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February 2016

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FDA grants orphan status for Amarantus' eltoprazine to treat PD-LID 11 February 2016 The US Food and Drug Administration (FDA) has granted orphan drug designation for Amarantus BioScience Holdings' (AMBS') eltoprazine to treat Parkinson's disease levodopa-induced dyskinesia...

Mylan offers $7.2bn to acquire Sweden's Meda 11 February 2016 Generic drugmaker Mylan has made an offer to acquire Swedish pharmaceutical firm Meda Aktiebolag (Meda) for $7.2bn in a cash-and-stock...

VBI Vaccines and GSK to evaluate LPV Platform for new vaccines with improved stability 10 February 2016 US-based biopharmaceutical firm VBI Vaccines (VBI) and GlaxoSmithKline Biologicals (GSK) have entered into a research collaboration to evaluate VBI’s LPV Platform, which helps in the development...

Adaptimmune's enhanced T-cell therapy gets FDA breakthrough status for synovial sarcoma 10 February 2016 The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for British biopharmaceutical firm Adaptimmune Therapeutics' affinity enhanced T-cell therapy targeting...

EMA establishes task force to fast-track trials on Zika virus 09 February 2016 The European Medicines Agency (EMA) has formed a task force to contribute to the global response to the threat of the deadly mosquito-transmitted Zika...

FDA grants orphan drug status for Epizyme's tazemetostat to treat malignant rhabdoid tumours 09 February 2016 The US Food and Drug Administration (FDA) has granted orphan drug designation for biopharmaceutical firm Epizyme's first-in-class EZH2 inhibitor, tazemetostat, to treat malignant rhabdoid...

Promius' Sernivo Spray gets FDA approval to treat moderate plaque psoriasis 08 February 2016 Indian-based Dr Reddy's Laboratories' US subsidiary Promius Pharma has received approval from the US Food and Drug Administration (FDA) for Sernivo (betamethasone dipropionate) Spray, 0.05%,...

FDA rejects Vertex's sNDA for Kalydeco to treat cystic fibrosis in people aged two years and older 08 February 2016 The US Food and Drug Administration (FDA) has rejected Vertex Pharmaceuticals' supplemental new drug application (sNDA) for Kalydeco (ivacaftor) designed to treat people with cystic fibrosis...

US proposes $1.1bn investment to address opioid abuse and heroin use 05 February 2016 The US federal government has proposed an investment of $1.1bn in the fiscal 2017 budget to address the prescription opioid abuse and heroin use in the...

Merck receives FDA approval for single-dose EMEND for injection 05 February 2016 Merck, commonly known as MSD, has received the US Food and Drug Administration (FDA) approval for its supplemental new drug application (sNDA) for single-dose EMEND (fosaprepitant dimeglumine)...

UK Government allocates £1m to fast-track Zika Virus research 04 February 2016 The UK Government has launched 'Rapid Response' to accelerate research aimed at tackling the risk posed by the mosquito-transmitted Zika...

AstraZeneca's Tagrisso lung cancer drug gets approval in Europe 04 February 2016 The European Commission (EC) has granted conditional marketing authorisation for AstraZeneca's Tagrisso (AZD9291, osimertinib) 80mg once-daily tablets to treat adults with locally advanced...

GSK and Adaptimmune expand cancer immunotherapy alliance 03 February 2016 GlaxoSmithKline (GSK) has expanded the collaboration agreement with Adaptimmune to accelerate development of the latter's lead clinical cancer programme, an affinity enhanced T-cell...

AstraZeneca acquires 55% stake in Acerta Pharma for $4bn 03 February 2016 AstraZeneca has completed the acquisition of 55% stake in Acerta Pharma, a privately-owned biopharmaceutical firm, for...

Bristol-Myers and Pfizer to develop Portola's andexanet alfa in Japan 02 February 2016 Bristol-Myers Squibb (BMS) and Pfizer have collaborated with Portola Pharmaceuticals (PTLA) to develop and commercialise its investigational agent andexanet alfa in Japan....

EMA validates Gilead’s Type II variation application for Truvada to reduce risk of HIV-1 infection 02 February 2016 The European Medicines Agency (EMA) has validated Gilead Sciences' Type II variation application for once-daily Truvada to reduce the risk of sexually acquired HIV-1 infection among...

Eisai’s Halaven Injection gets FDA approval to treat advanced liposarcoma 01 February 2016 The US Food and Drug Administration (FDA) has granted approval for Eisai's Halaven (eribulin mesylate) Injection (0.5mg/mL) to treat patients with unresectable or metastatic liposarcoma who...

Allergan and AstraZeneca to develop ATM-AVI for antibiotic-resistant gram-negative infections 01 February 2016 Irish drug-maker Allergan has entered into a global agreement with UK's AstraZeneca to develop and commercialise ATM-AVI, an investigational, fixed-dose antibiotic combining aztreonam and...

January 2016

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Zika virus expected to infect four million people in Americas: WHO 29 January 2016 The World Health Organisation (WHO) has reported that the mosquito-transmitted Zika virus is spreading explosively and could infect as many as three to four million people in the...

Sanofi collaborates with Iran Food and Drug Administration 29 January 2016 French pharmaceutical firm Sanofi has signed a Memorandum of Cooperation (MoC) with the Iran Food and Drug Administration, affiliated to the Ministry of Health and Medical Education of Iran,...

CRT and MSD to develop inhibitors of PRMT5 for cancer and blood disorders 28 January 2016 Cancer Research UK's development and commercialisation arm Cancer Research Technology (CRT) has entered into a licence agreement with MSD (Merck, in the US and Canada) to develop and...