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Yearly Archives: 2020

Fennec Pharmaceuticals Completes Rolling Submission of NDA to U.S. Food and Drug Administration for PEDMARK™ and Also Submits Marketing Authorization Application (MAA) to the...

Feb,11, 2020: Fennec Pharmaceuticals announced it has completed its rolling submission of an NDA to the U.S. FDA for PEDMARK™Â (a unique formulation of sodium thiosulfate)...

Roche provides topline results from the investigator-led Phase II/III trial with gantenerumab in exceptionally inherited form of Alzheimer’s disease

Feb 10, 2020: Roche announced that the gantenerumab arm of the Phase II/III DIAN-TU-001 study did not meet its primary endpoint in the people...

The Scottish Medicines Consortium approves first two ‘ultra-orphan’ pathway meds

Feb 10, 2020: Appraisal reports have been published for THE two medicines to treat exceptionally rare conditions, voretigene neparvovec (Luxturna) and burosumab (Crysvita). These are the first drugs to be tested along the ultra-orphan pathway a new approach...

Zealand Pharma announces proposal to acquire Valeritas

Feb 10, 2020: Zealand Pharma, a biotechnology company focused on the discovery and development of the innovative peptide-based medicines, announces a bid in order...

Extended coronavirus outbreak in China may affect the Indian pharmaceutical industry

Feb 9, 2020: Indian Pharma firms are closely monitoring the outbreak of the coronavirus in China as it could impact the supply of active pharmaceutical ingredients...

Clariant Masterbatches introduces brilliant new metallic aesthetic; targets premium packaging

Feb 07, 2020: Clariant Masterbatches has developed a novel chrome color that opens new opportunities for the designers and manufacturers of high-end products, bottles and packaging. Targeted...

Bionj awarded Amarin with innovator award for vascepa® development and regulatory approval cardiovascular risk

Feb 6, 2020: Amarin Corporation plc announced that BioNJ awarded Amarin with an Innovator Award in recognition of the approval of a new indication...

Nestlé Health Sciences and valbiotis agree to create and market TOTUM-63, a plant-derived active substance with clinically proven metabolic health benefits

Feb 5, 2020: Nestlé Health Science and Valbiotis, a research and development company committed to scientific innovation for preventing and fighting metabolic diseases, have...

How to Score AIR Under 100 in NIPER

This blog has been written after discussion with many NIPER qualifiers. Even the Writer of this blog is Ex NIPERian. He got 56 Rank...

USFDA Authorizes Marketing of the First Cardiac Ultrasound Software That Uses Artificial Intelligence to Guide User

Feb 7, 2020: U.S. FDA authorized marketing of software to assist medical professionals in the acquisition of cardiac ultrasound, or echocardiography, images. This software, called...

Sanofi brain-penetrant BTK (Bruton’s tyrosine kinase) inhibitor meets primary endpoint of Phase 2 trial in relapsing multiple sclerosis

Feb 6, 2020: Its primary endpoint was reached by the Sanofi Phase 2b trial evaluating its investigational BTK (Bruton's tyrosine kinase) inhibitor (SAR442168), an oral brain penetrating, selective small molecule. In the trial, as measured by the magnetic resonance imaging (MRI), SAR442168 significantly reduced disease activity associated despite multiple sclerosis (MS). With no new safety results, SAR442168 had been well accepted. The BTK inhibitor is deliberate to modulate both adaptive (B-cell activation) and innate (CNS microglial cells) immune cells linked to neuroinflammation in the...

Aquestive Therapeutics Announces FDA Confirmed 505(b)(2) Pathway for AQST-108 (Sublingual Film Formulation Delivering Systemic Epinephrine) for Anaphylaxis Treatment

Feb. 06, 2020: Aquestive Therapeutics, Inc, announced today that it had a constructive face-to-face pre-IND Application meeting with the U.S.FDA for its drug candidate,...
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