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☆ 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.

[1/4] A pack of birth control pills is displayed in this illustration picture taken in Philadelphia, Pennsylvania, U.S., July 11, 2022. REUTERS/Hannah Beier/IllustrationApril 10 (Reuters) - Over 300 biotech and pharmaceutical industry executives, including Pfizer Inc (PFE.N) CEO Albert Bourla, signed an open letter on Monday calling for reversal of a federal judge's decision to suspend sales of the abortion pill mifepristone. Last week's ruling by Judge Matthew Kacsmaryk undermines the FDA's authority, the letter's authors wrote, adding that it ignores decades of scientific evidence and legal precedent. The ruling could open the possibility to the banning of vaccines and contraception for women, said Levin. "It's the single worst threat to the industry in over 50 years."

April 3 (Reuters) - About one in six adults globally have experienced infertility at least once in their life, the World Health Organization (WHO) said in a report on Monday, urging countries to actively collect more consistent data on the disease. "Based on the data we have, we cannot say that infertility is increasing or constant ... the jury's still out on that question," he said, citing that data so far has been mixed and inconsistent. The report highlights the need for countries to collect and share consistent data on infertility, separated by age and cause, as well as information on those who need fertility care. About 17.8% of adults in high-income countries have experienced infertility at least once and about 16.5% of adults in low- and middle-income countries, according to the report. Reporting by Bhanvi Satija and Mariam Sunny in Bengaluru; Editing by Devika SyamnathOur Standards: The Thomson Reuters Trust Principles.

☆ EU backs use of Novo Nordisk's weight loss drug in adolescents
▼ + stars: | 2023-03-31 | by ( ) www.reuters.com time to read: +1 min

March 31 (Reuters) - The European Medicines Agency said on Friday its committee has recommended expanding the use of Danish drugmaker Novo Nordisk's (NOVOb.CO) weight loss drug in adolescents aged 12 years and older. Novo's Wegovy, a semaglutide-based drug, activates GLP-1, a hormone that triggers the feeling of fullness in the body after eating. It has been approved in the U.S. and European Union for treatment of obesity in adults. The company did not indicate a timeline for its plans to launch the drug, already available in Denmark and Norway, in other EU countries. Earlier this year, the American Academy of Pediatrics also recommended use of weight-loss drugs in children aged 12 years or older.

☆ Charles Rivers recommends against PETA's proposal for transparency on lab monkeys
▼ + stars: | 2023-03-31 | by ( ) www.reuters.com time to read: +2 min

March 31 (Reuters) - The board of Charles River Laboratories (CRL.N) has unanimously recommended against a shareholder proposal requiring transparency on its import practices of lab monkeys, according to a regulatory filing by the U.S. contract research organization firm. PETA's proposal also demands information on whether the monkeys are caught in the wild or bred in captivity. Charles River shareholders will vote on PETA and other proposals from the board at the company's annual meeting on May 9. According to government estimates, 95% of the 92,430 monkeys brought into the U.S. between 2019 and 2021 were long-tailed macaques. While Charles River's board recommended against PETA's proposal, it said the company will include information on how its "imports are purpose-bred in accordance with applicable laws" in its 2024 annual report, the filing on Thursday showed.

☆ Carl Icahn wants to bring back Illumina's ex-CEO -WSJ
▼ + stars: | 2023-03-29 | by ( ) www.reuters.com time to read: +1 min

[1/2] A sign at the front entrance to the global headquarters of Illumina is pictured in San Diego, California, U.S., November 28, 2022. REUTERS/Mike BlakeMarch 29 (Reuters) - Carl Icahn wants former Illumina (ILMN.O) CEO Jay Flatley back at the U.S. life sciences firm, the Wall Street Journal reported on Wednesday, as the activist investor intensifies his proxy fight that was launched earlier this month. In an interview with the WSJ, Icahn signaled that Illumina "should bring Flatley back as CEO immediately". Icahn and Illumina did not immediately respond to Reuters' request for comment. Reporting by Leroy Leo and Bhanvi Satija in Bengaluru; Editing by Rashmi AichOur Standards: The Thomson Reuters Trust Principles.

