FDA: Page
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EU launches landmark decentralized generic drug approval pilot program
Under the International General Drug Regulators Pilot Program (IGDRP), just one approval grants marketing authorization in several countries simultaneously.
By Nicole Gray • Aug. 11, 2014 -
UK regulators say Roche's Kadcyla is too expensive
National Health Services (NHS) says the drug, combined with Herceptin as a new treatment option for inoperable, HER2-positive, metastatic breast cancer, is too pricey.
By Nicole Gray • Aug. 11, 2014 -
Sex, drugs, and bribes: More on GSK's Chinese misadventures
Unraveling a complex web of bribery allegations, sexual innuendo, and dishonest informants.
By Nicole Gray • Aug. 11, 2014 -
WHO panel to debate ZMapp, ethics of experimental Ebola treatments
The World Health Organization (WHO) is convening a panel on Monday to discuss the ethical issues surrounding administering largely untested experimental treatments during public health emergencies.
By Sy Mukherjee • Aug. 11, 2014 -
Chinese authorities imprison GSK sex tape investigator, wife
GlaxoSmithKline's strange saga in China takes a new twist.
By Sy Mukherjee • Aug. 8, 2014 -
EMA green lights Pfizer bid to broaden pneumonia vaccine use
The goal is to expand use of Prevnar 13 in older adults beyond prevention of invasive pneumococcal disease.
By Nicole Gray • Aug. 8, 2014 -
AbbVie-Shire, other inversions on the chopping block as government mulls action
President Obama and the US Treasury are looking for ways to stop American corporations from moving their headquarters offshore.
By Nicole Gray • Aug. 8, 2014 -
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
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