A new pathway for follow-on biologics relies on data exclusivity to shield innovators from early competition
Jul 30, 2007
By:
Jill Wechsler
Twelve years is probably "the best deal the industry is going to get," comments former FDA official Scott Gottlieb. "This is a genuine compromise."
|
New vaccines can be good business and a huge boon to public health. But the challenge is to establish prices that ensure global access.
Jul 3, 2007
By:
Jill Wechsler
Not long ago, vaccines were Big Pharma's neglected stepchild—cheap, one-time treatments that scarcely made a profit. The pharmaceutical industry was moving away from them in a hurry.
|
Insurers and payers believe that more comparative information on medical treatments will save money and improve care, but such analysis may be costly to pharma
Jun 1, 2007
By:
Jill Wechsler
The danger is that effectiveness studies could be used to limit coverage to low-cost products and that additional research requirements for sponsors could be costly
|
|
Commissioner Andrew von Eschenbach on drug safety, DTC advertising, FDA's culture, and how the agency plans to bring itself into the age of molecular medicine
Jun 1, 2007
By:
Patrick Clinton, Jill Wechsler
There's tremendous opportunity for us to understand how drugs can be used even better to get the right outcome, not only how to contain them in order to avoid complications or adverse events
|
Innovators want exclusivity and clinical studies for follow-on biologics, but visions of billion-dollar savings may short-circuit the scientific debate
May 1, 2007
By:
Jill Wechsler
The push is on to establish an approval pathway for generic versions of biotech therapies. The Hatch-Waxman Act of 1984 established a process whereby generic-drug manufacturers could obtain approval for a product based on the innovator company's data. But Hatch-Waxman doesn't apply to biologics regulated by the Public Health Service Act, and generics makers—as well as some Big Pharma companies and small biotech firms—want Congress to give the Food and Drug Administration authority to set up a similar process for these products as well.
|
Forget Medicare price negotiations. Pending changes in Medicaid drug-pricing formulas will put even more pressure on pharmaceutical prices.
Apr 1, 2007
By:
Jill Wechsler
All the hoopla about Medicare drug prices is overshadowing the real action in pharmaceutical pricing: a less-noticed exercise that aims to reduce reimbursement for medicines purchased by state Medicaid programs. Retail pharmacists say the proposed changes will put them out of business, and pharmacy benefit managers (PBMs) fear an end to discount negotiations.
|
FDA seeks to regain public trust by making drug-safety information more transparent—and to head off more stringent legislation in the process. wave of collaborations between industry, non-profits, and government seeks affordable treatments for neglected diseases around the world.
Mar 1, 2007
By:
Jill Wechsler
Critics asked for a reevaluation of new drugs a year after launch. FDA's plan to issue report cards on new drugs responds to that demand—but not completely.
|
Feb 1, 2007
By:
Jill Wechsler
Democrats want more transparency from pharma, and Republicans also are making noise about pricing. But government drug reimbursement is hard to get right and often creates perverse patient care incentives.
|
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.
Jan 1, 2007
By:
Jill Wechsler
The anticipated Congressional free-for-all on the Bush administration will put FDA officials in the hot seat. There will be hearings on inadequate oversight of drug safety, conflicts of interest, importation, and hasty approvals.
|
|
PharmExec Blog
Follow Us
RSS
Bookstore
