Drugs in the Pipeline

Xeljanz Demonstrates Efficacy in Third Phase 3 Ulcerative Colitis Study

Xeljanz Demonstrates Efficacy in Third Phase 3 Ulcerative Colitis Study

Pfizer announced top-line results from OCTAVE Sustain, the third Phase 3 study of Xeljanz (tofacitinib citrate) for the potential treatment of patients with moderately to severely active ulcerative colitis (UC).

Investigational Drug Fast Tracked for NASH with Liver Fibrosis

Investigational Drug Fast Tracked for NASH with Liver Fibrosis

The FDA has granted Fast Track designation to SHP626 (volixibat; Shire) for the potential treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis

Positive Results for Postoperative IV Meloxicam Announced

Positive Results for Postoperative IV Meloxicam Announced

Recro Pharma announced positive results from the Phase 3 study for intravenous (IV) meloxicam (N1539) for the treatment of acute postoperative pain in patients following bunionectomy surgery.

FDA Fast Tracks Personalized Treatment for Type 1 Diabetes

FDA Fast Tracks Personalized Treatment for Type 1 Diabetes

The FDA has granted Fast Track designation to Caladrius Biosciences' product candidate CLBS03 (autologous expanded polyclonal regulatory T cells, or Tregs) for the treatment of Type 1 diabetes mellitus (T1DM).

Second Breakthrough Therapy Designation Granted for Darzalex

Second Breakthrough Therapy Designation Granted for Darzalex

The FDA has granted Breakthrough Therapy designation to Darzalex (daratumumab; Janssen Biotech) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of multiple myeloma in patients who have received at least one prior therapy.

Novel Alzheimer's Disease Therapy Demonstrates Efficacy as Monotherapy

Novel Alzheimer's Disease Therapy Demonstrates Efficacy as Monotherapy

TauRx Therapeutics announced findings from the Phase 3 trial of LMTX for the treatment of mild or moderate Alzheimer's disease (AD). Results were presented at the 2016 Alzheimer's Association International Conference (AAIC) in Toronto, Canada.

Complete Response Letter Issued for Dextenza for Post-Surgical Ocular Pain

Complete Response Letter Issued for Dextenza for Post-Surgical Ocular Pain

The FDA has issued a Complete Response Letter (CRL) to the New Drug Application (NDA) of Dextenza (dexamethasone insert; Ocular Therapeutix) 0.4mg for the intracanalicular treatment of ocular pain after ophthalmic surgery.

Investigational Ebola Vaccine Granted Breakthrough Therapy Status

Investigational Ebola Vaccine Granted Breakthrough Therapy Status

Merck announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the investigational vaccine V920 (rVSV-ZEBOV-GP, live attenuated) for the Ebola Zaire virus.

Safety of Glycopyrrolate Via eFlow Nebulizer Closed System Evaluated in COPD

Safety of Glycopyrrolate Via eFlow Nebulizer Closed System Evaluated in COPD

Sunovion announced positive findings from the GOLDEN-5 safety study evaluating SUN-101 (glycopyrrolate) delivered via an investigational nebulizer system (SUN-101/eFlow) for the treatment of moderate-to-very severe chronic obstructive pulmonary disease (COPD).

FDA to Review Investigational Bone-Forming Monoclonal Antibody for Osteoporosis

FDA to Review Investigational Bone-Forming Monoclonal Antibody for Osteoporosis

Amgen and UCB announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Intranasal Metoclopramide Evaluated for Diabetic Gastroparesis in Women

Intranasal Metoclopramide Evaluated for Diabetic Gastroparesis in Women

Evoke Pharma announced topline Phase 3 data demonstrating that treatment with EVK-001 for the symptomatic relief of acute and recurrent diabetic gastroparesis in adult women failed to achieve the primary endpoint at Week 4.

FDA Fast Tracks Esketamine Gel for Acute Inner Ear Tinnitus

FDA Fast Tracks Esketamine Gel for Acute Inner Ear Tinnitus

The Food and Drug Administration (FDA) has granted Fast Track designation to Keyzilen (AM-101; Auris Medical) for the treatment of acute peripheral tinnitus following cochlear injury or otitis media in adults.

FDA to Review Device-Based Approach for Tear Production

FDA to Review Device-Based Approach for Tear Production

Allergan announced the submission of a de novo application to the Food and Drug Administration (FDA) for the Oculeve Intranasal Tear Neurostimulator device.

Generic Nilandron Now Available

Generic Nilandron Now Available

ANI announced that the Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for nilutamide tablets, the generic version of Nilandron (Covis), indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer.

FDA Grants Orphan Drug Status to Narcolepsy Treatment

FDA Grants Orphan Drug Status to Narcolepsy Treatment

The Food and Drug Administration (FDA) has granted Orphan Drug designation for mazindol (NLS Pharma) for the treatment of narcolepsy.