Conagra shares gained 1.21 percent to $38.60 in after-hours trading. Analysts expect Nike Inc to post quarterly earnings at $0.4 per share on revenue of $8.39 billion after the closing bell. Nike shares declined 1.01 percent to close at $63.59 on Wednesday. Allergan plc reported that the FDA has accepted NDA for Seysara for treatment of moderate to
Although there are still a few days left for the year to end, 2017 has turned out to be pretty good for the pharma and biotech sector where FDA approvals are concerned. Immuno-oncology was a key focus area in 2017, whether it was to do with scientific conferences, clinical trial collaborations, acquisitions or FDA approvals. The $11.9 billion acqui
Gainers AEterna Zentaris Inc. rose 69.1 percent to $3.39 in pre-market trading after the company reported the FDA approval of Macrilen for diagnosis of adult growth hormone deficiency. Net Element International Inc rose 50.6 percent to $29.20 in the pre-market trading session following Wednesday announcement of Blockchain business unit. NXT-ID Inc.
LexinFintech priced its IPO at $9 per share. JetPay Corporation shares gained 62.5 percent to $4.305 as traders circulate a comparison article of JetPay versus BitPay. AEterna Zentaris Inc. shares jumped 44 percent to $2.89 after the company reported the FDA approval of Macrilen for diagnosis of adult growth hormone deficiency. Net Element Internat
Washington DC- 60 Degrees Pharmaceuticals announced it has submitted a New Drug Application to the United States Food and Drug Administration for the use of Tafenoquine to prevent malaria in adults traveling to areas where malaria is prevalent. Malaria, a life-threatening disease caused by Plasmodium parasites that are transmitted to people through
Survey Sampling International fielded the survey in October/ November 2017. Phil Smalley, Chief Medical Director of Wamberg Genomic Advisors has noted that in recent reports 3 the benefits of cancer genomic profiling include:. Tom Wamberg, CEO of Wamberg Genomic Advisors said, "It is encouraging to see in our recent survey the degree to which the p
-Abeona Therapeutics Inc., a leading clinical-stage biopharmaceutical company focused on developing novel gene and cell therapies for life-threatening rare diseases, announced today that the first patient in a Phase 1/ 2 clinical trial for ABO-101, a single treatment gene therapy for patients with Sanfilippo syndrome type B, has been dosed at Natio
This Management's Discussion and Analysis of Financial Conditions and Results of Operations and other portions of this report contain forward-looking information that involves risks and uncertainties. Overview Advaxis, Inc. is a late-stage biotechnology Company focused on the discovery, development and commercialization of proprietary Lm...
Aerie Pharmaceuticals` Rhopressa has secured Food and Drug Administration approval for use as an alternative to beta blockers in glaucoma patients that fail to respond adequately to prostaglandin analogues. There are 60 million cases of glaucoma worldwide, and according to the World Health Organization, glaucoma is the second leading reason why peo
AEterna Zentaris Inc. moved skyward Thursday after the company reported the FDA approval of Macrilen for diagnosis of adult growth hormone deficiency. The Company estimates that approximately 60,000 tests for suspected AGHD are being conducted each year across the United States, Canada and Europe. In the absence of an FDA- approved diagnostic te
DUBLIN, IRELAND- Allergan plc, a global biopharmaceutical company, today announced that VISTABEL has received a Positive Opinion from the Agence Nationale de Securite du Medicament et des Produits de Sante for the temporary improvement in the appearance of moderate to severe forehead lines in adults when the severity of the facial lines has an impo
WASHINGTON- Allergan plc, and Paratek Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration has accepted New Drug Application to review Seysara for moderate to severe acne vulgaris in patients 9 years of age and older. Allergan has U.S. rights to the development and commercialization of Seysara. Allergan owns the U.S. rights to
Altimmune, Inc., a clinical-stage immunotherapeutics company, today announced it has completed dosing of its HepTcell Phase 1 study in chronic hepatitis B. All doses were well tolerated, there were no hepatic flares, and no discontinuations. Additionally, the preliminary data showed evidence of dose dependent increases in cellular immune response
TRACON Pharmaceuticals, a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age related macular degeneration and fibrotic diseases, and Ambrx, Inc., today announced that they have entered into a licensing agreement for the development and commercialization o
RANCHO CUCAMONGA- Amphastar Pharmaceuticals, Inc., announced that today the U.S. Food and Drug Administration granted approval of its abbreviated new drug application for Sodium Nitroprusside Injection 25 mg/mL, 2 mL single dose vial, indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crisis.
La Jolla Pharmaceutical Company has an upcoming catalyst in the form of a Feb. 28 PDUFA date. Wainwright analyst Edward White initiated coverage of the shares of La Jolla with a Buy rating and a $62 price target. With the company having submitted the NDA for LJPC-501 a treatment candidate for vasodilatory shockm to the FDA, the PDUFA date is se
BOULDER- Array BioPharma announced today that it has entered into a clinical trial collaboration agreement with Pfizer to investigate the safety and efficacy of several novel anti-cancer combinations, including Array's MEK inhibitor, binimetinib, with Pfizer's investigational PARP inhibitor talazoparib, and avelumab, a human anti-PD-L1 IgG1...
Gary R. Pasternack, MD, PhD, Chief Executive Officer of Asklepion Pharmaceuticals, stated' This SPA confirms the ongoing collaborative discussion Asklepion has had with the Agency and we would like to thank the FDA for its invaluable guidance throughout this process. A Special Protocol Assessment from the FDA is a special procedure by which the FDA
And now, the FDA is helping the drug speed toward an approval in that population. Tagrisso has picked up the agencys priority review tag, AstraZeneca said on Thursday, based on results from the British companys phase 3 Flaura trial. Those results showed Tagrisso could cut the risk of disease progression or death in first-line, EGFR patients by 54%
The Dana-Farber Cancer Institute issued the following news release:. A targeted drug whose clinical testing was led by Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, has become a standard first-line therapy for certain newly diagnosed patients with advanced kidney cancer. The drug, cabozantinib, was approved today by the U.S. Food and Drug.
Bayer today announced that its collaboration partner Loxo Oncology, Inc., has initiated the submission of a rolling New Drug Application to the U.S. Food and Drug Administration for larotrectinib. Bayer and Loxo Oncology are jointly developing larotrectinib, an investigational compound being studied globally for the treatment of patients with cance
Beckman Coulter Diagnostics announced FDA clearance of its automated Access AMH immunoassay for in vitro diagnostic use in the U.S. This simple test aids healthcare providers in the assessment of a woman's ovarian reserve, and helps guide the clinical management of women struggling with infertility or planning to become pregnant later in life.
CAMBRIDGE, Mass.& CARLSBAD- Biogen and Ionis Pharmaceuticals, Inc. announced today that they have entered into a new collaboration agreement to identify new antisense oligonucleotide drug candidates for the treatment of spinal muscular atrophy. 'We are pleased to extend our collaboration with our valued colleagues at Ionis, which we believe complem
Biohaven Pharmaceutical Holding Company Ltd., a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, today announced that it has commenced enrollment in its Phase 2/ 3 clinical trial assessing the efficacy and safety of trigriluzole in patients with...
BioLineRx Ltd., a clinical-stage biopharmaceutical company focused on oncology and immunology, announced today initiation of the Phase 3 GENESIS clinical trial, in which BL-8040 will be compared to placebo, on top of granulocyte colony-stimulating factor, for the mobilization of hematopoietic stem cells used for autologous transplantation in multip