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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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Leqembi Coverage By Veterans Affairs Department Sign Of Success For Eisai’s Payer Engagement Strategy

Alzheimer’s product is following a different playbook than Aduhlem, reflecting better data – and hard-earned lessons. Eisai estimates that 80-90% of veterans who are eligible for Leqembi treatment based on the FDA label would also fit the VA’s criteria.

Government Payers Medicare

A Closing Door? New China Leadership Takes Reins Amid Growth Anxiety

China's just-concluded National Congress elected new senior government leadership, but shifting top-level policy priorities and a worsening wider operating environment mean observers are worried about continued growth and ongoing pressures on drug pricing.

China Policy

‘Inertia’ Likely To Restrain Biosimilar Humira In US Market, Experts Say

PBM contracting and payer formulary placement for branded Humira signal headwinds for biosimilar versions in the US, according to participants in an IQVIA-sponsored panel.

Biosimilars Market Access

Lilly’s Insulin Cost Cutting Plan: Replacing Rebates With Cost Sharing Help At Point Of Sale

Biden Administration praises Lilly for latest moves to improve affordability of insulin in private market and calls for other sponsors to follow suit. Lilly’s plan is also tactical, as manufacturers of highly-rebated drugs with serial price hikes face an increased rebate liability in Medicaid next year.

Reimbursement Pricing Strategies

ICER’s Leqembi Assessment Inches Higher, Still Sees Eisai Price As Too High

The drug pricing watchdog said in its revised report that Alzheimer’s therapy Leqembi (lecanemab) meets cost-effectiveness thresholds at $8,900-$21,500, below Eisai/Biogen’s $26,500 list price.

Cost Effectiveness Pricing Strategies

For Some Biotechs, IRA Remains Intangible – For Now

Some biotech leaders say IRA policies don’t feel consequential yet, though small companies could face impacts from R&D and M&A decision making at big pharmas.

Deals Medicare
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Regulation

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Pipeline Watch: Eight Approvals And 12 Phase III Trial Updates

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

Obstacle Thrown In Sarepta’s Path To Market As Gene Therapy Will Face AdComm After All

The route to market for Sarepta’s gene therapy candidate SRP-9001 for Duchenne muscular dystrophy has just got more complex after a U-turn by the US FDA. Its accelerated approval will now be scrutinized by outside experts – but the company remains confident in its data.

Companies Neurology

Novo Nordisk Hit With UK Industry Association Suspension Over Weight Loss Drug Promotion

Novo Nordisk has been hit by a serious sanction in the UK after having been found to effectively pay pharmacists to promote Saxenda.

Metabolic Disorders United Kingdom

Aldeyra All Set For Double Date With The FDA

The US agency is reviewing two of the US biotech’s drug with decisions expected on its methotrexate product for ocular lymphoma by June and on the dry eye drug reproxalap in November, as Aldeyra mulls its marketing strategy for both.

Ophthalmic Drug Review

Pipeline Watch: Seven Approvals And 15 Phase III Updates

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

J&J Wins EU Nod For Akeega To Go Up Against AZ/MSD’s Lynparza In First-Line mCRPC

Akeega, a combination of GSK’s PAPR inhibitor Zejula and J&J’s antiandrogenic drug Zytiga, has won a positive opinion from the CHMP in a lucrative first-line prostate cancer setting, hot on the heels of a broader approval for AstraZeneca’s blockbuster Lynparza.

Approvals Cancer
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