FDA: Page 118
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EMA to review programmed-death cell drug for cancer treatment
If approved, this drug will be the first PD-1 cancer treatment in Europe.
By Nicole Gray • July 3, 2014 -
France recommends use of off-label Avastin for AMD
Lawmakers are focused on cost savings, but cite evidence-based efficacy and safety as justification.
By Nicole Gray • July 2, 2014 -
Pozen takes aspirin/omeprazole combo back to FDA
The company has addressed concerns over its manufacturing facility.
By Nicole Gray • July 2, 2014 -
MannKind gets major boost after FDA approves inhaled insulin
This approval is a long time coming and could have a major impact on compliance among diabetes patients.
By Nicole Gray • June 30, 2014 -
Janssen files for expanded use of Velcade in EU patients
The company wants to make the drug available for patients with mantle cell lymphoma.
By Nicole Gray • June 30, 2014 -
NICE changes its position on Glivec use
The agency is liberalizing its previous stance even though the drug costs more than $35,000 per year.
By Nicole Gray • June 30, 2014 -
CHMP approves BMS' combo hep C therapy
The treatment is moving forward in Europe.
By Nicole Gray • June 30, 2014 -
Viiv's HIV combo drug recommended for approval by EMA advisers
It's likely the drug will become a formidable competitor to Gilead's Atripla.
By Nicole Gray • June 30, 2014 -
EMA recommends approval of Lilly's Lantus biosimilar
The decision marks a landmark moment for the biosimilars industry.
By Nicole Gray • June 27, 2014 -
EU advisors recommend Avastin for refractory ovarian cancer
The drug will be used in combination with chemotherapy to improve outcomes.
By Nicole Gray • June 27, 2014 -
Generic version of Diovan from India approved by FDA
This is the first generic version of the blood pressure drug available in the U.S.
By Nicole Gray • June 27, 2014 -
Boehringer's Pradaxa reversal drug gets breakthrough therapy status
The ability to reverse anticoagulation could help Pradaxa become the leading anticoagulant.
By Nicole Gray • June 27, 2014 -
Eisai files NDA for lenvatinib in Japan
Thyroid cancer affects up to 29,000 people in Japan.
By Nicole Gray • June 27, 2014 -
Deep Dive
4 takeaways about the U.S. biosimilars market
Take a deeper look at the emerging market, which could trigger a substantial reduction in key healthcare costs.
By Nicole Gray • June 26, 2014 -
NICE recommends Invokana for diabetes
This is the 10th drug that NICE has recommended for treatment of type 2 diabetes.
By Nicole Gray • June 26, 2014 -
FDA
FDA requests additional information on AstraZeneca's ovarian cancer drug
The agency has concerns related to efficacy and safety.
By Nicole Gray • June 26, 2014 -
High-dose liraglutide may be the next weight-loss breakthrough
It decreases risk of progression to diabetes in individuals with pre-diabetes.
By Nicole Gray • June 26, 2014 -
EMA grants orphan drug status to multiple myeloma treatment
Marizomib now has orphan drug status in the EU and the US.
By Nicole Gray • June 25, 2014 -
Roche applies for IND for idiopathic pulmonary fibrosis treatment
Erivedge was designated a breakthrough therapy for treatment of basal cell carcinoma.
By Nicole Gray • June 25, 2014 -
Bayer, Dimension Therapeutics collaborating on hemophilia A gene therapy
If the treatment makes it to market, it will be a major game-changer for patients.
By Nicole Gray • June 25, 2014 -
Inovio initiates early-stage clinical trials for cervical cancer drug
The candidate is part of the emerging class of immuno-oncologic drugs.
By Nicole Gray • June 25, 2014 -
Indian Health Ministry likely to expand list of essential medications, cap costs
The decision has major implications for American drug manufacturers.
By Nicole Gray • June 24, 2014 -
Kala Pharma advances clinical testing of ocular drug
The nanotechnology-based drug is being evaluated for use in dry eye disease and perisurgical inflammation of the eye.
By Nicole Gray • June 24, 2014 -
MacroGenic moves into phase 1 with new leukemia drug
This first-in-class candidate has a dual mechanism of action.
By Nicole Gray • June 24, 2014 -
Boehringer Ingelheim stops development of hepatitis C drug
The company cites the competitive landscape as the determining factor.
By Nicole Gray • June 24, 2014
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