Reuters Health News Summary

US FDA staff reviewers suggest Moderna's flu shot, mFlusiva, may be effective in adults 65 years and older, citing positive immune response and superior efficacy compared to standard-dose vaccines.

Following is a summary of current health news briefs.

Moderna flu shot data may support use in older adults, US FDA staff says

U.S. Food and Drug Administration staff reviewers said on Tuesday data demonstrating an immune response to Moderna's flu shot may support effectiveness in adults 65 years and older, sending its shares up 6%. Moderna's shot, mFlusiva, also showed superior relative vaccine efficacy versus a standard-dose flu vaccine in adults aged 50 to 64, they ​said in briefing documents published ahead of a meeting of the regulator's independent advisers on Thursday.

Congo Ebola outbreak may be worst ever, Africa CDC says

The head of Africa's Centres for Disease Control and Prevention warned on Tuesday that the Ebola outbreak in Congo could be the worst ever, ​saying that it could cost billions of dollars to contain later if critical weaknesses in the response are not addressed quickly. Over 800 cases of the rare Bundibugyo strain, for which there is no ‌proven treatment or vaccine, have been ​reported in Congo, 192 of them fatal. The disease, transmitted through body fluids even after death, is spreading fast across three provinces, government data shows.

India limits cough syrup sales to pharmacies after contamination cases

India has restricted cough syrup sales to licensed pharmacies especially in villages, preventing over-the-counter sales from retail outlets, as regulators step up scrutiny following contamination-linked child deaths last year. Some cough syrups were previously on an exemption list under drug rules, allowing them to be sold over the counter as household remedies under relaxed regulations.

Congo Ebola outbreak may be worst ever, Africa CDC says

The head of Africa's Centres for Disease Control and Prevention warned on Tuesday that the Ebola outbreak in Congo could be the worst ever, saying that currently tens of thousands of contacts of those ill with the disease had not been traced. "If we don't stop the outbreak very soon it will be worse than what we had in West Africa and eastern DRC," Africa CDC Director-General Jean ‌Kaseya told a virtual meeting of African heads of state in Burundi.

Moderna interested in Germany production, sees opportunity in BioNTech closures, says CEO

U.S. pharmaceutical company Moderna is interested in investing in production facilities in Germany, with an eye on plants that its German rival BioNTech plans to close, CEO Stephane Bancel told the German business daily Handelsblatt on Wednesday. "If we were to find the right partnership with the German government, these facilities would be an interesting option -compared with building a new one," Bancel said.

UniQure to seek approval for Huntington's therapy after FDA U-turn, shares skyrocket

UniQure said the U.S. health regulator has reversed its earlier position and will accept existing trial data for an accelerated review of its Huntington's treatment, sending the Dutch drugmaker's U.S.-listed shares up over 75% to a seven-month high on Wednesday. The U.S. Food and Drug Administration had indicated late last year that available data was insufficient to support a filing, with one senior regulator describing UniQure's therapy as a "failed product."

Federal judge sends Bayer's $7.25 billion Roundup settlement back to Missouri state court

A federal judge sent Bayer's proposed $7.25 billion Roundup settlement back to state court on Wednesday, overruling objections from plaintiffs who had argued the state court had no power to implement a nationwide resolution of lawsuits that claim the company's Roundup weedkiller causes cancer. U.S. District Judge Henry Edward Autrey in St. Louis sided with Bayer, concluding that the objecting plaintiffs ‌did not have the power to transfer the case to federal court because only the defendant in a case has that right.

US paying almost $25,000 a month to store unusable contraceptives stuck in Belgium

The United States is spending almost $25,000 every month to store contraceptives in Belgium that were originally bought for use in poorer nations but are now mainly unusable, according to a report from officials reviewed by Reuters. Around $9.7 million worth of contraceptives, including implants and pills, have been stuck in a Belgian warehouse since January last year, when the U.S. first froze foreign aid. The stock could have helped prevent millions of unwanted pregnancies and ‌saved lives, aid sources have said.

US Health Department announces over $700 million to combat mental health, addiction, homelessness

U.S. Health Secretary Robert F. Kennedy Jr. on Wednesday announced more than $700 million in new funding opportunities aimed at tackling mental illness, addiction and homelessness. The package includes a new $96 million grant program, Safety Through Recovery, Engagement, and Evidence-based Treatment and Support, or STREETS, which will award funding to eight communities, the Department of Health and Human Services said.

