Regulation

FDA approves Novartis’ Egaten to treat fascioliasis

Novartis has secured approval from the US Food and Drug Administration (FDA) for its Egaten (triclabendazole) to treat fascioliasis in patients six years of age and older.

FDA takes action against 17 firms for illegally selling products that claim to treat Alzheimer’s disease

The US Food and Drug Administration has posted 12 warning letters and 5 online advisory letters issued to foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions.

US court rejects Indivior’s appeal on Suboxone generic version

The US court has cleared way for Dr. Reddy's Laboratories to launch generic version of Indivior’s Suboxone (buprenorphine and naloxone) sublingual film, which is an opioid addiction treatment.

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).