FDA: Page 110
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EU reverses course, won't cede drug-related decisions to pharma
President-elect Jean-Claude Juncker's plan to shift the EMA from the Directorate General (DG) for Health and Consumers to DG Enterprise and Industry has been scrapped after considerable backlash.
By Nicole Gray • Oct. 24, 2014 -
EMA establishes expedited review framework for Ebola vaccines
The European Medicines Agency (EMA) has established an elite group of infectious disease specialists to help rapidly review Ebola vaccine submissions.
By Nicole Gray • Oct. 24, 2014 -
Deep Dive
Best of BD: Biosimilars in China: The coming revolution
Despite a less rigorous approach to approving biosimilars, China has several approved follow-on biologics—and a growing number of biotechs want to develop biosimilars that meet global standards.
By Nicole Gray • Oct. 22, 2014 -
Lilly, Boehringer fixed-dose diabetes combo could win FDA blessing soon
The FDA has agreed to review the empagliflozin/metformin fixed-dose combo from Eli Lilly and Boehringer Ingelheim.
By Nicole Gray • Oct. 22, 2014 -
Study: Parkinson's disease drugs make some patients want to party
The dopamine agonists used to treat Parkinson's patients can sometimes lead to an obsession with gambling and pornography, research finds.
By Nicole Gray • Oct. 22, 2014 -
FDA
How the FDA plans to stop facilities from undermining inspections
New FDA guidance regarding conduct during facility inspections outlines expectations for manufacturers—and for the FDA.
By Nicole Gray • Oct. 22, 2014 -
PhRMA fights back, blames insurance companies for drug access woes
AccessBetterCoverage.org is choc-full of insurance facts. But its real message is that health insurers, and not pharma, are guilty of shifting drug costs onto consumers.
By Nicole Gray • Oct. 21, 2014 -
EMA approves J&J's Imbruvica for two rare blood cancers
The likelihood of Imbruvica not being approved in any given market is slim.
By Nicole Gray • Oct. 20, 2014 -
EU contemplates adaptive licensing in the face of Ebola threat
The European Medicines Agency (EMA) has been developing a regulatory framework for quickly approving unauthorized drugs to be used to treat Ebola.
By Nicole Gray • Oct. 20, 2014 -
FDA
US orders 3 state-of-the-art labs to ramp up Ebola drug ZMapp production
The Biomedical Advanced Research and Development Authority (BARDA) has reached out to three advanced biology labs for detailed production plans for ZMapp.
By Nicole Gray • Oct. 20, 2014 -
FDA
Fearing creation of deadlier viruses, US tells scientists to halt bird flu research
Federal officials have decreed that certain studies involving mutant forms of the SARS, MERS, and influenza viruses be halted pending a thorough review of risks and benefits.
By Nicole Gray • Oct. 20, 2014 -
FDA approves Pfizer's addiction-fighting pain pill as US heroin deaths soar
Pfizer's Embeda (morphine and naltrexone) is the third abuse-deterrent painkiller to be approved by the FDA.
By Nicole Gray • Oct. 20, 2014 -
Sorry, Pfizer: FDA won't nix black box suicide warning for Chantix
As predicted, the FDA was skeptical of Pfizer's new data showing the controversial anti-smoking drug doesn't raise suicide risk.
By Sy Mukherjee • Oct. 17, 2014 -
Potential Novartis psoriasis blockbuster inches closer to approval
Secukinumab's likely approval will usher in a new era wherein interleukin-17 (IL-17) inhibitors compete head-to-head with tumor necrosis factor (TNF) blockers in the plague psoriasis market.
By Nicole Gray • Oct. 16, 2014 -
EMA considers relaxing clinical trial rules for rare-cancer patients
Representatives from Rare Cancers Europe (RCE) have asked the EMA to allow patients with rare cancers to gain earlier access to experimental drugs—even if that means bending the rules.
By Nicole Gray • Oct. 16, 2014 -
AbbVie-Shire deal effectively dead in the water
The Obama administration's renewed push to curb tax-inversion mergers claims its first victim.
By Sy Mukherjee • Oct. 16, 2014 -
FDA to generic drug makers: Looks matter
The FDA is concerned that differences between the appearance of branded drugs and their generic equivalents could negatively impact compliance and lead to medication errors.
By Nicole Gray • Oct. 16, 2014 -
FDA approves two competing 'breakthrough' IPF drugs in one day
The approval of Roche's Esbriet (pirfenidone) and Boehringer's Ofev (nintedanib) pits the two pharma giants against each other.
By Nicole Gray • Oct. 16, 2014 -
FDA approves telescope implant for younger end-stage AMD patients
VisionCare Ophthalmic Technologies' implantable miniature telescope may now be used on patients 65 and older with end-stage macular degeneration.
By Nicole Gray • Oct. 15, 2014 -
NICE to Celgene: We won't authorize NHS funding for Imnovid
The UK agency says that Imnovid (pomalidomide) doesn't offer enough benefit to justify its cost. The result? No access for multiple myeloma patients.
By Nicole Gray • Oct. 15, 2014 -
Pharma balks at new FDA final guidance on fixed-dose combinations
Pharma giants like Gilead and others with fixed-dose combos approved before last week aren't fans of the FDA's approach to determining such drugs' eligibility for market exclusivity.
By Nicole Gray • Oct. 15, 2014 -
FDA not likely to drop black box suicide warning for Pfizer's Chantix
With continued reports of psychiatric side effects and a spate of lawsuits underway, the FDA is not likely to drop the black box warning on Pfizer's Chantix despite new safety data from the company.
By Nicole Gray • Oct. 15, 2014 -
Patent battle brewing over Biogen's MS blockbuster Tecfidera
Danish firm Forward Pharma is raising $200 million for an IPO, with some proceeds going to fund patent litigation with Biogen.
By Nicole Gray • Oct. 15, 2014 -
Novartis may be fined $49M by Indian pricing authority
Novartis India has run afoul of pricing guidelines from the National Pharmaceutical Pricing Authority by pricing Voveran, considered an "essential medication," higher than allowed. A $49 million fine may follow.
By Nicole Gray • Oct. 14, 2014 -
Eisai/Helsinn's Akynzeo scores FDA approval for chemo-induced nausea
Fixed-dose combination therapy using two anti-emetics provides high levels of sustained relief for patients suffering from chemotherapy-induced nausea and vomiting (CINV).
By Nicole Gray • Oct. 14, 2014
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