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Research & Development

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Clear Path For AstraZeneca’s Roxadustat After Reassuring Safety Data

Strong results in non-dialysis patients are a particular boost for AZ and its partner, Fibrogen.

Clinical Trials Research & Development Blood & Coagulation Disorders

Clinical Trials

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Latest From Clinical Trials

J&J Targets Tremfya Growth In PsA

The healthcare giant is looking for a second approval for its IL-23 blocker and tells Scrip the results from the DISCOVER program show that the drug can make its mark in psoriatic arthritis as well as psoriasis.
Immune Disorders Clinical Trials

Adverse Event Concerns With Solid Biosciences' Candidate DMD Gene Therapy

The US FDA has for the second time placed a clinical hold on Solid Biosciences’ potential gene therapy for Duchenne muscular dystrophy, a move linked to a 70% decline in the company’s share price. The company had reported a serious adverse event in a patient treated with higher doses of the viral vector-delivered gene therapy.

 

Gene Therapy Clinical Trials

Japan Cancer Center Looks To Leverage Expertise As It Builds Pharma Ties

Japan's largest cancer center is looking to build on its tissue sample and genomic resources to further build its reputation as a partner facility for the pharma industry's oncology trials. 
Japan Cancer

VBI Looking To Market More Potent, Less Expensive Hepatitis B Vaccine

Sci-B-Vac was shown more effective at fewer doses than Engerix-B in a Phase III study. VBI Vaccines sees its hepatitis B vaccine hitting potential markets by 2021.

Vaccines Infectious Diseases

Cirius’ Mixed Phase IIb Results In NASH Don’t Quell Its Enthusiasm For Phase III

Privately held biotech plans to move insulin sensitizer into Phase III with ambitious goals of obtaining accelerated approval based on liver histology, while also trying to show long-term cardiovascular benefits.

Clinical Trials Business Strategies

Five Trials To Look Out For At The AHA Meeting

Philadelphia is due to host the American Heart Association (AHA) meeting for the first time from 16-18 November, with the conference taking place in its condensed three-day format for just the second time. Scrip takes a look at the expected highlights.

Clinical Trials Companies
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Approvals

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Latest From Approvals

Merck’s Ervebo Becomes World’s First Approved Ebola Vaccine

Merck Sharp & Dohme will begin manufacturing licensed doses of Ervebo in Germany and will continue to send investigational vaccine doses to Democratic Republic of Congo.

Vaccines Approvals

GW Gets Two Cannabis-Based Meds Backed By NICE

Two cannabis-based drugs developed by GW Pharmaceuticals have been approved for use on the NHS in England for the first time and will be prescribed to patients with epilepsy and multiple sclerosis.
Neurology Health Technology Assessment

Pipeline Watch: Phase III Readouts For Ibrexafungerp, Reloxaliase

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 Trofinetide, Gepotidacin

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

Astellas Gets Europe Okay For AML Drug Xospata

Following green lights in the US and Japan, Xospata has been approved for relapsed or refractory FLT3-positive acute myeloid leukemia. Getting first-line approval is the next step.
Cancer Approvals

Pipeline Watch: Phase III Readouts For Somatrogon, Fevipiprant

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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