Roche applies to EMA and FDA for shorter Ocrevus infusions 21-Apr-2020 By Ben Hargreaves Roche aims to reduce the infusion time of its treatment for multiple sclerosis from 3.5 to 2 hours.
Regeneron’s Ebola treatment given US priority review 21-Apr-2020 By Ben Hargreaves Regeneron’s triple antibody treatment for the Ebola virus has been provided US FDA priority review to speed regulatory action.
Biocon Biologics' biosimilar sites cleared by FDA 16-Apr-2020 By Ben Hargreaves The company announces that an inspection by the US FDA into its two sites had now been closed.
EMA gives nod to pre-filled syringe form of Eylea 09-Apr-2020 By Ben Hargreaves Bayer announces that the product will be made available through ‘efficient and convenient’ drug delivery method in Europe.
ElevateBio closes $170m Series B financing round 09-Apr-2020 By Ben Hargreaves The accelerator for cell and gene therapy startups reveals the closure of its second financing round and how the funds will be used.
Servier acquires Symphogen to pick up oncology pipeline 07-Apr-2020 By Ben Hargreaves Servier buy outs its former partner to bolster its antibody discovery and development capabilities within oncology.
J&J signs deal with Fate for off-the-shelf immunotherapies 06-Apr-2020 By Ben Hargreaves Fate Therapeutics and J&J will collaborate to progress candidates against four tumor-associated antigens.
FDA looks to accelerate plasma therapies for coronavirus 06-Apr-2020 By Ben Hargreaves US FDA looks to coordinate and speed up the development of blood-derived therapies to treat patients with COVID-19.
US FDA closes inspection of Biocon’s insulin facility 02-Apr-2020 By Ben Hargreaves The company announces that the problems raised by the FDA in February have been cleared.
Arch Venture raises $1.4bn fund to spur ‘healthcare revolution’ 02-Apr-2020 By Ben Hargreaves Arch Venture announces that it raised the sum across two funds, with the capital earmarked for early stage biotechs.
Takeda taps Evox for exosome therapeutics 30-Mar-2020 By Ben Hargreaves The partners will focus on developing five potential exosome treatment for rare diseases.
Novartis’ gene therapy takes additional step towards EU approval 30-Mar-2020 By Ben Hargreaves Zolgensma has received a recommendation for approval despite running into problems recently, including manufacturing questions and data integrity issues.
Insulin designated biologic in ‘landmark moment’ 24-Mar-2020 By Ben Hargreaves Manufacturers can now apply to the US FDA for the approval of biosimilars to insulin products.
Univercells spins out viral vector CDMO to meet capacity demands 20-Mar-2020 By Vassia Barba Univercells announces the launch of Exothera, a CDMO focusing on viral vectors to support cell and gene therapy developers.
Pharma events update: rescheduled, canceled, online 18-Mar-2020 By Jenni Spinner This list includes the industry events that have been postponed or moved because of the coronavirus pandemic.
