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☆ The ADHD drug market is already stretched thin. Now it's facing a back-to-school supply strain
▼ + stars: | 2023-08-26 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +8 min

Ten milligram tablets of the hyperactivity drug, Adderall, made by Shire Plc. Adderall and alternative ADHD medications apart from other drugs are Schedule 2 controlled substances. Production limitationsEnding the shortages of Adderall and other ADHD medications is no easy task. That means increasing the production of one drug could potentially require reducing production — and potentially impacting supply — of another drug, according to Ergun. That includes Aytu BioPharma, which makes an ADHD drug that used to be in shortage.

Persons: Jb Reed, It's, Erin Fox, they've, David Margraf, Margraf, drugmakers, Ozlem Ergun, Ergun, Novartis's, Michael Ganio, ASHP's Ganio, RJ Sangosti, Josh Disbrow, Fox Organizations: Shire Plc, Jb, Bloomberg, Getty, and Drug Administration, CNBC, University of Utah, American Society of Health, System Pharmacists, Centers for Disease Control, University of Minnesota's, Infectious Disease, Northeastern University, Teva Pharmaceuticals, Amneal Pharmaceuticals, Sandoz, Purdue Pharma, Rhodes Pharmaceuticals, Drug, Fox, Pharmacists, Drug Enforcement Administration, MediaNews, Denver, FDA, DEA Locations: U.S, Commerce City , Colorado

☆ Here are some of the companies saying weight loss drugs could impact their business
▼ + stars: | 2023-08-18 | by ( Alex Harring | ) www.cnbc.com time to read: +5 min

The impact of new weight loss treatments is being felt well beyond the health-care industry . During the second quarter, which beat expectations , shoppers were still focused on health and wellness, CEO Doug McMillon said Thursday. Some companies already bar weight loss medications from their insurance plans to keep costs down. Executives said it was tied to an increase in specialty drug use for weight loss and diabetes. Eli Lilly's Mounjaro hasn't yet been approved for weight loss, though some people are taking it off label for that reason.

Persons: Eli Lilly, Joe Scalzo, Scalzo, Atkins, Regeneron, George Yancopoulos, Doug McMillon, WMT, Kroger, Paul Sarvadi, Eli Lilly's Mounjaro, Stephan Tata, Tata hedged, Tata Organizations: Analysts, Novo Nordisk, Co, Simply, Atkins, Walmart, WMT KR, Kroger, Cardinal Health, Drug Administration, Tata Locations: U.S

☆ How Mexican narcos use remittances to wire U.S. drug profits home
▼ + stars: | 2023-08-18 | by ( Reuters Graphic | ) www.reuters.com time to read: +28 min

Now the news agency is the first to detail how Mexican drug gangs have harnessed legitimate remittance networks to repatriate their U.S. drug profits, and the factors that make this activity so difficult for authorities to detect and thwart. But authorities say Mexican drug cartels are piggybacking on this legal network to repatriate earnings from U.S. narcotics sales. A Reuters search of Mexican court records dating back to 2012 turned up no cases involving money laundering through remittances. Still, prosecutors in those cases mentioned several of those firms in court documents because they said the defendants had used their platforms to wire drug money. His office did not respond to requests for comment about law enforcement allegations that Mexican cartels are using remittances to launder drug money.

