November 2015

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.

Dr. Reddy’s Laboratories in a statement issued said that it has been made aware of an order passed by the District Court of Delaware, USA, granting a Temporary Restraining Order (TRO) with immediate effect on sales, delivery, transfer, or other disposition of its generic esomeprazole product in the US market.

Immune Pharmaceuticals Inc. announced that the US Food and Drug Administration (FDA) accepted the company's Investigational New Drug (IND) application for its first in class, lead product candidate, Bertilimumab, for the treatment of Bullous Pemphigoid (BP). This FDA acceptance enables the company to expand recruitment for its clinical trials.

Drugmaker Gilead Sciences Inc said U.S. Food and Drug Administration had approved the expanded use of its blockbuster hepatitis C drug, Harvoni. The drug can now be used to treat patients with subtypes of chronic hepatitis C virus (HCV) and patients who are co-infected with Human Immunodeficiency Virus (HIV), Gilead said in a statement. Gilead's Harvoni was first approved by the FDA in October 2014.

Boehringer Ingelheim today announced it has completed enrollment for the pivotal Phase III trial of BI695501, a biosimilar candidate to adalimumab (AbbVie’s Humira®). This announcement was made following recent results from a Phase I trial that demonstrated pharmacokinetic bioequivalence with both the U.S.-licensed and EU-approved reference products.These Phase I data for BI695501 were discussed at the American College of Rheumatology / Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in San Francisco.