Eisai Submits Fycompa Pediatric Indications to FDA
Eisai Inc. submitted a supplemental New Drug Application for priority review to the U.S. FDA for the company’s antiepileptic drug Fycompa (perampanel) CIII as monotherapy and adjunctive use.
New CDC Director Pledges to Take on AIDS and Opioid Epidemics
Days after being tapped to helm the U.S. Centers for Disease Control and Prevention (CDC), Dr. Robert Redfield predicted the AIDS epidemic can be defeated within the next three to seven years and the challenges of the opioid crisis can also be brought “to its knees.”
Researchers Develop Possible New RNA Therapy for West Nile Virus
A research group at Yale University and from Hanyang University, South Korea, developed a new RNA therapy for West Nile Virus.
Sunovion Submits NDA for Sublingual PD Treatment
Sunovion Pharmaceuticals announced the submission of a new drug application to the U.S. FDA for apomorphine sublingual film to treat OFF episodes in Parkinson’s disease (PD).
FDA Approves Amgen’s Blincyto for ALL
The FDA approved Amgen’s supplemental Biologic License Application for Blincyto (blinatumomab) to treat B-cell precursor acute lymphoblastic leukemia (ALL) under specific circumstances.
Coffee sellers in California must have cancer warning
Starbucks Corp. and other coffee sellers must put a cancer warning on coffee sold in California, a Los Angeles judge ruled, possibly exposing the companies to millions of dollars in fines.
Arkansas sues opioid manufacturers
Arkansas’ attorney general joined the widening mass of litigation against opioid manufacturers, accusing three drugmakers of promoting addictive painkillers in ways that falsely denied or trivialized their risks.
Sandbox Opens Contemporary New Workspace in Kansas City
Sandbox announced the opening of the independent, full-service agency’s new office space in Kansas City, Mo., uniting its two local locations under one roof.
Rare heart disease drug succeeds in late-stage study
Pfizer Inc.’s experimental drug to treat a rare and fatal disease linked to heart failure reduced deaths and need for hospitalizations in a late-stage study.
Unum Captures Nearly $70 Million in IPO
In an initial public offering, Unum Therapeutics snagged nearly $70 million to fund its antibody-coupled T-cell receptor technology.
MediciNova’s Drug Flunks Phase II Trial
La Jolla, Calif.-based MediciNova announced that the company’s Phase II clinical trial of ibudilast (MN-166) failed to meet its primary endpoint for methamphetamine dependence.
Edge Therapeutics Reports Phase III Failure of Brain-Bleed Drug, Prepares to Cut Staff
Shares of Edge Therapeutics were in a free fall following the company’s decision to discontinue development of a late-stage treatment for adults with aneurysmal subarachnoid hemorrhage.
Lawsuits Allege Safety Concern Over Novartis CML Drug Tasigna
A Novartis leukemia drug continues to be the subject of a handful of lawsuits filed by plaintiffs due to concerns over atherosclerosis-related conditions.
FDA Orphan Drug Designation Granted for MaxiNovel Pharmaceuticals’ MAX-40279 for the Treatment of Acute Myeloid Leukemia
MaxiNovel Pharmaceuticals, Inc. Announces FDA Orphan Drug Designation for MAX-40279 for the Treatment of Acute Myeloid Leukemia (AML) GUANGZHOU, China–(BUSINESS WIRE)–MaxiNovel Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (“FDA”) has granted MaxiNovel Orphan Drug Designation for MAX-40279 in the treatment of Acute Myeloid Leukemia (AML). AML is the most […]
Impax reaches $20 million deal to end trial over generic drug’s delay
Impax Laboratories Inc. agreed to pay $20 million to consumers and insurers to resolve claims that the drugmaker entered an anticompetitive deal to delay launching a generic, cheaper version of the acne medication Solodyn.
Dr. Reddy’s Laboratories Announces Senior Leadership Changes
Dr. Reddy’s Laboratories Ltd. announced a change in the makeup of the company’s senior leadership team.
Teva wins reversal of U.S. jury’s $235 million GSK drug patent verdict
A federal judge overturned a U.S. jury’s verdict that required Teva Pharmaceutical Industries Ltd. to pay GlaxoSmithKline Plc more than $235 million for infringing a patent covering its blood pressure drug Coreg.
FDA Approves Mylan’s New HIV Drug
The U.S. Food and Drug Administration approved Mylan NV’s Symfi (efavirnenz, lamivudine and tenofovir disoproxil fumarate) for adult and pediatric HIV-1 patients who weigh at least 40 kilograms.
Celgene and bluebird bio Team Up in New Deal
Celgene Corp. and bluebird bio Inc. inked a development and promotion deal for bb2121, bluebird’s B-cell maturation antigen CAR-T therapy for relapsed/refractory multiple myeloma.
Homology Medicines Snags $144 Million IPO
Two months after securing a new facility in Bedford, Mass., Homology Medicines raised $144 million in an initial public offering of stock.
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