02:58 , Sep 1, 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...
21:28 , Aug 1, 2018 |  BioCentury  |  Finance

Safety goes (Re)Viral

The clean safety profile and clinical efficacy of ReViral Ltd.’s respiratory syncytial virus therapy prompted Novo Ventures to co-lead the biotech’s $55 million series B round with fellow new investor New Leaf Venture Partners. The...
12:05 , Jun 22, 2018 |  BioCentury  |  Finance

Regenerating eastward

Having capitalized on the cell therapy expertise and manufacturing incentives of its European home base, Promethera Biosciences S.A. is expanding to Japan to tap the commitment to regenerative medicines among investors, pharmas and regulators. After...
13:01 , May 25, 2018 |  BioCentury  |  Product Development

Patients at the core

With excitement mounting for the seven hemophilia gene therapies in the clinic, the National Hemophilia Foundation wanted to avoid a scenario in which patients, physicians and payers had no good way to compare them. The...
21:48 , Apr 27, 2018 |  BioCentury  |  Regulation

Independent opportunities

The scenario the U.K. is trying to avoid is a full disconnect from EMA when the Brexit curtain falls. But a clean break from the agency could create opportunities for the U.K.’s Medicines and Healthcare...
00:24 , Nov 17, 2017 |  BC Extra  |  Politics & Policy

FDA unveils regenerative medicine policy framework

FDA unveiled a regenerative medicine framework on Thursday aimed at speeding the development and review of cell - and tissue-based therapies, including gene therapies, while also cracking down on those that would game the system....
23:25 , Nov 10, 2017 |  BioCentury  |  Regulation

Regulation relocation

Moving EMA’s headquarters hundreds of miles in a 16-month period is a mammoth task, considering it took the agency three years to move addresses from one end of London’s Canary Wharf to another. The move,...
20:06 , Oct 26, 2017 |  BC Innovations  |  Strategy

Capital call

Tasked by the U.K. government with outlining a plan to grow its life sciences industry post-Brexit, John Bell has laid out aggressive goals for creating a sustainable biotech sector, and wants to see the country...
19:00 , Oct 20, 2017 |  BioCentury  |  Regulation

Patients in focus

Just as FDA was wrapping up the inaugural meeting of its Patient Engagement Advisory Committee, another agency panel unanimously endorsed a gene therapy for a rare vision disorder based in large part on the testimony...
22:47 , Jul 13, 2017 |  BC Extra  |  Politics & Policy

Industry groups seek EU-U.K. regulatory partnership

On Thursday, a letter from four European and four British life sciences industry associations asked the U.K.'s Brexit negotiators to immediately begin discussions on a “cooperation agreement” between EMA and the U.K.'s Medicines and Healthcare...