Industry News Update: 2/14

This week in pharma:

  • Merck announced their data from three pivotal phase 3 trials focusing on treating advanced prostate cancer. The results were presented on Thursday, February 14, 2019 at the Genitourinary Cancers Symposium in San Francisco.

  • Merck was also granted an FDA priority review to make Keytruda first line therapy for patients with recurrent or metastatic head and neck squamous cell carcinoma.

  • Teva stock fell 11% in the premarket trade on Wednesday, February 13, 2019 due Copaxone’s generic competitors. An overall decline in their generic revenue has also been observed within recent months.

  • Celgene finally overcame its patent barrier for their “megablockbuster,” multiple myeloma drug Revlimid, relieving the concerns of recent buyer Bristol-Myers Squibb. This prevents Dr. Reddy’s and other competitors from making generics prior to 2023. However, just one day later, a European generic launched a copycat drug. Celgene is confident in their hold on the U.S. market and does not expect this to affect their sales.

  • The FDA discovered that Immunomedics tampered with their data at a plant in Morris Plains, New Jersey. Data. Immunomedics’ breast cancer antibody-drug conjugate, sacituzumab, included: bioburden sample manipulation, misrepresentation of a test procedure in the batch records, and backdating dates of analytical results.

  • Regeneron and Sanofi cut the US list price of Praluent by nearly 60% in an effort to reduce costs in high risks patients. This comes ahead of a late February US Senate Committee meeting where major pharmaceutical companies, including Sanofi, have been asked to testify about increasing drug prices in the US.

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