Drugs in the Pipeline

Eribulin vs. Dacarbazine for Soft Tissue Sarcoma: New Data Released

Eribulin vs. Dacarbazine for Soft Tissue Sarcoma: New Data Released

Eisai announced results from a Phase 3 trial investigating the use of eribulin vs. dacarbazine in patients with advanced soft tissue sarcomas.

New Data on Once-Daily Baricitinib for RA From Phase 3 Trial

Eli Lilly and Company and Incyte announced results from a second Phase 3 trial with baricitinib in patients with rheumatoid arthritis.

Breakthrough Therapy for Rare Enzyme Disorder Could Be Approved Even Sooner

The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for Kanuma (sebelipase alfa; Synageva BioPharma) for the treatment of lysosomal acid lipase deficiency (LAL Deficiency).

Shorter FDA Review for Tx of Rare Lung Disorder

The Food and Drug Administration (FDA) has accepted for Priority Review a supplemental New Drug Application (sNDA) for Rapamune (sirolimus; Pfizer) for the treatment of lymphangioleiomyomatosis (LAM).

New Oral Combo for Metastatic Colorectal Cancer To Get FDA Review

The Food and Drug Administration (FDA) has accepted Taiho's New Drug Application (NDA) for review for TAS-102 (nonproprietary names: trifluridine and tipiracil HCl) for the treatment of refractory metastatic colorectal cancer (mCRC).

FDA to Review Belbuca for Pain Management

The Food and Drug Administration (FDA) has accepted the NDA for review for Belbuca (buprenorphine HCl; Endo and BioDelivery Sciences) buccal film for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

FDA to Review Combination Therapy for Advanced Melanoma

The Food and Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of patients with BRAF V600 mutation-positive advanced melanoma.

Adcetris sBLA Submitted for Post-Transplant Hodgkin Lymphoma

Seattle Genetics has submitted a supplemental Biologics License Application (BLA) to the Food and Drug Administration (FDA) for Adcetris (brentuximab vedotin) as consolidation therapy immediately following an autologous stem cell transplant (ASCT) in Hodgkin lymphoma patients at high risk of relapse.

Entrectinib Designated Orphan Drug for Colorectal Cancer

The Food and Drug Administration (FDA) has granted Orphan Drug designation to entrectinib (Ignyta) for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive or ALK-positive colorectal cancer.

Hypoactive Sexual Desire Disorder Drug for Women Gets Closer to Approval

Sprout Pharmaceuticals has resubmitted its New Drug Application (NDA) to the FDA for flibanserin for Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women.

Orphan Drug Designation Granted to Glioblastoma Multiforme Therapy

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Saposin C, the active ingredient in BXQ-350 (Bexion) for the potential treatment of glioblastoma multiforme.

ALO-02 NDA Under Review for Pain Management

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALO-02 (oxycodone HCl and naltrexone HCl; Pfizer) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate.

Investigational Heart Failure Therapy Granted Priority Review

The Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for LCZ696 (Novartis) for the treatment of heart failure with reduced ejection fraction (HFrEF).

FDA Fast Tracks Intranasal Naloxone

Lightlake Therapeutics and Adapt Pharma Limited announced that the Food and Drug Administration (FDA) has granted Fast Track designation to its intranasal naloxone, an opioid antagonist for opioid overdose reversal treatment.

Lenvatinib Delays Progression of Advanced Thyroid Cancer in Clinical Trial

Lenvatinib Delays Progression of Advanced Thyroid Cancer in Clinical Trial

Oral lenvatinib delayed progression of advanced thyroid cancer by 18 months, compared with four months for patients treated with a placebo, according to results from a new clinical trial.