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☆ Sarepta surges after FDA panel backs Duchenne gene therapy
▼ + stars: | 2023-05-15 | by ( ) www.reuters.com time to read: +2 min

May 15 (Reuters) - Shares of Sarepta Therapeutics (SRPT.O) soared 29% premarket on Monday as a backing by the U.S. health regulator's advisers increased the certainty of an accelerated approval for the company's gene therapy for a muscle-wasting genetic disorder. Eight of the 14 advisers to the Food and Drug Administration late Friday voted that the company had enough data to support an accelerated approval for its gene therapy for Duchenne muscular dystrophy (DMD). The vote came after FDA staff had earlier last week voiced concerns that the data from the company's mid-stage trial lacked "unambiguous evidence" about benefits from the therapy. TD Cowen analyst Ritu Baral expects an approval for the therapy, especially considering the FDA leadership's interest in promoting biomarker-based accelerated approvals for gene therapies. The FDA, often follows the advice of its expert advisers but is not obligated to do so, is slated to make a decision on accelerated approval by May 29.

☆ Japan's Otsuka Pharma gets FDA approval for Alzheimer's agitation drug
▼ + stars: | 2023-05-11 | by ( ) www.reuters.com time to read: +1 min

May 11 (Reuters) - The U.S. Food and Drug Administration approved Otsuka Pharmaceutical's (4578.T) brexpiprazole to treat agitation in patients with Alzheimer's on Thursday, making it the first approved drug for the indication, the company said in a statement. Patients with Alzheimer's sometimes show signs of extreme aggression or become restless and anxious as their brain loses its ability to negotiate with new stimulus as a result of the disease. The approval of brexpiprazole is based on two late-stage studies, which showed significant improvement in calming agitated patients with Alzheimer's, when compared with a placebo. Brexpiprazole, co-developed with Danish drugmaker Lundbeck (HLUNb.CO), was previously approved in the U.S. to treat adults with major depressive disorder and schizophrenia. Reporting by Aditya Samal; Editing by Shounak DasguptaOur Standards: The Thomson Reuters Trust Principles.

☆ Global push to tackle maternal and newborn deaths has stalled, WHO report finds
▼ + stars: | 2023-05-09 | by ( ) www.reuters.com time to read: +2 min

Annually since 2015 there have been about 290,000 maternal deaths, 1.9 million stillbirths, and 2.3 million newborn deaths within a month after birth, the report said. Countries need to ramp up investment in primary care to see different results, said Anshu Banerjee, the WHO's director of maternal, newborn, child and adolescent health and ageing. Only 12% of 106 reporting countries have fully-financed maternal and newborn health plans, it said. The report also found that only 61% of reporting countries have systems for keeping track of stillbirths. The report found that 10 countries with the highest maternal deaths, stillbirths and neonatal deaths account for 60% of all such deaths globally.

☆ US FDA panel backs restricted use of AstraZeneca's prostrate cancer drug
▼ + stars: | 2023-04-28 | by ( ) www.reuters.com time to read: +2 min

April 28 (Reuters) - A panel of U.S. Food and Drug Administration advisers on Friday voted for the restricted use of British drugmaker AztraZeneca Plc's (AZN.L) experimental treatment, jointly developed with Merck & Co (MRK.N), for a type of prostate cancer. The FDA panel voted 11-1 with one abstention, in favor of Lynparza, in combination with other medications – abiraterone and prednisone or prednisolone – as a first-line treatment for a type of treatment-resistant prostate cancer in adult patients. They were withdrawn last year as second line of treatment for ovarian cancer patients after the FDA limited the use of PARP inhibitors and requested companies to pull the drug. Lynparza is already approved by the FDA to treat a type of breast cancer, ovarian cancer, as well as a different form of prostate cancer. Prostate cancer is the most common form of cancer among men in the United States with about 288,300 new cases in 2023, according to the American Cancer Society's estimates.

