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Twist Bioscience and Astellas Pharma have entered a collaboration to help the latter to discover antibodies for immunotherapies. In May 2022, they signed a research partnership and exclusive option licence agreement for the development of antibodies to reduce tumour microenvironment-mediated immunosuppression.
Brii Biosciences (Brii Bio) has exercised an option for the acquisition of exclusive development and marketing rights for Vir Biotechnology’s investigational antibody, VIR-3434, for Hepatitis B in Greater China, under a partnership agreement. The mAb is presently in the Phase II development stage.
Dudley, UK, April 18th 2023: Sterling Pharma Solutions, a global contract development and manufacturing organisation, today announced that it has been granted a Manufacturer’s Authorisation for Investigational Medicinal Products from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).
Ildong Pharmaceutical will licence a suite of Twist Bioscience's VHH antibody libraries after the two companies entered a partnership agreement. Twist's VHH libraries, used for discovering and developing antibodies for use in immuno-oncology, will be licensed by Ildong for three years for research and development works. .
Biocytogen Pharmaceuticals and ADC Therapeutics have signed an assessment and option agreement for evaluating antibodies against three tumour targets. Under the deal, ADC Therapeutics will receive a licence from Biocytogen to evaluate the latter’s antibodies against the targets.
Syncromune and Biocytogen Pharmaceuticals’ wholly owned subsidiary Eucure Biopharma have entered an exclusive global licence agreement for OX40 antibody YH002 and two other active ingredients. . Eucure will oversee the production and delivery of the drug, while Syncromune will handle the clinical development and marketing.
LegoChem Biosciences and Amgen have signed a multi-target research collaboration and license agreement to develop antibody-drug conjugates (ADC). The company will also be eligible for tiered royalties as a percentage of global commercial sales of the products.
Gilead Sciences has entered an exclusive option and partnership agreement with MacroGenics for developing bispecific antibodies. MGD024 is an investigational bispecific antibody that attaches to CD123 and CD3. The post Gilead partners with MacroGenics for bispecific antibody development appeared first on Pharmaceutical Technology.
Astellas has licensed rights to a drug developed by Selecta Biosciences that could make more patients eligible for treatment with its gene therapy for inherited neuromuscular disorder Pompe disease. The post Astellas licenses companion drug for Pompe gene therapy appeared first on.
AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted ADvantage Therapeutics’ immunotherapy AD04 an Innovation Passport for the treatment of Alzheimer’s disease. A recent wave of monoclonal antibodies, including the FDA-approved Eisai / Biogen ’s Leqembi (lecanemab), is expected to shake up the space.
With the latest development, Sanofi will licence a NK cell engager programme that acts on B7H3 from the antibody-based NK cell engager therapeutics (ANKET) platform of Innate. On choosing the candidate, the company will oversee the complete development, production and marketing.
The issues are holding up discussions between the agency and company about labeling and post-marketing requirements for teplizumab, and are concentrated around the pharmacokinetics data for the antibody, and whether it is comparable to the drug that its original developer Eli Lilly entered into clinical trials.
Dutch biotechnology company Synaffix and Amgen have entered a licensing agreement for the development of next-generation antibody-drug conjugates (ADCs). For four future programmes, Amgen will also have an option for exercising exclusive licenses for research and commercialisation. It is tunable to DAR1, DAR2 or DAR4 formats.
The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.
Reddy’s Laboratories have partnered for the development and commercialisation of the anti-PD-1 monoclonal antibody, toripalimab, in 21 countries. The company may also choose to expand the scope to license toripalimab in New Zealand, Australia, and in nine other countries. Junshi Biosciences may get an aggregate of up to $728.3m
a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.
Last year, Disc in-licensed bitopertin from Roche. In-licensed from AbbVie in 2019, DISC-0974 is a monoclonal antibody. It acts on hemojuvelin co-receptor and could hinder the production of hepcidin and boost serum iron levels in individuals with anaemia of inflammation.
While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. What is an Interchangeable Biological Product? What is a Biosimilar?
MorphoSys seemingly inexorable shift into an oncology pure-play has continued with an out-licensing deal for two programmes in the kidney disease and immunology categories to China’s HIBio. The move comes after MorphoSys announced in March that it would be cutting swathes of its early-stage pipeline in the wake of its $1.7
Lecanemab, the product of Phase IIb clinical research completed by BioArctic and collaborator Eisai, is one therapy making strides this year for Alzheimer’s disease. This year, the monoclonal antibody lecanemab is approaching final stages of investigation as a treatment for targeting the A? Next Stages in Clinical Research.
Epcoritamab is a bispecific antibody which targets CD3 on white blood cells and CD20 on tumour cells, and is designed to encourage an immune response against the cancer. billion product at peak. The post AbbVie preps filings for lymphoma bispecific licensed from Genmab appeared first on.
