Reuters Health News Summary

The US FDA has reversed its earlier rejection of Regenxbio's rare-disease gene therapy, paving the way for an accelerated approval application.

Following is a summary of current health news briefs.

US FDA reverses course on Regenxbio's rare-disease gene therapy, backs accelerated approval bid

Regenxbio said on Monday that the U.S. FDA had indicated it would ​reverse the earlier rejection of the company's rare-disease gene therapy, and that existing data would be sufficient to support an accelerated ​approval application. Shares of the Rockville, Maryland-based drug developer were up 10% in premarket trading.

China launches ‌inquiry ​into presence of formamide in diapers, CCTV reports

China's state market regulator has launched an inquiry into the presence of formamide in infant diapers, state broadcaster CCTV reported on Monday. Three diaper brands, Babycare, Huggies and Bibabebe, have said internal tests showed no trace of the substance in their products, according to a report by Global Times, a tabloid owned by China's paper of record People's Daily.

Merck's bowel disease drug meets main goal ‌in late-stage trial

Merck said on Monday its drug met the main goal in a late-stage trial testing it in patients with a type of inflammatory bowel disease. After 12 weeks, the drug, tulisokibart, showed clinical remission in symptoms of ulcerative colitis.

Definium's LSD-based pill reduces depression symptoms in late-stage trial

Definium Therapeutics said on Monday that a single dose of its LSD-based experimental pill significantly reduced symptoms of major depression in patients in a late-stage trial. The New York-based company said its drug, DT120, helped patients record significantly lower scores on a standard depression scale than those on placebo after six weeks, with an 8.1 point difference, meeting ‌the trial's main goal.

France bans alcohol consumption at music festivals under red heatwave alert

France said on Saturday that alcohol consumption during the annual Fete de la Musique festivals would be banned on June 21 in the departments or administrative districts that will be placed under ‌the red heatwave alert from noon on Sunday. "Prefects will issue decrees banning alcohol consumption in public spaces in the departments under red alert," the Prime Minister's office said in a statement following a crisis meeting called by PM Sebastien Lecornu.

Inghams locks down farms after Australia reports second H5N1 case

Inghams Group on Monday implemented a complete lockdown across all of its Western Australian farms and processing operations after Australia reported a second case of the highly pathogenic H5N1 bird flu. Here are some details:

Australia reports second H5N1 bird flu case in migratory seabird

Australia reported a second case of highly pathogenic H5N1 bird flu in Western Australia on Monday, after confirming its first over the weekend, as the government vowed to rein ⁠in the spread of ​the virus. A migratory seabird known as a northern giant petrel found sick on ⁠a remote beach tested positive, Agriculture Minister Julie Collins said, after a brown skua case on Saturday. Both birds were found near the coastal town of Esperance, about 570 km (350 miles) southeast of the state capital of Perth.

USDA reports three new cases of screwworm, bringing total to 15

The number of U.S. cases of New World screwworm has risen ⁠to 15 after three more animals tested positive in Texas, the Department of Agriculture said in a post on social media on Sunday. The USDA announcement comes nearly three weeks after the first domestic screwworm infestation in six decades was found in a Texas calf.

Factbox-Major deals involving US drugmakers and biotechs over the past decade

AbbVie has agreed ​to buy biotech Apogee Therapeutics for $10.9 billion in cash, as the U.S. drugmaker builds its next-generation immunology pipeline. The move adds to a growing list of high-profile transactions over the past decade by U.S. pharmaceutical companies to acquire promising therapies in fields ranging from ⁠oncology and neurology to rare diseases and obesity.

China approves CARsgen's CAR-T treatment for stomach cancer

China's drug regulator said on Monday it has approved a CARsgen Therapeutics treatment for stomach cancer, a new milestone for CAR-T therapies, which engineer patients' immune cells to recognise and kill cancer cells. The injection, also known as satri-cel, is globally the first approved CAR-T cell therapy for solid ⁠tumors, ​CARsgen CEO Li Zonghai told Reuters in an interview after the announcement.

South Africa court bars iDexis from selling compounded Ozempic in Novo Nordisk case

South Africa's High Court has granted Novo Nordisk an interim interdict barring a local pharmacy group from manufacturing and selling compounded weight-loss medicines containing semaglutide, in a ruling that shows tightening scrutiny of unregistered drugs. The Gauteng Division of the High Court in Pretoria ruled on Monday that iDexis and its director must immediately stop compounding, supplying and marketing semaglutide-based products pending the outcome of regulatory processes and potential review proceedings.

AbbVie bets $10.9 billion on Apogee ⁠in next-generation immunology growth push

AbbVie said on Monday it would buy biotech Apogee Therapeutics for $10.9 billion, in its largest buyout in more than five years to strengthen its next-gen immunology pipeline. The acquisition, one of the largest biotech deals of the year, underscores the surge in pharmaceutical ⁠dealmaking, as companies race to build their portfolios ahead of looming patent expirations on ⁠blockbuster treatments.

China closing in but US still leads in biotech innovation, survey finds

China, which now conducts more clinical drug trials than the U.S., still lags in several key areas of biotechnology innovation, according to a recent survey of senior U.S. leaders in industry and academia. The poll, conducted by Cure Innovation Index, found that China is seen as the clear leader in two out of six sectors: clinical development and supply chain.

Congo says ‌confirmed Ebola cases rise over 1,000

The Democratic ‌Republic of Congo said late on Sunday that confirmed Ebola cases in the country had risen to 1,003, including 254 deaths. In an update on ​Saturday, the government put confirmed cases at 956 and deaths at 247.