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Gilead’s HCV Authorized Generics Effort Will Draw Market Share From AbbVie

By marketing its own authorized generic versions of blockbuster HCV combos Epclusa and Harvoni, Gilead may eat into AbbVie’s large market share edge in US government-insured patients.

Life Cycle Management Commercial Generic Drugs

Mixed Results In AZ's DECLARE-TIMI 58 CV Trial Cloud Implications For Farxiga

While clarification on mixed DECLARE-TIMI 58 CV top-line data in diabetes patients is awaited at November's AHA meeting AstraZeneca says it is confidently pursuing independent studies of its SGLT-2 inhibitor Farxiga in heart failure and kidney disease patients.

Clinical Trials Companies Research and Development Strategies

Vertex Set To Dominate Cystic Fibrosis Market For The Next Decade

Vertex is set to reap huge benefits from its triple combination program for cystic fibrosis over the next 10 years, potentially becoming the biggest selling drug in this disease, according to a new report from Datamonitor Healthcare.

Respiratory Market Intelligence Commercial
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Case Study: Broad Thinking Yields Big Results

There are numerous details when considering product packaging that require both creative thinking and feature prioritization. Rather than developing a standard solution for the current need, it’s imperative to think broadly and design options that are cost-effective, simplify operations and save time and/or resources.

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'That's Huge, Folks:' Amarin's Vascepa Cuts CV Risk By 25% On Top Of Statins

Cardiovascular outcomes data exceeded expectations for the fish oil pill, vindicating Amarin, which has fought long and hard for Vascepa's place in the CV disease prevention market. A filing based on REDUCE-IT is expected in early 2019.

Clinical Trials Comparative Effectiveness Cardiovascular

United Neuroscience Hopes To Revive Vaccine Approach To Alzheimer’s

Emerging Company Profile: Dublin-based United Neuroscience, spun out of an animal vaccine maker, believes it can pick up and improve upon a vaccine approach to Alzheimer’s that was abandoned nearly two decades ago due to safety issues.

Research & Development StartUps and SMEs Neurology

Verastem’s Copiktra Gets Early Approval To Challenge Zydelig, Venclexta In Third-Line CLL

Copiktra (duvelisib) becomes the first dual inhibitor of PI3K delta and gamma to hit the market, placing it in competition with Gilead’s Zydelig and AbbVie’s Venclexta.

Approvals Cancer

AstraZeneca Makes European IO Debut With Imfinzi Lung Cancer Approval

Imfinzi will be the fourth PD-1/L1 inhibitor approved for lung cancer in Europe, but AstraZeneca could carve out a niche by being indicated for sequential use following chemoradiation.

Approvals ImmunoOncology

Novartis Cuts Jobs In Europe, Citing A Shifting Specialized Portfolio

The Swiss drug maker will cut 1,700 jobs in manufacturing and business services in Switzerland by 2022 and another 395 jobs in the UK.

Business Strategies Companies

Finance Watch: Lilly Completes Elanco Animal Health Spin-Out As New IPO Filings Keep Rising

Public Company Edition: Eli Lilly & Co. wasted no time spinning out its animal health business Elanco, which raised $1.5bn in its public debut. Also, as the biopharma IPO tally rises, Vivo Capital launches a new public life science company fund. Meanwhile, Concordia completes its recapitalization.

Financing Business Strategies

Clinuvel Is Planning For US Commercialization Of Ultra-Orphan Drug Scenesse

Clinuvel's Scenesse for the ultra-rare, light-induced disease erythoropoietic protoporphyria (EPP) is already approved in Europe and the company is hopeful that a rolling NDA submission could pave the way for a US launch.

Rare Diseases Business Strategies

Ipsen Sees First Mover Advantage In EU For Cabometyx In Liver Cancer

Ipsen CSO says CHMP recommendation for TKI Cabometyx should give it first mover advantage globally in liver cancer.

Approvals Business Strategies

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Lilly Moves Into Migraine Race With CHMP Okay

Competition is hotting up in the CGRP class of new migraine therapies, with Lilly's Emgality being recommended for approval in Europe, paving the way for a market share battle with Novartis' Aimovig.

Approvals Regulation Neurology

Biosimilar Firms Main Beneficiaries Of Korea R&D Cost Accounting Changes?

Helped by new guidelines, South Korean pharma and biotech firms now have clearer standards related to the reflection of R&D costs in their accounting books, with some pointing out that biosimilar companies may be the biggest beneficiaries. 

South Korea Financing

Merck & Co Needs To Go Low On Price For New HIV Drugs In EU

Pifeltro and Delstrigo have been backed for approval by the CHMP but how well they will fare on the market depends on a competitive pricing strategy and continuing to benefit from current European guidelines which recommend NNRTI-containing regimens for HIV.

Infectious Diseases Pricing Strategies

Roche To Set Right Avastin Post-Marketing Surveillance Delay In India

Roche is working towards implementing PMS studies for Avastin (bevacizumab) and ensuring that a suspension of marketing authorization for the product in first line ovarian cancer is lifted in India.

Policy & Regulation Regulation

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Roche’s Entrectinib Differentiates Itself From NSCLC Competitors With CNS Data

Roche’s investigational non-small cell lung cancer candidate entrectinib has shown to reduce tumors in people with ROS1-positive NSCLC, including those whose disease had spread to the central nervous system, differentiating it from potential competitors.

Cancer Clinical Trials Research & Development

AstraZeneca's PACIFIC Update Bolsters Imfinzi's Lead In Stage III Lung Cancer

Full PACIFIC data show strong overall survival benefit in all comers, though not in a post hoc analysis of those with low PD-L1 expression, about 20% of the population.

Clinical Trials ImmunoOncology

AZ Respiratory Head: Fasenra As Add-On Maintenance Can Reduce Exacerbations

AstraZeneca's head of respiratory tells Scrip BORA Phase III data should reinforce and extend physician confidence in Fasenra as a long-term asthma biologic. The drug is also driving wider growth of biologics in asthma.

Clinical Trials Companies

Pipeline Watch: Phase III Readouts For Oral Semaglutide, Roxadustat, Dasiglucagon

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.

 

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