FDA: Page
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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 -
FDA panel recommendation paves way for Novo Nordisk obesity drug approval
Reformulating Novo Nordisk's type 2 diabetes treatment Victoza as an obesity drug could bring the company an additional $1 billion in revenues.
By Nicole Gray • Sept. 15, 2014 -
Baxter's once-monthly Hyqvia for immune disorders wins FDA approval
Patients with primary immunodeficiency typically have to receive weekly or bi-weekly treatment.
By Nicole Gray • Sept. 15, 2014 -
Advocates furious over EU decision to cede authority back to pharma
The EU's Directorate-General for Health and Consumers will no longer have responsibility over the European Medicines Agency (EMA) and drug-related decisions. Health activists are appalled.
By Nicole Gray • Sept. 15, 2014 -
Justice Department to seek contempt charges against Bayer
The Justice Department says Bayer violated a court record while promoting its consumer health product Phillips Colon Health.
By Sy Mukherjee • Sept. 12, 2014 -
EMA approves first-ever insulin biosimilar, Lilly/BI's Abrasia
The approval sets up an immediate showdown with Sanofi and its flagship insulin product, Lantus.
By Nicole Gray • Sept. 12, 2014 -
FDA panel cautiously supports polypill
The polypill combines aspirin, a statin, and one or more blood pressure pills.
By Nicole Gray • Sept. 11, 2014 -
FDA approves controversial weight loss pill Contrave
The second time's the charm for Orexigen and Takeda's highly-anticipated weight loss drug.
By Sy Mukherjee • Sept. 11, 2014 -
FDA approves expanded use of Xtandi for prostate cancer
Xtandi-treated men with chemotherapy-naïve prostate cancer were able to defer chemo for 17 months in a trial.
By Nicole Gray • Sept. 11, 2014 -
NICE demands more transparency from pharma
The agency threatens to bypass companies and go straight to regulators if pharma firms fail to provide sufficient data for review.
By Nicole Gray • Sept. 11, 2014 -
Severe misconduct: Hyperion and Evotec halt diabetes drug trial
Employees were found to have manipulated trial data to show more favorable findings.
By Nicole Gray • Sept. 11, 2014 -
FDA narrowly rejects Actavis' blood pressure combo
The agency isn't convinced the dual-treatment is more effective than monotherapy.
By Sy Mukherjee • Sept. 10, 2014 -
FTC files first-ever 'pay-for-delay' lawsuit against Teva, AbbVie
The FTC is alleging that Teva, AbbVie, and other companies have illegally blocked access to generic testosterone gel.
By Nicole Gray • Sept. 9, 2014 -
NICE rejects Celgene's Abraxane for pancreatic cancer
Abraxane (nab-paclitaxel) has failed the "value-for-money" test.
By Nicole Gray • Sept. 9, 2014 -
Montgomery County Planning Commission
BMS sues Merck over historic PD-1 cancer drug Keytruda
Merck was first to the finish line with Keytruda approval. But BMS claims it owns the rights to a crucial component of PD-1 inhibition -- and that Merck is in violation of its patent.
By Nicole Gray • Sept. 9, 2014 -
Report: Government-supported cancer services at risk in the UK
A report commissioned by Cancer Research UK finds oncologists calling for "urgent action" to address the state of cancer care.
By Nicole Gray • Sept. 9, 2014 -
Deep Dive
The statin stumper: Are new cholesterol guidelines prudent or overzealous?
There may be controversy surrounding the guidelines -- but the American Heart Association is counting on the AHA/ACC 2013 guidance to save lives.
By Nicole Gray • Sept. 9, 2014
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