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Dado Ruvic - 1 Amgen's - 1 William Blair - 1 Matt Phipps - 1 Lumakras - 1 Bhanvi Satija - 1 Shounak Dasgupta - 1 Sherry Jacob - 1
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3 mentions found


☆ Amgen's late-stage data for lung cancer drug 'not adequate' - FDA staff
  + stars: | 2023-10-03 | by ( Bhanvi Satija Pratik Jain | Bhanvi Satija | Pratik Jain | ) www.reuters.com   time to read: +2 min
REUTERS/Dado Ruvic/Illustration/File photo Acquire Licensing RightsOct 3 (Reuters) - The U.S. Food and Drug Administration staff reviewers said on Tuesday Amgen's (AMGN.O) late-stage study might not be sufficient to confirm the effectiveness for its lung cancer drug, as the firm pursues a traditional nod for the treatment. Amgen's drug was granted accelerated approval by the U.S. FDA in 2021 for advanced lung cancer patients with KRAS mutations whose disease has worsened after treatment with chemotherapy or other medicines. The U.S. health regulator grants the so-called accelerated approval based on data that show therapies are likely to work, and requires confirmatory trials later to give them traditional approval. Data from the study showed Lumakras reduced the risk of disease progression in patients with advanced lung cancer by 34%, compared with chemotherapy in a clinical trial. The agency is expected to make a decision on traditional approval for the drug by Dec. 24.
Persons: Dado Ruvic, Amgen's, William Blair, Matt Phipps, Lumakras, Bhanvi Satija, Shounak Dasgupta, Sherry Jacob, Phillips Organizations: REUTERS, U.S . Food, Drug Administration, U.S, FDA, Thomson Locations: U.S, Bengaluru
☆ Catalent cuts forecast, delays results again as challenges mount
  + stars: | 2023-05-19 | by ( Bhanvi Satija Pratik Jain | Bhanvi Satija | Pratik Jain | ) www.reuters.com   time to read: +3 min
Catalent, one of the top contract manufacturers for pharmaceutical companies, said a drop in revenue from COVID vaccine manufacturing had coincided with higher-than-expected costs and production challenges at its facilities in Indiana and in Brussels. Adding to woes, its cost-cutting plans have been delayed due to regulatory inspections and subsequent corrective actions, the company said. Despite Friday's gain in shares, Catalent's stock is down 19% since it first disclosed production challenges at its three major production plants in April. Catalent cut its full-year revenue to a range of $4.25 billion to $4.35 billion, from its prior forecast of $4.63 billion to $4.88 billion. It also slashed its annual adjusted net income forecast to between $187 million and $228 million, from between $567 million and $648 million previously.
☆ U.S. FDA panel backs OTC opioid overdose drug, proposes label changes
  + stars: | 2023-02-16 | by ( Bhanvi Satija Pratik Jain | Bhanvi Satija | Pratik Jain | ) www.reuters.com   time to read: +3 min
Feb 15 (Reuters) - Emergent BioSolutions Inc's (EBS.N) over-the-counter version of opioid overdose reversing drug received unanimous support from U.S. Food and Drug Administration's panel of advisers, sending shares of the contract drugmaker up nearly 16% after market. The vote puts the naloxone-based treatment Narcan on track to potentially become the first opioid overdose drug to be sold OTC nationwide. Naloxone rapidly reverses or blocks the effects of an overdose, restoring normal respiration. However, most panelists emphasized that OTC use of the nasal spray was safe and proposed ways to improve its labeling, to avoid using the drug wrong. Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020.
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