NEWS

Roche’s Perjeta® Regimen For Breast Cancer Found to Greatly Extend Patients’ Lives: Phase III APHINITY study By: Basel Roche News Perjeta plus Herceptin and chemotherapy showed a statistically significant improvement in invasive disease-free survival (iDFS) for people with HER2-positive early breast cancer (eBC) compared to Herceptin and chemotherapy alone Data will be discussed with [..]

FDA Clears Test to Help Manage Antibiotic Treatment For Lower Respiratory Tract Infections And Sepsis Source: BioMérieux NEWS March 1, 2017 bioMérieux, a world leader in the field of in vitro diagnostics, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded use of VIDAS® B•R•A•H•M•S [..]

FDA Approved Marketing of for the Accelerate Pheno™ System and Accelerate PhenoTest™ BC Kit Source: Accelerate Diagnostic, Inc. March 1, 2017 Accelerate Diagnostics, Inc. (Accelerate) today announced that the U.S. Food and Drug Administration has granted the de novo request to market the Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit for [..]

Phase II study supports potential for Roche’s TECENTRIQ (atezolizumab) plus Avastin (bevacizumab) for local, advanced or metastatic renal cell carcinoma Study results also showed encouraging efficacy compared to sunitinib in those people whose disease expressed the PD-L1 (programmed death-ligand 1) protein Roche is evaluating TECENTRIQ plus Avastin in a Phase [..]

FDA Approves Drug to Treat Duchenne Muscular Dystrophy By: Marathon Pharma News February 9, 2017 Marathon Pharmaceuticals, LLC (Marathon), a U.S. research-based biopharmaceutical company focused solely on the development of new treatments for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of EMFLAZA™ (deflazacort) [..]

FDA permits marketing of first newborn screening system for detection of four, rare metabolic disorders By: FDA News February 4, 2017 The U.S. Food and Drug Administration permitted marketing of the Seeker System for the screening of four, rare Lysosomal Storage Disorders (LSDs) in newborns. The Seeker system is designed [..]

Novartis drug Votubia® receives EU approval to treat refractory partial-onset seizures in patients with TSC Approval addresses unmet need as up to 60% of patients with TSC suffering from seizures become unresponsive to available anti-epileptic therapies[1]   Decision marks the third TSC-related indication for Votubia in the EU, where it [..]

FDA Grants Priority Review For Genentech’s Actemra® (Tocilizumab) For Giant Cell Arteritis There have been no new therapies for GCA in more than 50 years Breakthrough Therapy Designation was granted to Actemra for the treatment of GCA by the FDA in 2016 January 24, 2017 Genentech, a member of the [..]

FDA approval to Trulance of Synergy Pharmaceuticals : for Chronic Idiopathic Constipation By: News Synergy Pharmaceuticals January 20, 2017 Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) announced today that the U.S. Food and Drug Administration (FDA) has approved TRULANCE™ (plecanatide) for the treatment of adults with chronic idiopathic constipation (CIC). TRULANCE is the first drug designed [..]

FDA grants Roche’s cancer immunotherapy TECENTRIQ (atezolizumab) Priority Review in additional type of advanced bladder cancer TECENTRIQ being evaluated as first-line treatment option for people not eligible for cisplatin chemotherapy Second Priority Review granted for TECENTRIQ in advanced bladder cancer  From Roche News 18 January 2017 Roche (SIX: RO, ROG; [..]

FDA Approves Genentech’s Lucentis® (Ranibizumab Injection) for Myopic Choroidal Neovascularization Myopic CNV is a complication of severe near-sightedness and most commonly affects people between ages 45 and 64 Granted Priority Review by the FDA Fifth FDA-approved indication for Lucentis since its launch in 2006 By: Genentech News January 18, 2017 [..]

New Powerful Method Towards The Development of Kinase Inhibitors Eric Bender | MIT Industrial Liaison Program January 18, 2017 “Kinase inhibitor” drugs, which target a class of enzymes that are crucial to keep cells running, make up one of the great success stories of modern medicine. “When kinase proteins go wrong, [..]

Novartis invests in next generation therapies to reduce cardiovascular risk in patients with underlying lipid disorders Novartis enters into an exclusive option agreement with Ionis and Akcea to license two investigational treatments expected to significantly reduce cardiovascular risk in patients living with elevated levels of lipoprotein Lp(a) or ApoCIII, which [..]

Pfizer Announces Positive Top-Line Results from the Comparative REFLECTIONS B538-02 Study for PF-06410293, a Potential Biosimilar to Humira®1 (adalimumab) January 9, 2017  Pfizer Inc. (NYSE:PFE) announced that the comparative, confirmatory REFLECTIONS B538-02 study met its primary objective by demonstrating equivalent efficacy as measured by the American College of Rheumatology 20 [..]

New Computational Model to Understand Inhibitory Neurons By: Larry Hardesty | MIT News Office January 9, 2017 Researchers at MIT’s Computer Science and Artificial Intelligence Laboratory have developed a new computational model of a neural circuit in the brain, which could shed light on the biological role of inhibitory neurons [..]

