FDA: Page 108
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3 compounding pharmacies sue Express Scripts over blocked coverage
Express Scripts, the largest pharmacy benefits manager in the U.S., has been refusing to cover certain active ingredients used by compounding pharmacies.
By Nicole Gray • Nov. 25, 2014 -
Lundbeck CEO resigns after serious conduct breaches
In 2013, Ulf Wiinberg failed to request the Lundbeck board's permission to receive shares from the founder of a biotech company. And then things got worse.
By Nicole Gray • Nov. 25, 2014 -
Novartis scientist who fabricated data fired and banned from receiving funding
Igor Dzhura has also been busy retracting papers rife with false data.
By Nicole Gray • Nov. 25, 2014 -
Hep C wars heat up as AbbVie scores likely EU approval for Harvoni challenger
AbbVie's new three-in-one therapy for hep C is getting closer to approval in the EU and gaining traction in multiple markets. Can it edge out Gilead's pricey Harvoni by undercutting the price?
By Nicole Gray • Nov. 24, 2014 -
EU regulators weigh in on hotly debated testosterone, heart attack link
After reviewing reams of data on the link between testosterone and heart attacks, the EMA has decided that the results are inconclusive. However, the agency is mandating updated product labeling.
By Nicole Gray • Nov. 24, 2014 -
EMA's updated conflict of interest policy reflects pragmatism, flexibility
The European Medicines Agency has updated its policy to reflect a pragmatic approach to conflict-of-interest policies for scientific committee members.
By Nicole Gray • Nov. 21, 2014 -
Judge refuses to block Ranbaxy's generic competitors
Ranbaxy fought back after the FDA revoked tentative approvals of its generic versions of Nexium and Valcyte, suing the agency and seeking injunctions against competitors. So far, the strategy isn't panning out.
By Nicole Gray • Nov. 21, 2014 -
Purdue joins burgeoning abuse-deterrent pain pill field with Hysingla approval
Concerns over the U.S. opiate addiction crisis led Purdue Pharma to develop a long-acting, opioid-based, non-acetaminophen painkiller with built-in abuse deterrence, Hysingla ER.
By Nicole Gray • Nov. 21, 2014 -
In massive transparency effort, feds push for failed clinical trial data reporting
Currently, drug sponsors are only required to post clinical trial results for approved drug (about 15,000 trials) on Clinicaltrials.gov. The NIH and HHS want to change that.
By Nicole Gray • Nov. 20, 2014 -
Deep Dive
ICYMI: Inside Indian pharma's push to reform and modernize
The rapidly-growing Indian pharma industry faces numerous quality challenges but is working hard at reform, including by addressing regulatory inconsistency around fixed-dose combos.
By Nicole Gray • Nov. 19, 2014 -
India's Ranbaxy sues FDA for yanking Nexium, Valcyte generics approval
The FDA is "violating constitutional rights exceeding its statutory authority" by revoking the tentative generic approvals, according to Ranbaxy.
By Nicole Gray • Nov. 19, 2014 -
Rainmaker: Gilead's Harvoni approved in the EU
The EMA has approved Harvoni (sofosbuvir/ledipasvir) for treatment-experienced patients with hepatitis C genotypes 1 or 4. Just how high will the sales fly?
By Nicole Gray • Nov. 19, 2014 -
HHS scraps regulations for 340B drug pricing program
HHS backs out of plans to expand 340B "mega rule" but plans to release new guidance in 2015.
By Sy Mukherjee , Marisa Torrieri • Nov. 18, 2014 -
FDA commish to talk drug safety at China regulatory chief confab
FDA Commissioner Margaret Hamburg will focus on cooperation on food and drug safety when she arrives in China for the International Summit of Heads of Medicines Regulatory Agencies.
By Nicole Gray • Nov. 18, 2014 -
Another big win for Roche as Avastin nabs FDA ovarian cancer indication
Avastin (bevacizumab) is one of the hardest working biologics in oncology, scoring two additional indications in the last six months.
By Nicole Gray • Nov. 17, 2014 -
Finally: FDA reverses course, OKs Sanofi's Lemtrada for MS
After being rejected by the FDA last December due to safety concerns, Lemtrada (alemtuzumab) has finally been approved—with some qualifications.
By Nicole Gray • Nov. 17, 2014 -
EU's top drug regulator forced out by EMA panel
The decision is being chalked up to a procedural formality, but reeks of politics.
By Nicole Gray • Nov. 16, 2014 -
Japanese transparency data raises eyebrows about pharma spending
Japan implemented its own "Sunshine Act" last year. But it's already leading to major controversy.
By Nicole Gray • Nov. 14, 2014 -
FDA approves new Invega indication for schizoaffective disorder
Janssen's Invega (paliperidone) label now covers more than just schizophrenia with a new indication for schizoaffective disorder—a condition that affects 750,000 Americans.
By Nicole Gray • Nov. 14, 2014 -
FDA
FDA has concerns over bioequivalence of two Concerta generics
The FDA has issued an alert that two extended-release Concerta generics made by Mallinckrodt and Kudco may not be therapeutically equivalent to the brand-name product.
By Nicole Gray • Nov. 14, 2014 -
Deep Dive
ICYMI: India's fixed-dose combo problem: Too much of a good thing?
Change is brewing in Indian pharma. But will it be enough?
By Nicole Gray • Nov. 14, 2014 -
Indian pharma really feeling the pain of lagging US generic approvals
Increased filings for new generic drugs, combined with increased inspections of Indian facilities beset by quality woes, has led to a severe revenue slowdown in India.
By Nicole Gray • Nov. 13, 2014 -
GSK applying for expanded Revolade indication in the EU
If GSK gets its way, Revoldate (eltrombopag) will be available in the EU for the treatment of severe aplastic anemia (SAA) in addition to its primary indication, thrombocytopenia.
By Nicole Gray • Nov. 13, 2014 -
No more half measures: Senate to add Ebola to priority review program
Next week, the Senate will consider making Ebola the 17th tropical disease target eligible for priority review. And other big changes to the program are coming, too.
By Nicole Gray • Nov. 13, 2014 -
10 major hospitals ask Congress to scrutinize Genentech distribution changes
In October, Ascension Health banned Genentech sales reps from its campus in response to a radical shift in distribution policy. Now, other major medical centers are piling on.
By Nicole Gray • Nov. 12, 2014
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