Billionaire George Soros Bets Big Against 2 Struggling Drugmakers , But One Could Make a Big Come…
Should you invest the way billionaire investors do? Source: BioSpace
Roche Boss Claims pRED Division Soon to Emerge from Genentech's Shadow
The fact that Roche has separate R&D units has been the topic of second-guessing on the part of observers and analysts. Source: BioSpace
Pfizer Strikes Deal With Array BioPharma on Anti-Cancer Development
Array BioPharma announced today that it has entered into a clinical trial collaboration agreement with Pfizer to investigate the safety and efficacy of several novel anti-cancer combinations. Source: BioSpace
Bay Area Bigfoot Biomedical Bags $37M Series B Financing
The round was co-led by funds managed by new investor Janus Henderson Investors. Source: BioSpace
Apotex Facility in India Flagged for GMP Non-Compliance
An Apotex Research facility in Bangalore, India was cited for non-compliance with GMP requirements after an inspection in November by the UK’s Medicines and Healthcare products Regulatory Agency revealed non-sterile…
Experts Weigh in at FDA Meeting on Patient-Centric Drug Development
The FDA received a wide range of comments and questions Monday at a public meeting to receive comments on a discussion document on patient-focused drug development — an early draft…
EMA Adopts ICH Guideline on Multi-Region Clinical Trials
The European Medicines Agency adopted the International Council for Harmonisation’s E17 guideline on multi-region clinical trials, which can support simultaneous product submissions in different parts of the world and more…
CBER Urges Sponsors to Adopt International Standards
CBER said it will prefer using internationally harmonized standards developed by third-party organizations — as opposed to maintaining its own — and it is urging sponsors of biologics to do…
FTC: Number of Pay-for Delay Settlements Continues to Drop
The number of “pay-for-delay” patent settlements agreed to by pharmaceutical companies in fiscal 2015 declined from the year before, according to a report from the Federal Trade Commission. Source: Generic…
FDA Takes Aim at Delaying Tactics for Shared REMS
The FDA is working to prevent manufacturers of branded high-risk drugs from stalling an application for approval of a generic competitor via manipulation of a requirement to share safety programs,…
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