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19358 items
5:00 PM, Aug 10, 2018  |  BioCentury | Product Development

Exacerbation management

Based on work spearheaded by the Cystic Fibrosis Foundation, Corbus Pharmaceuticals Holdings Inc. will be the first company to attempt to gain approval in CF based on pulmonary exacerbations instead of FEV1. The company is...
4:08 PM, Aug 10, 2018  |  BioCentury | Finance

Takeda gets Ambys-tious

After a two-year search, Takeda Pharmaceutical Co. Ltd.’s equity investment and option deal with newco Ambys Medicines finally gets the ball rolling on the pharma’s goal of building a liver franchise within its core area...
3:29 PM, Aug 10, 2018  |  BioCentury | Regulation

A new diagnosis

FDA has given up on the idea that diagnostic tests can be shoehorned into the medical device regulatory paradigm, and has asked Congress to create a new framework for oversight. Like FDA’s initiatives to revamp...
2:41 PM, Aug 10, 2018  |  BioCentury | Finance

Wnt to market

With no traditional life science VCs in its syndicate and little publicly disclosed about its science, Samumed LLC was able to raise a $438 million round at a premoney valuation of $12 billion, bringing its...
12:51 PM, Aug 10, 2018  |  BioCentury | Finance

Sound story

Preclinical data supporting Akouos Inc.’s hearing loss program convinced 5AM Ventures to re-up for a $50 million series A round, and those funds plus additions to the Akouos team have the company poised to take...
9:07 AM, Aug 10, 2018  |  BioCentury | Finance

Missing the obvious

Despite the vast amount of venture money being poured into innovation in healthcare, women’s health still remains an underserved market with significant untapped potential. The importance of this for public health is often overlooked in favor...
2:59 PM, Aug 07, 2018  |  BioCentury | Finance

Navigating the Hot Topics landscape

Investors are making aggressive bets on the ability of early stage companies to deliver on the next generation of therapeutics and technologies. But advances in biology and novel technologies come with challenges ranging from unknown...
6:27 PM, Aug 03, 2018  |  BioCentury | Strategy

Addressing sexual harassment claims at the board level

In today’s environment, no industry is immune from claims of workplace harassment. Allegations can not only tarnish a company’s -- and a board’s -- reputation, and impair shareholder value, but imperil the existence of a...
5:59 PM, Aug 03, 2018  |  BioCentury | Finance

Hong Kong’s first wave

Having broken the seal on the new biotech chapter of Hong Kong Exchange and Clearing Ltd., the performance of Ascletis Pharma Inc. and the next few companies to go out could determine what happens to...
5:46 PM, Aug 03, 2018  |  BioCentury | Finance

Functions of formulation

Halozyme Therapeutics Inc. is quickly expanding the reach of its Enhanze platform on the back of regulatory approvals for products that are now gaining market share, plus a playbook for streamlined early development it can...