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Research & Development

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ESMO Preview: Five Key Oncology Battlegrounds To Watch

GSK looks to become a cancer contender once again, while Merck and Roche go toe-to-toe in TNBC.

Cancer Research & Development ImmunoOncology
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Clinical Trials

Set Alert for Clinical Trials

Latest From Clinical Trials

Brighter News For Varlitinib As Results In Tough Cancer Type Encourage ASLAN

Following a major setback in another indication earlier this year, ASLAN’s lead asset is now seen as a potential new option for second-line use in biliary tract cancer following promising new data from a Chinese trial.

Clinical Trials Cancer

ESMO Preview: Five Key Oncology Battlegrounds To Watch

GSK looks to become a cancer contender once again, while Merck and Roche go toe-to-toe in TNBC.

Cancer Research & Development

Novartis Says SMA Baby Death Not Due To Zolgensma

The Swiss major has new data on its SMA gene therapy which has been found not to be the cause of the death of a six-month-old patient earlier this year.

Gene Therapy Neurology

Sanofi To Co-Develop Digital Therapeutic For MS Patients

Sanofi's latest digital health move will see it collaborating with Happify Health on a digital therapeutic for patients with multiple sclerosis, a therapeutic area it knows well.

 

Digital Health Deals

IPF Failure Sets Back Biogen’s Diversification Efforts

The company has discontinued a Phase II trial for BG00011, which was acquired in its 2012 Stromedix purchase, due to safety issues.

Clinical Trials Business Strategies

Acceleron Ends ACE-083 FSHD Testing After Phase II Failure

Acceleron ended testing of ACE-083 in facioscapulohumeral muscular dystrophy after the investigational drug missed Phase II endpoints.

Neurology Clinical Trials
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Approvals

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Latest From Approvals

Astellas Stays Ahead of Daiichi Sankyo In AML With CHMP Nod For Xospata

A positive opinion for its FLT3 inhibitor for acute myeloid leukemia gives Astellas a further advantage over its Japanese competitor's same-class offering, quizartinib.

Drug Review Cancer

Novo Anticipates Q4 Soft Launch For Closely Watched Oral GLP-1 Agent Rybelsus In The US

US CMO Todd Hobbs told Scrip the full launch will be in early 2020 as sales, manufacturing and reimbursement preparations for oral semaglutide continue based on the now-approved FDA label in type 2 diabetes.

Approvals Metabolic Disorders

Pipeline Watch: Phase II Starts In Hearing Loss, Type 1 Diabetes

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.

 

 

Approvals Pipeline Watch

Emmaus Fumes After EMA Rejects Sickle Cell Drug Again

The US firm has withdrawn its submission to get EU approval for Xyndari. After being turned down by the CHMP, Emmaus may try the decentralized approval procedure instead.

Drug Review Blood & Coagulation Disorders

J&J's Erleada Approved By FDA In New Prostate Cancer Indication

Erleada was approved for treatment of metastatic castration-sensitive prostate cancer (mCSPC), strengthening its position versus generic Zytiga and Pfizer/Astellas's Xtandi.

Cancer Approvals

Ardelyx Gets IBS-C Approval, But Focus Remains On Hyperphosphatemia

Tenapanor approved for IBS-C as Ibsrela, but Ardelyx is still seeking a commercial partner for that indication – and is maintaining focus on same molecule in hyperphosphatemia.

Approvals Business Strategies
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Post Marketing Regulation & Studies

Set Alert for Post Marketing Regulation

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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