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☆ U.S. FDA, CDC see early signal of Pfizer bivalent COVID shot's link to stroke
▼ + stars: | 2023-01-13 | by ( ) www.reuters.com time to read: +2 min

Jan 13 (Reuters) - A safety monitoring system flagged that U.S. drugmaker Pfizer Inc (PFE.N) and German partner BioNTech's updated COVID-19 shot could be linked to a type of brain stroke in older adults, according to preliminary data analyzed by U.S. health authorities. An ischemic stroke, also known as brain ischemia, is caused by blockages in arteries that carry blood to the brain. "Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public," the health authorities said. Pfizer and BioNTech said in a statement that they have been made aware of limited reports of ischemic strokes in people 65 and older following vaccination with their updated shot. This safety concern has not been identified with Moderna's (MRNA.O) bivalent shot and both the CDC and FDA continue to recommend that everyone aged 6 months and older stay up-to-date with their COVID-19 vaccination.

☆ Apple may add touch screens to Mac computers - Bloomberg News
▼ + stars: | 2023-01-11 | by ( ) www.reuters.com time to read: 1 min

Jan 11 (Reuters) - Apple Inc (AAPL.O) is actively working on adding touch screens to its Mac computers, Bloomberg News reported on Wednesday, citing people familiar with the project. The first touch-screen Mac could be launched as soon as 2025 as part of an update to Apple's MacBook Pro, the report said. Apple did not immediately respond to a Reuters request for comment. Reporting by Bhanvi Satija in Bengaluru; Editing by Maju Samuel and Devika SyamnathOur Standards: The Thomson Reuters Trust Principles.

☆ Starbucks' support staff to work from office thrice a week
▼ + stars: | 2023-01-11 | by ( ) www.reuters.com time to read: +1 min

Jan 11 (Reuters) - Starbucks Corp (SBUX.O) said on Wednesday its U.S. support center employees have to work from office at least three days a week, compared with a previous commitment of at least one day per week. Ride-hailing service Uber (UBER.N) has also asked employees to work from office twice a week, while Elon Musk told Twitter employees that remote work would no longer be allowed. Starbucks said the thrice-a-week policy to come into work was a requirement for all support employees, after several of them failed to meet the previous "minimum promise" of one day a week in office. The policy change also applies to region-based support partners within commuting distance of a regional office. For regional staff, the third day would be one when all partners were in the office together, according to the coffee chain giant.

☆ FDA warns Japan's Olympus units over testing violations
▼ + stars: | 2023-01-10 | by ( ) www.reuters.com time to read: +1 min

Jan 10 (Reuters) - The U.S. Food and Drug Administration on Monday said it has issued warning letters to manufacturers of medical scopes used in surgical procedures, citing violations found during inspections of facilities in Japan. Warning letters pertain to a category of devices known as endoscopes, which allow doctors to see and access the urinary tract, gastrointestinal tract, and respiratory tract, during diagnostic and therapeutic procedures. The health regulator released the letters on Monday, which were sent to units of Japan's Olympus Corp (7733.T) - Olympus Medical System Corp and Aizu Olympus Co -in December and November, respectively. The agency added that Olympus Medical did not develop medical device reporting procedures as mandated and did not submit them to the regulator in the required timeframes. These warning letters add to a history of the U.S. FDA's compliance actions against Olympus related to testing and manufacturing requirements.

☆ Qiagen acquires DNA-biometrics firm Verogen in $150 mln deal
▼ + stars: | 2023-01-09 | by ( ) www.reuters.com time to read: +1 min

Jan 9 (Reuters) - Life sciences firm Qiagen said on Monday it has acquired DNA-biometrics firm Verogen in a $150-million cash deal, strengthening its forensics portfolio. Qiagen expects about $20 million of sales from the Verogen portfolio this year. The deal is expected to be dilutive to Qiagen's 2023 adjusted profit per share by about 3 cents and neutral to the firm's 2024 profit. San Diego-based Verogen, founded in 2017, provides DNA-based human identification products and services, which are used in forensic analysis and to help resolve criminal and missing persons cases. Verogen's portfolio will complement Qiagen's sample collection and preparation kits, which are used to separate human DNA from forensic investigation samples for analysis.

