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Asia Pacific

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Latest From Asia Pacific

Astellas Offloads Japan Product Basket To Private Equity Group

Astellas has joined the growing ranks of research-based pharma firms offloading their older products in Japan, amid rising pricing and generic pressures and an increasing desire to focus on innovation.

Japan Commercial

Confidence High As AstraZeneca Adds Asia To Benralizumab Territories

In another vote of confidence in one of its newer respiratory assets, AstraZeneca is extending to Asia its already broad rights to benralizumab, adding to a deal it already has with Kyowa Hakko Kirin for Japan.

Asia Pacific Deals

Accusations Fly In Messy Ranbaxy Compensation Battle

The ongoing fight by Daiichi Sankyo for compensation from India’s Singh brothers over the company’s disastrous purchase of generic drugs giant Ranbaxy has heated up, with the Japanese firm now accusing the tycoons of not telling the truth about the value of assets meant to serve as security for damages.

India Legal Issues

China VC Roundup: Investors Flock To Rising Innovation, Expertise

The past few months have seen frenzied venture capital and other investment in the Chinese pharma and biotech space, driven by increasingly innovative startups run by big pharma veterans, while corporate ventures have been joining with private equity to build up specialist investment and M&A funds.

China Financing

Now Is The Time! Rule Changes To Open Up China To Foreign New Drugs?

The China FDA has outlined a raft of new measures to streamline the development and approval process for foreign new drugs, in changes that are likely to bolster multinationals’ interest and activity in China, and to quicken the pace of launches to potentially overcome the country’s “drug lag”.

China Drug Approval Standards

Big Pharma CEOs Descend On China: What’s The Likely Agenda?

In a major show of force, four global pharma CEOs are heading to China to participate in high-level open and closed-door discussions that are expected to include a range of policy and regulatory reform topics. Tapping into China’s push to improve health and develop an innovation-driven economy may provide new openings for their voices to be heard.

China Policy & Regulation
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Europe

Set Alert for Europe

Latest From Europe

Lost $700m Opportunity As PTC Bids Farewell to Translarna in CF

In withdrawing its European marketing application for Translarna in cystic fibrosis, PTC Therapeutics has bid farewell to a market opportunity once pegged at $700m.

Commercial Market Intelligence

NICE Appraisal Changes: A New Pricing Hurdle For Companies

New NICE and NHS England appraisal rules regarding timelines and price thresholds – labeled stark and contradictory – could fast-track new cost-effective drugs but then subject the same products to significant delays of multiple years.

Pricing Strategies United Kingdom

Politics Dilute Germany’s AMNOG Updates: Impact On Pharma Firms

New updates to Germany’s 2011 AMNOG healthcare reform act could lead to more conservative prescribing and benefit assessments for older products. Pricing measures were dropped but will likely resurface after September’s general elections.

Market Access Policy & Regulation

UK's Crackdown On Anti-Competitive Deals Continues; Actavis In Firing Line Again

The UK's competition authority is keen to expose supposed pay-for-delay deals made by pharmaceutical firms, and is warning drug suppliers to think twice before attempting agreements that slow the entry of generic products onto the UK market.

Generic Drugs Pricing Strategies

New EU Nod For J&J/Genmab's Darzalex Brings It Closer To Rivals

The EU's CHMP has given the go ahead to extend the EU licence for Janssen/Genmab's Darzalex to include its use earlier in the treatment paradigm, bringing into line with the US label and its rivals.

Europe Drug Review

Busy In-Tray Awaits New EFPIA Boss Nathalie Moll

Nathalie Moll is moving on from leading the biotech industry body EuropaBio to be the next director general of EFPIA, the federation that represents the R&D-based pharmaceutical industry in Europe. With issues such as the forthcoming Brexit negotiations, the EU’s inquiry into medicines access and pricing, and the implementation of the new Clinical Trials Regulation on the agenda, Moll will have a lot of weighty dossiers to deal with.

Policy & Regulation Leadership
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United States

Set Alert for United States

Latest From United States

Pfizer On Obamacare Rewind: No Short-Term Impact On Industry

Pfizer CEO Ian Read explains why industry has stayed on the sidelines during the current health reform debate and defends drug pricing practices during a speech to the National Press Club.

Policy Pricing Debate

Pfizer's Avelumab Makes Its Debut, In Rare Form Of Skin Cancer

Pfizer got Bavencio to market by focusing on an unmet need, but the PD-L1 inhibitor is still a few years behind, competing with other checkpoint inhibitors over more valuable indications.

Approvals ImmunoOncology

Quick Commercial Standouts Lacking Among 2016 US Launches

The number of novel drugs approved by FDA in 2016 was down versus prior years, and many of the drugs that did launch are off to a slow start. The expectation is increasingly for drugs to build sales over time.

Launches Commercial

Which Pharma Firm Increases US Prices The Most?

Transparency reports from companies aim to change conversation from prices to discounts, but also invite comparisons. Lilly, for example, saw a higher average list price increase in 2016 than Merck and Janssen, but its net prices grew by less than the others.

Pricing Debate Policy

Gottlieb Nomination As US FDA Chief Could Signal Changes To Generic Approval Process

Former deputy commissioner will also likely push increased use of biomarkers and more flexibility in off-label communication, among other reforms.

FDA Policy & Regulation

Why Is Drug Pricing Higher In US? Study Takes Aim At R&D Argument

Amgen, Biogen, Pfizer and Teva generated more than twice their global R&D budgets with higher pricing in the US compared to Western Europe and Canada, researchers at Memorial Sloan Kettering found.

Pricing Debate Pricing Strategies
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