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☆ EU proposal may accelerate pharma innovation decline, industry group says
▼ + stars: | 2023-11-06 | by ( Julia Payne | ) www.reuters.com time to read: +3 min

"Any changes to our incentives system would equally affect EU-based and foreign-based companies which bring medicines to the EU and, therefore, it would not put EU firms at a disadvantage," an EU Commission spokesperson said. Medication was the single biggest contributor to the EU’s trade surplus, with 235 billion euro ($252.13 billion) worth of exports in 2021. The EFPIA said small biotech companies have already moved to the United States and China. The Commission said its proposal would reduce new medicine approval times to 180 days from 400 days. Germany, Belgium and France would be the hardest hit by the proposed rules, the EFPIA said citing research by Dolon that it commissioned.

Persons: EFPIA, Lars Fruergaard Jorgensen, Jorgensen, Ozempic, " Jorgensen, Julia Payne, Lisa Shumaker Organizations: European Commission, European Federation of Pharmaceutical Industries, EU, Commission, Novo Nordisk, Thomson Locations: BRUSSELS, United States, China, Danish, Boston, U.S, Europe, EU, Germany, Belgium, France

☆ Novartis' Sandoz valued at $11.2 bln in market debut
▼ + stars: | 2023-10-04 | by ( ) www.reuters.com time to read: +1 min

A sign marks the Novartis Institutes for BioMedical Research facility in Cambridge, Massachusetts, U.S., June 16, 2021. REUTERS/Brian Snyder/File Photo Acquire Licensing RightsOct 4 (Reuters) - Sandoz (SDZ.S) made its market debut with a lower-than-expected valuation of 10.3 billion Swiss francs ($11.2 billion) on Wednesday, after the generic and biosimilar drugmaker was spun off from Swiss pharmaceutical company Novartis (NOVN.S). Deutsche Bank had said Sandoz, which accounted for 11% of Novartis' group operating profit in 2022, would likely be valued at $11-$13 billion, while brokerage Berenberg had forecast $17-$26 billion. The shares, which opened at 24 Swiss francs, became members of the Swiss Performance Index and the Swiss Leader Index, among other stock market gauges, and American depositary receipts also started trading on Wednesday. Novartis shareholders received one Sandoz share for every five Novartis shares they held as part of the transaction.

Persons: Brian Snyder, drugmaker, Sandoz, Berenberg, Vas Narasimhan, Ludwig Burger, Tristan Veyet, Clarence Fernandez, Mark Potter Organizations: Novartis, Research, REUTERS, Sandoz, Analysts, Deutsche Bank, Swiss, Thomson Locations: Cambridge , Massachusetts, U.S, Swiss, generics

☆ Sandoz owners are banking on margin cure
▼ + stars: | 2023-10-04 | by ( ) www.reuters.com time to read: +2 min

LONDON, Oct 4 (Reuters Breakingviews) - Sandoz’s (SDZ.S) investors are giving CEO Richard Saynor the benefit of the doubt. Shares in the generics drug maker, which $217 billion pharma giant Novartis (NOVN.S) has finally managed to spin off, started to trade in Zurich on Wednesday. There was a risk that Novartis investors, who have long called for a sale or spinoff, would quickly dump the new Sandoz shares. At current market prices, Sandoz is worth nearly $11 billion, or $14.4 billion once net debt is added in. For now, Novartis investors seem to believe Sandoz’s treatment may be effective.

Persons: Richard Saynor, Sandoz, Aimee Donnellan, Lisa Jucca, Streisand Neto Organizations: Reuters, Novartis, Sandoz, Hikma Pharmaceuticals, X, Brookfield pounces, Temasek, Thomson Locations: Zurich, That’s

☆ Stocks making the biggest moves premarket: Cal-Maine Foods, Intel, Apple & more
▼ + stars: | 2023-10-04 | by ( Pia Singh | ) www.cnbc.com time to read: +2 min

Intel — Shares popped 2.5% after the chipmaker announced it would be operating its programmable chip unit as a standalone business complete. Intel plans to conduct an initial public offering for the unit within the next two to three years. The firm is bullish on the stock thanks to progress on legacy projects and said Fluor is on the brink of a company turning point. Sunrun , Sunnova Energy International — Shares of Sunrun and Sunnova dropped 3% and 2.8%, respectively, after Truist Securities downgraded the solar panel installers to hold from buy on Wednesday. Cal-Maine Foods — The stock plunged 11.6% after the company came out with disappointing sales figures due to lower prices.

