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☆ U.S. FDA to soon decide on second round of Omicron-tailored boosters - WSJ
▼ + stars: | 2023-03-21 | by ( ) www.reuters.com time to read: +2 min

The agency continues to closely monitor the emerging data in the United States and globally, and that data will dictate any decision on additional updated boosters, the FDA said in a statement. The Centers for Disease Control and Prevention would have to recommend the shots after the FDA authorizes the second Omicron-tailored boosters from Pfizer-BioNTech (PFE.N)/(22UAy.DE) and Moderna (MRNA.O) for them to become widely available. Updated boosters have helped prevent symptomatic infections against the new XBB-related subvariants, according to data released by the CDC in January. The FDA authorized the so-called bivalent COVID boosters in August that target the BA.4 and BA.5 Omicron subvariants, along with the original strain of the coronavirus. Rollout of the updated boosters in the United States started the following month.

☆ US FDA to take steps to help gene therapies get accelerated approval
▼ + stars: | 2023-03-21 | by ( ) www.reuters.com time to read: +2 min

March 20 (Reuters) - The U.S. Food and Drug Administration is moving to optimize the development of gene therapies, including encouraging the use of biomarkers to help get accelerated approval of therapies for serious conditions, an agency official said. The FDA will support using biomarkers as substitutes for other biological indicators in gene-therapy clinical trials to help clinch "accelerated approval", the agency's Peter Marks said on Monday. The U.S. health regulator grants the so-called accelerated approval mainly for drugs and therapies targeted at rare diseases or small patient populations that have had no effective treatments available to them. "The FDA views gene therapy as an excellent opportunity to expedite the delivery of potentially life-saving therapies to patients with rare diseases," said Marks, who heads the FDA's Center for Biologics Evaluation and Research, in a statement. The company is seeking approval for its gene therapy under the FDA's accelerated pathway.

☆ FDA staff says safety issues with Biogen's ALS drug to not prevent approval
▼ + stars: | 2023-03-21 | by ( Bhanvi Satija | ) www.reuters.com time to read: +2 min

March 20 (Reuters) - The U.S. health regulator's staff said on Monday safety issues with Biogen Inc's (BIIB.O) drug to treat an ultra-rare form of amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig's disease, should not prevent its accelerated approval. The drug, tofersen, failed to meet its main goal of reducing symptoms but reduced protein neurofilament levels during a late-stage study. The risks related to Biogen's drug, such as spinal cord inflammation and optic nerve swelling, observed in trial patients "are acceptable to the patient population", the staff said. They added that a majority of these risks may be related to the way in which the drug is administered, rather than the drug itself. The company is seeking approval for the drug in ALS patients with mutation in a gene known as superoxide dismutase 1.

☆ US FDA staff flags no new safety concerns for Biogen's ALS drug
▼ + stars: | 2023-03-20 | by ( ) www.reuters.com time to read: +1 min

March 20 (Reuters) - Staff reviewers of U.S. drug regulator on Monday did not raise any new safety concerns about Biogen Inc's (BIIB.O) experimental drug for treating a rare type of amyotrophic lateral sclerosis, also known as Lou Gehrig's disease. The risks related to Biogen's drug, tofersen, "are acceptable to the patient population" and would not "preclude approval", staff reviewers said in briefing documents published on the agency's website. The agency has asked advisers to weigh in on approving the use of the drug based on available data, which shows it reduces a key protein related to the disease, and not disease symptoms. In October 2021, tofersen failed to meet the main goal of a late-stage study, but the company said trends of reduced disease progression were observed. Reporting by Raghav Mahobe and Bhanvi Satija in Bengaluru; Editing by Krishna Chandra Eluri and Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

☆ Novo Nordisk's diabetes drug Ozempic back in supply in US after months of shortage
▼ + stars: | 2023-03-17 | by ( ) www.reuters.com time to read: +1 min

March 17 (Reuters) - Novo Nordisk's (NOVOb.CO) best-selling diabetes treatment drug Ozempic is back on the shelves in the United States after months of shortage, the U.S. Food and Drug Administration (FDA) website showed on Friday. The main active ingredient in Ozempic is semaglutide, also the key ingredient in Novo's obesity drug Wegovy, which has been seeing supply shortage due to high demand. The company said the 0.25 mg, 0.5 mg and the 1 mg doses of Ozempic are available for patients. The 2 mg dose, however, has limited availability until the end of this month, largely due to the demand coupled with overall global supply constraints. "While product continues to be manufactured and shipped, patients in some areas of the country will experience delays with the 2mg dose," Novo Nordisk said.