☆ U.S. experts recommend weight-loss drugs for obese children
▼ + stars: | 2023-01-09 | by ( Bhanvi Satija | ) www.reuters.com time to read: +4 min

Metformin has been used off label to achieve weight loss in children. Of the 27 randomized trials of metformin for weight loss in children reviewed by the guidelines panel, 74% showed some positive effect of the medication. Wegovy last month won U.S. approval for chronic weight management in children ages 12 and older. For children ages 2 to 12 years, AAP said there was not currently enough evidence to recommend use of these medications. They also include recommendations for diagnosing obesity annually in children ages 6 years and older, through checks on BMI, and practices such as motivational interviewing.

☆ CVS Health in talks to buy Oak Street Health - Bloomberg News
▼ + stars: | 2023-01-09 | by ( ) www.reuters.com time to read: +1 min

Jan 9 (Reuters) - CVS Health Corp (CVS.N) is exploring an acquisition of primary care center operator Oak Street Health Inc (OSH.N), Bloomberg News reported on Monday citing people familiar with the matter. Shares of Oak Street Health rose 27% in after-hours trading after closing 4.25% higher at $22.57 on Monday, earning the Chicago-based company a market cap of $5.5 billion. CVS declined to comment while Oak Street did not immediately respond to a Reuters request. Oak Street Health runs primary care centers across United States for recipients of Medicare, the U.S. government insurance program for Americans aged 65 and older, and has private equity firms such as General Atlantic and Newlight Partners among its shareholders. CVS had also expressed interest in expanding into the primary care space, and was reportedly among the bidders to acquire primary care provider Cano Health before backing out.

☆ Eisai files for full FDA approval for Alzheimer's drug Leqembi
▼ + stars: | 2023-01-07 | by ( ) www.reuters.com time to read: 1 min

Jan 6 (Reuters) - Japanese drugmaker Eisai Co Ltd (4523.T) said on Saturday it had submitted an application to the U.S. Food and Drug Administration for a standard review of its Alzheimer's drug Leqembi, which was recently approved under the agency's accelerated review process. Reporting by Bhanvi Satija in Bengaluru; Editing by William MallardOur Standards: The Thomson Reuters Trust Principles.

☆ U.S. FDA approves Eisai, Biogen Alzheimer's drug
▼ + stars: | 2023-01-06 | by ( Deena Beasley | ) www.reuters.com time to read: +2 min

[1/2] The logo of Eisai Co Ltd is displayed at the company headquarters in Tokyo, Japan, March 8, 2018. REUTERS/Issei KatoJan 6 (Reuters) - The U.S. Food and Drug Administration on Friday approved the Alzheimer's drug lecanemab developed by Eisai Co Ltd (4523.T) and Biogen Inc (BIIB.O) for patients in the earliest stages of the mind-wasting disease. Eisai said the drug would launch at an annual price of $26,500. Eisai officials have said the company also plans to submit data from a recent successful clinical trial in 1,800 patients as the basis for a full standard review of Leqembi. That trial found that Leqembi, which is given by infusion, slowed the rate of cognitive decline in patients with early Alzheimer's by 27% compared to a placebo.

