As Chinese returnees transform their startups to fully-fledged biopharma operations with a full product lineup and the global market in sight, the journey has been filled with challenges. Based on interviews and on-the-ground reporting, this new series takes a closer look at several companies' experiences.

Plus deals involving LegoChem/Pyxix, Biohaven/Sosei Heptares, Kyowa Kirin/Helsinn, Dr. Reddy’s/Glenmark, Eisai/Wren, KoBioLabs/Kolmar Korea, Y-Biologics/Pierre Fabre, Generex/Chinese consortium.

Regulatory pressure to fully approve the first COVID-19 vaccine in China is mounting as top officials tour an inspection agency and two leading manufacturers. 

Helped by a hefty financing earlier this year, Bukwang subsidiary Contera Pharma is poised to speed ongoing multinational Phase II trials with its lead asset for Parkinson’s-associated dyskinesia by hiring CNS experts as new top executives, as the Korean firm looks to take it public in ground-breaking move.

As the MHRA prepares to grant approval to the Oxford/AstraZeneca vaccine, Wockhardt is set to supply 100 million doses for the UK government’s own use and its WHO commitments. The company is also in talks with global vaccine developers to manufacture their COVID-19 vaccines for emerging economies

A senior executive shares insights around how the global logistics provider is preparing to deliver the upcoming COVID-19 vaccines across the world. While the company has prior experience with the "deep frozen" temperatures needed for some candidates, there will still be specific challenges and complexities involved. 

As the MHRA prepares to grant approval to the Oxford/AstraZeneca vaccine, Wockhardt is set to supply 100 million doses for the UK government’s own use and its WHO commitments. The company is also in talks with global vaccine developers to manufacture their COVID-19 vaccines for emerging economies

After a stunning first efficacy readout for its mRNA-based vaccine, the biotech company's leaders in Europe talk about their rapid commercial and manufacturing scale-up.

Russian claims of superior efficacy two days after Pfizer’s good news look politically motivated

Sobi is launching the thrombocytopenia drug Doptelet in Europe after acquiring the originator, Dova Pharmaceuticals, and expects to capture significant market share from older products while adding to its business in rare diseases, hematology, and immunology.

The Dublin-based venture capital group will be looking to replicate the success of portfolio companies Inflazome and KaNDy, recently acquired by Roche and Bayer respectively, with the biotechs backed from its latest fund.

The UK has built one of the biggest and best ‘portfolios’ of COVID-19 vaccine candidates – but there are questions about its transparency and accountability.

After completing a major financing last year, expectations are rising at D&D Pharmatech as it progresses large-scale, Phase II global trials with its neuroinflammation pipeline for Parkinson’s and Alzheimer’s disease. Its CEO talks to Scrip about what's in store for the South Korean biotech.

The termination of a major idiopathic pulmonary fibrosis collaboration between Bridge Biotherapeutics and Boehringer Ingelheim is a blow to both companies in an increasingly competitive indication, but the Korean biotech says it's still committed to further development of the autotaxin inhibitor and will work out a future development plan.

Worst case scenario is civil unrest that might disrupt clinical trials and manufacturing. Under a more moderate scenario, companies must delay business planning because the US policy environment remains cloudy.

Mylan’s proposed $12bn combination with Pfizer’s Upjohn unit is expected to close next month following a settlement agreement with the FTC, with a requirement to address competition concerns in ten markets. The FTC was however strongly divided on the deal, with dissenters labelling the directives of the Commission as “deeply flawed, favoring routine over rigor.”

US FDA defers action on Spectrum’s approval application for neutropenia candidate Rolontis due to pandemic-related difficulties inspecting partner Hanmi’s plant. The action date has been put back by around four months although the companies stress no CRL has been issued. 

From efficacy endpoints to patient warehousing, US FDA advisors weigh in on vaccine development and regulatory review.