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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 |
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. |
Pharmaceutical Executive April 1, 2011 |
Revisiting Reform Courts, Congress review policies and programs shaping drug costs and access. |
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. |
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. |
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. |
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. |
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. |
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. |
Pharmaceutical Executive November 1, 2011 Jill Wechsler |
The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices. |
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. |
Pharmaceutical Executive April 10, 2014 |
Obama Policies Reshape Pharma Marketing Health reform initiatives promote transparency, challenge reimbursement, writes Jill Wechsler. |
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. |
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. |
Pharmaceutical Executive September 1, 2013 Jill Wechsler |
Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies. |
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. |
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. |
Pharmaceutical Executive June 1, 2014 Jill Wechsler |
What Price Innovation? Payers, drug plans seek clear assessment of drug value to rationalize high drug prices. |
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. |
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. |
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. |
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? |
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 |
Pharmaceutical Executive December 1, 2008 Jill Wechsler |
Challenge and Challenges Expanded healthcare coverage also fits the goals of pharma manufacturers. |
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. |
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. |
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. |
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. |
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. |
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. |
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? |
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. |
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. |
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. |
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 |
Pharmaceutical Executive December 1, 2011 Jill Wechsler |
FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes |
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. |
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. |
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. |
Pharmaceutical Executive May 1, 2009 Jill Wechsler |
Compared to What? Pharma fears comparative effectiveness research will focus on costs and stymie personalized medicine. |
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? |
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. |
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. |
Pharmaceutical Executive November 1, 2014 Jill Wechsler |
Outrage Grows Over Drug Pricing Insurers, physicians attack high-cost therapies in anticipation of specialty drug surge. |
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. |
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? |
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. |
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. |
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. |
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. |