☆ Moderna signs $35 million deal with cancer drug developer CytomX
▼ + stars: | 2023-01-05 | by ( ) www.reuters.com time to read: +1 min

Jan 5 (Reuters) - Moderna Inc (MRNA.O) on Thursday announced a $35 million licensing deal with cancer-focused drug developer CytomX Therapeutics (CTMX.O) to work on messenger RNA-based therapies for a wide range of diseases. The news comes a month after an experimental cancer vaccine from Moderna based on mRNA technology was shown to work against a type of skin cancer. The deal offers CytomX access to Moderna's mRNA technology, which has been used to develop COVID-19 vaccines, while Moderna would get access to CytomX's Probody platform, used in the development of cancer therapies targeting diseased tissues. Moderna said it will also pay tiered royalties to CytomX on global sales of any products which enter the market under the deal. The companies will work together to discover experimental therapies and Moderna will be responsible for human trials and commercial activities of products.

☆ J&J's consumer health unit Kenvue files for IPO, moving closer to spin-off
▼ + stars: | 2023-01-04 | by ( ) www.reuters.com time to read: +2 min

Jan 4 (Reuters) - Johnson & Johnson's (JNJ.N) consumer health unit Kenvue on Wednesday filed to be listed as an independent company, bringing the healthcare conglomerate a step closer to completing the biggest shakeup in its 135-year history. The filing, for Kenvue to list on the New York Stock Exchange under the ticker symbol "KVUE", comes more than a year after Johnson & Johnson announced its plan to break up into two companies. J&J's pharmaceutical and medical equipment units, which make cancer treatments and surgical tools, had recorded nearly $80 billion in sales in 2021, far ahead of its consumer products revenues. General Electric's (GE.N) spun-off healthcare unit, GE HealthCare Technologies , debuted as an independent company on Nasdaq on Wednesday. Kenvue said J&J will continue to own at least 80.1% of the voting power of the company's shares upon completion of the offering.

☆ WHO urges China to share specific data regularly on COVID situation
▼ + stars: | 2022-12-30 | by ( ) www.reuters.com time to read: +2 min

Dec 30 (Reuters) - The World Health Organization on Friday once again urged China's health officials to regularly share specific and real-time information on the COVID-19 situation in the country, as it continues to assess the latest surge in infections. The agency has asked Chinese officials to share more genetic sequencing data, as well as data on hospitalizations, deaths and vaccinations. COVID infections have risen across China this month after Beijing dismantled its zero-COVID policies including regular PCR testing on its population. The United States, South Korea, India, Italy, Japan and Taiwan have all imposed COVID tests for travellers from China in response. Senior Chinese health officials exchanged views with the WHO on the new coronavirus via a video conference, China's National Health Commission said in a statement earlier on Friday.

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.

☆ Pfizer's hemophilia B gene therapy succeeds in late-stage study
▼ + stars: | 2022-12-29 | by ( ) www.reuters.com time to read: +1 min

Dec 29 (Reuters) - U.S. drugmaker Pfizer Inc (PFE.N) said on Thursday its experimental gene therapy for the treatment of hemophilia B, a rare inherited blood disorder, met its main goal in a late-stage study. The drugmaker licensed its hemophilia B gene therapy from Roche's (ROG.S) Spark Therapeutics unit in 2014 for a $20-million upfront payment. Pfizer plans to discuss the late-stage data with regulatory authorities in Europe and the United States and share additional data for the experimental therapy at a scientific conference in early 2023. According to government data, the estimated prevalence of hemophilia in the United States is 12 cases per 100,000 males for hemophilia A and 3.7 cases per 100,000 males for hemophilia B. In November, the U.S. health regulator approved the first gene therapy, CSL Ltd and uniQure's Hemgenix, to treat hemophilia B.Pfizer is also testing other experimental gene therapies in late-stage trials as potential treatments for the bleeding disorder hemophilia A and muscular disorder Duchenne muscular dystrophy.

