Reuters Health News Summary

The FDA has approved the first generic version of Roche's flu drug Xofluza and also granted expanded use of Merck's pneumococcal vaccine for high-risk children and teenagers.

Following is a summary of current health news briefs.

FDA approves first generic version of Roche's flu drug

The U.S. Food and Drug Administration approved the first generic version of Roche's Xofluza, a single-dose flu medicine for certain patients aged five years and older, the regulator said on Wednesday. The approval of Norwich Pharmaceuticals' generic drug comes ahead of the flu season.

Merck's pneumococcal vaccine wins US approval ​for high-risk children, teens

Drugmaker Merck said on Thursday the U.S. health regulator has approved an expanded use of its pneumococcal vaccine for children and teenagers who face a higher risk of catching the bacterial disease due to chronic health conditions. Here are the details:

Pfizer CFO ​Dave Denton to step down, leave company in August

Pfizer said on Thursday that finance chief Dave Denton will step down and leave the company on August 15 ‌to take a role ​in the consumer goods industry. The U.S. drugmaker named Cecile Guegan, senior vice president of finance for its global biopharmaceutical business, as interim CFO, effective August 16.

Biogen targets immunology growth with $1 billion RayThera deal

Biogen has struck a deal to acquire private biotechnology company RayThera for up to $1 billion, the companies said on Wednesday, as the U.S.-listed drugmaker seeks to expand its pipeline in immunology. The transaction will include an upfront payment to RayThera shareholders, along with additional payments tied to clinical and regulatory milestones, the companies said in a statement.

Donors pledge $910 million for Ebola response in Congo, Uganda

Donors have pledged $910 million, including $80 million from African Union member states, to support the Ebola response in Congo and Uganda, the Africa Centres for Disease Control and Prevention said in a statement on Thursday.

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."

Exclusive-KKR eyes at least $1 billion stake in Medicover's India hospital arm, source says

KKR is in advanced talks to buy a majority stake in the Indian business of Sweden's Medicover for at least $1 billion, a source with direct knowledge of the matter said, a deal that would expand its healthcare bet in the world's most populous nation. Stockholm-listed Medicover issued a press release soon after Reuters sent a request for comment on ‌Wednesday night, saying Medicover Hospitals India is in discussions with KKR "regarding a potential sale of its Indian operations."

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 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.

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.

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.

Moderna's mRNA flu vaccine faces FDA advisory panel scrutiny

The U.S. Food and Drug Administration's advisory panel is set to vote on whether the benefits of Moderna's flu vaccine outweigh its risks in older adults, after regulators reversed course on rejecting the drugmaker's ⁠initial application for the shot. Moderna is seeking a traditional approval for the shot, called mFlusiva, for adults 50 to 64 years old, and an accelerated approval, which requires the company to conduct additional studies to confirm the vaccine's benefit, for adults 65 and older.

Novocure's brain cancer treatment fails to meet late-stage trial goal

Novocure said on Thursday that early use of its non-invasive cancer therapy did not significantly improve overall survival in patients with newly diagnosed brain tumors in a late-stage study. The company's shares were down 16.1% at $14.98 in premarket trading.

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.

Committee recommends Canada not permit euthanasia ‌solely for mental illness

Euthanasia should not be allowed for people seeking to be killed by medical professionals exclusively for mental illness reasons, according to a report published on Wednesday by a Canadian parliamentary committee. The report advises the Canadian government to amend its Criminal Code “to indefinitely exclude persons whose sole underlying medical ​condition is a mental illness from eligibility for medical assistance in dying,” saying the conditions needed for “safe and equitable implementation” cannot currently be met.