China

Regulatory reform in China enhancing clinical trials review and approval

In order to encourage innovation, speed up access to new drugs and meet the needs of patients, an updated investigational new drug (IND) review procedure was created in China and has been in effect for just over a year. The change drew discussion at both the DIA China 2019 meeting in Beijing in May as […]

Biopharma M&A engine fires up as new year rings in big deals

Bristol-Myers Squibb (BMS) Co.’s $74 billion bid for Celgene Corp. – which, if it closes, will become the largest M&A in biopharma history – “made for a fascinating opening” to the J.P. Morgan Healthcare Conference (JPM), said Jamie Munro, global practice leader, portfolio and licensing at Clarivate Analytics, especially given Celgene’s historic placemark as the […]

How regulation, innovation, quality and access are inevitably intertwined

In a global industry like pharmaceuticals, the interdependencies among quality, access, innovation and regulation can have global implications. That message comes through clearly in the 2018 CPhI Annual Report, the compilation of expert forecasts and analyses that the organization puts together. The articles, with their focus on the future direction, technologies, opportunities and threats in […]

Global issues stir debate at the 2018 MedTech Conference

News from the global stage resonated throughout the MedTech Conference as the industry gathered in Philadelphia for AdvaMed’s annual meeting.  Among the liveliest sessions were those focused on the future of the clinical trials landscape in the U.K. as a result of Brexit, the impact of trade wars on the industry, and Jeff Shuren, the […]

Key Q2 partnerships driving biopharma

Introduction During the second quarter of 2018, Cortellis Competitive Intelligence registered 985 new deals (excluding mergers & acquisitions) with a total disclosed deal value of $19.5 billion as part of its ongoing coverage of licensing activity in the life sciences sector compared to 964 and $35.6 billion in the first quarter and 1,104 and $13.6 […]

Global push in med-tech innovation prompts regulatory reviews and upgrades

In country after country, regulatory review and change in the med-tech industry have become a constant. Authorities are “advancing with the changing health care landscape,” as one industry representative put it, striking an upbeat note on recent regulatory updates around the world. In China, authorities seek to streamline reviews and approvals to drive innovation and […]

The challenge to stay competitive in the API industry

By the end of 2017, the worldwide demand for active pharmaceutical ingredients (APIs) is estimated to reach $92 billion, according to the European Fine Chemicals Group (EFCG).  Other analyst reports estimate the API manufacturing market to be worth more than $140 billion today and reach $186 billion by 2020. While details vary among analyst reports, […]

Despite solid API market growth, India and China face challenges – including around costs

Companies have chosen India as a sourcing destination for many years due to India’s lower cost structure for manufacturing, labor, materials and equipment. India possesses a large talent pool of chemical engineers and scientists and a large manufacturing capacity focused on regulated markets.  China also has a talented pool of scientists and engineers, a low […]