fda2outsideweb

FDA expands Imbruvica label with new survival data

May 11, 2016
Research and Development, Sales and Marketing AbbVie, FDA, Janssen, data, efficacy, expanded, imbruvica, label, late stage, phase III

The US Food and Drug Administration (FDA) has expanded the label of Imbruvica (ibrutinib) to include the data from recent …

gavel

Baxalta sues Chugai for haemophilia drug patent breach

May 11, 2016
Research and Development Baxalta, Chugai, breach, court, haemophilia, infringe, infringement, patent, sue, suing

Baxalta has taken Chugai Pharmaceuticals to the Tokyo district court, claiming that the Japanese company has infringed upon its patent …

incyte

Incyte acquires Ariad’s European operations in $140 million deal

May 10, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Ariad, Incyte, Operations, buy out, european, iclusig, leukaemia, out-license

Incyte (NASDAQ: INCY) has entered into an agreement with Ariad Pharmaceuticals (NASDAQ: ARIA) that will see the company acquire Ariad’s …

celltherapy

Cell Therapy signs £12.5 million licensing deal with Daiichi Sankyo for heart failure treatment

May 10, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Daiichi Sankyo, Deals, cell therapy, heart failure, licensing

UK-based Cell Therapy on Tuesday said it has signed a £12.5 million licensing deal with Japan’s Daiichi Sankyo (TYO: 4568) …

medivation

Medivation maybe mulling sale as bidding race heats up – Reports

May 10, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Amgen, Deals, M&A, MA, Medivation, Pfizer, Sanofi

Cancer drugmaker Medivation (Nasdaq: MDVN) is evaluating a potential sale following the recent string of offers from big pharma firms, …

vaccination

Takeda secures $38 million grant to develop affordable polio vaccine

May 10, 2016
Manufacturing and Production, Research and Development Bill and Melinda Gates Foundation, Gates Foundation, Takeda, Vaccine, access, developing countries, grant, polio

Takeda Pharmaceuticals has received a $38 million grant from the Bill and Melinda Gates Foundation to develop a low-cost polio …

Scottish Medicines Consortium does not back Vertex’ cystic fibrosis drugs Orkambi, Kalydeco

May 10, 2016
Manufacturing and Production, Research and Development Kalydeco, Orkambi, SMC, Vertex Pharma, cystic fibrosis, regulation

The Scottish Medicines Consortium did not back two cystic fibrosis therapies from Vertex Pharmaceutical (Nasdaq: VRTX).  SMC did not recommend …

cancer_cells

Second child cleared of leukaemia after Cellectis T-cell treatment

May 10, 2016
Manufacturing and Production, Research and Development cellecits, childhood, children, designer cells, leukaemia, rare, t cells, t-cells

A targeted T-cell oncology therapy has successfully treated a second baby with aggressive leukaemia who has remained in remission after …

China evaluating investigations into pharma firms to take on drug pricing issue

May 9, 2016
Business Services, Research and Development, Sales and Marketing China, France, G7, regulation

Lawmakers globally have acknowledged the concerns over unbridled drug costs as regulators stress the need for a more open debate …

abpi_reception_right

UK pharma would benefit by remaining in EU, says ABPI

May 9, 2016
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing ABPI, Andrew Witty, EU, brexit, letter, observer, pascal soriot, remain, stay

With the EU vote approaching, the Association of the British Pharmaceutical Industry (ABPI) has brought together 93 signatories, including the …

shutterstock_67313209

Focus: Governments evaluate policies, reforms as drug pricing debate rages on

May 9, 2016
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

By Anjali Shukla Lawmakers in France are set to urge the leaders of G7 countries to put in place guidelines …

hold_heart

Chiesi set to acquire Medicine Co cardiovascular assets, say reports

May 9, 2016
Sales and Marketing Chiesi, assets, cardiovascular, medicine co

Italian pharmaceutical company Chiesi are set to expand their global footprint as it nears an agreement to acquire Medicines Co’s …

stocks3

Endo shares plunge almost 40% as company cuts FY outlook

May 9, 2016
Sales and Marketing Endo International, earnings, outlook, revenue

Shares in Endo International (Nasdaq: ENDP) plunged to close down nearly 40% after the company cut its full-year earnings forecast …

needles

BTG acquires promising oncology pipeline in Galil Medical takeover

May 9, 2016
Manufacturing and Production, Research and Development, Sales and Marketing $84 million, BTG, cryoablation, galil medical, oncology, takeover

BTG (LSE: BTG) has announced that is has agreed to acquire Galil Medical, a leading provider of cryoablation products for …

allergan

Phase III trial meets primary endpoint for Allergan’s fibroid treatment

May 9, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Allergan, fibroid, phase 3, phase III, ulipristal, ulipristal acetate, uterine fibroid

Allergan (NYSE: AGN), in collaboration with Gedeon Richter, has announced positive results from a pivotal Phase III trial evaluating the …

stocks1

Weekly Movers: Bind Therapeutics, Sarepta, Idexx…

May 9, 2016
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

Pfizer (NYSE: PFE) and Amgen (Nasdaq: AMGN) are rumoured to be considering a bid for Medivation just as French drug …

stocks2

Clovis cuts staff by 35% after FDA knock back on lung cancer drug

May 6, 2016
Manufacturing and Production, Research and Development, Sales and Marketing FDA, Q1 results, clovis, failure, job cuts, job losses, rociletinib, workforce

Clovis Oncology (NASDAQ: CLVS) is set to cut up to 35% of its workforce following the US Food and Drug …

NICE recommends Sanofi, Amgen cholesterol drugs

May 6, 2016
Medical Communications, Sales and Marketing Amgen, Draft Guidance, NHS, NICE, Repatha, Sanofi, cardiovascular disease, cholesterol, final draft guidance, high cholesterol, praluent, recommendation, treatment

The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending two new drugs for the …

fda_logo-web

KemPharm’s pain drug fails to get FDA committee backing for abuse-deterrent capabilities; shares plunge

May 6, 2016
Medical Communications, Sales and Marketing

Shares in KemPharm (Nasdaq: KMPH) more than halved in pre-market trading after a US Food and Drug Administration advisory panel …

tug-of-war

Focus: Medivation tug-of-war rumbles on

May 6, 2016
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Amgen, AstraZeneca, Medivation, Pfizer, Sanofi, billion dollar, competition, oncology, pipeline, promising, takeover, tug of war

Medivation (NASDAQ: MDVN) has been making all the headlines as a list of suitors’ line up, all vying to secure …

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