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Policy & Regulation

China Vs. Cancer: Coverage For 17 Drugs Unveils Price Pressures, Commercial Battleground

While cancer drug makers generally applaud the rare reimbursement decision in China, some have pointed to mounting and significant pressure to lower prices, while insiders say the real battle has only just began and that translating the coverage into commercial success will take much more effort.

China Reimbursement Commercial

China Biotech Innovation Reaching Tipping Point?

A rapidly reforming policy and regulatory environment and a growing culture of innovation are encouraging capital and talent to pour into China, making it a question of when, rather than if, the payoffs will come for both consumers and investors.

China Financing Research & Development
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Policy

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Latest From Policy

Industry Makes A Drug Price Transparency Push In DTC Ads, But Is It Too Little Too Late?

PhRMA unveiled a voluntary policy under which drug makers will provide information in DTC ads about how to access drug prices and cost information. But hours later HHS issued a proposed rule on the same topic, only requiring drug makers to include WAC prices in TV ads. .

Pricing Debate Advertising, Marketing & Sales

AbbVie Deployed Nurses As 'Runners And Cappers' In Humira Kickback Scheme, Suit Alleges

California Insurance Commissioner claims AbbVie gave kickbacks for healthcare providers to prescribe Humira and had nurse 'ambassadors' insert themselves between patients and physicians.

Advertising, Marketing & Sales Legal Issues

Fix Antibiotic Payment Models To Spur R&D Investment, US FDA’s Gottlieb Says

Citing need for more ‘pull’ incentives to overcome commercial hurdles, FDA commissioner says a subscription-based fee reimbursement system would provide a foundation for return on investment of new antimicrobials targeting multi-drug resistant pathogens.

Infectious Diseases Reimbursement

CEO of New UK Cell And Gene Therapy Hub Says 'All Systems Are Go'

CEO of the Stevenage-based center hopes the new cell and gene manufacturing hub will see a growing life sciences ecosystem coalesce around it.

Regenerative Medicine United Kingdom

Express Scripts Rewards Low List-Priced Brands In 2019 Formulary, Retains Focus On Rebates

Mylan’s Symfi and Merck’s Zepatier gain preferred status on PBM's national preferred formulary for 2019. But more drugs are excluded from coverage – 242, up from 196 in 2018.

Pharmacy Benefit Management Pricing Strategies

Who's Promised What: A Guide To Pharma Drug Pricing Pledges

Pharma companies have responded to mounting political pressure to lower drug prices by pledging to limit increases and even roll back the costs of certain drugs, but it's hard to keep track of who has promised what exactly. Here, Scrip provides a listing of pharma pricing pledges.

Companies Pricing Debate
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Regulation

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Latest From Regulation

Paratek's Antibiotic Nuzyra Survived 20 Years – Now For The US Launch

Company still mulling pricing for broad-spectrum antibiotic Nuzyra (omadacycline), which is set to launch in the US in the first quarter, following FDA approval Oct. 2.

Approvals Infectious Diseases

Lilly Moves Into Migraine Race With CHMP Okay

Competition is hotting up in the CGRP class of new migraine therapies, with Lilly's Emgality being recommended for approval in Europe, paving the way for a market share battle with Novartis' Aimovig.

Approvals Regulation

Roche To Set Right Avastin Post-Marketing Surveillance Delay In India

Roche is working towards implementing PMS studies for Avastin (bevacizumab) and ensuring that a suspension of marketing authorization for the product in first line ovarian cancer is lifted in India.

Policy & Regulation Regulation

Finance Watch: Opko's Stock Halted As Nasdaq Awaits An Explanation For SEC Pump-And-Dump Lawsuit

Public Company Edition: An SEC complaint alleges that the company, Opko CEO Frost and co-defendants bought penny stocks, pumped up their value, then dumped shares for sizeable profits. Also, Pfizer and Retrophin float debt offerings, while Zealand sells royalties and milestone fees to raise cash.

Financing Regulation

From Interchangeability To Exclusivity: US FDA Looks For Ways To Make Biologics Market More Competitive

The agency is being urged to help spur biosimilar development and market success by finalizing guidance on interchangeability, enhancing public education efforts, and taking a more forceful approach to combating misinformation, while reference product sponsors want FDA to adopt 'umbrella' exclusivity to encourage innovative changes in novel biologics.

Biosimilars Biologics

Sunovion Must Regroup After Setback With Dasotraline In ADHD

Sunovion must find a new path forward for its dasotraline in attention deficit/hyperactivity disorder (ADHD), following a complete response letter from the US FDA.

Complete Response Letters Regulation
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