US expands COVID-19 convalescent plasma treatment trials
Operation Warp Speed and the NIH are funding the expansion of two trials evaluating the efficacy of convalescent plasma therapy in hospitalised COVID-19 patients.
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Outsourcing facility opens highly potent compound manufacturing suite
The development of a highly potent active pharmaceutical ingredient (HPAPI) contract manufacturing facility has been completed in the US.
IND granted to Ampion as COVID-19 treatment after Phase I study
The FDA has given the green light to an IND and further Phase I clinical trial of Ampio Pharmaceuticals' Ampion as an inhaled COVID-19 therapy.
EMA recommends seven medicines for approval after September meeting
Following its latest meeting, the EMA's CHMP has suggested granting marketing authorisation to seven medicines and extending the indications of 15 others.
UK Prime Minister visits the UK Vaccines Manufacturing and Innovation Centre (VMIC)
Prime Minister Boris Johnson visited the construction site of the VMIC and met scientists and engineers at the forefront of the UK’s COVID-19 response.
Avelumab significantly improves advanced bladder cancer patient survival
A Phase III trial concluded that avelumab is an effective maintenance therapy for patients with advanced or metastatic urothelial carcinoma, whose disease had not progressed after chemotherapy.
Smart biomaterial drug delivery system could improve CNS injury recovery
The implanted biomaterial drug delivery system releases methylprednisolone and reduces inflammation, promoting central nervous system (CNS) repair.
An overview of Indian COVID-19 vaccine supply and development
Prashant Khadayate, Pharma Analyst at GlobalData, explains what the current state of the COVID-19 pandemic is in India and what vaccine options are currently under development/testing.
Alter Pharma Group adopts Movilitas.Cloud to ensure safer goods and EU FMD compliance
Movilitas has announced that Alter Pharma Group has adopted its Movilitas.Cloud software to meet requirements throughout the product path and changes in packaging under the EU FMD regulation.
HPAPI facility developed to produce biodegradable contraceptive molecule
A new HPAPI manufacturing unit has been opened in France, with the capability to make a contraceptive with a superior safety profile and high level of biodegradability.
Gilead Sciences to acquire Immunomedics for $21 billion
Gilead is set to acquire Immunomedics for approximately $21 billion, with the transaction anticipated to close in the fourth quarter of 2020.
Baricitinib and remdesivir reduce time to recovery in COVID-19 patient trial
A study of baricitinib in combination with remdesivir has met its primary endpoint in COVID-19 patients, by reducing time to recovery in comparison with only remdesivir.
UK government inks deal for 60 million doses of Valneva COVID-19 vaccine
Valneva has agreed to supply the UK government with 60 million doses of its potential COVID-19 vaccine by the second half of 2021.
Phase III trial to study REGN-COV2, potential COVID-19 antibody treatment
REGN-COV2 will be evaluated alongside standard-of-care in a Phase III study as part of the COVID-19 RECOVERY trial.
Oral COVID-19 vaccine candidate to enter Phase I human trials
Vaxart's application for a Phase I clinical trial to evaluate its oral COVID-19 vaccine candidate has been cleared by the FDA.
