Search Results for drug prices

Showing 1 – 25  of 28

Congressmen Investigate 'Shadow Pricing' of MS Drugs By Zachary Brennan - Published 17 August 2017

Democratic Reps. Elijah E. Cummings (MD) and Peter Welch (VT) on Thursday sent letters to seven pharmaceutical companies requesting information about the skyrocketing prices for drugs used to treat multiple sclerosis (MS).

Categories: News, US, Crisis management, Drugs

Tags: MS drug prices, Teva, Bayer, Welch

Senate to Finish FDA User Fee Reauthorization Bill Ahead of Summer Recess By Zachary Brennan - Published 01 August 2017

Majority Leader Mitch McConnell (R-KY) said Tuesday that the Senate will follow its House counterparts and vote on the bipartisan US Food and Drug Administration (FDA) user fee reauthorization bill before heading to recess at the end of next week.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: FDA user fees, BsUFA, GDUFA, PDUFA, MDUFA, drug prices, Medicare

ICER to Work With VA on Drug Price Negotiations By Zachary Brennan - Published 03 July 2017

In a first for the Institute for Clinical and Economic Review (ICER), which estimates the cost-effectiveness of drugs, the Department of Veterans Affairs (VA) Pharmacy Benefits Management Services office (PBM) has agreed to use ICER drug assessment reports in drug coverage and price negotiations with the pharmaceutical industry.

Categories: News, US, Drugs, Government affairs, Regulatory intelligence

Tags: ICER, VA, drug prices

FDA to Speed Reviews of More Generic Drugs, Offers Lists of Those With No Competition By Zachary Brennan - Published 27 June 2017

The US Food and Drug Administration (FDA) took major steps toward increasing generic drug competition on Tuesday by releasing a list of off-patent pharmaceuticals with limited or no competition, and by prioritizing the review of abbreviated new drug applications (ANDAs) for which there are fewer than three ANDAs approved for the reference listed drug.

Categories: News, US, FDA, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: generic drugs, priority review of generics, drug price competition, drug prices

Trump Administration Officials Huddle at White House to Discuss Drug Pricing By Zachary Brennan - Published 16 June 2017

A White House spokesman confirmed to Focus that a meeting took place at the White House on Friday "as part of the ongoing discussions to reduce the burden of the high cost of drug prescriptions and unleash a wave of innovation to develop cures and treatments for patients."

Categories: News, US, FDA, Drugs

Tags: Trump, drug pricing, White House meeting on drug prices

Senate Committee Takes First Step on Rising Pharmaceutical Prices By Zachary Brennan - Published 13 June 2017

The US Senate Health, Education, Labor and Pensions Committee held the first of three hearings on rising pharmaceutical prices Tuesday, discussing the confusing system by which prices are set and possible ways to bring them down.

Categories: News, US, FDA, FTC, Crisis management, Drugs, Government affairs, Regulatory intelligence, Research and development

Tags: Senate HELP, drug prices, Pew, Manhattan Institute, Johns Hopkins, pharmaceutical prices

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

New Maryland Law to Restrict Generic Drug Price Increases By Zachary Brennan - Published 30 May 2017

A new Maryland law to keep generic drug prices from increasing by too much goes a step further than price transparency bills and laws in other states, but it’s leaving some with more questions about its broader impact.

Categories: News, US, Biologics and biotechnology, Business Skills, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: generic drug prices, state drug price legislation, drug price increases, Nevada insulin

Gottlieb: FDA Hiring Freeze Lifted, Plans for Increased Generic Competition Coming By Zachary Brennan - Published 25 May 2017

US Food and Drug Administration (FDA) commissioner Scott Gottlieb was in the hot seat on Thursday to defend President Donald Trump's budget plan to the House appropriations committee, though the conversation quickly dovetailed away from the billion-dollar user fee increase proposed in the budget and revealed that FDA as of Thursday is no longer subject to a hiring freeze.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: Scott Gottlieb, FDA budget 2018, FDA user fees, drug prices

Canada Proposes to Amend Drug Pricing Regulations By Zachary Brennan - Published 17 May 2017

For the first time in more than two decades, Canada’s government is looking to amend its drug pricing regulations to better protect Canadians from paying excessive prices for patented drugs.

Categories: News, Canada, US, FDA, Health Canada, NICE, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: drug pricing, Canada drug prices, QALY, PMPRB, generic drugmakers

Democrats Propose Wide-Ranging Bill to Lower Drug Costs By Zachary Brennan - Published 30 March 2017

House and Senate Democrats late Wednesday offered up a host of new provisions to bring down the rising cost of pharmaceuticals, many of which have been publicly opposed by the pharmaceutical industry.

Categories: News, US, FDA, Government affairs, Manufacturing, Research and development

Tags: drug prices, Medicare drug negotiations, drug imports, drug exclusivity, FDA regulations

Updated: Pharma Profits Continue to Dwarf R&D Spending as Pressure Mounts By Zachary Brennan - Published 27 March 2017

With the repeal of Obamacare on life support, the furor over rising prescription drug prices and President Donald Trump’s support for the cause could end up filling the vacant crossroads where bipartisanship meets change.

Categories: News, US, Business Skills, Drugs, Government affairs

Tags: drug company profits, drug prices, R&D spending on pharmaceuticals

Bills Introduced in March: Importation, Cancer Drugs and PBM Transparency By Zachary Brennan - Published 17 March 2017

At least nine US House and Senate bills introduced in March would impact the pharmaceutical industry, including three to allow for more prescription drug imports from Canada, pharmacy benefit management (PBM) transparency and one on cost sharing for cancer medicines.