Persons: Fluor, Sunnova, Moderna, StreetAccount, — CNBC's Brian Evans, Lisa Han Organizations: Intel, UBS, Apple, Sunnova Energy, Truist Securities, Moderna, pharma, Bank of America, Novartis —, Swiss drugmaker, Sandoz, SIX Swiss Exchange, Maine Foods, Revenue Locations: United States, Israel, Swiss, Cal

☆ Novartis unit Sandoz starts trading at 24 Swiss francs after completing spinoff
▼ + stars: | 2023-10-04 | by ( Elliot Smith | ) www.cnbc.com time to read: +1 min

Novartis said in August that it plans to spin off its generics unit Sandoz to sharpen its focus on its patented prescription medicines. Novartis on Wednesday completed the spinoff of its generics and biosimilars business Sandoz, whose shares began trading at 24 Swiss francs in the early minutes of the company's debut on the SIX Swiss Exchange. The Swiss drugmaker initially announced intentions to spin off the business in August, offering stakeholders one Sandoz share for every five Novartis shares via a dividend-in-kind distribution. Pure play companies refer to entities that target a single product or industry sector. Novartis shares climbed more than 3% in early trade in Zurich to lead the pan-European Stoxx 600 index .

Persons: Sandoz, Narasimhan, we've, CNBC's Julianna Tatelbaum Organizations: Novartis, Wednesday, SIX Swiss Exchange, CNBC Locations: Swiss, Zurich

☆ Buy this pharma stock that could more than double if it clears a legal battle, Jefferies says
▼ + stars: | 2023-09-20 | by ( Sarah Min | ) www.cnbc.com time to read: +2 min

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

☆ Global Regulation of Essential Medicines Is a Dangerous Mess - The New York Times
▼ + stars: | 2023-09-11 | by ( Vidya Krishnan | ) www.nytimes.com time to read: +3 min

has not released more recent numbers, and there is limited data on exactly how much of this comes from India. The global drug supply system is a vast and complex network. As of 2021, India manufactured 62 percent of the raw materials for drugs, known as active pharmaceutical ingredients. in 2001 set up a groundbreaking program to monitor safety and quality, called the Prequalification of Medicines Program or P.Q.P., which set global standards for H.I.V. The program is one of those unsung policies that keep the global health structure ticking.

Persons: —, Cipla Organizations: World Health Organization, Medicines Program Locations: India, China, United States, Europe, Sri Lanka, Gambia, Africa —, Saharan Africa, Indian

Sept 6 (Reuters) - Bristol Myers Squibb (BMY.N) has been accused in a new lawsuit of using fraudulent patents and other illegal tactics to maintain its monopoly on blockbuster blood cancer drug Pomalyst for years after it should have faced generic competition. A spokesperson for Bristol Myers did not immediately respond to a request for comment. Pomalyst is a top seller for Bristol Myers, bringing in nearly $3.5 billion out of $46.16 billion of its total revenue last year. The drug was developed by Celgene, a company acquired by Bristol Myers in 2019. The generic companies, which are also named as defendants in the lawsuit, did not immediately respond to requests for comment.

Persons: Pomalyst, Bristol Myers, Celgene, Brendan Pierson, Alexia Garamfalvi, Bill Berkrot Organizations: Bristol Myers Squibb, Louisiana, Pomalyst, Bristol, Celgene, U.S . Patent, Teva Pharmaceutical Industries, Aurobindo Pharma, Breckeridge Pharmaceutical, Natco Pharma, Thomson Locations: Manhattan, New York

☆ Troubled health name bounces after strong quarter and guidance. Here's our view on the stock
▼ + stars: | 2023-08-03 | by ( Zev Fima | ) www.cnbc.com time to read: +6 min

Another possible catalyst is the monetization of BHC's Bausch + Lomb (BLCO) stake. Bausch + Lomb update On the earnings release, management highlighted a change in thinking about how to handle their stake in Bausch + Lomb. We'll be on the lookout for more information on the Bausch + Lomb situation in the coming days. Guidance BHC management raised their full-year revenue guidance for 2023 while reaffirming their adjusted EBITDA outlook. Excluding Bausch + Lomb, the team now expects full-year revenue to be in the range of $4.5 billion to $4.65 billion.

