BioSpace News Archive

Career Advice

10 Signs You’re Ready for a Management Position in Biopharma

Making the step up into a management position is an important professional milestone. To help with that difficult decision, here are 10 signs you’re ready for a management position in biopharma.

August 28, 2018
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4 min read
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Editorial Staff
Drug Development

Akcea Therapeutics Stunned by FDA Rejection of FCS Treatment Waylivra, Shares Plunge

A betting man may have placed a pretty strong wager on the U.S. Food and Drug Administration’s approval of Akcea Therapeutics’ Waylivra (volanesorsen), a treatment for the rare lipid disorder familial chylomicronemia syndrome (FCS).

August 28, 2018
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3 min read
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Alex Keown
Drug Development

Biogen and Eisai Report Phase Ib Extension Data for Alzheimer’s Trial

Cambridge, Mass.-based Biogen and Tokyo, Japan-based Eisai Co. announced results from an analysis of their ongoing long-term extension (LTE) Phase Ib trial of aducanumab for Alzheimer’s disease.

August 28, 2018
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3 min read
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Mark Terry
Deals

Alzheon Takes Another Shot at an IPO

In April, Alzheon attempted an initial public offering (IPO) to raise $80 million, but withdrew the offering. It has decided to try again, filing with the U.S. Securities and Exchange Commission (SEC), indicating it planned to raise $40 million in an IPO.

August 28, 2018
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2 min read
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Mark Terry
Drug Development

What You May Have Missed: Top Biotech Stories for the Month of August

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.

August 28, 2018
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5 min read
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Mark Terry
Drug Development

Health Watchdog Group Calls for Termination of Sepsis Treatment Trial

Citing safety concerns, a watchdog organization is calling on the National institutes of Health to halt enrollment in a clinical trial evaluating a treatment for sepsis that the organization said is risky and flawed.

August 28, 2018
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2 min read
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Alex Keown
Business

3 of Vivek Ramaswamy’s ‘Vant Companies in the News: Roivant, Dermavant and Urovant

Three of Vivek Ramaswamy’s companies reported activity today including corporate changes, a licensed therapy and investment of $100 million.

August 28, 2018
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2 min read
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Mark Terry
Policy

U.K.’s NICE Rejects Gilead Sciences’ Yescarta Over the Drug’s Cost

The United Kingdom’s government-funded health service isn’t being so nice to Gilead Science’s CAR-T blood cancer treatment Yescarta. The country’s National Institute for Health and Care Excellence (NICE) said the therapy is too expensive for the agency to justify.

August 28, 2018
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2 min read
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Alex Keown
Policy

During A Busy August, FDA Issues Multiple New Draft Guidance Documents

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.

August 28, 2018
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4 min read
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Alex Keown
Business

Roche’s Diagnostics Division Head Roland Diggelmann Is Leaving the Company

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.

August 28, 2018
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2 min read
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Alex Keown