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Pharmaceutical Executive September 1, 2006 Kieran Hartsough |
Benchmarking AIDS Pharma is taking on the global AIDS crisis. But who has crafted the best approach? The Interfaith Center on Corporate Responsibility defines best practices and matches major companies head-to-head. Grades are posted inside. |
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 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 September 1, 2013 Stan Bernard |
The Drug Combination Competition Companies are leveraging combinations of drugs and other products to gain competitive advantage and market share. |
Pharmaceutical Executive January 1, 2014 Jill Wechsler |
Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing |
Managed Care February 2008 Martin Sipkoff |
FDA Approach to Generics May Be a Mixed Blessing A recently announced initiative is supposed to speed approval of generic drugs, but does it address some fundamental flaws in the approval process? |
BusinessWeek August 5, 2010 Bennett & Randall |
AIDS Drugs Flow to the Third World Drugmakers, once blasted for their practices, are slashing prices and licensing AIDS drugs for free to nonprofits or local manufacturers in developing countries. |
Pharmaceutical Executive January 1, 2012 Jill Wechsler |
New Year, New Issues Look for action in 2012 on drug access, shortages, innovation, and transparency. The 800-pound gorilla in the room is the looming Supreme Court decision on the constitutionality of the Obama health reform legislation. |
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. |
Salon.com June 1, 2001 Daryl Lindsey |
The AIDS-drug warrior Outspoken AIDS-drug activist Jamie Love says pharmaceutical companies must be forced to yield their patents to save hundreds of thousands of lives. Is he a visionary -- or a dangerous radical? |
Pharmaceutical Executive February 1, 2006 Joanna Breitstein |
Breath of Hope: TB in Africa For the first time in decades, the pharmaceutical industry has tuberculosis drugs in the pipeline. But it will take more than new pills to solve the problem. |
Pharmaceutical Executive October 1, 2012 Jill Wechsler |
Changes and Challenges at FDA New user fee programs precipitate major changes at an agency under constant and intense scrutiny. |
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 July 1, 2009 Jill Wechsler |
Safety and Security As FDA looks to balance risks and benefits, more regulations are on the horizon. |
Pharmaceutical Executive November 1, 2011 Jill Wechsler |
The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices. |
Salon.com May 1, 2001 Daryl Lindsey |
Amy and Goliath A first-year law student brought a giant pharmaceutical to its knees. But will her victory for South Africa's AIDS sufferers deprive the world of new medicines? |
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. |
The Motley Fool December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
The Motley Fool December 14, 2006 Stephen Albainy-Jenei |
Merck Gets Punk'd by Thailand Thailand issues a compulsory license to manufacture a generic version of Merck's patented AIDS drug. This is an act of humanitarian aid, but it is also an avenue for price and profit erosion worldwide. |
Pharmaceutical Executive May 1, 2011 Jill Wechsler |
Outrage Over Drug Prices Stiff price tags draw scrutiny from Congress and consumers, and raise questions about FDA policies |
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 December 1, 2005 Jill Wechsler |
Washington Report: Big Production Drug manufacturing costs too much and is cumbersome to regulate. FDA's answer: Quality by design, which shifts the emphasis from testing the final product to building quality into the manufacturing process from the beginning. |
Salon.com March 19, 2001 Ben Barber |
Fighting the plague The World Trade Organization steps into Africa's AIDS crisis, creating incentives for pharmaceutical companies to give some of their drugs away. |
Pharmaceutical Executive October 1, 2010 |
Taking a Less-Generic Route to Generics A leading pharmaceutical industry player speaks out on what is fueling success in the sector. |
The Motley Fool March 23, 2010 Brian Orelli |
No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma. |
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 July 3, 2007 Jill Wechsler |
Washington Report: Vaccines for Everyone New vaccines can be good business and a huge boon to public health. But the challenge is to establish prices that ensure global access, and to bring necessary medications to third-world countries. |
Chemistry World February 14, 2012 Rebecca Trager |
FDA proposes biosimilars approval pathway The US Food and Drug Administration has released its long awaited guidance to assist in the development and approval of so-called 'biosimilars' - biological drugs that are very similar to licensed ones. |
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 September 1, 2011 |
The Power of PDP Can cooperative ties between Big Pharma, NGOs, government, and international organizations pay the freight in making the fight against neglected diseases a permanent fix in global health? |
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. |
The Motley Fool February 16, 2010 Brian Orelli |
For Blockbuster Cancer Drugs, Approvals Are the Easy Part Don't get too excited. As an investor, you can lower your risk by investing in cancer drug companies after a clinical trial success but before an FDA approval, but you'll also reduce your reward. |
The Motley Fool July 16, 2011 Melly Alazraki |
HIV Studies May Not Mean Much to Gilead Studies find Gilead drugs can help prevent HIV infections, but that may not help sales. |
Fast Company March 2015 J.J. McCorvey |
How Drug Company Gilead Outpaces Its Competitors -- And Common Diseases Over the past few years, Gilead has ushered through four effective new treatments for HIV alone. |
The Motley Fool April 26, 2011 Brian Orelli |
There Is Only Downside in Consensus Hepatitis C advisory panels will almost certainly recommend approval. Almost. |
Pharmaceutical Executive September 1, 2011 Jill B. Conner |
Complex Biologics: The View from Teva Industry and regulators alike must grapple with the sensitivities associated with developing bio-similar drugs. |
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. |
BusinessWeek April 1, 2010 Bennett & Randall |
Will an AIDS Pill a Day Keep the Virus Away? Drugmaker Gilead is betting the one-pill PrEP treatment will slow the virus' spread - as are some of the world's top health agencies and philanthropists. |
The Motley Fool October 16, 2006 Brian Lawler |
The Coming Generic Drug Boom Generic drugmakers are poised to profit from several key factors. Investors, take note. |
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. |
The Motley Fool July 29, 2010 Brian Orelli |
Buy, Sell, or Hold: Biotech Generics Generic biotech drugs are coming. Hop on. |
The Motley Fool February 22, 2011 Brian Orelli |
A Billion-Dollar Market to Open "Very Soon" Biosimilar drugs are finally coming to the U.S. |
Managed Care March 2008 Martin Sipkoff |
The Epilepsy Battle in the War Between Brands and Generics Brand-name manufacturers and many neurologists see danger in generic substitution, but the FDA insists that the practice is safe |
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 February 1, 2014 Jill Wechsler |
Drug Coverage, Costs Under Scrutiny Benefits offered by insurance plans on health exchanges and through Medicare are raising concerns about patient access to needed therapies |
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 December 1, 2005 Alana Klein |
Thought Leader: A Q&A with Graham Allaway While researchers continue to hunt for new AIDS drugs, Graham Allaway, chief operating officer of Panacos Pharmaceuticals, is focusing on developing a treatment for patients failing therapy due to resistance. |
BusinessWeek August 26, 2010 Tom Randall |
Cocktails Are Next For Cancer-Drug Makers Taking a cue from the cocktails of drugs that have made AIDS survivable, drugmakers are pursuing combination therapies against cancer. |
The Motley Fool July 30, 2010 Brian Orelli |
A Faster Pathway to Drug Approvals A thinktank called the Pacific Research Institute has proposed letting drugs approved by the European Medicines Authority onto the market in the U.S. before the Food and Drug Administration has approved the drugs. |
The Motley Fool July 12, 2011 Tracy Staton |
Gilead First to Jump Into AIDS Patent Pool Gilead Sciences has broken the ice on the AIDS drug patent pool. |