DIRS.INFO The most relevant business & tech news

☆ EMA seeks to issue guidance on liver damage from Novartis' gene therapy
▼ + stars: | 2023-01-13 | by ( ) www.reuters.com time to read: +1 min

Jan 13 (Reuters) - The European Medicines Agency (EMA) said on Friday it plans to issue advice for physicians using Novartis AG's (NOVN.S) Zolgensma, calling on them to monitor patients for any liver injury after treatment. The statement follows two deaths due to liver failure after treatment with the gene therapy against spinal muscular atrophy, reported by Novartis in August. Spinal muscular atrophy is a group of rare genetic disorders which affect the nerve cells and cause muscle wasting and weakness. The advice for healthcare professionals has yet to be approved by further expert panels at EMA, which typically takes a few weeks. In Europe, however, such letters had been the subject of discussions with EMA, but Novartis would soon be cleared to send them in EU member states, it added.

GENEVA, Jan 11 (Reuters) - The World Health Organization said it is working with China to manage the risks of COVID-19 surging again as people travel for Lunar New Year celebrations but the country's response continues to be challenged by a lack of data. COVID-19 is spreading unchecked in China after the country lifted its zero-COVID policy in December, but the WHO said it still does not have enough information from China to make a full assessment of the dangers of the surge. That is also an issue in working with China on how to mitigate the risks of travel ahead of the Lunar New Year public holiday, which officially runs from Jan. 21, the WHO said. The WHO also said China is still heavily underreporting deaths from COVID-19, although it is now providing more information on its outbreak. "There are some very important information gaps that we are working with China to fill," said COVID-19 technical lead, Maria Van Kerkhove.

☆ Eisai, Biogen's Alzheimer's drug price should not dent demand, analysts say
▼ + stars: | 2023-01-09 | by ( ) www.reuters.com time to read: +2 min

Jan 9 (Reuters) - The $26,500-per-year price tag for Eisai Co Ltd (4523.T) and Biogen Inc's (BIIB.O) newly approved Alzheimer's disease drug is slightly above expectations, but should not dent demand for the promising therapy, Wall Street analysts said. The U.S. health regulator on Friday granted accelerated approval to the drug, Leqembi, and the decision was hailed by patient groups. However, the price tag is lower than that of Eisai and Biogen's first Alzheimer's disease drug, Aduhelm, which was initially priced at $56,000 annually before the drugmakers halved the price amid controversy over its approval. Eisai and Biogen said on Saturday the Japanese drugmaker had applied for full approval by the U.S. Food and Drug Administration. Some analysts expect broader coverage by Medicare if the drug is granted full approval.

☆ Novavax's longtime CEO Stanley Erck to retire
▼ + stars: | 2023-01-09 | by ( ) www.reuters.com time to read: +1 min

Jan 9 (Reuters) - Novavax Inc (NVAX.O) said on Monday its longtime chief executive officer, Stanley Erck, would retire and be succeeded by industry veteran John Jacobs, at a time when the COVID-19 vaccine maker looks to catch up with larger rivals. He joins Novavax from Harmony Biosciences (HRMY.O), where he served as CEO since June 2018. Erck, who has been at the helm of the company since 2011, was responsible for bringing Novavax's COVID vaccine, its first commercial product, to the market. However, the shot has been plagued by manufacturing snags, regulatory delays and sluggish uptake amid a global supply glut for vaccines and waning demand. Reporting by Raghav Mahobe in Bengaluru; Editing by Saumyadeb Chakrabarty and Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.

☆ Baxter International plans to spin off kidney care units
▼ + stars: | 2023-01-06 | by ( ) www.reuters.com time to read: +2 min

Jan 6 (Reuters) - Baxter International Inc (BAX.N) said on Friday it plans to spin off its kidney care units, becoming the latest medical device maker to slim down in the face of supply-chain challenges. The company plans to spin off its renal care and acute therapies units into a separate listed entity in the next 12-18 months. Dialysis operations, which are a part of Baxter's renal care unit, are a drag on the parent company's margins today, said Chief Financial Officer James Saccaro. For the nine months ended Sept. 30, the renal care unit reported sales of $2.77 billion, down from $2.87 billion the previous year. The acute therapies unit posted sales of $519 million, declining from $580 million a year ago.

