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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

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

Biopharmaceutical News and Research

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

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

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