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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.

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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.

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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.

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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 […]

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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.

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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.

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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.

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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.

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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.

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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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