Rivaroxaban Faces Uphill Battle At FDA Advisory Panel
The third time may not be the charm. Twice before the FDA has turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto (rivaroxaban). On Thursday the Cardiovascular and Renal Drugs Advisory Committee will take up the sNDA yet again, but FDA review documents posted today suggest that the company will again face an uphill battle. … Click here to read the full post on Forbes. (Source: CardioBrief)
Source: CardioBrief - January 14, 2014 Category: Cardiology Authors: Larry Husten Tags: MI/ACS People, Places & Events Policy & Ethics FDA advisory panel Johnson & Johnson rivaroxaban Source Type: blogs
Possible New Lease On Life For Two Cardiology Drugs From Merck And J&J
Early next year an FDA panel will review a new drug from Merck and a new indication for Xarelto (rivaroxaban), Johnson & Johnson’s highly successful new oral anticoagulant. Both drugs have had a rocky road getting to this stage and their success is by no means assured, but the announcement of the meeting of the FDA’s Cardiovascular and Renal Drugs Advisory Committee suggests that the companies have made progress resolving earlier problems. Merck’s new drug application for vorapaxar (Zontivity is the proposed trade name) will be discussed on January 15 for the proposed indication of reduction of ...
Source: CardioBrief - December 16, 2013 Category: Cardiology Authors: Larry Husten Tags: MI/ACS People, Places & Events Policy & Ethics Acute coronary syndrome Anticoagulant FDA food and drug administration Johnson & Johnson Merck New Drug Application rivaroxaban Xarelto Source Type: blogs
Will This Bill Relieve 'Hardship' Caused By Generic User Fees?
Nearly two years ago, the FDA was granted authority to charge user fees to generic drugmakers in hopes of accomplishing two pressing goals – bolstering oversight of the pharmaceutical supply chain by underwriting the cost of additional plant inspections and tackling a growing backlog of applications for approvals. But the effort has generated considerable grumbling.
As expected, there was a recent a rise in user fees, since there is a projected decline in the number of abbreviated new drug applications to be filed and there are fewer facilities that will carry the overall burden. And fees for the recently ended fiscal ye...
Source: Pharmalot - December 5, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations
Despite the FDA warnings and increased health risks, from 1999 through 2005, Janssen aggressively marketed Risperdal to control behavioral disturbances in dementia patients through an “ElderCare sales force” designed to target nursing homes and doctors who treated the elderly.
Allegations Include Off-label Marketing and Kickbacks to Doctors and Pharmacists.
+Alzheimer's Reading Room
Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natr...
Source: Alzheimer's Reading Room, The - November 5, 2013 Category: Dementia Authors: Bob DeMarco Source Type: blogs
Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations - DoJ
Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations
Allegations Include Off-label Marketing and Kickbacks to Doctors and Pharmacists
WASHINGTON - Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care phar...
Source: PharmaGossip - November 5, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
How brilliant is Brilinta?
AstraZeneca US drug trial queriedAstraZeneca's chief executive Pascal Soriot says he is very confident in the findings of the clinical trial of heart drug Brilinta. Photograph: Lynne Cameron/PAAstraZeneca is being investigated by US authorities over a clinical trial that was used to win marketing approval for its heart drug Brilinta, casting fresh doubts over the medicine.Brilinta sales have been a disappointment since its launch two years ago, although AstraZeneca has recently stepped up marketing efforts and hopes that further clinical tests will underscore its value in preventing heart attacks.The British drug...
Source: PharmaGossip - October 31, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Harvard Stem Cell Institute publishes initial clinical trial results
Starting with a discovery within zebrafish in 2007, Harvard Stem Cell Institute (HSCI) researchers have published initial results of a Stage Ib human clinical trial of a therapeutic that has the potential to improve the achievements of blood stem cell transplantation. This marks the first time, just nine brief years after Harvard’s major dedication to stem cell biology, that will investigators have carried a breakthrough from the lab bench to the clinic—fulfilling the promise on which HSCI was founded.
The particular Phase 1b safety study, published in the journal Bloodstream , included 12 adult individua...
Source: My Irritable Bowel Syndrome Story - October 8, 2013 Category: Other Conditions Authors: Ken Tags: IBS News Source Type: blogs
A 'Stunning Turn Of Events' For Sanofi And Its Diabetes Franchise
In an unexpected move, Sanofi has withdrawn its application for its lixisenatide diabetes drug with the FDA over concerns that “potential public disclosure” during the agency’s review of interim trial data could compromise the “integrity” of an ongoing study. The drugmaker, though, insists its decision is unrelated to any safety issues concerning the drug or any deficiencies in its new drug application.
