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Research & Development

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AstraZeneca’s Imfinzi-Treme Checkpoint Inhibitor Combination Fails Again In NSCLC

The Phase III NEPTUNE lung cancer trial found the combination of Imfinzi and tremelimumab was no better than chemotherapy at extending overall survival. After repeat setbacks, AstraZeneca is now running out of opportunities to show its dual checkpoint blockade is effective in NSCLC.

Clinical Trials Companies ImmunoOncology
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Clinical Trials

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Latest From Clinical Trials

Retrophin's Focus Shifts After Phase III PKAN Drug's Failure

Fosmetpantotenate missed all endpoints in a Phase III trial, so Retrophin will shelve the candidate for the rare disease PKAN. Now, the biotech turns focus to Phase III sparsentan in a pair of indications.

Clinical Trials Business Strategies

Longer Intervals OK With ViiV's Injectable Anti-HIV Regimen

Topline results from the Phase III ATLAS-2M study indicate that injections every two months of ViiV/Janssen’s two-drug anti-HIV regimen are non-inferior to a once-monthly injectable regimen.

 

Infectious Diseases Clinical Trials

Synlogic Pivots After First Clinical Failure

The synthetic biotics company is discontinuing development of SNYB1020, its first clinical-stage product, which failed to lower blood ammonia in cirrhosis patients.

Research and Development Strategies Clinical Trials

AstraZeneca’s Imfinzi-Treme Checkpoint Inhibitor Combination Fails Again In NSCLC

The Phase III NEPTUNE lung cancer trial found the combination of Imfinzi and tremelimumab was no better than chemotherapy at extending overall survival. After repeat setbacks, AstraZeneca is now running out of opportunities to show its dual checkpoint blockade is effective in NSCLC.

Clinical Trials Companies

Oxurion's Anti-PIGF Antibody Disappoints in Diabetic Macular Edema

The primary endpoint was missed in a Phase IIa study of Oxurion’s THR-317 in diabetic macular edema, but vision did improve in two patient subgroups.

 

Ophthalmic Clinical Trials

AZ's Dapagliflozin Impresses In Topline Phase III Heart Failure Study

AstraZeneca’s SGLT2 inhibitor has grabbed attention for its potential role in chronic heart failure patients, with or without type 2 diabetes, following initial results from the DAPA-HF study.

 

Clinical Trials Market Intelligence
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Approvals

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Latest From Approvals

Novo Nordisk's Ultra-Fast Acting Insulin Cleared For Pediatric Use In EU

A market opportunity has just opened up for Novo Nordisk’s ultra-fast acting mealtime insulin, Fiasp: its indications have just been extended to include younger EU patients who are aged more than one year.

 

Metabolic Disorders Approvals

Nabriva Faces Skepticism After Years Of Preparing For Novel Antibiotic Xenleta's Launch

Lefamulin was approved in the US to treat community-acquired bacterial pneumonia, providing a needed IV and oral drug initially in the hospital setting, but new antibiotics have been a tough sell.

Infectious Diseases Approvals

Pipeline Watch: Phase III Results With Osimertinib, Ripretinib And Evinacumab

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

Inrebic Approval Is A Boost For Myelofibrosis And Celgene's Buyer Bristol

Investors in Impact Biosciences, which sold the selective JAK2 inhibitor to Celgene for $1.1bn up front, could double their money with milestone fees based on fedratinib's approval.

Approvals Cancer

AbbVie’s Post-Humira Strategy Continues Taking Shape With Rinvoq Approval

AbbVie now has both of its Humira successors approved in the US, following April’s Skyrizi approval for psoriasis. But Rinvoq faces stiff competition both within the JAK1 class and in rheumatoid arthritis generally.

Approvals Business Strategies

Europe's Biotechs Gathering Steam With Filgotinib Filing

Galapagos is another step closer to commercializing its products with its lead candidate, filgotinib, now under the gaze of EU regulators.

Approvals Inflammation
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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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