Allergan’s ANDA product is a generic version of Celgene’s Abraxane®, which is indicated for the treatment of metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy; locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy; and metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. read more
A House of Delegates Adopt Policy to Guide Labeling and Measurement of Oral Liquid Medications
APhA Policy Supports Center for Disease Control and Prevention Initiative
WASHINGTON, DC – The American Pharmacists Association (APhA) House of Delegates voted to adopt new policy on the labeling and measurement of oral liquid medications at the recently completed APhA Annual Meeting in Baltimore Maryland. More than 300 delegates voted on the policy, which would support moving away from outdated dosing cups and teaspoons in favor of oral syringes and cups that measure only in the metric system (milliliter –mL) as the standard for prescribing and measuring all oral liquid medications read more
Medtronic Proposes Proxy Access
Medtronic plc (NYSE: MDT) will put forth a board proposal supporting the adoption of proxy access in its 2016 proxy statement. Proxy access would allow long-term shareholders the ability to nominate their own director candidates for election to the Board of Directors and have such director candi
dates included on the company’s proxy card, along with any candidates nominated by the Board of Directors. read more
Eagle Pharmaceuticals Receives Complete Response Letter from FDA on KANGIO (RTU bivalirudin) Application
Eagle Pharmaceuticals, Inc. (NASDAQ: EGRX) (“Eagle” or the “Company”) today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its KANGIO™ (bivalirudin injection), 505(b)(2) New Drug Application for a ready-to-use (“RTU”), stable liquid intravenous formulation of 5 mg/mL bivalirudin in a 50-mL vial intended for use as an anticoagulant in patients: (1) undergoing percutaneous coronary intervention (“PCI”) with use of glycoprotein IIb/IIIa inhibitor, (2) undergoing PCI with, or at risk of, heparin-induced thrombocytopenia (“HIT”) and thrombosis syndrome (“HITTS”), and/or (3) with unstable angina undergoing percutaneous transluminal coronary angioplasty (“PTCA”). read more
Merz Announces European Approval of Bocouture for the Treatment of Upper Facial Lines
Merz Pharma Group today announced that Bocouture® has been approved by European regulatory authorities for the treatment of upper facial lines, including horizontal frown lines, lateral periorbital lines and glabellar frown lines. Bocouture is the only neurotoxin approved in Europe* for this combined upper facial lines indication. read more
PixarBio Corporation Announces USFDA OPD Submission of NeuroRelease SCI for Orphan Drug Designation for Spinal Cord Injury
CAMBRIDGE, Mass.–(BUSINESS WIRE)–PixarBio Corporation today announced that it has filed an application with the US FDA Office of Orphan Products Development, for orphan drug status of our NeuroRelease SCI (NR-SCI) a novel drug candidate for the treatment of Spinal Cord Injury (SCI). read more
AXON Presented Its Tau Vaccine in Two Presentations at 14 AAT Conference
ATHENS, Greece–(BUSINESS WIRE)–AXON Neuroscience presented two topics from its disease modifying AD program at the 14th International Athens/Springfield Symposium on Advances in Alzheimer Therapy. In the first presentation Axon introduced the endpoints and the design of the phase II clinical trial with the first active tau vaccine, AADvac1, in patients with mild Alzheimer’s disease. In the second presentation, AXON presented the immunology profile of AADvac1 from the successful Phase I study which was performed in Austria with 30 patients at 4 clinical sites read more
The Myriad myRisk® Hereditary Cancer Test Identifies 60 Percent More Deleterious Mutations in Patients with Endometrial Cancer /New Data Presented at the Society for Gynecologic Oncology Annual Meeting
— Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced it will present two important new studies at the 2016 Society for Gynecologic Oncology annual meeting in San Diego, Calif.
The data demonstrate the ability of the myRisk® Hereditary Cancer test to identify deleterious mutations in patients with endometrial cancer. Additionally, a different study showed the superior ability of the combined three biomarker myChoice® HRD test to predict survival in patients with platinum treated ovarian cancer.
“Endometrial cancer is the most frequent gynecologic cancer and a significant number of these cases are due to mutations in hereditary cancer genes,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. “Our new data show that gene panel testing can identify many more patients with harmful mutations than testing Lynch Syndrome genes alone. The additional information provided by the myRisk Hereditary Cancer test will help physicians optimize care for their patients.”
Details about the featured Myriad presentations at SGO are below. Follow Myriad on Twitter via @MyriadGenetics and stay up-to-date with the meeting by using the hashtag #SGOMtg.
STELARA® (ustekinumab) Induced Clinical Response and Remission in Phase 3 Study for the Treatment of Patients with Moderate to Severe Crohn’s Disease Who Had Previously Failed or Were Intolerant to Anti-TNF-Alpha Therapy
Efficacy and safety results from second Phase 3 Induction Study (UNITI-1) in patients refractory to TNF Inhibitors, presented at the 11th European Crohn‘s and Colitis Organisation Congress
Phase 3 data presented at the 11th Congress of the European Crohn’s and Colitis Organisation (ECCO) showed that treatment with STELARA® (ustekinumab) induced clinical response and clinical remission in adult patients with moderate to severe Crohn’s disease who had previously failed or were intolerant to one or more anti-tumour necrosis factor (TNF)-alpha therapies (anti-TNF failure population). These data are important because there are relatively few treatment options available for patients who are refractory to TNF inhibitors.
PRNewswire/ — The Food and Drug Administration (FDA) Office of New Drugs (OND) today notified Fabre-Kramer Pharmaceuticals (Fabre-Kramer) that it has granted its appeal pursuant to the agency’s Formal Dispute Resolution (FDR) process and concluded that Travivo™ demonstrates substantial evidence of effectiveness in the treatment of Major Depressive Disorder (MDD). This decision overturns FDA’s previous position reached at a lower level and clears the path toward approval for Travivo, an antidepressant with a unique mechanism of action and a favorable side effect profile. read more
To accelerate the execution of Capio’s strategy – Modern Medicine and Modern Management, the company has strengthened its focus and organization of the Group Management, effective March 18, 2016.