decision that also briefly hit the share price of rival Bellus Health Inc. before it regained market traction late Jan. 24. The FDA had been reviewing gefapixant since March 2021, but the regulator is now asking for additional information related to measurement of efficacy in a dreaded complete response letter. Merck said the response was not related to the safety of gefapixant, a P2X3 receptor antagonist, under development for treatment of refractory chronic cough (RCC) or unexplained chronic cough in adults. Shares in Merck (NYSE:MRK) ticked down 1.4% to $78.86 while Bellus Health shares (NASDAQ:BLU) rose by 1.8% to $5.66.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arch, Kura, Lannett, Regulus.
Administering multiple booster doses against COVID-19 is not sustainable in the longer term, international drug regulators said during a meeting of the International Coalition of Medicines Regulatory Authorities, held Jan. 12. Regulators argued that a long-term strategy should involve vaccines capable of tackling several variants at once, not just omicron, and that tweaking existing vaccines and comparing them with first-generation vaccines using clinical studies is the way forward, according to a report from the meeting.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Amgen, AN2, Aptorum, Argenx, Beigene, Betterlife, Clairvoyant, Compass, Idorsia, Jeil, Marker, Novavax, Nuvation, Omeros, Opko, Palleon, Pfizer, Rockwell, Senhwa, Turning Point.
The FDA posted a recall of a vaporizer unit that is used in several anesthesia gas machines distributed by Getinge USA Sales LLC, of Wayne, N.J., an issue that has triggered eight complaints. While no injuries or deaths have been reported, this is a class I recall due to the prospect that the problem can trigger irritation of the lung as well as pulmonary edema.
Targetingone Corp. Ltd.’s new testing kit based on digital polymerase chain reaction (dPCR) techniques has received approval from China’s NMPA. It is the first dCPR-based testing kit to receive the country’s class III medical device registration certificate. The Beijing-based company collaborated with Tsinghua University, several hospitals and the Chinese Center for Disease Control and Prevention (CDC) participated to research and develop the testing kit.
The COVID-19 pandemic has hit supplies and devices across a broad range of categories over the past two years, and the latest addition to the list is the blood collection tube. The FDA announced that this shortage affects all types of blood collection tubes, thus affecting tubes for all uses, not just those used for testing for the SARS-CoV-2 virus.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Capillary Biomedical, Cardiovascular Systems, Orbusneich.