Industry News

- Read more about Sandoz Licenses its Biosimilar Rituximab to Kyowa Hakko Kirin in Japan
Sandoz, a Novartis company and the global leader in biosimilars, announced that it has entered into an exclusive license agreement with Kyowa Hakko Kirin Co., Ltd for the distribution and promotion of its biosimilar rituximab - a monoclonal antibody, in Japan.
- Read more about Athenex receive US FDA allowance of the IND application of Oradoxel, the proprietary oral form of Docetaxel
Athenex, Inc. announced that it has received United States Food and Drug Administration (US FDA) allowance to proceed in the clinic with its proprietary oral form of Docetaxel. This allowance to proceed represents Athenex’s sixth successful oncology investigational new drug (IND) application by the US FDA (5 oral anticancer drugs, one ointment) and the third such clinical drug candidate in Athenex’s oral absorption platform. Docetaxel is an established and effective high potency anti-cancer drug.
- Read more about Nivolumab with Ipilimumab regimen receives expanded FDA approval
U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
- Read more about Shire Completes Acquisition of Dyax
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.
- Read more about XTL Biopharmaceuticals announces Encouraging Feedback from U.S. FDA on its upcoming IND filing for Lupus Drug
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.
- Read more about Biocon announces data from key studies for Insulin Tregopil - Positive Clinical data sets the stage for further development by Biocon
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.
- Read more about Agenus announces clearance of IND applications by the FDA for anti-CTLA-4 and anti-GITR Antibodies
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.
- Read more about Amgen's Repatha® (Evolocumab) approved as first PCSK9 inhibitor in Japan for the treatment of High Cholesterol
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.
- Read more about Pelvalon receives FDA clearance of Second-Generation non-Surgical Therapy for women suffering from loss of Bowel control
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.

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- Read more about Cellceutix gain FDA Orphan Drug Designation for Kevetrin
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.