Scrip is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Policy & Regulation

PBMs Were On Capitol Hill, But Pharma Still Took Some Heat

Drug makers remained front and center during the Senate Finance Committee's third hearing on drug pricing, even though leaders from five pharmacy benefit managers were testifying.

Pricing Debate Politics Policy & Regulation

US FDA Filing Mistake For Fintepla Dents Zogenix

Zogenix seems only to have itself to blame for an unexpected refusal to file letter from the US agency for its novel treatment for Dravet syndrome that sent its shares tumbling by 31% on NASDAQ in after-hours trading.

Drug Review Policy & Regulation Neurology
Advertisement

Policy

Set Alert for Policy

Latest From Policy

ICER's Review Of Rebate Reform, At A Glance

The Institute for Clinical and Economic Review has weighed in on the pros and cons of rebate reform, surveying an assortment of payers, pharmacy benefit managers and pharmaceutical companies on alternative rebate models and their potential impact. 

Pharmacy Benefit Management Pricing Debate

Big Pharma At The Senate: When It Comes To Yes Or No Questions, There Are Still A Few Maybes

Our question-by-question infographic shows how Rx executives exhibited enough finesse to avoid any embarrassing sound bites at the Senate Finance Committee hearing on drug pricing.
Pricing Debate Pricing Strategies

Big Pharma Defuses Drug Pricing Landmines On Capitol Hill

Industry's top leaders weren't exactly eager to testify on Capitol Hill. Now they might be wondering why they waited so long. Seven pharma leaders avoided missteps during a Senate Finance Committee hearing on drug pricing Feb. 26.

Pricing Debate Legislation

Senate Drug Pricing Hearing Looms As Unparalleled Event For Pharma

From Vioxx to EpiPen, industry has been called in to testify before Congress on a range of issues. But with seven big pharma leaders having accepted the Senate Finance Committee's invitation Feb. 26, the stage is set for some exceptional political theater.
Pricing Debate Leadership

Commercial, Reimbursement Hurdles Need To Be Addressed By Antimicrobial Resistance Efforts

Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.

Infectious Diseases Commercial

No More Rebates: HHS Proposed Rule Revises Anti-Kickback Safe Harbor

Proposed US rule would establish two new safe harbors against anti-kickback enforcement, one covering price reductions at the point of sale and the other protecting flat service fees paid by manufacturers to pharmacy benefit managers. But rebates to "PBMs to buy formulary position" in Medicare/Medicaid would lose protection.

Pricing Strategies Pharmacy Benefit Management
See All

Regulation

Set Alert for Regulation

Latest From Regulation

Celgene/Bristol's Revlimid Patent Risk Incrementally Lower After PTAB Denies Alvogen IPR

Bristol-Myers Squibb pitches Celgene's pipeline as its most valuable asset, but investors remain fixated on the coming Revlimid patent cliff. A recent PTAB decision to deny an inter partes review incrementally decreased that risk.

Intellectual Property Business Strategies

From Stockpiling To Product Launches: Norgine Executive Shares Brexit Fears

A European firm with significant operations in the UK, Norgine has invested considerable resources in preparing for Brexit. With less than three weeks to go before the UK is scheduled to leave the EU, chief operating officer Peter Martin is very concerned about the risks of a no-deal Brexit, and the lack of clarity on what will happen next.

Brexit Trade

Roche's Tecentriq Steals Lead In Triple-Negative Breast Cancer

The PD-L1 inhibitor is the first checkpoint immunotherapy to gain approval in the tough-to-treat disease setting.

Approvals ImmunoOncology

AMAG's Makena Fails Confirmatory Pre-Term Birth Study, But May Not Be Pulled From Market

The company will conduct subgroup analyses to support ongoing use, but analysts believe Makena is unlikely to be pulled from the market when compounded progesterone is the only alternative therapy. Nevertheless, sales already are declining, since generics launched last year.
Drug Approval Standards Clinical Trials

UK Offers Pharma Firms Ferry Tickets To Avoid No-Deal Brexit Supply Disruptions

The UK health department says it has purchased ferry tickets that pharmaceutical companies can buy in order to transport their medicines and other product using alternative shipping routes between EU and UK ports in the event of a no-deal Brexit. It has also updated companies on how they can access additional warehousing space for medicine stockpiles.

United Kingdom Regulation

Mortality Signal For Pfizer's Xeljanz In Rheumatoid Arthritis Puts A Damper On JAK Class

Analyst speculates that risk of pulmonary embolism for a higher unapproved dose of Xeljanz in arthritis could trigger a label change for the same regimen in the drug's ulcerative colitis indication.

FDA Immune Disorders
See All
Advertisement
UsernamePublicRestriction

Register