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Latest Biotechnology, Pharmaceutical and Healthcare News from Speciality Pharma Journal

07:56 EDT 23rd September 2018 | BioPortfolio

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Showing News Articles 1–25 of 438 from Speciality Pharma Journal

Friday 21st September 2018

Medtronic to Acquire Mazor Robotics in $1.64 Billion Deal

DUBLIN and CAESAREA, Israel – September 20, 2018 – Medtronic plc (NYSE:MDT), a global leader in medical technology, and Mazor Robotics (NASDAQ:MZOR, TASE:MZOR.TZ), a pioneer in the field of robotic guidance systems, today announced the companies have entered into a definitive merger agreement under which Medtronic will acquire all outstanding ordinary shares of Mazor for $58.50 …...

Amicus Acquires Gene Therapy Portfolio of Ten AAV Programs in Neurologic Lysosomal Storage Disorders

CRANBURY, N.J., Sept. 20, 2018 (GLOBE NEWSWIRE) — Amicus Therapeutics (Nasdaq: FOLD) today announced the signing of a definitive agreement in which Amicus Therapeuticswill receive worldwide development and commercial rights for ten gene therapy programs developed at The Center for Gene Therapy at The Research Institute at Nationwide Children’s Hospital and The Ohio State Universi...

St. Jude Children’s Research Hospital and Tessa Therapeutics Collaborate to Develop Novel Therapies for Brain Cancer

MEMPHIS, Tenn. and SINGAPORE, Sept. 20, 2018 /PRNewswire/ — St. Jude Children’s Research Hospital (St. Jude), the U.S. hospital leading the way the world understands, treats and cures childhood cancer and other life-threatening diseases, together with Tessa Therapeutics (Tessa), a clinical stage biopharmaceutical company, today announced the establishment of a strategic collaboration f...

Celgene Drops Option to License OncoMed’s Bispecific Antibody Navicixizumab

REDWOOD CITY, Calif., Sept. 20, 2018 (GLOBE NEWSWIRE) — OncoMed Pharmaceuticals Inc. (NASDAQ: OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, today announced that Celgene has notified OncoMed that due to strategic product portfolio considerations Celgene has decided not to exercise its option to license OncoMed’s b...

FDA Grants Breakthrough Therapy Designation to Pfizer’s 20-Valent Pneumococcal Conjugate Vaccine for the Prevention of Invasive Disease and Pneumonia

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482077, received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older.2 Pf...

Molecular Templates and Takeda Enter Agreement for the Joint Development of a Protein-Based Oncology Therapy

AUSTIN, Texas, Sept. 19, 2018 (GLOBE NEWSWIRE) — Molecular Templates, Inc. (Nasdaq:MTEM) today announced an agreement with Takeda Pharmaceutical Company Limited (Takeda) for the joint development of CD38-targeted engineered toxin bodies (ETBs) for the treatment of patients with diseases such as multiple myeloma. The lead development candidate is a CD38-targeted ETB that resulted from a pre...

Catabasis to Present New Edasalonexent Clinical Results and Phase 3 Trial Design in Duchenne Muscular Dystrophy

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, today announced that the Company will share three presentations, including in the late breaking session, at the 23rd International Congress of the World Muscle Society, being held October 2 – 6, 2018, at the Intercontinental Hotel in Mendoza, Argentina. Presen...

Wednesday 19th September 2018

Pfizer Presents New Analyses from the Tafamidis Phase 3 Transthyretin Amyloid Cardiomyopathy Study

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that additional sensitivity and post-hoc analyses from the Tafamidis Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-ACT) study provide further detail on the effect of tafamidis across wild-type, hereditary, and New York Heart Association (NYHA) class sub-groups of patients with transthyretin amyloid cardiomyopathy (ATT...

Janssen Submits Application to FDA for Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer

HORSHAM, Pa., Sept. 18, 2018  — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of erdafitinib for the treatment of patients with locally advanced or metastatic urothelial cancer (UC) and certain fibroblast growth factor receptor (FGFR) …

LEO Pharma and MorphoSys Expand Strategic Alliance to Develop Peptide-derived Therapeutics

BALLERUP, Denmark & MARTINSRIED/MUNICH, Germany–(BUSINESS WIRE)–LEO Pharma A/S, a global leader in medical dermatology, and MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; NASDAQ: MOR) today announced an expansion of their existing strategic alliance to include peptide-derived therapeutics. The objective of the alliance is to identify novel, peptide-derived therapeutics for...

FDA Grants Rare Pediatric Disease Designation to Cellectar’s Investigational Treatment for Osteosarcoma

MADISON, Wis., Sept. 17, 2018 (GLOBE NEWSWIRE) — Cellectar Biosciences, Inc. (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, announces today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to CLR 131 for the treatment of …

Theravance Biopharma and Mylan Report New Data from Phase 3 Studies of Yupelri in COPD

DUBLIN and HERTFORDSHIRE, England and PITTSBURGH, Sept. 17, 2018 /PRNewswire/ — Theravance Biopharma, Inc. (NASDAQ :TBPH ) (“Theravance Biopharma”) and Mylan N.V. (NASDAQ :MYL ) (“Mylan”) today announced that positive new data from the companies’ Phase 3 clinical program for YUPELRI™ (revefenacin) inhalation solution were featured in an oral presentation at th...

