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 …

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 …

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, …

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 …

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. …

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 …

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 …

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 …

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 …

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 …

Just:: to help three health charities

January 7, 2011
Medical 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 …

GSK's UK headquarters

GSK signs £64m autoimmune antibody deal

January 7, 2011
Research and Development GSK, GlaxoSmithKline, ImmuTune IMP731, Immutep, autoimmune diseases

GlaxoSmithKline has signed a worldwide licence agreement for a novel antibody designed to treat autoimmune diseases.The company will pay up …

Sanofi workers strike in France

January 7, 2011
Research and Development, Sales and Marketing Sanofi, Sanofi-Aventis, strikes, unions

Sanofi-Aventis workers have gone on strike in France as the company looks to cut jobs. Nine unions representing workers at …

woolley_pau_clare_panter

Clare Panter joins Woolley Pau PR

January 7, 2011
Medical Communications Clare Panter, Woolley Pau, appointment, medical communications

Clare Panter has joined Woolley Pau’s PR arm as a PR account executive. She is a keen writer and recently …

Avastin (bevacizumab) packs

Study highlights Avastin heart failure risk

January 6, 2011
Research and Development, Sales and Marketing Roche, avastin, bevacizumab, breast cancer

A new study confirms that Roche’s Avastin is linked to a small but significant increased risk of heart failure in …

Biogen Idec appoints new head of R&D

January 6, 2011
Research and Development, Sales and Marketing Biogen IDEC, Douglas Williams, Steven Holtzman, appointment, research and development, sales and marketing

Biogen Idec has a new head of research and development, appointing Douglas Williams to oversee its global operations. The position …

Janssen’s Invega wins schizoaffective approval in Europe

January 6, 2011
Sales and Marketing Invega, Janssen, paliperidone ER, schizoaffective disorder, schizophrenia

Janssen’s Invega has become the first drug to be licensed in Europe to treat schizoaffective disorder. European regulators approved Invega …

Leukaemia drug fast-tracked by NICE

January 6, 2011
Sales and Marketing Bendamustine, Levact, NICE, Napp, chronic lymphocytic leukaemia, leukaemia

A treatment for patients with the most common form of leukaemia has been fast tracked by NICE because of strong …

Bayer submits new Xarelto indications for European approval

January 6, 2011
Sales and Marketing Bayer, DVT, Xarelto, atrial fibrillation, deep vein thrombosis, pulmonary embolism, rivaroxaban, stroke prevention

Bayer is seeking European regulatory approval for a batch of new indications for its oral anticoagulant Xarelto. The company is …

GSK's UK headquarters

GSK hits back at 60 Minutes whistleblower interview

January 6, 2011
Manufacturing and Production 60 Minutes, Avandamet, Bactroban, Cheryl Eckard, GSK, GlaxoSmithKline, Kytril, Paxil, manufacturing compliance

GlaxoSmithKline has responded to an edition of US current affairs show 60 Minutes centring on manufacturing problems at its now-closed …

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