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Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. The rejection and request for additional testing sharply contrasts the backing from the U.S. Food and Drug Administration's (FDA) independent experts for the spray, neffy, in May. EpiPen-maker Viatris (VTRS.O) had in June petitioned the FDA to require that ARS conduct more trials that closely mimic real-world conditions. It did not test neffy in anaphylaxis, a severe, life-threatening allergic reaction, due to ethical concerns. ARS expects to re-submit its application in the first half of 2024, with an FDA decision likely in the second half.
Persons: Andrew Kelly, William Blair, Tim Lugo, Stacey Saiontz, anaphylaxis, James Tarbox, Christy Santhosh, Sriparna Roy, Jahnavi, Varun Organizations: Food and Drug Administration, FDA, REUTERS, ARS Pharmaceuticals, U.S . Food, Pharma, Regulators, ARS, Texas Tech University Health Sciences Center, Thomson Locations: White Oak , Maryland, U.S, anaphylaxis, Bengaluru
Philip Morris International is considering selling off a stake in its largest pharmaceuticals unit. But more recently the division has struggled, and Philip Morris has had talks with Deutsche Bank on a range of options to try to grow its wellness and healthcare division, the WSJ first reported. In recent years, Philip Morris has also acquired Fertin Pharma, a nicotine gum maker, and OtiTopic, a respiratory drug maker. And, in the second quarter of this year, the company took a $680 million impairment charge related to its wellness and healthcare division. The news comes as the tobacco company continues to face resistance from public health groups.
Persons: Philip Morris, it's, Concordia, Philip Morris's Organizations: Philip Morris International, Marlboro, Deutsche Bank, WSJ, Fertin Pharma, PMI, Concordia, UN, Assembly Locations: New York
Investors should buy Bausch Health Companies as shares can more than double from here, Jefferies said. Bausch Health is embroiled in a legal battle over Xifaxan, its drug for irritable bowel syndrome with diarrhea, to prevent generics from entering the market. Bausch Health has been hoping to spin off its valuable vision care unit, Bausch + Lomb, for several years. Bausch Health shares are higher this year by more than 22%. The analyst cited other reasons why Bausch Health shares will get a boost.
Persons: Jefferies, Glen, mgt, Santangelo, Bausch, — CNBC's Michael Bloom Organizations: Health Companies, Health, Bausch Health, FDA Locations: Xifaxan, Norwich, Bausch, New Jersey
Louis Milione retired from the DEA a second time this summer amid reporting by The Associated Press on potential conflicts caused by his prior consulting for the pharmaceutical industry. Milione had spent four years at Guidepost prior to his return, leveraging his extensive experience and contacts from a 21-year DEA career. “Should we say Welcome Back?” Guidepost quipped in a social media post this week announcing Milione’s rehire as president of global investigations and regulatory compliance. His career stands out for two cycles through the revolving door between government and industry, raising questions about the potential impact on the DEA’s mission to police drug companies blamed for tens of thousands of American overdose deaths. Morris & Dickson is still challenging the ruling, which threatens to put the $4 billion a year company out of business.
Persons: Louis Milione, Milione, Anne Milgram’s, , ” Guidepost, Milione’s rehire, they’re, , Jeff Hauser, Viktor Bout, rehire Milione, Milgram, Lou Milione, Morris, Dickson, ” Milgram Organizations: WASHINGTON, Enforcement, Purdue Pharma, Associated Press, Guidepost Solutions, Justice, DEA’s, Dickson Co, DEA, AP, Morris, Department of Justice Locations: New York, America, Shreveport , Louisiana, Investigative@ap.org
The Carnival Miracle cruise ship operated by Carnival Cruise Line is docked at Pier 27 in San Francisco, Sept. 30, 2022. Dell Technologies — Shares rose more than 1.2% after Daiwa Capital Markets upgraded the computer stock to outperform from market perform. The Wall Street firm hiked its price target to $80 per share from $50, implying roughly 16% upside from Monday's close. Super Micro Computer — The information technology stock added more than 2% after Barclays initiated coverage of Super Micro Computer on Tuesday with an overweight rating. The firm's $327 price target represents nearly 34% upside from Monday's close.
