FDA: Page 116
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FDA
Cytori's stock plummets as stem-cell clinical trials are halted
The San Diego-based company has halted clinical trials of its stem-cell therapy in heart-failure patients due to safety concerns.
By Nicole Gray • Aug. 7, 2014 -
Pfizer to pay $35 million in Rapamune settlement
Wyeth, a subsidiary of Pfizer since 2009, was accused of deceptive marketing practices in 42 states.
By Nicole Gray • Aug. 7, 2014 -
Pfizer's Enbrel approved in the EU for rare inflammatory disease
Approval is based on strong clinical data showing significant improvement in disease activity compared with a placebo.
By Nicole Gray • Aug. 7, 2014 -
EU approves Avastin for recurrent ovarian cancer
In clinical studies, adding Avastin (bevacizumab) to chemotherapy increased progression-free survival (PFS) from 3.4 to 6.7 months.
By Nicole Gray • Aug. 7, 2014 -
Australia's drug regulator says Pradaxa safety advice will not change
Consumer health groups have requested a safety review of the drug because of deaths and adverse events.
By Nicole Gray • Aug. 6, 2014 -
UK to fund Roche's cash-saving cancer injection
The National Health Service (NHS) plans to save money by funding a subcutaneous formulation of the widely used cancer drug MabThera SC.
By Nicole Gray • Aug. 6, 2014 -
FDA
AbbVie's glioblastoma drug granted orphan status in US, EU
Promising phase I data prompted ABT-414's orphan drug designation.
By Nicole Gray • Aug. 6, 2014 -
Deep Dive
Prevention efforts critical as HIV stigma falls
Now that the CDC has issued HIV prevention guidelines, will use of Gilead's Truvada as a preventative medication take hold?
By Nicole Gray • Aug. 5, 2014 -
FDA expands use of Genzyme's Pompe disease treatment for young children
In addition to allowing children younger than eight with Pompe disease to be treated with Lumizyme (alglucosidade alfa), the FDA is also eliminating the REMS program for the drug.
By Nicole Gray • Aug. 4, 2014 -
FDA approves Boehringer/Eli Lilly Alliance type 2 diabetes drug
Jardiance (empagliflozin) can be used as a monotherapy or as part of a combination therapy.
By Nicole Gray • Aug. 4, 2014 -
Allergan files federal lawsuit against Valeant, Pershing Square
Allergan is accusing Valeant and Pershing Square of federal securities law violations, including insider trading and failing to disclose legally required information.
By Sy Mukherjee • Aug. 1, 2014 -
FDA
FDA unveils first-ever plans to regulate genetic diagnostic testing
“Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA,” said FDA Commissioner Dr. Margaret A. Hamburg.
By Sy Mukherjee • Aug. 1, 2014 -
Gilead scores exclusive licensing rights for Theraclone's HIV antibodies
Under the agreement, Gilead will have sole rights for creating and distributing products that use Theraclone's broadly neutralizing HIV-antibodies.
By Nicole Gray • July 31, 2014 -
WHO plans $100 million emergency response as Ebola deaths top 700
“The scale of the Ebola outbreak, and the persistent threat it poses, requires WHO and Guinea, Liberia and Sierra Leone to take the response to a new level,” said WHO Director-General Dr. Margaret Chan.
By Sy Mukherjee • July 31, 2014 -
Adamis tries to make its mark with low-cost epinephrine injector
If approved, this will be the first revenue-generating product for Adamis.
By Nicole Gray • July 31, 2014 -
FDA approves Eylea for treatment of DME
This is the third indication in the US for this drug, which is co-marketed by Bayer and Regerenon.
By Nicole Gray • July 31, 2014 -
Novartis' Simbrinza approved for glaucoma treatment in the EU
In clinical studies, Simbrinza lowered elevated intraocular pressure by as much as 37%.
By Nicole Gray • July 30, 2014 -
Generic drug use is saving UK's NHS $21 billion per year
The largest cost-savings have stemmed from more affordable versions of Lipitor.
By Nicole Gray • July 30, 2014 -
US-based Alimera Sciences gets approval to market Iluvien in Norway
The company’s strategy centers on broad penetration of the European market as well as gaining drug approvals in the US.
By Nicole Gray • July 30, 2014 -
AcelRx stock tumbles on FDA rejection of pain pill dispenser
AcelRx's stock was down almost 35% on the news.
By Nicole Gray • July 29, 2014 -
Two diabetes treatments recommended for EMA approval
Advisers have recommended drugs to improve glycemic control and decrease the rate of vision loss in diabetics.
By Nicole Gray • July 28, 2014 -
Gilead, Janssen-Cilag blood cancer drugs headed for European approval
35% of all leukemia cases are categorized as chronic lymphocytic leukemia (CLL).
By Nicole Gray • July 28, 2014 -
Investigation raises new questions about Boehringer's blood thinner
Boehringer Ingelheim goes on the defensive as British Medical Journal investigators express concerns about the drug's clinical study design and data calculations.
By Nicole Gray • July 25, 2014 -
GSK vies for approval of first-ever malaria vaccine
GSK has submitted an application to the EMA for a potential malaria vaccine, RTS,S. The application is supported by phase III trials in 13 different study centers in sub-Saharan Africa.
By Nicole Gray • July 25, 2014 -
Gilead enters the cancer drug arena as FDA approves Zydelig
Zydelig (idelalisib) has been approved by the FDA to treat certain blood cancers.
By Nicole Gray • July 24, 2014
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