Tufts: Biologics Manufacturers Need More Adaptable Strategies
Makers of biopharmaceuticals will need to become more modular and agile to adjust for trends in personalized medicine and oncology, according to the Tufts Center for the Study of Drug…
EMA Adopts Guideline on Treatments for Autism
The European Medicines Agency adopted a guideline for sponsors developing new products for autism spectrum disorder, providing recommendations on diagnostic criteria, target populations and clinical trial design. Source: International Pharmaceutical…
IGDRP Issues Guidance for Quality Assessment Reports
The International Generic Drug Regulators Programme released guidance for quality assessors in regulatory agencies on the preparation of quality assessment reports, and noted the guidance may be useful for anyone…
Viagra to Be Available Over-the-Counter in the UK Next Year
UK’s MHRA reclassified Pfizer’s Viagra (sildenafil), allowing it to be sold over the counter without a prescription, branded as Viagra Connect. Previous versions of the tablet will still be available…
Roche, Shire Patent Fight Escalates Over Haemophilia Drug
Roche's patent dispute with Shire over the new haemophilia drug Hemlibra has escalated, with Shire filing a new motion in a U.S. court that Roche says aims to stop some…
With a Collaboration Deal in Place with Merck, Cue Biopharma Plans $60 Million IPO
Cue BioPharma is on a roll, having recently signed a deal with Merck and is planning an IPO to raise up to $60M. Source: BioSpace
Bay Area Biotech Forges Multi-Year Research Deal with Genentech
A little less than two years after tying up a multi-billion deal with Sanofi, DiCE Molecules scored another collaborative deal. Source: BioSpace
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
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