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☆ Viking joins obesity drug race after promising early trial data
▼ + stars: | 2023-03-28 | by ( Mariam Esunny | ) www.reuters.com time to read: +2 min

March 28 (Reuters) - Viking Therapeutics Inc's (VKTX.O) experimental obesity drug helped reduce weight and was safe in an early-stage study, the company said on Tuesday, sparking a 60% rise in its shares. While Novo Nordisk (NOVOb.CO) already has its obesity drug, Wegovy, in the market, Eli Lilly is expecting approval for its treatment later this year. That could also make Viking a potential acquisition target, Laidlaw & Company analyst Yale Jen said. Viking said it was planning to test higher doses of the drug over a longer treatment window in a mid-stage trial, versus a shorter limit in the current, early-stage trial. Shares of Viking were trading at $14.15, bringing the drugmaker closer to a market capitalization of $1 billion.

March 24 (Reuters) - The U.S. Food and Drug Administration (FDA) on Friday approved Pharming Group's drug to treat a rare genetic disorder that leads to a weakened immune system, the Dutch company said. APDS causes a lack of functioning immune cells, B cells and T cells, which makes it difficult for people with this disorder to fight off bacterial and viral infections. At least two analysts expected the drug to be priced at as much as $400,000. Oppenheimer analyst Hartaj Singh expected Joenja to be priced between $250,000 and $400,000, and forecast peak sales of $200 million to $300 million, ahead of the approval. Joenja is an oral drug that targets and blocks a form of the protein called phosphoinositide 3-kinase delta (P13K).

☆ Pregnancy-related deaths in US surged during pandemic - CDC
▼ + stars: | 2023-03-16 | by ( Mariam Esunny | ) www.reuters.com time to read: +1 min

The United States has one of the highest rates of pregnancy-related deaths among developed countries. It recorded more than 1,200 deaths in pregnant women in 2021, compared with 861 in 2020 and 754 in 2019, according to CDC data. About 32.9 maternal deaths per 100,000 live births were reported in 2021, compared with 23.8 deaths per 100,000 live births in 2020 and 20.1 in 2019. The mortality rate for Black women in the United States was at 69.9 deaths per 100,000 live births in 2021, about 3 times higher than white and Hispanic women. UN agencies reported last month that nearly all parts of the world saw a spike in maternal mortality rates in 2020.

The panelists seemed significantly more confident about the demographic profile used during the GSK study in comparison to Pfizer's (PFE.N) RSV vaccine, which was recommended by the FDA panel on Tuesday. Pfizer and GSK are running a tight race to tap into the RSV vaccine market, which is estimated to be over $5 billion and could exceed $10 billion by 2030, according to analysts. There is currently no approved vaccine to prevent lower respiratory tract disease caused by RSV in older adults, which causes death of 14,000 adults aged 65 and older annually in the United States. In October, late-stage data of GSK's RSV vaccine showed it to be 82.6% effective in preventing lower respiratory tract disease in people aged 60 and over, while Pfizer's vaccine was 66.7% effective. If approved, we estimate peak sales for GSK vaccine to be about $2.8 billion globally, said Evan Wang, Guggenheim Securities analyst, ahead of the panel vote.

Feb 28 (Reuters) - A panel of outside advisers to the U.S. health regulator on Tuesday recommended Pfizer Inc's (PFE.N) respiratory syncytial virus (RSV) vaccine, bringing it closer to becoming one of the first approved RSV shots for older adults in the United States. GSK (GSK.L), which is another forerunner in a crowded race to develop the first RSV vaccine, will face scrutiny from a panel of experts to the FDA on Wednesday. "The population where the vaccine is going to potentially have the biggest impact is less represented in this study," said Hana Sahly, one of the 12 FDA panelists. The FDA is scheduled to decide on the vaccines by May, and typically follows the recommendations of its independent panel of experts. Pfizer's vaccine was 66.7% effective in preventing RSV-related lower respiratory tract illness with over two symptoms, while GSK's vaccine was 82.6% effective in preventing lower respiratory tract disease in people aged 60 and over.

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.

Feb 21 (Reuters) - Medtronic Plc (MDT.N) said on Tuesday it expects inflation in various markets to hit its profit in the next fiscal year after the medical device maker beat earnings estimate for the third quarter on strong demand for its heart and diabetes devices. While inflation in many countries has eased in recent months, the management expects a delayed improvement in its earnings as its costs remain high. "VBP has affected us more than many of our competitors, given the size and breadth of our business in China. Stifel analyst Rick Wise expects Medtronic to get past pricing pressure in China in "the not too distant future". Reporting by Leroy Leo and Mariam E Sunny in Bengaluru; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

Stabilization of Humira sales after the initial erosion, coupled with strong growth of its newer drugs Skyrizi and Rinvoq for autoimmune disorders, could provide a floor to its earnings in 2024. "Now it's a question of what will the volume erosion look like?" In the fourth quarter, Humira sales dropped 26.5% to $573 million in international markets such as Europe, where it already faces competition from multiple less expensive versions. Overall, Humira sales rose 4.6% to $5.58 billion, in line with estimates, lifted by growth in the U.S. market. Excluding items, AbbVie earned $3.60 per share in the fourth quarter, beating analysts' average estimates by 4 cents.

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