Article Listing - US FDA Deputy Commissioner named; Rx-OTC switch proponent out of running
American Diabetes Association calls for independent review of incretin-based therapy
12 June 2013
The American Diabetes Association is asking all pharmaceutical companies involved in the development or marketing of incretin-based medications, used to lower blood glucose levels, to make patient-level data on their products available for an independent review that could help settle the question of whether such therapies contribute to the development of pancreatitis or pancreatic cancer.
Amgen and Cytokinetics expand omecamtiv mecarbil accord
12 June 2013
USA-based Amgen (Nasdaq: AMGN), the world's largest independent biotech company, has expanded its strategic collaboration with Cytokinetics (Nasdaq: CYTK) to include Japan. In 2006, Cytokinetics and Amgen entered into a collaboration to discover, develop and commercialize novel small-molecule therapeutics that activate cardiac muscle contractility for potential applications in the treatment of heart failure.
Therapeutic effects of Eisai's lenvatinib in melanoma confirmed
12 June 2013
Japanese drug major Eisai (TYO: 4523) says that the therapeutic effects of lenvatinib, a VEGF receptor tyrosine kinase inhibitor and multi-kinase inhibitor discovered in-house, on melanoma have been confirmed in one of a series of joint development programs being conducted as part of the company's strategic collaboration with Quintiles (NYSE: Q). The finding has provided the basis for the first proof of concept (POC) to be achieved under the partnership.
Bristol-Myers Orencia equals Humira in head-to-head AMPLE RA study
12 June 2013
US drug major Bristol-Myers Squibb (NYSE: BMY) has announced the results of year two data from AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naive rheumatoid arthritis (RA) Subjects With Background Methotrexate), a first-of-its-kind trial of 646 patients comparing the subcutaneous (SC) formulation of Orencia (abatacept) versus AbbVie's (NYSE: ABBV) blockbuster drug Humira (adalimumab), each on a background of MTX, in biologic naive patients with moderate to severe RA. The AMPLE year two data are being presented this week at the European League Against Rheumatism (EULAR) annual congress and highlighted during a congress press conference.
NeuroVive signs deal with Isomerase Therapeutics; receives the first milestone from Sihuan
12 June 2013
Swedish mitochondrial medicine firm NeuroVive Pharmaceutical has signed a collaboration agreement with the UK's Isomerase Therapeutics to develop the molecules that were recently acquired by the British company from Biotica. In addition, the company's Asian subsidiary has received the first milestone payment from Sihuan Pharmaceutical (HKEx: 0460), the company's collaboration partner in China, under a deal signed last year (The Pharma Letter November 21, 2012).
Abcam in deal with Pfizer to supply compounds to researchers
12 June 2013
UK-based Abcam (AIM: ABC), a producer and distributor of protein research tools, has entered into a license agreement with global pharma behemoth Pfizer (NYSE: PFE). Under the terms of the agreement, Abcam's Biochemicals division will supply a range of authentic Pfizer compounds for use as preclinical research tools by researchers worldwide, alongside the Abcam Biochemicals range of over 2000 bioactive small molecules.
WTO TRIPS resolution excludes pharma from IP extension exemption for least-developed countries
12 June 2013
The Council for TRIPS (Trade-Related Aspects of Intellectual Property Rights) yesterday (June 11) adopted a resolution at the World Trade Organization (WTO) that allows least-developed countries (LDC) an eight year extension on an exemption in implementing intellectual property (IP) rules under the TRIPS Agreement, according to medical humanitarian organization Medecins Sans Frontieres (MSF).
UK's NICE gives thumbs up for GSK's Revolade as NHS blood disorder treatment
12 June 2013
UK drugs watch dog the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending pharma major GlaxoSmithKline's (LSE: GSK) Revolade (eltrombopag) as an option for treating some adults with the bleeding disorder, chronic immune (idiopathic) thrombocytopenic purpura.
ThromboGenics' Jetrea gets initial NICE recommendation for VMT
12 June 2013
Belgium-based biopharma company ThromboGenics (Euronext Brussels: THR) said this morning (June 12) that the UK's drugs watch dog the National Institute for Health and Care Excellence (NICE) has provisionally recommended its ophthalmic agent Jetrea (ocriplasmin) for reimbursement within the National Health Service (NHS).
US FDA considering making "masked" trial data available to outside experts
12 June 2013
According to a Federal Register posting, the US Food and Drug Administration is seeking public comments from interested persons on the proposed availability of "deidentified" and "masked" data derived from medical product applications.
- FDA probes two deaths possibly linked to Lilly's antipsychotic Zyprexa Relprevv
- Negative US patent ruling for Novo Nordisk on Prandin
- Aspen Pharma offers to buy GlaxoSmithKline's thrombosis brands and manufacturing site
- US Supreme Court says patent settlement can "sometimes" be illegal
- Daiichi Sankyo files for Japanese approval of Prasugrel