☆ 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.

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.

Although many public health experts are expressing concern about the rising COVID cases in China, infectious disease experts have been increasingly worried about the XBB.1.5 variant. Recombinants of the BA.2 variant, XBB and XBB.1.5, together accounted for 44.1% of the total cases in the country for the week ended Dec. 31. For the week ended Dec.24, XBB.1.5 had made up 21.7% of the total cases. The XBB variant has been driving up cases in parts of Asia, including Singapore. It accounted for 3.6% of the total cases in the U.S. this week compared with 4.2% in the previous week.

Dec 28 (Reuters) - TG Therapeutics Inc (TGTX.O) said on Wednesday that the U.S. health regulator had approved its monoclonal antibody for treating patients with relapsing forms of multiple sclerosis, sending its shares up nearly 9% in afternoon trade. TG Therapeutics said it was expecting to launch the drug, branded as Briumvi, in the first quarter of 2023, but did not give details on its pricing. Jefferies analyst Chris Howerton said ahead of the approval that he was expecting the drug to be priced in the range of $30,000 per patient per year. Multiple sclerosis is a neurological disease in which the immune system attacks the brain cells causing motor disabilities. Unlike other MS drugs that target T cells, Briumvi belongs to a class of drugs that tackles B cells' role in driving the inflammation that is central to neurological disease.

☆ U.S. FDA weighs regulating cannabis compound CBD in food, supplements - WSJ
▼ + stars: | 2022-12-27 | by ( ) www.reuters.com time to read: +1 min

Dec 27 (Reuters) - The U.S. Food and Drug Administration (FDA) is planning to make recommendations on how to regulate the use of popular cannabis compound CBD in food and supplements, the Wall Street Journal reported on Tuesday, citing agency officials. After weighing the evidence on the compound's safety, the FDA will decide within months how to regulate legal cannabis and whether that will require new agency rules or new legislation from Congress, according to the report. Cannabidiol, or CBD, is a non-psychoactive compound derived from cannabis. Cannabis products, excluding Jazz Pharmaceuticals PLC's (JAZZ.O) Epidiolex, are illegal at the federal level in the United States, although some states allow their use. Reporting by Raghav Mahobe in Bengaluru; Editing by Devika SyamnathOur Standards: The Thomson Reuters Trust Principles.

☆ U.S. FDA changes Plan B label to say it does not cause abortion
▼ + stars: | 2022-12-23 | by ( ) www.reuters.com time to read: +1 min

The consumer information distributed with the morning after pill known as Plan B One-Step, which has been available over the counter for everyone since 2013, now makes clear its mechanism of action does not alter the implantantion of an egg. It explains that Plan B One-Step works before the release of an egg from the ovary and as a result, usually stops or delays the release of an egg. The FDA also issued an updated question-and-answer section on its website, where the question "Is Plan B One-Step an abortifacient (causing abortion)" is answered with "No." The FDA said that current science suggests Plan B One-Step works by inhibiting or delaying ovulation and midcycle hormonal changes. Foundation Consumer Healthcare, which owns the Plan B brand, had requested approval to modify some of the mechanism of action information on the label, the U.S. Food and Drug Administration (FDA) said.