Persons: Truist, Deere, Cowen, shakeup, — CNBC's Michelle Fox, Hakyung Kim Organizations: Carnival Cruise, Royal Caribbean Group, Truist, Royal, Cruise Lines, Deere & Company, Starbucks, CVS Health, pharma, CVS, Dell Technologies, Daiwa, Markets, Barclays, Computer, JPMorgan Locations: San Francisco, Royal Caribbean, China
Investors should pounce on CVS' current attractive valuation, according to Evercore ISI. The firm upgraded the health and pharmacy stock to outperform from in-line in a Tuesday note, accompanied by an $83 per share price target up from $81. CVS stock has slipped more than 24% from the start of the year. CVS YTD mountain CVS stock. "CVS, like many [managed care organizations], is a complex organization, and we see a number of factors swinging in a positive direction, pointing to both a higher degree of confidence in [management's] outlook as well as supportive of higher valuation," Anderson said.
Persons: Elizabeth Anderson, Anderson, CNBC's Michael Bloom Organizations: CVS, ISI, Centers, Medicare, Services
Torrent is hoping to secure roughly $3 billion to $4 billion in financing for the bid for its much bigger rival, they said. Blackstone (BX.N) is also interested in bidding for Cipla, sources have also said. Apollo is "quite bullish on their Asia strategy, and India in particular...both Cipla and Torrent have strong balance sheets," the person said. Apollo and Torrent, which has yet to confirm its interest in Cipla, did not immediately respond to a request for comment. Foreign banks, including Morgan Stanley (MS.N) and Barclays (BARC.L), are also in talks with Torrent to extend loans and arrange financing for the deal, sources have said.
Persons: Danish Siddiqui, Bernstein, Blackstone, Morgan Stanley, Abbott, Sriram, Aditya Kalra, Edwina Gibbs Organizations: REUTERS, Danish, pharma, Pharmaceutical, Apollo Global Management, Capital Partners, Bain Capital, Blackstone, Mumbai International, JSW, Barclays, Pfizer, Thomson Locations: Cipla, Mumbai, India, MUMBAI, DELHI, Asia
Ozempic-maker Novo Nordisk is Europe's second-largest company by market capitalization. It's also boosting Denmark's economy all on its own. AdvertisementAdvertisementNot only that, Novo Nordisk has also been propping up Denmark's economy all on its own. Jonas Petersen, an analyst at Denmark's statistics department, further told the AFP that the trend is "changing the picture of the economy." Denmark's statistics department and Danske Bank's Olsen did not immediately respond to requests from Insider for comment sent outside regular business hours.
Persons: It's, would've, LVMH Moët Hennessy Louis Vuitton, Elon Musk, Amy Schumer, they've, Las Olsen, Jonas Petersen, Bank's Olsen Organizations: Novo Nordisk, pharma, Service, Novo Nordisk's, Novo, Danske Bank, AFP, Nordisk Locations: Wall, Silicon, Europe
REUTERS/Magali Druscovich/File Photo Acquire Licensing RightsLONDON, Sept 18 (Reuters) - Climate change and conflict are hitting efforts to tackle three of the world's deadliest infectious diseases, the head of the Global Fund to Fight AIDS, Tuberculosis and Malaria has warned. But the increasing challenges of climate change and conflict mean the world is likely to miss the target of putting an end to AIDS, TB and malaria by 2030 without “extraordinary steps”, said Peter Sands, executive director of the Global Fund. For example, malaria is spreading to highland parts of Africa that were previously too cold for the mosquito carrying the disease-causing parasite. For example, in 2022, 6.7 million people were treated for TB in the countries where the Global Fund invests, 1.4 million more people than in the previous year. For example, he said, many countries with the highest burden of TB are middle-income countries that have more capacity to fund health services domestically.
