Marketing authorisations for medicines: UK Decentralised Procedure slots available in all therapeutic areas in 2011
January 12, 2011Business 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 …
Servier’s Mediator provokes French drug safety controversy
January 12, 2011Sales 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are being asked about drug safety monitoring in France in connection with Servier’s Mediator (benfluorex) which was withdrawn …
Regulatory assistance available to Small and Medium-sized Enterprises (SMEs)
January 12, 2011Business 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 …
Deadline approaching for cancelling UK Licences
January 12, 2011Business 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 …
Updated report on origins of clinical trial participants
January 12, 2011Business 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 …
Scientific Advice and Guidance Available
January 12, 2011Business 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), …
UK trade associations form new life sciences lobbying group
January 11, 2011Research 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 …
Savient plays down gout drug manufacturing problems
January 11, 2011Manufacturing 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 …
Novartis challenges Roche with MabThera biosimilar
January 11, 2011Research 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 …
FDA launches online transparency initiative
January 11, 2011Medical 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 …
Dendreon will outsource first Provenge production in EU
January 11, 2011Manufacturing 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 …
Sanofi boosts emerging markets leadership team
January 11, 2011Sales 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, …
Doctors use GSK’s Pandemrix as seasonal flu vaccines fall short
January 10, 2011Sales 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 …
Sanofi’s Genzyme takeover bid focuses on Campath
January 10, 2011Research 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. …
More US recalls as bill seeks greater FDA powers
January 10, 2011Manufacturing 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 …
Dendreon eyes late 2011 European cancer vaccine filing
January 10, 2011Sales 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 …
Cephalon’s Paul Harmon joins IPHA board
January 10, 2011Sales 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 …
Regulators fast-track Merck’s hepatitis C drug boceprevir
January 7, 2011Sales 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 …
Digital Pharma: Pfizer, J&J and Merck withdraw iPhone apps
January 7, 2011Medical 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 …
Just:: to help three health charities
January 7, 2011Medical Communications charity, just health pr
Three healthcare charities are to receive help with communications free of charge from Just:: Health PR. The PR company is …
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