☆ Gilead buys out rights to cancer therapy from Jounce for $67 mln
▼ + stars: | 2022-12-28 | by ( ) www.reuters.com time to read: +1 min

Dec 27 (Reuters) - Gilead Sciences (GILD.O) will buy all the remaining rights for an experimental cancer therapy, GS-1811, from Jounce Therapeutics (JNCE.O) for $67 million, the drugmaker said on Tuesday. Shares of Jounce more than doubled to $1.68, while Gilead's shares fell marginally in after market trading. In 2020, the drugmakers had agreed to collaborate on development of GS-1811, when Gilead made an upfront payment of $85 million to Jounce. Under the initial terms, Jounce was eligible to get up to $685 million in milestone payments from Gilead, of which it has received $40 million so far. With the amendment, Jounce will no longer receive the remaining milestone payments or any of the sales-based royalties for the therapy.

☆ U.S. FDA advisers to weigh on updating initial COVID vaccine doses
▼ + stars: | 2022-12-16 | by ( ) www.reuters.com time to read: +1 min

Dec 16 (Reuters) - The U.S. Food and Drug Administration (FDA) said on Friday it planned to hold a meeting of outside experts next month to discuss whether initial doses of COVID-19 vaccines need to be updated to combat circulating variants. While updated booster doses from Pfizer (PFE.N) and Moderna (MRNA.O) are already approved for adults as well as children as young as five years, the FDA said it was important to weigh in on the composition of both initial and booster doses as new variants spread. The independent advisers, who are scheduled to meet on Jan. 26, are also expected to weigh in on whether the timing or composition of booster doses need to be adjusted. In June, advisers to the FDA had recommended a change in the composition of COVID-19 booster shots before fall to combat more recently circulating variants of the coronavirus. Reporting by Bhanvi Satija and Manas Mishra in Bengaluru; Editing by Sriraj Kalluvila and Sherry Jacob-PhillipsOur Standards: The Thomson Reuters Trust Principles.

☆ 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.

Amgen gains several approved drugs through the deal, a bulwark against rising competition for its blockbuster arthritis drug, Enbrel, from newer treatments. Sales of Amgen's Enbrel tumbled 14% in the latest reported quarter to $1.1 billion, extending a run of downbeat performances. The Horizon bid follows Amgen's $3.7 billion deal in August for rare blood vessel inflammation treatment maker ChemoCentryx Inc . The offer values Horizon at $27.8 billion on a fully diluted basis, according to the company, which includes ordinary shares to be vested. Based on Reuters calculations, it values Horizon at about $26 billion and gives Horizon a $28.3 billion valuation, including debt.

☆ Amgen to buy Horizon Therapeutics for $26.40 billion
▼ + stars: | 2022-12-12 | by ( ) www.reuters.com time to read: +1 min

Dec 12 (Reuters) - Amgen Inc (AMGN.O) will buy rare disease drugmaker Horizon Therapeutics Plc (HZNP.O) for $26.40 billion, it said on Monday, in its biggest deal ever that gives the biotech company access to blockbuster thyroid eye disease treatment Tepezza. The offer values Horizon at $27.8 billion on a fully diluted basis, according to the company, which includes ordinary shares to be vested. Based on Reuters calculations, it values Horizon at $26.40 billion. The offer values Horizon at $28.3 billion, including debt. The Wall Street Journal on Sunday reported that Amgen was close to acquiring Horizon after the other bidders pulled out of the race.

☆ U.S. FDA authorizes bivalent COVID shots for kids as young as 6 months old
▼ + stars: | 2022-12-08 | by ( ) www.reuters.com time to read: +2 min

The amended authorization on Thursday from the Food and Drug Administration allows use of Moderna's bivalent shot as a booster in children 6 months through 5 years of age, two months after their initial vaccination. Children who have completed their initial three-dose vaccination with Pfizer's original shot are not yet eligible to receive the bivalent booster, the agency said. The regulator added that data supporting use of Pfizer/BioNTech's bivalent shot as a booster in this age group is expected in January. Moderna's vaccine for children under 6 is a two-dose, 25 microgram vaccine, with the shots given about four weeks apart. Overall, 39.7 million people in United States have received a bivalent booster as of Nov. 30, data from the Centers for Disease Control and Prevention showed.

