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Featured Stories


A Q&A With Lilly Biomedicines President Christi Shaw

The Eli Lilly & Co. executive talked with Scrip about the competitive dynamics facing Taltz, the status of baricitinib and launching galcanezumab in the crowded CGRP class, as well as about industry issues like drug rebates, drug pricing and gender diversity.

Leadership Launches Business Strategies

PACIFIC Pays Off Again For AZ With Imfinzi Lung Cancer OS Success

Having already got off to a strong start on the US market on the back of stellar progression-free survival data, AstraZeneca’s immunotherapy Imfinzi has hit a second primary endpoint of the PACIFIC trial by improving overall survival in unresectable Stage III NSCLC patients, raising the bar even higher for future competition from rival PD-1/L1 inhibitors.

ImmunoOncology Clinical Trials Cancer

Early-Stage Idiopathic Pulmonary Fibrosis (IPF) Candidates Race to Phase III

Multiple IPF drugs are being rushed into Phase III based on early-stage signals of efficacy and safety presented at the ATS meeting. Scrip spoke with the University of Pittsburgh's Kevin Gibson about the candidates, trial design, combination therapy and limitations of current therapy.

Respiratory Research and Development Strategies BioPharmaceutical
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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

Set Alert for Commercial

Finance Watch: Six More IPO Filings As Three More Biopharmas Go Public In The US

Public Company Edition: Kiniksa, Scholar Rock and Iterum launch the most recent US IPOs and at least five more drug developers join the queue. Also, Polyphor go public in Switzerland, Valeant and Ligand sell notes, and MyoKardia led recent follow-on offerings.

Financing Business Strategies Research and Development Strategies

After Phase III Amyloidosis Failure Prothena Slashes Workforce In Restructuring

In the backlash following the failure of its late-stage amyloidosis drug, Prothena has announced it will cut 57% of its workforce as part of a restructuring plan.

Business Strategies Commercial Neurology

BioMarin Gets Second PKU Approval, Anticipates Slow Ramp-Up For Palynziq

Analysts say black box warning of anaphylaxis risk and REMS were anticipated. Company plans a gradual rollout of Palynziq, focusing first on Phase III clinical trial sites and patients.

Approvals Launches

Astellas Culls Positions Ahead Of Big Expiry

Astellas is looking to cut hundreds of positions in Japan as it faces a major upcoming patent expiry and refocuses under a new strategic plan.
Japan Commercial

Former Gilead CSO Bischofberger Lands At Kronos As C-Suite Moves To Start-Ups Continue

Norbert Bischofberger returns to his start-up roots, exiting Gilead after nearly 30 years to become CEO of Kronos, which is developing novel drugs directed at tough cancer targets. He's one of several big pharma/large biotech executives to venture recently into entrepreneurial opportunities.

Financing Leadership

Deal Watch: Allergan, Celgene, AstraZeneca Among Biopharmas Advancing Existing Partnerships

Recent deal-making has seen new developments to further existing agreements, including Allergan licensing a depression candidate from the spinout of a company it bought in 2015. Also, updates on deals involving Celgene, AstraZeneca and Daiichi Sankyo.

Deals Business Strategies

Remember When Provenge's Price Was Bold? Every New Cancer Drug In 2017 Cost $100,000 Or More

The price of new oncology brands doubled in the US from 2013 to 2017, bringing the median annual price to more than $160,000 last year, up from $79,000 in 2013, according to a new IQVIA report. Spending on cancer drugs in the US has doubled since 2012, reaching nearly $50bn in 2017.

Pricing Debate Pricing Strategies

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

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

More Evidence Needed For Chiesi’s Ultra Orphan Lamzede, Says NICE

Chiesi still has work to do to convince NICE that its ultra rare disease treatment Lamzede is a cost-effective treatment.

Rare Diseases Health Technology Assessment Market Access

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

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

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

Research & Development Explore this Topic

Set Alert for Research & Development

Pipeline Watch: Phase III Progress With Bempedoic Acid, Lefamulin, And Ibrutinib Combo

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events 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 Research & Development

Novo Nordisk Boosts Specialty R&D With Kidney Disease Deal

Denmark's diabetes specialty company has linked up with a US biotech to evaluate a lysophosphatidic acid receptor antagonist in diabetic and chronic kidney disease.

 

Deals Renal

Sanofi In Pole Position In Oral Type 1 Diabetes With Zynquista Filings

The French drugmaker and partner Lexicon now have a PDUFA date of March 22 next year for their dual inhibitor of SGLT-1 and SGLT-2 which is well placed to become the first oral antidiabetic to get the green light for use by adults with the type 1 form of the disease, in combination with insulin.

Clinical Trials Metabolic Disorders

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
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