A new drug developed by Merck & Co and Pfizer Inc won U.S. approval on Wednesday to treat type II diabetes, the Food and Drug Administration(FDA) said, adding another competitor to a growing class of treatments.
AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of TAGRISSO® (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations). The FDA has granted TAGRISSO Priority Review status, and previously granted Breakthrough Therapy Designation for TAGRISSO in the 1st-line treatment of patients with metastatic EGFR mutation-positive (EGFRm) NSCLC.
AstraZeneca today announced positive top-line results of the Phase IV ASCENT trial for Tudorza Pressair (aclidinium bromide 400 μg, twice-daily), a long-acting muscarinic antagonist (LAMA), in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), with a history of cardiovascular disease and/or significant cardiovascular risk factors.
Chinese biotech groups are on target to raise about $10bn this year from venture capital funding, initial public offerings and licensing deals with overseas pharma companies, in what is partly a bet that Chinese-developed drugs can compete globally.
Peptidream Inc. has scored another billion dollar-plus agreement to develop peptide-based therapies aimed at the treatment multiple disease targets.
Respiratory system drugs is a term used to describe a wide variety of medicines used to relieve, treat, or prevent respiratory diseases such as asthma, chronic bronchitis, chronic obstructive pulmonary disease (COPD), or pneumonia. Today, Ddu, the leading global pharmaceutical & medical device B2B online platform, will share China’s Import and Export Market Report of Respiratory System Drugs with you.
A venture capital firm in the Netherlands — backed by some big names in Big Pharma — has raised $95 million in a new fund to fuel European biotech startups.
The U.S. Food and Drug(FDA) Administration today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.
Keytruda (pembrolizumab) was the main bright spot for Merck as it weathered blows from the NotPetya cyber attack, new competition and pricing pressures in hepatitis C.
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Bydureon® BCise™ (exenatide extended-release) injectable suspension, a new formulation of Bydureon (exenatide extended-release) injectable suspension in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise, to improve glycemic control.
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