Persons: Magali, Peter Sands, Sands, Jennifer Rigby, Jane Merriman, Edwina Gibbs Organizations: REUTERS, Global Fund, AIDS, Tuberculosis, Malaria, UN, Assembly, Global, Thomson Locations: Buenos Aires, Argentina, Africa, Sudan, Ukraine, Afghanistan, Myanmar
LONDON, Sept 18 (Reuters) - Climate change and conflict are hitting efforts to tackle three of the world's deadliest infectious diseases, the head of the Global Fund to Fight AIDS, Tuberculosis and Malaria has warned. International initiatives to fight the diseases have largely recovered after being badly affected by the COVID-19 pandemic, according to the Fund’s 2023 results report released on Monday. But the increasing challenges of climate change and conflict mean the world is likely to miss the target of putting an end to AIDS, TB and malaria by 2030 without “extraordinary steps”, said Peter Sands, executive director of the Global Fund. The Fund also helped put 24.5 million people on antiretroviral therapy for HIV, and distributed 220 million mosquito nets. For example, malaria is spreading to highland parts of Africa that were previously too cold for the mosquito carrying the disease-causing parasite.
Persons: Peter Sands, Sands, Jennifer Rigby, Jane Merriman Organizations: Global Fund, AIDS, Tuberculosis, Malaria, Fund, UN, Assembly, Thomson Locations: Africa, Sudan, Ukraine, Afghanistan, Myanmar
This segment also handles the formulation, development and manufacturing for parenteral dose forms, including vials and prefilled syringes. Activist Commentary: Elliott is a very successful and astute activist investor, particularly in the technology sector. While as an activist Elliott will do whatever it feels is necessary to enhance shareholder value, in the past the firm has made significant use of the strategy of offering to acquire its portfolio companies as the best catalyst to enhance shareholder value. Like Catalent, Syneos is an outsourced pharma solutions company: It outsources R&D for pharmaceutical companies, whereas Catalent outsources manufacturing. If this does turn from a strategic review to an operational review, there is no guarantee that he keeps his job.
Persons: Catalent, there's, Elliott, Steven Barg, Frank D'Amelio, Stephanie Okey, Michelle Ryan, Johnson, Barg, Ryan, John Greisch, There's, Danaher, Alessandro Maselli, Ken Squire Organizations: Oral Technologies, Clinical, Pfizer, Rom Holdings, Bloomberg, Merck, Citrix Systems, Nielsen Holdings, Square, Veritas Capital, Syneos Health, 13D Locations: COOs, North America
Three-quarters of Americans, or 76%, favor allowing the federal health care program for the elderly to negotiate prices for certain prescription drugs. Americans are split on how Biden is handling the issue of prescription drug prices — 48% approve, making it a relative strong point for Biden, but 50% disapprove. Even among the Americans who support allowing Medicare to negotiate drug prices, approval of Biden’s handling of the issue remains relatively tepid. "They kept prescription drug prices high to increase their profits. “Well, we did it.”Ellen Daily, a 73-year-old retiree in Carrollton, Texas, said she strongly favors allowing Medicare to negotiate on drug prices.
Persons: Joe Biden, trumpeting, drugmakers, Biden, it's, Esperanza Baeza, I'm, , , ” Biden, Ellen Daily, Annie Lok, Lok, doesn’t Organizations: WASHINGTON, Associated Press, NORC, for Public Affairs Research, , Big Pharma, , Medicare, Pharmaceutical Research, Manufacturers of America, Services, Republican Locations: Chicago, Baeza, Carrollton , Texas, Queens , New York
AstraZeneca succession sickness demands urgent fix
  + stars: | 2023-09-15 | by ( Aimee Donnellan | ) www.reuters.com   time to read: +3 min
LONDON, Sept 15 (Reuters Breakingviews) - Can a CEO be worth $9 billion? That’s the question posed by the 4% fall in AstraZeneca’s (AZN.L) shares following an article stating boss Pascal Soriot may soon resign. The company has played down the report, and its stock has recovered, but the episode highlights its uncertain position were 64-year-old Soriot to leave. Without a clear succession plan, investors should prepare for further swings. Small wonder investors and analysts wonder whether AstraZeneca will be able to find a successor capable of replicating his success.
