Monoclonal Antibody News and Research

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Monoclonal antibodies (MAbs) are produced from a single B cell clone and can bind to a single type of antigen binding site. MAbs are homogenous antibodies that cannot form lattices with monomeric proteins as they can bind to only a single epitope on the antigen. Developed in the 1970s, MAbs can be produced against any given substance. Thus they can be used to detect and purify any substance of interest. This has made MAbs a powerful tool of molecular biology, biochemistry, and medicine.

ADCETRIS drug receives approval in Japan as frontline treatment option for Hodgkin lymphoma

Seattle Genetics, Inc. today announced that its collaborator, Takeda Pharmaceutical Company Limited, has received approval from the Japanese Ministry of Health, Labour and Welfare for ADCETRIS (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine as a frontline treatment option for CD30-positive Hodgkin lymphoma patients in Japan.

24 Sep 2018

Biogen and Eisai announce results of LTE Phase 1b study of aducanumab for treating MCI

Biogen and Eisai Co., Ltd. announced results from a recent analysis of the ongoing long-term extension Phase 1b study of aducanumab, an investigational treatment for mild cognitive impairment due to Alzheimer's disease and mild AD dementia.

24 Sep 2018

CHMP recommends approval of Gilenya for treatment of multiple sclerosis in children, adolescents

Novartis today announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Gilenya (fingolimod) for the treatment of children and adolescents 10 to 17 years of age with relapsing remitting forms of multiple sclerosis.

24 Sep 2018

Addition of CTLA4 targeted therapy to PD-1 targeted therapy may benefit patients with ovarian cancer

An analysis of the NRG Oncology clinical trial NRG-GY003 suggests that adding ipilimumab, a monoclonal antibody that targets the protein receptor CTLA-4, to a regimen with the checkpoint inhibitor nivolumab could improve the proportion with tumor response and progression-free survival hazard rates for women with recurrent epithelial ovarian cancer.

19 Sep 2018

Alector announces initiation of Phase 1 trial of AL001 for treating frontotemporal dementia

Alector, a privately held biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegeneration, today announced the initiation of its Phase 1 trial called INFRONT, which is evaluating AL001, the company's product candidate for the treatment of a genetically-defined sub-population of patients with frontotemporal dementia.

19 Sep 2018

Purifying Proteins from Mammalian Cell Culture

In many cases mammalian cells are the only option to produce recombinant proteins with correct post-translational modifications, e.g. glycosylation, which are required for proper function of the therapeutic protein.

From Sartorius 18 Sep 2018

FDA approves Teva’s AJOVY injection for preventive treatment of migraine in adults

Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration has approved AJOVY injection for the preventive treatment of migraine in adults.

17 Sep 2018

Neutrophil nanosponges provide hope for rheumatoid arthritis

Scientists in San Diego have developed nanosponges coated in neutrophil membranes that can prevent rheumatoid arthritis.

3 Sep 2018

New project aims to combat drug-resistant bacteria in hospitals

Antibiotic resistance is a big global public health problem. Of particular concern are multidrug-resistant Gram-negative bacteria, which are among the leading causes of serious, debilitating and life threatening healthcare-associated infections.

3 Sep 2018

Researchers launch clinical trial to assess new drug combination against metastatic breast cancers

Researchers at University of California San Diego School of Medicine have launched a phase Ib clinical trial to assess the safety and tolerability of cirmtuzumab, in combination with standard chemotherapy, to treat metastatic or locally advanced breast cancer that cannot be surgically removed.

28 Aug 2018

Grim updates on Ebola outbreak in Congo

According to the health ministry, there have been five new cases of Ebola and five deaths from haemmorhagic fever. Ebola cases now sum up at 96 (5 new cases) from the town of Mabalako-Mangina. A total of 69 are confirmed. 55 people have died.

22 Aug 2018

Advanced sequencing of nasal polyps provides new insights into allergic conditions

Nasal polyps - soft, grape-like outgrowths that can appear in the nasal passages and sinuses - can be chronic and relentless. Although noncancerous, these outgrowths can grow large enough to block the nose and sinuses, leading to discomfort, breathing problems and infections.

