pharma news

Feb 08, 2022

Biogen's Aduhelm Marketing and Approval are Under Scrutiny in New FTC and SEC Investigations Biogen can't seem to get a break when it comes to the Alzheimer's disease drug Aduhelm. Along with limited sales and a constraining Medicare coverage plan, the medicine is now facing additional scrutiny as part of a pair...

Feb 01, 2022

Immunocore Receives FDA Approval for the First Uveal Melanoma Treatment, As Well As the First T-cell Receptor Therapeutics Uveal Melanoma, an aggressive eye cancer, has proven to be a tough nut to crack for researchers seeking a cure. However, with the approval of a new treatment, those with the disorder will ha...

Jan 25, 2022

Merck’s Chronic Cough Med Gefapixant Receives A Red Flag From the FDA, Requests For More Data On 24th January 2022, Merck & Co. announced FDA rejection for its New Drug Application (NDA) of Gefapixant (experimental drug) for unexplained or chronic cough. FDA asked for additional information on the drug, rela...

Jan 18, 2022

Algernon receives positive FDA feedback on Phase IIb chronic cough trial The US Food and Drug Administration (FDA) has given positive feedback for Algernon Pharmaceuticals’ Phase IIb clinical trial of NP-120 (ifenprodil) for chronic cough treatment.  A receptor antagonist of N-methyl-D-aspartate (NMDA), ifenp...

Jan 11, 2022

Noxxon continues enrolment in a glioblastoma therapy trial Noxxon Pharma continues subject enrolment in the GLORIA clinical trial of NOX-A12 in brain cancer (glioblastoma) patients. The move comes after the Data Safety Monitoring Board (DSMB) evaluated safety results from the preliminary four-week treatment with...

Jan 04, 2022

FDA approves IND application of Accutar for a prostate cancer treatment trial The US Food and Drug Administration (FDA) has granted Accutar Biotechnology’s Investigational New Drug (IND) application for Phase I clinical trial of AC0176 for treating metastatic castration-resistant prostate cancer (mCRPC). An i...

Dec 28, 2021

Biogen-Eisai's potential Aduhelm sequel drug secured speedy review by FDA Biogen and Eisai’s Alzheimer’s disease treatment-in-waiting, lecanemab, has been secured a fast-track tag by the FDA, setting up a potentially swift path through the regulatory process. The drug is the next in line behind the pair’s app...

Dec 23, 2021

Sky receives FDA clearance to market the geko™ device for venous insufficiency and ischemia  On December 16, 2021, Sky Medical Technology Ltd, a medical device company, got approval from the US Food and Drug Administration (FDA) 510(k) to market the geko™ device for growing microcirculatory bl...

Dec 14, 2021

Pfizer acquires drugmaker Arena for USD 6.7 billion to address unmet needs Pfizer declared that it is acquiring Arena Pharmaceuticals, a drug company specializing in inflammation and immunology, for almost USD 7 billion. The pharma giant said it would finance the agreement, worth USD 6.7 billion, with cash on ha...

Dec 07, 2021

Aslan Pharmaceuticals enters into a strategic collaboration with IQVIA   ASLAN Pharmaceuticals announced the appointment of IQVIA Biotech, a provider of analytics, technology solutions, and clinical research services to the life sciences industry, as its preferred clinical research organisation for log...