FDA: Page 75
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FDA
FDA hits Nicox with CRL on eye drug application
Nicox indicated the FDA's rejection of its new drug application stemmed from issues with an API supplier.
By Joe Cantlupe • Oct. 11, 2016 -
Mylan pays to settle EpiPen matter
The specialty pharma is working urgently to put price gouging accusations behind it.
By Lisa LaMotta • Oct. 10, 2016 -
Prescribed Reading: Pharma re-focuses, face-off at ESMO, Hep C boxed
Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.
By Lisa LaMotta • Oct. 6, 2016 -
FDA adds boxed warning to hepatitis C drugs
The regulator cited two deaths and 24 adverse events related to hepatitis B reactivations among patients treated with new direct-acting antivirals.
By Joe Cantlupe • Oct. 5, 2016 -
FDA wants more info from Dynavax over Hep B vaccine
Dynavax Technologies revealed in an SEC filing it is working to resolve questions from the FDA over its previously rejected experimental vaccine.
By Joe Cantlupe • Oct. 5, 2016 -
Deep Dive
Biosimilars emerge in US, but what to call them?
With four biosimilars now approved in the U.S., the competitive threat for biologics is apparent. What's not clear? How to name them.
By Ned Pagliarulo • Oct. 3, 2016 -
Vertex lowers guidance despite FDA nod
The FDA approved Vertex's cystic fibrosis drug Orkambi for use in a new patient population, but sales of the drug in current indications have been flat.
By Joe Cantlupe • Sept. 30, 2016 -
FDA
FDA cites Chinese manufacturers for GMP lapses
One firm, Hebei Yuxing, was placed on the regulator's import ban list, which currently includes 54 Chinese suppliers.
By Ned Pagliarulo • Sept. 29, 2016 -
FDA hits pause on CEL-SCI Phase 3 trial
Few details were provided about a clinical hold for the company's only clinical-stage product.
By Jacob Bell • Sept. 28, 2016 -
FDA
With SPA in hand, Athersys eyes approval
Despite mixed clinical results, the biotech is hoping a recent agreement with the FDA opens a path to market.
By Lisa LaMotta • Sept. 28, 2016 -
Pain Therapeutics has three strikes, but not out on opioid drug
Despite the latest rejection from the FDA, the biotech will continue to pursue approval of its extended release oxycodone.
By Joe Cantlupe • Sept. 27, 2016 -
FDA
Repros gets another shot at FDA adcomm
The biotech will attempt to make regulatory headway for its reproductive disorder medication at an advisory committee meeting scheduled for Dec. 6.
By Joe Cantlupe • Sept. 27, 2016 -
Amgen scores first Humira biosimilar approval
AbbVie's best-selling product could soon see competition begin to chip away at its roughly $14 billion in annual sales.
By Lisa LaMotta • Sept. 25, 2016 -
FDA
Sarepta eyes windfall as clock ticks on FDA's voucher program
Congress has less than two weeks to extend the controversial pediatric priority review voucher program, or it will expire on October 1.
By Joe Cantlupe • Sept. 23, 2016 -
Compounding an answer to drug price pain, Imprimis exec says
Imprimis, a San Diego-based compounder, has been aggressive in building a business off of the sustained outrage over rising prescription drug prices.
By Joe Cantlupe • Sept. 23, 2016 -
AstraZeneca drops EMA application for cancer drug
The British pharma ran into roadblocks in the late stages of the regulatory process, leading to the decision to pull the plug on cediranib's application.
By Joe Cantlupe • Sept. 22, 2016 -
FDA
Deep Dive
Drama at FDA: 5 things to know about the Sarepta approval
Summary review documents released by the agency reveal the high-stakes decision sparked fierce debate among FDA leadership.
By Ned Pagliarulo , Lisa LaMotta • Sept. 19, 2016 -
Sarepta skyrockets as FDA approves DMD drug
The FDA's decision on eteplirsen comes almost 4 months after the original PDUFA date, a delay marked by contentious debate over the drug's benefit.
By Ned Pagliarulo , Lisa LaMotta • Sept. 19, 2016 -
Pfizer gets green light for Ibrance in EU
Rapidly increasing sales of Ibrance have made the drug a key part of Pfizer's revenue growth.
By Joe Cantlupe • Sept. 19, 2016 -
Novo pulls 71,000 kits of glucagon med from US market
The Danish drugmaker issued the recall of GlucaGen Hypokits after two customer complaints flagged detached needles.
By Ned Pagliarulo • Sept. 15, 2016 -
FDA panel backs removal of warning on Pfizer's Chantix
An advisory committee voted in favor of removing the black box warning, but the vote was far from unanimous.
By Lisa LaMotta • Sept. 15, 2016 -
PhRMA slams Colombian efforts to cut price of cancer drug
Colombia has taken steps to unilaterally lower the price of Novartis' leukemia drug Gleevec, despite the Swiss pharma's best efforts to prevent such a step.
By Suzanne Elvidge • Sept. 15, 2016 -
Shire immunodeficiency drug wins U.S. approval
Approval followed positive Phase 2/3 data in a North American study, and gives Shire market access on both sides of the Atlantic.
By Suzanne Elvidge • Sept. 15, 2016 -
UN group urges 'de-linkage' of R&D costs from drug prices
The pharma industry criticized the report's findings, which also recommended greater transparency around R&D costs.
By Ned Pagliarulo • Sept. 14, 2016 -
Pfizer's hopes for Chantix up in smoke?
Chantix, a smoking cessation drug, has carried a black box warning for years. Pfizer is hoping to win support for removal of the warning from a FDA adcomm.
By Lisa LaMotta • Sept. 14, 2016
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