Pfizer is betting big on its manufacturing plans in Europe, investing €1.2bn at respective sites in Ireland and Belgium to prepare for a number of launches it has lined up in the short term.

In this week's podcast edition of Five Must-Know Things: safety debate as more lecanemab data reported; amyloid discussions continue at Alzheimer’s meeting; China COVID unrest affect country’s biotech sector; and Merck’s CMO talks about post-Keytruda plans.

The microbiome therapy won approval for preventing recurrence of Clostridioides difficile infections, but an analyst said the future could be in more targeted approaches.

Transactions involving Biocon/Zentiva, CrystalGenomics/PanGen, Umoja/IASO, Marinus/Tenacia, Ono/Captor and Daewoong/HitGen plus deals in brief.

AC Immune has seen two big disappointments in its Alzheimer’s pipeline this year, but its partner Johnson & Johnson has put its faith in a novel vaccine-like approach to targeting the disease.

Zydus, along with Bristol Myers Squibb and generics companies like Mylan, Cipla and Dr. Reddy’s, has been named in an antitrust suit involving BMS’ blockbuster drug Revlimid. For now, it expects revenues from the generic to stretch beyond Q4 FY’23. Meanwhile, a recent acquisition of Watson, which made APIs for the Teva group, should shore up declining API revenues

In what appears to be a step towards a gradual shift away from its strict "COVID Zero" policies, China is poised to approve its first mRNA vaccine - in this case developed domestically - and will accelerate the roll-out of COVID-19 vaccinations in general to seniors over 80.

The move marks the second time since last year that Roche has withdrawn a urothelial carcinoma indication after its confirmatory trial failed to show an overall survival benefit.

Much of the biopharma and other health-related industries in China were already feeling the chill from ongoing macro-economic and other headwinds this year, which now look set to be complicated further by the added strain of social unrest over strict COVID containment policies. The combination of factors is already prompting some to take steps towards restructuring and divestments to survive.

The major’s radioligand therapy has succeeded in an earlier line of prostate cancer therapy that presents a large market opportunity, but some observers are keen to see full data before raising their sales projections.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

The FDA’s thumbs-down was largely expected after a negative advisory committee review and the path forward for the drug remains unclear – but the company is prioritizing other programs.