Manufacturing News and Research

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Manufacturing is the production of products across all industries, on a large-scale, using machinery.

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

Penumbra introduces new advancements in stroke thrombectomy aspiration technology

Penumbra, Inc., a global healthcare company focused on innovative therapies, today announced U.S. commercial availability of the Penumbra System's most advanced technology: Penumbra JET 7 and Penumbra JET D Reperfusion Catheters powered by the Penumbra ENGINE aspiration source.

4 Sep 2018

Leukogene receives STTR grant to optimize compound for treatment-resistant multiple myeloma

A $2 million phase 2 Small Business Technology Transfer grant to optimize a promising new compound that has shown efficacy in preclinical studies against treatment-resistant multiple myeloma has been awarded to a Medical University of South Carolina startup company, Leukogene Therapeutics, Inc., in collaboration with MUSC researcher and company founder, Nathan G. Dolloff, Ph.D. Dolloff is an assistant professor in the Department of Cell and Molecular Pharmacology & Experimental Therapeutics at MUSC and a member of MUSC Hollings Cancer Center.

31 Aug 2018

Eagle Pharmaceuticals completes enrollment of second clinical study to evaluate safety, efficacy of RYANODEX

Eagle Pharmaceuticals, Inc. today announced completion of enrollment of the Company's second clinical study to further evaluate the safety and efficacy of RYANODEX® (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke, an investigational new indication for the product.

30 Aug 2018

Shionogi launches Mulpleta in the U.S for safe, effective treatment of thrombocytopenia

Shionogi & Co., Ltd. announced today that Mulpleta (lusutrombopag), a once-daily, orally administered, small molecule thrombopoietin (TPO) receptor agonist for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure, is now available throughout the United States.

30 Aug 2018

Using novel gene therapy to cure infants born with severe combined immunodeficiency

Out of every 60,000 births, a baby arrives to face the world without a fully functioning immune system leaving them unequipped to fight even the most common infections.

29 Aug 2018

Cherwell confirms support for conference addressing key challenges in aseptic manufacturing of ATMPs

Cherwell Laboratories, supplier of environmental monitoring and process validation products, has confirmed its continued support for the Pharmaceutical & Healthcare Sciences Society - UCL Q3P Annual Conference 2018.

29 Aug 2018

FDA warns consumers and pet owners not to use drug products made by King Bio

The Food and Drug Administration is warning consumers and pet owners not to use drug products, including homeopathic drug products, made by King Bio Inc., Asheville, N.C., and labeled as Dr. King's, as these products may pose a safety risk to people (especially infants, children, pregnant women and those with compromised immune systems), as well as pets due to high levels of microbial contamination identified at the manufacturing site.

29 Aug 2018

Scientists develop urine diagnostic to detect parasitic worms that cause river blindness

Scientists at Scripps Research have developed a urine diagnostic to detect the parasitic worms that cause river blindness, also called onchocerciasis, a tropical disease that afflicts 18 to 120 million people worldwide.

28 Aug 2018

New personalized cellular therapy approved for use in the European Union

The European Commission has approved a personalized cellular therapy developed at the University of Pennsylvania's Abramson Cancer Center, making it the first chimeric antigen receptor (CAR) T cell therapy permitted for use in the European Union in two distinct indications.

27 Aug 2018

$Entresto drug can be initiated early and safely in heart failure patients with reduced ejection fraction$

Entresto drug can be initiated early and safely in heart failure patients with reduced ejection fraction

Data from the TRANSITION study presented today at the European Society of Cardiology Congress in Munich, Germany has shown that Entresto® can be initiated early and safely in a wide range of heart failure patients with reduced ejection fraction who have been stabilized after hospitalization due to an acute heart failure episode.

25 Aug 2018

Forbius receives $18.75 million grant from CPRIT for Phase 2a development of AVID100

Forbius announced today that it has been awarded a Product Development grant totaling $18.75 million from the Cancer Prevention and Research Institute of Texas.

25 Aug 2018

ITL Group announces completion of SMT manufacturing upgrade

Experienced medical device design, development, and manufacturing partner, ITL Group has announced further investment in its on-site PCB manufacturing facility.

From Vitl Life Science Solutions 24 Aug 2018

Bluebird bio collaborates with Gritstone Oncology to develop novel cancer cell therapies

Bluebird bio, Inc. and Gritstone Oncology, Inc. today announced a collaboration to research, develop and commercialize products for the treatment of cancer using cell therapy.

23 Aug 2018

KNAUER introduces single quadrupole mass spectrometer

KNAUER launched a single quadrupole mass spectrometer. With the KNAUER 4000MiD the Berlin-based company expands their preparative HPLC portfolio to the field of mass directed purification.

From KNAUER Wissenschaftliche Geräte GmbH 23 Aug 2018

Eisai: EC approves marketing of LENVIMA as first-line treatment for hepatocellular carcinoma

Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth N.J., U.S.A., known as MSD outside of the United States and Canada, announced today that the European Commission has granted a marketing authorization for the oral receptor tyrosine kinase inhibitor LENVIMA (lenvatinib mesylate) as a single agent for the first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have received no prior systemic therapy.

23 Aug 2018

Manufacturing News and Research

Further Reading

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

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

Penumbra introduces new advancements in stroke thrombectomy aspiration technology

Leukogene receives STTR grant to optimize compound for treatment-resistant multiple myeloma

Eagle Pharmaceuticals completes enrollment of second clinical study to evaluate safety, efficacy of RYANODEX

Shionogi launches Mulpleta in the U.S for safe, effective treatment of thrombocytopenia

Using novel gene therapy to cure infants born with severe combined immunodeficiency

Cherwell confirms support for conference addressing key challenges in aseptic manufacturing of ATMPs

FDA warns consumers and pet owners not to use drug products made by King Bio

Scientists develop urine diagnostic to detect parasitic worms that cause river blindness

New personalized cellular therapy approved for use in the European Union

Entresto drug can be initiated early and safely in heart failure patients with reduced ejection fraction

Forbius receives $18.75 million grant from CPRIT for Phase 2a development of AVID100

ITL Group announces completion of SMT manufacturing upgrade

Bluebird bio collaborates with Gritstone Oncology to develop novel cancer cell therapies

KNAUER introduces single quadrupole mass spectrometer

Eisai: EC approves marketing of LENVIMA as first-line treatment for hepatocellular carcinoma

Promising data supports development of AAVhu37-based gene therapy for hemophilia A

New drug shows potential to prevent painful side effect of therapy

Alternative devices can help when autoinjectors are unavailable

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

Exploring the G:Box and for high-quality imaging

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