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What's New And What's Next In CAR-T After ASH

Incremental updates at the recent ASH meeting shed light on which products may follow Novartis' Kymriah and Gilead/Kite's Yescarta into the commercial market. Will it be Celgene and Bluebird or Celgene and Juno? Where do Pfizer, Servier and Cellectis stand with their off-the-shelf options?

ImmunoOncology Cancer Market Access

ASH In Review: Roche Refreshes Hematology Portfolio With Robust New Drugs

Phase II data for antibody-drug conjugate polatuzumab vedotin in diffuse large B cell lymphoma suggest potential for a cure if the drug were given up front, Roche says on investor call after American Society of Hematology meeting.

Clinical Trials Cancer Blood & Coagulation Disorders

CHMP Negative On PharmaMar's Aplidin In Multiple Myeloma

Clouds are gathering over Spanish firm PharmaMar as the EU's CHMP rejects its multiple myeloma therapy Aplidin. Its reasons are not yet forthcoming.

Approvals Policy & Regulation Cancer

Family Comes First as BI Finance Chief Exits Over Future Direction

The departure of finance chief Simone Menne follows "divergent views" with the board over strategy shows that Boehringer Ingelheim will not countenance any moves that could threaten its independence.

Leadership Business Strategies Financing

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Commercial Fallout From Merck's Failed Keytruda Gastric Cancer Trial May Be Limited

Merck's KEYNOTE-061 gastric cancer study is the latest example of a checkpoint inhibitor failing in Phase III after accelerated approval.

Clinical Trials ImmunoOncology Cancer

Adapt Or Die: Sanofi CSO On R&D Challenges Within Unstable Industry

Sanofi's chief scientific officer Gary Nabel, who joined the company in 2012 from the NIH, discusses R&D challenges for Sanofi and the wider pharma industry, and highlights the company's biggest drug development achievements and toughest moments over the last few years.

Scrip 100 Leadership Research and Development Strategies

Schultz Swings The Cleaver At Teva, Cutting 25% Of The Workforce

Troubled Teva has been preparing employees for layoffs, but the final plan will reshape the generic drug giant entirely with 14,000 jobs being cut in a scramble to stabilize the company. Every business area and geography will be affected.

Generic Drugs Business Strategies

Interview: Actelion CEO Aims To Drive 'Small Big Company' To Greater Growth In J&J

Jane Griffiths tells Scrip that rather than reducing Actelion's reliance on PAH, there is still a lot to do in looking at different mechanisms and pathways for the disease and being under the J&J umbrella can only help.

Leadership M & A

Forge Therapeutics Excites Big Guns In Antibiotic World

Emerging Company Profile: Forge Therapeutics, which licensed intellectual property from the University of California San Diego in 2015, is aiming to have developed a novel class of antibiotic to treat Gram-negative superbugs, with its first drug candidate entering clinical development in 2020. The company has just announced an expanded research and discovery pact with Evotec in the UK, and boasts an impressive line-up of scientific advisors.

StartUps and SMEs Infectious Diseases

NousCom CEO Outlines Cancer Vaccine Strategy

NousCom CEO and co-founder Alfredo Nicosia speaks to Scrip senior editor Lucie Ellis during BIO-Europe, a partnering meeting held in berlin Nov. 6-8, about the company's recent series B financing.

Business Strategies Cancer

Deal Watch: Vertex Selects First Candidate Under CRISPR Gene-Editing Collaboration

Vertex hopes to develop CTX001 as a treatment for sickle cell disease and beta thalassemia. Allergan adds stalled uterine fibroid candidate in buyout of troubled Repros, Juno licenses multiple myeloma candidate from Lilly.

Deals M & A

Korea 2017 Review: Biosimilar Advances, R&D Progress Restore Confidence

Strong global advances in biosimilars and progress in new drug development as well as clampdowns on illegal rebate payments have dominated headlines in South Korea in 2017.

Commercial South Korea

Policy & Regulation Explore this Topic

Semaglutide's CHMP Backing Stipulates Post-Approval Safety Studies

Novo Nordisk's once-weekly diabetes treatment semaglutide wins backing from EMA's top advisory panel one week after the GLP-1 agonist was approved in the US, the first country to do so. Safety studies have been required.

Approvals Drug Safety Metabolic Disorders

Pfizer's Infliximab Biosimilar Approved In US But Won't Launch Against Inflectra

Ixifi (infliximab-qbtx), which references Janssen's Remicade, marks first US approval of a biosimilar developed entirely by Pfizer; big pharma says it is not currently planning to launch Ixifi because it remains "committed" to marketing Celltrion's Inflectra.

Approvals Biosimilars

Time Is Running Out For Industry To Prepare For Brexit, Firms Begin to Feel Staffing Effects

Nearly 18 months after the UK voted to leave the European Union, pharmaceutical companies and regulators are still in the dark as to what kind of regulatory arrangements will exist between the two parties after Brexit takes place in March 2019.

Scrip 100 Brexit

Brazil’s Spiraling Access Suits And The Potential Impact On Companies

Spending on medicines as a result of litigation against health authorities is soaring in Brazil. Scrip investigates the challenges firms may face in future, including greater pricing pressure, a more NICE-like health technology appraisal system and increased scrutiny over any perceived industry wrongdoing.

Scrip 100 Market Access

Research & Development Explore this Topic

Tech Transfer Roundup: Arrakis Gets Penn IP Toward Small Molecule RNA Therapies

Canaan Partners-backed biotech will investigate the therapeutic potential of three-way junctions in folded RNA. UC Berkeley and Duke sign separate license agreements related to CRISPR gene-editing technology.

Deals Platform Technologies Intellectual Property

Synthetic Biologics CEO On Pipeline Advances And The Microbiome

Scrip senior editor Lucie Ellis speaks to Jeff Riley, president and CEO of Synthetic Biologics, on the sidelines of the recent BIO-Europe partnering conference in Berlin about how the company is harnessing the microbiome to develop two late-stage therapeutics.

StartUps and SMEs Research and Development Strategies

Izana Bioscience Set Up For Ankylosing Spondylitis Breakthrough

A new UK company set up by entrepreneur Bryan Morton to develop an innovative medicine for ankylosing spondylitis may be an example of how start-up companies could be supported through the UK's just announced industrial strategy for the life sciences sector.

StartUps and SMEs Immune Disorders

A Star Is Born? HERCULES Data Shine At ASH For Ablynx's Caplacizumab

Strong Phase III HERCULES data mean Ablynx's caplacizumab is likely to sail through regulatory proceedings next year, becoming the first approved therapy for the rare blood disease, acquired thrombotic thrombocytopenic purpura.

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