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Regulatory Updates

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Pipeline Watch: Phase III Readouts In NSCLC, Ovarian Cancer And More

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.

Pipeline Watch Approvals

Gene Therapy Situation Gets More Awkward With Another Death In Astellas XLMTM Study

An expert pointed out that XLMTM patients are already at high risk, but if linked to therapy toxicity, the death could doom the ASPIRO trial.

Gene Therapy Biologics

Provention Maps Possible Regulatory Path For Troubled Teplizumab

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.

Companies Regulation

Delay For Calliditas Kidney Drug Not Major Cause For Concern

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.

Drug Review Renal

Amylyx Will Submit ALS Drug For Approval In The Coming Months

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.

Drug Approval Standards Neurology

Novartis's Tislelizumab Takes First Step On US Approval Path

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.

ImmunoOncology Drug Review

Pipeline Watch: Phase III Readouts In Asthma, NASH And More

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.

Pipeline Watch Approvals

Humanigen Aims For New EUA Request After FDA Turns Down Lenzilumab

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.

Coronavirus COVID-19 Regulation

JW Therapeutics Wins China’s Second CAR-T Approval

The approval of China's second CAR-T therapy has come amid reimbursement challenges, despite the pricing of its direct competitor being much lower than in the US. Chinese developers are pinning their hopes on rapid domestic market expansion via commercial insurance tie-ups as other CAR-Ts move through local development.

China Approvals

Stock Watch: How The Pandemic Impact On Pharma’s Value Chain Is Mutating

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.

Distribution Coronavirus COVID-19

Coronavirus Update: Another Post-Moderna Vaccine Death Reported In Japan

A third death has been reported in Japan following dosing with Moderna's mRNA vaccine and while an investigation is underway, it is not seen as product-related. Takeda has also signed a production and supply deal with Japan's government for Novavax's nanoparticle vaccine. 

Japan Coronavirus COVID-19

BioMarin Trial Halt Raises Another Safety Flag On AAV Gene Therapy

Animal studies have shown that AAV viral vectors can integrate into animal cell DNA – but whether that causes cancer, or could happen in humans, remains uncertain.

Liver & Hepatic Blood & Coagulation Disorders
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