Latest FDA Approvals in Health: Colorectal Cancer Therapy to Flavored Vapes

Recent health news includes multiple U.S. FDA approvals: Bristol Myers' colorectal cancer therapy, expanded use of Sarepta's Duchenne gene therapy, Roche's blood disorder drug, and Altria's flavored vapes. Court rulings affecting insurance coverage and healthcare IPOs, drug acquisitions, and international disease outbreaks were also highlighted.

Reuters | Updated: 22-06-2024 10:31 IST | Created: 22-06-2024 10:31 IST
Latest FDA Approvals in Health: Colorectal Cancer Therapy to Flavored Vapes
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Following is a summary of current health news briefs.

US FDA approves Bristol Myers' colorectal cancer therapy

The U.S. Food and Drug Administration has approved Bristol Myers Squibb's combination therapy for treating colorectal cancer in patients with a specific gene mutation, the health regulator said on Friday. The approval under the agency's accelerated process was based on an early- to mid-stage study, in which 94 previously treated patients were administered the oral drug Krazati, in combination with cetuximab.

Appeals court does not block US mandate to cover cancer screenings, HIV drugs

A U.S. appeals court on Friday refused to block a federal mandate requiring health insurers to cover preventive care services like cancer screenings and HIV-preventing medication at no extra cost to patients, but ruled against the government on a key legal issue that leaves the mandate's future in doubt. A unanimous panel of the 5th U.S. Circuit Court of Appeals agreed with a group of Christian businesses suing to challenge the mandate that claimed that the way services were chosen for coverage violates the U.S. Constitution.

Ardent Health discloses over 5% rise in annual revenue in US IPO filing

Ardent Health Partners disclosed a more than 5% rise in revenue for 2023 on Friday, as the healthcare provider revealed its paperwork for an initial public offering in the United States. The U.S. capital market has seen a recovery in the number of IPOs in 2024, after a nearly two-year dry spell, as expectations of a soft-landing for the economy encourage companies to list their shares.

US FDA approves expanded use of Sarepta's Duchenne gene therapy; shares jump

The U.S. Food and Drug Administration allowed the expanded use of Sarepta Therapeutics' gene therapy for patients with Duchenne muscular dystrophy aged four and older on Thursday, sending the company's shares up 36% in extended trading. The agency gave traditional approval to patients four years and above who can walk, as well as accelerated approval for those who cannot.

US FDA approves Roche's drug for a chronic blood disorder

The U.S. Food and Drug Administration on Thursday approved Roche's drug for a chronic blood disorder, the Swiss drugmaker said. The drug crovalimab, branded as PiaSky, is a monthly under-the-skin or intravenous treatment for paroxysmal nocturnal hemoglobinuria (PNH).

Amylyx to buy bankrupt Eiger's experimental drug to treat low blood sugar

Amylyx Pharmaceuticals has agreed to buy the rights to bankrupt drugmaker Eiger BioPharmaceuticals' experimental drug for low blood sugar in a $35.1 million deal, Eiger said in a filing on Friday. Amylyx's acquisition of avexitide would mean a foray into drug development for metabolic diseases. The company had so far been a developer of drugs to treat neurodegenerative diseases.

Takeda gives Sun Pharma, Cipla rights to commercialize gastro drug in India

Japan's Takeda Pharmaceutical gave India's Sun Pharmaceutical and Cipla the rights to commercialize gastrointestinal drug Vonoprazan in the country. The drug, which is sold in the form of tablets under the brand name 'Voltapraz', blocks a key step in the production of stomach acid, Sun Pharma said on Friday. Cipla announced the agreement late on Thursday.

Gabon detects first case of bird flu since 2022

Gabon has reported an outbreak of highly pathogenic H5N1 avian influenza, commonly called bird flu, for the first time since 2022 at a poultry market in the capital Libreville, the World Organisation for Animal Health (WOAH) said on Friday. The H5N1 strain of bird flu has killed or caused the culling of hundreds of millions of poultry globally in recent years and has increasingly been spreading to mammals, including cows in the United States.

In a first, FDA authorizes flavored vape products from Altria's NJOY for sale

The U.S. Food and Drug Administration authorized four of Altria's menthol e-cigarette products for sale in the country on Friday, making them the first ever flavored vapes the agency has permitted on the market. The decision shows vape makers can provide evidence satisfying the FDA that the benefits their products offer in terms of helping smokers quit outweigh the risks posed to youth.

Weight-loss drug Zepbound resolves sleep apnea in up to 52% of patients, Lilly says

Eli Lilly on Friday said its popular weight-loss drug Zepbound helped resolve moderate to severe obstructive sleep apnea in up to 52% of patients in two late-stage trials. U.S.-based Lilly and Danish rival Novo Nordisk are in a race to get their obesity drugs approved to treat other ailments. Novo's Wegovy was approved as a treatment for heart disease in March, while Lilly's own heart-disease trial for Zepbound is expected to conclude this year.

(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)

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