- Jun 12, 2017
The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.
- Jun 08, 2017
FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.
- May 31, 2017
Amgen filed a complaint against FDA claiming the agency unlawfully denied the company pediatric exclusivity for its secondary hyperparathyroidism treatment Sensipar.
- May 24, 2017
The Competition and Markets Authority is accusing Merck Sharp & Dohme of offering a discount for Remicade that may have restricted the sale of biosimilar competition in the UK.
- May 22, 2017
Janssen filed a lawsuit in a US District Court in New Jersey against Samsung Bioepis, claiming the company’s new biosimilar infringed on its Remicade patents.
PTSM: Pharmaceutical Technology Sourcing and Management - May 02, 2017
Innovative new technologies released over the past several months seek to enhance bio/pharmaceutical development and manufacturing.
- Apr 24, 2017
Sanofi filed an antitrust lawsuit with a district court in New Jersey alleging Mylan took steps to restrict access to a competing epinephrine autoinjector.
- Apr 24, 2017
Sanofi filed an antitrust lawsuit with a district court in New Jersey alleging Mylan took steps to restrict access to a competing epinephrine autoinjector.
- Apr 21, 2017
The agency approved Renflexis, a biosimilar to Janssen’s blockbuster rheumatoid arthritis treatment.
- Apr 21, 2017
Valeant said the IL-17 inhibitor will be listed at $3500 per month and is expected to be available for sale during the second half of 2017.
- Apr 21, 2017
Amgen asked a judge to issue a judgment of infringement involving Sanofi/Regeneron’s drug Dupixent and its use of a mechanism described in Amgen’s ‘487 patent.
- Apr 21, 2017
Amgen asked a judge to issue a judgment of infringement involving Sanofi/Regeneron’s drug Dupixent and its use of a mechanism described in Amgen’s ‘487 patent.
- Apr 21, 2017
The agency approved Renflexis, a biosimilar to Janssen’s blockbuster rheumatoid arthritis treatment.
- Apr 21, 2017
Valeant said the IL-17 inhibitor will be listed at $3500 per month and is expected to be available for sale during the second half of 2017.