Persons: Money, ”, “, Andrés Manuel López Obrador, ” Jorge Godínez, ” Godínez, John Cornyn of, Chuck Grassley, ” Grassley, pocketing, John Horn, remitters ”, Horn, – Oscar Gustavo Perez, Bernal, Itzayana Guadalupe Perez, Susan Fiorella Ayala, Chavez –, Los, –, Jose Luis Rosales, Ocampo, Josue Gama, Perez, Thania Rosales, Dulce Rosales, – Ana Lilia Leal, Martinez, Ana Paola Banda, Maria de Lourdes Carbajal, Henri Watson, Carbajal, Sigue, Sangita Bricker, Transfast –, ” Sigue, Transfast, fanny, Juan de Dios Gámez, Rubén Rocha, BanCoppel, Banorte, hadn’t, El, López Obrador, ” López Obrador, Signos, Signos Vitales, Oquitoa, Enrique Cardenas, Tim Walz, Keith Ellison Organizations: Sinaloa Cartel, Reuters, Jalisco New, Mexican, WorldRemit, ., National Intelligence, narcos, U.S, Republican U.S, Treasury, U.S . Department of, U.S ., Financial Intelligence Unit, “, Federal Bureau of Prisons, Los Rosales, Kansas City, ”, Leal, IDT Corporation, IDT, Mastercard, Express Cellular, Prosecutors, IRS, Western Union, U.S . Department of Justice, Federal Trade Commission, ‘, Banco Azteca, Elektra, World Bank, Minnesota, Caborca Locations: CULIACÁN, Mexico, Mexican, Culiacán, Sinaloa, United States, Jalisco, U.S, Colorado, Union, Americas, London, John Cornyn of Texas, Iowa, Ohio, Colorado , Georgia , Ohio , Oklahoma , Texas, Virginia, Washington, Georgia, Atlanta, Columbus, Rosales, Nayarit, Michoacan, Missouri, Texas, Florida, New Jersey, Miami, , New Jersey, Ria, Kansas, California, New York, Western, Sinaloan, Costa Rica, BanCoppel, India, China, Mexico City, Minnesota, Arizona , Colorado , Florida , Illinois, New Mexico, Nevada, Oquitoa, Sonora

☆ We Know Where New Weight Loss Drugs Came From, but Not Why They Work
▼ + stars: | 2023-08-17 | by ( Gina Kolata | More About Gina Kolata | ) www.nytimes.com time to read: +1 min

Every so often a drug comes along that has the potential to change the world. Medical specialists say the latest to offer that possibility are the new drugs that treat obesity — Ozempic, Wegovy, Mounjaro and more that may soon be coming onto the market. Obesity affects nearly 42 percent of American adults, and yet, Dr. Engel said, “we have been powerless.” Research into potential medical treatments for the condition led to failures. While other drugs discovered in recent decades for diseases like cancer, heart disease and Alzheimer’s were found through a logical process that led to clear targets for drug designers, the path that led to the obesity drugs was not like that. Researchers discovered by accident that exposing the brain to a natural hormone at levels never seen in nature elicited weight loss.

Persons: —, ”, Jonathan Engel, Engel Organizations: Baruch College Locations: New York

☆ Young people are at risk of harsh respiratory problems after 30 days of e-cigarette use, study says
▼ + stars: | 2023-08-15 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Young people are at risk of experiencing significant respiratory symptoms, including bronchitis and shortness of breath, after just 30 days of electronic cigarette use, according to a new study released Tuesday. They said the study, partly funded by the National Institutes of Health, contributes to existing evidence that e-cigarette use is associated with an increased risk of respiratory symptoms. Drug regulators should consider the findings and work to minimize the negative health impact of e-cigarette use on young people, the researchers added. E-cigarette usage is now substantially higher among youths and young adults than it is among adults overall in the U.S., according to the Centers for Disease Control and Prevention. She noted that the study examines only teens and young adults, and that in the demographic of all adults, people "often switch from using cigarettes to using e-cigarettes with likely fewer risks."

Persons: Tackett Organizations: Center for Tobacco Research, The Ohio State University Comprehensive Cancer Center, Southern California Keck School of Medicine, National Institutes of Health, Centers for Disease Control, Manufacturers, Brands, Food and Drug Administration Locations: U.S

☆ Cocaine cartels encroach on Unification Church’s Paraguayan paradise
▼ + stars: | 2023-08-10 | by ( Puerto Casado | ) www.reuters.com time to read: +20 min

Many of the runways are on land owned by the Unification Church of South Korea, founded by Rev. The Unification Church is a major power in this unruly region. Byun, the Unification Church lawyer, provided Reuters with an April 2022 document the church sent to Paraguayan anti-narcotics prosecutors, urging an investigation into potential illicit activity. Trouble in paradiseThe alleged drug-running on its land isn’t the only trouble the Unification Church has faced in the Chaco. Byun, the church lawyer, acknowledged the tensions with locals in Puerto Casado but declined to comment on the Myungs or the fire.

