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The Pharmafocus ASCO round-up

June 7, 2016 Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing ASCO, Pharmafocus

As the curtain falls on another annual ASCO (American Society of Clinical Oncology) congress, catch up on all the biggest …
Feature
novo_flag

Novo Nordisk presents positive long-term results for Saxenda

June 3, 2016 Medical Communications, Research and Development Novo Nordisk, cardiometabolic risk factors, liraglutide, saxenda, weight loss

Novo Nordisk has presented analysis covering three years of a late-stage trial for Saxenda (liarglutide 3mg) , which showed the …
News
shire_image_4

Shire completes Baxalta takeover

June 3, 2016 Medical Communications, Research and Development, Sales and Marketing Baxalta, Shire, deal, merger and acquisition, revenue, sales

UK drugmaker Shire (LSE: SHP) on Friday announced the completion of merger with rare disease specialist Baxalta (NYSE: BXLT).  The …
News
lab

Eisai partners with Novartis in renal cell carcinoma collaboration

June 3, 2016 Medical Communications, Sales and Marketing Afinitor, Eisai, Lenvima, Novartis, US, everolimus, lenvatinib mesylate

Eisai (TYO: 4523) has announced that it has entered into a partnership with Novartis Pharmaceuticals to collaborate on commercial and …
News

Bayer, Orion to start Phase III trials for prostate cancer drug

June 3, 2016 Medical Communications, Research and Development, Sales and Marketing Bayer, drug trial, orion, prostate cancer, research

German pharma and crop sciences giant Bayer (ETR: BAYN) and Orion Corp (Nasdaq Helsinki: ORNAV) have agreed to start a Phase …
News

New FDA expanded access guidelines spell trouble for Sarepta

June 2, 2016 Medical Communications, Research and Development, Sales and Marketing Duchenne Muscular Dystrophy, Eteplirsen, FDA, compassionate grounds, sarepta

New guidelines intended to streamline the process of expanded access to medicines by the US Food and Drug Administration (FDA) …
News
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Janssen says its Trevicta gets European regulatory approval as maintenance therapy for Schizophrenia

June 2, 2016 Medical Communications, Research and Development European Commission, Janssen, Trevicta, schizophrenia

Janssen said the European Commission has approved its Trevicta (paliperidone palmitate, a 3‑monthly injection) as maintenance treatment of schizophrenia.  Trevicta …
News

Nice rejects Janssen’s Imbruvica in draft guidance

June 1, 2016 Medical Communications, Research and Development

The UK regulators have not recommended Janssen’s leukaemia drug Imbruvica (ibrutinib) to treat in draft guidance. The National Institute for …
News
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Biogen says European regulatory committee adopts positive view for Tysabri

June 1, 2016 Medical Communications, Research and Development, Sales and Marketing Biogen, CHMP, EMA, Tysabri, multiple sclerosis

Biogen (Nasdaq: BIIB) said the European regulatory committee has backed the approval of a variation to the marketing authorization for its …
News
teva_copy

FDA asks Teva for further study on Huntington drug candidate

June 1, 2016 Medical Communications, Research and Development Huntington disease, Teva, US FDA, regulation

Israel-based Teva Pharmaceutical Industries (NYSE: TEVA) said the US regulators have put on hold the approval for its drug to …
News
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Uni spin out gets new chariman, CFO, COO

May 27, 2016 Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

Caldan Therapeutics is a spin-out company from the Universities of Glasgow and Southern Denmark which is looking at developing novel …
Appointment
clinical_trial_3

EMA to revise clinical trial guidelines

May 27, 2016 Medical Communications, Research and Development EMA, Guidelines, amend, clinical trial, review, revise

The European Medicines Agency (EMA) has announced that it will conduct a review in an attempt to revise its guidelines …
News
shire_image_4

Shire gets positive opinion from EMA on rare gastrointestinal disease treatment

May 27, 2016 Medical Communications, Research and Development, Sales and Marketing CHMP, EMA, Revestive, Shire, gastrointestinal, paediatric, short bowel syndrome, treatment

Shire (LSE: SHP) has announced that it has received a positive opinion from the European Medicines Agency’s (EMA) Committee for …
News
roche__tree

Roche says comparison study for its Gazyva/ Gazyvaro showed superior progression-free survival in follicular lymphoma

May 27, 2016 Medical Communications, Research and Development Comparison Study, Roche, drug trial, follicular lymphoma

Roche (SIX: ROG) on Friday said late-stage comparison trials for its drug to treat a slower form of non-Hodgkin lymphoma …
News

AstraZeneca says NDA for drug to treat hyperkalaemia gets observations from the US FDA

May 27, 2016 Medical Communications, Research and Development AstraZeneca, NDA, US FDA, regulation

UK pharma firm AstraZeneca (LSE: AZN) on Friday said the US Food and Drug Administration (FDA) has issued a complete …
News
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