NEWS

FDA Awards 15 Grants for Clinical Trials for The Product Development Against Rare Diseases By: FDA News The U.S. Food and Drug Administration announced that it has awarded 15 new clinical trial research grants totaling more than $22 million over the next four years to boost the development of products [..]

No More Finger Sticks: FDA Approved Abbott’s FreeStyle Libre Flash Glucose Monitoring System  By: ASweetLife News The U.S. FDA has approved Abbott’s FreeStyle Libre Flash Glucose Monitoring System as a replacement for blood glucose monitoring (BGM) for adults with diabetes. This revolutionary new glucose sensing technology eliminates the need for routine finger sticks and is the only [..]

FDA Approved Verzenio of Eli Lilly for Certain Advanced or Metastatic Breast Cancers By: FDA News The U.S. Food and Drug Administration approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking [..]

Rydapt® of Novartis Approved by EU for Acute Myeloid Leukemia (AML) and Systemic Mastocytosis (SM) By : Novartis News Novartis today announced that the European Commission (EC) approved Rydapt® (midostaurin) for two indications in rare, hard-to-treat cancers. Rydapt is approved for use in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine [..]

First Duodenoscope With Disposable Distal Cap Got Clearance by FDA By: FDA News The U.S. Food and Drug Administration cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing. The Pentax ED34-i10T model duodenoscope is intended to provide visualization and [..]

New FDA Approval to Bayer’s Copanlisib For Adults With Relapsed Follicular Lymphoma By: Bayer News Bayer Healthcare Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved copanlisib under the brand name Aliqopa™ 60 mg vial for injection for the treatment of adult patients with relapsed follicular lymphoma [..]

FDA Approved MVASI™ of Amgen And Allergan : First Biosimilar Treatment for Cancer By: Amgen News Amgen (NASDAQ: AMGN) and Allergan plc. (NYSE: AGN) announced that the U.S. Food and Drug Administration (FDA) has approved MVASI™ (bevacizumab-awwb) for all eligible indications of the reference product, Avastin® (bevacizumab). MVASI is the first anti-cancer biosimilar, as well [..]

FDA Breakthrough Therapy Designation: To Cemiplimab (REGN2810) of Regeneron and Sanofi  Source: Regeneron Pharmaceuticals, Inc. News Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation status to cemiplimab (REGN2810) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced [..]

U.S. FDA Approved Pfizer’s BESPONSA® : New Treatment For Relapsed or Refractory Acute Lymphoblastic Leukemia By: Pfizer News Pfizer Inc. (NYSE:PFE) announced that the U.S. Food and Drug Administration (FDA) has approved BESPONSA® (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1BESPONSA was reviewed [..]

AbbVie Receives FDA Approval of MAVYRET™ for the Treatment of Chronic Hepatitis C By: Abbvie News AbbVie, a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved MAVYRET™ (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes [..]

Puma’s NERLYNX™ (Neratinib) An Extended Adjuvant Treatment For Breast Cancer: Approved by FDA By: Puma Biotechnology News Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the U.S. Food and Drug Administration (FDA) has approved NERLYNX™ (neratinib), formerly known as PB272, a once-daily oral tyrosine kinase inhibitor for the extended adjuvant treatment of [..]

FDA Approves Gilead’s Vosevi™ for Re-Treatment of Hepatitis C By: Gilead Sciences News Gilead Sciences, Inc.(NASDAQ: GILD) announced that the U.S. Food and Drug Administration (FDA) has approved Vosevi™ (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a single-tablet regimen for the re-treatment of chronic hepatitis C virus (HCV) infection in adults [..]

FDA Recommended Approval For Gene-Altering Immunocellular Personalized Therapy Against Cancer By: Novartis News Novartis announced today that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) unanimously (10-0) recommended approval of CTL019 (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of relapsed or refractory (r/r) [..]

FDA Approves Endari™, the First Treatment for Pediatric Sickle Cell Disease By: Emmaus Life Sciences Inc. News Emmaus Life Sciences Inc. announced that the U.S. Food and Drug Administration (FDA) approved EndariTM (L-glutamine oral powder) to reduce the severe complications of sickle cell disease (SCD) in adult and pediatric patients age 5 [..]

FDA Approved HAEGARDA® First and Only Treatment for Angioedema: A Rare Hereditary Disease  By: CSL Behring News HAEGARDA has been shown to reduce HAE attacks by 95 percent (median) in patients with a life-threatening, rare genetic disorder Use of rescue medication was reduced by greater than 99 percent1 Subcutaneous administration builds [..]

US At Top in Biomedical Research, But China Is Growing Fast By: University of Michigan 18 June 2017 American scientific teams still publish significantly more biomedical research discoveries than teams from any other country, a new study shows, and the U.S. still leads the world in research and development expenditures. [..]

