Jill Wechsler

FDA leaders insist that the decision to approve Sarepta’s Exondys (eteplirsen) should not be considered a model for future development of orphan drugs.

Value assessment initiatives are expected to have a major impact on drug use and reimbursement.

Efforts to accelerate drug development will alter fee structure and require ready production sites.

Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.

Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.

Manufacturers and regulatory authorities seek coordinated lifecycle management policies.

Can Competition Block Excessive Pharma Price Hikes? EpiPen Saga Shows It’s Hard

Zika vaccine development is hindered by technical challenges and funding shortfalls.

Regulators and manufacturers address economic and ethical issues for scarce medicines.

FDA and industry seek speedy Congressional approval of new user fee plan.

Agency guidance and industry standards aim to reduce lapses and improve quality operations.

Pressure is mounting to reduce costs and spending on prescription drugs.

Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.

FDA and bio/pharma companies get serious about continuous manufacturing to ensure product quality.

Biomedical innovation legislation may stall in 2016.

Drug manufacturing lapses undermine NIH research programs.

FDA’s breakthrough drug initiative is more popular and successful than ever.

The campaign against opioid abuse opens door to more innovative therapies.

Even though the organizers of New York’s Tribeca Film Festival decided not to air the anti-vaccine film by discredited British researcher Andrew Wakefield, the so-called documentary is getting a healthy run and further perpetuating the myth of a link between childhood vaccination and autism.

Global outbreaks energize vaccine R&D and drive production modernization.

Industry is joining with academia and global health leaders to examine new approaches to biotech manufacturing.

Doctors and oncologists agree with pharma companies in opposing the latest proposal from the CMS to revise how it pays for drugs administered in doctors’ offices.

Policy makers debate strategies for promoting access to less costly medicines.

Vaccine R&D has grown exponentially in recent years, spurred by ethical and medical needs to combat lethal infectious outbreaks and increased funding from public and private agencies and organizations.

There was scant praise from the medical community for the eighth and final budget plan from the Obama administration.

In a hearing held on Feb. 4, 2016, executives from Valeant and Turing had a hard time explaining their rationales for exorbitant price hikes of older drugs.

FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.

Can the feds negotiate Medicare Part D prices?

FDA and industry seek a more consistent, flexible CMC review process for breakthrough therapies.

More “me-betters” and more focused breakthroughs could enhance new drug development.