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BioMarin’s Hemophilia A Gene Therapy Shows Promise in Clinical Trial

San Rafael, Calif.-based BioMarin Pharmaceutical announced positive Phase III clinical trial results for the company’s gene therapy, valoctocogene roxaparvovec, for adults with hemophilia A.

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Pfizer’s abrocitinib meets late-stage study goals

Pfizer Inc.’s experimental atopic dermatitis treatment abrocitinib met the main goals in a late-stage study that tested the drug in patients aged 12 and older with moderate to severe forms of the disease.

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AstraZeneca Halts Phase III CLL Trial Early After Primary Endpoints Are Met

AstraZeneca’s Calquence (acalabrutinib) hit the mark in a Phase III trial of previously treated patients with chronic lymphocytic leukemia (CLL).

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The obscure advisory committees at the heart of the U.S. drug pricing debate

Expectations were high during 2018 for three new migraine drugs hitting the market from Amgen Inc., Eli Lilly and Co. and Teva Pharmaceutical Industries Ltd. Priced around $7,000 each, the drugmakers called them “breakthrough” treatments designed to prevent migraines when taken year-round, and estimated that millions of patients could benefit. But a small group of medical experts who quietly advise U.S. health insurers on new drugs was not impressed, according to a private meeting held at UnitedHealth Group’s OptumRx offices in Chicago that was attended by Reuters.

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AACE Meeting: New Data from Phase 3 OPTIC Study

Horizon Pharma announced that new data from the Phase 3 confirmatory study evaluating teprotumumab for treating active thyroid eye disease were presented as part of a late-breaking oral presentation at the 2019 AACE Scientific and Clinical Congress.

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Teva stops testing migraine drug as cluster headache treatment

Teva Pharmaceutical Industries Ltd. will stop developing the migraine drug Ajovy for treating cluster headaches after finding the treatment was unlikely to meet the main goal of a late-stage trial.

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Galera Therapeutics Raises $150 Million for GC4419 Phase 3 Trial and Pre-Commercialization Activities in Lead Indication

Galera Therapeutics Inc.announced that the clinical-stage biotechnology company secured $150 million in a joint, oversubscribed Series C financing and royalty purchase agreement.

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Pfizer rare heart disease drug reduces risk of death by 30 percent in study

Pfizer Inc.’s tafamidis reduced the risk of death for patients with a rare and fatal heart disease by around 30 percent, boosting the prospects of what could be a billion-dollar-a-year drug.

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FDA Grants Breakthrough Therapy Designation for Tafamidis for the Treatment of Patients with Transthyretin Cardiomyopathy

Pfizer Inc. announced that tafamidis received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the treatment of patients with transthyretin cardiomyopathy, which is a rare, fatal and underdiagnosed condition associated with progressive heart failure.

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Sage Therapeutics’ Postpartum Depression Drug Heads to the FDA

Sage Therapeutics, located in Cambridge, Mass., submitted a New Drug Application to the U.S. Food and Drug Administration for brexanolone (SAGE-547) to treat postpartum depression.

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June 2019 Focus: Payer access, biotech/biopharma, DTC, rare diseases, and more!

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