Industry News

Shire plc announced that it has completed its acquisition of Dyax Corp. in an all-cash transaction valued at approximately $5.9 billion, comprised of $37.30 in cash per Dyax share.

XTL Biopharmaceuticals, a clinical-stage biopharmaceutical company developing its lead product for the treatment of lupus, announced the Company has received written guidance from the U.S. Food and Drug Administration (FDA) in response to a pre-investigational new drug (IND) meeting package regarding its upcoming IND filing for its drug candidate, hCDR1. Based on the FDA's response, XTL plans to file its IND, and in the coming quarters initiate a global clinical trial for hCDR1 in the treatment of systemic lupus erythematosus (SLE) in the U.S., Europe and Israel.

Biocon Ltd, Asia's premier biotechnology company, today announced key data on Insulin Tregopil (formerly referred to as IN-105) following Phase 1 studies that validate and provide the basis for the next phase of clinical development of this important molecule. The clinical studies on Insulin Tregopil, which were conducted in the US under a US IND, were initiated in partnership with Bristol-Myers Squibb (BMS) prior to their divestment of the diabetes franchise to AstraZeneca.

Agenus Inc., an immuno-oncology company developing checkpoint modulator antibodies and cancer vaccines, announced  that the U.S. Food and Drug Administration (FDA) cleared the company's investigational new drug (IND) application for AGEN1884, an immune checkpoint modulator (CPM) antibody that binds to cytotoxic T-lymphocyte antigen-4 (CTLA-4). Clearance was also received for a second CPM antibody partnered with Incyte (NASDAQ: INCY) for INCAGN1876, which targets glucocorticoid-induced TNFR-related protein (GITR). Clinical trials for both candidates are expected to begin in the first half of 2016.

Amgen announced that the Japanese Ministry of Health, Labour and Welfare has approved the cholesterol-lowering medication Repatha® (evolocumab) Injection, the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in Japan. Repatha is a human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood. Repatha was developed in Japan by Amgen Astellas BioPharma K.K. (AABP), a joint venture between Amgen and Astellas Pharma Inc., a pharmaceutical company headquartered in Tokyo.

Pelvalon, a medical device company dedicated to developing innovative solutions for women suffering from loss of bowel control, today announced limited U.S. commercial availability of its Eclipse™ System, following U.S. Food and Drug Administration (FDA) 510(k) clearance for the company’s next-generation device.

Cellceutix Corporation, a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that  we received the letter from the U.S. Food and Drug Administration (FDA) granting Orphan Drug Designation to Kevetrin for the treatment of pancreatic cancer. The work underscoring the new designation was conducted by Cellceutix scientists in collaboration with pancreatic cancer specialists at a world filed grant application.

Collegium Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s investigational new drug (IND) application to begin a clinical trial of Hydrocodone DETERx®, an abuse-deterrent, extended-release analgesic for the treatment of chronic pain. This proof of concept clinical trial is intended to evaluate the safety, bioavailability, and abuse deterrence properties of Hydrocodone DETERx.

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of Kyprolis® (carfilzomib) for Injection in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. The FDA also approved Kyprolis as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. This FDA decision converts to full approval the initial accelerated approval Kyprolis received in July 2012 as a single agent.

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's Humulin® R U-500 KwikPen®(insulin human injection) 500 units/mL, a pre-filled device containing Humulin R U-500, a highly concentrated formulation of insulin. Humulin R U-500 is the only FDA-approved insulin that is five-times more concentrated than standard U-100 insulin. This insulin is used to treat high blood sugar in people with type 1 and type 2 diabetes who need more than 200 units of insulin per day. The safety and efficacy of Humulin R U-500 used in combination with other insulins or delivered by an insulin infusion pump has not been determined.