☆ US FDA approves first OTC opioid overdose reversal drug
▼ + stars: | 2023-03-29 | by ( ) www.reuters.com time to read: +2 min

[1/2] A box of NARCAN nasal spray is photographed at an outpatient treatment center in Indiana, Pennsylvania, U.S. on August 9, 2017. The approval for OTC use of the naloxone-based nasal spray will help align the federal government's stance with states that have provisions to offer the drug without prescription at pharmacies. Drug-related overdose deaths in the United States rose about 15% year-over-year to more than 100,000 in 2021, as per official data. While the approval puts Emergent ahead in the OTC product race, analysts have said it is not likely to derive significant sales from the approval. Benchmark analyst Robert Wasserman said ahead of the approval that Narcan sales peaked in 2020 and have declined since.

☆ WHO revises COVID-19 vaccine recommendations for Omicron-era
▼ + stars: | 2023-03-28 | by ( ) www.reuters.com time to read: +3 min

[1/2] A 50 years old and immunocompromised resident receives a second booster shot of the coronavirus disease (COVID-19) vaccine in Waterford, Michigan, U.S., April 8, 2022. The health agency defined high-risk populations as older adults, as well as younger people with other significant risk factors. Meanwhile, it said healthy children and adolescents were "low priority" for COVID-19 vaccination, and urged countries to consider factors like disease burden before recommending vaccination of this group. It said the COVID-19 vaccines and boosters were safe for all ages, but the recommendations took into account other factors like cost-effectiveness. Some high-income countries like the United Kingdom and Canada are already offering those at high-risk COVID-19 boosters this spring, six months after their last dose.

March 21 (Reuters) - Altimmune Inc's (ALT.O) experimental obesity drug helped reduce weight by over 10% on average in a mid-stage trial, the company said on Tuesday, but safety concerns sent its shares tumbling more than 50%. Wolleben added that the drug showed " a little bit worse" tolerability than previous data. Patients who received a 2.4 milligram dose of Altimmune's experimental drug, pemvidutide, achieved average weight loss of 10.7% at the end of week 24, the company said. The data looked competitive to mid-stage data from Novo Nordisk's (NOVOb.CO) obesity drug Wegovy and Eli Lilly's (LLY.N) candidate for the condition, most analysts said. While Novo Nordisk's drug Wegovy is already available, Lilly expects approval for its obesity drug candidate, tirzepatide, this year.

☆ 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.

☆ 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.

☆ Pfizer agrees to revise EU COVID vaccine contract -FT
▼ + stars: | 2023-03-14 | by ( ) www.reuters.com time to read: +2 min

[1/2] Pfizer company logo is seen at a Pfizer office in Puurs, Belgium, December 2, 2022. Under the revised terms, Pfizer is asking for payment for doses ordered that will never be manufactured, the FT report said. Medzhidiev added that he believed other EU members also would not support the proposed deal in its current form. "The proposed Pfizer amendment to the Pfizer agreement is clearly unacceptable to us given the critical situation of vaccine oversupply in Bulgaria and unjustified financial burden for products destined for destruction," Medzhidiev said. The discussions included the possibility that Pfizer would reduce the up to 500 million COVID-19 vaccine doses the EU has committed to buy this year in return for a higher price.

☆ Veru to proceed with late-stage study of COVID pill despite FDA snub
▼ + stars: | 2023-03-14 | by ( ) www.reuters.com time to read: +1 min

Companies Veru Inc FollowMarch 14 (Reuters) - Drug developer Veru Inc (VERU.O) on Tuesday said it plans to proceed with a late-stage trial of its COVID-19 pill, weeks after the U.S. health regulator declined to authorize the oral drug to treat high-risk patients hospitalized with COVID-19. It will, however, stop the development of the drug as a potential treatment for prostate cancer as part of its strategy to cut costs. Veru plans to continue development of the oral drug, sabizabulin, in late-stage studies with high-risk hospitalized influenza patients and COVID-19 patients. It expects to report interim data from the COVID-19 trial next year. The company said it was planning to meet the U.S. Food and Drug Administration soon and will communicate details of the late-stage trial after the meeting.

