FDA: Page 98
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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 -
Sanofi, Gilead get boosts in Japan with new Lantus & Harvoni approvals
Two blockbuster medications are gaining entry into a new market.
By Nicole Gray • July 7, 2015 -
Pharma's newest adversaries on CME funding are... Hotel workers?
A 270,000-person strong hotel worker's union is fighting to end what it calls "out-of-control" CME payments by the pharma industry.
By Nicole Gray • July 7, 2015 -
Will Vertex finally become profitable after FDA approval for CF drug Orkambi?
The cost of the new therapy is $259,000 per patient per year.
By Nicole Gray • July 6, 2015 -
In rare move, Purdue pulls out of abuse-deterrent OxyContin meeting with FDA
The company wants more time to review its data before moving forward with its application.
By Nicole Gray • July 2, 2015 -
FDA gives pharmacies grace period to implement 'track and trace'
It's a pretty quick reaction to industry complaints by the agency.
By Nicole Gray • July 2, 2015 -
Deep Dive
'Innovation' is everywhere in biopharma—but what does that actually mean?
Innovation has many definitions. But it can’t exist without collaborative partnerships.
By Nicole Gray • July 2, 2015 -
Open Payments: Docs got $6.5 billion from drug/device industries in 2014
Payments cover everything from product development, to R&D, to dinner speakers and various types of consulting.
By Nicole Gray • July 1, 2015 -
Generics update: FDA releases new bioequivalence guidance
The FDA has released specific testing protocols to prove bioequivalence on almost 40 drugs, including Gilead's Sovaldi (sofosbuvir).
By Nicole Gray • June 30, 2015 -
EMA validates BioMarin's Duchenne Muscular Dystrophy treatment
Of the 23,000 boys and young men in Europe with Duchenne Muscular Dystrophy (DMD), about 3,000 will be candidates for BioMarin's treatment, drisapersen, if it is approved.
By Nicole Gray • June 26, 2015
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