AbbVie’s Elagolix succeeds in second phase 3 uterine fibroid study

AbbVie, along with Neurocrine Biosciences, announced that the Phase 3 ELARIS UF-II study (M12-817) of elagolix met its primary endpoint.

Kiadis raises €23.4m to develop immunotherapy for GVHD

Kiadis Pharma has raised €23.4m of funding in a private placement of 2.6 million new shares, for developing a T-cell immunotherapy product to reduce Graft versus Host Disease (GVHD) in hematopoietic stem cell transplantations (HSCT).

FDA grants Merck’s Keytruda priority review for cervical cancer

Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) has been granted priority review designation by the US Food and Drug Administration (FDA) for the treatment of advanced cervical cancer.

FDA upholds decision on generic version of GSK’s asthma/COPD inhaler Advair Diskus

The US Food and Drug Administration (FDA) has upheld the earlier decision of turning down Hikma and Vectura’s generic version of GlaxoSmithKline’s (GSK) Advair Diskus (fluticasone propionate and salmeterol inhalation powder).

Sarepta plans to submit NDA for Golodirsen Duchenne drug by year end

Sarepta Therapeutics has is planning to submit a new drug application (NDA) for accelerated approval of its duchenne muscular dystrophy (DMD) drug Golodirsen (SRP-4053).

Janssen’s Invokana reduces cardiovascular risk in diabetes patients

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced results of a new analysis showing that Invokana (canagliflozin) significantly reduced the risk of cardiovascular (CV) death or hospitalization for heart failure (HHF) in patients with type 2 diabetes (T2D) at high CV risk.

Biogen to acquire Pfizer’s schizophrenia drug for up to $590m

Biogen has agreed to buy Pfizer’s investigational schizophrenia drug, PF-04958242, in a deal worth about $590m.

Covance establishes new global unit for biologic drug development

LabCorp’s Covance Drug Development business has established a global immunology and immunotoxicology (I&I) unit to focus on the development of biologic drugs.

Prevail Therapeutics raises $75m financing for Parkinson’s gene therapies

Prevail Therapeutics has secured $75m series A financing to advance the development of gene therapies for patients with Parkinson’s and other neurodegenerative diseases.

Regeneron’s anti-cholesterol drug Praluent reduces death risk in trial

Praluent (alirocumab), an anti-cholesterol drug being developed by Regeneron Pharmaceuticals and Sanofi, has succeeded in the Odyssey Outcomes trial by decreasing the risk of death and heart attack in high-risk patients.