Industry News

Following the recommendation by an independent Data Monitoring Committee (DMC), Gilead Sciences, Inc.  announced that its Phase 3 Study 115 evaluating Zydelig (idelalisib) added to standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients will be unblinded early. The DMC recommendation is based upon a predefined interim analysis indicating a statistically significant benefit in efficacy for progression-free survival (PFS) and overall survival (OS) in patients receiving Zydelig plus bendamustine and rituximab, compared to those receiving only bendamustine and rituximab. The safety profile of Zydelig was consistent with prior studies. Detailed results from this study will be presented during a late-breaking abstracts session (#LBA-5) at the Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida taking place December 5-8.

Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, announced today that its state-of-the-art recombinant biologic manufacturing facility in Singapore received U.S. Food and Drug Administration (FDA) approval to produce ADVATE [Antihemophilic Factor (Recombinant)] bulk drug substance (BDS). The site received regulatory approval from the European Medicines Agency in January 2014 for the production of ADVATE.

NeuroSigma, Inc. (NeuroSigma), a California-based life sciences company, announced that it has received CE Mark approval for its Monarch eTNS System as treatment for attention-deficit/hyperactivity disorder (ADHD) in adults and children age 7 and older. This CE Mark approval is the first for any non-drug treatment of ADHD in the European Union (EU).

Gilead Sciences, Inc. announced it will present 32 scientific presentations related to its approved medicines and investigational therapies for the treatment of chronic hepatitis C virus (HCV) infection at The Liver Meeting 2015 in San Francisco.

U.S. Food and Drug Administration granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments. Darzalex is the first monoclonal antibody approved for treating multiple myeloma. Darzalex is marketed by Janssen Biotech of Horsham, Pennsylvania.

Coherus BioSciences and Baxalta has recently announced that CHS-0214, a proposed biosimilar of Enbrel (etanercept), met its primary endpoints in a confirmatory, double-blind, randomized, controlled, two-part phase 3 study. This on-going 52-week study is evaluating the efficacy and safety of CHS-0214 compared to Enbrel in patients with moderate-to-severe chronic plaque psoriasis. Coherus and Baxalta initiated a collaboration to develop and commercialise CHS-0214 in September of 2013.

Tata Consultancy Services, a leading IT services, consulting and business solutions firm, today announced the go-live of a comprehensive IT and business transformation program for Australian Pharmaceutical Industries (API), a leading Australian health and beauty company.

[adsense:336x280:8701650588]

AstraZeneca announced that the US Food and Drug Administration (FDA) has approved TAGRISSO (AZD9291) 80mg once-daily tablets for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

Merck Animal Health (known as MSD Animal Health outside the United States and Canada) and Harrisvaccines, Inc., announced the companies have entered into an agreement under which Merck Animal Health will acquire Harrisvaccines, a privately-held company that develops, manufactures and sells vaccines for food production and companion animals.

The U.S. Food and Drug Administration approved Baxalta US Inc, Adynovate, Antihemophilic Factor (Recombinant), PEGylated for use in adults and adolescents, aged 12 years and older, who have Hemophilia A. Adynovate is modified to last longer in the blood and potentially require less frequent injections than unmodified Antihemophilic Factor when used to reduce the frequency of bleeding.