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Kallyope, Novo Nordisk Team Up To Tackle Obesity

New York-based Kallyope and Danish company Novo Nordisk signed a research collaboration and option deal to discover novel therapeutics to treat obesity and diabetes.

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Organ-on-a-Chip Company Emulate Closes on $36 Million Series C Financing

Boston-based Emulate closed on a Series C round worth $36 million, led by Founders Fund.

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Chinese Biotechs Flex Financial Muscles With Continued Investments

Chinese companies and investors continue to flex their financial muscles with a series of deals that highlight the continued growing impact that country is having on the global pharmaceutical and biotech landscape.

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Cytokinetics’ Spinal Muscular Atrophy Drug Shows Promise in Phase II

South San Francisco-based Cytokinetics released data from the company’s Phase II clinical trial of reldesemtiv in patients with spinal muscular atrophy at the 2018 Annual Cure SMA Conference held in Dallas.

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Selecta Unveils Expanded Positive Clinical Data for Gout Treatment

Watertown, Mass.-based Selecta Biosciences is eying a Phase III trial for its gout treatment based on expanded positive data from an ongoing mid-stage study that showed a significant reduction of serum uric acid at 12 weeks.

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Anemia Patients Benefit from bluebird’s LentiGlobin Gene Therapy, Trial Data Shows

Cambridge, Mass.-based bluebird bio’s LentiGlobin gene therapy is increasing hemoglobin levels in anemia patients battling sickle cell disease and beta thalassemia, which reduces the need for blood transfusions in those patients.

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AMAG Pharmaceuticals Divests Cord Blood Registry for $530 Million

Waltham, Mass.-based AMAG Pharmaceuticals will secure $530 million in cash as the company divests Cord Blood Registry to GI Partners, a private equity investment firm.

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Study: Common Medications Taken By U.S. Adults Could Increase Risks of Depression, Suicide

A new study finds that one-third of adults in the United States are potentially at risk of depression due to their medications.

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Sage Therapeutics Forges $575 Million Deal With Shionogi to Market Depression Drug in Parts of Asia

Days after the U.S. Food and Drug Administration provided an expedited path forward for SAGE Therapeutics’ depression treatment SAGE-217, the company snagged a deal worth $575 million from Japanese pharma firm Shionogi & Co. Ltd. to market the potential drug in parts of Asia.

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FDA Commissioner Proposes Licensing Model for Antimicrobial Drugs

  By Alex Keown   Food and Drug Administration (FDA) chief Scott Gottlieb is making a pitch to change the reimbursement model for antimicrobial drugs that target multidrug-resistant infections. In a unique proposal, Gottlieb suggested that acute care providers move to a licensing model, similar to the way software is acquired.   “Developing new drugs […]

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Flex Pharma Shutters Phase II ALS Program

Boston-based Flex Pharma announced the closing of a Phase II clinical trial of FLX-787 in amyotrophic lateral sclerosis (ALS) and Charcot-Marie-Tooth (CMT).

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NYC Continues Quest to Become Premiere Biotech Hub

For the last several years, New York has been building itself up to be the largest biotech hub on the east coast. The drive has been part of initiatives launched by state and local government leaders that include hundreds of millions of dollars for investment.

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FDA Provides Expedited Path Forward For Sage’s Depression Treatment SAGE-217

Following a meeting with the U.S. Food and Drug Administration, SAGE Therapeutics is seeing the goal line for potential expedited approval of the company’s major depressive disorder and postpartum depression treatment SAGE-217 (brexanolone).

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Novartis Pays Regenxbio $100 Million for Gene Therapy Technology Under AveXis License Agreement

Rockville, Md.-based REGENXBIO snagged $100 million from Novartis under its license agreement with gene-therapy company AveXis, which the Swiss company acquired for $8.7 billion earlier in 2018.

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Vical Shares Plunge After Clinical Trial Failure

Six months after San Diego-based Vical saw a late-stage stem cell transplant trial flop, the company reported another fail, for its Phase II herpes drug.

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Venclexta\Rituxan Combo Gets FDA Approval

The U.S. FDA approved AbbVie and Roche’s combination of Venclexta and Rituxan to treat chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without 17p deletion in patients who have received at least one previous therapy.

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Melinta Therapeutics: $123 Million in Public Offering

New Haven, Conn.-based Melinta Therapeutics snagged $123 million in a public offering of 22,000,000 shares of its common stock.

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Translate Bio and Sanofi Ink Potential $850 Million mRNA Vaccine Development Deal

Translate Bio, headquartered in Lexington, Massachusetts, and Paris-based Sanofi are teaming up to develop five vaccines.

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FDA Approves Genentech’s Rituxan for Rare Skin Disease

The U.S. FDA approved Genentech’s Rituxan (rituximab) to treat adults with moderate to severe pemphigus vulgaris.

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French Company Ipsen to Move U.S. Headquarters to Boston

Ipsen plans to relocate the French company’s U.S. operations from New Jersey to Kendall Square in Cambridge, Mass.

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April 2018 Focus: Agency Profiles, Manny Awards and Annual Review


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