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.
READ MORE
Jump To Section
Featured Stories

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.

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.

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.
Aduhelm: One Year On
How Biogen’s Aduhelm Bet Became A Commercial Bust
Biogen caught a lucky break in getting the first FDA approval for a potentially disease-modifying Alzheimer’s therapy, but doubt over clinical benefit and commercial missteps have left Biogen in a precarious position a year later.
The Story of Aduhelm, From Early Studies To Commercial Demise
Medicare Coverage Restrictions For Expensive Drugs: Did Aduhelm Let The Genie Out Of The Bottle?
Aduhelm, One Year Later: US FDA’s Credibility, Accelerated Approval Pathway Feel The Bite From Alzheimer’s Drug Approval
CEO Vounatsos, Aduhelm Commercial Team To Exit As Biogen Shifts Focus
Latest News
Scrip Podcast
Insights and perspectives on commercial, R&D,
deal-making and business strategy developments.
More Podcasts
Infographics

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

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

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.
Commercial Explore this Topic
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Commercial
What’s Next At Dr Reddy’s: Biologics CDMO, Cell And Gene Therapy Push
Indian firms are getting their act together in areas like cell and gene therapy, with Dr Reddy’s aiming big and readying a facility alongside an alliance with a Chinese firm for a CAR-T therapy. The company is also doubling down in contract development and manufacturing, with an eye on opportunities in biologics.
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.
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.
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
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.
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.
Policy & Regulation Explore this Topic
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Policy & Regulation
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.
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.
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.
Research & Development
Remove Alert
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Research & Development
Texas To Tokyo: Japan Darvias Approval Marks End Of Long Development Road
Solasia's arsenical drug darinaparsin has received its global-first approval in Japan, for PTCL, in a landmark for the Texan chemist who discovered it back in the 70s and paving the way for wider indications and Asian markets.
Quick Listen: Scrip's Five Must-Know Things
In this week's podcast version of Five Must-Know Things: Genmab confident in CD20xCD3 battle; Alzheimer’s disappointment for Roche; Japan speed bump for Shionogi’s oral COVID antiviral; pharma’s view of psychedelics; and a roundup of key BIO sessions.
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.
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Article
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.