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Maryland-based REGENXBIO is expanding its gene therapy pipeline to include a new treatment for late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease, one of the most common forms of Batten disease.
Hemophilia A patients have another treatment option. This morning the U.S. Food and Drug Administration gave the nod to Bayer AG’s new treatment, Jivi (BAY94-9027).
Recently, Milton Packer, a renowned cardiologist at Baylor Scott & White Health, wrote a criticism of the Orphan Drug Act and the resulting problems caused by the biopharma industry. John LaMattina, formerly president of Pfizer Global Research and Development and a current senior partner at PureTech Ventures, responded to the editorial in Forbes. Let’s take a look.
The U.S. Food and Drug Administration (FDA) warned four online networks that operate 21 websites selling opioids online. The warning indicates they were “illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol.
Bristol-Myers Squibb has appointed Christopher Boerner to replace Murdo Gordon, who left the company on August 3. Boerner will take on the positions of executive vice president and chief commercial officer, effective immediately.
Touting that it is helping fight the opioid epidemic, Emergent BioSolutions is acquiring Adapt Pharma. Under the terms of the deal, Emergent will pay $635 million up front and up to $100 million in cash for various sales-based milestones through 2022.
As August rolls into September, BioSpace takes a look back at some key decisions made by the FDA. First are some of the draft guidance documents outlined by the FDA.
The biotech industry is fast-moving and dynamic, and staying on top of all the news can be hard for our busy readers. Here’s a look back at some of the top stories you may have missed this month.
Roche has been hit with another departing executive. This morning the Swiss pharma giant announced that Roland Diggelmann, the chief executive officer of the company’s diagnostics division, is leaving at the end of September.
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