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Top related persons:
Mara Goldstein - 3 Brendan McDermid - 1 Christy Santhosh - 1 Shinjini Ganguli - 1 Anil D'Silva - 1 Shailesh - 1 Shounak - 1 Nitin Kumar - 1
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U.S Rahway , New Jersey United States Japan Bengaluru Keytruda Chicago , Illinois Bristol
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Merck - 3 Co - 2 REUTERS - 1 U.S . Food - 1 Drug Administration - 1 FDA - 1 Staff - 1 European Union - 1

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5 mentions found


☆ US FDA staff flags concerns about Merck's chronic cough drug
  + stars: | 2023-11-15 | by ( Christy Santhosh Khushi Mandowara | Christy Santhosh | Khushi Mandowara | ) www.reuters.com   time to read: +2 min
REUTERS/Brendan McDermid/File Photo Acquire Licensing RightsNov 15 (Reuters) - The U.S. health regulator's staff on Wednesday flagged concerns that data on Merck's (MRK.N) chronic cough drug might not be enough to prove the treatment's meaningful benefit, documents released ahead of a meeting of independent experts showed. The concerns were raised after the company had submitted additional efficacy data to the U.S. Food and Drug Administration (FDA), which declined to approve the drug in January last year. A panel of expert advisers to the FDA is set to meet on Friday to discuss the efficacy of Merck's drug gefapixant. Staff assessment of the data submitted by Merck showed a small reduction in cough frequency and side effects such as loss of taste in patients who were administered the drug. The European Union and Japan have approved Merck's drug for the condition and it is sold under the brand name Lyfnua.
Persons: Brendan McDermid, Mara Goldstein, Christy Santhosh, Shinjini Ganguli, Anil D'Silva, Shailesh, Shounak Organizations: Merck, Co, REUTERS, U.S . Food, Drug Administration, FDA, Staff, European Union, Thomson Locations: Rahway , New Jersey, U.S, United States, Japan, Bengaluru
☆ These are Mizuho's top stock picks heading into November
  + stars: | 2023-11-05 | by ( Alex Harring | ) www.cnbc.com   time to read: +3 min
Mizuho's equity research team compiled its top buy-rated picks for the new month. The average price target for the stock, which is already up about 14% this year, implies an upside of about 15%. But the average analyst is bullish with a buy rating and price target implying an upside of almost 21%, per LSEG. The average Wall Street analyst rates EyePoint a buy, and the consensus price target implies the stock could skyrocket nearly 290%, per LSEG. The average analyst has a buy rating and price target reflecting 13.5% upside ahead, per LSEG.
Persons: Nitin Kumar, Mara Goldstein, Graig Suvannavejh, Siti Panigrahi, INTU, Panigrahi, — CNBC's Michael Bloom Organizations: Mizuho, Dow Jones, Nasdaq, Coterra Energy, Merck, Co, EyePoint Pharmaceuticals, Intuit, Small Locations: Keytruda
☆ Medicare drug price negotiations may have a muted impact on drugmakers in the near term
  + stars: | 2023-08-30 | by ( Annika Kim Constantino | ) www.cnbc.com   time to read: +2 min
But analysts say the drug price talks will likely have a muted financial impact on manufacturers, at least for this first round of prescription medicines. More broadly, some of the drugs on the list aren't significant contributors to their company's business in the first place. "The commercial impact of negotiations appears limited in the near term for this initial list of drugs," Mara Goldstein, managing director of Mizuho Securities, told CNBC. The list names drugs with the highest spending for Medicare Part D, which covers prescription medications, from June 2022 to May 2023. Several drugmakers, including a handful whose medications are on the list, have filed lawsuits in different federal courts seeking to stop the negotiations.
Persons: Eliquis, Mara Goldstein, Biden, Johnson, there's Organizations: New, Halsted Pharmacy, Medicare, Mizuho Securities, CNBC, Myers Squibb, Johnson, Merck, AstraZeneca, Supreme, U.S . Chamber of Commerce Locations: Chicago , Illinois, Bristol, U.S
☆ Merck scraps third prostate cancer study as Keytruda therapy disappoints
  + stars: | 2023-02-28 | by ( Bhanvi Satija | ) www.reuters.com   time to read: +2 min
The setbacks were likely to put Merck further behind in its quest to develop a treatment for advanced forms of the most common cancer type in the United States. It had in January stopped a late-stage study of the drug in some prostate cancer patients. An interim analysis showed the combination therapy did not extend survival or help extend the time a patient lives without the disease worsening compared to placebo, Merck said. Merck was testing its blockbuster immunotherapy in combination with androgen deprivation therapy and Xtandi, made by Pfizer Inc (PFE.N) and Astellas Pharma Inc (4503.T), in patients with an advanced form of treatment-resistant prostate cancer. Additionally, Merck said another combination treatment with Keytruda did not meet the main goal in a separate late-stage study for a type of lung cancer that can spread to other parts of the body.
☆ Merck could keep its patent edge by shifting Keytruda cancer drug to a simple shot
  + stars: | 2022-12-02 | by ( Michael Erman | ) www.reuters.com   time to read: +7 min
If successful, Merck could begin marketing the new formulation within a few years, a top Merck executive told Reuters. "The clock for that patent would start ticking from the time we would get that patent approved." Drug patents have a guaranteed term of exclusivity for 20 years after receiving a patent under U.S. law, but sometimes the companies are able to add additional patents that extend their exclusivity. Merck's patents on the subcutaneous version of Keytruda could protect that formulation until at least 2040, according to Tahir Amin, co-founder of drug patents watchdog group Initiative for Medicines, Access & Knowledge (I-MAK). Northwell's Mulloy said moving patients to subcutaneous versions of drugs also opens up spots in infusion centers for additional patients.
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