Pharma News

Get the latest news from world and India’s leading pharmaceutical companies Pharma Industry, pharmaceutical marketing, generic drugs, and Complete news for Pharmacy and Life Sciences professionals.

- 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.

[adsense:336x280:8701650588]
- Read more about Vitamin B12 levels drop among the elderly, autistic people
Vitamin B12 levels in the brain are significantly decreased in the elderly and are much lower in individuals with autism or schizophrenia as compared to their peers at similar ages, a new study has found.
- Read more about Gut neurons help our immune system control inflammation
Neurons present in our gut play a key role in protecting intestinal tissue from over-inflammation, says a new research from the Rockefeller University.
- Read more about How 'Black Death' pathogens survived in Europe
German Scientists have taken an important step forward in understanding "Black Death" that wrecked havoc in Europe hundreds of years ago.
- 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.
- Read more about Collegium Announces FDA acceptance of IND application for Abuse-Deterrent, Hydrocodone DETERx®
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.
- Read more about FDA Approves NEW Kyprolis® (Carfilzomib) COMBINATION THERAPY for the treatment of patients with Relapsed Or Refractory multiple myeloma
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.
- Read more about U.S. Food and Drug Administration Approves Humulin® R U-500 KwikPen®
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.