☆ Bristol Myers CEO Caforio steps down
▼ + stars: | 2023-04-26 | by ( ) www.reuters.com time to read: +1 min

[1/2] A sign stands outside a Bristol Myers Squibb facility in Cambridge, Massachusetts, U.S., May 20, 2021. REUTERS/Brian Snyder/File PhotoCompanies Bristol-Myers Squibb Co FollowApril 26 (Reuters) - Bristol Myers Squibb Co (BMY.N) said on Wednesday CEO Giovanni Caforio, who has been in the role since 2015, has decided to step down from his position. Outgoing CEO Giovanni will continue as executive chairman of the company's board. Bristol Myers is due to report first-quarter financial results on Thursday. Bristol Myers shares rose 0.39% to $68.29 in after-hours trading.

☆ Carrier to buy German firm Viessmann's unit in $13.17 bln deal
▼ + stars: | 2023-04-25 | by ( ) www.reuters.com time to read: +1 min

April 25 (Reuters) - Air conditioner maker Carrier Global Corp (CARR.N) said on Tuesday it would buy German industrial firm Viessmann Group's unit that makes heating boilers and heat pumps in a 12 billion euros ($13.17 billion) cash-and-stock deal. Under the deal, Viessmann Chief Executive Max Viessmann would join Carrier's board. The deal has been approved by the board of both companies and is expected to close by 2023 end. The company said the deal is expected to be modestly impact its adjusted profit in 2024 and would add to earnings in 2025. Separately, Carrier reported a 2% drop in its first-quarter profit, excluding items.

☆ US CDC signs off on second Omicron-updated COVID booster for older adults
▼ + stars: | 2023-04-19 | by ( ) www.reuters.com time to read: +1 min

April 19 (Reuters) - Older people and those with weakened immune systems may get a second dose of Omicron-targeting COVID-19 vaccines, the U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday. The agency's decision after its advisory committee's meeting aligns it with the U.S. Food and Drug Administration's authorization on Tuesday for a second dose of Omicron-updated booster for the specified high-risk population. Adults aged 65 years and older can take a second dose of the updated vaccine, the CDC said, while people who are immunocompromised can get additional doses. It also said the original COVID-19 vaccine will no longer be recommended for use in the United States. Monovalent COVID-19 vaccines from Novavax (NVAX.O) or Johnson & Johnson's (JNJ.N) Janssen were not affected by the changes made today, the agency said.

☆ Moderna to keep testing flu shot as it fails to meet 'early success' criteria
▼ + stars: | 2023-04-11 | by ( ) www.reuters.com time to read: +1 min

Companies Moderna Inc FollowApril 11 (Reuters) - Moderna Inc (MRNA.O) said on Tuesday it had not enrolled enough cases in a late-stage trial of its experimental flu vaccine to determine if the shot was successful or not, sending the company's shares down 8% in premarket trading. The company said, ahead of its annual vaccines conference, that it will continue testing the flu shot for efficacy. Moderna also forecast sales from its respiratory vaccines to be between $8 billion and $15 billion in 2027. It is testing vaccines against respiratory syncytial virus (RSV), influenza and a next-generation COVID-19 shot in late-stage studies. Reporting by Bhanvi Satija and Aditya Samal in Bengaluru; Editing by Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

☆ Sarepta slides as FDA about-turn on panel clouds gene therapy approval path
▼ + stars: | 2023-03-17 | by ( Aditya Samal | ) www.reuters.com time to read: +2 min

[1/2] Sign is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File PhotoMarch 17 (Reuters) - Shares of Sarepta Therapeutics Inc (SRPT.O) slumped as much as 21% on Friday on uncertainty over its gene therapy for Duchenne muscular dystrophy after the U.S. health regulator reversed its decision on a panel meeting. The U.S. Food and Drug Administration planned to hold a meeting of its independent experts to review the gene therapy, the company said late on Thursday, less than a month after saying it would not do so. Sarepta is developing SRP-9001 as the first gene therapy for the treatment of Duchenne muscular dystrophy, an inherited disorder of progressive muscular weakness typically seen in boys. Gene therapies such as BioMarin's (BMRN.O) bleeding disorder therapy have faced setbacks and tough scrutiny in the past, but the FDA approved multiple such products in 2022.

☆ 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.