☆ US FDA classifies recall of heart devices by Getinge as most serious
▼ + stars: | 2023-03-17 | by ( ) www.reuters.com time to read: +1 min

March 17 (Reuters) - The U.S. Food and Drug Administration (FDA) on Friday classified the recall of Getinge AB's (GETIb.ST) heart devices as the most serious type, saying their use may cause injuries or death. The Swedish medical equipment maker's unit, Datascope, recalled an estimated 2,300 devices in the United States in January. Coiled cable connecting the display and base on some devices of the company may fail, causing an unexpected shutdown, according to the FDA. In January, Datascope had also recalled 4,454 units initiated back in December. Reporting by Raghav Mahobe in Bengaluru; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

☆ Pfizer to replace migraine drug packaging over child safety concerns
▼ + stars: | 2023-03-16 | by ( ) www.reuters.com time to read: +1 min

[1/2] The Pfizer logo is pictured on their headquarters building in the Manhattan borough of New York City, New York, U.S., November 9, 2020. REUTERS/Carlo Allegri/File PhotoCompanies Pfizer Inc FollowMarch 16 (Reuters) - Pfizer Inc (PFE.N) said on Thursday it was working on a new child-proof packaging for its migraine drug, Nurtec ODT, after safety concerns led to a recall alert from the U.S. Consumer Product Safety Commission (CPSC). Pfizer said it was developing a new packaging for the drug acquired through its $11.6 billion buyout of Biohaven Pharmaceutical Holding in 2022. As an interim measure, the company has instructed pharmacists to place the drug packet in a child-resistant vial before dispensing it to patients. The orally disintegrating tablets are used for the treatment of acute migraine and as preventive treatment for episodic migraine in adults.

☆ Mozambique records rise in cholera cases, Malawi sees decline - WHO
▼ + stars: | 2023-03-15 | by ( ) www.reuters.com time to read: +1 min

[1/2] Eliza Tangwe, 18, takes a dose of oral cholera vaccine at a health centre in response to the latest cholera outbreak in Blantyre, Malawi, November 16, 2022. REUTERS/Eldson Chagara/March 15 (Reuters) - Mozambique recorded an increase in the number of cholera cases in the last few weeks, the World Health Organization said on Wednesday, even as many other African countries reported a decline. Mozambique's neighbor Malawi, which has been battling the deadliest cholera outbreak in its history, was now seeing a sustained decline in cases and deaths, WHO official and epidemiologist Dr Otim Ramadan said. Overall, cholera cases and deaths in Africa have been declining over recent weeks. So far this year, more than 40,000 cases have been reported in Africa, with Malawi accounting for more than half and Mozambique recording about 15%, WHO reported.

☆ Moderna to hire around 2,000 employees amid mRNA development push
▼ + stars: | 2023-03-10 | by ( ) www.reuters.com time to read: +1 min

Companies Moderna Inc FollowMarch 10 (Reuters) - Moderna Inc (MRNA.O) said on Friday it was planning to hire about 2,000 employees globally by 2023-end and set up new offices on the U.S. West Coast, as it aims to scale up development of new products amid declining COVID vaccine sales. The COVID vaccine maker said it will open new offices in California and Seattle, adding that its Genomics unit will expand to south San Francisco. Last month, Moderna forecast rising costs for 2023 and a decline in COVID vaccine sales, raising concerns that the company could post a loss this year. The firm had about 3,900 full-time employees as of Dec. 31, according to a regulatory filing. Reporting by Raghav Mahobe in Bengaluru; Editing by Anil D'Silva, Shinjini Ganguli and Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.

☆ U.S. FDA clears Abbott's blood test for concussions
▼ + stars: | 2023-03-07 | by ( ) www.reuters.com time to read: +1 min

March 7 (Reuters) - The U.S. Food and Drug Administration has cleared Abbott Laboratories' (ABT.N) blood test that would help doctors assess traumatic brain injury (TBI), commonly known as concussions, the company said on Tuesday. The clearance marks the first commercially available laboratory blood test for TBI, according to the company, helping the doctors to rule out need for a CT scan in patients with mild TBI. Abbott already has a plasma test for TBI and was cleared by the FDA in 2021. The new test measures two indicators in the blood that, in elevated concentrations, are tightly correlated to brain injury, the company said. Reporting by Raghav Mahobe in Bengaluru; Editing by Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.

