Health News Roundup: Canada approves Pfizer's gene therapy for bleeding disorder; US FDA approvals bounce back in 2023, sparking hopes of a biotech recovery; FDA ordered to reconsider denial of approval for vape products and more

As in other key sectors over the past year, junior doctors represented by the British Medical Association (BMA) have staged a series of walkouts to demand better pay in the face of soaring inflation. Dyne's shares jump after promising data on muscle disorder treatment Shares of drug developer Dyne Therapeutics jumped 18% on Wednesday after its experimental therapy for a muscle-wasting disorder called Duchenne muscular dystrophy(DMD) showed promise in a small, early-stage trial.

Following is a summary of current health news briefs.

Texas can ban emergency abortions despite federal guidance, court rules

The U.S. government cannot enforce federal guidance in Texas requiring emergency room doctors to perform abortions if necessary to stabilize emergency room patients, a federal appeals court ruled on Tuesday, siding with the state in a lawsuit accusing President Joe Biden's administration of overstepping its authority. The ruling by a unanimous panel of the 5th U.S. Circuit Court of Appeals comes amid a wave of lawsuits focusing on when abortions can be provided in states whose abortion bans have exceptions for medical emergencies.

CVS will remove AbbVie's Humira from some drug reimbursement lists in April

CVS Health said on Wednesday it will remove AbbVie's blockbuster rheumatoid arthritis drug Humira from some of its lists of preferred drugs for reimbursement as of April 1, and will recommend biosimilar versions of the medicine instead. CVS said Hyrimoz and an unbranded version of Humira, both from Swiss drugmaker Sandoz, will be covered across all its formularies, while branded and unbranded near copies of the drug from India's Biocon will be covered on some reimbursement lists.

Agios Pharma's blood disorder drug meets goals of late-stage study

Agios Pharmaceuticals' drug boosted hemoglobin levels in some patients with thalassemia in a late-stage study, taking the company closer to approval for the first ever oral treatment for less severe forms of the inherited blood disorder. The drug, mitapivat, met the main goal of the study as it showed a statistically significant increase in hemoglobin response compared with placebo in patients suffering from either alpha- or beta-thalassemia and were not dependent on transfusion, the firm said on Wednesday.

FDA ordered to reconsider denial of approval for vape products

A federal appeals court on Wednesday ordered the U.S. Food and Drug Administration to reconsider its decision barring two makers of flavored liquid for e-cigarettes from marketing their products, saying the agency had been arbitrary and capricious in refusing to consider the companies' marketing plans. The 9-5 decision by the New Orleans-based 5th U.S. Circuit Court of Appeals reversed a July 2022 decision by a three-judge panel of that court.

Mask mandates return at some US hospitals as COVID, flu jump

Hospitals in at least four U.S. states have reinstated mask mandates amid a rise in cases of COVID, seasonal flu and other respiratory illness. Healthcare facilities in New York, California, Illinois and Massachusetts have made masks mandatory among patients and providers.

Record-breaking doctors' strike piles pressure on England's health service

Junior doctors in England started a six-day walkout over pay on Wednesday, the longest strike in the 75-year history of the state-run National Health Service (NHS), which will hit patient care during a seasonal winter peak in demand. As in other key sectors over the past year, junior doctors represented by the British Medical Association (BMA) have staged a series of walkouts to demand better pay in the face of soaring inflation.

Dyne's shares jump after promising data on muscle disorder treatment

Shares of drug developer Dyne Therapeutics jumped 18% on Wednesday after its experimental therapy for a muscle-wasting disorder called Duchenne muscular dystrophy(DMD) showed promise in a small, early-stage trial. The early findings from therapy designated DYNE-251 weighed down on rival Sarepta Therapeutics, which makes several drugs to treat the condition, pushing its shares down 2.1% to $94.19 after the markets opened.

Canada approves Pfizer's gene therapy for bleeding disorder

Pfizer said on Wednesday that Canada's health regulator approved its gene therapy for the treatment of a rare inherited bleeding disorder called hemophilia B ahead of a U.S. decision. The approval was based on late-stage trials that showed a single dose of the therapy, to be sold under the brand name Beqvez, was superior to the current standard of care which involves replacing a blood-clotting protein called factor IX.

Brazilian city begins first mass vaccination against dengue

The city of Dourados in the Brazilian state of Mato Grosso do Sul on Wednesday began the country's first mass vaccination against dengue, the city's government said. The initiative aims to vaccinate around 150,000 residents of the city between the ages of 4 and 59 using the recently approved Japanese drugmaker Takeda's vaccine QDENGA.

US FDA approvals bounce back in 2023, sparking hopes of a biotech recovery

The U.S. Food and Drug Administration approved nearly 50% more novel drugs in 2023 than in 2022, putting it back on pace with historical levels, an improvement analysts and investors said could lead to increased investment in biotech firms. FDA nods for innovative therapies containing an active ingredient or molecule not previously approved, rose to 55 in 2023, up from 37 in 2022 and 51 in 2021. Historical data shows the FDA typically green lights about 45-50 new drugs a year and hit a peak of 59 in 2018.