FDA: Page 112
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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 -
Amgen scores priority review for chronic heart failure drug
Amgen received a fast-track designation for the treatment in May.
By Nicole Gray • Aug. 29, 2014 -
Final guidance: NICE recommends Biogen Idec's Tecfidera for RRMS
After an initial rejection in February, NICE has decided to recommend Tecfidera (dimethyl fumarate) -- with limitations.
By Nicole Gray • Aug. 29, 2014 -
NICE sounds costs concerns over BI's Jardiance, requests more data
The agency will not recommend BI's latest type 2 diabetes drug without more information about its cost-effectiveness.
By Nicole Gray • Aug. 29, 2014 -
Deep Dive
The biosimilars are coming: Tackling uncertainty and interchangeability
The Generic Pharmaceutical Association says biosimilar interchangeability "is the engine that drives generic competition." But how do we create a working definition for it?
By Nicole Gray • Aug. 28, 2014 -
EU approves BMS's Daklinza for hep C combo therapy
Using Bristol-Myers Squibb's (BMS) Daklinza (daclastavir) in combination with Sovaldi on advanced HPV-C patients yielded up to a 100% cure rate in clinical trials.
By Nicole Gray • Aug. 28, 2014 -
Velphoro wins EU approval for treating hyperphosphalemia
This phosphate binder will provide patients with a (wildberry-flavored) chewable treatment option that requires fewer pills than the current standard of care.
By Nicole Gray • Aug. 28, 2014 -
FDA
GSK's Promacta scores FDA approval for rare bone marrow disorder
This is the second FDA approval GlaxoSmithKline (GSK) has received for Promacta (eltrombopag).
By Nicole Gray • Aug. 28, 2014 -
FDA
Deep DiveThe biosimilars are coming: Why Basaglar and Zarzio are harbingers of a new pharma landscape
Biosimilars. Follow-on biologics. Subsequent-entry biologics. Call them what you want -- generic versions of branded biologics are a reality. But there's still work to be done on improving these products' approval pathway.
By Nicole Gray • Aug. 27, 2014 -
FDA approves Iroko's Zorvolex for treatment of osteoarthritis pain
Zorvolex (diclofenac) is the first FDA-approved, low-dose NSAID developed using Iroko’s SoluMatrix Fine Particle Technology.
By Nicole Gray • Aug. 27, 2014 -
MultiCell Tech scores patent for cancer-fighting immunotherapy platform
The immunotherapy shifts immune system response to viral infections and cancer alike -- and the new patent covers both MultiCell's drug compositions and platform technologies.
By Nicole Gray • Aug. 27, 2014 -
EMA prepares to review new Cubist antibiotic
Cubist has also submitted ceftolozane/tazobactam to the FDA for consideration as a treatment for complicated urinary tract and intra-abdominal infections.
By Nicole Gray • Aug. 26, 2014 -
Actavis, UCB Pharma butt heads over generic Neupro
UCB Pharma, the manufacturer of Neupro (rotigotine), is suing Actavis to stop commercialization of rotigotine before the expiration of certain US patents.
By Nicole Gray • Aug. 26, 2014 -
Pfizer, GSK's Viiv Healthcare nabs FDA approval for 3-in-1 HIV drug
Could ViiV's Triumeq outsell Gilead's own triple-combo, Atripla?
By Nicole Gray • Aug. 25, 2014
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