Advertisement

Topics

Latest Biotechnology, Pharmaceutical and Healthcare News from Speciality Pharma Journal

09:46 EST 21st January 2018 | BioPortfolio

Here are the most relevant search results for "Speciality Pharma Journal" found in our extensive news archives from over 250 global news sources.

More Information about Speciality Pharma Journal on BioPortfolio

In addition to our news stories we have dozens of PubMed Articles about Speciality Pharma Journal for you to read. Along with our medical data and news we also list Speciality Pharma Journal Clinical Trials, which are updated daily. BioPortfolio also has a large database of Speciality Pharma Journal Companies for you to search.

Showing News Articles 1–25 of 499 from Speciality Pharma Journal

Friday 19th January 2018

Orphazyme’s Arimoclomol Receives FDA Rare Pediatric Disease Designation for Niemann-Pick disease Type C

Copenhagen, Denmark, January 19, 2018 – Orphazyme A/S, a Danish biotech company listed on Nasdaq Copenhagen (TICKER: ORPHA.CO), with a late-stage, orphan-drug pipeline, today announced that arimoclomol has been granted rare pediatric disease designation by the US Food and Drug Administration (FDA) for the treatment of Niemann-Pick disease Type C (NPC). NPC is a genetic disease …

Merck to Present First-Time Data for Keytruda in Patients with Previously Treated Advanced Liver Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced findings from the registrational phase 2 KEYNOTE-224 trial investigating the use of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with advanced hepatocellular carcinoma (HCC), the most common type of liver cancer, who were previously treate...

QIAGEN Receives FDA Approval to Expand Use of EGFR Test in Non-Small Cell Lung Cancer

Germantown, Maryland, and Hilden, Germany, January 18, 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has approved a PMA supplement extending the indications for use of QIAGEN’s therascreen® EGFR RGQ PCR Kit as a companion diagnostic to guide the use of Boehringer Ingelheim’s targeted therapy …

Thursday 18th January 2018

MDxHealth Develops Blood Test to Guide Precision-Treatment of Castration-Resistant Prostate Cancer Patients

HERSTAL, BELGIUM and IRVINE, CA, January 18, 2018 – MDxHealth SA (“MDxHealth, or the “Company”), (Euronext: Brussels MDXH.BR), an international healthcare company, developing and offering molecular diagnostic tests to personalize the diagnosis and treatment of urologic cancer, today announced promising research results with a new liquid biopsy test in development. Data f...

OncoSec Provides Encouraging Clinical Observations Related to Triple Negative Breast Cancer Study

SAN DIEGO, Jan. 18, 2018 /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec” or the “Company”) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, today announced preliminary clinical observations related to its pilot biomarker OMS-I140 clinical trial of ImmunoPulse® IL-12 in patients with metastatic Triple Negative Breast Cancer (TNBC). The ...

Kite and Pfizer Collaborate to Evaluate Yescarta and Utomilumab in Large B-Cell Lymphoma

FOSTER CITY, Calif. & SANTA MONICA, Calif.–(BUSINESS WIRE)–Kite, a Gilead Company (Nasdaq: GILD), announced it has entered into a clinical trial collaboration with Pfizer, Inc. to evaluate the safety and efficacy of the investigational combination of Yescarta™ (axicabtagene ciloleucel) and Pfizer’s utomilumab, a fully humanized 4-1BB agonist monoclonal antibody, in patients...

Daiichi-Sankyo Presents Updated Data for DS-8201 in Patients with HER2-Expressing Gastric Cancer

TOKYO, BASKING RIDGE, N.J. and MUNICH, Jan. 18, 2018 /PRNewswire/ — Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that updated phase 1 safety and efficacy data for DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), in a subgroup of patients with HER2-expressing gastric cancer previously treated with trastuzumab and chemotherapy were presen...

FDA Approves Addition of Overall Survival Data to Kyprolis Label

THOUSAND OAKS, Calif., Jan. 17, 2018 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for KYPROLIS® (carfilzomib). Data added to the label demonstrated …

Wednesday 17th January 2018

FDA Grants Priority Review to Novartis’ Kymriah for Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Basel, January 17, 2018 – Novartis today announced that its supplemental Biologics License Application (sBLA) for KymriahTM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT) has bee...

Tuesday 16th January 2018

Merck’s Keytruda Significantly Improved Overall Survival and Progression-Free Survival in Late-Stage Lung Cancer Study

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-189 trial investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with pemetrexed (Alimta®) and cisplatin or carboplatin, for the first-line treatment of patients with metastatic non-squamous non-small cel...

Centrexion Therapeutics’ CNTX-4975 Receives Fast Track Designation from the FDA for Treatment of Knee Osteoarthritis Pain

BOSTON–(BUSINESS WIRE)–Centrexion Therapeutics Corporation, a company focused on developing non-opioid, non-steroidal therapeutics for the treatment of chronic pain, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CNTX-4975 for the treatment of pain associated with knee osteoarthritis. CNTX-4975, Centrexion’s Phase 3 ready lea...

FDA Approves New Indication for Boehringer Ingelheim’s Gilotrif in EGFR Mutation-Positive Non-Small Cell Lung Cancer

RIDGEFIELD, Conn., Jan. 16, 2018 /PRNewswire/ — Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as d...