Persons: Sun Myung, Michelle Byun, ” Byun, “, Moon, God, ”, Miguel Ángel Servín, Servín, Rodrigo Alvarez, Elva Cáceres, Marco Alcaraz, Cynthia Tarrago, Tarrago, Raimundo Va, Rodrigo Alvarenga Paredes, Byun, Alvarenga, “ Alvarenga, Rodrigo Álvarez, Álvarez, Pedro Juan Caballero, ‘ Lawless, –, Marcelo Pecci, José Carlos Acevedo, ” Acevedo, Pecci, Acevedo, Mario Abdo Benítez, James Laverty, Hak Ja, ” –, Carlos Casado, Anger, Locals, Lorenzo Myung, Martin Rodriguez, Rodriguez, Dora Irrazábal, Irrazábal, Alberto David Gauto, Gauto, Emilio Camacho, Moon’s, Hyun Jin, Preston, Hak, Hyung Jin, Sean, Massimo Introvigne, Sean Moon, Preston Moon, Puerto Casado, Virgilio Chamorro, Gabriel Stargardter, Daniela Desantis, Feilding, Tomas Bravo, John Emerson, Brian Thevenot Organizations: Unification Church of, Rev, Authorities, Reuters, Unification Church, Holy Spirit Association, South Korea’s Unification, Belgian, Sting, South, International Association of Parliamentarians, Peace, U.S . Federal Bureau of Investigation, Colorado Party, Yorker, U.S, Attorney, FBI, Capital Command, PCC, United Nations Office, Drugs, U.S . Drug, Carlos Casado SA, Salesian, Supreme, FARC, Peace Foundation, Center for Studies, New, Iron Ministries, Preston, Tomas Bravo Graphics Locations: Paraguayan, Unification Church of South Korea, SENAD Paraguay, Chaco, Paraguay, Korea, Bolivian, Peruvian, Atlantic, Brazil, Uruguay, Argentina, Europe, Argentine, Manhattan, “, Antwerp, Europe’s, Servín, Asunción, Seoul, New York City, United States, New Jersey, Tarrago, Va, U.S, Byun, Alvarenga, Chile, Ecuador, Colombian, Bolivia, American, South America, America, Puerto Casado, Gauto, Preston, Turin, Italy, Pennsylvania, Puerto

Customers shop for handguns at the Des Moines Fairgrounds Gun Show at the Iowa State Fairgrounds in Des Moines, Iowa, U.S. March 11, 2023. REUTERS/Jonathan Ernst/File PhotoAug 9 (Reuters) - A federal appeals court on Wednesday ruled that a decades-old law prohibiting users of illegal drugs from owning firearms was unconstitutional as applied to the case of a marijuana user, the latest fallout from a U.S. Supreme Court ruling last year that expanded gun rights. Circuit Court of Appeals concluded that the federal law violated a Mississippi man's right to "keep and bear arms" under the U.S. Constitution's Second Amendment. The U.S. Drug Enforcement Administration did not administer a drug test, though Daniels admitted he sometimes smoked marijuana, which federal law prohibits. While his case was pending, the conservative-majority Supreme Court in June 2022 declared for the first time that the Second Amendment protects an individual's right to carry a handgun in public for self-defense.

Persons: Jonathan Ernst, Patrick Daniels, Daniels, Jerry Smith, Ronald Reagan, Stephen Higginson, Barack Obama, Nate Raymond, Shri Navaratnam Organizations: Des Moines, Iowa State Fairgrounds, REUTERS, U.S, Supreme, Circuit, Appeals, U.S . Drug, Administration, New York, Thomson Locations: Des Moines , Iowa, U.S, New Orleans, Mississippi, Boston

☆ Fast, cheap and deadly
▼ + stars: | 2023-08-09 | by ( ) www.reuters.com time to read: +18 min

Fast, cheap and deadly How fentanyl replaced heroin and hooked AmericaLeer en EspañolReuters obtained and analyzed ten year’s worth of data on drugs seized by U.S. Customs and Border Protection (CBP) agents at ports of entry along the southern border. It shows: Fentanyl seizures by weight more than tripled in the last quarter of 2022 compared to a year earlier. Pills were mentioned in nearly half of fentanyl border seizure incidents in 2022, up from just 6% five years earlier. A fifth of fentanyl seizures take place on pedestrians, the Reuters analysis shows. Over the same period, heroin seizures fell more than 80% from over 2,000 kg, according to the Reuters analysis.

