Global

Both foreign and domestic pharmas are in a race to bring PD-1/PD-L1 inhibitors into China, writes Jin Zhang.

Chris Round, Head of International Operations & Global Core Franchises at Merck KGaA, Darmstadt, Germany talks to Pharm Exec about how the company's new treatments are positioned to advance the company’s “double mission."

With a new Commission looming, here’s who’s vying for the top spot in shaping EU strategy, including key questions in pharma.

The World Health Assembly's new resolution on transparency in the market for health-related products is weaker than the original draft but still contains measures that could have a substantial impact on market access around the world, writes Neil Grubert.

FDA is examining and updating its programs for overseeing global operations and international affairs.

European industry fights over every inch on comparative drug pricing initiative.

Pair of interviews spotlight the changing dynamics for C-suite business managers in two contrasting life sciences settings-big, established pharma and small, aggressive biotech.

Ed Schoonveld reviews the key topics discussed at the World Health Organization's second Fair Pricing Forum, held in Johannesburg, South Africa last month.

The UK has had in place what amount to two pricing schemes for branded medicines for years. But with major changes to both schemes set out in 2018, it’s now a new tale of two pricing schemes. Leela Barham reports.

Europe slow to action on emerging technologies, but the complex issues clouding EHRs and gene editing, for example, offer pause.

Joanna Huang analyses the use of external innovation tools among small and large pharma in China.

Despite a “temporary fix” at the ready, pharma supply repercussions loom if exit deal isn’t reached this month.

Dr. Lingshi Tan, a director at DIA, and chairman and CEO of Shanghai-based CRO dMed Company Limited, which he founded after establishing R&D operations for Pfizer in China, discusses the nation's regulatory evolution and opportunities for its government to strengthen collaborations with FDA and other leading global agencies.

How innovation growth has upped the pressure on China to compete globally, forcing upgrades in regulatory, quality, and standards.

How the nation’s rapidly changing regulatory climate is creating a new landscape for pharmaceutical service providers

Pharm Exec profiles Dr. Xiaobin Wu, an accomplished leader in helming China operations at big pharmas such as Pfizer and Bayer, who believes his recent jump to biotech as GM of China and president of BeiGene will deliver his most lasting legacy.

Green-lighting China as our coverage focus in the February issue wasn't without conflict or hesitation, but as our reporting of the nation's biopharma landscape shows, perseverance and growth many times go hand-in-hand.

Momentum and uncertainty shape the sector's economic picture.

What the new rules mean for Chinese-related investments and acquisitions in the US.

You can’t make progress without consensus. This holds true for Brexit and for the unparalleled opportunity that the WHO Roadmap report on Access to Medicines and Vaccines presents, writes IFPMA's Greg Perry.

Pharm Exec’s annual look at what lies ahead for the biopharma industry in the coming months examines eight key trends that are seemingly at tipping points in their evolution and poised to shape the life sciences landscape in 2019.

“You wanna play rough? Just try it!” was the gist of the New-Year message from the European pharma industry to the healthcare authorities circling around drug firms preparing for pricing discussions. Reflector reports.

As we pass the 6-month anniversary of theGeneral Data Protection Regulation's effective date, the number of organizations which boast 100% GDPR compliance has certainly increased. But life sciences companies are still grappling with implementation of the policy and procedure changes, writes Ashley Williams.

James Clark addresses one of the key questions data protection and compliance officers are asking following the implementation of the General Data Protection Regulation -"What role am I playing under the GDPR?"

As the EU prepares for a change of governance, policymakers should take note of recent comments about the "poisoned atmosphere" surrounding healthcare policy debates, writes Reflector.

Whatever the final outcome of Brexit, investing in supporting advocacy communities will be an important element of maintaining trusted relationships with patient groups and stakeholders in the UK and the EU, write Nick Hicks and Tamsin Rose.

This article discusses three key considerations a manufacturer should either understand or seek a consulting partner to guide them through a commercialization plan.

The Commission’s gestures toward enacting formal standards to digitize health records are masking wider policy gaps.

Emil Eifrem examines how life science researchers at Munich’s German Center for Diabetes Research are uncovering insights in their data with a new way of working with complex data

Parliament throws wrench in Commission’s plan to regulate HTA.