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Research & Development

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Imutex's Universal Flu Vaccine Inches Forward On New Data

The Imutex joint venture between hVIVO and the SEEK Group updates promise of its universal flu vaccine candidate after additional data from a Phase IIb study showed a statistically significant effect on its primary endpoint.

 

Clinical Trials Infectious Diseases Research & Development
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Clinical Trials

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Latest From Clinical Trials

United Neuroscience To Move Forward Alzheimer's Vaccine After Promising Phase IIa

It's early days yet and Alzheimer's is a field littered with failures, but the latest results for the vaccine UB-311 support advancing development.

Clinical Trials Research & Development

Aptinyx Says DPN Setback Just A Step In Seeking Chronic Pain Indication

Investors reacted negatively when Aptinyx’s lead candidate missed its primary endpoint in diabetic peripheral neuropathy, but CEO Riedel tries to emphasize the positives from the study while awaiting fibromyalgia data with NYX-2925.

Neurology Research & Development

Can Vivus Get Away Without Outcomes Study Of Obesity Drug Qsymia?

Fixed-dose combination of phentermine and topiramate is FDA-approved for chronic, long-term use, but the average duration in the real world is only about 2.1 months, which is reassuring for Qsymia’s cardiovascular safety, according to a new retrospective claims study.

Clinical Trials Cardiovascular

How Lilly Aims To Make Sure Good Drugs Don't Get Lost In Translation

SVP/CSO Daniel Skovronsky says the company has invested in technology and biotech-like teams to speed up the process of translating targets identified in house into human data for novel drugs.

Business Strategies Research and Development Strategies

Merck’s Keytruda Misses OS Endpoint, But Shows Utility In Subset Of Esophageal Cancer

A Phase III study testing Keytruda monotherapy in second-line esophageal cancer versus physician’s choice of chemotherapy shows a 31% reduction in risk of death for patients expressing PD-L1.

Clinical Trials ImmunoOncology

Loxo Links And Colorectal Cancer Data Put Array In M&A Spotlight

Following Lilly's proposed acquisition of Loxo, other possible takeover targets in the precision medicine field have emerged and Array, armed with more positive data on its colorectal cancer triplet, is near the top of the list.

M & A Cancer
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Approvals

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Latest From Approvals

J&J’s Erleada Gives Chase To Xtandi For Non-Metastatic Prostate Cancer With Approval In Europe

Astellas/Pfizer’s Xtandi and Johnson & Johnson’s Erleada are both now approved for non-metastatic castration-resistant prostate cancer in Europe, while Xtandi benefits from physician familiarity, Erleada has shown greater metastasis-free survival.

Cancer Approvals

In A Record Year For US FDA Approvals, Pfizer Came Out On Top

FDA’s approval teams cleared a total of 65 new molecular entities and novel biologics in 2018, blowing past previous records. Scrip looks at how that breaks down for industry leaders. 
Approvals Drug Review

Pipeline Watch: Phase III Starts In Psoriasis, Depression And Huntington's Disease

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

Novartis Gets NICE Headache From Aimovig Knockback

The cost-effectiveness watchdog is worried about the cost of Novartis's once-monthly first-in-class migraine drug and is not convinced it is more effective than Allergan’s Botox, which can require up to 40 injections into the head and neck.

Reimbursement Neurology

Anticancers, Orphans & The First CAR-Ts: New EU Drug Approvals In 2018

New approvals in the EU were again dominated by oncology drugs in 2018, although medicines for infectious diseases were a close second. The number of orphan drugs more than doubled over the previous year, to 17. There were also some star arrivals in multiple sclerosis, genetic disorders, metabolism and migraine.

Approvals Europe

Pipeline Watch: Phase III Starts With Sparsentan, Reloxaliase And Xenex

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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