Roche, Meiji & Fedora next in line to combat superbugs with antibiotics booster

Roche makes its next move in antibiotic research with its licensing deal with Meiji Seika Pharma and Canada’s Fedora. The deal, worth up to $750 million, allows Roche the right to develop and commercialize beta-lactamase inhibitor OP0595 internationally, with exception to Japan. Meiji gets to keep its sole rights. Beta-lactamase inhibitors restore or potentiate the activity of beta-lactam antibiotics. The …

Top 50 Pharmaceutical Companies 2014

Who are the top pharmaceutical companies in the world and what are they worth in 2014? The Pharmaceutical and Biotechnology continue to dominate the world’s R&D expenditure, with more companies in the top 10 than any other sector. This year, whilst Novartis has knocked Roche from their top spot, individual R&D spends by pharma and biotechs fail to compete with …

Video: Biomarkers in Drug Discovery

Did you know that one of the earliest uses of biomarkers to gauge the failure of a biological processes in the body was 2500 years ago by Hindu doctors? The physicians would test the sugar levels of patient’s urine by seeing whether or not ants were attracted to it. If ants were attracted by the presence of sugars, the conclusion …

Indian Pharma: Biocon’s Herceptin biosimilar & the uncertain future

Mylan-Biocon: trastuzumab biosimilar On Monday it was announced that Biocon had received approval from the Drug Controller of India for the first biosimilar to Roche’s widely used HER2 breast cancer drug, Herceptin. Biocon and partner Mylan’s trastuzumab product, one of five biologics in development between the Indian company and the American giant, will be sold under the name of Hetraz. …

Roche drops Herceptin patent in India, opens door to biosimilars

Roche has decided not to pursue a patent for Herceptin (trastuzumab) in India, following the dismissal of certain patent applications made by Roche to the Indian patent office last month.  “Roche has come to the conclusion not to pursue Indian Patent No. 205534 (the secondary patent) and the related divisional applications,” said a Roche spokesperson, according to Bloomberg. “This decision …

How to overcome global clinical data management challenges

This presentation was delivered by Andrew Taylor, Head of Asia-Pacific Clinical Data Management, Roche at BioPharma Asia 2013. Click here to download the presentation. The presentation focuses on: •Technical Guidelines for Data Management in Clinical Trials (SFDA, CDE)•The development of a China office as part of a global Pharma data management function•Leveraging global resources, systems & processes to accelerate the …

Safety concerns put an end to Roche’s late-stage diabetes trial

Roche's phase III trial for diabetes candidate aleglitazar has been dogged by safety concerns, prompting the Swiss biotech to discontinue investigation of the drug. The AleCardio trial was evaluating the efficacy and safety of aleglitazar in patients with a recent acute coronary syndrome event and type 2 diabetes mellitus, but a review by the Data and Safety Monitoring Board (DSMB) …