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Using plants as bioreactors to produce proteins for therapeutics
European Pharmaceutical Review explores how plants can be used for large-scale, glycosylated protein bioproduction for the pharma industry.
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Antibodies
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Keytruda® (pembrolizumab) with chemotherapy meets Phase III PFS endpoint
The drug’s developers reveal Keytruda increased progression-free survival (PFS) in patients with metastatic triple-negative breast cancer (mTNBC) expressing PD-L1.
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FDA approves Keytruda for patients with high-risk, non-muscle invasive bladder cancer
Keytruda is the first anti-PD-1 monoclonal antibody therapy approved for patients with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer.
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First company awarded market authorisation under new Chinese drug law
The mAb tislelizumab has been granted approval from Chinese authorities, making Boehringer Ingelheim Biopharmaceuticals the first MAH under the new system.
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WHO announces first biosimilar medicine pre-qualification
A trastuzumab biosimilar has been pre-qualified by WHO, marking its first, to improve access to the breast cancer treatment.
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Multiple sclerosis drug market predicted to reach $32.9bn by 2028
Driven by the launch of various pipeline agents, a new report has projected that the multiple sclerosis therapeutics market will reach $32.9 billion in 2028.
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Broadly neutralising antibody to be developed for HIV-1 treatment
The investigational broadly neutralising antibody, N6LS, is to be developed by ViiV Healthcare for the treatment and prevention of HIV-1.
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Medicine delivery by drone – implications for safety and quality
Drones that transport medicines to emergency situations, urban environments or geographically-challenging locations are increasingly being utilised to improve delivery, however, there are few studies on their impact on drug stability. Here, Paul Royall and Patrick Courtney explore the implications of drone delivery on the safety and quality of medicines.
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Data of rheumatoid arthritis treatment study released
New data shows the non-inferiority of efficacy for the subcutaneous (SC) formulation of CT-P13 to the intravenous (IV) formulation of CT-P13 in people with rheumatoid arthritis.
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Hereditary angioedema treatment recommended by NICE
Lanadelumab, a preventive treatment for hereditary angioedema, has been recommended as a cost-effective use of NHS resources.
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Multiple myeloma treatment granted Orphan Drug Designation
Orphan Drug Designation has been given to bispecific antibody candidate, GBR 1342, for the treatment of multiple myeloma.
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Can calorimetry provide accurate estimates of long‑term stability for monoclonal antibodies?
Differential scanning calorimetry (DSC) has been one of the most widely used techniques to characterise the temperature stability of monoclonal antibodies (mAbs) and provide important information in formulation optimisation. However, despite its widespread use, not all the information contained in DSC data, especially denaturation kinetics, is routinely extracted. In this…
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Antibody drug conjugates market to be worth $15bn by 2030
Antibody drug conjugates are presently recognised as a potent class of targeted anticancer therapies which will result in growth in the market.
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Bioprocessing & Bioproduction In-Depth Focus 2019
This In-Depth Focus includes articles estimating the long-term stability of mAbs and exploring an automated approach in continuous biopharma production.
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FDA antibody biosimilar product approvals increase in 2019
2019 has seen a marked increase of antibody biosimilar product approvals in the first half of the year, according to a report.