Phase III Study Showed Roche’s Alecensa Is Superior To Crizotinib For Lung Cancer Data will be simultaneously published in the New England Journal of Medicine, and featured in the official ASCO press programme By: Roche News Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the phase III ALEX study showed [..]

Pfizer’s Trumenba® Approved By European Commission For Meningococcal Group B Disease May 31, 2017  Pfizer Inc. (NYSE:PFE) announced that the European Commission (EC) has approved TRUMENBA® (Meningococcal Group B Vaccine) for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in individuals 10 years of age [..]

Genentech’s Actemra (Tocilizumab) for Giant Cell Arteritis Is Now Approved by FDA FDA previously granted Priority Review and Breakthrough Therapy Designation for Actemra in GCA Sixth FDA approval for Actemra since its U.S. launch in 2010 Source: Genentech NEWS May 23, 2017 Genentech, a member of the Roche Group (SIX: [..]

FDA Approved KALYDECO®  To Treat Additional Mutations of Cystic Fibrosis Source: Vertex Pharmaceuticals Inc. News Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that the U.S. Food and Drug Administration (FDA) has approved KALYDECO® (ivacaftor) for use in people with cystic fibrosis (CF) ages 2 and older who have one of 23 [..]

FDA Granted Approval To Novartis Rydapt® For Acute Myeloid Leukemia Approval in newly diagnosed FLT3-mutated AML represents the first new treatment in more than 25 years[1],[2]  Rydapt treatment regimen in FLT3-mutated AML demonstrated a significant improvement in overall survival with a 23% reduction in the risk of death[3]  Rydapt is [..]

FDA Approves Brineura™ As The First Treatment of CLN2 Disease  SOURCE: BioMarin Pharmaceutical Inc. Apr 27, 2017 BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that the U.S. Food and Drug Administration (FDA) approved Brineura™ (cerliponase alfa) to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and [..]

Novartis CAR-T Cell Therapy (CTL019) Receives FDA Breakthrough Therapy Designation  Source: Novartis NEWS April 22, 2017 R/r DLBCL, an aggressive cancer with limited options, is the second indication for CTL019 to receive Breakthrough Therapy designation Advances in CTL019 result from collaboration with the University of Pennsylvania; regulatory submissions for r/r [..]

FDA Approved Neurocrine’s INGREZZATM As First and Only Treatment for Tardive Dyskinesia (TD) April 19, 2017 Source: Neurocrine Biosciences, Inc NEWS Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced that the U.S. Food and Drug Administration (FDA) has approved INGREZZATM (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD). INGREZZA, a novel, selective [..]

FDA Approves Gilead’s Two New Hepatitis C Drugs For Pediatric Patients Source: BUSINESS WIRE |  April, 15 2017 Gilead Sciences, Inc. (NASDAQ: GILD) announced that the U.S. Food and Drug Administration (FDA) has approved supplemental indications for Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) tablets and Sovaldi® (sofosbuvir 400 mg) tablets [..]

FDA Approves Genentech’s OCREVUS™ (Ocrelizumab) For Multiple Sclerosis An important new treatment option for people with relapsing forms of multiple sclerosis (RMS) demonstrating superior efficacy on the three major markers of disease activity compared with Rebif® A favorable benefit-risk profile demonstrated in three large Phase III studies with a diverse [..]

FDA Approves Xadago® (Safinamide) For Parkinson’s Disease By: Newron Pharmaceuticals News March 23, 2017  Newron Pharmaceuticals S.p.A. (“Newron”, SIX: NWRN), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, and its partners Zambon S.p.A. and US WorldMeds, [..]

FDA Approved Kisqali® (ribociclib, LEE011) of Novartis for HR+/HER2- Metastatic Breast Cancer The digital press release with multimedia content can be accessed here March 17, 2017 By : Novartis News   At this interim analysis, Kisqali plus letrozole reduced risk of disease progression or death by 44% over letrozole alone, [..]

FDA Approved Lexicon Pharma’s Xermelo® Against Carcinoid Syndrome Diarrhea Source: FDA News and Lexpharma News March 9, 2017 The U.S. Food and Drug Administration today approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment of adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately controlled. Carcinoid [..]

GSK’s MUSCA Study Shows Nucala® Found Significantly Effective In Severe Asthma Patients Issued From: London UK – LSE Announcement GlaxoSmithKline plc (LSE/NYSE:GSK) today announced data demonstrating that severe asthma patients, whose disease is driven by eosinophilic inflammation, treated with first-in-class biologic Nucala® (mepolizumab) added-on to standard of care, achieved clinically and [..]