Regulation

Finch gets FDA breakthrough therapy status for CP101 to treat recurrent C. Difficile infection

Finch Therapeutics Group has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational drug CP101 to treat patients with recurrent Clostridium difficile (C. difficile) infection.

FDA extends review period for Incyte’s GVHD treatment Jakafi

The US Food and Drug Administration (FDA) has extended the review period for Incyte’s supplemental new drug application (sNDA) for acute graft-versus-host disease (GVHD) treatment Jakafi (ruxolitinib).

Sanofi gets FDA nod for blood disorder drug Cablivi

Sanofi has secured approval from the US Food and Drug Administration (FDA) for its blood-disorder drug Cablivi (caplacizumab-yhdp).

AstraZeneca’s RSV drug MEDI8897 gets FDA’s breakthrough therapy designation

AstraZeneca’s MEDI8897 has secured breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for the prevention of lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV).

Roche seeks FDA approval for Kadcyla in HER2-positive early breast cancer

Roche has submitted a supplemental biologics license application (sBLA) in the US seeking approval for Kadcyla (trastuzumab emtansine) for the adjuvant treatment of a type of early breast cancer.

CHMP recommends Keytruda-chemo combo in squamous NSCLC

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Merck’s Keytruda plus chemotherapy to treat metastatic squamous non-small cell lung cancer (NSCLC).

AstraZeneca’s Forxiga recommended for marketing authorization in EU

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended AstraZeneca’s Forxiga (dapagliflozin) to treat adults with type-1 diabetes (T1D).

Merck’s 15-valent pneumococcal conjugate vaccine gets FDA breakthrough therapy designation

Merck has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its V114 investigational 15-valent pneumococcal conjugate vaccine.

Vertex secures Health Canada approval for expanded use of KALYDECO

Vertex Pharmaceuticals announced that Health Canada has granted Market Authorization for KALYDECO (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12 to <24 months who have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.