Persons: it's, Refinitiv, BHC's Bausch, Bausch, We'll, Generics, Jim Cramer's, Jim Cramer, Jim, Rafael Henrique Organizations: Health, Bausch Health, Management, Bausch Health Companies, BHC's, Dentistry, CNBC Locations: BHC, Bausch, East, Africa, Canada, Asia, China

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

☆ Drug shortages’ effects on cancer research may be felt for years to come
▼ + stars: | 2023-07-20 | by ( Jen Christensen | ) edition.cnn.com time to read: +8 min

But these shortages aren’t just bad for current patients, experts say; their effects on cancer research may be felt for years to come. The National Cancer Institute, the federal government’s main agency for cancer research and training, told CNN that at least 174 of its own trials may be affected by the shortages. Cisplatin and other platinum-based drugs are prescribed for 10% to 20% of all cancer patients, according to the National Cancer Institute. Crucial work on hold“With drug shortages, trials have become almost like an impossible task. “These drug shortages come and go, and there’s no real rhyme or reason, and there seems to be no rhyme or reason in terms of which institutions have shortages.

Persons: Joe Biden, it’s, ’ ”, Shadia Jalal, Indiana University Melvin, Jalal, She’s, they’ve, ” Jalal, “, ”, haven’t, “ We’ve, Mark Fleury, Fleury, you’re, ” Fleury, Dmitry Walker, Merck, We’ve, ” Walker, there’s, Biden, Lawrence Feldman, ” Feldman, Feldman, Dr, Sanjay Gupta, ‘ Organizations: CNN, National Cancer Institute, American Society of Health, Cancer, Indiana University, Bren Simon Comprehensive Cancer Center, Hematology, Oncology, IU School of Medicine, Hoosier Cancer Research Network, Veterans Administration, American Cancer Society Cancer Action Network, American Cancer Society, WVU Medicine, US Food, Pharmacists, National Comprehensive Cancer Network, University of Illinois Medical Center, CNN Health Locations: United States, China, Chicago

☆ Novartis stock jumps after drugmaker raises full-year guidance, launches $15 billion buyback
▼ + stars: | 2023-07-18 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Novartis shares jumped on Tuesday after the Swiss drugmaker raised its full-year guidance on strong drug sales and announced a $15 billion share buyback. Novartis expects sales to rise by a high-single-digit percentage in 2023, an increase from a previous expectation of mid-single-digit growth. Novartis reported total revenue of $13.62 billion for the quarter, up around 7% from $12.78 billion the same period a year ago. The company's innovative medicines business, which develops patented medicines, raked in sales of $11.24 billion for the quarter. The company's generic medicines division, Sandoz, posted sales of $2.38 billion, up 5% from a year ago.

Persons: Sandoz, Roche Organizations: Novartis, Refinitiv, Sandoz Locations: Swiss, U.S

☆ Obesity drug Wegovy's popularity has US employers rethinking insurance coverage
▼ + stars: | 2023-06-27 | by ( Patrick Wingrove | ) www.reuters.com time to read: +6 min

[1/2] A selection of injector pens for the Saxenda weight loss drug are shown in this photo illustration in Chicago, Illinois, U.S., March 31, 2023. A new and more expensive version of the drug specifically for weight loss, called Wegovy, had been approved in 2021 by U.S. health regulators. Employers that cover weight-loss drugs have required medical practices to document patients’ need for Wegovy since it was approved. The federal Medicare healthcare program for Americans aged 65 and older cannot cover weight loss treatments by law. Only 16 states – the most populous being California, Pennsylvania and Michigan – cover Wegovy and other obesity drugs under their Medicaid plans for low-income patients.