Persons: Pascal Soriot, AstraZeneca’s, Ivan Menezes, Debra Crew, Soriot, Susan Galbraith, David Fredrickson, Luke Miels, Soriot’s, Neil Unmack, Streisand Neto Organizations: Reuters, Pfizer, pharma, Novartis, Sanofi, GSK, AstraZeneca, Diageo, Thomson Locations: AstraZeneca’s, Swedish
But a person who worked closely with Ramaswamy said, "He thinks people are put on this earth to serve him." Roivant attracted investors including Masayoshi Son's SoftBank Vision Fund, Peter Thiel's Founders Fund, and the hedge fund Viking Global Investors. Former Roivant employees said Ramaswamy worked hard and expected the same of others. McLaughlin called the employee's recollection "inaccurate," adding that Ramaswamy "has never once raised his voice or used bad language with employees." At Roivant, Ramaswamy kept his politics largely to himself, former employees said.
Persons: Vivek Ramaswamy, Ramaswamy, He's, Donald Trump, Mike Pence, Nikki Haley, Ron DeSantis, Trump, George Soros, didn't, Taco Bell, he's, , Vivek, Tricia McLaughlin, he'd, McLaughlin, takeout, Forbes, Vivek doesn't, they've, Roivant, Masayoshi, Peter Thiel's, Thiel, JD Vance, Bill Ackman, who'd, . Ramaswamy, Erik Gordon, Vance, John Phillips, Joyce Rosely, Phillips, Anson Frericks, they'd, Rosely, Frericks, They're, they're, Eric Balchunas, Todd Rosenbluth, Rosenbluth, Christopher Lenzo, Brandon Bell, Vivek Ramaswamy's, Katherine Long, Jack Newsham, Meghan Morris Organizations: pharma, Army Rangers, Biotech, Republican, nab, GOP, of Education, FBI, Nuclear Regulatory Commission, Federal Reserve, Florida, Roivant Sciences, General Electric, Yale Law School, Army, Rangers, Harvard, Yale, Fund, Viking Global, Leerink Partners, GlaxoSmithKline, Forbes, Big Pharma, Japan's Sumitomo Pharma Co, ., University of Michigan, FDA, US, Yale Law, ESG, The, Texas, Indiana, BlackRock, Vanguard, Bloomberg Intelligence, Fair, SEC Locations: Mexico, FiveThirtyEight, Roivant, Patagonia, Iowa, New York, Ohio, The Lever
Brochures are seen at a branch of Axis Bank in Mumbai, India, January 22, 2018. REUTERS/Danish Siddiqui/File photo Acquire Licensing RightsNEW DELHI, Sept 15 (Reuters) - The co-CEO of Axis Bank's (AXBK.NS) investment banking unit Axis Capital, Chirag Negandhi, has resigned, according to an internal memo seen by Reuters on Friday. The investment bank will likely tap an outside candidate for Negandhi's role, two sources with direct knowledge of the matter told Reuters. Axis Capital named another co-Chief Executive Salil Pitale as the interim managing director and CEO, as per the memo. Negandhi spent more than 13 years at the Axis' investment banking unit and would continue for three more months, the source added.
Persons: Danish Siddiqui, Salil Pitale, Negandhi, Sriram Mani, Tanvi Mehta, Sethuraman, Shweta Agarwal Organizations: Axis Bank, REUTERS, Danish, Capital, Chirag Negandhi, Reuters, Axis Capital, Cyient DLM, Mankind Pharma, Bikaji, Thomson Locations: Mumbai, India, DELHI, Axis
CAPE TOWN, South Africa (AP) — U.S.-based pharmaceuticals company Johnson & Johnson is being investigated in South Africa for allegedly charging “excessive” prices for a key tuberculosis drug, the country's antitrust regulator said Friday. It is desperately-needed by South Africa, where the infectious disease is the leading cause of death, killing more than 50,000 people in 2021. South Africa has more than 7 million people living with HIV, more than any other country in the world. The group says the contracts show J&J charged South Africa 15% more per vaccine dose than it charged the much richer European Union. Pfizer charged South Africa more than 30% more per vaccine than it charged the African Union, even as South Africa struggled to acquire doses while having more COVID-19 infections than anywhere else on the continent.