Baby formula maker Nara issues US-wide recall after FDA, CDC flag infant botulism cases

Baby formula maker Nara Organics said it is voluntarily recalling all of its infant formula, currently available in the United States, over potential risk of bacterial contamination. The company said the U.S. FDA and CDC contacted it late Friday and provided information about three infant botulism cases involving babies who had consumed Nara's formula.

EU supports ebola response with €493 million in vaccines, treatment and health aid

The European Commission said on Wednesday it will fund the response to the ebola outbreak in Central Africa with a €493 million ($572 million) financial aid package. The amount comprises frontline medical support for the immediate outbreak response, humanitarian assistance in the Great Lakes region and Uganda, vaccine and treatment research for filoviruses as well as longer-term work to improve preparedness and health systems.

Novo Nordisk to seek approval soon to sell Wegovy pill in China

Novo Nordisk plans to seek Chinese regulatory approval for its Wegovy weight-loss pill "very soon," its CEO said on Tuesday, as it moves to catch up with rival Eli Lilly in the world's second-largest pharmaceutical market. Denmark's Novo and U.S.-based Lilly believe weight-loss pills could attract patients reluctant to use injections and are racing to expand use of ⁠drugs that have transformed obesity treatment ​and reshaped the global pharmaceutical industry.

Edgewise shares slip after heart-disease drug trial data disappoints investors

Edgewise Therapeutics shares fell nearly 10% on Tuesday after the efficacy of its experimental heart-disease drug ⁠in a mid-stage study fell short of investor expectations. The Boulder, Colorado-based company was testing the drug EDG-7500 in patients with two types of hypertrophic cardiomyopathy (HCM), a condition where the heart muscle thickens and makes it harder to pump blood properly.

Ebola Bundibugyo vaccine candidates could enter Phase 1 trials as early as July

Lead vaccine candidates developed by Oxford University and Moderna against Ebola Bundibugyo, the deadly virus that has swept through eastern Democratic Republic of Congo, could enter Phase 1 trials as early as July, with field trials possible within several months, the head of the Coalition for Epidemic Preparedness Innovations, Richard Hatchett, said on Tuesday.

Moderna announces executive changes ahead of potential launches

Moderna appointed a new chief commercial officer and widened its president's role to oversee certain franchises, the vaccine maker said on Tuesday, as it prepares ⁠for potential product launches over the next couple of years. Here are some details:

Kennedy orders American exposed to hantavirus to stay quarantined against her will, WSJ reports

U.S. Health Secretary Robert F. Kennedy Jr. has ordered an American passenger exposed to hantavirus on a cruise ship to remain in quarantine despite medical advice and against her will, the Wall Street Journal reported on Tuesday. The passenger, Angela Perryman, 47, was one of 18 Americans quarantined in the U.S. after Andes hantavirus cases were found aboard a cruise ship earlier this year. The group had initially been placed at a Nebraska quarantine unit.

US sues New York health officials over alleged fraud in Medicaid homecare program

The Trump administration sued top New York health officials on Tuesday over an alleged scheme to rig ​the bidding process for managing the state's estimated $10 billion Medicaid homecare program, harming patients and caregivers as well as taxpayers. The U.S. Department of Justice said the lawsuit aims to stop an alleged fraudulent scheme in which Public Partnerships LLC generated millions of dollars of improper profits after being "pre-selected" to take over New York's Consumer Directed Personal Assistance Program, or CDPAP.

US progesterone supplies tighten as menopause treatment demand grows

U.S. supplies of progesterone are coming under strain, with patients, clinicians, and pharmacists reporting recent intermittent shortages of oral versions of the hormone used in many fertility and menopause treatments. The ⁠supply concerns come as women going through menopause across the country are already facing difficulties filling prescriptions for estrogen patches, another commonly used hormone therapy.

Jazz Pharma, AbCellera ink antibody deal worth up to $876 million

Jazz Pharmaceuticals has signed a research collaboration and licensing agreement with Canada's AbCellera to develop T-cell engaging multispecific antibodies for cancer, the companies said on Wednesday. AbCellera will receive $56 million upfront for two initial programs expected to begin within 12 months, with an additional $28 million tied to the start of a third program. It is also eligible for up to $792 million per program in option fees and milestone payments if Jazz opts to advance candidates, along with tiered royalties on future sales.

