Biopharmaceutical News and Research

RSS

FDA approves manufacturing of Insmed's ARIKAYCE at Therapure Biopharma's Mississauga facility

Therapure Biomanufacturing, an integrated contract development and manufacturing organization and a division of Therapure Biopharma Inc., today announced approval for the manufacturing of Insmed Incorporated's ARIKAYCE® at its Mississauga facility by the U.S. Food and Drug Administration.

3 Oct 2018

Alnylam reports further progress on broadening the therapeutic potential of RNAi

Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced today further progress on the Company's platform efforts in extrahepatic delivery of novel siRNA conjugates, including central nervous system (CNS) and ocular delivery in rat and non-human primates (NHPs).

3 Oct 2018

Pfizer announces FDA approval of VIZIMPRO for first-line treatment of EGFR-mutated metastatic NSCLC

Pfizer Inc. today announced that the U.S. Food and Drug Administration has approved VIZIMPRO [vih-ZIM-pro] (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

28 Sep 2018

BHCGC consortium to play key role in NIH's large-scale effort to advance precision medicine

The Baylor College of Medicine Human Genome Sequencing Center today announced participation in the National Institutes of Health All of Us Research Program, a large-scale effort to advance precision medicine.

27 Sep 2018

FLX Bio treats first patient in its Phase 1/2 clinical trial of FLX475 for treating various advanced cancers

FLX Bio, Inc., a clinical-stage, biopharmaceutical company focused on the development of oral small-molecule drugs that target drivers of cancer and other immune-related disorders, today announced that the first patient has been treated in its Phase 1/2 clinical trial of FLX475 in patients with various advanced cancers. FLX475 is an oral, small molecule CCR4 antagonist that selectively inhibits migration of regulatory T cells into the tumor microenvironment.

27 Sep 2018

CytoSen receives favorable response from FDA to its pre-IND meeting package for CSTD002-NK

CytoSen Therapeutics, a private biopharmaceutical company accelerating innovation in Natural Killer cell therapy, today announced it has received a favorable response from the U.S. Food and Drug Administration to its pre-Investigational New Drug meeting package for the proposed Phase 2 trial of CytoSen's adoptive NK cell therapy, CSTD002-NK, for the reduction of relapse in high risk acute myeloid leukemia or myelodysplastic syndrome in patients undergoing haploidentical hematopoietic stem cell transplantation.

27 Sep 2018

Alnylam announces positive results from Phase 3 Study of givosiran for treating acute hepatic porphyria

Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced today positive topline results from the interim analysis of the ENVISION Phase 3 Study of givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 for the treatment of acute hepatic porphyria.

27 Sep 2018

Crown Bioscience announces successful validation of well-characterized prostate cancer PDX models

Crown Bioscience, a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, has announced the addition of unique, well characterized, fully annotated patient-derived xenograft models of prostate cancer.

27 Sep 2018

Gilead Sciences plans to launch authorized generic versions of Epclusa and Harvoni in the US

Gilead Sciences, Inc. announced today plans to launch authorized generic versions of Epclusa and Harvoni, Gilead's leading treatments for chronic hepatitis C virus, in the United States, through a newly created subsidiary, Asegua Therapeutics LLC.

24 Sep 2018

Lumos acquires license for LUM-201 drug that promotes secretion of growth hormone

Lumos Pharma, Inc., a clinical stage biopharmaceutical company focused on development and commercialization of therapeutics for rare and neglected diseases, today announced that it has acquired the license for LUM-201, an investigational orally administered small molecule that promotes secretion of growth hormone from the pituitary gland, from Ammonett Pharma LLC.

24 Sep 2018

Alexion announces positive results from Phase 3 PREVENT study of Soliris in patients with NMOSD

Alexion Pharmaceuticals, Inc. today announced positive topline results from the Phase 3 PREVENT study of Soliris in patients with anti-aquaporin-4 auto antibody-positive neuromyelitis optica spectrum disorder.

24 Sep 2018

FDA lifts partial clinical hold that paused enrollment of new patients in tazemetosta clinical trials

Epizyme, Inc., a clinical-stage company developing novel epigenetic therapies, today announced the U.S. Food and Drug Administration has lifted the partial clinical hold that had paused U.S.-based enrollment of new patients in its tazemetostat clinical trials.

24 Sep 2018

FARXIGA receives positive results in Phase III DECLARE-TIMI 58 cardiovascular outcomes trial

AstraZeneca today announced positive results from the Phase III DECLARE-TIMI 58 cardiovascular outcomes trial for FARXIGA, the broadest SGLT-2 inhibitor CVOT conducted to date.

