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An interim report by French government inspectors has identified three "major failings" in the conduct of the Phase I trial run by the CRO Biotrial that led to ...
With key clinical data readouts expected at the end of 2016 and the start of 2017, Corbus Pharmaceuticals Holdings Inc.'s CEO Dr. Yuval Cohen expects the next ...
As understanding increases about the complex reasons for brain injury in new-borns, the paucity of the drug R&D pipeline is thrown into fresh ...
The House Oversight and Government Reform Committee hearing on drug prices was the hottest spot in a very damp and cold Washington on Feb. 4 and former Turing ...
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), told lawmakers on Feb. 4 she was concerned the agency's biosimilars ...
 
Torrent Pharmaceuticals reported a strong set of numbers for the third quarter ended December 2015, despite turbulence in markets like Brazil, where it has done some sharp "belt tightening", and ...
A regular roundup of commercial stories appearing in Scrip's sister publication PharmAsia News, whose multilingual team of regional experts provides authoritative business intelligence focused on the ...
Gilead Sciences has moved court to block an alleged copy of its blockbuster hepatitis C treatment, Harvoni (sofosbuvir/ledipasvir), in India which it believes not only wrongly rides on the brand name ...
UK technology commercialization and investment group, Imperial Innovations, is raising £100m via a placement of new shares to invest in novel and existing portfolio businesses. Imperial Innovations, ...
 
Results from Amgen 's Phase III GAUSS-3 trial evaluating Repatha (evolocumab) in patients with high cholesterol have added to the growing evidence that the novel drug has the ability to reduce LDL ...
The Phase III TOWER study of Amgen 's bispecific CD19-directed CD3 T cell engager (BiTE) Blincyto (blinatumomab) has been halted early after a pre-specified analysis showed that it has already met ...
The hopes of patients with Duchenne muscular dystrophy hit another roadblock this week as the patient group received news that Eli Lily & Co.'s tadalafil was not effective in treating the devastating ...
India's Bharat Biotech International Ltd. has announced what it called two "promising" potential vaccine candidates to protect against the mosquito-borne Zika virus which has been declared an ...
 
After coming under fire for failing to do enough to address the explosion in misuse, abuse and addiction to prescription opioids in the US, the FDA on Feb. 4 said it was overhauling its policies with ...
Companies are welcoming pan-European health technology assessment initiatives, including those aimed at promoting parallel advice and early multi-HTA dialogues, according to a new report from ...
Eli Lilly & Co . appears to be on course to bringing its anticancer, Cyramza (ramucirumab), to India, after a key local expert panel recommended the product for marketing in two indications. A ...
Mylan's generic versions of zonisamide capsules, amlodipine-valsartan tablets and rasagiline tablets received positive opinions from the EU's top scientific advisory panel on Jan. 28, but the US ...
 
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07 February 2016






Regulatory, Legislative, Legal and Political Biopharma News

Also covered:

• Efforts 'Moving Rapidly' On Two Zika Vaccine Candidates
• Fauci: Considerable Pharma Interest In Zika Vaccine
• Will Liability, Advertising Lawsuits Plague Biosimilars Market?
• Generics 'Express Lane' Urged To Rival High-Priced Drugs
• Plus other Washington news


Read more...

 

Outlook of Big Pharma - Part 1 17 July 2015

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Scrip 100
16 December 2015

EVENTS
04 April 2016
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06 April 2016
Hamburg, Germany
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