The European Medicines Agency (EMA) has accepted AstraZeneca’s variation to the marketing authorisation application (MAAv) submission for Tagrisso (osimertinib) to treat patients with non-small-cell lung cancer (NSCLC).
GSK seeks FDA approval for tafenoquine to treat P. vivax malaria
GSK has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for the approval of single-dose tafenoquine to cure patients with Plasmodium vivax (P. vivax).
Sobi receives approval for Orfadin to treat HT-1 patients in Canada
Swedish Orphan Biovitrum (Sobi) has received approval from Health Canada for an oral suspension formulation of Orfadin (nitisinone) to treat patients with hereditary tyrosinemia type 1 (HT-1).
US FDA grants fast-track status to Stealth’s elamipretide
The US Food and Drug Administration (FDA) has granted fast-track designation for Stealth BioTherapeutics’ lead candidate, elamipretide, to treat patients with Barth syndrome.
Biogen and Alkermes to develop ALKS 8700 for MS treatment
Biogen has entered a global licence and collaboration agreement with Alkermes for the development and commercialisation of ALKS 8700 to treat patients with multiple sclerosis (MS).
HitGen to identify new small molecule leads for Boehringer
China-based biotechnology company HitGen has entered a drug discovery research collaboration with German firm Boehringer Ingelheim to discover new small molecule leads.
Pharming submits application to FDA for Ruconest to treat HAE
Netherlands-based biotechnology company Pharming Group has submitted a supplemental biologics licence application (BLA) to the US Food and Drug Administration (FDA) for Ruconest (Recombinant Human C1 Esterase Inhibitor / conestat.
Merck to submit CDF proposal for cancer drug
The UK National Institute for Health and Care Excellence (NICE) has invited Merck to submit a Cancer Drugs Fund (CDF) proposal for its immunotherapy, avelumab, for the treatment of patients.
GSK and Innoviva file sNDA for expanded scope of Trelegy Ellipta
GlaxoSmithKline (GSK) and Innoviva have submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for the expanded indication of Trelegy Ellipta to treat patients.
Specialised Therapeutics to commercialise Puma’s Nerlynx for breast cancer
International biopharmaceutical company Specialised Therapeutics has signed an agreement to commercialise Puma Biotechnology’s Nerlynx (neratinib) throughout South East Asia for the treatment of breast cancer.