As India gets set to resume COVID-19 vaccine diplomacy from October, a new rule which will require Indians visiting UK who are fully vaccinated with AstraZeneca partner Serum Institute’s vaccine to undergo quarantine has sparked a row. Meanwhile, Indian companies await a nod from the WHO for wider acceptance of their COVID-19 vaccines.

The UK’s choice of the mRNA vaccines as COVID-19 boosters is no surprise – but not releasing the key study data behind the decision is.

Big pharma leaders warn of steep cuts to R&D and US jobs if US drug pricing reform legislation paves the way for direct government price negotiations.

Biogen is ‘pleased’ access will be available through exceptions process in formulary restrictions though the US veterans agency does not expect there will be ‘significant’ interest among its clinicians in prescribing through that process. Price was not deciding factor, agency says.

The US president’s remarks appear aimed at drawing more support for the negotiation policy. But critics are likely to be skeptical about whether such a process could result in a “fair” price.

They may have a good shot at passage given recent actions by President Biden and the Federal Trade Commission, and bipartisan interest in drug pricing. 

Provention has been working hard collecting necessary data for a potential BLA resubmission for teplizumab in patients at risk of developing type 1 diabetes after receiving a complete response letter in July. Hopes rest on a Type A meeting with the FDA in Q4.

Shares in Sweden's Calliditas have taken a tumble on the news that the US FDA has pushed back the action date for its immunoglobulin A nephropathy Nefecon. However, the company, and certain analysts, are less worried, believing the delay is just a blip.

After discussions with the US FDA, the company determined it can file AMX0035 based on Phase II/III results and interim Phase III data. Amylyx is sticking with its go-it-alone strategy for global commercialization.

Novartis has filed the PD-1 inhibitor tislelizumab, licensed from BeiGene, for second-line esophageal cancer with the FDA, the first submission outside China for the closely-watched therapy.

The company plans to make a new EUA request prior to filing a BLA, but does not yet have a specific timeline. Meanwhile, it has been preparing for the drug’s distribution as a COVID-19 treatment.

From clinical trials to in-person sales calls, the pharmaceutical value chain has been tested by the COVID-19 pandemic, but has held up. Nevertheless, recent friction within this chain may be more than a passing irritation.