Health News Roundup: U.S. FDA approves Amylyx ALS drug; Biohaven's ALS drug fails to meet study goals and more
The new contract follows another one from the DoD earlier this year for the procurement of $7.4 million worth of oral Tpoxx, with all drugs expected to be delivered this year, the company said.
Following is a summary of current health news briefs.
Illumina launches next-generation DNA sequencers
Illumina Inc, the top maker of DNA sequencers used to speed drug development and other research, on Thursday announced the launch of its next-generation NovaSeq X systems, which it said can generate more than 20,000 whole genomes per year, or 2.5 times that of prior sequencers. The larger-scale throughput will make the systems, the largest of which is priced at $1.25 million, more cost-effective for customers, Illumina Chief Commercial Officer Susan Tousi told Reuters.
Biohaven's ALS drug fails to meet study goals
Biohaven Pharmaceutical Holding Company Ltd said on Thursday its experimental drug to treat amyotrophic lateral sclerosis (ALS) failed a clinical study, the second therapy by the drugmaker to fail trials in recent months. The migraine drugmaker in May agreed to an $11.6 billion acquisition deal by Pfizer Inc, which plans to spin off its non-migraine drugs into a new publicly traded company.
China Walvax's mRNA COVID vaccine obtains first approval overseas
The Indonesian food and drugs agency (BPOM) said on Thursday it has approved the emergency use of an mRNA COVID-19 vaccine developed by China's Walvax Biotechnology. It is the first authorisation for a China-developed COVID shot based on the novel mRNA technology, which Pfizer/BioNTech and Moderna also use in their COVID vaccines, after more than two years of development.
U.S. FDA approves Amylyx ALS drug
The U.S. Food and Drug Administration on Thursday approved Amylyx Pharmaceuticals Inc's drug for slowing progression of ALS, or amyotrophic lateral sclerosis, and potentially delaying death. The Amylyx drug, to be sold under the brand name Relyvrio, is a combination of the generic compounds sodium phenylbutyrate and taurursodiol. The company says they work together to prevent nerve cells in the brain and spinal cord from dying prematurely.
Gilead widens battle against alleged counterfeit HIV drug ring
A federal judge in New York has frozen the assets of dozens of people and entities accused of operating a massive nationwide scheme to distribute counterfeit bottles of Gilead Sciences Inc HIV drugs, including two alleged "kingpins." Gilead, which has been pursuing alleged counterfeiters in a civil lawsuit since last year, said in a court filing unsealed on Wednesday it had uncovered an operation that was "staggering in scope," responsible for sales of hundreds of millions of dollars of counterfeit bottles of its top sellers Descovy, Genvoya and Biktarvy, and other medicines.
Japan health panel recommends allowing import, use of medical marijuana products
A Japanese health ministry panel on Thursday recommended revising the nation's drug laws to allow for the importation and use of medicinal marijuana products. The recommendation was based on meeting medical needs and to harmonise Japan with international standards, the committee said in a report. The revision would apply to marijuana products whose safety and efficacy were confirmed under laws governing pharmaceuticals and medical devices.
Taiwan to end COVID quarantine for arrivals, welcome back tourists
Taiwan will end its mandatory COVID-19 quarantine for arrivals from Oct. 13 and welcome tourists back, the government said on Thursday, completing a major step on its plan to re-open to the outside world. Taiwan had kept some of its entry and quarantine rules in place as large parts of the rest of Asia relaxed or lifted them completely, although in June it cut the number of days required in isolation for arrivals to three from seven previously.
Alzheimer's drug study yields positive results, say makers Eisai and Biogen
An experimental Alzheimer's drug made by Eisai Co Ltd and Biogen slowed cognitive and functional decline in a large trial of patients in the early stages of the disease, they said on Tuesday, potentially a rare win in a field littered with failed drugs. Multiple drugmakers have so far tried and failed to find an effective treatment for the brain-wasting disease that affects about 55 million people globally. A breakthrough would be a major boost to similar studies being run by Roche and Eli Lilly.
Siga Tech receives $10.7-million order for antiviral Tpoxx amid monkeypox outbreak
Siga Technologies said on Thursday it has won a new contract for its oral antiviral drug, Tpoxx, worth up to $10.7 million from the U.S. Department of Defense as the country stocks up on the treatment amid a monkeypox outbreak. The U.S. Centers for Disease Control and Prevention (CDC) earlier this month issued a guidance for the expanded use of the drug, which is approved only for smallpox by the U.S. Food and Drug Administration (FDA), to help tackle the monkeypox spread. Siga said it aims to deliver $5.1 million worth of oral Tpoxx drugs this year, with the remaining subject to the discretion of the department. The new contract follows another one from the DoD earlier this year for the procurement of $7.4 million worth of oral Tpoxx, with all drugs expected to be delivered this year, the company said. The company also said in August the U.S. government would buy $26-million worth of intravenous formulation of Tpoxx for patients unable to swallow the oral pill as monkeypox symptoms include rashes and blisters in the mouth. More than 65,000 cases of monkeypox disease have been confirmed in over 90 countries where the disease is not endemic, with the World Health Organization declaring it a global health emergency in July. This has led to a flurry of orders for Siga, with the company earlier this week disclosing about $16 million in international procurement orders received in August and early September.
India's top court legalises abortion regardless of marital status
India's top court on Thursday upheld the right of a woman to an abortion up to 24 weeks into pregnancy regardless of marital status, a decision widely hailed by women's rights activists. The right to abortion has proved contentious globally after the U.S. Supreme Court overturned in June its landmark 1973 decision in Roe v. Wade that had legalised the procedure across the United States.
(With inputs from agencies.)