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Research & Development

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Bristol’s Checkmate-331 Failure Not Likely To Endanger SCLC Labeling For Opdivo

Opdivo failed to meet an overall survival endpoint in a Phase III confirmatory study in small-cell lung cancer. But several analysts think Bristol will keep the SCLC labeling obtained in August due to lack of treatment options for these patients.

ImmunoOncology Clinical Trials Research & Development
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Clinical Trials

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Latest From Clinical Trials

Pivotal Data Put Roche's Kadcyla In Position For Earlier Breast Cancer

KATHERINE supports filings for earlier use of Kadyla in adjuvant setting of metastastic breast cancer.

Clinical Trials ImmunoOncology

Chugai May Not Win Race For $500m Neuromyelitis Optica Market, But May Best Soliris On Ease Of Use

While Chugai’s satralizumab may not be odds on to win the race for approval, it may beat Alexion’s Soliris on ease of use with a regimen of subcutaneous application once a month versus Soliris’ fortnightly IV.

Clinical Trials Rare Diseases

Bristol’s Checkmate-331 Failure Not Likely To Endanger SCLC Labeling For Opdivo

Opdivo failed to meet an overall survival endpoint in a Phase III confirmatory study in small-cell lung cancer. But several analysts think Bristol will keep the SCLC labeling obtained in August due to lack of treatment options for these patients.

ImmunoOncology Clinical Trials

Merck of Germany's Hunt For MS BTKi Partner Boosted By Evobrutinib Data

German Merck tells Scrip its quest to find a partner for its Bruton’s tyrosine kinase inhibitor evobrutinib should be helped by positive 24-week Phase IIb data in relapsing multiple sclerosis.

Clinical Trials Companies

Ionis Catches The Eye With New Roche Alliance

October has been a very good month for Ionis. Following US approval of Tegredi, it has now signed a potentially lucrative deal with existing partner Roche for another antisense drug, this time to tackle advanced dry AMD.

Ophthalmic Deals

Key Cancer Data To Be Unveiled At ESMO In Munich

Big pharma and little biotechs are getting ready to pack their bags for Germany where over 2,000 abstracts will be presented at ESMO and the fine details on some major oncology studies will be closely watched.

Cancer Clinical Trials
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Approvals

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Latest From Approvals

Early Yutiq Approval Gives EyePoint Two Ophthalmic Drugs To Launch In 2019

Yutiq, for posterior uveitis, will compete with two existing steroid products and should launch during the first quarter of 2019. EyePoint’s Dexycu, although approved in February, is still in scale-up and probably will launch a bit later.

Approvals Ophthalmic

Pipeline Watch: Phase III Starts With STR001, Cabometyx And Brazikumab

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

INFOGRAPHIC: Winners In 2019 Launches

Highlighting key late-stage drugs that could reach their first markets during 2019, including first-in-class products, medicines likely to become standards of care, and products introduced for major new indications.

Policy & Regulation Approvals

Akcea Expects Convenience Edge For Tegsedi, Despite Monitoring Requirements

Approved two months after Alnylam’s Onpattro, Tegsedi is priced almost identically in the same hATTR indication. Ionis affiliate Akcea hopes weekly subcutaneous administration will provide convenience benefit compared to I.V. Onpattro.

Approvals Commercial

Pipeline Watch: Phase III Starts With Sintilimab, Lumasiran And Glepaglutide

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

Acacia Aghast As FDA Says No To Barhemsys

The UK company has been stunned by a complete response letter for its nausea and vomiting therapy which relates to problems at its contract manufacturer but is not linked to the data package. Despite the setback, Acacia is sticking to a first-half 2019 launch plan.

FDA Manufacturing
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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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