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

Policy & Regulation

Bayer's Weinand On Broadening Value-Based Pricing Views

Bayer's pharma head Dieter Weinand talks about his biggest issues with current value-based pricing assessments for new drugs and how companion diagnostics will pave the way to easier pricing of oncology therapies.

Pricing Strategies Reimbursement Cancer

Drug Promotion: FDA Loosens Reins But Industry Wants More Room To Run

Agency proposes a safe harbor for certain communications with payers about approved uses and investigational drugs, but drug manufacturers ask the US agency to expressly protect from enforcement manufacturer communications about off-label uses.

Advertising, Marketing & Sales Reimbursement Regulation
Advertisement

Policy

Set Alert for Policy

Latest From Policy

Scrip Asks… Is The Biosimilar Cost-Saving Theory Sustainable?

Scrip asks industry whether the promise of biosimilars producing substantial cost-savings is a sustainable model to help healthcare systems afford the next wave of expensive biologics. Drug developers and trade associations comment on the caveats still in play when it comes to biosimilars, cost-cutting and market access.

Biosimilars Market Access

Real World Evidence Is Critical To Pharma’s Future: Can We Agree On What It Is?

Urgent calls for industry to generate and apply real world evidence were matched at a recent conference only by complaints about challenges faced by this growing, ill-defined evidence category.

Research and Development Strategies Clinical Trials

Catch Me If You Can: Knowing How To Innovate Matters In China

Given the host of recent and planned policy and regulatory changes in China, the traditional lines between multinational and local companies in the country will become increasingly blurred. These who know how to innovate in different ways in the fast-changing environment will have the most to gain, says the head of one major pharma industry trade group.

China Innovation

Tymlos, Evenity Pricing: Should Generic Zoledronic Be Reference Point?

ICER draft report concluding data are insufficient to distinguish the effectiveness of anabolic treatments for osteoporosis from generic zoledronic acid raises questions about price premiums for the newer treatments.

Reimbursement Pricing Strategies

Scientists Marched To Protect NIH Grants, But Where Was Pharma?

Funding from the US National Institutes of Health is a vital source for biomedical research and pharmaceutical pipelines in turn – but biopharma companies have been largely silent on the matter.

Innovation Research and Development Strategies

PhRMA Uses Allergan Stage In Campaign To Keep Focus On Industry's Reputation For Innovation

PhRMA CEO Stephen Ubl visited Allergan's Irvine, Calif. R&D and manufacturing campus as the trade association continues its "Go Boldly" campaign promoting biopharma innovation in an effort to counteract the hit the industry's reputation has taken from drug pricing concerns.

Innovation Pricing Debate
See All

Regulation

Set Alert for Regulation

Latest From Regulation

Sickle Cell Innovators Required: Emmaus' Pending Approval Highlights Rare Disease Void

FDA approval is likely for Emmaus' sickle cell drug L-glutamine this summer, representing the first new product for the disease since 1998 – a decision FDA advisory committee panelists hope will spur more innovation.

Approvals Research and Development Strategies

Keytruda Approval Opens New Routes For Immuno-Oncology

Merck's PD-1 inhibitor holds the first cancer indication based on biomarkers rather than tumor location. The most significant market will be colorectal cancer, but Bristol-Myers Squibb's Opdivo is pending for the same subgroup and Roche's Tecentriq could eventually gain a broader approval.

Approvals Drug Approval Standards

Chiesi Wins EU Nod For COPD Triple Combo, But Partner Is Predicted For Launch

Chiesi's triple combination therapy for COPD, Trimbow, has secured its first approval globally after winning a positive recommendation from the CHMP for its use in Europe – but analysts expect a respiratory partner will be required to launch the product.

Approvals Respiratory

‘Excessive Pricing’ Inquiry Widens As EC’s First Antitrust Price Probe Targets Aspen Pharma

The litany of complaints against pharmaceutical companies for imposing “excessive” prices on generic drugs is growing after the European Commission decided to pursue Aspen Pharma over price rises imposed on a range of anticancer products it acquired from GSK.

Europe Generic Drugs

Keytruda/Chemo Combo Approval Means Merck Holds Crown, For Now

FDA's approval of Merck's Keytruda/chemo combo based on Phase II data secures the company's position in the prized first-line lung cancer indication, but Phase III readouts from other combination trials are right around the corner.

Approvals Cancer

Mylan Takes Issue With FDA Over 'Major' CRL For Advair Generic

FDA's complete response letter to Mylan's ANDA for a generic version of Advair was deemed a "major" CRL, likely delaying a launch into 2018.

Generic Drugs Respiratory
See All
UsernamePublicRestriction

Register