☆ Opko Health soars after deal with Merck for experimental Epstein-Barr vaccine
▼ + stars: | 2023-03-08 | by ( ) www.reuters.com time to read: +1 min

March 8 (Reuters) - Opko Health Inc (OPK.O) said on Wednesday it signed a deal with Merck & Co Inc (MRK.N) potentially worth up to $922.5 million for its experimental Epstein-Barr virus vaccine. Merck will take over the clinical and regulatory activities related to the vaccine, as well its commercialization once the drugmaker files a joint application with Opko unit ModeX Therapeutics to test it in humans, the company said. Opko will receive an upfront payment of $50 million and is eligible for milestone payments of up to $872.5 million, plus royalties on global sales. There is currently no vaccine for the Epstein-Barr virus, which is the leading cause of mononucleosis, or mono, commonly called the "kissing disease". Reporting by Aditya Samal in Bengaluru; Editing by Pooja DesaiOur Standards: The Thomson Reuters Trust Principles.

☆ Reata shares triple after surprise FDA nod for rare disease drug
▼ + stars: | 2023-03-01 | by ( ) www.reuters.com time to read: +2 min

March 1 (Reuters) - Shares of Reata Pharmaceuticals Inc (RETA.O) tripled in value on Wednesday after the U.S. Food and Drug Administration (FDA) approved its rare disease drug, ending years of uncertainty over its future. The U.S. biotech firm's shares jumped to $93, the highest since late 2021, on more than 16 million shares traded, a record one-day volume for the stock. Reata's drug Skyclarys is the first approved treatment for Friedreich's Ataxia, a rare genetic disorder that causes progressive damage to the nervous system and can lead to premature death. The nod follows years of back and forth between Reata and the FDA. Reata's shares had tumbled 30% following Dunn's resignation as investors fretted about the possibility of approval under a new division head.

☆ Reata shares hit 1-year high after surprise FDA nod for rare disease drug
▼ + stars: | 2023-03-01 | by ( ) www.reuters.com time to read: +2 min

March 1 (Reuters) - Shares of Reata Pharmaceuticals Inc (RETA.O) soared 175% to hit a one-year high in early trading on Wednesday, after the U.S. Food and Drug Administration (FDA) approved its rare disease drug and ended years of uncertainty over its future. The U.S. biotech firm's shares jumped to $86, their highest since December 2021. The nod follows years of back and forth between Reata and the FDA. Reata's shares had tumbled 30% following Dunn's resignation as investors had fretted about the possibility of approval under a new division head. "We've followed some pretty dramatic stories in the past, but the Reata odyssey is in the Hall of Fame," said Baird analyst Brian Skorney.

☆ Reata shares surge after surprise FDA nod for rare disease drug
▼ + stars: | 2023-03-01 | by ( ) www.reuters.com time to read: +1 min

March 1 (Reuters) - Shares of U.S. biotech firm Reata Pharmaceuticals Inc (RETA.O) more than doubled in premarket trading on Wednesday, a day after the Food and Drug Administration (FDA) approved its rare disease drug and ended years of uncertainty over its future. The drug Skyclarys is the first approved treatment for Friedreich's Ataxia, a rare genetic disorder that causes progressive damage to the nervous system and can lead to premature death. The approval follows years of back and forth between Reata and the FDA, which in 2020 said the data from a mid-stage trial was not enough to support an approval. The FDA has previously approved drugs for neurological conditions based on limited data such as for Biogen Inc's Alzheimer's drug Aduhelm and Amylyx's (AMLX.O) ALS drug. Reata's shares were up 174.2% to $85.47 before the bell.

