EU patent office denies Alexion two Soliris patents
Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) disclosed in a Sept. 5 SEC filing that the European Patent office declined to grant two Soliris eculizumab patents: one covering pharmaceutical compositions and the other covering composition of matter. The company, which took a hit Aug. 30 when the U.S. Patent and Trademark Office said it will review the validity of three Soliris patents based on an inter partes review challenge from Amgen Inc. (NASDAQ:AMGN), is considering appealing the EU decision (see "Alexion Sinks as PTAB Institutes Review").
Breakthrough for Novartis' NSCLC candidate
Ahead of an expected NDA submission next quarter, FDA granted breakthrough therapy designation to capmatinib from Novartis AG (NYSE:NVS; SIX:NOVN) for first-line treatment of metastatic non-small cell lung cancer harboring c-MET (c-Met receptor tyrosine kinase; MET; HGFR) exon 14 skipping mutations.
Tecentriq gets EC approval in 1L NSCLC
The European Commission extended the label of Tecentriq atezolizumab from Roche (SIX:ROG; OTCQX:RHHBY) to include first-line treatment in combination with chemotherapy for non-squamous NSCLC.
Lilly's pain trial proposal selected for FDA trial program
Eli Lilly and Co. (NYSE:LLY) announced that its chronic pain clinical trial protocol will be included in FDA's Complex Innovative Trial Designs (CID) Pilot Meeting Program. The pharma's proposal includes a master protocol for multiple chronic pain indications, and a Lilly spokesperson told BioCentury "we are moving forward with implementing the protocol" (see "FDA Pilot to Promote Clinical Trial Innovation").
Boehringer's Ofev approved for rare lung condition
FDA approved Ofev nintedanib from Boehringer Ingelheim GmbH (Ingelheim, Germany) to treat systemic sclerosis interstitial lung disease, the first therapy approved for the rare lung condition. Ofev is already approved for idiopathic pulmonary fibrosis.