Regulation

AstraZeneca’s Fasenra gets approval in Europe for severe eosinophilic asthma

AstraZeneca has secured approval from the European Commission (EC) for Fasenra (benralizumab) as an add-on maintenance treatment for patients with severe eosinophilic asthma.

Lipocine Announces Outcome of FDA Advisory Committee Meeting for TLANDO, Testosterone Replacement Therapy in Adult Males with Hypogonadism

Lipocine Inc., a specialty pharmaceutical company, announced that the Bone, Reproductive and Urologic Drugs Advisory Committee ("BRUDAC") of the U.S. Food and Drug Administration ("FDA") voted six in favor and thirteen against the benefit/risk profile of TLANDO, the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

FDA expands use of Amgen’s XGEVA drug

Amgen has secured approval from the US Food and Drug Administration (FDA) for its supplemental biologics license application (sBLA) of XGEVA (denosumab) to expand the currently approved indication to prevent skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.

Novartis’ Promacta gets FDA breakthrough designation for severe aplastic anemia

Novartis’ drug Promacta (eltrombopag) has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for first-line treatment of severe aplastic anemia (SAA).

Roche secures cancer drug approvals in Europe and US

Switzerland-based drug manufacturer Roche has secured approvals for two cancer drugs in Europe and the US.

Spark’s gene therapy Luxturna secures FDA approval for rare form of blindness

Spark Therapeutics’ gene therapy Luxturna (voretigene neparvovec) has been approved by the US Food and Drug Administration (FDA) for the treatment of children and adults having a rare inherited form of vision loss that could lead to blindness.

Alnylam, Sanofi submit MAA to EMA for patisiran to treat hereditary ATTR amyloidosis

Alnylam Pharmaceuticals and Sanofi Genzyme have submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of adults with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).

FDA proposes risk-based enforcement approach to homeopathic drugs

The US Food and Drug Administration (FDA) is proposing new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs.

CHMP recommends approval of darvadstrocel to treat complex perianal fistulas in Crohn’s disease

Takeda Pharmaceutical and TiGenix reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), in conjunction with the Committee for Advanced Therapies (CAT), has adopted a positive opinion recommending a marketing authorization (MA) for investigational compound Cx601 (darvadstrocel).