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19391 items
8:01 PM, Aug 31, 2018  |  BioCentury | Politics, Policy & Law

A pathway to Biopharma 3.0

As market and social forces continue to tighten around the biopharmaceutical industry, drug companies need to start evolving toward a new business model that both capitalizes on the potential of new technologies and accommodates society’s...
7:58 PM, Aug 31, 2018  |  BioCentury | Politics, Policy & Law

Stepping Through

Once considered obstacles to biomedical product development, regulators around the world have become enablers of the kinds of scientific and economic innovations that will underpin new business models. They are building gateways that could help...
12:02 PM, Aug 30, 2018  |  BioCentury | Finance

Building a deeper Harbour

With an $85 million B round in hand, Harbour BioMed plans to advance newly in-licensed clinical programs while simultaneously building its pipeline through its internal platform and co-discovery deals. Singapore sovereign wealth fund GIC led the...
1:59 PM, Aug 29, 2018  |  BioCentury | Finance

Sweetening the pot

KaNDy Therapeutics Ltd. believes its first venture round as an independent company will fund development of a non-hormonal therapy for menopausal symptoms that will be ready for a Phase III trial by 2020. Longitude Capital led...
2:24 PM, Aug 24, 2018  |  BioCentury | Politics, Policy & Law

The Louisiana purchase

Faced with a choice between treating its HCV population or funding other public services like education, Louisiana’s Department of Health Secretary Rebekah Gee was motivated to find a way to do both. Working with drug...
12:35 PM, Aug 24, 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...
6:59 PM, Aug 17, 2018  |  BioCentury | Product Development

Agreement to differ

FDA’s approval of Alnylam’s Onpattro marks the start of a showdown in the Orphan disease hATTR amyloidosis, with Akcea’s Tegsedi likely coming to the U.S. market in less than two months. Alnylam has used its...
6:40 PM, Aug 17, 2018  |  BioCentury | Regulation

Pediatric push

FDA has endorsed extrapolation of therapeutic efficacy from adults to children for new drugs to treat partial onset seizures in a draft guidance and is now discussing in public meetings whether the approach can be...
5:11 PM, Aug 17, 2018  |  BioCentury | Product Development

Doing more with less

In rare diseases where natural history data are scarce, Phase II studies may have to perform dual duty to both seek efficacy signals and test out new endpoints. Ovid Therapeutics Inc. and Clementia Pharmaceuticals Inc....
3:33 PM, Aug 17, 2018  |  BioCentury | Finance

Vaccine volatility

The last two weeks have not been kind to biopharma companies listed on Chinese exchanges, and Thursday’s announcements regarding the resignations of officials over a vaccine scandal could further dampen sentiment. Earlier this month, the...