FDA: Page 100
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US, Cuban research firms forge historic pact on lung cancer vax development
The Roswell Park Cancer Institute is teaming up with with the Center for Molecular Immunology in Cuba in a sign of normalizing relations with America.
By Nicole Gray • April 22, 2015 -
EU's first-ever gene therapy bumps up against renewed regulatory scrutiny
Glybera is authorized to treat lipoprotein lipase deficiency and costs $1.18 million.
By Nicole Gray • April 20, 2015 -
WHO promises reforms after 'slow and insufficient' Ebola response
The agency concedes that it was not aggressive enough about alerting the world of the Ebola threat.
By Nicole Gray • April 20, 2015 -
Sandoz wins first FDA nod for generic of Teva MS flagship Copaxone
The drug brought Teva more than $3.1 billion in U.S. sales last year.
By Nicole Gray • April 17, 2015 -
FDA approves first major new heart failure drug in a decade
Amgen's Corlanor (ivabradine) is a first-in-class therapy approved to reduce hospitalization from worsening heart failure.
By Nicole Gray • April 16, 2015 -
Retrieved from Flickr.
FDA panel endorses new heart failure warnings for key AZ diabetes med
A label update seems likely at this point, but distribution will proceed normally.
By Nicole Gray • April 15, 2015 -
WHO calls for universal clinical trial transparency
The global health agency is adding to the growing chorus demanding full transparency.
By Nicole Gray • April 15, 2015 -
UPDATE: FDA says key AstraZeneca diabetes drug may 'significantly' increase death risk
The entire DPP-4 inhibitor diabetes therapeutic class is now being called into question, and the consequences could be dire for AZ, Takeda, and Merck.
By Sy Mukherjee • April 13, 2015 -
Shire nabs priority review for potential blockbuster dry eye drug
According to the company, Lifitegrast will be the first dry eye treatment designed to treat both the signs and symptoms of dry eye disease.
By Nicole Gray • April 10, 2015 -
Deep Dive
Inside the FDA labeling fight that could upend the generics market
As Ralph Neas prepares to step down as president and CEO of GPhA, he finds himself embroiled in a passionate debate that cuts to the the very heart of the Hatch-Waxman Act.
By Nicole Gray • April 8, 2015 -
Hospira gets yet another FDA warning letter before Pfizer buyout
The FDA has sent the company a letter chastising it for failure to properly investigate customer complaints.
By Nicole Gray • April 7, 2015 -
Shire bullish on 2017 approval of new, longer-lasting ADHD pill
Approval of SHP465 could allow Shire to maintain dominance of the ADHD market for more than a decade.
By Nicole Gray • April 7, 2015 -
Did Novartis try to sabotage Avastin ophthalmic trials?
Novartis and Roche manufacture Lucentis (ranibizumab) for wet AMD—a considerably more expensive treatment option than Avastin (bevacizumab).
By Nicole Gray • April 6, 2015 -
FDA
FDA issues final guidance on abuse-deterrent opioids
Guidance from the FDA focuses heavily on which studies best demonstrate whether an opioid can be considered abuse deterrent.
By Nicole Gray • April 2, 2015 -
Amgen loses Neupogen biosimilar battle—again
The request was intended to delay the introduction of biosimilar Neupogen (filgrastim).
By Nicole Gray • April 1, 2015 -
Report claims FDA is behind the times on employees' free speech
According to the Union of Concerned Scientists, the FDA does not measure up to other federal agencies when it comes to freedom of speech or social media policies.
By Nicole Gray • April 1, 2015 -
UK opposition leader gives pharma a pass on his profit margin cap proposal
Labour Party leader Ed Miliband says that pharma companies wouldn't be beholden to a proposed 5% profit margin cap.
By Nicole Gray • March 31, 2015 -
In final speech, outgoing FDA chief defends US drug approvals record
Margaret Hamburg responded to critics pushing for a faster approval process.
By Nicole Gray • March 30, 2015 -
Novo to try for US Tresiba approval once again
After an initial rejection.
By Nicole Gray • March 27, 2015 -
Obama administration releases first major long-term 'superbug' response plan
The National Action Plan for Combating Antibiotic Resistant Bacteria is broad in scope. But some say it still doesn't go far enough.
By Sy Mukherjee • March 27, 2015 -
Treatment for inhalational anthrax wins US approval
Anthrasil (Anthrax Immune Globulin) is intended to be used with appropriate antibiotics to counteract the toxins produced when Bacillus anthracis is inhaled.
By Nicole Gray • March 25, 2015 -
Regeneron's Eylea nabs yet another FDA approval for expanded label
Eylea (aflibercept) is now approved for treatment of diabetic retinopathy (DR) in patients with diabetic macular edema (DME).
By Nicole Gray • March 25, 2015 -
FDA's rare disease pediatric voucher program could become permanent
The 2012 priority review voucher program is slated to expire in a year.
By Nicole Gray • March 25, 2015 -
Montgomery County Planning Commission
Merck's Keytruda bests Yervoy, shows promise as first-line melanoma med
Can Opdivo be Bristol-Myers' saving grace?
By Nicole Gray • March 25, 2015 -
FDA to reconsider homeopathy regulatory framework after 25 years
The agency is holding a public hearing April 20-21 to seek information on homeopathic products.
By Nicole Gray • March 25, 2015
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