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.