Persons: Jim Vondruska, Shawnte, Aon, Mercer, Willis Towers Watson, Eli Lilly, Jeff Levin, Levin, Scherz, Michael Manolakis, William Yancy, Manolakis, Patrick Wingrove, Michele Gershberg, Suzanne Goldenberg Organizations: REUTERS, New, Warner Bros, Warner Bros Discovery Inc, Reuters, Marsh & McLennan, Employers, Barclays Research, Novo Nordisk, Duke University, Thomson Locations: Chicago , Illinois, U.S, New York, Marsh, Wegovy, California, Pennsylvania, Michigan

☆ A son died, his parents tried to sue. How U.S. courts protect Big Pharma
▼ + stars: | 2023-06-26 | by ( ) www.reuters.com time to read: +26 min

His parents soon started exploring a lawsuit against Merck, the developer of the blockbuster asthma and allergy drug, Singulair, along with the manufacturer of the generic version their son took. That meant Merck had written the warning label, with federal approval, on the generic version of Singulair that Nicholas England took. But his parents couldn’t sue Merck, either, because their son had never taken its name-brand version of Singulair. The generic drug manufacturer that made the pills England took, Teva Pharmaceuticals, did not respond to inquiries. Since Merck’s patent on Singulair expired in 2012, major generic drug manufacturers have sold millions of prescriptions under the drug’s scientific name, montelukast.

Persons: Nicholas England, Nicholas, Merck, ”, Jennifer England, Nicholas’s, ” Merck, Organon, “, George W, Bush, Daniel Troy, Troy, Medtronic, Nicholas England’s, Adam Zimmerman, ” Zimmerman, Jay Lefkowitz, Ellis, shouldn’t, Bayer, drugmaker Wyeth, Phenegran, Jan Gilpin’s, mumbling, ” Gilpin, ” “, hadn’t, Singulair, Gilpin, Stephane Bissonnette, suicidality, Dr, Judith Kramer, Duke, Robert England, Robert said, Kim Beck Organizations: Merck, U.S, Teva Pharmaceuticals, Reuters, U.S . Food, Drug Administration, FDA, Big, Corporate America, Corporations, Administration, ”, New, University of Southern California’s Gould School of Law, Norfolk, Union Pacific, Federal Railroad Safety, Pacific, GlaxoSmithKline, Monsanto, Bayer, Parent Locations: Virginia, England, U.S, New York, Kirkland, East Palestine , Ohio, Louisiana, Atlanta, Vermont, Wise , Virginia, Wisconsin

☆ Alibaba and more: Morgan Stanley names 5 global stocks with at least 50% upside
▼ + stars: | 2023-06-19 | by ( Ganesh Rao | ) www.cnbc.com time to read: +4 min

Morgan Stanley expects five of its top Asia stock picks to rise by more than 50% over the next 12 months. Alibaba Alibaba Group, the Chinese technology giant that's also listed in the United States, is making significant progress in its restructuring process, according to Morgan Stanley. "The likelihood of generics being immediately released in May 2024 is low," Morgan Stanley analysts Shinichiro Muraoka and Jaeheon Lee said in a note to clients on June 12. Sea Despite the challenges from inflation and post-pandemic economic reopenings, Morgan Stanley still sees long-term potential in Sea Limited . JD.com Morgan Stanley highlighted JD.com , a leading Chinese e-commerce company, for its potential growth as Chinese consumer spending picks up.

Persons: Morgan Stanley, Morgan Stanley's, Morgan, Gary Yu, Astellas, Astellas Pharma Morgan Stanley, Shinichiro Muraoka, Jaeheon Lee, JD.com Morgan Stanley, Eddy Wang, Ping, Jenny Jiang Organizations: Asia, Alibaba, Street, Astellas Pharma, Ping An Insurance Locations: Asia, Asia Pacific, Japan, China, India, United States, U.S, Singapore

☆ Ozempic is taking China by storm. Drugmakers are scrambling to boost supplies
▼ + stars: | 2023-06-06 | by ( Laura He | ) edition.cnn.com time to read: +5 min

Hong Kong CNN —Ozempic, originally a medication for treating diabetes, is in high demand worldwide with celebrities and social media users touting it as a miracle drug for weight loss. “This is a wonder drug,” according to a popular series of posts on Xiaohongshu, a Chinese social app similar to Instagram. Soaring pricesThe social media hype was so enormous that Xiaohongshu launched a crackdown in February and deleted more than 5,000 posts sharing weight loss experiences with Ozempic. Fill the shortageThe weight loss drug market in China is expected to boom in the coming years. Novo Nordisk has applied to China’s drug regulator to widen the scope of use for semaglutide, according to the National Medical Products Administration.