☆ U.S. FDA to restrict unlawful import of veterinary tranquilizer Xylazine
▼ + stars: | 2023-02-28 | by ( ) www.reuters.com time to read: +1 min

Feb 28 (Reuters) - U.S. health regulators on Tuesday issued an import alert for drug ingredients and products related to Xylazine, used largely as a veterinary tranquilizer but has been a drug of abuse, to restrict its unlawful entry into the United States. The Food and Drug Administration (FDA) said its move aims to prevent the drug from entering the U.S. market for illicit purposes, while maintaining availability for its legitimate uses in animals. Under the alert, the FDA will do an entry review of evidence offered by importers if incoming Xylazine is properly labeled, not adulterated, and for legitimate use. Xylazine is approved by the FDA only for veterinary use and German drugmaker Bayer's (BAYGn.DE) animal sedative drug Rompun is among the drugs which are based on Xylazine. "The FDA remains concerned about the increasing prevalence of Xylazine mixed with illicit drugs, and this action is one part of broader efforts the agency is undertaking to address this issue," FDA Commissioner Robert Califf said in the statement.

☆ Not enough data to support multiple annual COVID boosters, U.S. CDC advisers say
▼ + stars: | 2023-02-24 | by ( Aditya Samal | ) www.reuters.com time to read: +2 min

[1/2] A general view of the Centers for Disease Control and Prevention (CDC) headquarters in Atlanta, Georgia September 30, 2014. The CDC advisers did not vote on new recommendations for how the COVID-19 shots should be administered on Friday. But ACIP advised showing flexibility in recommendations for those with compromised or weakened immune systems to allow more frequent doses for those most vulnerable to severe COVID. About 53.3 million people in the United States - around 16% of the U.S. population - have received a COVID-19 booster shot since updated versions of the vaccines were authorized in September. That compares with 230 million people, around 70% of the population, that received an initial two-dose series of the COVID vaccines.

☆ Moderna reaffirms 2023 COVID vaccine sales forecast of $5 billion
▼ + stars: | 2023-02-23 | by ( ) www.reuters.com time to read: 1 min

Companies Moderna Inc FollowFeb 23 (Reuters) - Moderna Inc (MRNA.O) reaffirmed its annual sales forecast of $5 billion for its COVID-19 vaccines, which was below market expectations as the company anticipated lower demand in the fourth year of the pandemic. Sales of the COVID vaccine, Moderna's sole commercial product, were widely expected to fall sharply this year from $18.4 billion in 2022. Moderna's forecast was lower than Refinitiv estimates of $6.98 billion. The company also reiterated its plans to file for regulatory approval its respiratory syncytial virus vaccine in the first half of 2023 as it looks to build its product portfolio beyond COVID vaccines. Reporting by Aditya Samal and Leroy Leo; Editing by Arun KoyyurOur Standards: The Thomson Reuters Trust Principles.

☆ Tenet Healthcare's fourth-quarter beat puts 2023 concerns at bay
▼ + stars: | 2023-02-09 | by ( ) www.reuters.com time to read: +2 min

Feb 9 (Reuters) - Tenet Healthcare Corp (THC.N) on Thursday beat Wall Street estimates for fourth-quarter results as growth in its outpatient service business put concerns around the hospital operator's weak 2023 forecast at bay. HCA Healthcare also recently forecast lower-than-expected 2023 profit, but bet on improved staffing trends and lower labor costs to drive growth for the year. "As expected, the 2023 forecast came in below consensus estimates, but we believe investors had already priced that in," SVB Securities analyst Whit Mayo said. Tenet is betting on growth in its ambulatory care unit, which deals with patients who are not bedridden and don't require overnight hospitalization. On an adjusted basis, Tenet reported a net income of $1.96 per share for the quarter ended Dec. 31, beating estimates of $1.23 per share.

FILE PHOTO: The Johnson & Johnson logo is displayed on a screen on the floor of the New York Stock Exchange (NYSE) in New York, U.S., May 29, 2019. REUTERS/Brendan McDermid/File Photo(Reuters) - Johnson & Johnson will look for opportunities to merge with or acquire firms that add value to its focus areas of eye care, surgical robots, orthopedics and cardiovascular products, the company’s Chief Executive Officer Joaquin Duato said on Monday. The healthcare giant is in the process of spinning off its consumer healthcare business under the brand Kenvue to focus on its pharmaceutical and medical devices businesses. J&J last month completed its acquisition of heart pump maker Abiomed for $16.6 billion, which will operate as an independent division in its medical devices business. The company’s CEO expects J&J to continue growing towards its goal of $60 billion in pharmaceutical sales by 2025, and is confident of exceeding current Street expectations by the targeted year.

