BioSpace News Archive

FDA

Karolinska Development’s portfolio company OssDsign announces FDA clearance for Cranioplug

Karolinska Development’s portfolio company OssDsign announces that its latest product Cranioplug has received 510(k) clearance by the FDA, which allows marketing and sales of the product in US. The implant is the first product of its kind in the US market.

October 26, 2018
·
2 min read
Rigel offers free webinars

MEDICAL professionals are being offered the chance to improve patient safety thanks to a series of webinars delivered by biomedical testing experts at Rigel Medical.

October 26, 2018
·
1 min read
Business

Synergy Pharma Struggles Despite Promising Market Opportunities in 2019

After providing an update of its ongoing strategic review, New York-based Synergy Pharmaceuticals’ stock plunged more than 71 percent.

October 26, 2018
·
3 min read
·
Mark Terry
Policy

FDA Action Alert: Merck’s Keytruda in Lung Cancer, Trevena and AcelRx Drugs for Pain

As we end October and head into November, the Food and Drug Administration (FDA) continues its work. This upcoming week has several PDUFA action dates for drug applications. Here’s a look.

October 26, 2018
·
2 min read
·
Mark Terry
Pharm Country

Glycotest Inc. Closes $10 Million Series A Financing

Glycotest Inc., Inc. announced today the close of a Series A funding round of $10 million from Shanghai Fosun Pharmaceutical Co., Ltd.

October 26, 2018
·
4 min read
Policy

Almac Group Announces Successful HSA Inspection of Singapore Facility

Growth in Asia continues with ongoing investment in Headquarters site

October 26, 2018
·
2 min read
BioCapital

Science Top Company List Ranks Innovation and Work Culture

In a survey of more than 8,000 people in the biotech and pharma industry for Science, Regeneron Pharmaceuticals, topped the list.

October 26, 2018
·
3 min read
·
Mark Terry
Drug Development

Ultragenyx Plunges With Phase III Failure, Company to Discontinue Glut1 DS Development Program

Shares of Ultragenyx are down more than 15 percent this morning after the company announced its Phase III drug candidate UX007 failed to hit the mark as a treatment for patients with glucose transporter type-1 deficiency syndrome.

October 26, 2018
·
2 min read
·
Alex Keown
Business

OncoDNA Signs Distribution Agreement with Gammaray Private Health Services in Turkey and AMS 2000 Trading Impex in Romania

Agreement demonstrates growing use of OncoDNA solutions across Europe

October 26, 2018
·
4 min read
Business

FDA Seeks Public Consultation on New Classification Systems-Based Biowaivers Guideline

The U.S. Food and Drug Administration (FDA) is eying the spring of 2019 to finalize its biopharmaceutical classification system-based biowaivers guidelines. On Thursday, the regulatory agency released the draft guidance for public consultation.

October 26, 2018
·
2 min read
·
Alex Keown