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Featured Stories


Severe Asthma Market Snapshot: A Competitive Therapy Area That Will Test Payers' Influence

Several biologic drugs are now available for the 10% of asthma patients with severe uncontrolled disease, and Dupixent could join them later this year, setting the therapy area up for a competitive showdown.

Respiratory Market Access Pricing Strategies

Merck's Stellar Keytruda Squamous Lung Cancer Data Refute Naysayers

In Phase III KEYNOTE-407 of squamous NSCLC, Keytruda/chemo combo shows overall survival benefit, which was reassuring news for doctors – and investors – ahead of ASCO.

Gilead May Have Better Takeover Targets Than Tesaro

Gilead has once more been mentioned as a prospective acquirer of Tesaro, but analysts at Datamonitor Healthcare's PharmaVitae believe that CAR-T and NASH are the areas where the company is more likely to seek buys that reduce its reliance on hepatitis C and HIV therapies.

M & A Cancer Liver & Hepatic
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Addressing the Data Challenges of Pharmacovigilance

Thought Leadership from Oracle Health Sciences

Oracle Health Sciences

As pharmacovigilance adopts next-generation technology by leveraging artificial intelligence (AI) and the cloud, new possibilities are opening up for knowledge generation from the data collected and processed.

In a recent study commissioned by Oracle Health Sciences and conducted by Informa Pharma Intelligence, PV experts responded to the data challenges of pharmacovigilance. Read this whitepaper which explores the survey results and looks into three important developments around drug safety data, their analysis and how the industry is preparing for them.

Survey results include:

  • Artificial intelligence in adverse event processing.
  • Cloud solutions for pharmacovigilance.
  • Regulatory requirements for reporting.
View Survey Results

 

Commercial Explore this Topic

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Cipla Sounds The Bugle On US Respiratory Ambition

One "sizeable" respiratory inhalation launch in the US every year, starting next year, is what Cipla is targeting as it expands its global franchise in the segment, though a filing this year for generic Advair isn't likely. The Indian firm also expects to sew up multiple biosimilar deals targeted at key emerging markets.

Commercial Strategy Sales & Earnings

Cara’s Partnership With Vifor Fresenius Provides Validation For Pruritis Drug Korsuva

A Vifor Fresenius joint venture will market Korsuva for CKD-associated pruritis to Fresenius dialysis centers in Europe, and also will do a co-promotion with Cara in the US that may provide a significant head start for the drug.

Deals Commercial Renal

New Chugai CEO Lays Course As He Takes Reins

Chugai's new CEO Tatsuro Kosaka took up his position in March and is charged with taking the major Japanese company through the next stage of development as key products reach the global market and others begin to face biosimilar competition. In this first part of a two-part exclusive interview, he outlines the firm's vision, approach to R&D and how the strategic alliance with Roche is playing out. 

Japan Business Strategies

Appointments: News From Sensei, DelMar, Seattle Genetics, Astellas, Galecto, Roivant Sciences And PDL BioPharma

This week's announcements include new CEOs at Sensei and DelMar, new chief medical officers at Seattle Genetics, Astellas Pharma, Galecto Biotech and Roivant Sciences, and new business development heads at Roivant and PDL BioPharma.

Appointments Commercial

Strides’ Founder Resumes Charge After Dismal Q4 Earnings

Strides Shasun founder Arun Kumar has moved back into the driver’s seat to focus on “course correction” after the Indian drug maker racked up an unexpected quarterly loss that triggered a massive share selloff.

India Commercial

Dova’s Doptelet Gets First-To-Market Edge In Thrombocytopenia, Ahead Of Shionogi

Dova CEO Alex Sapir very confident of oral thrombopoietin receptor antagonist’s chances of taking market share from current standard of care, platelet transfusions, citing safety and convenience advantages.

Approvals Commercial

Pfizer's Three-Pronged Oncology Strategy Includes Expanding Ibrance, Xtandi, Developing Blockbuster Combos

Xtandi use in early prostate cancer, lorlatinib as second-line treatment for non-small cell lung cancer and dacomitinib for first-line NSCLC have upcoming user fee dates.

Research and Development Strategies Cancer

Diurnal Adrenal Franchise Takes Shape With Alkindi Launch

With the launch in Germany of Alkindi, Diurnal has kickstarted its plan of offering therapies that treat patients with cortisol deficiency diseases from birth right the way through to old age and the market is potentially a very lucrative one.

Metabolic Disorders Launches

Policy & Regulation Explore this Topic

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Missing In Action: China’s Best Shot In Ebola Vaccine Race

As the Congo grapples with the latest outbreak of Ebola, China has approved its first domestically developed vaccine in record time, hailing it a national innovation champion. But as the World Health Organization starts vaccinations in Africa, can China make the cut and compete with global players including Merck & Co?

China Vaccines Policy & Regulation

BioMarin, Spark Hemophilia Gene Therapies Progress As Accelerated Approval Favors Their Indications

As updated Phase I/II results for BioMarin's hemophilia A and Spark's hemophilia B gene therapies were presented on May 22, it was revealed that FDA plans to make hemophilia the first gene therapy indication eligible for accelerated approval based on a surrogate endpoint.

Clinical Trials Drug Approval Standards

AstraZeneca’s Lokelma Approved In US With Label Benefits Over Veltassa

After delays caused by two complete response letters, AstraZeneca’s Lokelma has been approved in the US with label benefits over its major competitor, Vifor Pharma’s Veltessa.

Approvals Policy & Regulation

FDA Flags Lower Efficacy For Merck's Keytruda, Roche's Tecentriq In Frontline Bladder Cancer Trials

In patients with previously untreated metastatic bladder cancer with low PD-L1 expression, PD-1 drugs alone don't work as well as chemo.

ImmunoOncology Approvals

Research & Development Explore this Topic

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Dupixent Shines At ATS, But Experts Question Which Novel Biologic Physicians Will Choose

Phase III studies testing Dupixent in moderate-to-severe asthma were largely positive, but subgroup details raise questions about how it will compete against biologics targeting the IL-5 pathway. Some experts urge comparison trials to inform physicians' decisions about long-term use.

Respiratory Clinical Trials Comparative Effectiveness

Esperion Posts Positive Phase III Bempedoic Acid Results, But Future Fixed-Dose Data Are Key

Esperion reported positive results from the third of five Phase III studies expected to read out this year, but data for a bempedoic acid/ezetimibe fixed-dose combo expected in August may be the key to the drug's commercial future.

Clinical Trials Cardiovascular

BioMarin, Spark Hemophilia Gene Therapies Progress As Accelerated Approval Favors Their Indications

As updated Phase I/II results for BioMarin's hemophilia A and Spark's hemophilia B gene therapies were presented on May 22, it was revealed that FDA plans to make hemophilia the first gene therapy indication eligible for accelerated approval based on a surrogate endpoint.

Clinical Trials Drug Approval Standards

Can Synthetic Vaccines Change The World’s Approach To Infectious Disease Crises?

Emerging Company Profile: Emergex Vaccines will use its nanobody technology to develop entirely synthetic immunizations against the world’s most concerning infectious diseases, including Ebola; evolving current options for vaccine stockpiling and national repositories.

StartUps and SMEs Infectious Diseases
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