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Policy & Regulation

New National Security Checks Could Hinder Investment, Warns UK Biotech Sector

Life science SMEs and their investors need to comply with new UK government checks on their dealmaking.

Companies Commercial Regulation

Novo Nordisk On The Pluses And Minuses Of The UK Post-Brexit R&D Environment

Post-Brexit Britain offers a fertile R&D ecosystem, but it needs to improve uptake in novel medicines there and strike a lasting deal with the EU over batch testing, Novo Nordisk’s UK general manager Pinder Sahota tells Scrip.

Brexit Clinical Trials Companies

Policy

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Latest From Policy

UK Travel Rule Sparks Row As India Seeks To Resume COVID-19 Vaccine Diplomacy

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.

Policy Coronavirus COVID-19

UK Chooses Pfizer And Moderna For COVID-19 Boosters, But Questions Remain On Unpublished Trial Data

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.

Coronavirus COVID-19 Vaccines

Pharma On Its Back Foot As US Drug Price Reform Advances

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.

Pricing Debate Politics

VA's Aduhelm Restrictions: Big Symbolism But Small Impact?

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.

Reimbursement Policy

Biden Pitches Medicare Price Negotiations That Acknowledge R&D Costs, Allow ‘Significant’ Profits

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.

Pricing Debate Legislation

Drug Pricing Measures Clear US Senate Judiciary Committee

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. 

Pricing Debate Legislation
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Regulation

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Latest From Regulation

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

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

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
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