Regulation

Janssen gets EC nod for prostate cancer drug Erleada

The Janssen Pharmaceutical Companies of Johnson & Johnson has secured marketing approval from the European Commission (EC) for Erleada (apalutamide) to treat non-metastatic castration-resistant prostate cancer (nmCRPC).

Silence’s SLN124 gets orphan designation in Europe for β-Thalassemia

Silence Therapeutics’ lead candidate SLN124 has secured orphan drug designation in the European Union for the treatment of β-Thalassemia.

Exelixis announces US FDA approval of CABOMETYX tablets for previously treated HCC

Exelixis announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX (cabozantinib) tablets for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Pfizer’s tafamidis secures FDA priority review for ATTR-CM

Pfizer’s tafamidis meglumine form (20mg capsule) has secured priority review from the US Food and Drug Administration (FDA) for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM).

Diurnal secures second US patent for Chronocort

UK-based specialty pharma company Diurnal Group said that the US Patent and Trademark Office (USPTO) has granted a second US patent for Chronocort (modified release hydrocortisone).

Ocular seeks FDA nod for expanded indication of Dextenza eye treatment

Ocular Therapeutix is seeking approval from the US Food and Drug Administration (FDA) for Dextenza (dexamethasone ophthalmic insert) to expand the current indication to include the treatment of ocular inflammation following ophthalmic surgery.

Novartis gets breakthrough therapy status for sickle cell disease treatment crizanlizumab

Novartis has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for crizanlizumab (SEG101) to prevent vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD).

Ironwood, Allergan set to resolve LINZESS patent litigation with Mylan

Ironwood Pharmaceuticals and Allergan have reached an agreement with Mylan Pharmaceuticals to resolve patent litigations over Mylan’s abbreviated new drug applications (ANDAs) seeking approval to market generic versions of LINZESS (linaclotide) before the expiration of their applicable patents.

BMS’ Sprycel secures FDA approval to treat pediatric Ph+ ALL

The US Food and Drug Administration (FDA) has expanded the approval of Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) tablets to include the treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in pediatric patients, aged one year or more.