Health News Roundup: US FDA approves Ionis-AstraZeneca's nerve disease drug; Cuba quietly authorizes euthanasia and more

Shares of the biotech company fell 35.9% to 33 cents before the bell. Bristol Myers to buy schizophrenia drugmaker Karuna Therapeutics for $14 billion Bristol Myers Squibb on Friday agreed to buy Karuna Therapeutics for $14 billion, gaining a promising new type of antipsychotic medicine to help power growth as patents on its older therapies expire later this decade.


Devdiscourse News Desk | Updated: 23-12-2023 02:36 IST | Created: 23-12-2023 02:30 IST
Health News Roundup: US FDA approves Ionis-AstraZeneca's nerve disease drug; Cuba quietly authorizes euthanasia and more
Representative image Image Credit: ANI

Following is a summary of current health news briefs.

US finds no novel pathogens in genetic testing of mystery illness in dogs

Testing of the mysterious respiratory illness affecting dogs across the United States has not yet revealed any new pathogens or any common cause for the wave of infections that have alarmed pet owners, the agriculture department said. Instead, common causes of canine infectious respiratory disease have been identified in many of these cases through genetic sequencing of samples, the U.S. Department of Agriculture (USDA) said in an emailed statement.

Colombia's cannabis industry in crisis over regulatory, political hurdles

More than 17 acres of land owned by a Colombian-Canadian company near Bogota were once meant to grow 25 varieties of cannabis, but over the past year weeds have overtaken greenhouses and 200 of its 218 employees have been fired. The company is a victim of long-running problems for Colombia's legal marijuana industry, which attracted huge investment after cannabis was legalized for medicinal use in 2017. At the time, Colombia was one of the first countries in Latin America to pass such legislation and held out the promise of legalizing marijuana sales for recreational use next.

Jazz Pharmaceuticals' PTSD drug fails in mid-stage trial

Jazz Pharmaceuticals said on Thursday its post-traumatic stress disorder (PTSD) drug failed to meet the main goal in a mid-stage study. Shares of the company fell as much as 4% in after-market trading.

UnitedHealth agrees to sell Brazil unit Amil -report

The board of UnitedHealth Group approved the sale of its Brazilian health insurance operator Amil to businessman Jose Serpieri Filho, local newspaper Valor Economico said on Friday.

Amil has 5.4 million health and dental insurance beneficiaries in Brazil and its sale was in the making for years.

Clene says FDA finds ALS drug data not enough for accelerated nod

Clene said on Thursday data on its therapy to treat a type of neurological disease did not meet the U.S. drug regulator's target for accelerated approval. Shares of the biotech company fell 35.9% to 33 cents before the bell.

Bristol Myers to buy schizophrenia drugmaker Karuna Therapeutics for $14 billion

Bristol Myers Squibb on Friday agreed to buy Karuna Therapeutics for $14 billion, gaining a promising new type of antipsychotic medicine to help power growth as patents on its older therapies expire later this decade. Karuna's experimental schizophrenia drug, called KarXT, should drive sales through the late 2020s and into the next decade, at a time when two of its top drugs, blood cancer treatment Revlimid and blood thinner Eliquis face generic competition. The drugmaker is also expected to face revenue losses for two of its other top sellers, cancer immunotherapy Opdivo and blood thinner Eliquis, as they lose patent protection later this decade. Eliquis is also among the 10 drugs expected to be subject to drug price negotiations by the U.S. Medicare health program in 2026. "We still have considerable financial power to do business development and engage in bringing innovation into the company," Bristol Myers Chief Executive Chris Boerner said in an interview, although he plans to eschew larger, transformative deals. "We have ample opportunity to build additional depth in therapeutic areas that we're in today - think oncology or cardiovascular disease - and to continue to enhance in areas that are maybe a little bit more nascent" like neuroscience. Boerner said KarXT could be a multi-billion dollar drug across several indications, noting it could help patients with Bipolar I disorder and those with psychosis and agitation from Alzheimer's disease. Under the terms of the deal, Bristol would pay $330 a share in cash for Karuna, which represents a 53.4% premium to its last closing price. Karuna's shares rose to $316.80 in early trading. Bristol shares rose 2.5%. Through Friday, its shares had lost nearly 30% of their value this year versus an over 20% rise in the S&P 500 index. US PATENT PROTECTION THROUGH MID-30S Boerner took over as CEO of Bristol in November, days after the company lowered its near-term expectations for its new pipeline portfolio. Analysts have forecast multibillion dollars in peak sales for KarXT, with a decision on its approval for schizophrenia due by September next year. While there are several older drugs for schizophrenia, KarXT is a new type of antipsychotic medicine that activates proteins called muscarinic receptors in the central nervous system, while existing antipsychotic drugs block proteins called dopamine receptors. In clinical trials, the drug helped patients reduce symptoms without many of the adverse events typically associated with current antipsychotic treatments, such as sleepiness, weight gain and involuntary movement. Karuna's drug is expected to be patent-protected in the United States through the mid-2030s. The deal is expected to hit Bristol Myers' earnings per share by roughly 30 cents in 2024 due to the financing costs. The deal is "fairly valued in our view and can’t rule out another potential bidder, given this is first-in-class in an area that has not seen a new mechanism approval in decades," said William Blair analyst Myles Minter.The acquisition comes roughly two months after Bristol's deal to buy cancer drugmaker Mirati Therapeutics for as much as $5.8 billion.

Exclusive-India probe into bribery claim in toxic syrup tests nears completion

India is close to finishing an investigation into a "comprehensive and exhaustive" complaint that a state drug regulator, in return for a bribe, helped switch samples of cough syrups linked to the deaths of children in Gambia before the samples were tested in India, the investigator told Reuters. While the World Health Organization (WHO) linked the syrups made by India's Maiden Pharmaceuticals to the deaths of 70 children in the African country last year, India's government says tests at an Indian government laboratory showed the syrups were not toxic. Maiden has said it had not "done anything wrong".

US FDA approves Ionis-AstraZeneca's nerve disease drug

The U.S. Food and Drug Administration (FDA) on Thursday approved Ionis Pharmaceuticals and partner AstraZeneca's drug to treat nerve damage caused by a life-shortening rare disease. The drug, branded as Wainua, is approved for patients with polyneuropathy, or nerve damage caused by hereditary transthyretin amyloidosis (ATTR-PN), which affects an estimated 40,000 patients globally.

US FDA warns about counterfeit versions of Novo's diabetes drug Ozempic

The U.S. Food and Drug Administration on Thursday warned consumers not to use counterfeit versions of Novo Nordisk's diabetes drug Ozempic that have been found in the country's drug supply chain. The health regulator said it will continue to investigate counterfeit Ozempic 1 milligram injections and has seized thousands of units, but flagged that some may still be available for purchase.

Cuba quietly authorizes euthanasia

Cuba on Friday became the second country in Latin America and the Caribbean to authorize euthanasia, following Colombia. The Communist-run country’s National Assembly passed the measure as part of legislation updating the nation’s legal framework for its universal and free healthcare system.

(With inputs from agencies.)

Give Feedback