European regulators and health experts have recommended a second booster dose of mRNA COVID-19 vaccines for people between 60 and 79 years of age and for vulnerable people with medical conditions, as Moderna Inc. filed fresh data from its omicron subvariant-adapted shot.
More than two years after the U.S. FDA shocked Intercept Pharmaceuticals Inc. with its rejection of obeticholic acid to treat fibrosis due to nonalcoholic steatohepatitis (NASH), the company has announced data it said will form the basis of a NDA refile in the disease for which there is no approved therapy.
Hot on the heels of a groundbreaking deal brokered by the U.K.’s NICE to finance an antibiotic with a subscription-style payment plan, three European life sciences companies have formed a joint venture (JV) to create next-generation antimicrobials and diagnostics to fight antimicrobial resistance.
Genmab A/S, of Copenhagen, Denmark, said it intends to file a BLA with the U.S. FDA for its subcutaneous bispecific antibody epcoritamab, for patients with relapsed/refractory large B-cell lymphoma in the second half of 2022.
Pfizer Inc. and Biontech SE have signed a deal with the U.S. government to supply up to 300 million doses of COVID-19 vaccines in a deal worth more than $3.2 billion. Depending on the U.S. FDA, the vaccine doses fulfilling the order may include the companies’ omicron-adapted candidate, which they reported June 25 demonstrated a high immune response against the omicron BA.1 subvariant of SARS-CoV-2, when given as a fourth booster.
The U.S. FDA has put five phase III studies of Sanofi SA’s potential multiple sclerosis and myasthenia gravis blockbuster tolebrutinib on partial clinical hold after several cases of liver injury were identified after exposure to the drug. Sanofi said new recruitment in the U.S. is paused and participants who have been part of the trial for fewer than 60 days should stop taking tolebrutinib, although those taking the drug for longer can continue.
Shares in Ipsen SA edged higher June 29 after the firm announced it had refiled its palovarotene NDA with the U.S. FDA for the ultra-rare disease fibrodysplasia ossificans progressiva. The regulator granted a six-month priority review for the drug, which was once written off and had its FDA filing pulled in 2021 after officials asked for further analyses and data.
Spero Therapeutics Inc.’s oral antibiotic, tebipenem Hbr, has been rejected by the U.S. FDA for adults with complicated urinary tract infection, after the regulator said a further trial is needed for approval.
New data confirming that Gilead Sciences Inc.’s Hepcludex (bulevirtide) effectively cures hepatitis delta virus (hepatitis D), one of the most severe viral infections of the liver, and favorable phase III results from Madrigal Pharmaceuticals Inc.’s nonalcoholic steatohepatitis (NASH) contender were among the highest-profile scientific announcements at the International Liver Congress (ILC) 2022.
Although there has been huge progress in treatment of cystic fibrosis over the last decade, with Vertex Pharmaceuticals Inc. becoming the first to address the underlying cause of the disease with its Kalydeco (ivacaftor), approved in 2012, there are still many patients who aren’t eligible for treatment.