Persons: Bryce Pardo, Troy Miller, Joe Biden, Andres Manuel Lopez Obrador, ”, Chris Urben, Urben, Joaquin ‘ El Chapo ’ Guzman, “, CBP’s Miller, Jonathan Caulkins, James Mandryck, Oxycontin, Lopez Obrador, narcotrafficking, Lopez, Rosa Rodriguez, Cecilia Farfan, Mendez, Freed, Pardo, Romain Le Cour, Cour, Carlos Perez, Perez Organizations: Reuters, U.S . Customs, Border Protection, U.S . Centers for Disease Control, United Nations Office, Drugs, DEA, CBP, U.S, Nardello, Carnegie Mellon University, U.S . Postal Service, Chinese Foreign Ministry, Mexico's, North, Forensic Laboratory, University of California, Global, Transnational, U.S . Congress ’ Commission, New Generation, Center for Research Locations: Mexican, U.S, Mexico, Sinaloa, El Paso, Arizona’s Nogales, United States, offscreen, sierra, China, Beijing, Washington, University of California San Diego ., ”, New, New Generation Jalisco, Mexico City

☆ Insurers face long road, high cost to cover obesity drugs after promising Wegovy heart health data
▼ + stars: | 2023-08-09 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +8 min

There is likely a long way to go before the U.S. sees increased insurance coverage for obesity drugs. While the trial results demonstrate that obesity drugs may have significant health benefits beyond shedding unwanted pounds, organizations representing U.S. insurers emphasized that the data is still preliminary. "Health insurance providers will continue to analyze new evidence as it becomes available," he added. Ceci Connolly, CEO of the Alliance of Community Health Plans, acknowledged the promise of the data but said "outrageous prices should give everyone pause." The organization represents regional, community-based health plans that cover more than 18 million Americans across the U.S.

Persons: Jim Vondruska, Wegovy, Eli Lilly, David Allen, Ceci Connolly, Jared Holz, It's, Debra Tyler's, Joe Buglewicz, Eduardo Grunvald, George Frey, UCSD's Gunvald, Eli, Ethan Lazarus, Lazarus Organizations: Reuters Novo Nordisk, Novo Nordisk, America's Health, Alliance of Community Health, U.S, Drugs, Pfizer, Medicare, CVS, Aetna, CNBC, Washington Post, Getty, UCSD Health's Center, International Foundation of Employee, University of Texas System, UTS, Novo, Reuters, Obesity Medicine Association, New England, of Medicine Locations: Chicago , Illinois, U.S, Mizuho, Killingworth, Conn, Texas

REUTERS/Andrew Kelly/File PhotoAug 7 (Reuters) - The U.S. drug regulator's approval of Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) first-of-its-kind postpartum depression (PPD) pill is unlikely to allay the drugmakers' growth concerns, analysts said on Monday. Adverse commentary after their PPD drug was approved by the U.S. Food and Drug Administration (FDA) on Friday sent Sage shares tumbling 40%, while Biogen dropped 3% in premarket trading. Zurzuvae's use as a clinical depression treatment represents a more than $1 billion sales opportunity compared with $250 million to $500 million potential for postpartum depression, said Jefferies analyst Michael Yee. "Postpartum depression is not necessarily where a big commercial opportunity is," Biogen CEO Christopher Viehbacher said last month. The U.S. FDA said last week that additional studies might be required to support the drug's approval for major depressive disorder (MDD), or clinical depression.

Persons: Andrew Kelly, Sage, Biogen, Baird, Brian Skorney, Skorney, Zurzuvae, Jefferies, Michael Yee, Christopher Viehbacher, Yee, Mariam Sunny, Bhanvi, Manas Mishra, Vinay Dwivedi Organizations: Food and Drug Administration, FDA, REUTERS, Sage Therapeutics, U.S . Food, Drug Administration, U.S, Thomson Locations: White Oak , Maryland, U.S, Bengaluru

A trader works on the floor of the New York Stock Exchange (NYSE) in New York City, U.S., July 26, 2023. U.S. stocks have sharply rallied in 2023, with the benchmark S&P 500 (.SPX) clocking 17% gains year to date, fueled by optimism around artificial intelligence and hopes of a soft landing for the world's largest economy. "But in the service side, it's been pretty sticky and that's one reason why it's taking a lot longer for inflation to subside." Reuters GraphicsOverall, second-quarter earnings have been better-than-expected so far, with 79.1% of the 422 S&P 500 companies that have reported as of Friday beating analysts' estimates, according to Refinitiv data. The S&P index recorded 17 new 52-week highs and seven new lows, while the Nasdaq recorded 46 new highs and 128 new lows.

