FDA: Page 115
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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 -
Pharmacist tied to tainted steroids, meningitis outbreak case arrested at airport
This is the first arrest stemming from the 2012 tainted steroid scandal that infected hundreds with meningitis and killed 64 people.
By Sy Mukherjee • Sept. 4, 2014 -
NICE reverses course, says 'yes' to Alexion's pricey Soliris
The drug had previously been rejected for its exorbitant annual price tag of $540,000 per patient.
By Nicole Gray • Sept. 4, 2014 -
EU expands use of Allergan's Ozurdex again
Analysts consider Ozurdex a growing therapy that will nab market share from the anti-VEGF medications that currently dominate DME treatment.
By Nicole Gray • Sept. 4, 2014 -
FDA
10-year data show no link between Actos and bladder cancer risk
Eli Lilly and Takeda are submitting new epidemiological data on the drug to regulators in the US, Europe, and Japan.
By Nicole Gray • Sept. 2, 2014
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