Regulatory

The public and policymakers seek more transparency in pricing and product development.

Adhering to new compliance legislation such as Identification of Medicinal Products (IDMP) can bring a pharma company benefits as well as challenges, writes Darren Cooper.

Advocates on all sides applauded the request to increase funding significantly for FDA under the Trump administration’s budget for fiscal year 2019.

Commissioner Scott Gottlieb has outlined FDA plans to continue the fight against opioid addiction and to prepare a “comprehensive plan” to bolster the market for biosimilars.

Low-cost follow-ons and biosimilars please payers but heighten competitive battles with brands.

Amidst the continuing clamor for government action to curb prescription drug prices, a more collaborative effort aims to broaden the debate to consider the full range of health care services and rates that affect spending in this area. Jill Wechsler reports.

In his State-of-the-Union address this week, President Trump continued his harangue about unfair drug prices in the U.S., but he surprised many observers by failing to call for full repeal of the Affordable Care Act.

Reflector reports on the EU's legislative move to push the fifty or so national and regional HTA organizations in Europe towards greater cooperation.

States will continue to press for price controls, while FDA will tackle opioids and promote innovation.

If confirmed as the next secretary of the Department of Health and Human Services (HHS), Alex Azar says that a top priority is to make drugs more affordable.

By enacting landmark tax reform legislation that makes major changes in the corporate tax structure, Congress this week delivered a significant Christmas present to President Trump - and to industry, writes Jill Wechsler.

In 2017, patients gained access to the first gene therapies and more orphan and breakthrough drugs.

Experts slam drug prices and endorse government price negotiations and curbs on drug advertising.

As FDA and industry near the halfway mark in the process for establishing a national electronic drug tracking system by 2023, there’s concern among pharma companies, wholesaler/distributors, and pharmacists about meeting the deadline

Jill Wechsler discusses the hot topic of how FDA should oversee combination products that incorporate a digital health component.

The GAIN Act creates a process for the Qualified Infectious Disease Product (QIDP) designation, which provides a range of incentives for developing antimicrobial therapies for combating resistant organisms. But while the program has been successful in driving innovation, commercial viability remains a question.

Medical use of marijuana for a broad range of conditions is expanding rapidly in the US, but the future for this market is still uncertain, writes Harriet Kozak.

While most pharma companies are in partial production using generators, few are operating at 100% capacity, writes Jill Wechsler.

Agency leaders go slow in weighing changes to DTC ads and off-label marketing.

FDA is evaluating whether limiting warnings in TV commercials to the most serious adverse effects might be more informative for consumers than the current laundry lists of potential side effects.

The extensive volume of pharmaceutical manufacturing in Puerto Rico is driving FDA efforts to assess facility damage and logistical problems to ensure continued supply of critical medicines. Jill Wechsler reports.

Jayachandra Reddy and Rishit Thakkar discuss the challenges facing early entrants in the Non-alcoholic Steatohepatitis market.

While biopharma companies have pressed hard for clarity on the data required to gain market approval of biosimilars that can be filled by a pharmacist without prescriber pre-approval, the progress towards "interchangeability" has been slow. Jill Wechsler reports.

Can the pharma industry truly achieve a patient-centric supply chain? How some clinical trial logistics companies are racing ahead in making the patient a key link in the chain.