Biopharmaceutical News and Research

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Research finds physical connection between the brain's fluid reservoirs and meningeal lymphatics

PureTech Health plc, an advanced biopharmaceutical company developing novel medicines for dysfunctions of the Brain-Immune-Gut Axis, today notes the publication of research in Nature Neuroscience that identifies the physical connection between the brain's fluid reservoirs and the meningeal lymphatics, through which immune cells traffic out of the central nervous system.

18 Sep 2018

LEO Pharma and MorphoSys announce expansion of strategic alliance to develop peptide-derived drugs

LEO Pharma A/S, a global leader in medical dermatology, and MorphoSys AG today announced an expansion of their existing strategic alliance to include peptide-derived therapeutics.

18 Sep 2018

Lymphatic vessels surrounding the brain play crucial role in multiple sclerosis, research suggests

Lymphatic vessels that clean the brain of harmful material play a crucial role in the development and progression of multiple sclerosis, new research from the University of Virginia School of Medicine suggests.

18 Sep 2018

FDA approves new treatment for people with hairy cell leukemia

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

14 Sep 2018

PAREXEL launches Patient Innovation Center to improve drug development process

PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, today announced the launch of its Patient Innovation Center.

From Parexel 12 Sep 2018

Verastem doses first patient in Phase I/II clinical trial of duvelisib in combination with venetoclax

Verastem, Inc., operating as Verastem Oncology, a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced dosing of the first patient in a multicenter Phase I/II clinical trial at the Dana-Farber/Harvard Cancer Center of duvelisib in combination with venetoclax in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

6 Sep 2018

BeiGene collaborates with SpringWorks to evaluate new combinational therapy for solid tumors

BeiGene, Ltd., a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, and SpringWorks Therapeutics, a clinical-stage rare disease and oncology company focused on sourcing and developing innovative treatments for underserved patient populations, announced today that the companies have entered into a global clinical collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of combining BeiGene's investigational RAF dimer inhibitor, lifirafenib and SpringWorks Therapeutics' investigational MEK inhibitor, PD-0325901, in patients with advanced solid tumors.

6 Sep 2018

Sartorius Stedim Biotech and Repligen collaborate to create novel perfusion-enabled bioreactors

Sartorius Stedim Biotech, a leading international supplier for the biopharmaceutical industry, and Repligen Corporation, a global life sciences company focused on bioprocessing technologies, have entered into a collaboration agreement to integrate Repligen’s XCell ATF cell retention control technology into SSB’s BIOSTAT STR large-scale single-use bioreactors to create novel perfusion-enabled bioreactors.

From Sartorius 5 Sep 2018

Sunovion receives Complete Response Letter from FDA for dasotraline NDA

Sunovion Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration issued a Complete Response Letter for the New Drug Application for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor, for the treatment of attention-deficit hyperactivity disorder.

3 Sep 2018

Pfizer terminates clinical studies evaluating domagrozumab for treatment of Duchenne muscular dystrophy

Pfizer Inc. announced today that it is terminating two ongoing clinical studies evaluating domagrozumab (PF-06252616) for the treatment of Duchenne muscular dystrophy (DMD): a Phase 2 safety and efficacy study (B5161002) and an open-label extension study (B5161004).

30 Aug 2018

Celmatix and Ferring announce genomics collaboration aimed at uncovering new insights into ovarian biology

Ferring Pharmaceuticals and Celmatix today announced an ambitious genomics collaboration aimed at uncovering new insights into ovarian biology and accelerating the development of personalized interventions in reproductive medicine and women's health.

30 Aug 2018

FDA accepts Bristol-Myers Squibb’s application for Sprycel for treating pediatric leukemia

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration accepted its supplemental Biologics License Application for Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.

30 Aug 2018

EC grants marketing authorization for ONPATTRO (patisiran) in Europe

Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced today that the European Commission (EC) has granted marketing authorization for ONPATTRO (patisiran) for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adults with stage 1 or stage 2 polyneuropathy.