Monday 15th January 2018

FDA Approves Teva’s Trisenox Injection for First-Line Treatment of Acute Promyelocytic Leukemia

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced that the U.S. Food and Drug Administration (FDA) has approved the use of TRISENOX® (arsenic trioxide) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17...

Friday 12th January 2018

FDA Approves AstraZeneca’s PARP Inhibitor to Treat Breast Cancer Patients with a BRCA Gene Mutation

The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast …

FDA Grants Fast Track Designation to Concert’s CTP-543 for the Treatment of Alopecia Areata

LEXINGTON, Mass.–(BUSINESS WIRE)–Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CTP-543, a novel, oral Janus kinase (JAK) inhibitor for the treatment of moderate-to-severe alopecia areata, an autoimmune disorder in which the immune system attacks hair follicles, resulting in patchy or...

OPKO’s GeneDx and Radboud Collaborate to Identify Novel Genes and Pathways to Understand Genetic Diseases

MIAMI, Jan. 12, 2018 (GLOBE NEWSWIRE) — OPKO Health, Inc. (NASDAQ:OPK), announces today that GeneDx, Inc., a subsidiary of OPKO’s BioReference Laboratories, has entered into a research collaboration with the Radboud University Medical Center, Nijmegen, Netherlands. Through the agreement, GeneDX and Radboud aim to identify novel genes and pathways to help understand the causes, clinical ...

Immunomedics Enters Agreement with University of Wisconsin to Expand Sacituzumab Govitecan into Prostate Cancer

MORRIS PLAINS, N.J., Jan. 11, 2018 (GLOBE NEWSWIRE) — Immunomedics, Inc., (NASDAQ:IMMU) (“Immunomedics” or the “Company”) today announced a collaboration with the Carbone Cancer Center at the University of Wisconsin, through Immunomedics entering an agreement with The Prostate Cancer Clinical Trials Consortium (PCCTC), to investigate Immunomedics’ lead antibody-drug conjugate (AD...

70% of Advanced Prostate Cancer Patients Treated with ProscaVax Demonstrate Improvements in PSA Doubling Time

BATON ROUGE, La., Jan. 10, 2018 (GLOBE NEWSWIRE) — OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) (“OncBioMune” or the “Company”), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, today announces the latest follow-up data from the Company’s Phase 1a trial of P...

Thursday 11th January 2018

Adimab and Boehringer Ingelheim Enter Antibody Discovery Collaboration

LEBANON, N.H.–(BUSINESS WIRE)–Adimab, LLC, the global leader in the discovery and optimization of fully human monoclonal and bispecific antibodies, today announced a multi-target partnership with Boehringer Ingelheim (BI). Under the terms of the agreement, Adimab will use its proprietary platform to discover and optimize antibodies against targets chosen by BI, who will have the rights...

Syndax and Genentech Collaborate to Evaluate Immunotherapy Combination in Metastatic Breast Cancer

WALTHAM, Mass., Jan. 10, 2018 /PRNewswire/ — Syndax Pharmaceuticals, Inc. (“Syndax,” the “Company” or “we”) (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing entinostat and SNDX-6352 in multiple cancer indications, today announced a new clinical collaboration with Genentech, a member of the Roche Group. As part of the collaboration, the...

Incorporation of Thermo Fisher QuantStudio 5 PCR Instrument into Target Selector Platform Improves Detection of Lung Cancer Biomarkers

SAN DIEGO, Jan. 9, 2018 /PRNewswire/ — Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, announces that incorporation of the Thermo Fisher QuantStudio5 (QS5) real-time PCR instrument into the Company’s Target Selector™ ctDNA...

Biohaven Announces Positive Results from Bioequivalence Study with its Amyotrophic Lateral Sclerosis Drug

NEW HAVEN, Conn., Jan. 9, 2018 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) (“Biohaven” or the “Company”) announced positive results today from its bioequivalence study with BHV-0223, an innovative sublingual formulation of riluzole. The study was designed to demonstrate pharmacokinetic equivalence of sublingual BHV-0223 compared to the ref...

Tuesday 9th January 2018

FDA Grants Breakthrough Therapy Designation to Eisai and Merck’s Kidney Cancer Combo Therapy

TOKYO and KENILWORTH, N.J., Jan. 9, 2018 /PRNewswire/ — Eisai Co., Ltd. and Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that they received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for Eisai’s multiple receptor tyrosine kinase inhibitor LENVIMA® (lenvatinib) in combination with Merck’s anti-PD-1 &#...

Monday 8th January 2018

Ablynx Rejects Novo Nordisk’s $3.1 Billion Acquisition Proposal

GHENT, Belgium, 8 January 2018 – Ablynx NV (Euronext Brussels and Nasdaq: ABLX) (“Ablynx” or the “Company”) today confirmed that on December 22, 2017 it received an unsolicited conditional proposal from Novo Nordisk A/S (CSE: NOVO B) (NYSE:NVO) (“Novo Nordisk”) to acquire all of the outstanding shares of Ablynx for €28.00 (or approximately $33.661) per …

Exelixis and StemSynergy Enter Exclusive Licensing Agreement for the Development of Novel Anticancer Therapies

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ: EXEL) today announced that it has entered into an exclusive collaboration and license agreement with StemSynergy Therapeutics, Inc., (StemSynergy) for the discovery and development of novel oncology compounds targeting Casein Kinase 1 alpha (CK1α), a component of the Wnt signaling pathway implicated in key oncogenic ...


Quick Search
Advertisement

 

News Quicklinks