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.
The good news first. A new U.S. Congressional Budget Office (CBO) report shows that, on average, Americans who can get the treatment they need with generics may be paying less for their prescription drugs than they were a decade ago. The bad news? Those who have no choice other than a brand drug may be paying a whole lot more.
PERTH, Australia – In preparation for easing COVID-19 restrictions and opening its international borders, Australia has added a new vaccine and two new oral antiviral therapies to its arsenal to fight the omicron variant of the SARS-CoV-2 virus that is sweeping the globe. Australia’s Therapeutic Goods Administration granted provisional approval on Jan. 20 to Biocelect Pty Ltd. (on behalf of Novavax Inc.) for its COVID-19 vaccine, Nuvaxovid, as well as two oral antiviral treatments.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Bioinvent, Chemocentryx, Cytomx, Galapagos, Gamida, Kinnate, Neurophth, Numinus, Regeneron, Revance, Yumanity.
The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) unveiled a proposal to overhaul its requirements for clinical trials for drugs and devices, just one of several significant regulatory proposals in recent months. One of the proposed changes would be to require more patient engagement in the design of trials, while another feature would allow sponsors to go through the MHRA process and an ethics review in a single application, thus potentially streamlining the up-front work required for these studies.
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