First Drug for Spinal Muscular Atrophy, SPINRAZA™ (nusinersen), Approved by FDA January 1, 2017 The U.S. Food and Drug Administration (FDA) approved Biogen’s (NASDAQ: BIIB) SPINRAZA™ (nusinersen) under Priority Review for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. SPINRAZA is the first and only treatment approved in [..]

New Oral Drug, Selumetinib Demonstrates Shrinkage in Pediatric Neural Tumors in Early-Phase Trial  January 1, 2017 By: NIH News In an early-phase clinical trial of a new oral drug, selumetinib, children with the common genetic disorder neurofibromatosis type 1 (NF1) and plexiform neurofibromas, tumors of the peripheral nerves, tolerated selumetinib and, [..]

Pfizer Completes Acquisition of Small Molecule Anti-Infective Business From AstraZeneca December 23, 2016 Pfizer Inc. (NYSE:PFE) today announced that it has completed the acquisition of the development and commercialization rights to AstraZeneca’s late-stage small molecule anti-infective business, primarily outside the United States. The agreement includes the commercialization and development rights [..]

Final Trial Results Confirm Ebola Vaccine Provides High Protection Against Disease WHO News | GENEVA 23 DECEMBER 2016 An experimental Ebola vaccine was highly protective against the deadly virus in a major trial in Guinea, according to results published today in The Lancet. The vaccine is the first to prevent [..]

FDA Accepts Supplemental New Drug Application for Pfizer’s IBRANCE® (palbociclib) in HR+, HER2- Metastatic Breast Cancer December 22, 2016   Pfizer Inc. (NYSE:PFE) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for its first-in-class CDK 4/6 inhibitor, IBRANCE® (palbociclib). The [..]

Microbiotica: Sangar Institute Spin-out; Will Get £8m Funding From Cambridge Innovation Capital plc and IP Group plc By : Media Team Sangar Institute December 21, 2016 Cambridge Innovation Capital plc (CIC), a Cambridge-based investor in technology and healthcare companies, and IP Group plc, the developer of intellectual property-based businesses, announce the creation [..]

FDA Approved Rubraca™ (Rucaparib) of Clovis Oncology For the Treatment of Advanced Ovarian Cancer due to BRCA Mutations December 20, 2016 Rubraca received approval under the FDA’s accelerated approval program based on objective response rate and duration of response Most common Grade 3-4 adverse reaction was anemia; most common Grade 3-4 laboratory [..]

  Pfizer Receives Approval in the European Union for Nimenrix™ (Meningococcal Group A, C, W-135, and Y Conjugate Vaccine) in Infants Six Weeks of Age and Older Pfizer NEWS December 20, 2016 Pfizer Inc. (NYSE:PFE) announced that the European Commission (EC) has approved an expanded indication for Nimenrix™ (meningococcal group [..]

FDA Clears Integration Between LifeScan’s OneTouch Verio Flex® Blood Glucose Monitoring System and WellDoc’s BlueStar® Diabetes Management Platform J&J News December 17, 2016 LifeScan, Inc., part of the Johnson & Johnson Diabetes Care Companies and a world leader in blood glucose monitoring, today announced the U.S. Food and Drug Administration (FDA) [..]

Novartis receives positive CHMP recommendation for Ilaris® to treat rare diseases in adults and children called Periodic Fever Syndromes Ilaris® (canakinumab) is recommended for approval in Europe for the treatment of three Periodic Fever Syndromes: TRAPS, HIDS/MKD and FMF disease   If approved, Ilaris will be the first and only [..]

Novartis bolsters innovative dermatology portfolio through acquisition of Ziarco Group Limited   Investigational ZPL389 showed a clinically and statistically significant improvement of eczema lesions, leading to a 50% reduction in EASI score compared to placebo after eight weeks of treatment with a favorable safety profile   Eczema is a chronic, [..]

FDA Approves Removal Of Boxed Warning Regarding Serious Neuropsychiatric Events From CHANTIX® (varenicline) Labeling Labeling Revisions Also Include Updates to Corresponding Warning and Addition of Clinical Data on Superior Efficacy of CHANTIX Compared to Bupropion or Nicotine Patch1 Labeling Revisions May Further Encourage Smokers and Healthcare Providers to Discuss Smoking [..]

KEYTRUDA® (pembrolizumab) Demonstrated Improved Health-Related Quality of Life Compared to Chemotherapy in First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) Findings Presented in Plenary Session at 17 th World Conference on Lung Cancer December 16, 2016 Merck (NYSE:MRK), known as MSD outside the United States and Canada, [..]

FDA Approves MACI for the Treatment of Symptomatic Cartilage Defects of the Knee in Adults December 16, 2016  (GLOBE NEWSWIRE) Vericel Corporation (NASDAQ:VCEL), a leading developer of expanded autologous cell therapies for the treatment of patients with serious diseases and conditions, today announced that the U.S. Food and Drug Administration [..]

MIT Energy Initiative report provides guidance for evolving electric power sector Emily Dahl | MIT Energy Initiative December 16, 2016 Distributed energy resources — relatively small-scale power technologies such as solar, wind, energy storage, and power electronics and control devices — are being deployed rapidly in the global shift toward [..]