Jan 5 (Reuters) - Walgreens Boots Alliance (WBA.O) said on Thursday it will not strike new deals in the short term after a spate of acquisitions in recent years, as it focuses on ramping up sales at its newer healthcare business. "We're not considering any M&A type activity in the short term. We need to focus on integration activities," Chief Financial Officer James Kehoe said in a post-earnings conference call. Walgreens said same-store pharmacy sales rose 4.8% in the reported quarter from a year earlier, but below Evercore ISI's estimates of 5% growth. Net loss attributable to Walgreens was $3.72 billion, for the quarter ended Nov. 30, compared with a profit of $3.58 billion, a year earlier.

☆ Walgreens posts loss on $6.5 bln opioid litigation charge
▼ + stars: | 2023-01-05 | by ( ) www.reuters.com time to read: +2 min

Jan 5 (Reuters) - Drugstore chain Walgreens Boots Alliance Inc (WBA.O) reported a net quarterly loss on Thursday as it took a $6.5 billion opioid litigation charge, sending its shares down nearly 2% in premarket trade. CVS took a pre-tax charge of $5.2 billion in its third quarter related to the settlement. It administered about 8 million vaccines in the first quarter down from 15.6 million in the same period a year earlier. In November, Walgreens said it was acquiring urgent care provider Summit Health through its VillageMD unit in a deal valued at $9 bln to expand its healthcare footprint. Excluding items, the company earned $1.16 per share in the first quarter, above Refinitiv IBES estimates of $1.14 a share.

☆ Summit Therapeutics in up to $5 bln licensing deal for Akeso's cancer therapy
▼ + stars: | 2022-12-06 | by ( ) www.reuters.com time to read: +1 min

Dec 6 (Reuters) - Summit Therapeutics Inc (SMMT.O) said on Tuesday it would license China-based Akeso Inc's (9926.HK) experimental cancer therapy in a deal worth up to $5 billion, sending its shares up 57% in premarket trade. The deal involves an upfront payment of $500 million to Akeso, which will also be eligible for regulatory and commercial milestone payments of up to $4.5 billion. Additionally, Akeso will be eligible to receive low double-digit royalties on net sales, Summit said in a statement. Through the deal, Summit will get the rights to develop and commercialize the drug, ivonescimab, in the United States, Canada, Europe, and Japan, while Akeso will retain the rights for rest of the world, including China. The company also announced a $500 million rights offering and the issuance of $520 million in promissory notes.

☆ United States to end mpox emergency declaration
▼ + stars: | 2022-12-02 | by ( ) www.reuters.com time to read: +3 min

Dec 2 (Reuters) - Mpox is expected to no longer be considered a public health emergency in the United States from Feb. 1, 2023, the U.S. health department said on Friday. The months-long declaration was meant to tackle the largest-ever outbreak of cases in the country. The WHO label, a "public health emergency of international concern (PHEIC)", is designed to trigger a coordinated international response and could unlock funding to collaborate on sharing vaccines and treatments. The disease, which is endemic in parts of Africa, began spreading in Europe earlier this year before moving to the United States. More than 29,000 cases have been reported in the United States in the outbreak this year, including two deaths, according to government data.

☆ U.S. FDA declines to approve Y-mAbs's pediatric cancer drug
▼ + stars: | 2022-12-01 | by ( ) www.reuters.com time to read: +1 min

The FDA's decision follows a unanimous vote by its advisers in October against the drug, omburtamab, to treat neuroblastoma due to insufficient evidence that it improves overall survival. The FDA and its advisers had raised issues over the strength of the data and uncertainty over trial results. The company already has a neuroblastoma drug Danyelza, approved in 2020, which generated $32.8 million in revenue in the first nine months of 2022. Omburtamab was being developed to treat cancer in the cerebrospinal fluid that provides nutrients and chemicals to the brain and spinal cord. Danyelza, on the other hand, is approved for the treatment of relapsed or refractory neuroblastoma in the bone or bone marrow.

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