Although insulin list prices are high in the U.S., drugmakers typically pay substantial rebates to private insurers and government programs, resulting in lower prices for most Americans with insurance. U.S.-listed Novo Nordisk shares rose as much as 1.7% to $142.95, while Denmark-listed shares closed marginally higher on Tuesday. Eli Lilly shares were down slightly. "I think it is a relatively natural consequence of what we have seen their competitor Eli Lilly do. Eli Lilly, Sanofi and Novo Nordisk make up 90% of the U.S. market for insulin.

☆ U.S. FDA approves Acadia's Rett syndrome drug
▼ + stars: | 2023-03-14 | by ( ) www.reuters.com time to read: +3 min

The approval comes months after the FDA declined to approve expanded use of Acadia's drug Nuplazid to treat psychosis related to Alzheimer's disease. Acadia said it plans to make the drug available to patients by the end of April. He forecast peak U.S. trofinetide sales of $487.2 million by 2035. After the FDA declined to approve the expanded use of Nuplazid, Acadia said it would not pursue that indication for Nuplazid further. Improvement of symptoms was measured according to the assessment scales Rett Syndrome Behaviour Questionnaire and the Clinical Global Impression of Improvement.

☆ Novo Nordisk joins Lilly in plans to slash U.S. insulin prices
▼ + stars: | 2023-03-14 | by ( ) www.reuters.com time to read: +1 min

March 14 (Reuters) - Novo Nordisk (NOVOb.CO) said on Tuesday it would cut U.S. list prices for several insulin drugs by up to 75% next year, joining rival Eli Lilly as drugmakers come under pressure for high prices of the life-sustaining treatment. The moves follow President Joe Biden's Inflation Reduction Act last year that capped insulin prices for Medicare recipients at $35 per month, but that does not extend to patients without insurance. Novo will reduce the list price of its NovoLog insulin by 75%, and for Novolin and Levemir by 65%. The company also said it would reduce the list price of unbranded insulin products to match lowered price of respective branded insulin products. Eli Lilly and Co (LLY.N) said earlier this month that it would cut the list prices for its most commonly prescribed insulin products by 70% from the fourth quarter of this year.

☆ Novo Nordisk to cut price of insulin by up to 75% - WSJ
▼ + stars: | 2023-03-14 | by ( ) www.reuters.com time to read: 1 min

Companies Novo Nordisk A/S FollowMarch 14 (Reuters) - Drugmaker Novo Nordisk (NOVOb.CO) is planning to cut list prices for several insulin drugs by up to 75% in the United States, the Wall Street Journal reported on Tuesday, citing a senior company executive. Reporting by Bhanvi Satija in Bengaluru; Editing by Saumyadeb ChakrabartyOur Standards: The Thomson Reuters Trust Principles.

☆ Activist investor Icahn launches proxy fight at Illumina
▼ + stars: | 2023-03-13 | by ( ) www.reuters.com time to read: +2 min

REUTERS/Mike BlakeMarch 13 (Reuters) - Activist investor Carl Icahn on Monday launched a proxy fight at Illumina Inc (ILMN.O), saying the life sciences company's takeover of Grail Inc (GRAL.O) had cost shareholders about $50 billion since the closing of the deal. Shares of Illumina jumped more than 20% to $233.50 in morning trade, and have declined 7.2% since the deal closed in August 2021. Icahn plans to nominate three people to Illumina's board at the company's upcoming shareholder meeting, he said in a letter sent to shareholders. "We have therefore determined to launch a proxy contest to attempt to gain board representation," Icahn said, adding he feared the company's board will continue to pursue the Grail transaction. Icahn said his nominees - Vincent Intrieri, Jesse Lynn and Andrew Teno - would help keep Illumina from "sinking further".

Washington-based Seagen is a pioneer of antibody-drug conjugates, which work like "guided missiles" designed for a targeted destructive effect and spare healthy cells. The Pfizer logo is pictured on their headquarters building in the Manhattan borough of New York City, New York, U.S., November 9, 2020. The drugmaker expects more than $10 billion in sales from Seagen products in 2030, and another $15 billion from its other recent acquisitions. Pfizer said antitrust regulators could closely review the deal due to its size but eventually approve it. Pfizer rival Merck & Co Inc (MRK.N) and Seagen were in advanced deal talks last year but those reportedly collapsed over antitrust concerns.

