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Don’t Expect Business As Usual From EMA During Transition, Says BIA Head

BIA CEO Steve Bates says life science companies should not expect business as usual during the EMA’s relocation to Amsterdam, but notes that firms and industry associations are “absolutely aligned” on the need for continued close cooperation between the UK and the EU after Brexit. He also warned that firms may be holding back on investments in clinical trials in the UK.

Brexit Clinical Trials Research and Development Strategies

Celgene's Partnered Pipeline Delivers Successes And Setbacks

Celgene won the first approval for a drug developed under its aggressive deal-making strategy in 2017 and several potential blockbusters in its partnered pipeline are edging closer to the market. Ozanimod will soon face regulatory approval, but the next-in-line acquired asset GED-0301 had a major setback. Scrip considers the contribution externally derived products have made – and will make – to Celgene’s business.

Deals Business Strategies Companies

Pfizer Bets On Gene Therapy For Rare Diseases In China

After excluding China from its early development plans for domagrozumab, Pfizer’s rare disease R&D team is now gearing to commence a clinical study of the investigational compound on Duchenne muscular dystrophy patients soon.

Clinical Trials Rare Diseases Asia Pacific
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Will J&J TRANSFORM Esketamine Into A Viable Depression Treatment?

In early 2018 Johnson & Johnson is expecting to announce the first data from its long-awaited pivotal clinical trial program for esketamine in treatment-resistant depression; a successful result will open a lucrative commercial opportunity for J&J and give the wider depression market a new direction for growth.

Scrip 100 Neurology Market Intelligence


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Tesaro Shakes Up EU PARP Market With Zejula Launches

EU approval signals the start of a marketing push against the combined might of AstraZeneca and Merck & Co – Tesaro believes it has the label to set it apart. For now, at least.

Cancer Approvals Launches

Finance Watch: A Bountiful November Harvest For Venture-Backed Biopharma

Five funds raised more than $1bn to back biotech firms; Arcus leads recent VC rounds with $107m GV-backed Series C; Celgene, Valeant sell notes to retire debt; and Alnylam cashes in on investor goodwill.

Financing Business Strategies StartUps and SMEs

Hurricane Maria Tests Pharma Business Continuity Plans

Puerto Rico's slow recovery from Hurricane Maria provides insight into what happens when disaster strikes a node of the global pharmaceutical manufacturing network. Initial efforts to ward off US drug shortages focus on generic injectables that can't support expensive business continuity plans – but even critical prescription brands could be threatened if the US territory's power grid remains off line too long.

Manufacturing Scrip 100

With Phase III Failure, Cytokinetics Shelves Tirasemtiv, Pivots To ALS Backup

Partnered with Astellas, the San Francisco-area biotech hopes next-generation CK-107 will succeed in a measure of slow vital capacity due to stronger potency and better tolerability compared to tirasemtiv.

Clinical Trials Rare Diseases

Sanpower Reconstructs Dendreon Deal To Drive Better Growth

Sanpower Group is planning the first Asian launch of Provenge in Hong Kong after acquiring a local cell therapy manufacturing facility, amid the ongoing sale of Dendreon to its public holding company Nanjing Cenbest, the latest deal in the surge of traditional companies breaking into the healthcare sector in China.

China Commercial

Advicenne Launches IPO With Kidney Drug Close To Filing

Looking to raise up to €39.7m through a stock market listing, French firm Advicenne has been developing ADV7103, which could soon become the first drug to be approved for distal renal tubular acidosis.

Financing Renal

BMS Q&A: Hunting For Biomarkers To Improve Treatment Of Autoimmune Diseases

Bristol-Myers R&D leaders Brian Gavin and Sean Connolly offered insight into the company's immunology focus for autoimmune diseases, which increasingly is driven by a search for biomarkers that point to the best use of the big pharma's drugs.

Personalized Medicine Immune Disorders

TiGenix CEO Confident Of European Green Light For Lead Asset

TiGenix CEO Eduardo Bravo outlines group's commercialization plans for CPF candidate Cx601 in Europe and the US.

Approvals Business Strategies

Policy & Regulation Explore this Topic

Amsterdam wins European Medicines Agency After Milan Loses Coin Toss In Tight Race

London has lost the European Medicines Agency to Amsterdam after the Dutch capital beat Milan in a voting process that ended in the drawing of lots. The Italian pharmaceutical industry was understandably disappointed at losing, but the EMA said the decision “ticked a lot of our boxes” and would help to keep down staff losses and ensure business continuity.

Brexit Regulation Europe

Ardelyx Outlines Next Phase III Steps For Tenapanor, Ditches RDX7675

New Phase III study of tenapanor in hyperphosphatemia will include an active control arm for safety monitoring, per US FDA guidance, slightly lengthening timeline.

Business Strategies Research and Development Strategies

Political Bargaining Intensifies Before Vote On EMA’s New Home

In the run-up to Monday’s vote on the EMA’s future home, political horse-trading and vote-swapping behind the scenes makes it difficult to predict which EU city will win the prized agency.

Brexit Regulation

Ultragenyx Gets Commercial Feet Wet With Mepsevii Launch In Sly Syndrome

Commercial opportunity for Mepsevii is small, but launch paves way for company's second product burosumab, following on its heels.

Launches Commercial

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Iovance Biotherapeutics CEO On TIL Immunotherapy For Solid Tumors

2018 will be a big year for the clinical stage biotechnology company, which is banking on progressing novel tumor infiltrating lymphocytes for the treatment of solid tumors.

Business Strategies Cancer ImmunoOncology

With Phase III Failure, Cytokinetics Shelves Tirasemtiv, Pivots To ALS Backup

Partnered with Astellas, the San Francisco-area biotech hopes next-generation CK-107 will succeed in a measure of slow vital capacity due to stronger potency and better tolerability compared to tirasemtiv.

Clinical Trials Rare Diseases

Ardelyx Outlines Next Phase III Steps For Tenapanor, Ditches RDX7675

New Phase III study of tenapanor in hyperphosphatemia will include an active control arm for safety monitoring, per US FDA guidance, slightly lengthening timeline.

Business Strategies Research and Development Strategies

Galapagos Glides Towards Triple Combo Studies In Cystic Fibrosis

Positive topline data from the ALBATROSS Phase II study suggest Galapagos's GLPG2222 is well tolerated and could bring additional therapeutic benefits to cystic fibrosis patients.

Rare Diseases Respiratory
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