☆ CVS, Walgreens limit purchase of children's pain medicines
▼ + stars: | 2022-12-19 | by ( ) www.reuters.com time to read: +1 min

Dec 19 (Reuters) - Pharmacy chains CVS Health Corp (CVS.N) and Walgreens Boots Alliance Inc (WBA.O) limited purchase of children's pain drugs as they face supply constraints and high demand with the United States experiencing one of the worst flu season in a decade. CVS said there is currently a two-product limit on all children's pain-relief products at all its pharmacy locations and online, while Walgreens said it had put a limit of six over-the-counter pediatric fever reducers per online transaction. Bloomberg Law, which first reported about the purchase limit, said U.S. supermarket chain Kroger Co (KR.N) was also putting a limit over the purchases to two children's pain medicine products. Kroger did not immediately respond to a Reuters request for comment. Reporting by Raghav Mahobe and Ananya Mariam Rajesh in Bengaluru; Editing by Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

☆ Madrigal NASH drug meets goals in much-awaited trial, shares surge
▼ + stars: | 2022-12-19 | by ( ) www.reuters.com time to read: +1 min

Dec 19 (Reuters) - Madrigal Pharmaceuticals' (MDGL.O) experimental drug for fatty liver disease met both of the main goals in a highly anticipated late-stage study, it said on Monday, sending the company's shares soaring over 200%. The positive data sets the stage for the drug, resmetirom, to become the first approved treatment for NASH, or nonalcoholic steatohepatitis, a disease that affects about 5% of adults in the United States. Data from the trial shows a lower 80 milligram dose helped 26% of patients reach NASH resolution, compared to 30% for a higher 100 milligram dose, and 10% for placebo. NASH is a form of nonalcoholic fatty liver disease, characterized by the organ developing fibrosis or scarring, which can progress to cirrhosis and liver failure. The company plans to file a marketing application seeking accelerated approval for the drug in the first half of 2023.

☆ AbbVie to leave leading U.S. drug industry trade group
▼ + stars: | 2022-12-15 | by ( ) www.reuters.com time to read: +1 min

Dec 15 (Reuters) - AbbVie Inc (ABBV.N) is leaving Pharmaceutical Research and Manufacturers of America (PhRMA), the leading U.S. drug industry group said on Thursday. Politico, which first reported on AbbVie's exit, said the drugmaker was also leaving the industry group Biotechnology Innovation Organization as well as Business Roundtable, citing a person with knowledge of the matter. Reuters reported in August the pharmaceutical industry spent at least $142.6 million on lobbying Congress and federal agencies in the first half of 2022, more than any industry. AbbVie said it regularly evaluated its memberships with industry trade associations and decided not to renew with select trade associations, without naming the groups. "AbbVie has decided not to renew their membership with PhRMA in 2023.

☆ Eisai shares plunge 10% in Tokyo after report of death in Alzheimer's trial
▼ + stars: | 2022-11-29 | by ( ) www.reuters.com time to read: +1 min

TOKYO, Nov 29 (Reuters) - Shares in Japanese drugmaker Eisai Co (4523.T) headed for their biggest plunge in more than a year on Tuesday after a report that a woman in a trial of the company's Alzheimer's disease treatment died. Eisai's shares sank 10% to 8,595 yen, leading decliners on the benchmark Nikkei index (.N225), which slid 0.5% in the morning session. Shares in Biogen sank 4.3% on Monday. Eisai and Biogen shares have been on a roller coaster in recent years on prospects for their candidates to battle dementia. Lecanemab was shown to slow cognitive and functional decline in a large trial of patients in the early stages of Alzheimer's disease, Eisai and Biogen said in September.

☆ Measles now an imminent global threat due to pandemic, say WHO and CDC
▼ + stars: | 2022-11-23 | by ( Jennifer Rigby | ) www.reuters.com time to read: +2 min

[1/2] A vial of the measles, mumps, and rubella (MMR) vaccine is pictured at the International Community Health Services clinic in Seattle, Washington, U.S., March 20, 2019. Measles is one of the most contagious human viruses and is almost entirely preventable through vaccination. However, it requires 95% vaccine coverage to prevent outbreaks among populations. A record high of nearly 40 million children missed a measles vaccine dose in 2021 due to hurdles created by the COVID pandemic, the WHO and the U.S. Centers for Disease Control and Prevention (CDC) said in a joint report. While measles cases have not yet gone up dramatically compared to previous years, now is the time to act, the WHO's measles lead, Patrick O'Connor, told Reuters.

