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Global trial to evaluate Kevzara® (sarilumab) as COVID-19 therapy initiated
A Phase II/III trial to study Kevzara (sarilumab) as a method to reduce the inflammatory response in the lungs of COVID-19 patients has begun outside of the US.
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Therapeutics
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FDA approves Zeposia® (ozanimod) to treat relapsing forms of multiple sclerosis
The US FDA has granted approval to BMS for Zeposia, a once daily oral medication for the treatment of relapsing forms of multiple sclerosis.
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Committee for Medicinal Products for Human Use (CHMP) meeting highlights
A summary of the CHMP meeting conclusions, including medicines recommended for approval and indication extension and several safety review findings.
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Biopharma industry leaders collaborate to combat COVID-19
The International Federation of Pharmaceutical Manufacturers and Associations has announced that the biopharma industry has responding swiftly to the COVID-19 pandemic and will further increase its efforts.
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Indian government ceases exports of Ipca (hydroxychloroquine)
India has stopped exporting the malaria drug Ipca (hydroxychloroquine), despite the FDA lifting its ban on imports due to its potential as a coronavirus treatment.
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Developers request revocation of remdesivir’s ODD for COVID-19
Gilead Sciences say they are confident they can maintain an expedited regulatory review timeline for remdesivir as a treatment for COVID-19 without Orphan Drug Designation (ODD).
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Potential COVID-19 therapeutics currently in development
As the world rushes to identify the best coronavirus treatments and vaccines, John Cahill rounds up the latest developments in potential COVID-19 therapies.
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FDA hands Boehringer and Lilly complete response letter for insulin adjunct
Boehringer Ingelheim and Eli Lilly have received a complete response letter from the US FDA for their sNDA of empagliflozin 2.5mg, an insulin adjunct.
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COVID-19 update: Eli Lilly assures security of insulin supply
Having become aware of insulin shortages in pharmacies, the company has stated that its products are not backordered and should be available for delivery by wholesalers.
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Anti-malarial drugs donated to aid fight against COVID-19
The producers of hydroxychloroquine have stated they will donate 130 million doses if the drug is approved as a treatment for the COVID-19 coronavirus.
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Cabenuva (cabotegravir and rilpivirine) granted approval by Health Canada
The first regulatory approval for Cabenuva (cabotegravir and rilpivirine) has been granted by Health Canada, in conjunction with use of Vocabria.
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Novartis recalls Sandimmune and Neoral over risk of poisoning
The company is recalling 100mg blister packages of both Sandimmune and Neoral due to their packaging not being child-resistant, a fault that could result in infants being poisoned.
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Researchers to trial SNG001 therapeutic in COVID-19 patients
Hospitalised patients in the UK will inhale the interferon beta 1a (IFN-β) formulation or a placebo to see if SNG001 is effective against the COVID-19 coronavirus.
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Digitalising marketing to physicians: what pharma needs to know
European Pharmaceutical Review explores how the pharmaceutical industry could develop its digital marketing and sales strategies to better align with physician expectations and needs.
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Study evaluates if siltuximab benefits COVID-19 patients with respiratory complications
The SISCO study will assess if the anti-IL-6 antibody siltuximab can aid patients suffering Acute Respiratory Distress Syndrome as a complication of the COVID-19 coronavirus.
