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Regulatory Updates

Set Alert for Regulatory Updates

Vertex Secures Phase II Win In Rare Kidney Condition

The firm’s sole nephrological asset has demonstrated proof of concept, helping advance the novel gene-targeted therapy into pivotal development early next year.

Clinical Trials Renal

BeyondSpring's Next Move Uncertain After Plinabulin CRL

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

Approvals Research & Development

Coronavirus Update: Lukewarm US Panel For Molnupiravir, Inovio, Bharat Look At Omicron

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. 

Coronavirus COVID-19 Approvals

VBI Poised To Take On GSK, Dynavax As Hep B Vaccination Market Takes Off

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.

Approvals Vaccines

Did MEI/Kyowa Kirin Beat The PI3K Tolerability Trap?

PI3K-delta inhibitors have often suffered from safety and tolerability issues, but Phase II data show higher efficacy and lower discontinuation rates for zandelisib than others in the class.

Cancer Business Strategies

SynAct Surveys Its Options As Rheumatoid Arthritis Asset Succeeds At Phase II

The company’s lead candidate, AP1189, has shown promise in a mid-stage rheumatoid arthritis study, sparking plans for an imminent strategic business collaboration. 

Clinical Trials Companies

Stock Watch: Drug Safety In The Spotlight

Are three FDA clinical holds in less than four days a symptom of lax safety programs at some biotech companies? And what does the latest publication on Aduhelm say about the relationship between safety and accelerated approval?

Stock Watch Drug Safety

In Case You Missed It …

We clean out your Thanksgiving and Black Friday inbox so you don’t have to. Stories you may have missed over the holidays.

Commercial Regulation

Quick Listen: Scrip's Five Must-Know Things

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.

Business Strategies Commercial

Pfizer/BioNTech’s Comirnaty Supply Agreements Unaffected Despite EU Green Light For Under-12s

Pfizer and BioNTech’s Comirnaty supply under existing agreements will continue as planned despite anticipated expansion into a new child sub-population in Europe.

Vaccines Regulation

Novo Nordisk Braced For China Insulin Scheme Impact

The value-based procurement scheme in China is about to be implemented on insulin products and while most of Novo Nordisk's therapies were included in the tender, price cuts are going to impact global sales growth by 3% next year.

China Market Access

Pipeline Watch: Six Phase III Trial Starts Plus 19 New Approvals

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
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