☆ California to not do business with Walgreens over abortion pills issue, Governor says
▼ + stars: | 2023-03-06 | by ( ) www.reuters.com time to read: +1 min

March 6 (Reuters) - California would not do business with Walgreens Boots Alliance Inc (WBA.O), state Governor Gavin Newsom said in a tweet on Monday, days after the pharmacy chain said it will not dispense abortion pills in some Republican states. The state refuses to do business with Walgreens or "any company that cowers to the extremists and puts women's lives at risk," Democrat governor Newsom said. The company said last week it will steer clear from 20 states, including states where abortion remains legal, where the Republican attorneys general have warned it of risking breaking the law if it distributed abortion pills. The U.S. Food and Drug Administration in January allowed retail pharmacies to sell abortion pill mifepristone, including by mail, provided they were certified under special safety rules for the drug. Reporting by Raghav Mahobe in Bengaluru; Editing by Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

☆ Aclaris shares tank as skin disorder drug fails mid-stage study
▼ + stars: | 2023-03-06 | by ( ) www.reuters.com time to read: +1 min

Companies Aclaris Therapeutics Inc FollowMarch 6 (Reuters) - Aclaris Therapeutics Inc (ACRS.O) said on Monday its experimental drug failed to meet the main goal of a mid-stage study to treat a painful skin disorder, sending its shares tumbling more than 36% in premarket trading. The drug, zunsemetinib, did not meet the main goal of reducing abscesses in patients with moderate to severe hidradenitis suppurativa (HS) at week 12, compared with a placebo. HS is a chronic inflammatory skin condition that causes abscesses and scarring on the skin. The study also failed to meet its secondary goals, which included percentage of patients who achieved at least a 50% reduction in number of inflammatory lesions, Aclaris said. The drug is being tested to treat other inflammatory conditions such as rheumatoid arthritis and psoriatic arthritis, far bigger markets than HS.

Feb 28 (Reuters) - The U.S. Food and Drug Administration on Tuesday approved Reata Pharmaceuticals Inc's (RETA.O) drug for the treatment of a rare genetic disorder that causes progressive damage to the nervous system, sending shares up nearly 160% after the bell. The drug, Skyclarys, is Reata's first product to gain approval, and Jefferies analyst Maury Raycroft projected that U.S. sales of the drug could reach $400 million by 2030. Reata estimates the disorder, called Friedreich's ataxia, affects about 5,000 patients in the United States. Raycroft, before the FDA decision, estimated the drug could be priced at about $425,000 per patient annually. The FDA has previously approved drugs for neurological conditions based on limited data such as for Biogen Inc's (BIIB.O) Alzheimer's drug Aduhelm and Amylyx's ALS drug.

☆ Northwest Syria of 'greatest concern' after quake -WHO
▼ + stars: | 2023-02-15 | by ( ) www.reuters.com time to read: +2 min

"It's clear that the zone of greatest concern at the moment is the area of northwestern Syria," WHO's emergencies director, Mike Ryan, told a briefing in Geneva. We have to remember here that in Syria, we've had ten years of war. Dr. Tedros Adhanom Ghebreyesus, the head of the World Health Organization (WHO), speaks with a man as he visits quake survivors at a hospital in Aleppo, in the aftermath of the earthquake, Syria February 11, 2023. We've seen the deployment of emergency medical teams. We've seen all the things that we need to see in a disaster.

☆ Globus Medical's $3 bln deal for NuVasive to fortify spinal business spooks investors
▼ + stars: | 2023-02-09 | by ( Raghav Mahobe | ) www.reuters.com time to read: +2 min

Feb 9 (Reuters) - Globus Medical Inc (GMED.N) said on Thursday it would acquire peer NuVasive Inc (NUVA.O) in an all-stock deal valued at about $3 billion to build scale in the competitive market for spinal devices. NuVasive shareholders will receive 0.75 of Globus shares, implying a per-share offer of $57.72 and a premium of about 26% to Wednesday's close. Shares of Globus Medical fell more than 17%, with analysts raising concerns around deals in spinal device space. "We both have very rich product portfolios to still develop," said Globus Medical Chief Executive Officer Daniel Scavilla. NuVasive shareholders will own about 28% of the combined company, while Globus shareholders will own the rest.

