BioSpace News Archive

Policy

Genentech and Hemophilia Patients Eye Oct. 4 for Hemlibra Ruling

Hemophilia patients could have an easier time taking their medication if the U.S. Food and Drug Administration (FDA) gives the green light for the newest indication of Genentech’s Hemlibra for patients who do not have Factor VIII inhibitors.

September 17, 2018
·
3 min read
·
Alex Keown
Business

Medtronic Joins Catalyst CEO Champions For Change and Pledges to Accelerate Women Into Management and Board Seats

Medtronic CEO Omar Ishrak Commits to Continue Accelerating Diversity, Inclusion and Gender Equality

September 17, 2018
·
2 min read
Oxurion NV to present further scientific findings supporting therapeutic potential of THR-317 and THR-687 as promising new therapies for Diabetic Eye Disease at upcoming EURETINA 2018 in Vienna, Austria

Oxurion NV announced today that it will give two presentations at the Euretina International Congress, which is being held in Vienna, Austria, from 20 to 23 September 2018.

September 17, 2018
·
4 min read
Drug Development

GamaMabs Pharma starts a phase 2 study of monoclonal antibody GM102 in patients with advanced or metastatic colorectal cancer

C201 phase 2 will study immuno-enhancer antibody GM102, targeting AMHRII as a single agent and in combination with Trifluridine/Tipiracil (Lonsurf®)

September 17, 2018
·
3 min read
Business

BIA Separations Expands with New Upstream Processing Facility

Investment in new lab will support integrated optimisation of upstream and downstream process development

September 17, 2018
·
2 min read
Drug Development

FDA Lifts Partial Clinical Hold on Mersana Therapeutics’ ADC XM-1522

Shares of Cambridge, Mass.-based Mersana Therapeutics are up more than 7 percent in premarket trading after the company announced that it will be able to continue with its Phase I trial studying the antibody drug conjugate XMT-1522 as a potential treatment for some breast cancer patients.

September 17, 2018
·
2 min read
·
Alex Keown
Drug Development

AstraZeneca Plans to Seek Regulatory Approval for COPD Drug PT010 Following Phase III Trial

Following a setback in a chronic obstructive pulmonary disease (COPD) clinical trial in August, AstraZeneca unveiled data from a separate trial on Sunday that showed its triple combination therapy PT010 outperformed its dual-therapy rivals eight of nine times.

September 17, 2018
·
3 min read
·
Alex Keown
Business

Realm Therapeutics Slashes Staff and Explores Potential Sale as the Company Conducts a Strategic Review

Following a trial failure with its atopic dermatitis treatment, Malvern, Penn.-based Realm Therapeutics has opted to discontinue all of its drug development programs and is considering a potential sale of the company.

September 17, 2018
·
2 min read
·
Alex Keown
Business

CRISPR Therapeutics and ViaCyte Collaborate to Tackle Type 1 Diabetes

CRISPR Therapeutics and ViaCyte are collaborating to discover, develop and commercialize a gene-edited allogeneic stem cell therapy or therapies for diabetes.

September 17, 2018
·
3 min read
·
Mark Terry
Policy

House Rejects Senate Bill Provision to Require Disclosure of Drug Prices in Television Commercials

The U.S. House of Representatives has split with the Senate over requiring pharmaceutical companies to disclose the list price of their prescription medications in television advertisements.

September 17, 2018
·
2 min read
·
Alex Keown