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Pharmaceutical Executive
January 1, 2014
Jill Wechsler
Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing mark for My Articles similar articles
Pharmaceutical Executive
January 1, 2013
Jill Wechsler
Transformation to Characterize 2013 FDA policies will reshape drug development, while pressure to cut healthcare spending may alter drug coverage and pricing. mark for My Articles similar articles
Pharmaceutical Executive
April 1, 2011
Revisiting Reform Courts, Congress review policies and programs shaping drug costs and access. mark for My Articles similar articles
Pharmaceutical Executive
August 1, 2012
Jill Wechsler
Fleshing Out FDASIA Medical apps, e-submissions, counterfeit drugs, and imports tucked into fairly "clean" user-fee renewal legislation. In late June leading legislators reached across party lines to quickly approve the Food and Drug Administration Safety and Innovation Act. mark for My Articles similar articles
Pharmaceutical Executive
January 1, 2011
Jill Wechsler
Politics & PDUFA Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead. mark for My Articles similar articles
Pharmaceutical Executive
January 1, 2007
Jill Wechsler
Washington Report: A Full Plate It's going to be a busy year in Washington for the pharmaceutical industry. Drug safety, unapproved uses, e-data requirements, and a shift to personalized medicine are just a few of the hot issues on tap for 2007. mark for My Articles similar articles
Pharmaceutical Executive
February 1, 2013
Jill Wechsler
Breakthrough Year for New Drugs More new medicines gained market approval, but marketers face resistance from payers looking to cut healthcare spending. mark for My Articles similar articles
Pharmaceutical Executive
September 1, 2011
Jill Wechsler
Rebates and Reform User-fee renewal legislation sets the stage for new policies affecting reimbursement, research, and regulatory oversight. mark for My Articles similar articles
Pharmaceutical Executive
December 1, 2012
Jill Wechsler
Obamacare, Innovation and Pricing Tax and budget decisions will shape the healthcare market and drug research and regulation. mark for My Articles similar articles
Pharmaceutical Executive
November 1, 2011
Jill Wechsler
The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices. mark for My Articles similar articles
Pharmaceutical Executive
April 1, 2012
Jill Wechsler
Shortages and Sunshine Disclosure rules the day, as industry confronts demands to report supply problems, results of clinical trials, and payment to doctors. mark for My Articles similar articles
Pharmaceutical Executive
April 10, 2014
Obama Policies Reshape Pharma Marketing Health reform initiatives promote transparency, challenge reimbursement, writes Jill Wechsler. mark for My Articles similar articles
Pharmaceutical Executive
November 1, 2013
Jill Wechsler
Transparency Troubles for Pharma High prices, murky financial relations, and a reluctance to disclose clinical data undermine public trust in industry and the research enterprise. mark for My Articles similar articles
Pharmaceutical Executive
June 1, 2012
Jill Wechsler
Innovation and Collaboration A rash of "pro-innovative" approaches for testing and regulating medical products offer ways to speed more new products to market. mark for My Articles similar articles
Pharmaceutical Executive
September 1, 2013
Jill Wechsler
Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies. mark for My Articles similar articles
Pharmaceutical Executive
March 1, 2013
Jill Wechsler
Another Round of FDA Legislation? Pressure for action on key enforcement and regulatory issues may prompt congressional action this year. mark for My Articles similar articles
Pharmaceutical Executive
March 1, 2012
Jill Wechsler
When Talk is Not So Cheap FDA and industry are pushing user fees, while they struggle with curbs on communications. mark for My Articles similar articles
Pharmaceutical Executive
June 1, 2014
Jill Wechsler
What Price Innovation? Payers, drug plans seek clear assessment of drug value to rationalize high drug prices. mark for My Articles similar articles
Pharmaceutical Executive
January 1, 2011
The Steep, Slow Climb A survey of leading experts reveals 2011's sobering reality and the trends that smart drugmakers will follow into the next decade. mark for My Articles similar articles
Pharmaceutical Executive
July 1, 2012
Jill Wechsler
Who Will Pay for New Drugs? Comparative research documenting value and affordability is key to obtaining coverage for high-cost therapies. mark for My Articles similar articles
Pharmaceutical Executive
July 1, 2014
Jill Wechsler
Pre-emption and States' Rights Pharma backs federal standards for compassionate use, drug importing, data transparency, and track-and-trace. mark for My Articles similar articles
Pharmaceutical Executive
February 1, 2012
Jill Wechsler
Costs and Benefits of Health Reform Will expanded markets and accountable care organizations offset higher rebates, added fees, and closer scrutiny of marketing and prices? mark for My Articles similar articles
Pharmaceutical Executive
December 1, 2010
Jill Wechsler
New Ballgame in Washington Republican gains in Congress create uncertainty for health reform, drug regulation, and biomedical research mark for My Articles similar articles
Pharmaceutical Executive
December 1, 2008
Jill Wechsler
Challenge and Challenges Expanded healthcare coverage also fits the goals of pharma manufacturers. mark for My Articles similar articles
Pharmaceutical Executive
February 1, 2006
Jill Wechsler
Washington Report: Cross-Agency Collaboration for Part D Medicare Part D gives CMS more clout over coverage, pricing, and even drug development. mark for My Articles similar articles
Pharmaceutical Executive
July 1, 2013
Jill Wechsler
Seeking Supply Chain Security FDA wants pharma leaders to do more to ensure drug quality at home and abroad. mark for My Articles similar articles
Pharmaceutical Executive
September 1, 2012
Jill Wechsler
Costs, Coverage, and Court Decisions Its election season and drug pricing issues are once again front and center in the policy wars on managing the high cost of healthcare. mark for My Articles similar articles
Pharmaceutical Executive
May 1, 2007
