BioSpace News Archive

The CHMP positive opinion for ADCETRIS will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the 28 countries of the European Union (EU), Norway, Liechtenstein and Iceland.

Medicare beneficiaries in 23 additional states have been granted reimbursed access to the Transoral Incisionless Fundoplication (TIF) 2.0 procedure following positive coverage decisions by Medicare Administrative Contractors (MACs) Noridian Health Care Solutions (Noridian) and National Government Services, Inc. (NGS).

Albireo reported a net loss of $6.5 million for the third quarter of 2017 compared with a net loss of $4.0 million for the third quarter of 2016.

As of September 30, 2017, cash, cash equivalents and short-term investments were $30.4 million, as compared to $10.5 million as of December 31, 2016.

For the quarter ended September 30, 2017, Celsion reported a net loss of $5.7 million, or $(0.70) per share, compared to a net loss of $6.4 million, or $(3.22) per share, in the same period of 2016

The study demonstrated no adverse clinical findings after repeated intravenous administration of the maximum achievable dose of 3DNA nanocarrier.

For the three months ended September 30, 2017, Mateon reported a net loss of $3.5 million, compared to a net loss of $3.2 million for the three months ended September 30, 2016.

This is the first study to examine the potential health economic value of RST in MM within the EU.

The FDA today issued a safety communication to warn consumers and health care practitioners about the serious injuries and disfigurement that can result from using injectable silicone or products being falsely marketed as FDA-approved dermal fillers for the purpose of enhancing the size of their buttocks, breasts and other body parts.

Monopar Therapeutics today announced the acquisition of GPX-150 from privately held Gem Pharmaceuticals concurrent with $9.7M of new financing.