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FDA clears Arena and Eisai’s obesity drug

June 28, 2012
Sales and Marketing Arena, Belviq, Eisai, FDA, Qnexa, Roche, obesity

Eisai and Arena’s Belviq has gained FDA approval, making it the first obesity drug to be approved in over ten …

News

Astellas submits new prostate cancer drug to EMA

June 28, 2012
Research 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 …

News
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Witty warns EU leaders over pricing

June 27, 2012
Sales 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 …

News
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ABPI to no longer ‘shy away’ from big issues

June 27, 2012
Medical 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 …

News
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NICE final yes for Zytiga and Tarceva

June 27, 2012
Sales 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 …

News

Amylin withheld safety data, says FDA

June 27, 2012
Research 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 …

News
CSL Behring

CSL Behring launches new dosing app

June 27, 2012
Medical 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 …

News

Eisai to enter Russia with epilepsy launch

June 27, 2012
Sales 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 …

News

Roche cuts 1,000 R&D jobs

June 27, 2012
Research 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 …

News
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Roche’s Perjeta increases survival

June 27, 2012
Research 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 …

News

London Trust on the brink of going bust

June 26, 2012
Sales 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. …

News
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Generic approval for Shire’s hyperactivity drug

June 26, 2012
Sales 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 …

News
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Roche earmarks $300m for diagnostics HQ

June 26, 2012
Manufacturing 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, …

News

Pharma manufacturing news in brief

June 26, 2012
Manufacturing 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 …

News
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FDA looks to start supply chain security programme

June 26, 2012
Manufacturing 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 …

News
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FDA delays Eliquis approval

June 26, 2012
Sales 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 …

News
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Pharma companies share $400m US biosecurity contract

June 26, 2012
Manufacturing 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 …

News
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FDA rejects licence extension for Xarelto

June 26, 2012
Sales 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 …

News

MPs find NHS bodies still blocking treatments

June 25, 2012
Sales 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 …

News

Steve Bates appointed chief executive of the BioIndustry Association

June 25, 2012
Business 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 …

Appointment
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