Merck seeks new Keytruda indication in US

April 20, 2015
Sales and Marketing Cancer, FDA, NSCLC, PD-L1, US, keytruda, lung, pembrolizumab

Merck is seeking FDA approval for its successful melanoma drug Keytruda to be used treating lung cancer. The Supplemental Biologics …

Round one to Pfizer in Zoloft lawsuit battle

April 20, 2015
Sales and Marketing Pfizer, Zoloft, antidepressant, birth defects, law suits, legal, sertraline

Pfizer’s Zoloft did not cause a young boy’s birth defects, a jury has ruled, in the first of a thousand …

AstraZeneca lung drug shows promise

April 20, 2015
Sales and Marketing AZ, AZD9291, AstraZeneca, European Lung Cancer Congress, NSCLC, Orphan

AstraZeneca’s non-small cell lung cancer offering AZD9291 has been shown to delay disease progression by over a year. Data presented …

What you need to know about the EU Clinical Trial Regulation

April 20, 2015
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing ABPI, EU Clinical Trial Regulation, EU-CTR, Virginia Acha

 Where did the EU Clinical Trial Regulation come from? The EU Clinical Trial Regulation (EU-CTR) was approved in April 2014 …

Celgene appoints former Cubist chief executive

April 20, 2015
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Celgene, cubist, michael bonney

Celgene has elected pharma veteran Michael Bonney to join its board of directors. Bonney served as chief executive and board …

GSK sees further US job losses following Novartis deal

April 17, 2015
Research and Development, Sales and Marketing GSK, Jobs, Novartis, cuts, merger, pittsburgh, restructuring

Hundreds more jobs are at risk within GlaxoSmithKline as the fallout from the company’s asset-swapping deal with Novartis continues. Staff …

AstraZeneca bags another FDA orphan status in cancer

April 17, 2015
Sales and Marketing AstraZeneca, Cancer, FDA, GlaxoSmithKline, mekinist, melanoma, oncology, selumetinib, trametinib

The FDA has granted AstraZeneca’s cancer medicine selumetinib orphan drug designation for the treatment of uveal melanoma. The company will …

FDA approves generic Copaxone for multiple sclerosis

April 17, 2015
Sales and Marketing FDA, Sandoz, Teva, glatiramer acetate injection, glatopa

The FDA has signed-off on the first generic version of Copaxone to treat people with relapsing forms of multiple sclerosis …

Merck chief executive replaces Pfizer boss as PhRMA chairman

April 17, 2015
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing George Scangos, Ian Read, Joaquin Duato, Kenneth Frazier, PhRMA

Chairman and chief executive of Merck Kenneth Frazier is to replace Pfizer boss Ian Read as chairman at the Pharmaceutical …

Merck Serono gains head of global clinical development

April 17, 2015
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Alise Reicin, Merck, Merck Serono

Merck Serono, the biopharma business of Merck, has appointed Dr Alise Reicin as senior vice president and head of its …

AstraZeneca signs immuno-oncology deal with UK firm

April 16, 2015
Research and Development, Sales and Marketing AstraZeneca, IMCgp100, MEDI4736, MedImmune, Oxford, immuno-oncology, immunocore, melanoma, tremelimumab

UK pharma and biotech firms AstraZeneca and Immunocore are teaming up to launch early-stage studies of potential new cancer treatments. …

FDA approves Amgen’s heart failure drug

April 16, 2015
Sales and Marketing Amgen, Corlanor, FDA, NICE, Vectibix, heart, ivabradine

Amgen has earned sign-off from the FDA for Corlanor as a treatment for people with worsening heart failure symptoms. Corlanor …

AbbVie hep C drug gets priority review in Japan

April 16, 2015
Sales and Marketing AbbVie, EC, EU, Europe, Exviera, FDA, Japan, Viekira Pak, Viekirax, hepatitis C, ombitasvir/paritaprevir/ritonavir

AbbVie’s combination hepatitis C treatment looks set to be approved in yet another country after being granted priority review in …

Sun Pharma and Technion form oncology research pact

April 16, 2015
Research and Development, Sales and Marketing Cancer, Sun Pharma, institute of technology, oncology, technion

Mumbai-based Sun Pharmaceuticals Industries is teaming up with the Israel Institute of Technology Technion to develop new oncology drugs. This …

New managing director for PM Devereux

April 16, 2015
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Julian Seward, PM Devereux

Healthcare, science and technology architectural firm PM Devereux has confirmed the appointment of Julian Seward as a managing director. Seward …

Pfizer breast cancer trial stopped following promising results

April 15, 2015
Sales and Marketing ASCO, FDA, Pfizer, ibrance, palbociclib

Regulators have stopped a Phase III clinical trial of Pfizer’s Ibrance early after it demonstrated improved survival in women with …

Trial results back NICE decision on Novartis cancer drug

April 15, 2015
Sales and Marketing Arzerra, Cancer, NHS, NICE, chemo, chlorambucil, fludarabine, leukaemia, ofatumumab

Treatment with Arzerra improves survival in people with chronic lymphocytic leukaemia (CLL) according to study results that back NICE’s decision …

Merck hires life sciences business head

April 15, 2015
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Merck, Merck Millipore, Sigma-Aldrich, udit batra

Merck has confirmed that the current chief executive and president of Merck Millipore Dr Udit Batra has been appointed to lead …

FDA grants AstraZeneca immune drug orphan status

April 15, 2015
Sales and Marketing AstraZeneca, FDA, Iressa, MEDI4736, MedImmune, NSCLC, US, gefitinib, non-small cell lung cancer, tremelimumab

The US Food and Drug Administration has granted orphan drug designation to AstraZeneca’s anti-CTLA-4 monoclonal antibody tremelimumab for the treatment …

AZ and Takeda diabetes drugs get FDA safety update

April 15, 2015
Manufacturing and Production, Sales and Marketing AstraZeneca, FDA, Nesina, Onglyza, Takeda, alogliptin, cardiovascular, diabetes, saxagliptin

An FDA advisory committee has said that the labels of two type 2 diabetes drugs should be changed to warn …

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