PERTH, Australia – A new parliamentary report, The New Frontier: Delivering better health for all Australians, is recommending significant reforms to the nation’s health care system to ensure Australians have faster access to new drugs and devices. The House of Representatives Standing Committee on Health, Aged Care and Sport examined the range of new drugs and emerging medical technologies that are in development and progressing through the regulatory system in Australia and in other countries.
Moderna Inc. reached a milestone of sorts Jan. 31 as the U.S. FDA fully approved its COVID-19 vaccine, Spikevax (elasomeran), for use in adults. Meanwhile, the Moderna and Pfizer Inc.-Biontech SE vaccines are in the sights of the U.S. Congressional Progressive Caucus, which is pushing the Biden administration to do more to ensure global vaccination.
Pfizer Inc.’s oral antiviral Paxlovid (nirmatrelvir) COVID-19 antiviral looks set for approval in the European Union after it was given the green light by its top regulatory committee. The EMA’s Committee for Medicinal Products for Human Use recommended conditional marketing authorization for treatment of COVID-19 in adults who don’t require supplemental oxygen but are at increased risk for progressing to severe disease.
Pfizer Inc. CEO Albert Bourla has been talking for the past few weeks about creating a vaccine to control the omicron variant. Now the company, with partner Biontech SE, has initiated a clinical study of its new candidate by testing it in healthy adults. Bourla has said the company can adapt its vaccine to new variants in under three months and could have one ready to go in March if necessary.
Once again, the U.S. FDA giveth and it taketh away. Just a few days after expanding its approval for Gilead Sciences Inc.’s Veklury (remdesivir) to provide access to more people infected with COVID-19, the FDA essentially shut down the use of two monoclonal antibody (mAb) treatments Jan. 24 that had been authorized to treat mild-to-moderate COVID-19 infections – Regeneron Inc.’s Regen-Cov (Ronapreve in Europe), an antibody cocktail of casirivimab and imdevimab, and Eli Lilly and Co.’s bamlanivimab and etesevimab that are administered together.
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.
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.
Cansino Biologics Inc. has received marketing approval from the NMPA for its ACYW-135 meningococcal conjugate vaccine, Menhycia, making it the first of its kind to be authorized in China. The approval marks “an important step in accelerating the development of China’s meningococcal vaccine immunization strategy,” the company said.
Should the U.S. government be in the business of manufacturing COVID-19 vaccines? Several prominent Democratic senators and representatives would say yes.
Two Janus kinase (JAK) inhibitors, Abbvie Inc.'s Rinvoq (upadacitinib) and Pfizer Inc.'s Cibinqo (abrocitinib), have won U.S. FDA approvals for the treatment of people with moderate to severe atopic dermatitis. Reviews of both products for the indication were delayed due to FDA concerns about class risks. Accordingly, each is labeled with a boxed warning regarding risks of serious infection, mortality, malignancy, major adverse cardiovascular events and thrombosis.
