China drug regulator calling on international pharmaceutical companies to bring "urgently-needed" new drugs to China

China drug regulator calling on international pharmaceutical companies to bring "urgently-needed" new drugs to China

On 8 August 2018, in an unprecedented regulatory action, China National Drug Administration (CNDA) (formerly known as CFDA) called on international pharmaceutical companies to bring 48 new drugs to China. These new drugs are viewed to be urgently needed in China and have already been approved and marketed in the U.S., EU and Japan for […]

Discovering New Drug Targets Using High-Throughput Screening

Discovering New Drug Targets Using High-Throughput Screening

What Is High-Throughput Screening? Automatic testing of vast numbers of chemical and/or biological compounds searching for a specific biological target is part of a drug discovery process known as high-throughput screening (HTS). Such methods are widely utilized in the pharmaceutical industry and makes use of robotics and automation to test the biological or biochemical activity […]

Iclaprim Gets Priority Review for Acute Bacterial Skin/Skin Structure Infections

Iclaprim Gets Priority Review for Acute Bacterial Skin/Skin Structure Infections

Iclaprim is an investigational diaminopyrimidine antibiotic Iclaprim is an investigational diaminopyrimidine antibiotic with a targeted Gram-positive spectrum of activity and a distinct mechanism of action demonstrated by rapid bactericidal activity in vitro; it works by inhibiting the dihydrofolate reductase (DHFR) enzyme. Clinical data has indicated that the drug exhibits a low propensity for resistance development […]

How Stemline's Latest Catalyst Shifts The Investment Thesis

How Stemline's Latest Catalyst Shifts The Investment Thesis

2018 has been no stranger to exciting developments in biotech, what with the first approvals for RNAi technology, emerging gene therapies, and treatment options for rare forms of cancer. In particular, for me, it’s been a banner year for several companies going it on their own in the development of key cancer drugs. Stakeholders of […]

FDA Action Alert: Amicus, Vertex and TherapeuticsMD

FDA Action Alert: Amicus, Vertex and TherapeuticsMD

This week had three important target action dates, known as Prescription Drug User Fee Act (PDUFA) dates, for the U.S. Food and Drug Administration (FDA). The agency got ahead of its schedule and approved all of these drugs. Let’s take a look. Amicus Therapeutics and Migalastat for Fabry Disease The FDA had a PDUFA date […]

Cumberland Pharmaceuticals Reports Second Quarter 2018 Financial Results

Cumberland Pharmaceuticals Reports Second Quarter 2018 Financial Results

NASHVILLE, Tenn., Aug. 14, 2018 /PRNewswire/ — Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company focused on hospital acute care, gastroenterology, and oncology supportive care today announced second quarter 2018 financial results and Company update. Cumberland has a portfolio of seven U.S. Food and Drug Administration (FDA) approved brands. Net revenues for the quarter were […]

Correvio Reports Second Quarter 2018 Financial Results

Correvio Reports Second Quarter 2018 Financial Results

Management to Host Conference Call and Webcast Today, August 14, 2018 at 4:30 p.m. Eastern (1:30 p.m. Pacific) NASDAQ: CORV  TSX: CORV VANCOUVER, Aug. 14, 2018 /PRNewswire/ – Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a revenue-generating, specialty pharmaceutical company focused on commercializing hospital drugs, today reported financial results for its second quarter ended June 30, 2018 […]

Elite Pharmaceuticals unveils positive top-line data from key bio-equivalence study for undisclosed antibiotic generic …

Elite Pharmaceuticals unveils positive top-line data from key bio-equivalence study for undisclosed antibiotic generic …

Inc (), a pharmaceutical group that develops abuse-deterrent opioids and niche generic drugs, has unveiled positive top-line results from key bio-equivalence studies conducted for an undisclosed antibiotic generic drug now being co-developed with SunGen Pharma. The top-line results show that the generic product is bio-equivalent to its branded product in studies where patients […]

CASI Pharmaceuticals Announces Second Quarter And First Half 2018 Financial And Business Results

CASI Pharmaceuticals Announces Second Quarter And First Half 2018 Financial And Business Results

ROCKVILLE, Md., Aug. 14, 2018 /PRNewswire/ — CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world, today reported financial results for the second quarter and six months ended June 30, 2018 and […]

FDA to Review Midazolam Nasal Spray for Seizure Clusters

FDA to Review Midazolam Nasal Spray for Seizure Clusters

The product is intended to be delivered intranasally without active inhalation by the patient The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for a novel, investigational midazolam formulation for the acute treatment of seizures in patients who require control of intermittent bouts of increased seizure activity (e.g. seizure clusters, […]

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