Persons: Brendan McDermid, Dow, Charlie Ripley, it's, John Williams, Michelle Bowman, Vaibhav, Zachary Kirkhorn, Berkshire Hathaway, Warren Buffett, Tyson, packer, Bansari Mayur Kamdar, Johann M, Saumyadeb Chakrabarty, Maju Samuel Organizations: New York Stock Exchange, REUTERS, Berkshire, Tyson, Dow, Nasdaq, Federal, CPI, Allianz Investment Management, York Fed, Dow Jones, Apple, Reuters, Sage Therapeutics, Tyson Foods, Yellow Corp, NYSE, Thomson Locations: New York City, U.S, Bengaluru

☆ FDA approves oral pill for postpartum depression for first time
▼ + stars: | 2023-08-05 | by ( ) www.reuters.com time to read: +2 min

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo/File PhotoAug 4 (Reuters) - The U.S. Food and Drug Administration (FDA) on Friday approved Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) oral pill to treat postpartum depression (PPD) in adults. The companies had sought the FDA's approval for the drug, Zurzuvae, to treat major depressive disorder (MDD), or clinical depression, as well as postpartum depression, which affect millions of people. Analysts have anticipated that the stocks of both companies would fall if the drug was approved only for postpartum depression, due to the smaller patient population. Until now, the FDA said, treatment for postpartum depression was available only as an intravenous injection.

Persons: Andrew Kelly, Zurzuvae, Biogen, Sage, Sriparna Roy, Lavanya, Krishna Chandra Eluri, Leslie Adler, William Mallard Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug Administration, Sage Therapeutics, U.S . Drug Enforcement Administration, Therapeutics, Thomson Locations: White Oak , Maryland, U.S, United States, Bengaluru

☆ Walgreens sells $1.85 bln of AmerisourceBergen shares, further cutting stake
▼ + stars: | 2023-08-03 | by ( ) www.reuters.com time to read: +1 min

Pigeons are seen resting on signage for Walgreens, owned by the Walgreens Boots Alliance, Inc., in Manhattan, New York City, U.S., November 26, 2021. REUTERS/Andrew Kelly/File PhotoAug 3 (Reuters) - Walgreens Boots Alliance (WBA.O) has sold some AmerisourceBergen Corp's (ABC.N) shares for proceeds of about $1.85 billion, the U.S. drugstore chain said on Thursday, further cutting its ownership in the drug distributor to about 16%. The latest share sale includes $250 million that drug distributor AmerisourceBergen will buy back from Walgreens under its share repurchase program, Walgreens added. Walgreens sold some AmerisourceBergen shares for $694 million in May. After the latest share sell, Walgreens will remain AmerisourceBergen's largest shareholder.

Persons: Andrew Kelly, Mrinmay Dey, Jamie Freed Organizations: Walgreens, Walgreens Boots Alliance, Inc, REUTERS, Thomson Locations: Manhattan , New York City, U.S, AmerisourceBergen, Bengaluru

The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. Merck said Keytruda sales for the quarter jumped 19% to $6.3 billion, surpassing analysts' average estimate of $5.9 billion. Sales of Gardasil, which prevents cancers caused by HPV, surged 47% to $2.5 billion, also well above Wall Street estimates of $2.1 billion. There is room for further Gardasil growth as its use expands into treating males and moves into smaller cities, he added. Despite those challenges, Merck raised its full-year sales forecast to $58.6 to $59.6 billion, from its prior view of $57.7 billion to $58.9 billion.

