Another Roche move against biosimilars: Kadcyla now approved in EU, Posted on Biosilimar News
Roche today announced that Kadcyla (trastuzumab emtansine or T-DM1), the latest targeted medicine from its HER2 franchise and its first antibody-drug conjugate, has been approved by the European Commission for people with previously treated HER2-positive advanced breast cancer. Specifically, Kadcyla is indicated as a single agent for the treatment of adults with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received Herceptin (trastuzumab) and a taxane, separately or in combination. [Read More…]Cadence Pharmaceuticals announces favorable ruling in OFIRMEV patent litigation, Posted on PBR
Cadence Pharmaceuticals has announced that the US District Court for the District of Delaware has ruled in favor of the company in its patent infringement lawsuit against Exela Pharma Sciences over OFIRMEV, an intravenous formulation of acetaminophen. SCR Pharmatop, the patent owner, and Cadence Pharmaceuticals have filed a lawsuit against Exela Pharma Sciences in August 2011 for violating of two patents, US 6,028,222 and US 6,992,218, covering OFIRMEV. [Read More…]Cadence: Best Case Outcome On Ofirmev Patent Litigation, Posted on Seeking Alpha
Patent Litigation on Ofirmev – Cadence (CADX) just received the best possible news on a trial judge’s decision on a patent challenge against Ofirmev. The U.S. District Court for the District of Delaware has ruled in favor of Cadence in the company’s patent infringement lawsuit against Exela Pharma Sciences. The court ruled that the two key patents protecting Ofirmev were infringed by Exela’s generic version. These were 6,028,222, which expires on August 5, 2017 (or February 5, 2018, if pediatric exclusivity is granted), and U.S. 6,992,218, which expires on June 6, 2021 (or December 6, 2021, if pediatric exclusivity is granted). [Read More…]AstraZeneca Receives Mixed Decision on US Patent Litigation By Patricia Van Arnum, Posted on PharmaTech.com
AstraZeneca received a mixed decision regarding US patent litigation for its asthma drug Pulmicort Respules (budesonide). A US federal appeals court has reversed and remanded for further proceeding a trial-court decision that generic-drug company defendants involved in the litigation did not infringe a US patent (US Patent No. 7,524,834) protecting the drug. That patent covers sterile glucocorticosteroids and sterile formulations containing glucocorticosteroid and use thereof in the treatment of an allergic and/or inflammatory condition of the nose or the lungs (1). The US federal appeals court, however, upheld the trial-court’s decision that another patent (US Patent No. 6,598,603) protecting AstraZeneca’s Pulmicort Respules in the US is valid. [Read More…]IPISC announces IP insurance for the Biotechnology/Pharma Industry, Posted on PR News
LOUISVILLE, Ky., Nov. 14, 2013 /PRNewswire/ — As owners of intellectual property (IP), predominantly patents, the Biotechnology industry is particularly susceptible to others infringing their patent rights, as well others charging them with IP infringement for the products they are developing, which may have similar or even unrelated IP rights. [Read More…]Group urges anti-corruption commission to probe big pharma donations By Karen DeWitt, Posted on North Country Public Radio
Governor Cuomo’s anti-corruption commission held another hearing Monday evening focusing on reforming the state’s campaign finance system. A reform group is out with a report that they say raises questions about five million dollars spent on lobbying and donations by the pharmaceutical industry. Common Cause says the Moreland Commission should open a probe to see if there’s a link between nearly $1.3 billion spent by major pharmaceutical companies on lobbying and campaign donations to New York State politicians and the failure to pass major consumer-friendly bills regulating Big Pharma. [Read More…]What does an effective anti-bribery and corruption programme require? By Liu Xiangwen, Monique Carroll and Zhu Yuanyuan, Posted on Lexology
Much has been written on bribery and corruption in China, including the differences between criminal bribery and commercial bribery, and of course, the need for an effective compliance programme. However, foreign companies operating in certain complex or sensitive industries in China need to do more than instil an anti-corruption policy. What is needed is an in-depth understanding of the unique legal environment in their industries. This is because in some industries, particular conduct or business models permitted elsewhere, may be very sensitive and considered bribery or corruption. [Read More…]Live Industry News
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