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Research & Development

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New Front Opens in First-Line Ovarian Cancer Market: GSK’s Zejula Vs. AZ’s Lynparza

Two new PARP inhibitor studiesGSK’s PRIMA and AstraZeneca/Merck & Co.’s PAOLA-1  – are set to widen the ovarian cancer market after they reported highly positive first-line results in advanced patients at ESMO.

Clinical Trials Cancer Comparative Effectiveness
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Clinical Trials

Set Alert for Clinical Trials

Latest From Clinical Trials

Pfizer's Abrocitinib Looks Competitive In Atopic Dermatitis

The first detailed Phase III results for the company's next-generation oral JAK inhibitor abrocitinib appear to show efficacy on par or better than data from Sanofi/Regeneron's Dupixent and may give Lilly's Olumiant a run for its money in AD.

Clinical Trials Research and Development Strategies

Interview: Akari's Coversin Ticking Along Nicely

The C5 complement inhibitor class is in the news following UCB's bid for Ra Pharmaceuticals. Akari's CEO tells Scrip he thinks Coversin, which inhibits leukotriene B4 as well as C5, may offer more benefits in certain orphan diseases.

Rare Diseases Inflammation

Pharma Will Embrace Basket And Umbrella Trials, Despite Challenges

New approaches in study design and methodology, including master protocol trials, are being adopted by biopharma.
Clinical Trials FDA

MolMed Pulls Zalmoxis Cell Therapy In EU

The Italian biotech will redirect investment, initially reserved for Zalmoxis, to other activities that would better meet its business objectives.

Europe Clinical Trials

Bayer/Ionis Advance Next-Generation Antithrombotic After Positive Clinical Results

In a collaboration with Ionis Pharmaceuticals, Bayer is pressing ahead with Phase II clinical studies of an antisense molecule designed to reduce Factor XI production and prevent thrombosis.


Cardiovascular Clinical Trials

Mixed Data For Merck KGaA's Disease-Modifying OA Drug

Sprifermin could be the first drug to affect the underlying disease process in osteoarthritis but data show no significant improvement in symptoms.
Inflammation Clinical Trials
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Approvals

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Latest From Approvals

Lilly Expands Migraine Franchise With Reyvow Approval

Reyvow gives Lilly a second MOA in migraine, following the anti-CGRP biologic Emgality, and adds an acute therapy to the preventive agent approved in 2018.

Approvals Business Strategies

MolMed Pulls Zalmoxis Cell Therapy In EU

The Italian biotech will redirect investment, initially reserved for Zalmoxis, to other activities that would better meet its business objectives.

Europe Clinical Trials

Clinuvel Completes Arduous Journey To US Approval Of Scenesse

First-in-class drug for rare disease EPP obtains FDA approval, company plans treatment center-based rollout. Scenesse, on the market in Europe since 2016, has faced reimbursement hurdles.

Approvals Business Strategies

Label Battles: Beovu And Eylea Contest Begins In AMD

Shares in Eylea-maker Regeneron slid after FDA approved Novartis's competing VEGF inhibitor for treating AMD, but some observers said investors had overreacted.

Commercial Companies

Pipeline Watch: Anticancers Take Center Stage

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

AstraZeneca Gains US OK For Fasenra In Patient-Friendly Form

The company is keeping up the pressure on GSK, getting approval for self-administration for Fasenra a few months after a similar green light for severe asthma rival Nucala.

Respiratory Approvals
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Post Marketing Regulation & Studies

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Latest From Post Market Regulation & Studies

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

Real World Data Helping To Drive Rise Of Novartis' Entresto

Patients with heart failure on Entresto say they have fewer symptoms and greater quality of life, according to a registry study and Novartis is hoping that this and other real world data will propel the drug towards its peak sales target of $5bn.

Cardiovascular Life Cycle Management

Repatha Inroads Build Gradually As EU Extension Nears

Europe is expected to follow where the US led in expanding the label for Amgen's PCSK9 inhibitor Repatha to include a prevention indication for heart attacks and strokes. But growth will be hard-won.

Approvals Cardiovascular

Biogen, AbbVie Withdraw Struggling MS Drug Zinbryta Due To Safety Issues

Antibody was approved in the US with a liver safety warning while EU regulators recently limited the drug's use. Now, EMA has begun an urgent review of reports of inflammatory brain disorders related to Zinbryta.
Drug Safety Post Market Regulation & Studies

Siliq Probably Isn't The Light At The End Of Valeant's Tunnel

Valeant is touting Siliq to lead new product growth, but the drug's significant safety concerns in a competitive psoriasis market likely will offset efficacy advantages it could offer.

Drug Safety Risk Management

Nearing Finish Line, HCV Race Focuses On Salvage Therapy

With few remaining unmet needs in hepatitis C, Gilead, Merck and AbbVie are focusing on tough-to-treat niches with their next-gen combination regimens, especially treatment-experienced patients who failed on prior direct-acting antiviral therapy. Merck also is studying injectable drug users in an effort to eradicate HCV entirely.

Infectious Diseases Liver & Hepatic
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