Persons: Brendan McDermid, Merck, Rob Davis, Davis, Keytruda, Caroline Litchfield, Litchfield, Bill Smead, Prometheus, drugmaker, Michael Erman, Leroy Leo, Bill Berkrot Organizations: Merck, Co, REUTERS, Reuters Connect Companies Merck, Merck & Co, Keytruda, Prometheus Biosciences, Analysts, Prometheus, Smead Capital Management, drugmaker, Thomson Locations: Rahway , New Jersey, U.S, United States, China, Europe, Germany, New York, Bengaluru

☆ Merck beats quarterly sales estimate on top drugs' strength
▼ + stars: | 2023-08-01 | by ( Michael Erman | ) www.reuters.com time to read: +3 min

Companies Merck & Co Inc FollowAug 1 (Reuters) - Merck & Co (MRK.N) posted better-than-expected second-quarter sales on Tuesday on strong demand for its two top-selling products, cancer immunotherapy Keytruda and human papillomavirus (HPV) vaccine Gardasil. Shares of Merck rose about 2% at $108.45 in premarket trading after the company also raised its full-year revenue forecast. Merck said Keytruda sales for the quarter jumped 19% to $6.3 billion, surpassing analysts' average estimate of $5.9 billion. Sales of Gardasil, which prevents cancers caused by HPV, surged 47% to $2.5 billion, also well above Wall Street estimates of $2.1 billion. Merck said it now expects full-year sales of $58.6 to $59.6 billion, up from its prior view of $57.7 billion to $58.9 billion.

Persons: Merck, Rob Davis, Davis, Keytruda, Cantor Fitzgerald, Louise Chen, Prometheus, drugmaker, Michael Erman, Leroy Leo, Bill Berkrot Organizations: Merck, Co, Merck & Co, Merck's, Prometheus Biosciences, Analysts, Prometheus, Thomson Locations: United States, China, U.S, New York, Bengaluru

SummaryCompanies Q2 sales and earnings beat estimatesReiterates full-year guidanceNo revenue from COVID vaccine in Q2Shares up 3.1% in early tradeCompany is largest drugmaker in ChinaLONDON, July 28 (Reuters) - AstraZeneca (AZN.L) on Friday delivered better-than-expected profits and sales in the second quarter as a strong performance of its blockbuster cancer drugs helped offset the loss of COVID-19 vaccine sales. The Anglo-Swedish drugmaker posted an adjusted profit of $2.15 per share, up 25% and exceeding the $1.98 per share expected in company-compiled consensus estimates. Total revenue in the quarter was $11.4 billion, up 6% and beating company-compiled analyst estimates of $10.97 billion. Excluding COVID medicines, sales in China grew by 7% at constant exchange rates in the quarter, the fourth consecutive quarter of growth on that basis. AstraZeneca is the largest drugmaker in China, which accounted for 13% of last year's revenue.

Persons: Swedish drugmaker, Pascal Soriot, Markus Manns, Alexion, drugmaker, Maggie Fick, Radhika Anilkumar, Nivedita Bhattacharjee, Josephine Mason Organizations: AstraZeneca, UK's, Pfizer, Moderna, U.S, Union Investment, Thomson Locations: China LONDON, Swedish, China, London, Bengaluru

☆ Mexican president refutes DEA estimates of cartel strength
▼ + stars: | 2023-07-28 | by ( ) www.reuters.com time to read: +2 min

The comments come in response to testimony from U.S. Drug Enforcement Administration (DEA) Chief Anne Milgram on Mexican cartels as part of a hearing in the U.S. Congress. Speaking at a press conference, Lopez Obrador questioned her figures and urged the DEA to share more details. The pushback from Lopez Obrador is the latest in ongoing tensions between the Mexican government and the DEA. His government dropped the case against Mexico's former Defense Minister Salvador Cienfuegos, who the DEA alleged colluded with drug lords. Lopez Obrador accused the DEA of fabricating the case.

