Vaccines

A series of surprise rejections has made for an FDA that drug and vaccine manufacturers are finding much harder to read than in years past.

As the Danish vaccine maker plots further M&A activity.

Amid a wider domestic market downturn, Beijing Health Guard’s three Phase III trials for two of its HPV vaccine candidates were suspended in January and February due to overdue payments to sites.

The company said the FDA has now accepted its application for mRNA-1010, but it will have to do a postmarketing study in individuals aged 65 and older.

Kangtai has decided to terminate the original plan for a roughly $400m partnership with AstraZeneca announced in March 2025 which was expected to establish the UK major's first vaccine manufacturing site in China.

Moderna said the refusal-to-file (RTF) letter the US FDA issued declining to review the BLA for mRNA-1010 was not in line with guidance from the agency before and after the seasonal influenza vaccine candidate’s Phase III program.

At a recent discussion in South Korea, CEPI and other participants explored ways to discover new health cooperation models that go beyond traditional aid approaches and to strengthen Korea’s role.

The French firm will always ‘defend with evidence’ the positive impact of vaccination, ‘irrespective of who is in office,’ the French firm’s CEO has declared.

A CEPI-supported partnership between MSD Hilleman and SK bioscience aims to improve Ebola vaccine manufacturing and supply.

Intranasal H5N1 vaccine experts discuss Phase I data, mucosal immunity, BARDA/NIH funding realities and how BlueWillow Biologics' NanoVax platform could strengthen global pandemic flu preparedness and respiratory defenses.

A year after Valneva entered a tech transfer agreement for its chikungunya vaccine with Serum Institute, the deal has been called off. Regulatory approvals for the vaccine in Asia are yet to be obtained and the biologics license for Ixchiq remains suspended in the US. What happens hereon?

Anvisa, the Brazilian medicines regulator, has published a new Q&A document relating to clinical research requirements. Meanwhile, the regulator’s new innovation committee, set up to monitor and evaluate innovative products, has set out its key priority areas.