FDA: Page
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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 -
Companies collaborate to fight multidrug-resistant pathogens
A new diagnostic test is available in Europe and coming to the U.S., but that's just the first step.
By Nicole Gray • June 22, 2014 -
NICE approves Effient for broader use
The product is now acceptable for treatment of many types of acute coronary syndrome.
By Nicole Gray • June 22, 2014 -
Sivextro approved for hard-to-treat skin infections
This is the second drug covered under the FDA's new Qualified Infectious Disease Program designation.
By Nicole Gray • June 22, 2014 -
Deep Dive
Theory can outrun reality on drug approval fast track
The designation can create a buzz that is often not justified.
By Nicole Gray • June 20, 2014 -
FDA seeks to widen warning on testosterone products
The agency wants the products to include a warning about blood clots in veins.
By Randy Lilleston • June 20, 2014 -
J&J rachets up R&D through 12 new alliances
The company has many collaborations underway.
By Nicole Gray • June 20, 2014 -
J&J acquires global rights to influenza drug
If approved, the vaccine would be a new treatment approach to an age-old viral condition.
By Nicole Gray • June 20, 2014 -
Takeda halts development of prostate cancer drug
Phase III trials showed increased progression-free survival, but no significant increases in overall survival.
By Nicole Gray • June 20, 2014 -
PhRMA highlights clinical development of drugs aimed at older Americans
For people over 65, 95% of healthcare spending is for chronic diseases.
By Nicole Gray • June 20, 2014 -
Bellerophon Therapeutics moves PAH treatment into phase II
This add-on therapy could help patients who need additional support despite receiving standard-of-care treatment.
By Nicole Gray • June 20, 2014 -
Pfizer expands immuno-oncology research through Cellectics parnership
Pfizer is expanding oncology research by collaborating with Cellectics, which brings a unique immuno-oncology research platform to the partnership.
By Nicole Gray • June 19, 2014 -
NICE: More novel anticoagulant use could reduce strokes
The British agency has recommended adding novel anticoagulants to formularies throughout the UK.
By Nicole Gray • June 18, 2014 -
Gardasil approved in EU for prevention of anal cancer
The drug now has an expanded therapeutic role in Europe that also includes HPV prevention in adolescents.
By Nicole Gray • June 18, 2014 -
Pfizer, Novartis push for approval of meningitis vaccines
The two companies each have developed a vaccine to prevent a virulent form of meningitis.
By Nicole Gray • June 18, 2014 -
New prescription erectile dysfunction cream introduced to UK
Vitaros (alprostadil cream) is the first cream available for treating erectile function.
By Nicole Gray • June 18, 2014 -
JNJ partners with Viiv to create new combo HIV drug
The medication could end up rivaling Atripla.
By Nicole Gray • June 17, 2014 -
Intarcia presents positive phase III data on a once-yearly diabetes drug
The new therapy may be the key to controlling high blood sugar levels. Intarcia presented positive data at ADA 2014.
By Nicole Gray • June 17, 2014
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