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Pharma relieved as Senate backs FDA fees

May 30, 2012
Business Services, Manufacturing and Production, Research and Development, Sales and Marketing FDA, PDUFA, PhRMA, US

The US Senate has approved a law that will continue to allow pharma firms to help fund the FDA.  The …

News

Photo story: GSK’s 2012 legacy

May 30, 2012
Research and Development Andrew Witty, GSK, Olympics 2012

Tuesday May 29, 2012: GlaxoSmithKline chief executive, Sir Andrew Witty makes a speech at a conference at the company’s headquarters …

Feature

GSK starts combination trial for melanoma

May 30, 2012
Research and Development, Sales and Marketing GSK, R&D, Roche, Zelboraf, melanoma

GlaxoSmithKline has begun a combination trial for two of its investigational skin cancer drugs.  The firm will combine dabrafenib, its …

News

UK Prix Galien shortlist announced

May 30, 2012
Business Services, Medical Communications, Research and Development, Sales and Marketing Bayer, Janssen, Xarelto, awards, prix galien

The UK award for the most innovative new drug has been moved a step closer with the release of a …

News
brian_jolly_at_onyx_scientific_

Onyx appoints Brian Jolly to commercial team

May 30, 2012
Business Services, Manufacturing and Production, Research and Development, Sales and Marketing CMO, Onyx, manufacturing

Onyx Scientific the chemistry and manufacturing specialist has bolstered its business development team with the appointment of a new director. …

Appointment

Landmark CF treatment set for European approval

May 30, 2012
Sales and Marketing CHMP, Europe, Kalydeco, Vertex, cystic fibrosis

A European committee is recommending the approval of Vertex’s first-in-class treatment for cystic fibrosis.  Kalydeco (ivacaftor) is a landmark in …

News

Government outlines new commissioning landscape

May 29, 2012
CCG, NHS, PCTs, commissioning, health reforms

The government has outlined the new commissioning landscape in England as GPs look to take over commissioning responsibility.  The NHS …

News

Sanofi/Regeneron cholesterol drug reaches Phase III

May 29, 2012
Research and Development, Sales and Marketing Amgen, PCKS9, Regeneron, SAR236553, Sanofi

Sanofi and Regeneron’s anti-cholesterol drug has impressed in a mid-stage trial, and will now progress into Phase III.  The firms’ …

News

Lundbeck’s Alzheimer’s drug shows promise

May 29, 2012
Research and Development, Sales and Marketing Alzheimer's, Lundbeck

Lundbeck’s Alzheimer’s candidate Lu AE58054 has shown signs in a phase II study of helping patients’ mental activity. Sufferers receiving …

News

Pharma manufacturing news in brief

May 29, 2012
Manufacturing and Production Adienne Pharma & Biotech, Hospira, Neuroptis Biotech, Provence Technologies, Selexis and Florida Biologix, baxter

Hospira overfilled Carpuject cartridges, high-potency certification at Baxter, plus updates from Provence Technologies, Selexis and Florida Biologix. 

News
mabthera image

EMA backs MabThera despite contamination issue

May 29, 2012
Manufacturing and Production EMA, MabThera, Phil Taylor, Roche, manufacturing

The European Medicines Agency has completed a safety review of Roche’s MabThera convened after bacterial contamination was discovered in bioreactors …

News
Merck image

Merck extends biocatalysis collaboration with Codexis

May 29, 2012
Manufacturing and Production Codexis, Merck, Phil Taylor, Victrelis, manufacturing

Biocatalyst specialist Codexis has signed a three-year extension of its catalyst and process development collaboration with Merck to develop enzymes …

News
Pradaxa image

European OK for Pradaxa, but more details required

May 29, 2012
Research and Development, Sales and Marketing Boehringer, CHMP, EMA, Europe, Pradaxa

The European Medicines Agency says that Boehringher’s Pradaxa can stay on the market, but will need more safety information.  The …

News

Cancer Drugs Fund ‘the wrong choice’ for Wales

May 29, 2012
Sales and Marketing CDF, Cancer, NHS, Wales, Welsh

The Welsh health minister Lesley Griffiths has said that a Cancer Drugs Fund is ‘not the right course’ for Wales. …

News

Recommendations for two Eisai epilepsy drugs

May 28, 2012
Sales and Marketing CHMP, Eisai, Zonegra, epilepsy

European regulators are likely to approve two of Eisai’s epilepsy drugs after advisers recommended both of them.First-in-class Fycompa (perampanel) has …

News

Latest FDA warning letters cite Tedec-Meiji, BMP Pharma

May 28, 2012
Manufacturing and Production BMP Pharma, FDA, Tedec-Meiji Farma

Spanish drugmaker Tedec-Meiji Farma and German active pharmaceutical ingredient (API) producer BMP Pharma both feature in the latest crop of …

News

Life bolsters its client services team with two additions

May 28, 2012
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

Life Healthcare Communications has developed its client services team with two new appointments to further support the needs of its …

Appointment

Pfizer’s Inlyta gains European recommendation

May 28, 2012
Sales and Marketing Inlyta. axitinib, Sutent, renal cell carcinoma

Pfizer’s kidney cancer pill Inlyta has been recommended for use by a European committee. The Committee for Medicinal Products for …

News
Richard Bergstrom

Public-private alliance to discover new antibiotics

May 25, 2012
AstraZeneca, EFPIA, GSK, Janssen, Sanofi, antibiotic, bacterial infection

 A Europe-wide public-private partnership is to put €224m (£180m) into finding new antibiotics for all manner of bacterial infections such …

News

Groundbreaking CF drug recommended in Europe

May 25, 2012
Sales and Marketing CHMP, EMA, Kalydeco, Vertex, cystic fibrosis

The first-in-class treatment for cystic fibrosis Kalydeco has been recommended by the EMA’s medicines committee. Kalydeco (ivacaftor) promises to be …

News
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