Search Results for Valeant

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Sanofi and J&J Lead the Way With Clinical Trial Transparency, Study Finds By Zachary Brennan - Published 05 December 2017

Clinical trial transparency among large pharmaceutical companies is high, although opportunities for improvement remain, according to a study published Tuesday in the BMJ.

Categories: News, US, FDA, Clinical, Research and development

Tags: clinical trial transparency, Johnson & Johnson, Sanofi, Valeant, Allergan

Senate to Take on Pharmaceutical Prices Again: Real Reform or More of the Same? By Zachary Brennan - Published 12 June 2017

The Senate Health, Education, Labor & Pensions (HELP) committee is holding a hearing Tuesday on prescription drug costs and will look to address how the drug delivery system affects what patients pay.

Categories: News, US, FDA, Crisis management, Drugs, Government affairs

Tags: Senate HELP, Mylan, Valeant, Turing, drug prices

FDA Explains Why Newly Approved Biologic’s Name Lacks a Suffix By Zachary Brennan - Published 17 February 2017

The US Food and Drug Administration (FDA) approved a new biologic this week, but its name did not adhere to recently finalized guidance calling for all new and previously approved biologics and biosimilars to have a four-letter random suffix attached to their nonproprietary names.

Categories: News, US, FDA, Biologics and biotechnology

Tags: Valeant, Siliq, nonproprietary names of biologics, biosimilars

Senators Look to Halt Price Spikes of Off-Patent Drugs By Zachary Brennan - Published 21 December 2016

Sens. Susan Collins (R-ME) and Claire McCaskill (D-MO) on Wednesday released a 131-page report explaining the details behind specific price increases for off-patent drugs and ways Congress can combat such spikes.

Categories: News, US, FDA, Crisis management, Drugs, Government affairs, Reimbursement

Tags: Valeant, Turing, Rodelis, Retrophin, Syprine, Cuprimine

FDA Warns Valeant Over Quality System Violations By Zachary Brennan - Published 08 November 2016

In a letter dated 3 November and released Tuesday, the US Food and Drug Administration (FDA) warned Valeant Pharmaceuticals over quality system violations.

Categories: News, US, FDA, Drugs, Medical Devices, Quality

Tags: Valeant Pharmaceuticals, FDA warning letter

Developing the Next Female Viagra? FDA Offers Draft Guidance With Caveats By Zachary Brennan - Published 25 October 2016

The controversial US Food and Drug Administration (FDA) approval last year of the first drug intended to treat women bothered by a lower sex drive has opened the door for other companies to develop similar drugs.

Categories: News, US, CDER, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: Viagra, Addyi, Valeant, low sexual interest, lower sex drive, FSIAD, HSDD

FDA Hits Valeant’s Bausch & Lomb With Form 483 By Zachary Brennan - Published 06 September 2016

The US Food and Drug Administration (FDA) on Tuesday released a Form 483 for Valeant’s Bausch & Lomb sterile drug manufacturing facility in Tampa, FL, citing the site for microbiological contamination of drugs purporting to be sterile.

Categories: News, US, FDA, Compliance, Crisis management, Drugs, Due Diligence, Government affairs

Tags: Valeant Pharmaceuticals, Bausch & Lomb, FDA Form 483

Senate Committee Offers Inside Look at the Rise and Fall of Valeant Pharmaceuticals By Zachary Brennan - Published 09 May 2016

The 800 pages of internal emails, correspondence and drug pricing statistics released by the Senate Special Committee on Aging over the weekend offers an inside look at how the multi-billion dollar Valeant Pharmaceuticals with 22,000+ employees jacked up the prices of a number of drugs, by as much as 6,000%, and then lamented the subsequent media and investor questions.

Categories: News, Canada, US, Compliance, Crisis management

Tags: Valeant Pharmaceuticals, drug pricing, pharmaceutical prices

Arbitrary Pharmaceutical Price Gouging: Valeant Defends its Business Model By Zachary Brennan - Published 27 April 2016

As the anger over Martin Shkreli’s infamously steep and entirely arbitrary price hike of a rare disease drug has subsided, Congress has begun to turn its attention to other companies, such as Valeant Pharmaceuticals, which rely on price gouging as the foundation of their business models.

Categories: News, US, Business Skills, Crisis management, Drugs, Reimbursement

Tags: Shkreli, Valeant, Ackman, Pershing, Walgreens

Updated: Governor Takes Issue With Super Bowl Drug Ad as New House Bill Looks to Restrict DTC Pharma Advertising By Zachary Brennan - Published 16 February 2016

Vermont Gov. Peter Shumlin (D) has sent a letter to pharmaceutical companies AstraZeneca and Daiichi Sankyo calling on them to pull their advertisement that aired during the Super Bowl. The ad promoted a drug to treat opioid-induced constipation.

Categories: News, US, FDA, Advertising and Promotion, Compliance, Crisis management, Drugs, Government affairs

Tags: Manchin, Markey, opioids, Califf, FDA, Valeant, AstraZeneca, Daiichi Sankyo

House Hearing Focuses on Harm Done by Drug Price Spikes By Zachary Brennan - Published 04 February 2016

The highly anticipated House Oversight Committee hearing on Thursday was not without its fireworks, though beyond the airing of a lot of discontent, few new options for halting drug price increases were brought to the table.

Categories: News, US, FDA, Drugs, Ethics, Government affairs, Reimbursement

Tags: Shkreli, Oversight hearing, Turing Pharmaceuticals, Valeant Pharmaceuticals

Arizona Supreme Court Ruling Realigns State With Others on Drugmakers’ Warning Labels, Lawyer Says By Zachary Brennan - Published 27 January 2016

An Arizona Supreme Court ruling last week brought the state in line with a number of other states in terms of its use of the “learned intermediary doctrine,” under which drug manufacturers satisfy their duty to warn consumers about their products by giving appropriate warnings to a prescribing physician or other health care provider.

Categories: News, US, Advertising and Promotion, Biologics and biotechnology, Drugs, Due Diligence, Labeling, Quality, Regulatory intelligence

Tags: Valeant, learned intermediary doctrine, pharmaceutical warning labels

Senators Investigate Rising Drug Prices as HHS Plans Action By Zachary Brennan - Published 04 November 2015

The fire stoked by rising drug prices is starting to spread through government, particularly as Sens. Susan Collins (R-ME) and Claire McCaskill (D-MO) on Wednesday announced a bipartisan Senate investigation into pharmaceutical price gouging with letters to four companies.

Categories: News, US, DOJ, FDA, FTC, Business Skills, Compliance, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Elijah Cummings, Valeant Pharmaceuticals, drug prices, Senate investigation