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 leave company ​in August

Pfizer said on Thursday that finance chief Dave Denton will leave on August 15 to return to the consumer goods industry, after helping the U.S. drugmaker navigate its post-COVID transition. The ‌company named Cecile Guegan, ​senior vice president of finance for its global biopharmaceuticals business, as interim chief financial officer. Guegan has held a range of finance roles over 20 years at Pfizer.

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.

Ebola response received less than 10% of pledges, Africa CDC says

Less than 10% of pledges made to support the fight against Ebola in Congo and Uganda have been received from donors, Africa's top health body said on Thursday. Donors have pledged $910 million, including $80 million from African Union member states, according to the latest data from the Africa Centres for Disease Control and Prevention.

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."

Trump administration asks appeals court to let Kennedy pick vaccine panel members

The Trump administration is urging a U.S. appeals court to overturn a ruling that blocked Health Secretary Robert F. Kennedy Jr.'s appointees from serving on a key vaccine advisory panel, saying the committee is unable to make annual recommendations on ‌flu shots after a judge wrongly disabled it. The U.S. Department of Justice made that argument in a brief filed late on Wednesday before the 1st U.S. Circuit Court of Appeals in its appeal of Boston-based U.S. District Judge Brian Murphy's March 16 ruling, which also blocked the panel from reducing the number of routinely recommended childhood vaccinations.

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 proposes testosterone therapy label updates

The U.S. health department said on Thursday it was seeking updates to labels for testosterone replacement therapies after reviewing new clinical data and other evidence. The proposed changes would remove limits on use in men with age-related low testosterone, revise warnings on enlarged prostate and update information related to prostate cancer risk, the U.S. Department of Health and Human Services 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.

What pet owners need to know about New World screwworm

Screwworm, a parasitic fly whose flesh-eating larvae feed on living animals, re-entered the U.S. Southwest in June for the first time since the 1970s, posing a threat to the livestock industry as well as wildlife and household pets. This is what veterinarians say pet owners, particularly those near the U.S.-Mexico border, need to know:

Congo says number of confirmed Ebola cases rises to 896

The ⁠number of confirmed Ebola cases in ​the Democratic Republic of Congo has increased to 896, including 232 deaths, government data showed late on Thursday. The number represented the total number of confirmed cases as of ⁠Wednesday, according to a situation report that documented 21 new cases and six new deaths in the previous 24 hours.

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.

FTC requiring Aurobindo Pharma to divest from four drug products to complete acquistion of Lannett

The U.S. Federal Trade Commission is requiring Aurobindo Pharma Limited to divest four different generic drug products to complete its $250 million acquisition of Lannett Company Inc., the agency said on Thursday in ⁠a statement. The agency will require Aurobindo to divest to Quagen Pharmaceuticals an immunosuppressant prescribed to prevent organ transplant rejection, a cholesterol management drug, a drug prescribed to treat dry mouth in radiation therapy patients and a drug prescribed to reduce stomach acid.

Kardigan surges in Nasdaq debut after upsized $400 million IPO

Kardigan's shares rose 31% above their initial public offering price on Thursday after the heart drug developer raised $400 million in an upsized U.S. initial public offering, signaling strong investor appetite for new biotech listings. The Princeton, New Jersey-based company's shares opened at $16.25, above its IPO price of $16 per share, and were last up 22.3%.

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.

Cholera death toll in northeast Nigeria rises to 90, UN says

At least 90 people have died and more than 12,000 others have been infected in a fast-spreading cholera outbreak in Nigeria's conflict-hit Borno state, the U.N. Office for the Coordination of Humanitarian Affairs (OCHA) said on Thursday. Death toll from the outbreak that began in early May rose from 74, with about 7,800 infections reported.

US FDA advisers vote in favor of Moderna's flu vaccine

The U.S. Food and Drug Administration's advisers on Thursday backed approval of Moderna's flu vaccine in ⁠adults ​aged 50 and older, saying its benefits outweigh the risks. All nine panel members unanimously voted in favor of use of the shot in adults between 50 and 64 and in adults aged 65 and above.

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.

US CDC activates $107 million in emergency funding for Ebola response

The U.S. Centers for Disease Control and Prevention said on Thursday it would make available $107 million in emergency funding to strengthen its domestic and international response to the Ebola outbreak in the Democratic Republic of Congo and Uganda. The agency currently has 23 field staff supporting epidemiological investigations and the DRC health ministry, Dr. Satish Pillai, the incident manager for the CDC's Ebola response, said in a briefing. There are ⁠over 125 CDC staff across the DRC and Uganda working on the response, he said.

Moderna's mRNA flu vaccine backed by FDA advisers

Advisers to the U.S. Food and Drug Administration on Thursday backed approval of Moderna's flu vaccine for adults aged 50 and older, saying its benefits outweigh its risks, boosting the company's chances of launching the first mRNA-based seasonal flu shot. The FDA's Vaccines and Related Biological Products Advisory Committee meeting was seen as a test of whether the agency is reverting to its longstanding approach to vaccine reviews after recent leadership turnover.

Early use of ⁠Novocure's brain cancer therapy shows no significant survival benefit in late-stage trial

Novocure said on Thursday that a late-stage trial showed early use of its non-invasive cancer therapy did not significantly ⁠improve overall survival in patients with newly diagnosed brain tumors. The company's shares were down 19.1% at $14.29 in morning 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.

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.