Health News Roundup: FDA reviewers raise doubts over data on Sarepta's gene therapy; Martin Shkreli-founded drug company files for bankruptcy and more

The agency's staff on Wednesday highlighted several issues with the data and said that existing studies did not provide "unambigious evidence" that the gene therapy will benefit patients with Duchenne muscular dystrophy. U.S. FDA advisers back Perrigo birth control pill for over-the-counter use A U.S. Food and Drug Administration advisory panel on Wednesday voted in favor of allowing sales of Perrigo Co's contraceptive drug without a prescription, paving the way for the country's first over-the-counter birth control pill.

Following is a summary of current health news briefs.

Bayer, Bicycle Therapeutics in cancer radiotherapy drug alliance

German drugmaker Bayer on Wednesday said it acquired the rights to work with Bicycle Therapeutics on the British biotech firm's radiotherapy cancer drug candidates. Under the deal, Bicycle stands to receive an upfront payment of $45 million and potentially up $1.7 billion, contingent on development and commercial achievements, plus tiered royalties on sales.

Pharma CEOs to testify in U.S. Senate hearing on insulin prices

The leaders of major insulin makers and pharmacy benefit managers (PBMs) are set to blame each other on Wednesday in their testimonies during a U.S. Senate committee hearing on making the life-saving drug more affordable. PBMs negotiate with drugmakers for rebates and lower fees on behalf of employers and other clients, and reimburse pharmacies for prescriptions they dispense. Both sides blame each other for high drug prices.

Lingering nerve symptoms from Lyme disease may be tied to immune response

Neurologic complications of Lyme disease such as hand and feet numbness and pain that do not resolve with treatment may be due to an exaggerated immune response rather than the infection itself, a study published on Wednesday suggests. Researchers found that Lyme disease patients with persistent central nervous system problems have high blood levels of interferon alpha, an inflammatory protein produced by the immune system in response to infection.

The U.S. COVID health emergency is ending. What changes?

The U.S. government on Thursday will end the COVID-19 Public Health Emergency that allowed millions of Americans to receive vaccines, tests and treatments at no cost. The emergency is also tied to telehealth flexibilities, Medicaid enrollment safeguards, and the ability of government health agencies to collect data on the spread of the coronavirus.

FDA reviewers raise doubts over data on Sarepta's gene therapy

The U.S. Food and Drug Administration's staff reviewers raised concerns over limited data on Sarepta Therapeutics Inc's gene therapy for a muscle-wasting disorder, ahead of a meeting of the agency's advisers on Friday. The agency's staff on Wednesday highlighted several issues with the data and said that existing studies did not provide "unambigious evidence" that the gene therapy will benefit patients with Duchenne muscular dystrophy.

U.S. FDA advisers back Perrigo birth control pill for over-the-counter use

A U.S. Food and Drug Administration advisory panel on Wednesday voted in favor of allowing sales of Perrigo Co's contraceptive drug without a prescription, paving the way for the country's first over-the-counter birth control pill. The panel found the drug to be an effective OTC option with some members noting that it could expand the availability of birth-control alternatives to more people.

Potential weight-loss drug meets goals in mid-stage trial as race accelerates

Denmark's Zealand Pharma and Boehringer Ingelheim said their experimental obesity treatment achieved up to 14.9% weight loss in a mid-stage trial, lining up a potential contestant in the booming obesity drug market. In a statement on Wednesday, the partners said that the Phase II dose-finding trial met its primary endpoint of weight loss after 46 weeks.

Martin Shkreli-founded drug company files for bankruptcy

Vyera Pharmaceuticals, which previously settled price-fixing charges that resulted in founder Martin Shkreli being banned from the pharmaceutical industry, filed for bankruptcy late Tuesday to sell its assets. Vyera said its bankruptcy was the result of declining profits, increased competition for generic drugs, and litigation alleging that Vyera suppressed competition for its most valuable drug, Daraprim.

BioNTech, Roche's experimental pancreatic cancer treatment wins Nature plaudit

Scientific journal Nature on Wednesday said a personalised treatment based on messenger RNA by BioNTech potentially bodes well for the future of fighting an extremely aggressive form of cancer after the regimen was shown to trigger a promising immune reaction in some pancreatic cancer patients.

Results of a trial in the first phase of testing on humans showed that half of the 16 trial participants, who had undergone surgery to remove their tumour, had developed T cells that can potentially recognise cancerous cells and stop them from re-emerging, Nature said in a paper on Wednesday.

India builds more hospitals as population surges but doctors in short supply

Mithilesh Chaudhary, 21, coughs weakly as he struggles to his feet after spending the night outside the state-run All India Institute of Medical Sciences (AIIMS) in New Delhi. "We have been sleeping on the footpath for two nights," said his grandfather Bhim Lal, as the two waited in a line of about 100 people outside the hospital's main gate, seeking an appointment.