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258375 items
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extrapolation of therapeutic efficacy from adults to children for new drugs to treat partial onset seizures in a draft guidance and is now discussing in public meetings whether the approach can be...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....
4:51 PM, Aug 17, 2018  |  BC Extra | Financial News

Antibacterial company Entasis proposes NASDAQ IPO

Entasis Therapeutics Inc. (Waltham, Mass.) proposed on Friday to raise $86.3 million in an IPO on NASDAQ underwritten by Credit Suisse, BMO Capital Markets, SunTrust Robinson Humphrey and Wedbush PacGrow. In September, the antibacterial company raised...
4:37 PM, Aug 17, 2018  |  BC Extra | Financial News

Harbin Gloria selling stake in biotech unit

Harbin Gloria Pharmaceuticals Co. Ltd. (SZSE:002437) said Friday it plans to sell a 51% stake in biotech subsidiary Guangzhou Gloria Biotechnology Co. Ltd. (Guangzhou, China) to 6 Dimensions Capital, Boyu Capital and two other investors. The...
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...
2:53 PM, Aug 17, 2018  |  BioCentury | Finance

MD Anderson’s blooms

The recent launch of Magnolia Neurosciences Corp. with a $31 million series A round is the latest example of a broader effort by the University of Texas MD Anderson Cancer Center to ramp up company...
1:34 PM, Aug 17, 2018  |  BC Extra | Politics & Policy

China unveils cancer drugs for medical insurance access negotiation

China's State Medical Insurance Administration announced 18 cancer drugs that will be included in 2018 medical insurance access negotiations. Companies with drugs on the list will now enter into negotiations to include the drugs on...
1:30 PM, Aug 17, 2018  |  BioCentury | Finance

Location, location, biotech

Chinese real estate investor Xuechao Wang placed a bet on a domestic cancer start up 16 years ago, which helped pave the way for the country’s first homegrown targeted cancer therapy. Now, market growth in...
11:59 AM, Aug 17, 2018  |  BC Week In Review | Company News  |  Sales & Marketing

Vertex nears Orkambi reimbursement agreement with Australia

Australia's Pharmaceutical Benefits Advisory Committee (PBAC) recommended in July that the government subsidize the price of Orkambi lumacaftor/ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX). The drug is approved to treat cystic fibrosis in patients ages six...