J&J faces FDA scrutiny for another manufacturing unit

May 27, 2010
Manufacturing and Production Advanced Sterilization Products, Ethicon, J&J, JJ, McNeil, manufacturing compliance

Another Johnson & Johnson subsidiary has come under scrutiny by FDA for failing to meet quality standards in its manufacturing. …

Genzyme confirms details of consent decree and $175m fine

May 27, 2010
Manufacturing and Production Cerezyme, Fabrazyme, Genzyme, Lumizyme, Thyrogen, manufacturing compliance

Genzyme’s predictions on the penalties levied for the ongoing problems at its manufacturing facility in Allston Landing have been confirmed, …

FDA approves Genzyme’s Lumizyme

May 27, 2010
Sales and Marketing Genzyme, Lumizyme, Myozyme, Pompe disease

US biotech Genzyme is celebrating FDA approval of its late-onset treatment for Pompe disease Lumizyme. The green light to market …

Roche forms translational medicine research hub

May 26, 2010
Research and Development Roche, Switzerland, academic research, translational

Roche is linking up with Basel’s university and university hospital in a ‘strategic alliance’ that will establish and manage what …

NICE rejects Bayer’s liver cancer drug

May 26, 2010
Sales and Marketing NICE, Nexavar, patient access scheme

Bayer’s liver cancer drug Nexavar has been rejected by NICE after it deemed the drug too costly for a marginal …

Full steam ahead for NHS boards

May 26, 2010
Monitor, NHS, government

The government is setting up new NHS boards that will act independently to allocate resources and oversee the commissioning of …

Abbott sign

Abbott starts head-to-head MS trial

May 25, 2010
Research and Development, Sales and Marketing Abbott, Avonex, Biogen, Gilena, daclizumab

Abbott has started enrolment for a phase III trial of daclizumab, a once-monthly injection for relapsing-remitting multiple sclerosis that it …

European green light for Allergan’s Ozurdex

May 25, 2010
Sales and Marketing Allergan, CHMP, Ozurdex, macular oedema

European authorities have given the green light for Ozurdex, a treatment for adults with a potentially serious eye disease. Ozurdex …

Takeda appoints Kiyohiko Tamura

May 25, 2010
Sales and Marketing Takeda, appointment, sales and marketing

Japanese pharma company Takeda has appointed Kiyohiko Tamura general manager of its newly established Office of the President & CEO. …

MMR website

MMR doctor struck off

May 25, 2010
GMC, MMR

The doctor at the centre of a 12-year MMR vaccine debate has been struck off the medical register after being …

Kaiser Permanente unit joins Quintiles ‘Prime Site’ network

May 25, 2010
Research and Development CRO, Kaiser Permanente, Quintiles

A unit of US health maintenance organisation Kaiser Permanente has become the fourth in Quintiles’ network of ‘Prime Sites’ – …

Lucentis boosted by diabetic vision study

May 24, 2010
Research and Development, Sales and Marketing AMD, DME, Lucentis, Novartis

A phase III trial of Novartis’ ranibizumab has shown it to be superior at promoting vision gain in patients with …

Boehringer selects lead candidate for Alzheimer’s

May 24, 2010
Research and Development Ablynx, Boehringer

Boehringer Ingelheim has selected a lead candidate for further development to treat Alzheimer’s disease from its collaboration with Ablynx. Belgium-based …

Eisai opens $100m parenterals plant in North Carolina

May 24, 2010
Manufacturing and Production, Research and Development Aricept, Eisai, eribulin, parenterals

Japanese drugmaker Eisai has opened a 65,000-sq.ft. facility at Research Triangle Park in North Carolina, USA, which will serve as …

First artificial life created

May 24, 2010
Research and Development Cell biology, Venter, cell, genome

Scientists in the US have succeeded in developing the first living cell to be controlled entirely by synthetic DNA. The …

Pharma manufacturing news in brief

May 24, 2010
Manufacturing and Production Angel Biotech, Halozyme, Johnson Matthey, Ranbaxy, Sagent Pharmaceuticals, baxter

There are more quality problems to report on the manufacturing beat this week, with recalls for Ranbaxy, Halozyme/Baxter and Sagent …

Iressa

Asda cuts cancer drugs prices

May 24, 2010
Sales and Marketing Asda, Cancer, market access, price cuts, pricing, supermarket

UK supermarket chain Asda has started selling privately prescribed cancer drugs on a not-for-profit basis. The vast majority of drugs …

Turkey: volatility and growth

May 24, 2010
Sales and Marketing Turkey, em

The economic woes of Greece are currently the most worrying problem within the European Union’s single currency region the Eurozone, …

German patent setback for GlaxoSmithKline’s Seretide

May 21, 2010
Sales and Marketing GSK, Germany, Seretide

A Munich court has ruled GlaxoSmithKline’s combination patent for its asthma and COPD treatment Seretide is not valid. The Federal …

MedUniverse

Digital Pharma: Doctors.net.uk’s Nordic expansion

May 21, 2010
Medical Communications, Sales and Marketing community, digital pharma, doctors.net, meduniverse

UK online doctors network Doctors.net.uk has taken a stake in its Swedish counterpart MedUniverse as part of international expansion plans. …

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