FDA: Page 114
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Cost concerns drive UK authority to spurn popular ulcerative colitis drugs
UK's NICE will deny funding for three of the top ulcerative colitis treatments from Merck and AbbVie, citing lack of sufficient evidence of clinical efficacy and cost-effectiveness.
By Nicole Gray • Sept. 25, 2014 -
FDA approves Celgene's potential blockbuster Otezla for psoriasis
This is Otezla's second approval in six months.
By Nicole Gray • Sept. 25, 2014 -
India's drug-pricing authority drops price caps on nonessential drugs
A simple message on the NPPA website announced that price caps for nonessential drugs would be eliminated -- effective immediately.
By Nicole Gray • Sept. 25, 2014 -
Nigerian health minister declares Nigeria 'Ebola-free'
“Presently, there is no single case of Ebola virus disease in Nigeria. None.” - Dr. Onyebuchi Chukwu
By Nicole Gray • Sept. 24, 2014 -
CDC: Dire outlook for Ebola in West Africa
Up to 1.4 million people could be infected by January 2015, according to CDC experts.
By Nicole Gray • Sept. 24, 2014 -
Deep Dive
Does this month mark the beginning of a new era in cancer care?
Merck’s widely touted humanized PD-1 antibody is likely to win U.S. approval within the month, making it the first FDA-approved PD-1 drug -- and ushering in a new era of immuno-oncology.
By Nicole Gray • Sept. 23, 2014 -
Tax-inversion hopefuls balk at new White House plans to curb deals
Companies whose tax-shifting mergers aren't finalized are nervous about the Obama admin's "first, targeted steps" to curb the increasingly popular deals.
By Sy Mukherjee • Sept. 23, 2014 -
Wales NHS approves Celgene's Abraxane for pancreatic cancer
The approval lies in stark contrast with NICE's decision to reject the drug in the UK.
By Nicole Gray • Sept. 23, 2014 -
UK public health advocates: Boys need HPV vaccine, too
US, Australia, Austria and parts of Canada already make the vaccine available for boys. Will the UK join them?
By Nicole Gray • Sept. 23, 2014 -
Amgen seeks FDA approval for breakthrough orphan leukemia drug
The FDA is reviewing Amgen's immunotherapy cancer drug, blinatumomab, for treatment of certain forms of acute lymphoblastic leukemia (ALL).
By Nicole Gray • Sept. 23, 2014 -
UPDATED: Tekmira tempers expectations as regulators clear Ebola drug for emergency use
Patients in the U.S. and Canada will have access to TKM-Ebola, while a charitable organization is issuing grants to expedite clinical trials of the drug and two other Ebola treatments.
By Sy Mukherjee • Sept. 23, 2014 -
India's Sun Pharma, Merck pen unique $80M development deal
Most Indian pharma companies reverse-engineer patented products. Not this time.
By Nicole Gray • Sept. 22, 2014 -
Gilead's Zydelig approved in the EU for rare blood cancers
Treatment could cost $7,000 to $7,500 per month if U.S. prices are any indication.
By Nicole Gray • Sept. 22, 2014 -
UPDATED: GSK found guilty of bribery in China, fined record $489 million
Former GSK China head Mark Reilly and four others company execs were also sentenced to prison terms.
By Sy Mukherjee • Sept. 19, 2014 -
Lilly enters crowded diabetes field as FDA approves once-weekly Trulicity
Can the clinically impressive once-weekly treatment compete with Novo's Victoza?
By Sy Mukherjee • Sept. 19, 2014 -
Pharma breathes a sigh of relief as Scots say 'No' to independence
Scotland will remain part of the UK and continue to receive much of its healthcare funding from the National Health Service.
By Nicole Gray • Sept. 19, 2014 -
President Obama issues Executive Order to combat antibiotic resistance
The proposed plan earmarks $900 million annually for surveillance and research and $800 million for incentivizing pharma companies to develop new antibiotics.
By Nicole Gray • Sept. 19, 2014 -
NICE approves comprehensive funding for GSK melanoma drug Tafinlar
GSK's data was so convincing that NICE agreed to fully recommend this melanoma drug in line with its approved indication.
By Nicole Gray • Sept. 19, 2014 -
NICE agrees to fund Janssen's Olysio for hep C
But the approval comes with some unexpected restrictions.
By Nicole Gray • Sept. 19, 2014 -
Deep Dive
ICYMI: How one Shanghai pharma became a model for malaria drug production
With half the world at risk for malaria, large-scale treatment production is crucial. Pharma companies in China and France are collaborating to make it happen.
By Nicole Gray • Sept. 18, 2014 -
EU approves updated and expanded Gardasil labeling
New data from Sanofi Pasteur suggests the HPV vaccine Gardasil is effective against HPV 6,11,16, and 18.
By Nicole Gray • Sept. 17, 2014 -
UK approves first therapy under new fast-track access program
The cancer therapy DVCax-L is the very first medication to receive the Promising Innovative Medicine designation in the UK.
By Nicole Gray • Sept. 17, 2014 -
AstraZeneca's opioid constipation drug wins US approval
The FDA has approved Movantik (naloxegol) to treat opioid-induced constipation in adults with non-cancer pain.
By Nicole Gray • Sept. 17, 2014 -
Shire's ADHD blockbuster Vyvanse scores priority review for binge eating disorder
If approved, Vyvanse sales for binge eating treatment could reach $220 million by 2017, analysts say.
By Nicole Gray • Sept. 16, 2014 -
FDA panel recommends NPS Pharma's orphan drug Naptara
With a PDUFA date of October 24, things are looking good for NPS Pharma's likely blockbuster for a rare endocrine disorder.
By Nicole Gray • Sept. 16, 2014
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