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Research & Development

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'Pharma Fireworks': Pipeline Catalysts To Watch Out For In Q2

Scrip looks at some the key clinical and regulatory pharma events that will spark attention during the next three months, according to Biomedtracker's latest quarterly outlook report.

Clinical Trials Drug Review Market Intelligence
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Clinical Trials

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Latest From Clinical Trials

Lilly/Pfizer’s Tanezumab Safety Takes A Hit With Latest Phase III Results

Larger of two doses of the NGF inhibitor hit two efficacy endpoints, but the rate of joint health outcomes on a composite measure was higher than control by a statistically significant margin.

Clinical Trials Drug Safety

Aptinyx Sees Path Forward In DPN With Long-Term Patients

After disappointing top-line Phase II data in diabetic peripheral neuropathy with NYX-2925, Aptinyx says the full dataset shows significance across endpoints in patients four years or more past diagnosis; a second Phase II study in this subgroup is planned.

Clinical Trials Business Strategies

BIO-Europe Spring 2019: RedHill Preps NDA Submission For Antibiotic Talicia

Gilead Raday, chief operating officer of RedHill Biopharma, talks to Lucie Ellis, executive editor of In Vivo, about recently published late-stage data and next steps for its antibiotic asset, Talicia (RHB-105), for the treatment of Helicobacter pylori infection. 

Clinical Trials Infectious Diseases

Further Iclaprim Analyses Ahead Of Crucial Months For Motif Bio

A 3 May meeting with the FDA is likely to be crucial for the future commercialization strategy for the biotech’s precision-targeted antibacterial.

Infectious Diseases Clinical Trials

CymaBay Following The Leaders, Pursues NASH, PBC Simultaneously

Biotech thinks its PPAR delta agonist will prove much more potent than Genfit’s elafibranor from the same class and will offer a better tolerability profile than Intercept’s OCA.

Liver & Hepatic Business Strategies

NASH News & Notes From The European Liver Meeting

Non-alcoholic steatohepatitis (NASH) was a focal point of EASL’s conference. Madrigal becomes the fifth company into Phase III in NASH, but Viking’s competing THR agonist is progressing also.

Liver & Hepatic Research & Development
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Approvals

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Latest From Approvals

Gelesis's Obesity Product FDA Acceptance Gives Boost To PureTech's Portfolio


PureTech's affiliate Gelesis has received FDA clearance for its Plenity capsule to treat overweight-obese adults, and plans to launch it commercially in the second half. 
Approvals Metabolic Disorders

Pipeline Watch: Promising Clinical Trial Results In NASH

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

ViiV's Dovato: Treatment-Naive HIV Is Earmarked For The "Complete Regimen"

The first approval in the US of a once-daily single-tablet, two-drug regimen for treatment-naive HIV from the HIV/AIDS therapy specialist, ViiV Healthcare, suggests a shift away from three-drug regimens for HIV/AIDS could be gathering pace.

Approvals Infectious Diseases

Pipeline Watch: Phase III Starts With Patidegib, Reproxalap

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

Aveo's Tivozanib Under CHMP Spotlight If Negative OS Trend Continues In TIVO-3

An August 2019 analysis of overall survival in the TIVO-3 study of Aveo’s tivozanib in advanced renal cell carcinoma is now an interim rather than a final analysis, but EU regulators may take action if a negative overall survival trend is found to be continuing.

 

Cancer Clinical Trials

Merck KGaA Plays Down Mavenclad Label And $99,500 annual Price For 10 MS Pills

Merck KGaA's multiple sclerosis pill Mavenclad has finally won FDA approval, but some analysts think its US label, stipulating second-line use in relapsing MS but not in patients with clinically isolated syndrome, may hurt its uptake there.

Approvals Neurology
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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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