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Six major risks facing pharmaceutical manufacturers in 2021
In this article, Shannon Flynn outlines six of the key risks threatening pharmaceutical manufacturers’ recovery from COVID-19 in 2021.
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Therapeutics
news
CMOs should invest in biologic API manufacturing capabilities, says GlobalData
Research shows the complexity and number of biologics is increasing, as is the frequency at which their active pharmaceutical ingredient (API) production is outsourced.
news
FDA outlines plan for making inspections more consistent going forward
The new report shows over 8,000 planned inspections were postponed due to COVID-19 and outlines the FDA’s plan for a more consistent future state of operations.
news
First AI designed Alzheimer’s drug to enter clinical trials
The trial of DSP-0038, an Alzheimer’s disease psychosis drug designed using artificial intelligence, will assess its ability to improve the behavioural and psychological symptoms of dementia.
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Pakistan approves Zofin™ for compassionate use in COVID-19 patient
Organicell’s Zofin™ therapy has been approved by the Pakistani regulators to be used for a patient with severe COVID-19 on compassionate grounds.
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Gene therapy successfully treats rare immunodeficiency in paediatric patients
In three Phase I/II trials an experimental gene therapy caused all but two patients with severe combined immunodeficiency to acquire and retain robust immune function for more than two years.
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MDMA-assisted therapy successful in PTSD patients
Three sessions of MDMA-assisted talk therapy resulted in significant symptom reductions for 88 percent of patients with severe, chronic post-traumatic stress disorder (PTSD).
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EMA begins rolling reviews for a COVID-19 therapeutic and a vaccine
The European Medicines Agency (EMA) has initiated a rolling reviews of Vero Cell, an inactivated COVID-19 vaccine, and sotrovimab, a monoclonal antibody.
podcasts
EPR Podcast Episode 2 – Bioavailability enhancement with Dr Deanna Mudie, Lonza
In this podcast, Lonza’s Dr Deanna Mudie explains the importance of bioavailability, how to achieve desired bioavailability and top tips for how to select the correct dissolution media for your testing needs.
news
Benlysta approved for adult patients with active lupus nephritis in Europe
The indication of Benlysta (belimumab) was extended after it significantly improved renal outcomes in those with active lupus nephritis.
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Sonelokimab shows promise in Phase II psoriasis trial
In the trial, 57 percent of patients with moderate to severe psoriasis treated with 120mg of sonelokimab achieved total skin clearance in 24 weeks.
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Scientists show 3D printed tablet porosity can regulate drug release
Investigators suggest using 3D printing to adjust tablet porosity could allow for personalised medicines to be made at the point-of-care.
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AstraZeneca’s Tagrisso: first medicine approved in the UK under Project Orbis
Tagrisso (osimertinib) was approved for an indication extension after it reduced risk of death by over 80 percent in certain early-stage non-small cell lung cancer patients.
news
Charles River Laboratories generates $824 million in first quarter
Charles River Laboratories International’s first quarter revenue was approximately 17 percent higher in Q1 2021, with organic revenue growth of 13 percent.
news
EC approves Xtandi™ for third prostate cancer indication
Xtandi™ (enzalutamide) was approved for metastatic hormone-sensitive prostate cancer after it reduced the risk of radiographic progression or death by 61 percent in a trial.
