Business Wire

AIDS Healthcare Foundation (AHF), the largest global AIDS organization and a vocal critic of runaway drug pricing and drug profiteering, blasted Gilead Sciences, Inc. over newly instituted price hikes of 6.9% on three key HIV/AIDS treatments despite the fact that the patent for a key component of each treatment—tenofovir—expired in mid-December.

Teva Pharmaceutical Industries Ltd announced the exclusive launch of a generic version of Reyataz®1 (atazanavir) capsules in the U.S.

AMAG Pharmaceuticals, Inc announced the issuance of U.S. Patent Number 9,844,558 entitled “Methods of Reducing Risk of Preterm Birth.” This newly issued patent is directed to subcutaneous administration and dosing of Makena® (hydroxyprogesterone caproate injection) and is expected to expire on May 2, 2036. Makena is a treatment to reduce the risk of preterm birth in women who are pregnant with one baby and who spontaneously delivered one preterm baby in the past.

F. Hoffmann-La Roche Ltd. obtained approval from the European Commission, for Alecensa® as monotherapy indicated for “the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)”. In addition, the EU marketing authorisation for Alecensa has been switched from conditional approval (given in February 2017) to a full approval for the treatment of people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib (second-line).

Vedanta Biosciences, an affiliate of PureTech Health developing a new category of therapies for immune-mediated and infectious diseases based on rationally defined consortium of human microbiome-derived bacteria, announced that the United States Patent and Trademark Office (USPTO) has issued four new patents, US 9,801,933, US 9,808,519, US 9,827,276, and US 9,833,483. The new patents broadly cover pharmaceutical compositions including Clostridium bacterial strains and methods of use for therapeutic products, including consortia of bacterial strains and spore-forming fractions based on beneficial bacteria. The newly issued patents are exclusively licensed to Vedanta under an agreement with the University of Tokyo and provide coverage through at least 2031. These issuances further strengthen Vedanta’s leading intellectual property position in the microbiome field, which includes previous issuances US 9,415,079, US 9,421,230, US 9,433,652, US 9,642,882, US 9,662,381, EP2575835, JP5592958, JP5853063, and JP6115971.

Vedanta Biosciences, an affiliate of PureTech Health developing a new category of therapies for immune and infectious diseases based on rationally designed consortia of human microbiome-derived bacteria, announced that it has exclusively sub-licensed key intellectual property from JSR Corporation to develop and commercialize microbiome-derived cancer immunotherapies based on live biotherapeutics. These live biotherapeutics have been shown to activate CD8+ T cells, a type of white blood cell that is the predominant effector in cancer immunotherapy. The sub-licensed intellectual property is based on the pioneering research of Dr. Kenya Honda, Professor, of Keio University School of Medicine and his collaborators in the University of Tokyo in Japan. An IND filing for the lead product candidate is planned in 2018.

ISR's CRO Quality Benchmarking - Phase IV Service Providers (9th Edition) report provides pharmaceutical sponsors and service providers a Consumer Reports-style analysis of CRO quality. Respondents supplied performance ratings based on their experiences with 24 Phase IV CROs, making this report the most comprehensive assessment of CRO service quality in the industry.

Takeda Pharmaceutical Company Limited announced that data from the pivotal Phase 2 ALTA (ALK in Lung Cancer Trial of AP26113) clinical trial evaluating ALUNBRIGTM (brigatinib) in patients with locally advanced or metastatic anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) who have progressed on crizotinib will be presented in an oral session at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC) on Monday, October 16, 4:30 p.m.- 4:40 p.m. JST. The presentation will share updated safety and efficacy data from the trial as of February 21, 2017, which continue to support previously reported clinical results.

AstraZeneca and its partner Chi-Med presented preliminary safety and clinical activity of savolitinib when given in combination with either Tagrisso (osimertinib) or Iressa (gefitinib) in two Phase Ib trials conducted in patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) with MET-amplification who had progressed following 1st-line treatment with an EGFR inhibitor.1,2 In both trials, the addition of savolitinib (600mg, once daily), an investigational selective inhibitor of c-MET (mesenchymal epithelial transition factor) receptor tyrosine kinase, to osimertinib (80mg, once daily) or gefitinib (250mg, once daily) demonstrated preliminary anti-tumour activity. The data were shared in two oral presentations at the International Association for the Study of Lung Cancer 18th World Conference on Lung Cancer (WCLC) in Yokohama, Japan, 15-18 October 2017.

Konica Minolta, Inc. and Boston-based Invicro LLC (“Invicro”) announced that they have concluded an agreement whereby Konica Minolta will acquire Invicro, a leading provider of imaging services and software for research and drug development.