20:49 , May 24, 2019 |  BioCentury  |  Finance

How Europe’s hotspots of innovation could fuel its rise as a global player in new modalities

It is clear that Europe has hotspots of innovation that are discovering and developing the next wave of new therapeutic modalities. Nearly every category of new modality has a European champion, with clusters forming around...
20:59 , Feb 15, 2019 |  BC Extra  |  Politics & Policy

FDA releases final regenerative medicine guidances

FDA Friday released final versions of two guidance documents that are intended to facilitate the development of regenerative medicines. Draft versions of the Evaluation of Devices Used with Regenerative Medicine Advanced Therapies and Expedited Programs...
18:26 , Dec 5, 2018 |  BC Extra  |  Politics & Policy

U.K. unveils second life sciences deal, headlined by UCB investment

Just days ahead of a Parliamentary vote on a Brexit deal, the U.K. government announced Wednesday a second deal for life sciences that comprises mostly industry investment into the U.K. spearheaded by a £1 billion...
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,...