Articles

The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.

First Participant Dosed in CureVac’s COVID-19 Vaccine Clinical Trial

Through the acquisition, Bristol Myers Squibb will gain access to MyoKardia’s mavacamten, a cardiovascular drug for the treatment of obstructive hypertrophic cardiomyopathy, a chronic heart disease.



Bristol Myers Squibb to Acquire MyoKardia for $13.1 Billion

The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.

EMA Confirms Standards for COVID-19 Treatment Evaluations

The agency published recommendations for the development of drugs and biologics for the adjuvant treatment of renal cell carcinoma.

FDA Guidance on Treatments for Renal Cell Carcinoma

Sean Milmo is a freelance writer based in Essex, UK.

Regulatory bodies are adapting to new ways of working to cope with the impact of COVID-19.

Regulating with Flexibility: The Pandemic Effect

The guidance discusses acceptable clinical endpoints for demonstrating effectiveness of drugs developed to treat opioid use disorder.

FDA Releases Guidance on Drugs for Treatment of Opioid Use Disorder

The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.

Regulatory Review of COVID-19 Vaccine Begins in Europe

Sterling Pharma Solutions has acquired Alcami’s API facility in Germantown, WI.

Sterling Pharma Solutions Acquires US API Facility

Symbiosis has successfully completed a scheduled inspection by MHRA.

Symbiosis Successfully Completes MHRA Audit Inspection

Optimus Holding has successfully completed the acquisition of OM Pharma.

News