Specialty Pharma Journal

Blueprint Medicines Submits NDA to the FDA for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST

CAMBRIDGE, Mass., June 14, 2019 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC),…
Updated Efficacy Data from GBT’s Phase 3 Study Show Statistically Significant and Sustained Improvements in Hemoglobin with Voxelotor

AMSTERDAM, The Netherlands, June 14, 2019 (GLOBE NEWSWIRE) — Global Blood Therapeutics, Inc. (…
Janssen Reports Top-Line Phase 3 Results for Tremfya in Adults with Active Psoriatic Arthritis

HORSHAM, Pa.–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies of Johnson & Johns…
Bristol-Myers Squibb Announces Empliciti-Based Combination Showed Improvements Across All Efficacy Endpoints in Phase 2 Trial in Multiple Myeloma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced…
Enanta’s EDP-938 Achieved its Primary and Secondary Endpoints in Phase 2a Human Challenge Study in Healthy Adults with Respiratory Syncytial Virus

WATERTOWN, Mass.–(BUSINESS WIRE)–Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research …

The 2017 Hepatitis C Treatment Landscape

February 22, 2017 Blog

Last year, 2016, brought a whirlwind of changes and progress to the hepatitis C field, …
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Understanding the Hepatitis C Testing Process

February 15, 2017 Blog
Potential New Medication for Lymphoma

February 8, 2017 Blog

Apellis’ APL-2 Receives Fast Track Designation from the FDA for the Treatment of Paroxysmal Nocturnal Hemoglobinuria

February 12, 2019 FDA News, Rare Diseases

WALTHAM Mass., and CRESTWOOD, Ky., Feb. 11, 2019 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals Inc., (Nasdaq:APLS) a clinical-stage …

FDA Grants Clementia’s Palovarotene Rare Pediatric Disease Designation for Fibrodysplasia Ossificans Progressiva

February 12, 2019 FDA News, Rare Diseases

MONTREAL, Feb. 11, 2019 (GLOBE NEWSWIRE) — Clementia Pharmaceuticals Inc. (Nasdaq: CMTA), a clinical-stage biopharmaceutical …

UniQure Announces Updated Clinical Data from Phase IIb Study of AMT-061 in Patients with Hemophilia B

February 8, 2019 Hemophilia

LEXINGTON, Mass. and AMSTERDAM, The Netherlands, Feb. 08, 2019 (GLOBE NEWSWIRE) — uniQure N.V. (NASDAQ: QURE), a …

BioMarin’s Ongoing Study of Brineura Demonstrates Durable Treatment Benefit in Patients with CLN2 Disease

February 8, 2019 Rare Diseases

SAN RAFAEL, Calif., Feb. 7, 2019 /PRNewswire/ — BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that an ongoing …

FDA Approves Grifols’ Procleix Babesia Assay for Donor Screening on Procleix Panther System

February 8, 2019 FDA News, Technology & Devices

BARCELONA, Spain, Feb. 7, 2019 /PRNewswire/ — Grifols, a leading global producer of plasma-derived medicines …

Sangamo Announces Interim Results Of Phase 1/2 Study of SB-913 Showing Preliminary Evidence Of In Vivo Genome Editing In Patients With MPS II

February 8, 2019 Rare Diseases

BRISBANE, Calif., Feb. 7, 2019 /PRNewswire/ — Sangamo Therapeutics, Inc. (NASDAQ: SGMO) today reported preliminary molecular and enzymatic evidence …

Solid Biosciences Announces Preliminary SGT-001 Data and Intention to Dose Escalate in IGNITE DMD Clinical Trial for Duchenne Muscular Dystrophy

February 7, 2019 Rare Diseases

CAMBRIDGE, Mass., Feb. 07, 2019 (GLOBE NEWSWIRE) — Solid Biosciences (Nasdaq: SLDB) announced today preliminary …

TamRx Launches to Develop Pipeline of Immuno-Oncology Products for Treatment of Cancers

February 7, 2019 Business News, Oncology

CLEVELAND–(BUSINESS WIRE)–BioMotiv, a drug development accelerator associated with The Harrington Project for Discovery & Development, and …

Evotec and Galapagos Enter Collaboration Focused on a Novel Target in the Field of Fibrosis

February 7, 2019 Business News

Mechelen, Belgium, and Hamburg, Germany; 7 February 2019, 7.30 CET – Evotec AG (Frankfurt Stock …

FDA Extends Review Period for Incyte’s Jakafi in Acute Graft-Versus-Host Disease

February 7, 2019 FDA News

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte (Nasdaq:INCY)announced today that the U.S. Food and Drug Administration (FDA) has extended …

Newly Published Study Shows DecisionDx-Melanoma Prognostic Test Accurately Identified Risk for Patients with Melanoma of the Head and Neck

February 7, 2019 Oncology, Technology & Devices

FRIENDSWOOD, Texas–(BUSINESS WIRE)–Castle Biosciences, Inc., a skin cancer diagnostics company providing personalized genomic information to …

Sanofi Announces FDA Approval of Cablivi, the First Nanobody-Based Medicine for Patients with a Rare Blood-Clotting Disorder

February 7, 2019 Autoimmune Disorders, FDA News, Rare Diseases

PARIS – February 6, 2019 – The U.S. Food and Drug Administration (FDA) has approved Cablivi® (caplacizumab-yhdp) …

Data from Alnylam’s Phase 1 Trial of Givosiran Published in The New England Journal of Medicine

February 7, 2019 Rare Diseases

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that results …

Takeda Announces Results from IIIb/IV Trial – a Randomized PK-Guided Prophylaxis Study Evaluating Higher Factor VIII Levels in Hemophilia A

February 6, 2019 Hemophilia

CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”), the global biotechnology leader …

Ampio Updates Status of Osteoarthritis Pivotal Clinical Trial of Ampion to be Carried Out Under a Special Protocol Assessment

February 6, 2019 FDA News, Osteoarthritis

ENGLEWOOD, Colo., Feb. 6, 2019 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced …

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