US FDA sends 25 letters to telehealth companies over claims on compounded weight-loss drugs

The U.S. Food and Drug Administration issued 25 warning letters to telehealth companies for marketing false and misleading claims ⁠about compounded ​versions of Eli Lilly and Novo Nordisk's hugely popular weight loss and diabetes drugs. The letters, that were posted on the health regulator's website on Tuesday, were sent to companies like Medica Weight Loss, Ready Med, Clover Meds among others earlier this month.

Analysis-Big pharma taps UK playbook to pressure European capitals on drug prices

Global pharmaceutical companies, facing pushback from European capitals on drug pricing, are turning to a playbook that brought them recent success in Britain: threats of pulling investment and expansion plans to pressure policymakers. The latest target has been Germany, which is debating legislation to tighten spending on medicines. The industry notched a win in Britain when the government agreed to increase spending on medicines as part of a broader deal to avoid Washington-imposed tariffs.

Italy's privacy watchdog fines Emirates over handling of passenger health data

Italy's data protection authority said on Wednesday it had fined the Emirates airline €180,000 ($208,890) for the allegedly unfair handling of health data of passengers with reduced mobility. The case stemmed from a complaint by a passenger who said Emirates had made her fill in a medical form even though she was not among the categories required to submit such documentation.

Advocacy groups urge U.S. to share experimental Ebola drug for outbreak trials

A clutch of advocacy groups on Tuesday urged the U.S. government to make an experimental Ebola treatment by Mapp Biopharmaceutical available ⁠for clinical trials and emergency use in countries responding to the Bundibugyo Ebola outbreak. Their letter to the Biomedical Advanced Research and Development Authority (BARDA) sought coordination with the World Health Organization (WHO), Africa Centres for Disease Control and Prevention, governments of the countries affected and medical humanitarian groups.

Congo Ebola response strained a month after WHO declares international emergency

Health workers battling an Ebola outbreak in eastern Democratic Republic of Congo lack the personnel to identify suspected cases, the ambulances to transport them and even the construction materials to build isolation wards, officials and aid workers told Reuters. A month after the World Health Organization declared an international emergency, ⁠the outbreak of the rare Bundibugyo strain has grown to more than 800 confirmed cases, with warnings mounting that it could become the worst on record — surpassing the 2014-16 West Africa epidemic that ⁠killed more than 11,000 people.

China steps up Ebola monitoring with revised prevention plan

China on Tuesday issued a revised prevention and control plan for the Ebola epidemic, requiring close contacts of Ebola cases to undergo tracking and quarantined medical observation and laying out more stringent monitoring protocols for medical institutions and customs. The National Disease Control and Prevention Administration revised the plan after recent Ebola outbreaks in the Democratic Republic of the Congo and Uganda, the administration said in a statement.

US FDA approves GSK's oral antibiotic for drug-resistant UTIs

The U.S. FDA has approved GSK's oral antibiotic to treat complicated urinary tract infections, the regulator said on Wednesday, giving patients a new treatment option against drug-resistant infections. The approval of the oral antibiotic, branded as Utebzi, offers a more convenient way to treat complicated infections—including a type of kidney inflammation called pyelonephritis—at home instead of in a hospital.

Robots improve drug tests for catching lurking cancer cells

We also highlight some potentially good news for people suffering knee arthritis pain, ‌a treatment that can help delay or avoid replacement surgery. ROBOTS HELP FIND CANCER CELLS THAT ESCAPED TREATMENT

US FTC sues transgender ‌health nonprofit over youth care standards

The U.S. Federal Trade Commission and four states accused a nonprofit focused on transgender health of making misleading statements about the benefits of gender-affirming treatments for young people in a lawsuit filed on Wednesday. The lawsuit against the World Professional Association for Transgender Health (WPATH) is the latest move by the Trump administration and ​Republican-led states to limit gender-affirming medical care for transgender youth. Texas, Iowa, Nebraska and Alaska joined the lawsuit filed in federal court in Fort Worth, Texas.