Health News Roundup:US FDA declines to approve Ascendis' hormone disorder therapy; Australia to ban recreational vaping in e-cigarette crackdown and more

Following is a summary of current health news briefs. US FDA declines to approve Ascendis' hormone disorder therapy Ascendis Pharma A/S said on Monday the U.S. Food & Drug Administration had declined to approve the Danish drugmaker's experimental therapy to treat adult patients with a hormone disorder called hypoparathyroidism, citing concerns linked to manufacturing control of the drug and device combination.

Following is a summary of current health news briefs.

US FDA declines to approve Ascendis' hormone disorder therapy

Ascendis Pharma A/S said on Monday the U.S. Food & Drug Administration had declined to approve the Danish drugmaker's experimental therapy to treat adult patients with a hormone disorder called hypoparathyroidism, citing concerns linked to manufacturing control of the drug and device combination. The company's U.S.-listed shares surged 19% in premarket trade as the agency did not express concerns about the clinical data submitted and did not seek fresh pre-clinical or late-stage trials in a so-called complete response letter.

Australia to ban recreational vaping in e-cigarette crackdown

Australia banned recreational vaping and tightened other aspects of e-cigarette laws on Tuesday in the biggest crackdown on the tobacco industry in more than a decade to try to stop an alarming rise in teenage vaping. The government aims to ban all disposable vapes, which often comes in fruity flavours, ban the import of non-prescription vapes and limit nicotine levels, aiming for the sale of vapes to be confined to helping smokers quit.

Japan's Astellas to buy Iveric Bio for $5.9 billion to expand eyesight treatments

Japan's Astellas Pharma said on Monday it agreed to buy U.S. drugmaker Iveric Bio Inc for about $5.9 billion in its biggest acquisition, giving it access to a range of ophthalmology treatments. The deal marks the fifth major overseas acquisition by Astellas, Japan's third biggest drugmaker by sales, since 2019 in a push to shore up its pipeline as its main sellers lose patent protection.

Indian cough syrup: mystery middleman may be new clue

An unnamed middleman in Mumbai provided a crucial raw material used in Indian-made cough syrups that have been linked to the deaths of more than 70 children in Gambia, a chemicals trader involved in the supply chain told Reuters. The World Health Organization said last year the syrups, made by Indian manufacturer Maiden Pharmaceuticals Ltd, contained lethal toxins ethylene glycol (EG) and diethylene glycol (DEG) – used in car brake fluid. These ingredients can be used by unscrupulous actors as a substitute for propylene glycol (PG), which is a key base of syrupy medicines – because they can cost less than half the price, as Reuters reported in March.

US FDA panel backs restricted use of AstraZeneca's prostate cancer drug (April 28)

A panel of U.S. Food and Drug Administration advisers on Friday voted for the restricted use of British drugmaker AstraZeneca Plc's experimental treatment, jointly developed with Merck & Co, for a type of prostate cancer. The FDA panel voted 11-1 with one abstention, in favor of Lynparza, in combination with other medications – abiraterone and prednisone or prednisolone – as a first-line treatment for a type of treatment-resistant prostate cancer in adult patients.

Stryker lifts profit forecast on robust demand for devices

Medical technology company Stryker Corp on Monday raised its full-year profit forecast, citing stronger demand for the company's surgical devices. Device makers, lately, have been reporting a recovery in sales as staff shortages ease and procedure volumes pick up in hospitals. Last week, peer Edwards Lifesciences Corp raised its sales and profit forecasts for 2023, citing strong demand for the company's artificial heart valves.

US to end COVID vaccination requirements on May 11 for foreign travelers, federal workers

The United States will end its COVID-19 vaccination requirements for international travelers and federal workers on May 11, when the coronavirus public health emergency ends, the White House said on Monday. In February, the U.S. House of Representatives voted to lift the requirement that most foreign air travelers be vaccinated against COVID-19, one of the few remaining pandemic travel restrictions still in place.

US FDA halts India's Sun Pharma trials on dermatological drug

The U.S. Food and Drug Administration (FDA) has asked India's Sun Pharmaceutical Industries Ltd to halt tests on one dose of an experimental dermatological drug due to the potential of blood clots, the company said on Tuesday. The FDA has also said that patients with alopecia areata - an autoimmune condition that results in patchy hair loss - on the 12 mg dose of the drug deuruxolitinib should discontinue its use, Sun Pharma said.

US Supreme Court spurns challenge to Indiana abortion cremation or burial law

The U.S. Supreme Court on Monday declined to hear a challenge to the legality of an Indiana requirement that abortion providers bury or cremate embryonic or fetal remains following the procedure, sidestepping another dispute involving a contentious Republican-backed state policy concerning abortion. The justices turned away an appeal by an Indianapolis abortion clinic and two women who underwent abortions at the facility of a decision by the Chicago-based 7th U.S. Circuit Court of Appeals to reinstate Indiana's requirement after a federal judge had invalidated it.

Biopharma firm Acelyrin seeks $1.5 billion valuation in US IPO

Late-stage clinical biopharma company Acelyrin Inc said on Monday that it was seeking a valuation of up to $1.5 billion in its initial public offering in the United States that comes at a time when new listings are testing investors' appetite. The Los Angeles-based company is aiming to raise up to roughly $370 million, by selling 20.6 million shares at nearly the top-end of its proposed price range of $16 to $18 per share, the company said in a filing.