Persons: Andres Manuel Lopez Obrador, Anne Milgram, Milgram, Lopez Obrador, Salvador Cienfuegos, Sarah Kinosian, Alistair Bell, Richard Chang Organizations: Mexico Presidency, REUTERS, REUTERS MEXICO CITY, U.S, . Drug Enforcement Administration, U.S . Congress, Jalisco New Generation, U.S ., DEA, Mexico's, Defense, Thomson Locations: Tepic, Nayarit, Mexico, REUTERS MEXICO, United, Sinaloa Cartel, Jalisco, Sinaloa, CJNG

SummaryCompanies Plans to file trial data with FDAComments sooth some investor concernsAbsence of "clinically meaningful" in interim trial data worried investorsLONDON, July 28 (Reuters) - AstraZeneca Chief Executive Pascal Soriot said on Friday the company is "very encouraged" by interim data from a key lung cancer drug trial, but he did not explain why the company had not declared results as "clinically meaningful". The drugmaker's (AZN.L) shares fell by as much as 8% earlier this month after the company released interim data from the late-stage clinical trial called TROPION-Lung01 testing an experimental precision drug called datopotamab deruxtecan. Speaking to media on Friday after the company released better-than-expected quarterly results, Soriot said people would understand when full results are released why the company did not use that description, but he did not comment further. The company said on Friday it will continue with its plan to file data from the trial with the U.S. Food and Drug Administration (FDA), soothing some investor concerns. In a briefing with analysts, Susan Galbraith, executive vice president of oncology R&D, said the FDA response to the data so far had been "encouraging".

Persons: Pascal Soriot, Soriot, Susan Galbraith, Maggie Fick, Josephine Mason, David Evans, Susan Fenton Organizations: LONDON, AstraZeneca, U.S . Food, Drug Administration, FDA, U.S, Thomson

☆ NY drug dealer sentenced in overdose death of 'The Wire' actor
▼ + stars: | 2023-07-26 | by ( Rich Mckay | ) www.reuters.com time to read: +2 min

"For decades the defendant has been selling deadly narcotics: heroin and now heroin laced with fentanyl," they wrote in court papers. An autopsy and court records show that Williams, 54, died of a drug overdose and was found in his Brooklyn apartment on Sept. 6, 2021. Fentanyl was associated with 70,600 of the drug overdoses in the U.S. in 2021, according to the National Institutes of Health. Among the real-life struggles he tapped were his bouts with drug addiction, which he brought to his best known role for "The Wire." Williams also won praise for his performance in "Boardwalk Empire," an HBO series set in Atlantic City, New Jersey during the Prohibition era of the 1920s.

Persons: Michael K, Williams, Omar Little, Carlos Macci, Prosecutors, Macci, Rich McKay, Noeleen Walder, Cynthia Osterman Organizations: HBO, National Institutes of Health, Thomson Locations: Brooklyn, U.S, New York, Baltimore, Atlantic City , New Jersey, Atlanta

GSK reckons the spin-off has allowed the company to sharpen its focus on vaccines and infectious diseases and with $7 billion generated by the Haleon spin-off, it can fund deals to bolster a lacklustre drug pipeline. The company also reported an adjusted profit of 38.8 pence per share for the quarter, on sales of about 7.18 billion pounds ($9.26 billion). Analysts were expecting a profit of 34.7 pence per share on sales of about 6.77 billion pounds, according to company-compiled consensus estimates. Sales of Shingrix, the company's top-selling drug, generated 880 million pounds, beating analyst estimates of 872 million pounds. Sales of HIV treatments generated 1.58 billion in the quarter, ahead of the company-compiled consensus of about 1.5 billion pounds in the quarter.

Persons: Zantac, Emma Walmsley, Walmsley, Markus Manns, Dani Saurymper, Maggie Fick, Radhika Anilkumar, Janane Venkatraman, Savio D'Souza, Josephine Mason Organizations: GSK, British, Analysts, U.S, Union Investment, Pacific Asset Management, Thomson Locations: London, Bengaluru

☆ Launch of arthritis drug biosimilars ramps up US pressure on pricing 'middlemen'
▼ + stars: | 2023-07-25 | by ( Patrick Wingrove | ) www.reuters.com time to read: +5 min

Seven drugmakers this month launched their own versions, known as biosimilars, of AbbVie's (ABBV.N) flagship arthritis drug Humira, once the world's top-selling prescription medicine. Three have kept their list price within 5%-7% of AbbVie's, two priced at an 85% discount and two have offered both types of prices. For insured patients who are often on the hook for co-pays of 10% to 25% of the list price, the savings have been minimal. Reuters GraphicsThe Biden administration has made lowering drug prices a priority. Amgen offered 5% and 55% discounts to AbbVie's $6,922 per month Humira price tag, and both were included on drug coverage lists at two large PBMs.

