Health News Roundup: US finds no novel pathogens in genetic testing of mystery illness in dogs; Zealand says US FDA turns down drug for low blood sugar in infants and more

Zealand is seeking FDA approval for dasiglucagon, which it plans to use in patients aged seven days or older with congenital hyperinsulinism (CHI), a genetic disorder in which the pancreas secretes too much insulin. UnitedHealth agrees to sell Brazil unit Amil to Qualicorp founder -sources UnitedHealth Group agreed on Friday to sell its Brazilian health insurance operator Amil to businessman Jose Seripieri Filho, two sources with knowledge of the matter said.


Devdiscourse News Desk | Updated: 23-12-2023 18:40 IST | Created: 23-12-2023 18:29 IST
Health News Roundup: US finds no novel pathogens in genetic testing of mystery illness in dogs; Zealand says US FDA turns down drug for low blood sugar in infants and more
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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.

Zealand says US FDA turns down drug for low blood sugar in infants

Zealand Pharma said on Saturday that the U.S. Food and Drug Administration (FDA) had declined to approve its drug for preventing and treating low blood sugar in children with a genetic disorder after finding deficiencies at a third-party manufacturing facility. Zealand is seeking FDA approval for dasiglucagon, which it plans to use in patients aged seven days or older with congenital hyperinsulinism (CHI), a genetic disorder in which the pancreas secretes too much insulin.

UnitedHealth agrees to sell Brazil unit Amil to Qualicorp founder -sources

UnitedHealth Group agreed on Friday to sell its Brazilian health insurance operator Amil to businessman Jose Seripieri Filho, two sources with knowledge of the matter said. The information was earlier reported by local newspaper Valor Economico. One of the sources, who asked not to be identified discussing confidential information, said Seripieri's bid is around 2.5 billion reais ($515 million). Amil has 5.4 million health and dental insurance beneficiaries in Brazil and its sale was in the making for years. Seripieri is the founder and former chief executive of health insurance firm Qualicorp, which he left in 2019. UnitedHealth said it does not comment on rumors and speculation.

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.

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.

CDC says JN.1 variant accounts for 39%-50% of COVID cases in US

The U.S. Centers for Disease Control and Prevention (CDC) said on Friday that COVID subvariant JN.1 accounts for 39% to 50% of cases in the United States as of Dec. 23, according to the agency's projections. This is an increase from the estimated 15% to 29% of cases in the United States, the CDC had projected as of Dec. 8.

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.

India firm denies tampering with tests in probe of cough syrup deaths

India's Maiden Pharmaceuticals, whose cough syrups have been linked to the deaths of children in Gambia, on Saturday denied it had tampered with test samples or bribed officials to do so, as alleged in a complaint under investigation by local health officials. An investigator with the state of Haryana's Food and Drug Administration told Reuters on Friday he was close to finishing a probe into whether a state drug regulator was bribed to switch samples, tested by the Indian government, that contradicted the World Health Organization's findings of toxic substances in the cough syrups.

GSK to cut US prices for Advair, Valtrex and Lamictal

Drugmaker GSK Plc said on Friday that it will cut U.S. list prices on asthma drug Advair, herpes drug Valtrex, and anti-epileptic medication Lamictal on Jan. 1, 2024. The price cuts come after several companies have already announced price decreases for insulins earlier this year as they worked to avoid potential penalties under 2021's American Rescue Plan Act if they had kept prices high.

(With inputs from agencies.)

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