Persons: Hong Kong CNN — Ozempic, they’ve, ” Ozempic, Xiaohongshu, Ozempic, Kevin Frayer, hasn’t Organizations: Hong Kong CNN, Daily, First Affiliated, of Sun, University, Novo Nordisk, Tebon Securities, National Medical Products Administration, ., CNN, Huadong, Intellectual, Beijing Intellectual Property Locations: Hong Kong, China, Ozempic, Guangzhou, Shanghai, Hangzhou, Beijing

☆ Analysis: Stelara patent deal puts J&J back on path to $57 bln 2025 revenue forecast
▼ + stars: | 2023-06-05 | by ( Patrick Wingrove | ) www.reuters.com time to read: +4 min

Stelara, introduced in 2009, has been J&J’s top-selling drug since 2019, with sales reaching $9.7 billion in 2022. J&J is forecasting $57 billion in pharmaceutical sales by 2025 after reducing its previous view of $60 billion in April, citing currency dynamics that hurt its pharmaceutical business in 2022. That would add around $4.6 billion to average estimates for pharmaceutical sales, as long as no biosimilars enter the market before 2025. Amgen said last month the confidential settlement it signed with J&J will allow it to sell its Stelara biosimilar no later than Jan. 1, 2025. “If no Stelara biosimilars enter in 2024, I think growth should continue at around 4% in 2023 and 2024,” Huynh said.

Persons: Johnson, Amgen, ”, Vamil, Trung Huynh, ” Huynh, Teva, biosimilar, Divan, Alvotech, Patrick Wingrove, Caroline Humer, Bill Berkrot Organizations: Amgen Inc, Analysts, Stelara, Reuters Graphics Reuters, Reuters, New, J, Credit Suisse, Food and Drug Administration, Alvotech’s, Thomson Locations: New Brunswick , New Jersey, Alvotech’s Reykjavik

[1/5] Abdessalem Maraouni, a Tunisian university student displays a medicine box of "Celluvisc" at his home in Tunis, Tunisia May 29, 2023. Tunisia imports all medicine through the state-owned Central Pharmacy, which provides drugs to hospitals and pharmacies around the country which offer them to patients at a subsidised rate. Amira said the Central Pharmacy owed about 1 billion dinars ($325 million) to suppliers. Tunisia's Health Ministry and Central Pharmacy did not respond to requests for comment. MEDICINE EXCHANGEFrom the roof of his Tunis house, retired soldier Nabil Boukhili has opened an unofficial medicine exchange for his neighbourhood in coordination with local doctors.

Persons: Maaoui, Faourati, Kais Saied, Naoufel Amira, Amira, Nabil Boukhili, Boukhili, I've, Najia, Abdessalem Maraouni, Kamal, Tarek Amara, Jihed Abidellaoui, Angus McDowall, Ros Russell Organizations: REUTERS, Monetary Fund, Central Pharmacy, Tunisia's Syndicate, Tunisia's Health Ministry, Reuters, Thomson Locations: Tunis, Tunisia, TUNIS, Europe

☆ Novartis names Sandoz board members ahead of spin-off
▼ + stars: | 2023-05-15 | by ( ) www.reuters.com time to read: +1 min

ZURICH, May 15 (Reuters) - Novartis (NOVN.S) on Monday named the intended new board members of Sandoz, the generics business it plans to spin off to shareholders later this year. The Basel company approved the recommendations of Sandoz Chairman-designate Gilbert Ghostine for the 10 members of the board, which will start preparatory work in June. Others to be appointed to the board include former Novartis executive Karen Huebscher, Aarti Shah, who worked at Eli Lilly (LLY.N), and Deutsche Lufthansa (LHAG.DE) CFO Remco Steenburgen. Unilever (ULVR.L) Chief Legal Officer Maria Varsellona, and former Procter & Gamble (PG.N) executive Yannis Skoufalos, complete the nominations to the committee. "The Sandoz Board of Directors will start preparatory work from June onwards and will be effective following the planned spin-off of Sandoz in the second half of 2023, subject to Novartis Board of Directors and shareholder approval," Novartis said on Monday.

