Regulation

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.

AbbVie presents applications to FDA and EMA for approval of SKYRIZI in psoriatic arthritis

AbbVie has submitted applications seeking approval for SKYRIZI (risankizumab-rzaa, 150 mg) and SKYRIZI (risankizumab, 150 mg) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively, for the treatment of adults with active psoriatic arthritis.

USFDA extends review period for Eli Lilly and Incyte’s sNDA for baricitinib

The US Food and Drug Administration (FDA) has extended the review period for Eli Lilly and Incyte’s supplemental New Drug Application (sNDA) for OLUMIANT (baricitinib).