Actelion’s Opsumit Significantly Improved Pulmonary Vascular Resistance in First Trial in Portopulmonary Hypertension

ALLSCHWIL, Switzerland–(BUSINESS WIRE)–Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has announced the results of the first randomized controlled trial in portopulmonary hypertension (PoPH), which showed OPSUMIT® (macitentan) significantly improved pulmonary vascular resistance (PVR) compared with placebo, meeting the primary endp...

Clinical Trial Data for Nintedanib in Patients with Advanced Idiopathic Pulmonary Fibrosis Published

Ingelheim, Germany, 16 September 2018 – Results from the INSTAGE® trial have been presented at the 2018 European Respiratory Society (ERS) conference in Paris and published in the New England Journal of Medicine.1 The trial reports clinical data on a subset of patients with IPF and severe impairment in gas exchange, for whom only limited data exist. Data suggest …

Pfizer Presents Positive Phase 2 Data in Alopecia Areata During Late-Breaker Session at the EADV Congress

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced results from its Phase 2a study of PF-06651600, an oral Janus kinase (JAK) 3 inhibitor, and PF-06700841, a tyrosine kinase (TYK) 2/JAK1 inhibitor, compared to placebo, in patients with moderate to severe alopecia areata (AA), an autoimmune disease characterized by hair loss and often associated with profound psychological ...

FDA Approves Teva’s Ajovy Injection for the Prevention and Treatment of Migraine in Adults

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved AJOVYTM (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults. AJOVY, a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the recept...

Friday 14th September 2018

Supernus Gains Epilepsy Drug through Acquisition of Biscayne Neurotherapeutics

ROCKVILLE, Md., Sept. 13, 2018 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that it entered into a merger agreement to acquire Biscayne Neurotherapeutics (Biscayne), a privately-held company developing a novel treatmen...

Thursday 13th September 2018

FDA Approves Lumoxiti for the Treatment of Certain Patients with Relapsed or Refractory Hairy Cell Leukemia

AstraZeneca and MedImmune, its global biologics research and development arm, announced today that the US Food and Drug Administration (FDA) has approved Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxi...

Natera and Bristol-Myers Squibb Partner to Investigate Signatera ctDNA Assay as a Potential Biomarker for Opdivo in a NSCLC Clinical Trial

SAN CARLOS, Calif., Sept. 13, 2018 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced an agreement with Bristol-Myers Squibb to use Natera’s Signatera™ custom circulating tumor DNA (ctDNA) assay in a Phase 2 study in the adjuvant non-small cell lung cancer (NSCLC) setting. The study will use the Signatera ctDNA assay to …

FDA Grants Fast Track Designation to ArQule’s Miransertib for the Treatment of PIK3CA-Related Overgrowth Spectrum

BURLINGTON, Mass.–(BUSINESS WIRE)–ArQule, Inc. (Nasdaq: ARQL) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to miransertib (ARQ 092) for the treatment of PIK3CA-Related Overgrowth Spectrum (PROS), a group of related, ultra-rare genetic disorders characterized by excessive tissue growth in various parts of the body. The FDA’s Fast ...

FDA to Review Regeneron’s sBLA of Eylea Injection for the Treatment of Diabetic Retinopathy

TARRYTOWN, N.Y., Sept. 13, 2018 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.(NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) of EYLEA®(aflibercept) Injection for the treatment of diabetic retinopathy (DR), the leading cause of vision loss for patients with diabetes. The target ...

Patient-Reported Outcomes Data from Three Phase 3 Studies of Risankizumab Show Significant Improvements in Health-Related Quality of Life for Psoriasis Patients

NORTH CHICAGO, Ill., Sept. 13, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new patient-reported outcomes data from three pivotal Phase 3 trials evaluating risankizumab, an investigational interleukin-23 (IL-23) inhibitor, in adult patients with moderate to severe plaque psoriasis. Across all three trials, patients reported si...

Boehringer Ingelheim Acquires All Shares of ViraTherapeutics to Develop Next Generation Viral-Based Immuno-Oncology Therapies

INGELHEIM, Germany–(BUSINESS WIRE)–Boehringer Ingelheim today announced that it has acquired all shares of ViraTherapeutics, a biopharmaceutical company specializing in the development of oncolytic viral therapies. ViraTherapeutics developed the lead candidate VSV-GP (Vesicular Stomatitis Virus (VSV) with modified glycoprotein (GP)), which is being investigated alone and in combination...

Novartis Announces Publication of Landmark Study Demonstrating Significant Benefit of Gilenya in Children and Adolescents with MS

Basel, September 12, 2018 – Novartis today announced that The New England Journal of Medicine (NEJM) has published full results from the landmark Phase III Gilenya® (fingolimod) PARADIGMS study, the first-ever controlled, randomized study specifically designed for children and adolescents (aged 10 to 17) with relapsing forms of MS (RMS). Children and adolescents with MS experience mor...

Wednesday 12th September 2018

Gilead and Precision BioSciences Collaborate to Develop Therapies Against Hepatitis B Virus Using ARCUS Genome Editing

FOSTER CITY, Calif. & DURHAM, N.C.–(BUSINESS WIRE)–Gilead Sciences (Nasdaq: GILD) and Precision BioSciences announced today that the companies have entered into a strategic collaboration to develop therapies targeting the in vivo elimination of hepatitis B virus (HBV) with Precision’s proprietary genome editing platform, ARCUS. An estimated 257 million people are living with HB...


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