☆ Pfizer signs $43 bln Seagen deal in cancer drug push
▼ + stars: | 2023-03-13 | by ( Manas Mishra | ) www.reuters.com time to read: +2 min

The deal, Pfizer's biggest in a string of acquisitions after a once-in-a-lifetime cash windfall from its COVID-19 vaccine and pill, will add four approved cancer therapies with combined sales of nearly $2 billion in 2022. Pfizer will pay $229 in cash per Seagen share, a 32.7% premium to Friday's closing price. The drugmaker expects more than $10 billion in "risk-adjusted" sales from Seagen in 2030. Pfizer's portfolio of oncology therapies includes 24 approved drugs, including breast cancer treatment Ibrance. Pfizer rival Merck & Co Inc (MRK.N) and Seagen were in advanced deal talks last year but that reportedly collapsed over fears of tough antitrust scrutiny.

☆ U.S. FDA approves Acadia's genetic Rett syndrome drug
▼ + stars: | 2023-03-11 | by ( ) www.reuters.com time to read: +3 min

March 10 (Reuters) - The U.S. Food and Drug Administration approved Acadia Pharmaceuticals Inc's (ACAD.O) drug for the treatment of Rett syndrome, a genetic brain disorder, the company said on Friday, making it the first approved drug for the condition. The approval comes months after the FDA declined to approve expanded use of Acadia's drug Nuplazid to treat psychosis related to Alzheimer's disease. Acadia said it plans to make the drug available to patients by the end of April. He forecast peak U.S. trofinetide sales of $487.2 million by 2035. Improvement of symptoms was measured according to the assessment scales Rett Syndrome Behaviour Questionnaire and the Clinical Global Impression of Improvement.

LONDON, March 7 (Reuters) - Thousands of people in Ukraine have sustained complex injuries linked to the war and need rehabilitation services and equipment to help them, a senior World Health Organization (WHO) official said on Tuesday. They include fractures, amputations, spinal cord injuries, traumatic brain injuries and burns, Dr Satish Mishra from the WHO's regional office for Europe, told a media briefing. Since then, the pandemic and the war have significantly increased the need for rehab services, he added. In comparison, about 2 in 5 people across the European region in 2019 had a health condition that could have benefited from rehabilitation services, according to Morgan. Russia calls its actions in Ukraine a "special military operation" and says it does not target civilians.

☆ WHO still working to identify the origins of COVID-19
▼ + stars: | 2023-03-03 | by ( ) www.reuters.com time to read: +2 min

GENEVA, March 3 (Reuters) - The World Health Organization (WHO) is still working to identify the origins of the COVID-19 pandemic, its director general said on Friday, after a U.S. agency was reported to have assessed the pandemic had likely been caused by a Chinese laboratory leak. The Wall Street Journal reported on Sunday that the U.S. Energy Department had concluded the pandemic likely arose from a Chinese laboratory leak, an assessment Beijing denies. "I wish to be very clear that WHO has not abandoned any plans to identify the origins of the COVID-19 pandemic," Tedros said. Four other U.S. agencies, along with a national intelligence panel, still think COVID-19 was likely the result of natural transmission, while two are undecided, the Journal reported. On Friday, she urged countries, institutions and research groups that might have any information on the origins of the pandemic to share it with the international community.

The company — which has its COVID-19 vaccine as the only marketed product after 35 years in business — on Tuesday flagged significant uncertainty around its 2023 revenue, funding from the U.S. government, and pending arbitration with global vaccine alliance Gavi. Syringes with needles are seen in front of a displayed Novavax logo in this illustration taken, November 27, 2021. Novavax faces near-term risks as protein-based vaccines take longer to produce than mRNA-based competitors, Novavax CEO John Jacobs has said. "While there is the potential for a substantial booster market ... we don't expect Novavax to be a major player in the booster opportunity." As of last close, Novavax's U.S.-listed shares were down 97% from their February 2021 record high of $331.68.

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