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

By Press release submission | Sep 6, 2019

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.

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

Reform

By Press release submission | Sep 5, 2019

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).

AMNEAL PHARMACEUTICALS: Announces Approval of Generic Version of Amicar®

FDA Approval

By Press release submission | Sep 5, 2019

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

TRICIDA: Announces Submission of New Drug Application for Veverimer for the Treatment of Metabolic Acidosis in Patients with Chronic Kidney Disease

Patients

By Press release submission | Sep 4, 2019

NDA Submitted under the FDA’s Accelerated Approval Program

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

Patients

By Press release submission | Sep 4, 2019

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.

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

Patients

By Press release submission | Sep 3, 2019

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.

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

Patients

By Press release submission | Sep 3, 2019

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.

U.S. FOOD AND DRUG ADMINISTRATION: FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy

Regulation

By Press release submission | Sep 3, 2019

Stemell sold stem cell products without required FDA approval

BIOMED: Impella® SmartAssist Platform Launches at ESC, Designed to Further Improve Patient Outcomes

Patients

By Press release submission | Aug 31, 2019

Abiomed (NASDAQ: ABMD) announces that the Impella CP® with SmartAssist technology, which is designed to improve patient outcomes with advanced algorithms and simplified patient management, will be commercially available in Europe beginning at the European Society of Cardiology (ESC) Congress 2019 through a controlled roll out process at select sites.

FRESENIUS KABI: Introduces Phenylephrine Hydrochloride Injection, USP

Regulation

By Press release submission | Aug 31, 2019

Generic Equivalent to Vazculep® is Newest Addition to Broad Portfolio of Anesthesia and Analgesia Products

CARSGEN THERAPEUTICS: Receives US FDA Orphan Drug Designation For Fully Human Anti-BCMA (B Cell Maturation Antigen) Autologous Chimeric Antigen Receptor (CAR) T Cells For The Treatment Of Multiple Myeloma

Patients

By Press release submission | Aug 31, 2019

CARsgen Therapeutics Inc., a clinical-stage biopharmaceutical company today announced the United States Food and Drug Administration (FDA) has granted orphan drug designation to its investigational CAR-T cell therapy fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cells (ct053) for the treatment of multiple myeloma.

AKORN: Receives FDA Approval for Azelastine Hydrochloride Nasal Spray, 0.15%

FDA Approval

By Press release submission | Aug 29, 2019

Akorn, Inc. (Nasdaq: AKRX), a leading specialty generic pharmaceutical company, announced that it received a new Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for Azelastine Hydrochloride Nasal Spray, 0.15%. The product is manufactured at Akorn’s Amityville, New York manufacturing facility.

U.S. FOOD AND DRUG ADMINISTRATION: FDA recommends health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components to reduce risk of patient infection

Patients

By Press release submission | Aug 29, 2019

In continued efforts to protect patient safety, FDA orders new postmarket studies for manufacturers, requests real-world contamination rates in duodenoscope labeling and warns about certain test strips illegally marketed to assess duodenoscope cleanliness

EMALEX BIOSCIENCES: Receives FDA Fast Track Designation for Ecopipam for the Treatment of Patients with Tourette Syndrome

Patients

By Press release submission | Aug 28, 2019

Emalex Biosciences, Inc. (Emalex), a biopharmaceutical company developing innovative therapies for patients with neurological and psychiatric conditions, announced today that it has received Fast Track designation for its investigational product, ecopipam, from the U.S. Food and Drug Administration (FDA) for the treatment of patients with Tourette Syndrome (TS).

KYOWA KIRIN CO., LTD.: Kyowa Kirin Announces FDA Approval of NOURIANZ™ (istradefylline) for Use in Parkinson’s Disease

FDA Approval

By Press release submission | Aug 28, 2019

First and only Adenosine A2A receptor antagonist for use in Parkinson’s Disease in the U.S.

U.S. FOOD AND DRUG ADMINISTRATION: Statement calling on all sectors of the papaya industry to improve practices to better protect consumers

Reform

By Press release submission | Aug 27, 2019

The U.S. Food and Drug Administration works tirelessly to ensure that foods available to consumers, whether they are produced domestically or abroad, meet the FDA’s food safety requirements and that we are using all available tools to ensure compliance.

ELI LILLY & COMPANY: Lilly Receives U.S. FDA Approval for Taltz® (ixekizumab) for the Treatment of Active Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)

Patients

By Press release submission | Aug 26, 2019

Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA).

US WORLDMEDS: FDA Approves US WorldMeds' MYOBLOC® (rimabotulinumtoxinB) Injection for Chronic Sialorrhea

FDA Approval

By Press release submission | Aug 26, 2019

MYOBLOC is the only approved botulinum toxin for chronic sialorrhea that provides significant results in as early as one week(1),(2)

SAREPTA THERAPEUTICS: Receives Complete Response Letter from the US Food and Drug Administration for Golodirsen New Drug Application

Reform

By Press release submission | Aug 23, 2019

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) seeking accelerated approval of golodirsen injection for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping.

CERECOR: Receives Fast Track Designation from FDA for CERC-802 for the Treatment of Mannose-Phosphate Isomerase Deficiency

Patients

By Press release submission | Aug 22, 2019

Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases in pediatrics and neurology, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for CERC-802, an ultra-pure, oral formulation of D-mannose currently in development for the treatment of Mannose-Phosphate Isomerase Deficiency, also known as MPI-CDG or CDG-1b.

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