☆ Bausch Health's quarter disappoints, guidance beats. But uncertainty prevails over patent litigation
▼ + stars: | 2023-05-04 | by ( Zev Fima | ) www.cnbc.com time to read: +5 min

Xifaxan sales were also up 7%. Internationally, reported Q1 sales of $247 million missed estimates but grew 1% compared to the year-ago period. Organic sales grew 5%, driven by strength in Canada and Europe. Organic sales grew 6%. Excluding Bausch + Lomb, the team reiterated their revenue guidance of $4.45 billion to $4.6 billion, as well as their adjusted EBITDA guidance of $2.3 billion to $2.4 billion.

☆ European drug discounts will ruffle U.S. funder
▼ + stars: | 2023-04-28 | by ( ) www.reuters.com time to read: +2 min

LODNON, April 28 (Reuters Breakingviews) - Europe’s plan to slash prices on pharmaceutical drugs could set off tensions with the U.S. The European Union proposed on Wednesday a legislative overhaul of the sector across the 27-nation bloc. This would incentivise drug makers like AstraZeneca (AZN.L) and GSK (GSK.L) to sell to all European countries at once. And although the U.S. is trying to tackle soaring prices with the Inflation Reduction Act, Europe’s falling drug costs will widen the gap once again. This creates a problem for the U.S. government, which funds more drug development than any other country.

The ruling blocks proposed Otezla generics until 2028. A spokesperson for Sandoz said Wednesday that the company was pleased with the decision allowing for Otezla generics in 2028 instead of 2034. Celgene sued several drugmakers over their proposed Otezla generics starting in 2018, and 17 of the 19 lawsuits have been settled since. U.S. District Judge Michael Shipp said in 2021 that Switzerland-based Sandoz and India-based Zydus' generics would infringe three Amgen patents. The case is Amgen Inc v. Sandoz Inc, U.S. Court of Appeals for the Federal Circuit, Nos.

CNN —A 13-year-old in Ohio has died after “he took a bunch of Benadryl,” trying a dangerous TikTok challenge that’s circulating online, according to a CNN affiliate and a GoFundMe account from his family. Jacob Stevens was participating in a TikTok challenge with some friends at home when he ingested the antihistamine, the family donation account states. Overdosing on Benadryl can result in “serious heart problems, seizures, coma, or even death,” the US Food and Drug Administration said in a 2020 warning to the public about the deadly “Benadryl Challenge” on TikTok. In a statement to CNN, TikTok said, “Our deepest sympathies go out to the family. At TikTok, we strictly prohibit and remove content that promotes dangerous behavior with the safety of our community as a priority.

REUTERS/Brian Snyder/File PhotoWASHINGTON, April 17 (Reuters) - The U.S. Supreme Court on Monday declined to hear Novartis Pharmaceuticals Corp's (NOVN.S) bid to revive a key patent on its blockbuster multiple sclerosis drug Gilenya that was invalidated amid a legal dispute with China's HEC Pharm Co Ltd (1558.HK). Novartis sued HEC and more than a dozen other generic drugmakers for patent infringement in Delaware federal court after they applied for FDA approval of Gilenya generics. Novartis settled with some of the drugmakers, allowing for some Gilenya generics before a key patent's 2027 expiration. The Supreme Court in October rejected a Novartis emergency bid to pause the decision. HEC responded that the Federal Circuit "followed its own rules," and that "no Federal Circuit judge - including the dissenter - suggested any procedural concern" with the decision.

☆ FDA Forces the Only Drug for Preterm Births to Leave Market
▼ + stars: | 2023-04-06 | by ( Liz Essley Whyte | ) www.wsj.com time to read: 1 min

The FDA typically nudges manufacturers to withdraw drugs voluntarily; it is rare for the agency to force a drug withdrawal. The only drug on the market to help prevent preterm births must stop being sold immediately, a move that comes after scientists at the Food and Drug Administration earlier determined it was ineffective. The FDA said Thursday it is withdrawing its approval for the drug Makena and its generics because the drugs no longer are shown to be effective and the benefits don’t outweigh the risks. Makena, as well as its generics, can no longer be lawfully distributed in interstate commerce.

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