FDA: Page 110
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Zogenix files for addiction-fighting version of controversial pain pill Zohydro
In the face of anti-opiate crackdowns, Zogenix wants to transition to the harder-to-abuse formulation of its potential blockbuster painkiller Zohydro ER by Q2 2015.
By Sy Mukherjee • Oct. 1, 2014 -
Report: 700-plus biosimilars in development worldwide
Thomson Reuters Bioworld reports that 245 biopharma companies are at work on biosimilars -- a market segment with projected sales of $25 billion by 2019.
By Nicole Gray • Sept. 30, 2014 -
Deep Dive
Access wanted: What it takes for patients to get the drugs they need
The U.S. ranks 7th in terms of patient access to drugs, right alongside Central and South America -- and different patient groups face their own unique barriers to access.
By Nicole Gray • Sept. 30, 2014 -
FDA rejects anti-addiction rule that would ban crushable Ritalin, opiates
The FDA has no plans to force drug makers to reformulate addictive medications to make them harder to abuse -- for now.
By Sy Mukherjee • Sept. 30, 2014 -
EU regulators to patients: Help us evaluate drugs
This is the first time that patients have ever been invited to participate in risk/benefit conversations by the European Medicines Agency.
By Nicole Gray • Sept. 29, 2014 -
AbbVie racks up another Humira approval from the FDA
The FDA has approved Humira (adalimumab) for the treatment of pediatric Crohn’s disease in patients as young as six.
By Nicole Gray • Sept. 29, 2014 -
15 new medications headed toward EU approval
The European Medicines Agency (EMA) is starting to review a roster of recently recommended medicines, including treatments for cancer, COPD, diabetes, HIV, hepatitis C, and Cushing’s syndrome.
By Nicole Gray • Sept. 29, 2014 -
Actavis to continue sales of cheaper Alzheimer's drug for 60 days
The response to Actavis' "forced switch" from Namenda (memantine) IR to the new Namenda XR formulation has been contentious -- and litigious.
By Nicole Gray • Sept. 26, 2014 -
Federal judge dismisses racketeering charges against AbbVie, Abbott
AbbVie and Abbott dodge a RICO conviction over allegedly forcing health plans to pay unnecessarily for pricey Humira and AndroGel instead of generics.
By Sy Mukherjee • Sept. 26, 2014 -
Almirall, AZ big winners as key committee recommends COPD combo
An EMA advisory committee is recommending a combo therapy using Eklira (aclidinium) and formeterol. And that's good news for AstraZeneca.
By Nicole Gray • Sept. 26, 2014 -
BI scores an FDA approval for mist-based COPD drug
After rejecting Spiriva (tiotropium) Respimat in 2008, the FDA has approved the mist version of Spiriva, giving patients the choice to use another version of the widely used COPD drug.
By Nicole Gray • Sept. 26, 2014 -
Novartis to seek approval for potential psoriatic arthritis blockbuster
Novartis has a promising candidate for an increasingly competitive psoriatic arthritis therapeutic market.
By Nicole Gray • Sept. 26, 2014 -
Cost concerns drive UK authority to spurn popular ulcerative colitis drugs
UK's NICE will deny funding for three of the top ulcerative colitis treatments from Merck and AbbVie, citing lack of sufficient evidence of clinical efficacy and cost-effectiveness.
By Nicole Gray • Sept. 25, 2014 -
FDA approves Celgene's potential blockbuster Otezla for psoriasis
This is Otezla's second approval in six months.
By Nicole Gray • Sept. 25, 2014 -
India's drug-pricing authority drops price caps on nonessential drugs
A simple message on the NPPA website announced that price caps for nonessential drugs would be eliminated -- effective immediately.
By Nicole Gray • Sept. 25, 2014 -
Nigerian health minister declares Nigeria 'Ebola-free'
“Presently, there is no single case of Ebola virus disease in Nigeria. None.” - Dr. Onyebuchi Chukwu
By Nicole Gray • Sept. 24, 2014 -
CDC: Dire outlook for Ebola in West Africa
Up to 1.4 million people could be infected by January 2015, according to CDC experts.
By Nicole Gray • Sept. 24, 2014 -
Deep Dive
Does this month mark the beginning of a new era in cancer care?
Merck’s widely touted humanized PD-1 antibody is likely to win U.S. approval within the month, making it the first FDA-approved PD-1 drug -- and ushering in a new era of immuno-oncology.
By Nicole Gray • Sept. 23, 2014 -
Tax-inversion hopefuls balk at new White House plans to curb deals
Companies whose tax-shifting mergers aren't finalized are nervous about the Obama admin's "first, targeted steps" to curb the increasingly popular deals.
By Sy Mukherjee • Sept. 23, 2014 -
Wales NHS approves Celgene's Abraxane for pancreatic cancer
The approval lies in stark contrast with NICE's decision to reject the drug in the UK.
By Nicole Gray • Sept. 23, 2014 -
UK public health advocates: Boys need HPV vaccine, too
US, Australia, Austria and parts of Canada already make the vaccine available for boys. Will the UK join them?
By Nicole Gray • Sept. 23, 2014 -
Amgen seeks FDA approval for breakthrough orphan leukemia drug
The FDA is reviewing Amgen's immunotherapy cancer drug, blinatumomab, for treatment of certain forms of acute lymphoblastic leukemia (ALL).
By Nicole Gray • Sept. 23, 2014 -
UPDATED: Tekmira tempers expectations as regulators clear Ebola drug for emergency use
Patients in the U.S. and Canada will have access to TKM-Ebola, while a charitable organization is issuing grants to expedite clinical trials of the drug and two other Ebola treatments.
By Sy Mukherjee • Sept. 23, 2014 -
India's Sun Pharma, Merck pen unique $80M development deal
Most Indian pharma companies reverse-engineer patented products. Not this time.
By Nicole Gray • Sept. 22, 2014 -
Gilead's Zydelig approved in the EU for rare blood cancers
Treatment could cost $7,000 to $7,500 per month if U.S. prices are any indication.
By Nicole Gray • Sept. 22, 2014
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