Research and Development

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msd

Merck says US FDA accepts its sBLA for Keytruda

March 8, 2016 Manufacturing and Production, Research and Development Merck & Co, US FDA, keytruda, melanoma

US pharma giant Merck & Co said the US Food and Drug Administration (FDA) has accepted for review a new …
gsk_corp_hq_brentford_2

GSK says long-term study for Nucala backs safety profile

March 8, 2016 Manufacturing and Production, Research and Development GSK, GlaxoSmithKline, Nucala, asthma

UK pharma major GlaxoSmithKline (LSE: GSK) said its asthma drug, Nucala (mepolizumab) showed a similar safety profile in a long-term …
ema_logo

EMA launches PRIME scheme

March 8, 2016 Manufacturing and Production, Research and Development EMA, Guido Rasi, PRIME

The European Medicines Agency (EMA) has launched its new PRIME (priority medicines) scheme, which aims to strengthen support to medicines …
astrazeneca_plaque

AstraZeneca’s Faslodex gets US FDA nod in combination treatment for breast cancer

March 8, 2016 Manufacturing and Production, Research and Development AstraZeneca, Faslodex, US FDA, palbociclib

UK drug-maker AstraZeneca said the US Food and Drug Administration (FDA) has approved a new indication expanding the use of …
bms

BMS criticises Scottish regulator over Opdivo skin cancer ‘no’

March 7, 2016 Medical Communications, Research and Development Bristol-Myers Sqibb, NICE, SMC, melanoma, opdivo

Bristol-Myers Squibb says the Scottish Medicines Consortium’s (SMC) decision not to recommend its immunotherapy Opdivo (nivolumab) as a monotherapy for …
eli_lilly

Eli Lilly’s plaque psoriasis treatment impresses in Phase III trials

March 7, 2016 Research and Development, Sales and Marketing Eli Lilly, Enbrel, ixekizumab, psoriasis

Eli Lilly has announced late-stage trial data showing ixekuzimab treatment resulted in clinically meaningful improvements in as early as one …
novo_nordisk

Novo Nordisk reports five-year Victoza cardiovascular safety data

March 7, 2016 Research and Development, Sales and Marketing Novo Nordisk, Victoza

Novo Nordisk has announced the top-line results from a trial investigating the cardiovascular safety of Victoza (liraglutide [rDNA origin] injection) …
csl_behring

FDA approves CSL Behring’s new haemophilia B treatment

March 7, 2016 Research and Development, Sales and Marketing CSL Behring, haemophilia

The US Food and Drug Administration (FDA) has approved CSL Behring’s Idelvion (Coagulation Factor IX (Recombinant)), a novel, long-acting albumin …

Novartis says its psoriasis drug bests Janssen’s in comparison study

March 7, 2016 Research and Development, Sales and Marketing Cosentyx, Novartis, Stelara

Novartis has announced new data from a study comparing its drug Cosentyx to Janssen’s Stelara, which it says demonstrates Cosentyx’s …
teva_copy

Teva suffers EpiPen generic setback after FDA rejection

March 4, 2016 Medical Communications, Research and Development FDA, Teva, analphylaxis, approval, auto injector, auto-injector, rejection

The release of Teva Pharmaceuticals generic for the anaphylaxis treatment, EpiPen (epinephrine), is now expected to be severely delayed after …
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Sanofi Genzyme present positive Phase 2 results for fatal neuromuscular disease treatment

March 4, 2016 Medical Communications, Research and Development Pompe disease, Sanofi, clinical trial, neuromuscular, phase 2

Sanofi Genzyme, the branch of the French-based pharma company that focuses on diseases difficult to diagnose and treat, have published …
baxalta

Baxalta seeks European marketing rights for haemophilia drug

March 3, 2016 Research and Development, Sales and Marketing Adynovi haemophilia a, Baxalta

Baxalta says it has filed for marketing authorisation for its haemophilia drug Adynovi with European regulators. The European Medicines Agency …
ucb_logo_and_chief_executive

UCB targets regulatory filing for its osteoporosis drug in 2016

March 3, 2016 Medical Communications, Research and Development, Sales and Marketing Romosozumab, UCB Pharma, osteoporosis

Belgian drug company UCB says it is looking at a regulatory filing for its trial drug romosozumab to treat osteoporosis …
the_european_molecular_biology_laboratory

Merck announces drug discovery collaboration with European Molecular Biology Laboratory

March 3, 2016 Research and Development Cancer, Merck, biomarkers

Merck has announced that it has entered into a research collaboration with the European Molecular Biology Laboratory (EMBL), that will …
amgen_flag

Amgen sues Novartis over Enbrel biosimilar

March 3, 2016 Research and Development, Sales and Marketing Amgen, Novartis, Sandoz, biosimilars

Amgen has filed a suit in a US court against Novartis’ generics unit Sandoz, in a bid to protect bestselling …
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