FDA approves new indication for Novartis’ Afinitor
February 29, 2016Research and Development, Sales and Marketing Afinitor, Novartis
Novartis’ cancer drug Afinitor (everolimus) has been granted FDA approval in a new indication: for the treatment of adult patients …
Eisai slams new Cancer Drugs Fund for delaying patient access
February 26, 2016Research and Development, Sales and Marketing Cancer Drugs Fund, Eisai, Lenvima
Eisai has aimed strong criticism at NHS England for its approval of reforms to the Cancer Drugs Fund, calling the …
Positive CHMP opinion for Gilead’s Descovy
February 26, 2016Research and Development Gilead Sciences
The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the EMA, has adopted a positive opinion …
Boehringer’s OFEV slows IPF disease progression by half in trials
February 26, 2016Research and Development, Sales and Marketing Boehringer Ingelheim, IPF, ofev
Boehringer Ingelheim has revealed pooled analysis data from three trials, showing that its drug OFEV significantly reduces the risk of …
INTERVIEW: AstraZeneca on the Cancer Drugs Fund reforms
February 26, 2016Medical Communications, Research and Development, Sales and Marketing Cancer Drugs Fund
Greg Rossi, head of the Oncology Business Unit, AstraZeneca UK and Ireland, and the company’s market access team, spoke to …
Bayer names Werner Baumann new CEO
February 26, 2016Medical Communications Bayer
Werner Baumann will become the new chief executive of Bayer AG from May 1, the company has announced. The decision …
Obama announces acceleration of Precision Medicines Initiative
February 26, 2016Medical Communications, Research and Development Obama, Precision Medicine, cancer moonshot, genomics
A year after Barack Obama announced the $200 million Precision Medicines Initiative (PMI), the US President yesterday outlined the next …
MHRA approves new indication for MSD’s Ezetrol
February 26, 2016Medical Communications, Research and Development, Sales and Marketing MHRA, MSD, NICE, ezetrol
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication for MSD’s Ezetrol (ezetimibe), making it …
NHS England approves Cancer Drugs Fund proposals
February 26, 2016Medical Communications, Research and Development ABPI, Cancer Drugs Fund, NHS England
NHS England has approved proposed reforms of the Cancer Drugs Fund, following the end of the 12-week consultation period earlier …
EMA recommends AZ/Acerta drug for orphan status in three indications
February 25, 2016Research and Development AstraZeneca, EMA, Orphan Drugs
The European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has recommended AstraZeneca and Acerta’s acalabrutinib (ACP-196) for designation …
The Medicines Patent Pool – five years on
February 25, 2016Research and Development, Sales and Marketing
Introduction The Medicines Patent Pool (MPP) was founded five years ago as a program to improve access to affordable and …
Gilead announces HIV regimen trial results
February 25, 2016Medical Communications, Research and Development, Sales and Marketing Gilead Sciences
Gilead Sciences has reported 48-week Phase III trial results suggesting fixed-dose Emtriva and tenofovir alafenamide (F/TAF) combinations matched its Truvada …
Senate confirms Dr Robert Califf to lead FDA
February 25, 2016Medical Communications Drug pricing, FDA, Robert Califf
The US Senate has confirmed Dr Robert Califf as Commissioner of the Food and Drugs Administration, in an overwhelming 89-4 …
European Commission approves Lilly’s Portrazza for NSCLC
February 24, 2016Research and Development Eli Lilly, Portrazza
The European Commission has approved Eli Lilly’s Portrazza (necitumumab), in combination with gemcitabine and cisplatin chemotherapy, as a first-line treatment …
J&J fined $72 million in talc cancer case
February 24, 2016Research and Development, Sales and Marketing Johnson & Johnson
A Missouri jury has ruled that Johnson & Johnson must pay $72 million to the family of an Alabama woman, …
Janssen says cabotegravir/rilpivirine combo matches three-drug HIV maintenance therapy
February 24, 2016Research and Development Janssen, ViiV
Janssen has announced 32-week data from an ongoing phase IIb study of an HIV regimen comprised of its rilpivirine and …
NeuroVive board selects Erik Kinnman as new CEO
February 23, 2016Mitochondrial medicine specialist NeuroVive Pharmaceutical’s board of directors has selected Erik Kinnman as the company’s new chief executive, from March …
Novo Nordisk says Tresiba reduces hypoglycaemia risk vs Lantus
February 23, 2016Manufacturing and Production, Research and Development Novo Nordisk
Novo Nordisk has announced trial results suggesting that its drug Tresiba (insulin degludec) carries a reduced risk of hypoglycaemia episodes, …
Valeant likely to restate financial results after Philidore review
February 23, 2016Manufacturing and Production, Medical Communications, Sales and Marketing Howard Schiller, Philidore, Valeant
Valeant says it is likely to restate its financial results for the last two years, in the wake of the …
ViiV completes BMS HIV pipeline purchase
February 23, 2016Manufacturing and Production, Medical Communications, Research and Development Bristol-Myers Squibb, GSK, HIV, Pfizer, Shionogi, ViiV
ViiV Healthcare has completed its previously-announced acquisition of Bristol-Myers Squibb’s late-stage HIV R&D assets and its portfolio of preclinical and …
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