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

Tags: Cummings, Sanders, drug prices, PBMs

Trump Working on ‘New System’ to Increase Drug Competition By Zachary Brennan - Published 07 March 2017

President Donald Trump tweeted Tuesday morning that he’s “working on a new system where there will be competition in the Drug Industry,” though how such a system would work alongside the generic drug and biosimilar competitors, remains to be understood.

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

Tags: Trump, drug prices, Cummings, Sanders, FDA regulations

Senators Call on HHS to Allow Canadian Drug Imports if Prices Spike By Zachary Brennan - Published 14 February 2017

Sens. Charles Grassley (R-IA), John McCain (R-AZ) and Amy Klobuchar (D-MN) on Tuesday sent a letter to Tom Price, the newly confirmed secretary of the Department of Health and Human Services (HHS), calling on him to fast-track the approval of prescription drugs imported from Canada in four different circumstances, including if the price of a drug increases significantly.

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

Tags: Klobuchar, McCain, Grassley, Canada drug imports, drug prices

Senate Democrats to Trump: Work With us to Lower Drug Prices By Zachary Brennan - Published 20 December 2016

Sens. Sherrod Brown (D-OH), Al Franken (D-MN) and 17 of their Democratic and Independent colleagues on Tuesday sent a letter to President-elect Donald Trump, urging him to combat the pharmaceutical industry’s “abusive tactics” that “price lifesaving drugs out of reach for those in need.”

Categories: News, US, Drugs, Reimbursement

Tags: Franken, Elizabeth Warren, Trump, CMS, drug prices

Vermont Drug Price Transparency: New Law Calls Out Egregious Price Spikes By Zachary Brennan - Published 06 December 2016

Last June, Vermont Governor Peter Shumlin (D) signed into law a new pharmaceutical price transparency bill that sought to expose the companies and products seeing the largest price hikes.

Categories: News, US, Biologics and biotechnology, Business and Leadership, Drugs, Regulatory intelligence, Regulatory strategy, Reimbursement, Submission and registration

Tags: pharmaceutical price transparency, drug prices, increases in drug prices, Vermont pharmaceuticals, Medicaid

Generic Drug Backlog at FDA: A Dive Into the Confusing Numbers By Zachary Brennan - Published 01 November 2016

As the debate over skyrocketing drug prices continues, at least one solution has cropped up in nearly every conversation: Reduce the generic drug backlog at the US Food and Drug Administration (FDA), create more competition and drug prices will come down.

Categories: News, US, FDA, Generic drugs, Government affairs

Tags: generic drug approvals, drug prices, high drug prices, ANDA approvals, generic drug backlog, FDA backlog

New House, Senate Bills Would Require Companies to Justify Drug Price Hikes of More Than 10% By Zachary Brennan - Published 15 September 2016

US Sens. Tammy Baldwin (D-WI) and John McCain (R-AZ), as well as Rep. Jan Schakowsky (D-IL), on Thursday introduced new bills that would require drug manufacturers to disclose and provide more information about planned drug price increases, as well as data on research and development costs.

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

Tags: drug prices, Schakosky, Tammy Baldwin, John McCain, drug price transparency

What Drugs Really Cost: GAO Wants CMS to Find Out By Zachary Brennan - Published 02 August 2016

In order to help ensure the accuracy of Medicare Part B drug payment rates, the US Government Accountability Office (GAO) on Monday urged Congress to require all manufacturers of Part B drugs paid at average sales price (ASP) to submit sales price data to the Centers for Medicare & Medicaid Services (CMS). 

Categories: News, US, Biologics and biotechnology, Drugs, Government affairs, Reimbursement

Tags: GAO, CMS drug prices, Part B, drug pricing, ASP

Asia Regulatory Roundup: China’s Anti-Corruption Agency Chides CFDA Over Loopholes (7 June 2016) By Nick Paul Taylor - Published 07 June 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, Biologics and biotechnology, Clinical, Crisis management, Drugs, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, China drug regulations, DCGI, Pakistan drug prices

European Regulators Drawn Into Debate on Drug Pricing By Zachary Brennan - Published 12 May 2016

Although drug regulators aren’t supposed to be concerned with pricing when making decisions on products’ safety and efficacy, they’re increasingly being drawn into what two representatives of the European Medicines Agency (EMA) and the heads of two national regulators call an “acrimonious debate” over drug costs.

Categories: News, Europe, US, EC, EMA, MHRA, NICE, Biologics and biotechnology, Crisis management, Drugs, Government affairs

Tags: EU drug prices, pharmaceutical drug pricing, drug price policies, EMA and drug pricing

MSF: Access to New TB Medicines Falters Despite Conditional Approvals By Zachary Brennan - Published 21 March 2016

Doctors without Borders (MSF) released a new report on Monday offering details on how the first new drugs in nearly half a century were conditionally approved to treat tuberculosis (TB),  though only 2% of the roughly 150,000 who could benefit from these treatments have access to them.

Categories: News, Africa, Asia, Latin America and Caribbean, EMA, WHO, Crisis management, Drugs, Government affairs, Regulatory intelligence, Submission and registration

Tags: MSF, Doctors Without Borders, TB medicines, TB drug prices, Otsuka

Asia Regulatory Roundup: CFDA Consults on Good Supply Practices, Traceability (23 February 2016) By Nick Paul Taylor - Published 23 February 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, WHO, Compliance, Crisis management, Drugs, Due Diligence, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, Ali Health, drug monitoring, drug prices, traditional medicine

Senators Urge Obama to Take Action on Drug Prices By Zachary Brennan - Published 03 February 2016

Policy solutions to bring down the rising tide of prescription drug prices should be included in next year’s budget, eight senators said in a letter sent to President Barack Obama on Tuesday.

Categories: News, US, Crisis management, Drugs, Government affairs, Postmarket surveillance, Reimbursement

Tags: drug prices, Medicare Part D, government drug price negotiations, Obama budget FY2017