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Research & Development

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Phase II Success Positions Ra For Potential Blockbuster Opportunity In Myasthenia Gravis

Ra hopes to launch a Phase III program for zilucoplan next year, with a goal of bringing an alternative therapy for MG patients into competition with Alexion’s Soliris.

Clinical Trials Rare Diseases Research & Development
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Clinical Trials

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Latest From Clinical Trials

AZ Goes Into The MYSTIC And Finds Positives For Imfinzi

Against all the odds, AstraZeneca still has hopes for Imfinzi in first-line NSCLC with data from the failed MYSTIC trial suggesting strong survival in patients with a high tumour mutation burden.

ImmunoOncology Clinical Trials

Valbenazine's Consistent But Weak Effect In Tourette Dismays Neurocrine

In "very top-line" Phase IIb data, the magnitude of the treatment effect for valbenazine in children with Tourette syndrome was weaker than expected, and its loss from active development means there will be only a handful of candidates under evaluation for the disorder.

Clinical Trials Neurology

ECLIPSE: J&J's Tremfya Beats Novartis' Cosentyx For Long-Term Psoriasis Clearance

Novartis stresses long-term safety database for Cosentyx – with five years' worth of data in three indications – psoriasis, psoriatic arthritis and ankylosing spondylitis.

Clinical Trials Research & Development

Eisai Adds To Alzheimer's Arsenal With Anti-Tau Drug

It is a field littered with failures but Eisai remains hopeful that its pipeline of candidates for Alzheimer's disease, which has just been added to, gives the firm a number of shots at getting a disease-modifying agent to market.

Neurology Pricing Debate

Phase II Success Positions Ra For Potential Blockbuster Opportunity In Myasthenia Gravis

Ra hopes to launch a Phase III program for zilucoplan next year, with a goal of bringing an alternative therapy for MG patients into competition with Alexion’s Soliris.

Clinical Trials Rare Diseases

In NASH Race, Bad News For Conatus, Good News For Genfit In PBC

Conatus’ emricasan fails to meet the primary endpoint for portal hypertension in NASH patients with cirrhosis, but firm stresses promising subgroup data. Genfit hits Phase II primary endpoint in PBC with elafibranor, which is also in Phase III for NASH.

Liver & Hepatic Clinical Trials
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Approvals

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Latest From Approvals

Pipeline Watch: Phase III Trials Announced For AD04, Pegzilarginase And Trigriluzole

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

Pipeline Watch: Phase III Starts With Elacestrant, Crizanlizumab And Vutrisiran

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

Roche's Tecentriq Becomes Second In PD-1/L1 Family To Gain First-Line Lung Cancer Approval

The PD-L1 inhibitor's label excludes NSCLC patients with EGFR or ALK mutations, which could have been an advantage, but the indication largely reflects the registrational IMpower150 clinical trial's population.

Approvals ImmunoOncology

AML Paradigm Shift: Doctors Welcome Many New Approvals And Approaches

This year's ASH meeting reflected a peak of development success, with many new approvals and many more in the pipeline.

Clinical Trials Cancer

World First Korea Darbepoetin Biosimilar Approval To Speed CKD's Global Entry?

With a global first marketing authorization for its darbepoetin biosimilar in South Korea, Chong Kun Dang aims to speed up the product’s entry into the Japanese and other international markets and progress clinical rials with other biosimilars and novel biologics.

South Korea Biosimilars

Pipeline Watch: Phase III Starts With PRN1008, JZP-258 And Nolasiban

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
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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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