Search Results for Janssen

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FDA Adds Boxed Warning to Janssen's Type 2 Diabetes Drug Label By Zachary Brennan - Published 16 May 2017

Based on new data from two large clinical trials, the US Food and Drug Administration (FDA) on Tuesday concluded that Janssen’s type 2 diabetes medicine canagliflozin (brand names include Invokana, Invokamet and Invokamet XR) causes an increased risk of leg and foot amputations.

Categories: News, Europe, US, EMA, FDA, MHRA, Clinical, Crisis management, Drugs, Postmarket surveillance

Tags: Janssen, SGLT2 inhibitors, FDA warning

Pediatric Priority Review Vouchers on the Chopping Block as Reauthorization Stalls By Zachary Brennan - Published 22 September 2016

Congress and President Barack Obama have one week to reauthorize the pediatric priority review voucher (PRV) program, which will sunset on 30 September 2016 after seven pediatric PRVs have been awarded, one of which sold for $350 million last year.

Categories: News, US, FDA, Biologics and biotechnology, Drugs

Tags: priority review vouchers, PRV, pediatric PRV, Sarepta, Janssen, Alexion

EMA, MHRA, Janssen Warn of Increased Risk of Toe Amputation With Type 2 Diabetes Drug By Zachary Brennan - Published 11 May 2016

A two-fold higher incidence of lower limb amputation, primarily of the toe, has been seen in a clinical trial with canagliflozin, Janssen, the European Medicines Agency (EMA) and UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said in a letter to health professionals.

Categories: News, Europe, EMA, MHRA, Active pharmaceutical ingredients, Biologics and biotechnology, Crisis management, Drugs, Labeling, Postmarket surveillance

Tags: Janssen, Johnson & Johnson, Pfizer, GlaxoSmithKline, canagliflozin, Celgene, Novartis

FDA Allows First Switch From Batch to Continuous Manufacturing for HIV Drug By Zachary Brennan - Published 12 April 2016

The US Food and Drug Administration (FDA) for the first time in its history allowed a manufacturer to switch from the more antiquated batch manufacturing process to a continuous manufacturing process – a move that FDA is seeking to encourage among more pharmaceutical manufacturers.

Categories: News, US, FDA, Compliance, Drugs, Due Diligence, Manufacturing, Quality

Tags: continuous manufacturing, Janssen, Prezista, Vertex, batch manufacturing

J&J Petition Claims FDA Decision Meant to Ease Drug Shortages Puts Some Future Patients at Risk By Alexander Gaffney, RAC - Published 05 March 2014

Categories: US, FDA

Tags: Sun Pharma, Orange Book, Janssen, J&J, Lipodox, Doxil, RLD, ANDA, Citizen Petition, Latest News, NDA

NICE Asks Janssen for More Data for Multiple Myeloma Drug By Louise Zornoza, RegLink - Published 13 November 2013

Categories: NICE

Tags: Janssen, UK, draft guidance, EU

J&J to Pay $2.2 Billion for Off-Label Marketing of Risperdal in Third-Largest Settlement Ever By Alexander Gaffney, RF News Editor - Published 04 November 2013

Categories: US, DOJ

Tags: Corporate Integrity Agreement, CIA, Risperdal, Janssen, J&J, Settlement, Fine, Latest News

J&J's Janssen Gets Second Untitled Letter in as Many Months as FDA Targets Xarelto Advertising Piece By Alexander Gaffney, RF News Editor - Published 19 June 2013

Categories: US, FDA

Tags: Untitled Letter, Janssen, J&J, Xarelto, Johnson & Johnson, Latest News, fair balance

Cancer Drug Returns, and with it FDA's Willingness to Go After its Manufacturer By Alexander Gaffney, RF News Editor - Published 07 June 2013

Categories: US, FDA

Tags: Doxirubicin, Untitled Letter, Janssen, Doxil, Misbranded, Shortages, Drug Shortage, Latest News, Shortage, marketing

Exclusive: FDA to Continue Regulatory Exception for Doxil Substitute By Alexander Gaffney, RF News Editor - Published 18 October 2012

Categories: FDA

Tags: Sun Pharma, Ben Venue, Janssen, J&J, Lipodox, Doxil, Shortages, Latest News, Drug Shortages

J&J Settles Court Cases In Advance of Testimony by Former FDA Commissioner By Alexander Gaffney - Published 05 October 2012

Tags: Shareholder, Risperdal, Janssen, J&J, Kessler, Settlement, Lawsuit, Johnson & Johnson, Latest News, regulatory

Advisory Committee Votes Against Label Expansion for J&J/Bayer's Xarelto By Alexander Gaffney - Published 24 May 2012

Categories: FDA

Tags: Against, Temple, Nissen, ACS, Vote, Janssen, J&J, Bayer, Xarelto, Latest News, cardiovascular, advisory committee

Arkansas Slams J&J With $1.2 Billion Fine for Risperdal Marketing Tactics By Alexander Gaffney - Published 12 April 2012

Tags: $JNJ, Arkansas, Risperdal, Janssen, Lawsuit, Fine, Johnson & Johnson, Latest News, pharmaceutical, marketing, drug

J&J Faces Larger Fine as DOJ Rejects $1B Risperdal Settlement By Alexander Gaffney - Published 13 March 2012

Categories: DOJ

Tags: Prosecutors, Risperdal, Janssen, J&J, Antipsychotic, Lawsuit, Fine, Johnson & Johnson, Latest News