Regulation

ViiV begins rolling submission for cabotegravir to prevent HIV in US

ViiV Healthcare has initiated a rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for long-acting cabotegravir to prevent human immunodeficiency virus (HIV).

WHO grants emergency use listing for Moderna’s Covid-19 vaccine

World Health Organization (WHO) has granted emergency use listing (EUL) for Moderna's Covid-19 vaccine to prevent the infection in people aged 18 years and above.

Merck signs voluntary licences with Indian companies on molnupiravir

Merck, called as MSD outside the US and Canada, has signed voluntary licensing agreements with five Indian generic drug makers to expand access to Molnupiravir, an experimental oral antiviral Covid-19 therapy.

EMA’s CHMP recommends EU approval for AstraZeneca and Merck’s selumetinib

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorisation for AstraZeneca and Merck’s selumetinib to treat paediatric patients aged three years and older with neurofibromatosis type 1 (NF1), symptomatic and inoperable plexiform neurofibromas (PN).

Johnson & Johnson to resume Covid-19 vaccine roll-out in Europe after EMA review

Johnson & Johnson (J&J) will resume Covid-19 vaccine roll-out in Europe following the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed the overall benefit-risk profile being positive.

US clearance granted for AstraZeneca’s proposed acquisition of Alexion

The US Federal trade Commission review has granted clearance for AstraZeneca’s proposed acquisition of Alexion Pharmaceuticals, achieving an important milestone in the completion process.

GSK and Vir announce EMA review of VIR-7831 for early treatment of Covid-19

GlaxoSmithKline and Vir Biotechnology have announced the European Medicines Agency (EMA) review of VIR-7831 (GSK4182136) for the early treatment of Covid-19.

Trodelvy granted accelerated approval by USFDA for metastatic urothelial cancer

Gilead Sciences has announced the accelerated approval of Trodelvy (or sacituzumab govitecan-hziy) by the US Food and Drug Administration (FDA) in the treatment of locally advanced or metastatic urothelial cancer (UC) in adult patients.

Dr. Reddy’s secures EUA for Sputnik V in India

Integrated pharmaceutical company Dr. Reddy’s Laboratories has secured Emergency Use Authorisation (EUA) from the Drug Controller General of India (DCGI) to import Russia’s Sputnik V vaccine into India.