Company

Product

Description

Indication

Status

Allergan plc, of Dublin

Avycaz (ceftazidime and avibactam)

Third-generation cephalosporin and bactericidal agent

Complicated urinary tract infections and complicated intra-abdominal infections

FDA accepted for review the supplemental NDA seeking to expand label to include treating cUTIs and cIAIs, in combination with metronidazole, in pediatric patients, ages 3 months to under 18 years

Auris Medical Holding AG, of Zug, Switzerland

AM-201

Intranasal betahistine formulation

Prevention of olanzapine-induced weight gain

Results of pre-IND meeting showed FDA supports planned multiple-dose phase I trial in healthy subjects in combination with olanzapine and endorsed weight gain normalized to baseline body weight vs. placebo as primary efficacy endpoint for subsequent phase II trial; agency also deemed 505(b)(2) pathway appropriate for the AM-201 program

Biolinerx Ltd., of Tel Aviv, Israel

AGI-134

Synthetic alpha-Gal glycolipid

Solid tumors

FDA granted biological product designation, providing eligibility to obtain 12 years of market exclusivity upon approval

Intelgenx Corp., of Saint Laurent, Quebec

Rizaport (oral thin film rizatriptan benzoate)

5-HT1 receptor agonist

Acute migraine

FDA accepted the 505(b)(2) NDA resubmission; PDUFA date is April 1, 2019

Ose Immunotherapeutics SA, of Nantes, France

Tedopi

Combination of 10 neo-epitopes aimed at stimulating T lymphocytes

Advanced or metastatic pancreatic cancer

French regulators approved a phase II trial testing Tedopi plus Opdivo (nivolumab, Bristol-Myers Squibb Co.) vs. FOLFIRI

Pliant Therapeutics Inc., of South San Francisco

PLN-74809

Antifibrotic compound

Primary sclerosing cholangitis

FDA granted orphan drug designation

Sage Therapeutics Inc., of Cambridge, Mass.

Zulresso (brexanolone)

Allosteric modulator of synaptic and extrasynaptic GABAA receptors

Postpartum depression

FDA extended the PDUFA date for the priority review NDA from Dec. 19, 2018, to March 19, 2019, to allow for submission of a risk evaluation and mitigation strategy with elements to ensure safe use

Stemline Therapeutics Inc., of New York

Elzonris (tagraxofusp; SL-401)

Targets CD123

Blastic plasmacytoid dendritic cell neoplasm

EMA granted accelerated assessment for the upcoming MAA, which Stemline expects to complete in the first quarter of 2019

Swedish Biovitrum AB, of Stockholm, and Novimmune SA, of Geneva

Gamifant (emapalumab-lzsg)

Interferon gamma-blocking antibody

Primary hemophagocytic lymphohistiocytosis

Approved by FDA for use in pediatric (newborn and older) and adult patients with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy


Notes

For more information about individual companies and/or products, see Cortellis.

 

No Comments