Regulation

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.

Zydus Cadila secures USFDA nod to market acne drug

Zydus Cadila, an Indian pharmaceutical company, has obtained final approval from the US Food and Drug Administration (FDA) to market Clindamycin Phosphate and Benzoyl Peroxide Gel.

US FDA approves Sanofi’s new pediatric vaccine

The US Food and Drug Administration (FDA) has approved Sanofi’s pediatric hexavalent combination vaccine for use in children between six weeks and five years of age.

FDA accepts Kala Pharmaceuticals’ NDA for KPI-121 0.25%

The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) submitted by Kala Pharmaceuticals for its KPI-121 0.25% product candidate.