Reuters Health News Summary

The US FDA has reversed its decision on Regenxbio's rare-disease gene therapy, indicating existing data could support 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 the U.S. FDA has indicated that existing data for its rare-disease gene therapy could support an accelerated ​approval application, reversing course months after declining to approve the treatment. Regenxbio shares were up 16%.

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 experimental drug met the main goal and key secondary goals in a late-stage trial in patients with a type of inflammatory bowel disease. At 12 weeks, the drug, tulisokibart, showed clinical remission in symptoms of ulcerative colitis.

US FDA declines to approve Achieve Life Sciences' smoking-cessation drug

The ‌U.S. Food and Drug Administration has declined to approve Achieve Life Sciences' drug to treat nicotine dependence in adults, citing unresolved issues found at a third-party manufacturing facility and final product labeling that was not completed by the agency's action date. The FDA did not identify any deficiencies related to the drug's clinical efficacy or safety in its complete response letter, Achieve added in its statement on Monday.

US FDA updates guidance to speed up drug development

The U.S. Food and Drug Administration said on Monday it is launching a series of measures to speed up drug research, from early-stage investigational studies to late-stage trials, under an initiative called Operation TrialBlazer. Here are some details:

Definium's LSD-based depression pill delivers strong late-stage results, shares surge

Definium Therapeutics said a single dose of its LSD-based experimental ‌pill significantly reduced symptoms of major depression in patients in a late-stage trial, sending its shares soaring 55% to a more than four-year high on Monday. The experimental drug 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, the company said.

Pfizer's ‌experimental drug misses main goal of lung cancer trial

Pfizer said on Monday its drug for a type of lung cancer missed the main goal of improving survival in patients compared to a generic drug in a late-stage trial. The drug was being tested in locally advanced, unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) who had received one or more lines of prior therapy versus docetaxel.

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 African court grants Novo Nordisk petition to block Ozempic copies

South Africa's High Court on Monday granted an interim order to block a local pharmacy group from manufacturing and selling weight-loss medicines containing semaglutide, the key ingredient in Novo Nordisk's Ozempic and Wegovy drugs. Following an application from Novo, the court ruled that iDexis and its director must immediately stop ⁠compounding, ​supplying and marketing semaglutide-based products pending the outcome of further investigations.

AbbVie sharpens immunology focus with $10.9 billion Apogee deal

AbbVie said on Monday it would buy Apogee Therapeutics for $10.9 billion, the company's largest buyout in more than five years, as it seeks to bolster its treatment pipeline for inflammatory diseases like atopic dermatitis and asthma. 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 leads in biotech quality, commercial reach, survey finds

China, which now conducts more clinical drug trials than the U.S., still lags in the quality and commercial reach of its biomedical science, 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.

Ebola infects more than 1,000 in Congo, spreads to kill toddler in new camp

Ebola has now infected more than 1,000 people in the Democratic Republic ⁠of Congo in an outbreak that has spread to a third displacement camp and killed an 18-month-old ⁠girl, official reports showed. The confirmed death count stood at 254, Congo's government said late on Sunday, more than a month after the declaration of the outbreak of the rare Bundibugyo strain that has no approved treatment or vaccine.

Nuvectis gains two experimental drugs in licensing deal with China's Haisco

Nuvectis Pharma said on Monday it had licensed exclusive rights outside China to two experimental drugs from Haisco Pharmaceutical Group, targeting complement-mediated diseases and cancer to broaden its pipeline. Here are some details of the deal:

Trump CDC nominee Schwartz to resign posts, sell holdings if confirmed

Erica ‌Schwartz, President Donald Trump's nominee to lead the U.S. Centers for ‌Disease Control and Prevention, said she will resign from UnitedHealth and board roles, sell healthcare-related holdings and recuse herself from matters involving former employers and clients if confirmed, in a financial disclosure ​to the HHS Ethics counsel. Here are some details from the letter dated June 16: