Chinese firm BeyondSpring dealt a setback after the US FDA refuses to approve plinabulin for chemotherapy-induced neutropenia.

A US FDA review panel has given a lukewarm reception to molnupiravir, while Inovio is assessing its vaccine candidates against the new omicron variant, J&J nears a South African vaccine deal with Aspen, and South Korea brings in new COVID-19 measures. Meanwhile, Serum exports Novavax vaccine, Bharat looks at Covaxin in Omicron and Ocugen's Covaxin trial put on hold. 

VBI Vaccines obtained FDA approval of its three-antigen hepatitis B vaccine PreHevbrio and will take on GSK’s Engerix-B and Dynavax’s Heplisav-B as CDC recommends universal HBV immunization.

The response rate, with five complete responses, exceeds known responses to standard-of-care chemotherapy in heavily pre-treated folate receptor alpha-high patients. A US FDA filing is on track for early 2022.

In this week's podcast edition of Five Must-Know Things: the prospects and plans for J&J’s pharma and oncology business; China looks more inward under new policies; an important US approval for Takeda; and Moderna’s co-founder shares tips on innovation.

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.

A landmark approval and domestic tie-up in China mark the fast innovation that is shaping the country’s health sector.

Maribavir is the first antiviral agent targeting and inhibiting the pUL97 protein kinase, as well as Takeda's second new molecular entity approved by FDA this year.

The Irish firm needs to give regulators in the US more information on its epidermolysis bullosa therapy but is confident of address those requests from its "existing data within the time periods required," according to CEO Joe Wiley.

The approval of Fyarro marks the first for advanced malignant PEComa, a rare cancer that affects only 100-300 people in the US; it's also the first launch for Aadi Biosciences.

Very early launch numbers look good in France and Germany, but US launch will be more challenging due to a fragmented patient base, the company said. Launch price is a flat $899 per vial.

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.