Astellas submits new prostate cancer drug to EMA
June 28, 2012Research and Development, Sales and Marketing Astellas, EMA, Medivation, NICE, Zytiga, enzalutamide
Astellas has submitted its investigational prostate cancer drug enzalutamide to the European Medicines Agency. Enzalutamide is a once-daily pill that works …
Witty warns EU leaders over pricing
June 27, 2012Sales and Marketing EFPIA, EU, GSK, Greece, R&D, Witty, pricing
Sir Andrew Witty has waded into the debate over Europe’s economic future with a plea for pharma innovation to be …
ABPI to no longer ‘shy away’ from big issues
June 27, 2012Medical Communications, Sales and Marketing ABPI, Callaghan, NHS, VBP, Whitehead
The ABPI will actively seek to tackle tough issues like animal testing and clinical trial problems, as it looks to …
NICE final yes for Zytiga and Tarceva
June 27, 2012Sales and Marketing Janssen, NHS, NICE, NSCLC, Roche, Tarceva, Zytiga
In final guidance published today, NICE is recommending two new drugs for patients with prostate and lung cancer. Janssen’s Zytiga …
Amylin withheld safety data, says FDA
June 27, 2012Research and Development, Sales and Marketing Amylin, Bydureon, Byetta, FDA, lilly
The US medicines regulator says Amylin held back data relating to the safety of its diabetes drug Bydureon. The allegation …
CSL Behring launches new dosing app
June 27, 2012Medical Communications Beriplex P/N, CSL Behring, app, digital
Biotherapy firm CSL Behring UK has launched an app for doctors to aid the management of its anaesthetic treatment Beriplex …
Eisai to enter Russia with epilepsy launch
June 27, 2012Sales and Marketing Eisai, Russia, Zonegran, emerging markets, epilepsy
Eisai is to enter the Russian market for the first time with the launch of epilepsy drug Zonegran. Entry into the …
Roche cuts 1,000 R&D jobs
June 27, 2012Research and Development, Sales and Marketing AZ, Genentech, Novartis, R&D, Roche, cuts
Roche will make major cuts to its research operations in the US and revamp operations in Europe. Roche will close …
Roche’s Perjeta increases survival
June 27, 2012Research and Development, Sales and Marketing EMA, FDA, Herceptin, Perjeta, Roche, breast cancer
Roche’s new drug Perjeta has scored another trial success by increasing overall survival in certain breast cancer patients. The new …
London Trust on the brink of going bust
June 26, 2012Sales and Marketing Lansley, NHS, South London Healthcare, reforms
For the first time in its history an NHS Trust is facing bankruptcy and could be dissolved by the government. …
Generic approval for Shire’s hyperactivity drug
June 26, 2012Sales and Marketing ADHD, Adderall XR, FDA, IMS Health, Impax, Shire, Teva
US regulators have delivered a blow to Shire by allowing Actavis Group to produce a generic version of its hyperactivity …
Roche earmarks $300m for diagnostics HQ
June 26, 2012Manufacturing and Production Diagnostics, Illumina, Roche, US, manufacturing
Roche has said it intends to invest $300 million over the next 10 years at its diagnostics headquarters in Indianapolis, …
Pharma manufacturing news in brief
June 26, 2012Manufacturing and Production Cook Pharmica, Ubichem Fine Chemicals, Unilife Corp, West Pharmaceutical Services
Unilfe wins a new syringe contract, West Pharma signs a deal with Amgen, plus facility updates from Cook Pharmica and …
FDA looks to start supply chain security programme
June 26, 2012Manufacturing and Production CDER, FDA, OMB, ORA, manufacturing
The FDA has submitted a formal application to start a supply chain security pilot programme for overseas manufacturers of finished …
FDA delays Eliquis approval
June 26, 2012Sales and Marketing BMS, Eliquis, FDA, Pfizer, Xarelto
The FDA has asked Pfizer and Bristol-Myers Squibb for more information about its key blood thinner Eliquis. The US regulator …
Pharma companies share $400m US biosecurity contract
June 26, 2012Manufacturing and Production Emergent BioSolutions, GSK, Novartis, manufacturing
GlaxoSmithKline, Novartis and Emergent BioSolutions will share a $400 million contract from the US government to provide vaccine manufacturing capacity …
FDA rejects licence extension for Xarelto
June 26, 2012Sales and Marketing ACS, Bayer, FDA, J&J, JJ, Pradaxa, Xarelto
The FDA has set a Complete Response Letter to Bayer and J&J over its blood thinner Xarelto. The firms, which …
MPs find NHS bodies still blocking treatments
June 25, 2012Sales and Marketing CCGs, MPs, NHS, NICE, PCTs, Pfizer, viagra
The Labour party has uncovered new restrictions to treatments and drugs in the NHS, which it says is hurting patients …
Steve Bates appointed chief executive of the BioIndustry Association
June 25, 2012Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing BIA, Genzyme, Steve Bates
The BioIndustry Association (BIA) has appointed Steve Bates as its chief executive. Bates has worked both in biotech and the …
Roche failed to investigate 80,000 safety incidents
June 25, 2012Manufacturing and Production, Sales and Marketing EMA, MHRA, Roche, pharmacovigilance
The European Medicines Agency is investigating Roche after ‘deficiencies’ in the manufacturer’s pharmacovigilance processes came to light. It has emerged …
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