Persons: Johnson, Bedaquiline, Janssen, Norbert Ndjeka, Ndjeka, Intiative, J Organizations: , Johnson, J's, Janssen Pharmaceuticals, South Africa's, World Health Organization, WHO, Global, J, bedaquiline, Commission, Pfizer, Health, Union, African Union, Initiative, ___ AP Locations: CAPE, South Africa, J's Belgium, Africa, Africa's, ___, africa
LONDON, Sept 13 (Reuters) - France's radiation watchdog has banned sales of Apple's (AAPL.O) iPhone 12 after tests that it said showed the smartphone breached European radiation exposure limits. Apple disputes the watchdog's conclusions, saying the iPhone 12 was certified by multiple international bodies as compliant with global radiation standards. The ANFR said it recently carried out random tests on 141 phones, including iPhone 12, bought from shops. Smartphone radiation tests have so far led to 42 imposed sale stops in the country, it said. The ANFR said the iPhone 12 had failed to meet European Union standards, raising questions over whether more sales bans could be coming elsewhere.
Persons: Jean, Noel Barrot, Le, ANFR, Rodney Croft, Apple, Martin Coulter, Jennifer Rigby, Elizabeth Pineau, Mark Potter, Josie Kao Organizations: Agence Nationale des, Apple, Digital Minister, Reuters, International Commission, EU, WHO, International Agency for Research, Cancer, APPLE, Union, Germany's Federal, for Radiation, Thomson Locations: France
Toxic cough syrup made and sold in India may have been the start of a recent global wave of contamination. Irfan was one of at least 16 children whom authorities in India’s northern region of Jammu and Kashmir found had been poisoned. Digital says there was no DEG in its syrup and its medicines are not to blame. The rash of poisonings has led to criminal probes, lawsuits and a surge in regulatory scrutiny in India and abroad. Still, despite intense lobbying on behalf of the families of the children in Jammu, no one has yet been found guilty in a court of law for the cough syrup deaths.
Persons: Jafar Din’s, Irfan, Din, , Organizations: Digital Vision Pharma, Digital Vision, Digital, Reuters, World Health Organization, WHO Locations: India, Jammu city, India’s, Jammu, Kashmir, Himachal Pradesh, Gambia, Uzbekistan, Cameroon
The number of prescription opioid pills shipped in the U.S. in the second half of the 2010s decreased sharply even as a nationwide overdose crisis continued to deepen, according to data released Tuesday. But Mougey pointed out that as prescription drug shipments decreased, illicit opioids — particularly heroin and illegally produced versions of fentanyl — increased. During that time, prescription drugs were the opioids linked to the most deaths in the U.S. The newly released data is the first deep look at what happened with prescription drug shipments later in the 2010s. By the early 2010s, policymakers and doctors were restricting access to prescription opioids.
Persons: ” Peter Mougey, Mougey, Dan Polster, Sackler, Polster, ” Polster Organizations: U.S . Drug, Administration, System, U.S, District, Washington Post, HD Media, Purdue Pharma, Kroger Locations: U.S, ARCOS, Appalachia, Cleveland, West Virginia
Shortly after the opening bell, we will be selling 40 shares of Eli Lilly (LLY) at roughly $596. In a sector that has been a poor performer this year, Eli Lilly has been the star of the show. Quarter to date, Eli Lilly shares have rallied about 27%, while the sector's performance is flat. LLY YTD mountain Eli Lilly YTD performance The enthusiasm for Eli Lilly up to this point has been justified. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER .
Persons: Eli Lilly, Jim Cramer's, Eli Lilly YTD, Jim Cramer, Jim, Frederick Florin Organizations: CNBC, AFP, Getty Locations: Fegersheim, France
The firm upgraded the stock to outperform from "peer perform," noting it has an "attractive" risk-reward ratio. Analyst Justin Lake raised his price target to $80, implying 16.4% upside from Monday's close of $68.75, which was the firm's previous price target. The analyst said he sees potential for CVS to more conservatively set expectations for earnings growth in 2025 and beyond in the high single-digit range. The stock has gained 5.5% so far this month, however, and rose 4.4% during Monday's trading session. Combined, Lake said these efforts should effectively allow CVS to "reinvest for future growth."
