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Aduhelm: One Year Later

The US FDA gave accelerated approval to Biogen’s aducanumab for Alzheimer’s one year ago. Our in-house expert journalists analyzed the impact of this consequential and contentious decision through multiple lenses.

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BioMarin Rolls Up Sleeves To Prepare For Roctavian’s EU Debut

The company plans to start in Germany with an outcomes-based payment model. But while a US FDA nod seems likely, analysts have been more cautious about calling US approval a done deal.

Gene Therapy Market Access Blood & Coagulation Disorders

Argenx Eyes Hat-Trick Of Successful Launches For Vyvgart After CHMP Thumbs-Up

Anant Murthy, general manager of Argenx Europe, tells Scrip that the commercial infrastructure is in place for Vyvgart to enjoy a strong launch for the rare neuromuscular disorder which will mirror those seen in the US and Japan.

Launches Rare Diseases Business Strategies

Sarepta’s Exondys 51 Successor On Clinical Hold, But Quick Resolution Expected

The FDA placed a hold on the Phase II study of SRP-5051, which uses the company’s next-generation peptide conjugation technology, but Sarepta thinks it can address safety questions in short order.

Drug Safety Clinical Trials FDA

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Insights and perspectives on commercial, R&D,

deal-making and business strategy developments.

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COVID-19 Vaccine Pediatric Landscape In India - Biological E Scores, Zydus At Zero

India’s COVID-19 immunization focus has shifted to children as over 88% adults are fully vaccinated. However, Scrip’s examination of weekly data reveals the number of doses given to children are also dropping sharply off peaks. Meanwhile, Biological E is winning over others like Novavax in this segment while Zydus Lifesciences is yet to score

Commercial Coronavirus COVID-19

Russia-Ukraine War Likely To Claim Sputnik V Partners As Casualty

In light of the Russia-Ukraine conflict, Scrip looks at data to gauge if manufacturing partners for COVID-19 vaccine Sputnik V or Light, in India, China and Korea could be left holding unsold inventory earmarked for exports

Commercial Coronavirus COVID-19

Who Were Big Pharma's Top Deal-Makers In 2021?

INFOGRAPHIC: Roche/Genentech was the busiest deal-maker in big pharma for second consecutive year in 2021, followed by Sanofi, Takeda, Lilly, Novartis and Pfizer.

Deals M & A

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Latest From Commercial

Asia Deal Watch: invoX Builds Novel Pipeline Through $161m F-star Acquisition

F-star's novel bispecific technology attracts Sino Biopharma-affiliated acquisition, Shionogi agreement with GARDP brings antibiotic cefiderocol to 135 countries, deal with WinHealth covering Greater China expands Quoin’s licensing of Netherton syndrome candidate to 60 nations, Kyorin and CellGenTech team up in Fabry disease.

Deal Watch Business Strategies

Encouraging Biomarker Data Lift UniQure’s Huntington’s Disease Hopes

Hopes rise as first four evaluable patients experienced no serious adverse events, and a sustained decline in level of key Huntington’s disease protein with the novel gene therapy product.

Companies Clinical Trials

COVID-19 Vaccine Pediatric Landscape In India - Biological E Scores, Zydus At Zero

India’s COVID-19 immunization focus has shifted to children as over 88% adults are fully vaccinated. However, Scrip’s examination of weekly data reveals the number of doses given to children are also dropping sharply off peaks. Meanwhile, Biological E is winning over others like Novavax in this segment while Zydus Lifesciences is yet to score

Commercial Coronavirus COVID-19

China Rush Over? Korean Firms Step Up To Seize Opportunities

Falling foreign investment and increasing business uncertainties in China could present new opportunities for the Korean biopharma sector, which is stepping up globalization and R&D efforts to seek growth.

South Korea Financing

Novartis Scores Its First Tumor-Agnostic Label For Two Nearly Decade-Old Cancer Drugs

The FDA approved Tafinlar/Mekinist for BRAF V600E-mutated solid tumors, based in part on a Phase II basket trial studying more than two dozen drugs across dozens of cancers based on genetic testing.

Approvals Cancer

Are Market Conditions Setting Up A Biopharma M&A Wave?

A new EY report contends that declining biotech valuations and the need for large pharma to add pipeline assets may create conditions for a buyer’s market – although year-to-date M&A activity has been lackluster.

M & A Business Strategies
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Shionogi Hit By Surprise Japan Road Bump For Oral COVID Drug

After months of speculation and anticipation, Shionogi’s once-daily oral antiviral for the treatment of COVID-19 has stumbled after receiving an unexpected preliminary decision on its emergency approval from an advisory committee in Japan.

Japan Approvals

FTC To Investigate PBM Practices, Including Focus On Consumer Costs, Access

Federal Trade Commission study of the six largest pharmacy benefit managers in the US wins the unanimous support of commissioners after its scope was broadened from an earlier version.

Pricing Debate Policy

Seres Pivotal Success And BLA Filing A Boost To Microbiome Modulator Field

The US firm has started a rolling US BLA for its infectious disease candidate, SER-109, following positive data from a second late-stage study, a milestone which could draw attention to firms in the microbiome space. 

Companies Infectious Diseases
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Research & Development

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Encouraging Biomarker Data Lift UniQure’s Huntington’s Disease Hopes

Hopes rise as first four evaluable patients experienced no serious adverse events, and a sustained decline in level of key Huntington’s disease protein with the novel gene therapy product.

Companies Clinical Trials

Pipeline Watch: 18 New Approvals Plus 14 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

GSK And Novartis Double Down On Neglected Disease R&D Spend

GSK will invest over $1bn over the next decade to develop medicines that combat malaria, neglected tropical diseases and antibiotic resistance, while Novartis is putting in $250m over the next five years.

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