FDA: Page
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Amgen's Repatha becomes world's first approved PCSK9 inhibitor
Repatha (evolocumab) was approved in the E.U. for treatment of uncontrolled hypercholesterolemia when other treatment regimens are not sufficient.
By Nicole Gray • July 22, 2015 -
FDA chastises Vista Pharma for not paying generic drug user fees
This is the fourth time this month that the FDA has sent a warning letter to a generics company for failure to pay GDUFA fees on time.
By Nicole Gray • July 21, 2015 -
Bristol-Myers' rock star Opdivo continues to roll, this time in kidney cancer
An ongoing trial was stopped early after Opdivo proved more effective than everolimus in providing a survival advantage.
By Nicole Gray • July 20, 2015 -
Novogen gets FDA approval for Anisina orphan drug status
Anisina is being developed to treat neuroblastoma, with a focus on children.
By Nicole Gray • July 20, 2015 -
FDA grants AbbVie's anti-tau drug orphan status
ABBV-8E12 is being developed to treat progressive supranuclear palsy (PSP), a rare neurodegenerative disease.
By Nicole Gray • July 20, 2015 -
NICE recommends Daiichi Sankyo's oral blood thinner
Lixiana (edoxaban) is a cost-effective drug, according to the National Institute of Care and Excellence.
By Nicole Gray • July 20, 2015 -
WHO prequalifies Novartis' Coartem for malaria
The newest formulation of Coartem is the first and only high strength ACT antimalarial treatment available for large-scale public use.
By Nicole Gray • July 20, 2015 -
Deep Dive
Innovation vs. access: The big drug battle in Trans-Pacific Partnership negotiations
The generics industry worries over the intellectual property provisions of the complex trade agreement.
By Nicole Gray • July 17, 2015 -
FDA huddles with Google to improve adverse-event reporting
The FDA Adverse Event Reporting System (FAERS) does not capture all events because of underreporting.
By Nicole Gray • July 17, 2015 -
FDA
Teva gets FDA OK to market generic Axert
Teva will enjoy market exclusivity for a few months until the migraine drug's patent expires.
By Nicole Gray • July 16, 2015 -
BMS nabs EU approval for once-daily HIV combo pill
Evotaz is a combination of BMS' Reyataz (atazanavir), a protease inhibitor, and Gilead's Tybost, a pharmacokinetic enhancer.
By Nicole Gray • July 16, 2015 -
Allergan faces lost sales as Namenda generics hit market
The drug giant is anticipating a $200 million loss in forecasted sales.
By Nicole Gray • July 16, 2015 -
NHS Scotland approves funding for five new drugs
Patients in Scotland now have access to newly covered drugs for thyroid cancer, pulmonary arterial hypertension, Crohn's disaease and other conditions -- but Lyparza, used to treat ovarian cancer, was rejected for funding.
By Nicole Gray • July 15, 2015 -
EU agency to investigate HPV vaccine safety
The European Medicines Agency maintains that the benefits of vaccination against HPV outweigh the risks, but that inquiry into side effects is warranted.
By Nicole Gray • July 15, 2015 -
FDA approves AZ's Iressa for lung cancer
IRESSA (gefitinib) tablets are approved for first-line use in patients with metastatic non-small cell lung cancer (NSCLC).
By Nicole Gray • July 14, 2015 -
Amgen awaiting FDA decision on cancer drug Kyprolis
The drug currently is used as a third-line treatment for multiple myeloma.
By Nicole Gray • July 13, 2015 -
Janssen-Cilag's Imbruvica approved in EU to treat rare blood cancer
It now is approved in all 28 member states to treat Waldenstrom’s macroglobulinemia (WM).
By Nicole Gray • July 13, 2015 -
In reversal, NHS making Takeda's Entyvio available to Crohn's patients
Entyvio (vedolizumab) was initally denied for coverage by the UK's National Institute for Health and Care Excellence (NICE) in December 2014.
By Nicole Gray • July 12, 2015 -
FDA approves Otsuka/Lundbeck drug for both depression and schizophrenia
Rexulti (brexipiprazole) is approved for treatment of adults, including use as adjunctive therapy in patients with major depressive disorder (MDD) and montherapy in patients with schizophrenia.
By Nicole Gray • July 12, 2015 -
House overwhelmingly votes to pass 21st Century Cures FDA reform bill
The final vote tally was 344-77. Next up: A potentially more complicated landscape in the Senate.
By Sy Mukherjee • July 10, 2015 -
Will public pressure drive the FDA to approve a so-so female libido drug?
Three panel members have come out in oppostion to the med despite advocate group pressure and an intense social media campaign.
By Nicole Gray • July 10, 2015 -
FDA support for Lilly cancer drug comes down to unmet needs vs side effects
The therapy has shown increased risk of blood clots in patients.
By Nicole Gray • July 10, 2015 -
Novartis files leukemia drug Arzerra in the EU
Arzerra (ofatumumab) was developed for treatment of relapsed chronic lymphocytic leukemia (CLL).
By Nicole Gray • July 9, 2015 -
Novartis set to redraw the heart failure map with rapid approval of game-changer Entresto
This may be one of the most important pharmaceutical advances of the 21st century.
By Sy Mukherjee • July 8, 2015 -
FDA
Lilly's lung cancer drug seen as risky by FDA—but will that matter?
In one study, 9% of necitumumab-treated patients experienced blood clots.
By Nicole Gray • July 8, 2015
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