☆ U.S. FDA grants priority review to Pfizer's RSV vaccine
▼ + stars: | 2022-12-07 | by ( ) www.reuters.com time to read: +1 min

Dec 7 (Reuters) - Pfizer Inc (PFE.N) said on Wednesday the U.S. Food and Drug Administration will review its respiratory syncytial virus (RSV) vaccine candidate on priority. It could become the first approved RSV vaccine in the U.S. for older adults who are at risk of the lung disease. Pfizer's application to the FDA is supported by data from a late-stage study in which the vaccine was found safe and effective. There are no U.S. approved vaccines for RSV, a common virus that typically causes mild cold-like symptoms but can be fatal for young kids and older adults. RSV is estimated to cause about 14,000 annual deaths among older adults in the United States.

☆ U.S. FDA grants priority review for Emergent's OTC opioid drug
▼ + stars: | 2022-12-06 | by ( ) www.reuters.com time to read: +1 min

Companies Emergent BioSolutions Inc FollowDec 6 (Reuters) - Contract drugmaker Emergent Biosolutions (EBS.N) on Tuesday said its over-the-counter nasal spray as a treatment for suspected opioid overdose would be reviewed on a priority basis by the U.S. health regulator. Emergent is seeking the U.S. Food and Drug Administration's approval for a prescription-free sale of its nasal spray, Narcan, which is already cleared for the treatment of opioid overdose in the country. If approved following the agency's priority review by March 29, the spray could become the first naloxone-based drug to be sold over the counter. The worsening opioid crisis has prompted U.S. President Joe Biden's administration to develop newer strategies, including the use of naloxone. Reporting by Bhanvi Satija and Khushi Mandowara in Bengaluru; Editing by Anil D'SilvaOur Standards: The Thomson Reuters Trust Principles.

☆ U.S. FDA to review Emergent's OTC opioid overdose drug on priority
▼ + stars: | 2022-12-06 | by ( ) www.reuters.com time to read: +2 min

Dec 6 (Reuters) - Contract drugmaker Emergent Biosolutions (EBS.N) said on Tuesday its over-the-counter nasal spray as a treatment for suspected opioid overdose would be reviewed on a priority basis by the U.S. health regulator. Emergent is seeking the U.S. Food and Drug Administration's approval for a prescription-free sale of its nasal spray, Narcan, which is already cleared for the treatment of opioid overdose in the country. The agency will make its decision by March 29 and its priority review status puts Narcan on track to become the first naloxone-based drug to be sold over the counter, Benchmark analyst Robert Wasserman said. If approved, Narcan could face competition from generic versions of the drug, pressuring margins for Emergent, Cowen analyst Boris Peaker said. Rival Opiant Pharmaceuticals' (OPNT.O) drug nalmafene is also under the FDA's review and could pose additional risk to Narcan sales, as it provides better protection against an opioid overdose, Peaker added.

☆ 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.

☆ Drop in COVID alertness could create deadly new variant - WHO
▼ + stars: | 2022-12-02 | by ( Bhanvi Satija | ) www.reuters.com time to read: +2 min

Dec 2 (Reuters) - Lapses in strategies to tackle COVID-19 this year continue to create the perfect conditions for a deadly new variant to emerge, as parts of China witness a rise in infections, the head of the World Health Organization said on Friday. BAY ISMOYO/Pool via REUTERS 1 2"Gaps in testing ... and vaccination are continuing to create the perfect conditions for a new variant of concern to emerge that could cause significant mortality," Tedros said. COVID-19 infections are at record highs in China and have started to rise in parts of Britain after months of decline. Further easing of COVID-19 testing requirements and quarantine rules in some Chinese cities was met with a mix of relief and worry on Friday, as hundreds of millions await an expected shift in national virus policies after widespread social unrest. The WHO urged governments globally to focus on reaching those at risk, such as people over the age of 60 and those with underlying conditions, for vaccination.

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