24 Sep 2018

$CHMP grants positive opinion for VENCLYXTO plus rituximab for treating relapsed/refractory CLL$

CHMP grants positive opinion for VENCLYXTO plus rituximab for treating relapsed/refractory CLL

AbbVie, a research-based global biopharmaceutical company, announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion for VENCLYXTO® in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia who have received at least one prior therapy.

21 Sep 2018

CHMP provides positive opinion to Cabometyx for previously-treated patients with hepatocellular carcinoma

Ipsen announced today that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, provided a positive opinion for Cabometyx (cabozantinib) as a monotherapy for the treatment of hepatocellular carcinoma in adults who have been previously treated with sorafenib.

21 Sep 2018

Pfizer’s 20vPnC vaccine receives Breakthrough Therapy designation from FDA

Pfizer Inc. announced today that its 20-Valent Pneumococcal Conjugate Vaccine candidate, PF-06482077, received Breakthrough Therapy designation from the US Food and Drug Administration for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older. Pfizer expects to start Phase 3 trials in a few months.

20 Sep 2018

Cell Medica successfully doses first patient with CMD-501 targeting pediatric neuroblastoma

Cell Medica announces the treatment of the first patient world-wide to receive CMD-501, an autologous CAR-NKT therapy targeting pediatric neuroblastoma

20 Sep 2018

Celltrion and Emory University sign 'Incubation' agreement to develop new drug candidates for atherosclerosis

Celltrion, Inc. signed an 'Incubation' agreement with Emory University in Atlanta to support the research and development of new drug candidates for atherosclerosis.

20 Sep 2018

NIH and FDA call for eliminating involvement of RAC in human gene therapy experiments

Recently, the U.S. National Institutes of Health and Food and Drug Administration called for the eliminating involvement of the Recombinant DNA Advisory Committee in human gene therapy experiments, marking the end of an era of federal government oversight

20 Sep 2018

PAREXEL partners with Datavant to enhance clinical study design and generate real-world evidence

PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, and Datavant, Inc., a healthcare technology company focused on enabling the secure de-identification and linking of healthcare datasets, today announced they are partnering to enhance clinical study design and operations, as well as the generation of real-world evidence.

18 Sep 2018

Biopharmaceutical News and Research

FDA approves manufacturing of Insmed's ARIKAYCE at Therapure Biopharma's Mississauga facility

Alnylam reports further progress on broadening the therapeutic potential of RNAi

Pfizer announces FDA approval of VIZIMPRO for first-line treatment of EGFR-mutated metastatic NSCLC

BHCGC consortium to play key role in NIH's large-scale effort to advance precision medicine

FLX Bio treats first patient in its Phase 1/2 clinical trial of FLX475 for treating various advanced cancers

CytoSen receives favorable response from FDA to its pre-IND meeting package for CSTD002-NK

Alnylam announces positive results from Phase 3 Study of givosiran for treating acute hepatic porphyria

Crown Bioscience announces successful validation of well-characterized prostate cancer PDX models

Gilead Sciences plans to launch authorized generic versions of Epclusa and Harvoni in the US

Lumos acquires license for LUM-201 drug that promotes secretion of growth hormone

Alexion announces positive results from Phase 3 PREVENT study of Soliris in patients with NMOSD

FDA lifts partial clinical hold that paused enrollment of new patients in tazemetosta clinical trials

FARXIGA receives positive results in Phase III DECLARE-TIMI 58 cardiovascular outcomes trial

CHMP grants positive opinion for VENCLYXTO plus rituximab for treating relapsed/refractory CLL

CHMP provides positive opinion to Cabometyx for previously-treated patients with hepatocellular carcinoma

Pfizer’s 20vPnC vaccine receives Breakthrough Therapy designation from FDA

Cell Medica successfully doses first patient with CMD-501 targeting pediatric neuroblastoma

Celltrion and Emory University sign 'Incubation' agreement to develop new drug candidates for atherosclerosis

NIH and FDA call for eliminating involvement of RAC in human gene therapy experiments

PAREXEL partners with Datavant to enhance clinical study design and generate real-world evidence

Free eBook - From lab to market: Accelerate your bioprocessing journey eBook

Advancing Neuroscience Research Through Collaboration and Patient-Centered Innovation

The impact of vibration on microscopy

How Omics Technologies Are Transforming Biological Research and Drug Discovery

Latest News