☆ Gavi rejects Novavax's claim on COVID vaccine deal breach
▼ + stars: | 2022-11-22 | by ( ) www.reuters.com time to read: +2 min

Nov 22 (Reuters) - Global vaccine alliance Gavi on Tuesday rejected Novavax's (NVAX.O) claim that the group had breached an advance purchase agreement to procure 350 million doses of the company's COVID-19 vaccine. Novavax also has a pact with Serum Institute of India for manufacturing a version of the vaccine under the brand Covovax, which would also be supplied to the COVAX facility. Gavi's spokesperson said Serum Institute had a 300 million dose commitment for Covovax, with options for 750 million more doses if needed. A spokesperson for Serum Institute declined to comment. Novavax recently cut its full-year forecast yet again, hurt by late authorizations of its COVID vaccine globally amid a waning demand for shots.

☆ Merck to acquire Imago BioSciences for $1.35 bln
▼ + stars: | 2022-11-21 | by ( Svea Herbst-Bayliss | ) www.reuters.com time to read: +1 min

Nov 21 (Reuters) - Merck & Co Inc (MRK.N) said on Monday it will acquire cancer drug developer Imago BioSciences Inc (IMGO.O) for a total equity value of $1.35 billion to expand its portfolio of blood disorder treatments. The drugmaker's offer of $36 per share in cash for Imago represents a nearly 107% premium to the company's last close. With Merck's blockbuster cancer immunotherapy Keytruda expected to lose key patents in 2028, the company has been trying to expand its drug portfolio. Imago, which develops drugs for the treatment of bone marrow-related diseases, is currently testing its lead drug bomedemstat for treating a chronic cancer known as myeloproliferative neoplasms. The Imago deal is expected to close in the first quarter of 2023, according to the companies.

☆ Provention Bio diabetes drug to cost $13,850/vial
▼ + stars: | 2022-11-18 | by ( ) www.reuters.com time to read: +1 min

Nov 18 (Reuters) - Provention Bio Inc (PRVB.O) said on Friday its recently approved diabetes drug, teplizumab, would cost $13,850 a vial. A 14-day regimen of the drug would translate to a price of $193,900, the company said on a conference call. In October, Provention signed a co-promotion deal for the drug with Sanofi (SASY.PA), offering the French drugmaker first negotiation for exclusive global rights to commercialize the drug in exchange for an upfront payment of $20 million. As per the deal, the approval also allows Sanofi to purchase up to $35 million of Provention's common shares. Shares of New Jersey-based Provention Bio were down nearly 8% before the bell.

☆ Opioid overdose reversal drug likely safe for OTC use, says FDA
▼ + stars: | 2022-11-15 | by ( ) www.reuters.com time to read: +1 min

Nov 15 (Reuters) - Opioid overdose reversal drug naloxone may be safe and effective for over-the-counter use in some forms, the U.S. Food and Drug Administration (FDA) said on Tuesday, potentially paving the way for its use federally. The FDA would still require data on individual products from manufacturers for them to be available over the counter at a federal level. The drug regulator's preliminary assessment included up to 4 milligrams dose of naloxone nasal spray and up to 2 milligrams when given through an auto injector. The agency said the assessment does not cover higher dose naloxone products and those supplied in other forms for which more data was needed. More than 16,000 people have died from overdoses involving prescription opioids in 2020, according to government data.

☆ U.S. FDA panel votes against Veru's COVID-19 pill
▼ + stars: | 2022-11-09 | by ( ) www.reuters.com time to read: +2 min

The panel voted 8-5 against the oral drug sabizabulin's usage. The unfavorable vote decreases the chances of authorization for Veru, which is already lagging in the race to develop a COVID-19 treatment. If authorized, the pill would provide an additional treatment option as the disease moves from a pandemic to an endemic stage. While data has shown the drug can also produce antiviral and anti-inflammatory responses, the FDA staff reviewers have said its mechanism of action in COVID-19 was uncertain. The FDA is not obligated to follow the recommendations of the panel, but usually does.