☆ Globus Medical to buy NuVasive in deal valued at about $3 billion
▼ + stars: | 2023-02-09 | by ( ) www.reuters.com time to read: +1 min

Feb 9 (Reuters) - Device maker Globus Medical Inc (GMED.N) said on Thursday it was acquiring peer NuVasive Inc (NUVA.O) in an all-stock deal valued at about $3 billion to increase its scale in the competitive surgical space. NuVasive shareholders will receive 0.75 of Globus' share, which implies a stock price of $57.72 for NuVasive, representing a premium of about 26% to its last close. The company reported sales of $896.5 million for the first nine months of 2022. It reported sales of $748.3 million for the first three quarters of last year. Following the close of the transaction, NuVasive shareholders will own about 28% of the combined company, and Globus Medical shareholders will own around 72%.

☆ Factbox: Which CVS rivals also own primary care services
▼ + stars: | 2023-02-08 | by ( ) www.reuters.com time to read: +2 min

Here is a list of some big companies that are also providing medical services or have announced similar deals:UnitedHealth Group IncUnitedHealth's (UNH.N) Optum Health business provides services that range from primary care to specialty care such as cardiology and oncology. UnitedHealth last year also announced a deal to buy LHC Group (LHCG.O), which provides healthcare services at home, for about $5.4 billion. Walgreens Boots AlliancePharmacy chain Walgreens (WBA.O) in 2021 took a majority stake in primary care provider VillageMD, which has nearly 400 clinics in the United States including 200 co-located with Walgreens retails stores, as of the end of 2022. VillageMD completed the acquisition of urgent care provider Summit Health in a deal valued at $9 billion. Amazon.com IncAmazon.com Inc (AMZN.O) agreed to buy primary care provider One Medical for $3.49 billion in July to expand its virtual healthcare and add brick-and-mortar doctors' offices.

☆ CVS digs into primary care with $9.5 bln Oak Street Health deal
▼ + stars: | 2023-02-08 | by ( ) www.reuters.com time to read: +2 min

Feb 8 (Reuters) - CVS Health Corp (CVS.N) said on Wednesday it would buy Oak Street Health Inc (OSH.N) for about $9.5 billion in cash, expanding its healthcare services by adding hundreds of primary care clinics mostly for older people. Shares of the primary care firm rose 5% before the bell. The Oak Street deal echoes similar moves by rivals into primary care. Walgreens Boots Alliance (WBA.O) and Cigna (CI.N) have made investments in primary care provider VillageMD, and Amazon (AMZN.O) announced a $3.49 billion deal last year to buy One Medical (ONEM.O) to expand into the space. UnitedHealth Group Inc (UNH.N) also runs urgent care, primary care and surgical care centers.

☆ CVS Health beats quarterly profit estimates on lower medical costs
▼ + stars: | 2023-02-08 | by ( ) www.reuters.com time to read: 1 min

Companies CVS Health Corp FollowFeb 8 (Reuters) - CVS Health (CVS.N) beat quarterly profit estimates on Wednesday, as a decline in hospitalizations from COVID-19 helped bring down medical costs at its Aetna insurance business. The company posted an adjusted profit of $1.99 per share, above estimates of $1.92 per share, according to Refinitiv IBES data. CVS reaffirmed its full-year adjusted profit forecast of between $8.70 and $8.90 per share. Reporting by Raghav Mahobe and Bhanvi Satija in Bengaluru; Editing by Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

Feb 7 (Reuters) - Centene Corp (CNC.N) on Tuesday said profit at its fast-growing Medicare Advantage (MA) business will take a beating in 2024 due to a sharp cut in its rating by a U.S. federal agency and likely lower-than-expected government payouts to health insurers. Centene does not expect its MA business to grow next year and it will likely "shrink a little", Chief Financial Officer Andrew Asher said in a post-earnings conference call. Asher said the company expects negative profit margins in the business in 2024 temporarily, after CMS cut star rating for Centene's MA plans in October. MA plans are government-supported insurance plans that private companies offer people over 65 years of age. Revenue from Centene's Medicare health insurance business rose about 24% to $5.45 billion from a year earlier.