Instead, Sanofi plans to resubmit the application in 2015, after its Elixa study is completed in about 15 months. At the same time, the drugmaker told employees this morning that the additional 200 to 300 sales re...
Source: Pharmalot - September 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
FDA: Guidance Safety Labeling Changes
Discussion Periods and Extensions
If FDA does not agree with the wording in the submitted supplement or the reasoning of the rebuttal statement, FDA must initiate discussions that do not extend for more than 30 days after the receipt of the submission (section 505(o)(4)(C) and (D)).
Under section 505(o)(4)(D), FDA may extend the discussion period for more than 30 days, if FDA determines that an extension of the discussion period is warranted. FDA expects that an extension of the discussion period (usually for another 30 days) will be warranted when a 30-day discussion period may not suffice to adequately address all ...
Source: Policy and Medicine - August 21, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
FDA Soliciting Input on Global Supply Chain Provisions in FDASIA
In a recent post from the FDA Voice Blog, Office of Compliance Director for FDA's Center for Drug Evaluation and Research (CDER) wrote about the agency's future activities to help combat the globalized supply chain—in particular about the Food and Drug Administration Safety and Innovation Act (FDASIA).
In addition to sharing his priorities about resolving problems regarding drug compounding, Office of Compliance Director Howard Sklamberg noted that one of his main priorities is the globalized supply chain. He noted how today, "nearly 40 percent of the drugs Americans take are imported and nearly 80 percent of the a...
Source: Policy and Medicine - July 26, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
Clot Wars contd.
FDA has Xarelto concernsPublished on 02/07/13 at 08:24amThe FDA is unsure about an application to further extend the licence for Janssen and Bayer HealthCare’s blood thinner Xarelto to cover a rare complication in heart patients, and has asked for more information.The US regulator has issued a complete response letter for a supplemental New Drug Application (sNDA) for the pill to reduce the risk of stent thrombosis in people with acute coronary syndrome (ACS).The uncommon condition occurs when blood pools at the site of stents implanted in patients’ coronary arteries - about 1.5 million people have these fitted each ye...
Source: PharmaGossip - July 2, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
FDA Turns Back New Indication For Rivaroxaban To Prevent Stent Thrombosis In ACS Patients
Johnson & Johnson said today that it had received a complete response letter from the FDA for the supplemental new drug application for rivaroxaban (Xarrelto) for the prevention of stent thrombosis in patients with acute coronary syndromes (ACS). Earlier this year the FDA turned down for the second time the sNDA for the general use of rivaroxaban to treat ACS patients. … Click here to read the full story on Forbes. (Source: CardioBrief)
Source: CardioBrief - June 28, 2013 Category: Cardiology Authors: Larry Husten Tags: MI/ACS People, Places & Events Acute coronary syndrome Bayer FDA food and drug administration Johnson and Johnson rivaroxaban Source Type: blogs
FDA Expanded Access to Investigational Drugs for Treatment Use: Draft Guidance
The Food and Drug Administration (FDA) recently released a Draft Guidance for Industry, in the form of Question and Answer (Qs & As) regarding "Expanded Access to Investigational Drugs for Treatment Use"—also commonly known as "compassionate use."
The draft guidance is intended to provide information for industry, researchers, physicians, and patients about the implementation of FDA's regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (IND) (21 CFR part 312, subpart I), which went into effect on October 13, 2009.
Since 2009, FDA has received ...
Source: Policy and Medicine - June 25, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
FDA Five Year Plan on Risk Benefits Framework
Conclusions and Reasons, where:
Evidence and Uncertainties presents the facts, uncertainties, and any assumptions made to address these uncertainties that contribute to the assessment of benefit and risk.
Conclusions and Reasons captures the implications of the facts, uncertainties, and assumptions with respect to regulatory decision-making, drawing conclusions from the evidence and uncertainties and explaining the bases for those conclusions.
The first two decision factors, Analysis of Condition and Current Treatment Options, represent the framework’s therapeutic area considerations and are distinct from the other dr...
Source: Policy and Medicine - May 31, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and welcome to another busy day. As usual, we are scrambling about on the Pharmalot corporate campus in order to deposit the short people at their schoolhouses and sorting out plans for the long weekend coming up. Meanwhile, though, there is much to do. The world has not stopped spinning, of course. So here are some tidbits. Hope your day is a success and do stay in touch...
Wockhardt Says FDA Import Alert Could Hurt $100M In Sales (Business Standard)
J&J To Submit 17 New Drug Applications By 2017 (Dow Jones)
FDA Panel Says Merck Sleeping Pill Is Safe At Low Doses (Bloomberg News)
Glaxo Flu Sh...
Source: Pharmalot - May 23, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