Persons: Justin Lake, Lake, Brian Kane, — CNBC's Michael Bloom Organizations: CVS, Wolf Research, Blue, Aetna, CNBC Locations: California
Jaap Arriens | Nurphoto | Getty ImagesHeather Le Biller shed 9 pounds within the first week of taking Novo Nordisk 's blockbuster diabetes drug Ozempic – and then even more as she continued treatment. That means it could take years before the Food and Drug Administration and other regulators worldwide approve drugs like Ozempic and Wegovy as addiction treatments. Jerlhag and her colleagues at the University of Gothenburg in Sweden have studied the effect of GLP-1s on addictive behaviors for more than a decade. "The mechanism in the brain that regulates overeating is important in regulating addictive behaviors as well," Leggio told CNBC. Still, NIDA's Leggio advises against using GLP-1s off-label to reduce addictive behaviors, "simply because there's not enough evidence in humans that they work."
Persons: Jaap Arriens, Heather Le Biller, Ozempic –, Le Biller, they're, Angela Fitch, Brandon Bell, Dr, Lorenzo Leggio, semaglutide, , Eli Lilly, pharmacologist, Jerlhag, George Frey, NIDA's, Leggio, Steven Batash, Batash, NIDA's Leggio Organizations: Nurphoto, Novo Nordisk, CNBC, Wegovy, Obesity Medicine Association, and Drug Administration, Pharma, National Institute on Drug, University of Gothenburg, Company, Reuters, Brigade, Getty Locations: Riga, Latvia, France, Ozempic, Novo, U.S, Italian, Austin , Texas, Sweden, Provo , Utah, Queens , New York
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Persons: Dow Jones Organizations: biden
In this article LLYNOVO.B-DK Follow your favorite stocks CREATE FREE ACCOUNTOzempic drug to treat diabetes. Since Wegovy and Mounjaro have been on the market, "neither company can make the drug fast enough," she said. The Food and Drug Administration approved Ozempic in 2017 for diabetes and Wegovy in 2021 to treat obesity. Mounjaro, introduced in 2022 to treat diabetes, contains GLP-1, plus GIP, a similar appetite suppressor that can lead to weight loss. Coverage for Mounjaro ($1,023 per month) to treat diabetes varies based on an individual's insurance plan and drug benefits.
Persons: Eli Lilly, Novo's, Lilly's, Emily Field, Lilly, David Ricks, CNBC's Jim Cramer, Ozempic, Novo, Mounjaro, George Frey, Lars Fruergaard Jorgensen, Wajahat Mehal, Tom Carper, Bill Cassidy of, We've, Camilla Sylvest, there's, Sylvest, Cowen, What's, It's, Mike Mason, Amgen, Emmanuel Papadakis Organizations: Novo Nordisk, Pfizer, Amgen, Barclays, Nordisk, Drug Administration, Mounjaro, SVB Securities, Food and Drug Administration, Pharmacy, Reuters Novo, Novo, Wegovy, European Union, Medicare, Yale School, Metabolic, Congressional Black Caucus, CDC, pharma, American Medical Association, , Big Pharma, American Diabetes Association, Deutsche Bank Locations: Lilly, Denmark, Provo , Utah, U.S, European, Delaware, Bill Cassidy of Louisiana, Novo, Kalundborg, Hillerød, Boone County , Indiana
The biopharmaceutical sector is poised to bounce back this year, and Gilead Sciences could be a key beneficiary, according to Bank of America. Analyst Geoff Meacham upgraded Gilead to buy from neutral. He increased his target price for the stock by $7 to $95, which suggests shares stand to gain 28.5% from where they closed Thursday. Shares of California-based Gilead have dropped 13.9% so far this year. "With the potential for broader interest in the sector, we are more optimistic on performance into 2H23," Meacham said.
Persons: Geoff Meacham, Meacham, biopharma, — Michael Bloom Organizations: Gilead Sciences, Bank of America, PrEP, Kite Pharma Locations: Gilead, California, HCV
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