The U.S. Food and Drug Administration today approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. read more
Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication – Risk of Serious Liver Injury
FDA is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, FDA is requiring the manufacturer to include information about serious liver injury adverse events to the Contraindications, Warnings and Precautions, Postmarketing Experience, and Hepatic Impairment sections of the Viekira Pak and Technivie drug labels. read more
Spectrum Pharmaceuticals Receives Complete Response Letter (CRL) from U.S. Food and Drug Administration (FDA) for EVOMELA™ (melphalan) for Injection
HENDERSON, Nev.–(EON: Enhanced Online News)–Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA). A Complete Response Letter is a communication from the FDA that informs companies that an application cannot be approved in its present form. In the letter, the FDA did not identify any clinical deficiency in Spectrum’s NDA package. read more
Nihon Kohden to Unveil BSM-1700 Transport Monitor at ANESTHESIA 2015
IRVINE, Calif.–(BUSINESS WIRE)–Nihon Kohden, a U.S.-market leader in medical instrumentation solutions, will showcase its novel BSM-1700 transport monitor at the Anesthesia Society of America’s ANESTHESIA 2015 meeting, held Oct. 24-28 in San Diego, Calif. Developed to address the heightened safety challenges of transporting at-risk patients between points of care in the hospital setting, the lightweight monitor is the only one of its kind to capture the most comprehensive set of physiologic parameters needed during transit in a standard configuration, making it uniquely capable of safeguarding patients at one of the most critical points in the care continuum. read more
Research and Markets: European Epilepsy Drugs Market Analysis 2015-2019 With Eisai, GlaxoSmithKline, Pfizer & UCB Dominating
The report forecasts the epilepsy drugs market in Europe to grow at a CAGR of 3.22% over the period 2014-2019.
The report, Epilepsy Drugs Market in Europe 2015-2019, has been prepared based on an in-depth market analysis with inputs from industry experts. It covers the market size and forecast as well as market segmentation and pipeline landscape. The report includes a discussion of the key vendors operating in this market.
Amgen Receives CHMP Positive Opinion For IMLYGIC™ (Talimogene Laherparepvec)
THOUSAND OAKS, Calif., Oct. 23, 2015 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending that IMLYGIC™ (talimogene laherparepvec) be granted approval for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease. If approved by the European Commission, IMLYGIC would be the first in a class of novel agents known as oncolytic immunotherapies. read more
Novartis receives positive CHMP opinion for the first IL-17A inhibitor Cosentyx(TM) to treat ankylosing spondylitis and psoriatic arthritis
Basel, October 23, 2015 – Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Cosentyx™ (secukinumab) in Europe to treat ankylosing spondylitis (AS) and psoriatic arthritis (PsA) patients. Following two separate regulatory submissions, Cosentyx is now recommended for the treatment of active AS in adults who have responded inadequately to conventional therapy, such as non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of active PsA in adult patients alone or in combination with methotrexate (MTX) when the response to previous disease modifying anti-rheumatic drug (DMARD) therapy has been inadequate. read more
Proof-of-concept Study of Fruquintinib in Non-small Cell Lung Cancer Triggers Milestone Payment
Hutchison China MediTech Limited (“Chi-Med”) (AIM: HCM) today announces that Hutchison MediPharma Limited (“HMP”), its drug R&D subsidiary, is set to receive a US$10 million milestone payment, in the fourth quarter of 2015, from its partner Eli Lilly and Company (“Lilly”).