FDA: Page 114
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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 -
Pfizer, BMS score FDA hat-trick with another Eliquis approval
Eliquis (apixiban) can now be used to treat and prevent deep-vein thrombosis (DVT) and pulmonary embolism (PE).
By Nicole Gray • Aug. 22, 2014 -
FDA approves GSK asthma inhaler Arnuity Ellipta
Arnuity Ellipta (fluticasone furoate) is a once-daily inhaler for asthma maintenance or prophylactic asthma therapy in patients aged 12 and up.
By Nicole Gray • Aug. 21, 2014 -
NICE reverses course, recommends Celgene's Revlimid for rare MDS form
UK's NICE had previously decided that Revlimid (lenalidomide) should not be funded for treatment of myelodysplastic syndrome (MDS) over questions of the drug's ability to extend lives.
By Nicole Gray • Aug. 21, 2014 -
Hospira wins temporary restraining order against Precedex generics
A federal judge has issued a temporary restraining order blocking the FDA's decision to allow generic versions of Hospira's IV sedative.
By Sy Mukherjee • Aug. 20, 2014 -
1000s of companies revolt against Obamacare medical device tax
A federal audit finds that device tax revenues are far lower than expected, driven by companies' non-compliance.
By Sy Mukherjee • Aug. 20, 2014 -
Lilly, Boehringer win tentative FDA approval for Sanofi diabetes biosimilar
The provisional nature of the approval for this long-acting insulin is not based on safety concerns, but rather an ongoing patent-infringement spat with Sanofi.
By Nicole Gray • Aug. 20, 2014 -
Novo hit with fine for stalling Tresiba rejection disclosure
The company denies any wrongdoing, but agrees to pay an $89,000 fine.
By Nicole Gray • Aug. 20, 2014 -
Pfizer files NDA for breast cancer breakthrough therapy
Palbociclib was designated as a breakthrough treatment by the FDA last year based on interim data showing significant improvements in progression-free survival (PFS) for breast cancer patients.
By Nicole Gray • Aug. 19, 2014 -
Eisai files thyroid cancer drug in US, EU
This first-in-class treatment was filed in Japan in late June. It has been granted orphan drug designation in Japan, the EU and the US.
By Nicole Gray • Aug. 19, 2014
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