30 Aug 2018

Drug used for chest pain does not decrease chance of first occurrence of ventricular arrhythmias

A clinical trial of more than 1,000 patients with implantable cardioverter defibrillators found that the drug ranolazine was safe but didn't significantly decrease the likelihood of the first occurrence of ventricular tachycardia, ventricular fibrillation or death in this high-risk population.

29 Aug 2018

Scientists publish study results of AAV therapy product for treatment of RHO-adRP

Ophthotech Corporation announced today that scientists at the University of Pennsylvania and University of Florida published proof-of-concept study results on an adeno-associated virus gene therapy product candidate for the treatment of rhodopsin-mediated autosomal dominant retinitis pigmentosa licensed by Ophthotech.

22 Aug 2018

RDMD raises $3 million in seed funding to accelerate rare disease research, drug development

RDMD, a healthcare technology company dedicated to accelerating research for patients with rare diseases, today announced that it has raised $3 million in seed financing.

20 Aug 2018

Harbour Biomed and Kelun-Biotech collaborate to develop, commercialize anti-PD-L1 antibody

Harbour BioMed today announced it has entered into an exclusive strategic partnership with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. to develop and commercialize A167, an anti-PD-L1 antibody in Phase 2 clinical development, worldwide outside of the Greater China region.

20 Aug 2018

New polyclonal immunotherapy successfully neutralizes Ebola virus

SAB Biotherapeutics, Inc., a clinical-stage biopharmaceutical company, today announced that its anti-Ebola immunotherapy (SAB-139) provided "100% protection against a lethal dose of the Ebola virus" in a recent animal study published in The Journal of Infectious Diseases.

15 Aug 2018

One-two punch of powerful antibodies may be best way to stop Ebola virus

A one-two punch of powerful antibodies may be the best way to stop Ebola virus, reports an international team of scientists in the journal Cell.

10 Aug 2018

EMA grants orphan designation to selumetinib for treatment of neurofibromatosis type 1

AstraZeneca and Merck, known as MSD outside the U.S. and Canada, today announced that the European Medicines Agency (EMA) has granted orphan designation to selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1 (NF1).

3 Aug 2018

Biopharmaceutical News and Research

Research finds physical connection between the brain's fluid reservoirs and meningeal lymphatics

LEO Pharma and MorphoSys announce expansion of strategic alliance to develop peptide-derived drugs

Lymphatic vessels surrounding the brain play crucial role in multiple sclerosis, research suggests

FDA approves new treatment for people with hairy cell leukemia

PAREXEL launches Patient Innovation Center to improve drug development process

Verastem doses first patient in Phase I/II clinical trial of duvelisib in combination with venetoclax

BeiGene collaborates with SpringWorks to evaluate new combinational therapy for solid tumors

Sartorius Stedim Biotech and Repligen collaborate to create novel perfusion-enabled bioreactors

Sunovion receives Complete Response Letter from FDA for dasotraline NDA

Pfizer terminates clinical studies evaluating domagrozumab for treatment of Duchenne muscular dystrophy

Celmatix and Ferring announce genomics collaboration aimed at uncovering new insights into ovarian biology

FDA accepts Bristol-Myers Squibb’s application for Sprycel for treating pediatric leukemia

EC grants marketing authorization for ONPATTRO (patisiran) in Europe

Drug used for chest pain does not decrease chance of first occurrence of ventricular arrhythmias

Scientists publish study results of AAV therapy product for treatment of RHO-adRP

RDMD raises $3 million in seed funding to accelerate rare disease research, drug development

Harbour Biomed and Kelun-Biotech collaborate to develop, commercialize anti-PD-L1 antibody

New polyclonal immunotherapy successfully neutralizes Ebola virus

One-two punch of powerful antibodies may be best way to stop Ebola virus

EMA grants orphan designation to selumetinib for treatment of neurofibromatosis type 1

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