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Dr Simon Thorn joins Spectrum Regulatory Solutions

January 12, 2011
Research and Development Dr Simon Thorn, Specrum Regulatory Services, appointment, research and development

Spectrum Regulatory Solutions has appointed Dr Simon Thorn as a senior regulatory writer. He has more than 15 years experience …

Appointment

Marketing authorisations for medicines: UK Decentralised Procedure slots available in all therapeutic areas in 2011

January 12, 2011
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

The MHRA has reported it has RMS decentralised procedure slots available in 2011 for all therapeutic areas, including biologicals and …

News
Press release

Servier’s Mediator provokes French drug safety controversy

January 12, 2011
Sales and Marketing AFSSAPS, France, Mediator, Servier, benfluorex, drug safety

Serious questions are being asked about drug safety monitoring in France in connection with Servier’s Mediator (benfluorex) which was withdrawn …

News

Regulatory assistance available to Small and Medium-sized Enterprises (SMEs)

January 12, 2011
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

The increasing number of SMEs in Europe is seen to be a driving force to facilitate economic growth, new product …

News
Press release

Deadline approaching for cancelling UK Licences

January 12, 2011
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

The MHRA has recently advised all holders of UK marketing authorisations, registrations and licences to inform them by the 31st …

News
Press release

Updated report on origins of clinical trial participants

January 12, 2011
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

The European Medicines Agency has published an updated report detailing the geographical origins of patients included in clinical trials for …

News
Press release

Scientific Advice and Guidance Available

January 12, 2011
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

In April, we reported how a joint pilot scheme operated by the UK Medicines & Healthcare Products Regulatory Agency (MHRA), …

News
Press release
ABPI

UK trade associations form new life sciences lobbying group

January 11, 2011
Research and Development, Sales and Marketing ABHI, ABPI, BIA, BIVDA, LifeSciencesUK, lobbying

Four industry trade associations including pharma body the ABPI have banded together to form a new lobbying group representing life …

News

Savient plays down gout drug manufacturing problems

January 11, 2011
Manufacturing and Production, Sales and Marketing Krystexxa, Savient, biologic manufacturing, gout, manufacturing compliance, pegloticase

Savient Pharmaceuticals has reported that some production batches of Krystexxa, its recently-approved second-line treatment for gout, have failed to meet …

News

Novartis challenges Roche with MabThera biosimilar

January 11, 2011
Research and Development Lonza MabThera, Novartis, Roche, Teva, biosimilar, rituximab

Novartis’ generics unit Sandoz has begun mid-stage trials of a biosimilar version of Roche’s blockbuster drug MabThera. The phase II …

News
Food and Drug Administration (FDA)

FDA launches online transparency initiative

January 11, 2011
Medical Communications, Research and Development, Sales and Marketing FDA, Joshua Sharfstein, transparency

The FDA has launched a new online resource to increase the transparency of its processes and help save companies time …

News

Dendreon will outsource first Provenge production in EU

January 11, 2011
Manufacturing and Production Dendreon, Provenge, cancer vaccine, contract manufacturing, sipuleucel-T, vaccine manufacturing, vaccines

US oncology specialist Dendreon has decided to hire a contract manufacturer for its cell-based cancer therapy Provenge in Europe to …

News

Sanofi boosts emerging markets leadership team

January 11, 2011
Sales and Marketing Brazil, China, Heraldo Marchezini, Japan, Jeremy Moulding Russia, Patrick Aghanian, Sanofi-Aventis, Thomas Kelly, appointments, emerging markets, sales and marketing

Sanofi-Aventis has bolstered its emerging markets team with the appointment of four senior managers. They are Patrick Aghanian, Thomas Kelly, …

Appointment
GlaxoSmithKline’s H1N1 vaccine Pandemrix

Doctors use GSK’s Pandemrix as seasonal flu vaccines fall short

January 10, 2011
Sales and Marketing GSK, GlaxoSmithKline, Pandemrix, flu, h1n1, influenza, vaccines

Doctors may have to use last year’s stock of the H1N1 vaccine Pandemrix as the government admits there are some …

News

Sanofi’s Genzyme takeover bid focuses on Campath

January 10, 2011
Research and Development, Sales and Marketing Genzyme, Sanofi, Sanofi-Aventis, biotech acquisition

Sanofi-Aventis and Genzyme have come back to the negotiation table to discuss the potential of Genzyme’s multiple sclerosis drug Campath. …

News

More US recalls as bill seeks greater FDA powers

January 10, 2011
Manufacturing and Production Centocor Ortho Biotech, Cumberland Pharmaceuticals, FDA, RiteDose Corp, Sandoz, Sigma-tau Pharmasource, Teva Pharmaceuticals, manufacturing compliance, recalls

Product recalls continue to make headlines in the pharmaceutical sector, with several new incidents either side of the New Year …

News

Dendreon eyes late 2011 European cancer vaccine filing

January 10, 2011
Sales and Marketing Cancer, Denreon, Provenge, cancer vaccine, sipuleucel, vaccines

Dendreon Group is to seek marketing authorisation in Europe for the world’s first immunotherapy cancer vaccine in late 2011 or …

News

Cephalon’s Paul Harmon joins IPHA board

January 10, 2011
Sales and Marketing Cephalon, IPHA, Paul Harmon, appointment, sales and marketing

Cephalon’s Paul Harmon has been elected to the prescription medicines division strategy board of Irish pharma association IPHA, a role …

Appointment

Regulators fast-track Merck’s hepatitis C drug boceprevir

January 7, 2011
Sales and Marketing Merck & Co, boceprevir, hepatitis C, telaprevir

Merck’s new oral hepatitis C drug boceprevir will receive fast track reviews from both the FDA and the EMA after …

News
Pfizer's Les Meningo – Smash Pursuit iPhone app

Digital Pharma: Pfizer, J&J and Merck withdraw iPhone apps

January 7, 2011
Medical Communications Android, Blackberry, Digital Pharma blog, Johnson & Johnson, Merck, Pfizer, apps, ipad, iphone

Big pharma companies have pulled a number of apps from the iTunes store, but it’s not a sign the industry …

News
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