Jill Wechsler
Washington Report: Pathways for Proteins The push is on to establish an approval pathway for generic versions of biotech therapies. Innovators want exclusivity and clinical studies for follow-on biologics, but visions of billion-dollar savings may short-circuit the scientific debate. mark for My Articles similar articles
Pharmaceutical Executive
March 1, 2009
Jill Wechsler
Through the Looking Glass Pharma relations with researchers are critical for developing new technology, and reformers will discourage inappropriate relationships by making any links to pharmaceutical marketing known to all. mark for My Articles similar articles
Pharmaceutical Executive
December 1, 2013
FDA Pursues Delicate Balancing Act The Agency struggles to ensure access to needed medicines while minimizing potential risks, writes Jill Wechsler. mark for My Articles similar articles
Pharmaceutical Executive
January 1, 2006
Clinton & Wechsler
What Ever Happened to Critical Path FDA's ambitious program to improve drug development disappeared from view almost as soon as it was announced. Suddenly, it's back, but is it here to stay? mark for My Articles similar articles
Pharmaceutical Executive
October 1, 2011
Jill Wechsler
At the Helm of Industry As the lead FDA official overseeing the testing and approval of new drugs and biotech therapies for some 20 years, Dr. Janet Woodcock has built a robust and modern drug regulatory system. mark for My Articles similar articles
Pharmaceutical Executive
March 1, 2012
Ron Cohen
FDA's Necessary Dose of Reality There's no fast-acting salve, but there are several steps that can be taken to streamline many of the procedures at FDA. And it begins with leadership. mark for My Articles similar articles
Pharmaceutical Executive
April 1, 2011
Off-Label But On Point? Use of off-label drugs is a balancing act for physicians, and poses even more problems for pharma. The FDA is moving slowly to help. mark for My Articles similar articles
Pharmaceutical Executive
February 1, 2011
Jill Wechsler
Challenges, Changes, Commitments The Three Cs could be taxing on FDA resources as the new Congress brings stiffer oversight and leadership revisions to the agency mark for My Articles similar articles
Pharmaceutical Executive
December 1, 2011
Jill Wechsler
FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes mark for My Articles similar articles
Pharmaceutical Executive
November 1, 2012
Jill Wechsler
Budgets, Biosimilars, and Bad Ads While the nation was embroiled in the presidential elections, a number of important legal and regulatory issues absorbed pharmaceutical executives. mark for My Articles similar articles
Chemistry World
November 2, 2011
Rebecca Trager
Escalating Drug Dearth Spooks White House Manufacturing problems are the principal reason for the rapid growth in drug shortages. mark for My Articles similar articles
Pharmaceutical Executive
January 1, 2012
William Looney
Pharma 2012: Hard Times Before the Harvest 2012 will be a transition year for pharma, one of the most important in its history. The challenge is that many new treatments may not complete the move from 'bench to bedside' in time to plug the yawning revenue gap. mark for My Articles similar articles
Pharmaceutical Executive
May 1, 2009
Jill Wechsler
Compared to What? Pharma fears comparative effectiveness research will focus on costs and stymie personalized medicine. mark for My Articles similar articles
Pharmaceutical Executive
February 1, 2011
Jill Wechsler
The Building Block of Drug Discovery With Francis Collins now calling the shots at NIH, will be be able to deliver on the innovations behind the genome? mark for My Articles similar articles
Pharmaceutical Executive
September 1, 2010
Explaining the Drug Drought Industry needs to engage in a broader public debate on ways to rekindle the innovative engine in new drug discovery and development. mark for My Articles similar articles
Pharmaceutical Executive
October 1, 2011
Jill Wechsler
"Representing" Healthcare to the Fullest Since coming to Congress about 35 years ago, Henry Waxman, Congressional Representative from Los Angeles, California, has been pivotal in shaping legislation on health and drug regulatory issues. mark for My Articles similar articles
Pharmaceutical Executive
November 1, 2014
Jill Wechsler
Outrage Grows Over Drug Pricing Insurers, physicians attack high-cost therapies in anticipation of specialty drug surge. mark for My Articles similar articles
Pharmaceutical Executive
July 30, 2007
Jill Wechsler
Washington Report: Exclusivity vs. Patents To encourage innovation while supporting access to less costly therapies, Congress proposes an extensive data-exclusivity period that would delay Food and Drug Administration approval of a follow-on biologic application for 12 years. mark for My Articles similar articles
Pharmaceutical Executive
January 1, 2009
Jill Wechsler
FDA Turnaround Time Will more resources and new leadership fix FDA, or is a major overhaul in order? mark for My Articles similar articles
Pharmaceutical Executive
August 1, 2012
Sunny Outlook for Biopharm 2020? Albert Wertheimer looks beyond today's dark clouds with a comparatively sunny forecast for the biopharm industry in 2020. Just watch out for the harsh light of complacency. mark for My Articles similar articles
Pharmaceutical Executive
June 1, 2005
Jill Wechsler
Washington Report: "D" Is for Data It is critical for Medicare to address important questions on drug safety and utilization, and about how prescribing decisions affect health outcomes and costs. mark for My Articles similar articles
Pharmaceutical Executive
August 1, 2005
Jill Wechsler
Washington Report: Treating Patents It may seem unusual that a court ruling challenging patent protections is considered a victory for Big Pharma. But the decision was supported by pharmaceutical companies, along with the Justice Department, as a way to spur biomedical research and new-drug development. mark for My Articles similar articles
Pharmaceutical Executive
June 1, 2014
Jill Wechsler
Compassionate Use Requests Complicate Drug Development Pharma, HCPs, and regulators walk tightrope in addressing early-access push while supporting biomedical R&D. mark for My Articles similar articles