☆ Centene profit beats on easing medical costs, Medicare boost
▼ + stars: | 2023-02-07 | by ( ) www.reuters.com time to read: +1 min

Feb 7 (Reuters) - Health insurer Centene Corp (CNC.N) beat fourth-quarter profit estimates by a small margin on Tuesday, helped by easing medical costs and steady demand for its government-backed Medicare health insurance business. Most health insurers saw their costs fluctuate during the pandemic, but have benefited in recent quarters from declining COVID-related hospitalizations. Larger rival UnitedHealth (UNH.N) recently said medical costs were more predictable with the world in the third year of COVID-19. Medicaid program helps cover medical costs for some people with limited income and resources. Revenue from Centene's Medicare health insurance business rose about 24% to $5.45 billion from a year earlier.

☆ U.S. FDA removes COVID test requirements for Pfizer, Merck pills
▼ + stars: | 2023-02-01 | by ( ) www.reuters.com time to read: +1 min

[1/2] Pfizer logo is seen in this illustration taken, May 1, 2022. REUTERS/Dado Ruvic/IllustrationFeb 1 (Reuters) - The U.S. Food and Drug Administration (FDA) on Wednesday removed the need for a positive test for COVID-19 treatments from Pfizer Inc (PFE.N) and Merck & Co Inc (MRK.N). Pfizer's Paxlovid and Merck's Lagevrio pills were given emergency use authorizations in Dec. 2021 for patients with mild-to-moderate COVID who tested positive for the virus, and who were at risk of progressing to severe COVID. Still, the FDA said the patients should have a current diagnosis of mild-to-moderate COVID infection. Reporting by Raghav Mahobe in Bengaluru; Editing by Krishna Chandra EluriOur Standards: The Thomson Reuters Trust Principles.

"Today we have additional evidence to show that these updated vaccines are protecting people against the latest COVID-19 variants," Dr. Brendan Jackson, head of the U.S. Centers for Disease Control and Prevention's COVID-19 response, told reporters in a briefing. Released last fall, the updated boosters target the BA.4 and BA.5 Omicron variants of the SARS-CoV-2 virus, which are no longer dominant. It showed that the updated vaccine helped prevent illness in roughly half of the people who had previously received two to four doses of the original COVID-19 vaccine, CDC said. The CDC said the updated vaccine worked similarly against BA.5-related infections and XBB/XBB.1.5-related infections. Given the findings, the CDC urged people to stay up to date on their recommended COVID-19 vaccines.

☆ Merck scraps Keytruda trial for prostate cancer after dismal interim data
▼ + stars: | 2023-01-25 | by ( ) www.reuters.com time to read: +1 min

Jan 25 (Reuters) - Merck & Co Inc (MRK.N) said on Wednesday it was discontinuing a late-stage trial of its blockbuster immunotherapy Keytruda in some prostate cancer patients after interim data showed it was unlikely to meet the study's main goals. The interim analysis showed the therapy did not extend survival or help extend the time a patient lives without the disease worsening, the U.S. drugmaker said. The trial had enrolled 1,251 patients who received the combination therapy with Keytruda or a placebo. Prostate cancer is the most common cancer in the United States with nearly 270,000 new cases and 34,500 deaths in the country in 2022, according to government data estimates. Separately, Merck said Keytruda in combination with a chemotherapy showed significant improvement in overall survival in patients with an advanced type of bile duct cancer.

☆ CVS names new pharmacy services, consumer product chiefs
▼ + stars: | 2023-01-23 | by ( ) www.reuters.com time to read: +1 min

Jan 23 (Reuters) - CVS Health Corp (CVS.N) said on Monday that David Joyner would return to head the U.S. diversified healthcare company's pharmacy services and tapped former Cigna Corp (CI.N) executive Amy Bricker as its chief product officer for consumer business. Joyner will become the chief of the pharmacy services segment, which also includes the company's pharmacy benefits management business Caremark, effective Jan. 30. Bricker will start in the newly created role in February after serving as president of Express Scripts, rival Cigna Corp's pharmacy benefits unit. Its largest health insurance plan for Medicare recipients received a lower performance rating from the U.S. Centers for Medicare and Medicaid Services in October. The lower rating could affect payments from the government for 2024, the company said.

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