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Policy & Regulation

Mylan Gets Expert Panel Go-Ahead For Pretomanid In India

Tuberculosis drug pretomanid gets endorsement, with Phase III trial waiver, from a key expert panel that advises India's drugs regulator, but roll out plan needs to be defined under the country’s national TB program, say health activists.
Research & Development Clinical Trials India

FDA Requests Belviq Be Pulled From The US Market Due To Cancer Risk

The agency requested the weight loss pill be voluntarily recalled by Eisai, the death knell for a trio of obesity drugs that launched early in the last decade. 
Metabolic Disorders Drug Safety Regulation

Policy

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Latest From Policy

Indian Pharma Monitoring Coronavirus Fallout On Production

With several Chinese manufacturing facilities shut at least till 10 February, Indian pharma companies are keeping a close watch on the evolving coronavirus situation. API inventory can last for a while, but if intermediates supplies don’t resume soon the fallout could be grim.

Commercial Manufacturing

Biogen's Tecfidera Safe Following IPR Decision – For Now

Tecfidera accounts for nearly one-third of Biogen's revenues, so the patent decision relieves one overhang for the company. However, other ANDA challenges are ongoing.
Intellectual Property Legal Issues

NICE Rejects Janssen’s Treatment-Resistant Depression Drug Spravato

Draft guidance questions lack of evidence comparing new nasal treatment with older therapies.

United Kingdom Neurology

The ICER Process: Allergan Engagement Improves Cost Effectiveness Rating For Ubrelvy

ICER president Steve Pearson is ‘cautiously optimistic’ that net pricing for acute migraine treatments will align with benefits once discounts are factored in.

Pricing Strategies Reimbursement

Biopharma Leaders Join Trump And Thunberg In Davos

Often dismissed as a meeting of the global elite, Davos is nevertheless a chance for biopharma leaders to take part in ‘big picture’ debates

Business Strategies Commercial

Bayer's Efforts To Pioneer Tumor-Agnostic Market In Europe Held Back

Bayer’s drive to lead a new market opportunity in Europe for histology-independent cancer agents like Vitrakvi has been set back by interim decisions from the UK’s NICE and Germany’s IQWiG, but there is a now a clear pathway to follow.

 

Cancer Health Technology Assessment
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Regulation

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Latest From Regulation

Esperion’s Nexletol Reaches The Cholesterol Market Priced To Sell

Esperion obtained an on-time approval of Nexletol (bempedoic acid) for a pair of LDL cholesterol-lowering indications on 21 February. 
Approvals Cardiovascular

Genfit Delays NASH Data While It Confers With US FDA On Methodology

Genfit will delay unblinding of data from its nearly complete Phase III study of elafibranor to get insight from the FDA on statistical methods in order to optimize its NDA.

Clinical Trials Drug Review

US Approval For Peanut Allergy Therapy Palforzia

Aimmune has secured approval for the first ever peanut allergy treatment, but safety, cost and administration issues could limit the drug's uptake.

United States Approvals

Novartis Inks World-First Pact With NHS England For Inclisiran

The innovative collaboration should accelerate access to the first-in-class cholesterol lowering drug acquired with The Medicines Company buy.

United Kingdom Deals

Scrip Asks…What Does 2020 Hold For Biopharma? Part 3: Policy And Regulation

The US election will intensify  the spotlight on drug costs, regulators will have their hands full with advanced therapy filings, and the need to address rising infectious disease threats will mount. Biosimilars, cannabis and Brexit are among other hot topics for 2020.

Policy Regulation

Lynparza Gets US OK For Pancreatic Cancer

The leading PARP inhibitor gets a new tumor type added to its label after a narrow ODAC vote in favor less than a fortnight ago.

Approvals United States
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