☆ FDA staff flags uncertainties on Veru's COVID drug; EUA hopes lift shares
▼ + stars: | 2022-11-07 | by ( Bhanvi Satija | ) www.reuters.com time to read: +2 min

Nov 7 (Reuters) - Staff reviewers at the U.S. Food and Drug Administration on Monday identified several uncertainties around Veru Inc's (VERU.O) data for its experimental COVID-19 drug but did not raise any new concerns, sending its shares surging 52%. A panel of the health regulator's outside experts is scheduled to discuss authorization of the drug later this week, including whether additional data is required. Cantor Fitzgerald analyst Brandon Folkes said the FDA is "leading the advisory committee towards granting an EUA" provided Veru commits to an adequate post-EUA study. Veru has applied for an EUA for the drug, sabizabulin, as a treatment for hospitalized moderate-to-severe COVID-19 patients at high risk of developing an acute respiratory distress syndrome. If authorized, sabizabulin, which Veru was originally testing as a treatment for prostate cancer, would become its second drug on the market.

☆ FDA staff flags several uncertainties with Veru's COVID-19 drug
▼ + stars: | 2022-11-07 | by ( ) www.reuters.com time to read: +1 min

Nov 7 (Reuters) - U.S. Food and Drug Administration staff said on Monday Veru Inc's (VERU.O) experimental drug for COVID-19 met the main goal of reducing the death rate in a late-stage trial, but flagged a number of uncertainties with the data. Staff reviewers said the data did not help in clearly identifying a relevant patient population and remained unclear about the mortality rate in the placebo group. Veru has applied for emergency use authorization for its drug, sabizabulin, as a treatment for hospitalized moderate-to-severe COVID patients at high risk of developing an acute respiratory distress syndrome. A panel of FDA's outside experts is scheduled to discuss approval of the drug later this week. Reporting by Bhanvi Satija and Raghav Mahobe in Bengaluru; Editing by Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

☆ Gilead, Kite in process of pausing Twitter advertising
▼ + stars: | 2022-11-07 | by ( ) www.reuters.com time to read: +1 min

Nov 7 (Reuters) - Gilead Sciences Inc (GILD.O) said on Monday the company and its unit Kite were in the "process of pausing advertising" on Twitter, after Elon Musk completed his takeover of the social media company. In a statement to Reuters, Gilead said it was monitoring its advertising spend and waiting to better understand how community standards and content moderation will be handled on Twitter now. Gilead joins a growing list of U.S. companies, including General Motors (GM.N) and General Mills (GIS.N), who have either paused or are in the process of re-evaluating advertising on the social media platform. Last week, the Wall Street Journal reported Oreo maker Mondelez International Inc (MDLZ.O) and U.S. drugmaker Pfizer Inc (PFE.N) had also temporarily halted advertising with Twitter. Reporting by Bhanvi Satija and Raghav Mahobe in Bengaluru; Editing by Krishna Chandra EluriOur Standards: The Thomson Reuters Trust Principles.

☆ COVID variants BQ.1/BQ.1.1 make up 35% of U.S. cases
▼ + stars: | 2022-11-04 | by ( ) www.reuters.com time to read: +2 min

The subvariants made up nearly 9% of total cases in the week of Oct. 15 and their proportion has been rising steadily among circulating cases since then. New variants are monitored closely by regulators and vaccine manufacturers in case they start to evade protection offered by current shots. BQ.1.1 made up nearly 19% of circulating variants and BQ.1 was estimated to make up 16.5% of circulating cases in the week of Nov. 5, the U.S. CDC said on Friday. The BA.5 subvariant, which drove up cases earlier this year, is estimated to make up about 39% of cases, compared with nearly 51% in the week ended Oct. 29. Coronavirus cases saw a small uptick for the week ended Nov. 2, data from CDC showed.

Search resuls for: "Raghav Mahobe"

25 mentions found