Sunday, February 23, 2020

Sunday, February 23, 2020

Latest News

INOTREM: Announces Fast Track Designation Granted by U.S. FDA to Nangibotide Development Program for the Treatment of Septic Shock

Inotrem S.A., a biotechnology company specialized in immunotherapy for acute and chronic inflammatory syndromes, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nangibotide development program for the treatment of septic shock.

PUMA BIOTECHNOLOGY: FDA Grants Orphan Drug Designation to Puma Biotechnology’s NERLYNX® for the Treatment of Breast Cancer Patients with Brain Metastases

Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NERLYNX® (neratinib) for the treatment of breast cancer patients with brain metastases.

RA PHARMACEUTICALS: Receives Orphan Drug Designation from the U.S. FDA for Zilucoplan for the Treatment of Myasthenia Gravis

Ra Pharmaceuticals, Inc. (Nasdaq:RARX) today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to zilucoplan for the treatment of myasthenia gravis.

Sen. Durbin calls for more e-cigarette product regulation from FDA

Following the death of an Illinois citizen who suffered from respiratory illness after vaping, Sen. Dick Durbin (D-IL) sent a letter to the Food and Drug Administration and the Center for Tobacco Products demanding that they remove e-cigarettes and related vaping products off of the market.

FDA approves clinical trial for Sanfilippo syndrome

The Food and Drug Administration gave the go-ahead last week to accept Seelos Therapeutics’ application for a new drug to combat Sanfilippo syndrome, a rare genetic defect.

AMNEAL PHARMACEUTICALS: Announces Approval of Generic Version of Amicar®

Company granted 180 days of exclusivity under FDA Competitive Generic Therapy approval pathway

LINEAGE CELL THERAPEUTICS: Announces Issuance of U.S. Patent for Method of Treating Spinal Cord Injury With Stem Cell-Derived Oligodendrocyte Progenitor Cells

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,286,009, entitled “Pluripotent stem cell-derived oligodendrocyte progenitor cells for the treatment of spinal cord injury” covering methods for utilizing pluripotent stem cell-derived oligodendrocyte progenitor cells (OPCs) for the treatment of spinal cord injury (SCI).

FDA Update: August medical device recalls

Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.

VIELA BIO: Announces Publication in The Lancet of Pivotal Study Results of Inebilizumab in Patients with Neuromyelitis Optica Spectrum Disorder

Viela Bio today announced that peer-reviewed journal, The Lancet, has published results from its pivotal study of inebilizumab in patients with neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that can result in severe muscle weakness and paralysis, loss of vision, respiratory failure and neuropathic pain.

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first treatment for patients with rare type of lung disease

The U.S. Food and Drug Administration today approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. It is the first FDA-approved treatment for this rare lung condition.

GBT: Announces U.S. Food and Drug Administration Acceptance of New Drug Application and Priority Review for Voxelotor for the Treatment of Sickle Cell Disease

Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) seeking accelerated approval for voxelotor, an oral, once-daily therapy in development for the treatment of sickle cell disease (SCD).

COCONUT COALITION OF THE AMERICAS: The Coconut Coalition of the Americas Launches Initiative to Remove Coconut From the FDA Major Food Allergen List

The Coconut Coalition of the Americas (CCA), announced the launch of an initiative to make it clear that coconuts are not tree nut allergens.

JENKINS EYE CARE: Offers First and Only FDA-approved Trifocal Lens: AcrySof IQ PanOptix Trifocal IOL

Ophthalmological surgeons Tyrie Jenkins, M.D. and Jeffrey Peterson, M.D., Ph.D., of Jenkins Eye Care, now offer cataract patients a trifocal lens that provides a combination of near, intermediate and distance vision.

FDA Health News