FDA clarifies import rules for ‘pre-launch’ medicines
July 29, 2013Manufacturing and Production Draft Guidance, FDA, pre launch, pre-launch
New draft guidance on the import of unapproved medicines in anticipation of approval in the US has been published by …
Patients and profits – time for new priorities
July 29, 2013Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing China, McConaghie, andrew, pharma, profits
Pharmaceutical journalists don’t retire, they just go off patent. Well, I’m not retiring as such, but after ten years as …
EMA: no cancer risk from GLP-1s
July 29, 2013Research and Development, Sales and Marketing Cancer, EMA, GLP-1s
One of the European Medicines Agency’s key advisory groups has decided that concerns over an increased cancer risk with some …
AZ and BMS go for second Forxiga submission
July 29, 2013Sales and Marketing AZ, BMS, FDA, Forxiga
AstraZeneca and partner Bristol-Myers Squibb have resubmitted their diabetes drug Forxiga to the FDA 18 months after it was rejected …
Boehringer nears European approval for first cancer drug
July 29, 2013Sales and Marketing Boehringer, Cancer, FDA, afatinib
Boehringer’s first cancer drug is just months away from being approved in Europe after a committee for the EMA gave …
PCI hires associate director of Clinical Trials
July 29, 2013Manufacturing and Production, Research and Development, Sales and Marketing
Pharma packaging and clinical trials services firm PCI has appointed Tim Roberts as an associate director of Clinical Trials.The changes …
Contract research news in brief
July 26, 2013Research and Development Ascendancy Healthcare, CRO Solutions, Clinical Research Advantage, ResearchDx, SPS Pharma Services, VxP Pharma
Quintiles wins multi-year contract in China, CRO Solutions sets up niche subsidiary and CRA buys CNS unit, plus relocations for …
Dementia project pays out £50 million
July 26, 2013Medical Communications, Sales and Marketing Jeremy Hunt, dementia
Over a hundred hospitals and care homes across England have been awarded a share of a £50million fund to help …
Sharp fall in sales for Bristol-Myers Squibb
July 26, 2013Sales and Marketing Avapro, BMS, Plavix, Q2
Bristol-Myers Squibb has seen a fall in sales over the past three months as it struggles with major patent losses. …
Lilly beats estimates with solid Q2 performance
July 26, 2013Sales and Marketing Q2, cymbalta, lilly, zyprexa
Lilly posted a healthy set of financials at the end of July as the company looks to keep its growth …
Teva and Lonza abandon biosimilars joint venture
July 26, 2013Manufacturing and Production, Research and Development CMO, Levin, Lonza, Teva, biosimilars
Escalating costs have led Teva and contract manufacturing organisation (CMO) Lonza to abandon a joint venture set up in 2009 …
Two non-executive directors join NICE Board
July 26, 2013Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing DoH, NICE, finbarr martin, mumford
The Department of Health has announced that two new non-executive directors will join the National Institute for Health and Care …
Strong growth for Roche in latest results
July 25, 2013Sales and Marketing Alexion, Q2, Rituxan, Roche
Roche has seen strong sales growth in the past six months as it lines up new products to replace its …
UK rejects meningitis B vaccine Bexsero
July 25, 2013Sales and Marketing Bexsero, Novartis, Vaccine, meningitis b
The UK government’s department for vaccinations has stunned observers by failing to back the world’s only vaccine for meningitis B. …
Actions in China ‘shameful’ says GSK boss
July 25, 2013Medical Communications, Sales and Marketing China, GSK, Witty, bribery
GlaxoSmithKline has admitted that allegations of corruption at its China business are ‘shameful’ and will seek out its cause. Speaking …
Chiltern hires Andrew Monaghan as director
July 25, 2013Manufacturing and Production, Research and Development, Sales and Marketing CRO, chiltern, monaghan
Contract research organisation Chiltern has appointed Andrew Monaghan as its director of Global Pharmacovigilance. Monaghan has more than 30 years’ …
Benlysta once again rejected by NICE
July 25, 2013Sales and Marketing Benlysta, GSK, NHS, NICE
NICE has opened a second public consultation for GSK’s lupus drug Benlysta after the Institute has again rejected the medicine …
AMRI says troubled Burlington plant back on track
July 24, 2013Manufacturing and Production AMRI, FDA, GMP
It looks like contract research and manufacturing organisation AMRI can put the quality problems at its facility in Burlington behind …
GSK sales up – impact of China allegations to follow
July 24, 2013Sales and Marketing GSK, Q2, Seretide, Seroxat, Witty, bribery, transparency
GlaxoSmithKline has reported a modest rise in sales but the fallout from China’s bribery probe dominates the firm’s release of …
Transition Therapeutics buys into Lilly bone drug
July 24, 2013Research and Development, Sales and Marketing Transition, bone, lilly
Transition Therapeutics has bought Lilly’s early-stage osteoarthritis drug TT-601 that is designed to help patients with chronic bone pain. Transition …
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