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Top related persons:
Novo - 1 Boehringer - 1 Lina Khan - 1 Biden - 1 drugmakers - 1 Joe Biden's - 1
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Top related orgs:
Federal Trade Commission - 1 FTC - 1 Novo Nordisk - 1 AstraZeneca - 1 Covis Pharma - 1 GlaxoSmithKline - 1 Novartis - 1 Teva Pharmaceuticals - 1

Search resuls for: "Covis Pharma"


5 mentions found


☆ FTC challenges 'junk' patents held by 10 drugmakers, including for Novo Nordisk's Ozempic
  + stars: | 2024-04-30 | by ( Annika Kim Constantino | ) www.cnbc.com   time to read: +2 min
The Federal Trade Commission on Tuesday said it is challenging hundreds of alleged "junk" patents held by pharmaceutical companies for 20 brand-name drugs, including Novo Nordisk's blockbuster drugs Ozempic, Saxenda and Victoza. The FTC issued letters to 10 companies, warning them that certain drug patents were improperly listed. Many of the drug patents are for Type 2 diabetes, along with asthma and inhalers for chronic obstructive pulmonary disease, or COPD. Generic drugmakers can only launch cheaper versions of a branded drug if the patents have expired or are successfully challenged in court. The FTC first challenged dozens of branded drug patents last fall, leading three drugmakers to comply and delist their patents with the FDA.
Persons: Novo, Boehringer, Lina Khan, Biden, drugmakers, Joe Biden's Organizations: Federal Trade Commission, FTC, Novo Nordisk, AstraZeneca, Covis Pharma, GlaxoSmithKline, Novartis, Teva Pharmaceuticals, Amphastar Pharmaceuticals, Food and Drug Administration, FDA Locations: U.S
☆ Drug to Prevent Preterm Births to Be Pulled From Market
  + stars: | 2023-03-07 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
Photo: Eric Lee for The Wall Street JournalMakena was the only drug approved by the FDA to reduce the risk of preterm birth in women with a history of early deliveries. Covis Pharma Group said it will stop selling its drug to prevent preterm births, after a study couldn’t confirm the medicine worked and U.S. health regulators were taking steps that could have it pulled. Makena was the only drug approved by the Food and Drug Administration to reduce the risk of preterm birth in women with a history of early deliveries.
☆ Exclusive: Caligan urges Anika Therapeutics to conduct review, plans board challenge
  + stars: | 2023-02-21 | by ( Svea Herbst-Bayliss | ) www.reuters.com   time to read: +3 min
Caligan Partners owns a roughly 4% stake in Anika and is ratcheting up pressure to protest an underperforming stock price and losses at the company's joint preservation segment. "Anika may be better positioned as a private company or as part of a larger organization," Caligan's managing partner, David Johnson, wrote to the board. Anika's osteoarthritis knee pain relief injection treatments would be attractive to other companies and could be worth almost $60 per share, Johnson wrote. On Tuesday, the company's stock price climbed nearly 6% as the broader market declined. Anika is best known for its viscosupplement portfolio, including Monovisc and Orthovisc, marketed by Johnson & Johnson (JNJ.N).
☆ FDA Advisers Recommend Pulling Drug to Prevent Preterm Births From Market
  + stars: | 2022-10-19 | by ( Liz Essley Whyte | ) www.wsj.com   time to read: 1 min
The Food and Drug Administration, in Silver Spring, Md., is expected to order the drug Makena removed from the market. Health experts advising the Food and Drug Administration recommended the agency pull from the market a drug used to prevent preterm births. The advisers voted against the FDA allowing Covis Pharma Group’s Makena to remain on the market, after the drug failed a trial to confirm its benefit.
☆ FDA panel recommends revoking the approval of controversial drug for preterm births
  + stars: | 2022-10-19 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms Berkeley-Lovelace-Jr.Jpg | Berkeley Lovelace Jr. | ) www.nbcnews.com   time to read: +4 min
The panel voted on three questions: whether the drug is effective, whether trial data support its approval and whether it should remain on the market. The trial found that the drug failed to reduce the risk of preterm births or produce better health outcomes for newborns. When a 2019 trial showed that the drug produced no benefits, the same FDA advisory panel voted to revoke the drug's approval. What's more, "retaining Makena’s approval likely hinders study of more promising treatments for preterm birth," FDA scientists wrote. It also proposed a partial withdrawal of the drug, making the drug only available to women at the highest risk of preterm birth.
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