In the partnership’s discovery phase, RAVEN, an artificial intelligence (AI) platform of Evaxion will be leveraged for designing a next-generation vaccine candidate that induces cellular as well as humoral/antibody responses. Using ExpreS 2 ion’s ExpreS2 platform, the company will manufacture the antigen constructs obtained from RAVEN.
The US Food and Drug Administration (FDA) has granted priority review to Roche’s Biologics License Application (BLA) of Lunsumio (mosunetuzumab) to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL). These patients should have received a minimum of two prior systemic therapies.
ITIL-168 is an autologous TIL therapy, meaning that patients need to undergo apheresis and wait for the product to be manufactured and reinfused. Only 29% of patients successfully received the CAR-T product within 12 months, and 31.9%
Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR.
Regeneron Pharmaceuticals has entered a collaboration and licensing agreement with CytomX Therapeutics for developing conditionally-activated bispecific cancer therapies. Under the deal, the companies will work together on the discovery activities for identifying and validating the conditionally active bispecific antibodies.
Seagen specialises in developing antibody-drug conjugates (ADCs) which will complement Pfizer’s oncology portfolio. This figure derives from net product sales in addition to revenues gained from royalties and licensing agreements. compound annual growth rate (CAGR) according to Pfizer’s risk-adjusted projection.
Seagen also will make potential development, regulatory and commercial milestone payments of up to nearly $650m, as well as royalty payments on the sales of the product in the future. Under this deal, Seagen also holds an option for nominating up to two more tumour targets for biospecifics leveraging the Gammabody platform.
Nuvaxovid demonstrated a significant antibody response when given as a booster dose after primary vaccination with other authorised Covid-19 doses in the COV-BOOST trial. SK bioscience is manufacturing Nuvaxovid’s drug substance, and drug product for domestic use after the companies signed a licensing agreement in Korea.
AstraZeneca has clearly made the rare disease transthyretin amyloidosis (ATTR) a key component of its rare disease pipeline, licensing a second drug candidate in the space of a couple of months. The new agreement comes just days after AZ closed a $3.1 billion on the first nine months of 2021, well ahead of Pfizer’s own forecasts.
The US Food and Drug Administration (FDA) has accepted Sandoz’s biologics license application (BLA) for its proposed biosimilar denosumab. The human monoclonal antibody denosumab has been designed to bind to osteoclasts activator, RANKL protein.
Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. The product is designed for the prevention and treatment of COVID-19, along with related coronaviruses. before expanding it into Europe.
Gilead Sciences’ Kite unit has teamed up with the UK’s Oxford BioTherapeutics (OBT) to develop a new clutch of cell therapy products for solid tumours and blood cancers. The partnership covers up to five oncology targets identified by OBT using its discovery platform, and the UK firm will try to develop antibodies against them.
Germany’s Merck KGaA has said it needs to double the productivity of its R&D operations, with the aim of launching a new product every 18 months on average, to boost its pharma business. It also says it will focus on technological areas where it has strength, such as antibody-drug conjugates.
CDMO Sterling Pharma Solutions has been granted a Manufacturerâs Authorisation for Investigational Medicinal Products from the UKâs Medicines and Healthcare products Regulatory Agency (MHRA).
Boehringer Ingelheim’s Cyltezo has become the second interchangeable biosimilar approved by the FDA, and the first approved interchangeable monoclonal antibody. In July 2021, the agency approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn) for the treatment of diabetes.
Monoclonal antibodies have made an important contribution to the treatment of COVID-19. The post Cantex secures license to develop small molecule-drug for inflammatory lung diseases appeared first on. However, their efficacy is limited, and they can be challenging to manufacture, store, distribute and administer.”
However, it is possible to target CD33 in the clinic, as evidenced by the FDA approval of Pfizer’s anti-CD33 antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) in 2000. GlobalData’s Pharma Intelligence Center shows 19 autologous CAR-T cell products in Phase I, and nine products in Phase II, globally.
Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. It is still not known whether having antibodies will protect people from a second infection. Coronavirus infection triggers the immune system to produce antibodies.
KaliVir, Astellas Pharma forms a licensing deal for VET2-L2 oncolytic virus. KaliVir Immunotherapeutics and Astellas Pharma entered into a worldwide exclusive licensing agreement for the development, research, and commercialization of VET2-L2 to widen the horizon of therapeutic approaches available in the Immuno-Oncology market.
Gilead Sciences has made yet another rush into the oncology category, licensing a bispecific antibody from MacroGenics in development as a treatment for CD123-positive blood cancers, including acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS).
The US Food and Drug Administration (FDA) has accepted Roche ’s supplemental Biologics License Application (sBLA) for Polivy (polatuzumab vedotin-piiq) plus Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to treat priorly untreated diffuse large B-cell lymphoma (DLBCL) patients.
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