Persons: Dado Ruvic, Humira, Ameet Sarpatwari, Biden, PBMs, Cigna, UnitedHealth, Amgen, Robin Feldman, Ron Wyden, Wyden, Chuck Grassley, Grassley, Patrick Wingrove, Moira Warburton, Josephine Walker, Caroline Humer, Bill Berkrot Organizations: REUTERS, Association for Accessible Medicines, Harvard Medical School, Reuters, Lawmakers, Federal Trade Commission, FTC, CVS, Biosimilars, Healthcare, Novartis, Sandoz, Reuters Graphics Reuters, University California College of the, Democratic, Republican, Thomson Locations: U.S, Humira, San Francisco, New York, Washington

☆ How U.S. Drug Companies Could Tip Europe Into Recession
▼ + stars: | 2023-07-23 | by ( Paul Hannon | ) www.wsj.com time to read: 1 min

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Persons: Dow Jones

The promising drug, then in the early stages of testing, was an updated version of tenofovir. The “patent extension strategy,” as the Gilead documents repeatedly called it, would allow the company to keep prices high for its tenofovir-based drugs. Gilead could switch patients to its new drug just before cheap generics hit the market. By putting tenofovir on a path to remain a moneymaking juggernaut for decades, the strategy was potentially worth billions of dollars. The delayed release of the new treatment is now the subject of state and federal lawsuits in which some 26,000 patients who took Gilead’s older H.I.V.

Persons: Gilead

[1/2] The roof of a Pfizer facility shows heavy damage after a tornado passed the area in Rocky Mount, North Carolina, U.S. July 19, 2023. ABC Affiliate WTVD via REUTERSJuly 21 (Reuters) - Most of the tornado damage at Pfizer Inc's (PFE.N) Rocky Mount, North Carolina plant was to the warehouse and not manufacturing facilities, CEO Albert Bourla said on Friday, easing concerns about long-term drug shortages from the plant. Nonetheless, Bourla told a news conference in Rocky Mount that it will be a monumental task to repair the damage. "We are moving full speed to bring this manufacturing plant into action again," Bourla said, noting that crews were working to restore power to the plant. The Rocky Mount plant is one of the largest factories for sterile injectable medicines in the world.

Persons: Albert Bourla, Bourla, Soumi Saha, Saha, Lisa Mulloy, Erin Fox, David Ljunggren, Michael Erman, Shivani Tanna, Rami Ayyub, Doina Chiacu, Cynthia Osterman, Diane Craft Organizations: Pfizer, ABC, WTVD, REUTERS, Pfizer Inc's, U.S, American Society of Health, System Pharmacists, U.S . Food, Drug Administration, FDA, Premier Inc, University of Utah Health, Thomson Locations: Rocky Mount, North Carolina, U.S, Rocky, Bengaluru

☆ Venezuela's ex-spymaster pleads not guilty to US drug trafficking charges
▼ + stars: | 2023-07-20 | by ( Luc Cohen | Thomson Reuters | Reports On The New York Federal Courts. Previously Worked As A Correspondent In Venezuela | ) www.reuters.com time to read: +2 min

Hugo Carvajal, 63, arrived in the United states on Wednesday after being extradited from Spain. "General Carvajal looks forward to fighting these outrageous charges in court before an unbiased American jury," Margulis-Ohnuma told reporters after the hearing. The drugs were ultimately bound for the United States, according to prosecutors. Dozens of Venezuelan military leaders, politicians and businessmen have been charged by the United States with corruption and drug trafficking. He was arrested in Spain on the U.S. drug charges later that year, but went into hiding after a court initially approved his extradition.

Persons: Hugo Carvajal, Judge Stewart Aaron, Zachary Margulis, Ohnuma, Carvajal, General Carvajal, Hugo Chavez's, El, Chavez, Nicolas Maduro, Maduro, Luc Cohen, Daniel Wallis Organizations: YORK, Department of Justice, U.S, American, U.S . State Department, Washington, Thomson Locations: United, Spain, Manhattan, Mexico, Venezuela, United States, Washington, Caracas, Aruba, Netherlands, Maduro, New York

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