22 Aug 2018

FDA approves Dako PD-L1 IHC 22C3 pharmDx assay for expanded use in urothelial carcinoma

Agilent Technologies Inc. today announced that the U.S. Food and Drug Administration has approved its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use in urothelial carcinoma.

22 Aug 2018

Ology Bioservices wins $8.4 million worth agreement to manufacture anti-Ebola monoclonal antibody

Ology Bioservices, Inc., a biologics contract development and manufacturing organization, announced today that it was awarded an Other Transaction Agreement to support the Joint Project Manager Medical Countermeasure Systems, a component of the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense for advanced biologics manufacturing services—specifically, to manufacture an anti-Ebola monoclonal antibody.

17 Aug 2018

New HIV therapy suppresses viral replication and increases immune cells in drug-resistant patients

In a study, a new HIV drug reduced viral replication and increased immune cells in individuals with advanced, drug-resistant HIV infection. Used in combination with existing HIV medications, the drug is a promising strategy for patients who have run out of effective treatment options, the researchers said.

16 Aug 2018

Ebola outbreak in Congo spreads to active combat zone

The outbreak of the deadly Ebola in the Democratic Republic of Congo has spread outside the province of North Kivu according to a statement made by the country’s health ministry yesterday. With this the viral infection has reached an active conflict zone and this may mean that it could spread wider now.

14 Aug 2018

FDA approves drug for rare, hard-to-treat types of non-Hodgkin lymphoma

The U.S. Food and Drug Administration today approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.

8 Aug 2018

Researchers characterize production process for standardized monoclonal antibody

Researchers have taken the first step towards developing a method for the production of a standardized monoclonal antibody (mAb).

1 Aug 2018

Researchers engineer three cell lines to produce nonproprietary versions of NISTmAb

When the National Institute of Standards and Technology issued the world's first standardized monoclonal antibody in July 2016, the exhaustively analyzed protein known as NISTmAb was intended as a valuable tool for biopharmaceutical companies.

1 Aug 2018

European Commission approves Pfizer’s first oncology biosimilar

Pfizer Inc. today announced the European Commission has approved TRAZIMERA, a biosimilar to Herceptin (trastuzumab), for the treatment of human epidermal growth factor overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

31 Jul 2018

Monoclonal Antibody News and Research

Further Reading

ADCETRIS drug receives approval in Japan as frontline treatment option for Hodgkin lymphoma

Biogen and Eisai announce results of LTE Phase 1b study of aducanumab for treating MCI

CHMP recommends approval of Gilenya for treatment of multiple sclerosis in children, adolescents

Addition of CTLA4 targeted therapy to PD-1 targeted therapy may benefit patients with ovarian cancer

Alector announces initiation of Phase 1 trial of AL001 for treating frontotemporal dementia

Purifying Proteins from Mammalian Cell Culture

FDA approves Teva’s AJOVY injection for preventive treatment of migraine in adults

Neutrophil nanosponges provide hope for rheumatoid arthritis

New project aims to combat drug-resistant bacteria in hospitals

Researchers launch clinical trial to assess new drug combination against metastatic breast cancers

Grim updates on Ebola outbreak in Congo

Advanced sequencing of nasal polyps provides new insights into allergic conditions

FDA approves Dako PD-L1 IHC 22C3 pharmDx assay for expanded use in urothelial carcinoma

Ology Bioservices wins $8.4 million worth agreement to manufacture anti-Ebola monoclonal antibody

New HIV therapy suppresses viral replication and increases immune cells in drug-resistant patients

Ebola outbreak in Congo spreads to active combat zone

FDA approves drug for rare, hard-to-treat types of non-Hodgkin lymphoma

Researchers characterize production process for standardized monoclonal antibody

Researchers engineer three cell lines to produce nonproprietary versions of NISTmAb

European Commission approves Pfizer’s first oncology biosimilar

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