Sunday, October 20, 2019

Sunday, October 20, 2019

Latest News

NOVO NORDISK: FDA approves Rybelsus® (semaglutide), the first GLP-1 analog treatment available in a pill for adults with type 2 diabetes

Rybelsus® represents an innovation in diabetes treatment by providing a GLP-1 receptor agonist in an oral formulation

U.S. FDA: FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma

The U.S. Food and Drug Administration is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners.

ENDO: Announces Submission of Biologics License Application to FDA for Collagenase Clostridium Histolyticum (CCH) in Patients with Cellulite

Endo International plc (NASDAQ: ENDP) announced today that the Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks.

ICUS: Simple CEUS Scan Helps Diagnose Liver Cancer When MRI is Uncertain

A new study shows that a simple, non-invasive “contrast enhanced ultrasound” (CEUS) scan can be more accurate and reliable than a more expensive MRI procedure for diagnosis of liver tumors and determining whether they are cancerous.

ASTEX PHARMACEUTICALS: Announces That Its Novel, Oral Hypomethylating Agent ASTX727 Has Been Granted Orphan Drug Designation for the Treatment of Myelodysplastic Syndromes (Including Chronic Myelomonocytic Leukemia) by the US FDA

Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan, announces that the US Food & Drug Administration (FDA) has granted orphan drug designation for the company’s orally administered fixed-dose combination of cedazuridine and decitabine (ASTX727 or C-DEC) for the treatment of myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML).

U.S. FDA: Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications

Protecting patients is the FDA’s highest priority, and Americans can be confident in the quality of the products the agency approves.

APIFIX: Receives FDA Approval to Commercialize MID-C System for Motion-Preserving Deformity Treatment of Progressive Idiopathic Scoliosis in Adolescents

FDA approves ApiFix’s unique self-adjusting pediatric device designed to benefit young scoliosis patients with a less invasive surgical treatment

U.S. FDA: Requests recall of sterile compounded drug products produced by Pacifico National Inc., dba AmEx Pharmacy, reminds patients and health care professionals to stop using due to potential risks

The U.S. Food and Drug Administration is reminding patients and health care professionals not to use drug products intended to be sterile made by Pacifico National Inc., an outsourcing facility doing business as AmEx Pharmacy, in Melbourne, Florida.

STALICLA: Announces Completion of pre-IND Meeting With FDA on STP1 for Subgroup of Patients With Autism Spectrum Disorder (ASD)

STP1 is a pioneering investigational precision medicine that aims to provide an effective treatment option for a subgroup of patients with ASD (referred to as ‘Phenotype 1’). Phenotype 1 is estimated to include 20% of the total ASD population (2 million out of 10 million patients with ASD across Europe and North America), meaning STP1 has the potential to be a ‘game-changing’ influence in the field.

BEIGENE: Announces U.S. FDA Acceptance and Grant of Priority Review for its New Drug Application of Zanubrutinib in Patients with Relapsed/Refractory Mantle Cell Lymphoma

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for zanubrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

VANDA PHARMACEUTICALS: FDA Update for HETLIOZ® in the Treatment of Jet Lag Disorder

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that on August 16 2019, it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of Jet Lag Disorder (JLD).

EDWARDS LIFE SCIENCES CORPORATION: Edwards SAPIEN 3 TAVR Receives FDA Approval For Low-Risk Patients

Superior TAVR Valve Available for All Patients Diagnosed with Severe, Symptomatic Aortic Stenosis

NATIONAL KIDNEY FOUNDATION: IgA Nephropathy Patients Invited to Speak About their Disease to the FDA

National Kidney Foundation and IGAN Foundation of America organizing meeting to hear voices of patients with this chronic kidney disease

ABBVIE: Receives FDA Approval of RINVOQ™ (upadacitinib), an Oral JAK Inhibitor For The Treatment of Moderate to Severe Rheumatoid Arthritis

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ™ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR).1 RINVOQ is expected to be available in the U.S. in late August 2019.

EMPHYCORP INC.: FDA Submission for Rx New Non-Steroidal Nasal Spray for Pulmonary Fibrosis w/ No Known Side Effects

EmphyCorp Inc., a Private Corporation, is proud to announce the completion of a clinical trial to define medical endpoints as requested by the FDA for the NDA marketing application in patients with Pulmonary Fibrosis, under its Orphan Drug Designations for the treatment of Interstitial Lung Diseases (ILD), which includes Pulmonary Fibrosis and Cystic Fibrosis.

FDA Reporter