FDA: Page 113
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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 -
Servier slammed for withholding antidepressant trial data
The Association of the British Pharmaceutical Industry has cited Servier for failing to disclose key data from a study of the antidepressant Valdoxan.
By Nicole Gray • Sept. 8, 2014 -
FDA gives a qualified 'yes' to Keryx's chronic kidney disease drug
But the approval come with a warning for patients.
By Nicole Gray • Sept. 8, 2014 -
FDA approves first-ever kidney injury diagnostic NephroCheck
Physicians can now use a first-in-class diagnostic to assess what’s next for critically ill patients -- but is it as accurate as it needs to be?
By Nicole Gray • Sept. 8, 2014 -
Montgomery County Planning Commission
History is made: FDA approves Merck's PD-1 inhibitor Keytruda for melanoma
With the earlier-than-expected approval, Merck beats out Bristol-Myers Squibb to become the first-ever company to have a certified PD-1 drug.
By Nicole Gray • Sept. 5, 2014 -
Viiv's 3-in-1 HIV combo drug Triumeq nabs European marketing authorization
Viiv’s new 3-in-1 oral HIV treatment gains rapid approval in the EU, just as it did in the U.S. Is it poised to outperform Atripla?
By Nicole Gray • Sept. 5, 2014
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