COVID-19 cell therapy drives Mesoblast to seek manufacturing muscle 31-Aug-2020 By Nick Taylor Mesoblast plans “rapid scale-up in manufacturing” to meet anticipated demand for COVID-19 cell therapy.
Bavarian Nordic warns COVID-19 may delay plans for RSV vaccine 27-Aug-2020 By Nick Taylor Bavarian Nordic weighs options for RSV vaccine amid concerns COVID-19 response will drive down prevalence of pathogen.
SubjectWell eyes diversity in COVID-19 vaccine trials 27-Aug-2020 By Jenni Spinner The clinical trials marketplace company reportedly is connecting sites with 10,000 patients a month, with 40% of them from non-white groups.
Collaborative VLP tech bolsters COVID-19 vaccine development 26-Aug-2020 By Maggie Lynch VLP platform using structural elements of coronavirus and modified surface spike molecules could be an ‘ideal’ for COVID-19 vaccine development.
SAM vaccine technology rapidly effective against Zika 26-Aug-2020 By Maggie Lynch Preclinical proof of concept study concludes SAM vaccine candidate delivered through CNE can rapidly elicit protective immunity against ZIKV, with potential use for additional antigens.
Bavarian Nordic’s freeze-dried smallpox vaccine clears clinical test 25-Aug-2020 By Nick Taylor Phase 3 trial of Bavarian Nordic’s freeze-dried smallpox vaccine hits primary endpoint, teeing biotech up to fulfill $299 million government contract.
AbCellera buys OrthoMab platform to move into bispecifics 24-Aug-2020 By Nick Taylor AbCellera buys OrthoMab platform from Dualogics to enable development of bispecific antibodies.
FDA rejection of BioMarin gene therapy raises durability questions 20-Aug-2020 By Nick Taylor The US Food and Drug Administration (FDA) has rejected approval of BioMarin’s hemophilia A gene therapy amid durability doubts.
AdComm backs Mesoblast cell therapy despite manufacturing concerns 18-Aug-2020 By Nick Taylor Advisory committee votes in favor of Mesoblast’s allogeneic cell therapy despite questions about manufacturing consistency.
UK strikes deals with J&J, Novavax to source 90m COVID-19 vaccines 17-Aug-2020 By Nick Taylor UK government reaches agreements to buy millions of COVID-19 vaccines from Johnson & Johnson and Novavax, bringing total stockpile up to 340 million.
Gates Foundation gives Dynavax COVID-19 grant to scale up adjuvant production 17-Aug-2020 By Nick Taylor Dynavax gets Bill & Melinda Gates Foundation funding to scale up production of adjuvant for use in COVID-19 vaccines.
Regeneron targets September data drop from COVID-19 antibody trial 11-Aug-2020 By Nick Taylor Regeneron Pharmaceuticals aims to post initial virology and biomarker data from clinical trials of its COVID-19 antibody cocktail next month.
Allogene CAR-T plant on track despite ‘minor delays’ due to COVID-19 10-Aug-2020 By Nick Taylor Allogene Therapeutics maintains 2021 completion date for US CAR-T manufacturing facility despite COVID-19 causing “minor delays.”
Incyte bullish about virtual launch of rival to CAR-T therapies 06-Aug-2020 By Nick Taylor Incyte talks up ability to successfully launch newly approved blood cancer drug despite disruption caused by COVID-19.
AstraZeneca taps 20-plus partners to hit goal of 2bn COVID-19 vaccines 06-Aug-2020 By Nick Taylor AstraZeneca creates “parallel supply chains” through partnerships to support rapid scaling up of COVID-19 vaccine capacity.
Lilly: Maximizing manufacturing capacity is key to COVID-19 antibody strategy 04-Aug-2020 By Nick Taylor Eli Lilly cites need to maximize production capacity to explain decision to develop a single-antibody candidate against COVID-19.
Sangamo and Novartis partner on gene therapies for autism 03-Aug-2020 By Ben Hargreaves The two companies will develop three neurodevelopmental targets, using the former’s zinc-finger technology.
Fujifilm to produce COVID-19 vaccines, BARDA speeds up capacity boost 03-Aug-2020 By Ben Hargreaves US BARDA drafts Fujifilm Diosynth into its vaccine production effort, offering to also accelerate capacity expansion.
Moderna enters P3 trials for vaccine, with $483m BARDA push 30-Jul-2020 By Ben Hargreaves US government supports Moderna’s clinical program for its COVID-19 vaccine with financial backing.
Fujifilm Diosynth partners with Novavax to manufacture COVID-19 vaccine 28-Jul-2020 By Ben Hargreaves Novavax utilizes US government funds to agree the manufacture of bulk drug substance for potential vaccine.
Ireland calls attention to cell and gene infrastructure 22-Jul-2020 By Ben Hargreaves A report by IDA outlines investment made by biopharma into cell and gene development and manufacturing capabilities.
MassBio wants improved manufacturing to maintain biohub position 22-Jul-2020 By Ben Hargreaves The organization calls for capabilities to manufacture advanced therapeutics, such as cell and gene therapies.
Marken adds multiple depot locations, boosts capacity for cell and gene 21-Jul-2020 By Ben Hargreaves Marken announces the addition of two depots in the US and Ukraine, as well as logistics branches in Ireland and the Netherlands.
Catalent to invest $30m on clinical manufacturing site in France 21-Jul-2020 By Ben Hargreaves The company invests into its clinical biologics formulation development and drug fill-finish services.
Merck KGaA takes up option to license bispecific antibody 20-Jul-2020 By Ben Hargreaves The company opts into its second bispecific antibody through its partnership with F-star Therapeutics.
Moderna releases positive early vaccine data, signs fill-finish deal 16-Jul-2020 By Ben Hargreaves The biotech provides more detail on Phase I study of its COVID-19 vaccine and agrees commercial fill-finish manufacturing.
Merck CEO: COVID-19 vaccine manufacture and distribution ‘huge issue’ 15-Jul-2020 By Ben Hargreaves Kenneth Frazier states manufacture of potential vaccine is ‘bigger challenge’ than developing an effective vaccine.
Takeda deal looks to bolster biologics pipeline 14-Jul-2020 By Ben Hargreaves Takeda partners with Twist Bioscience for access to platform to discover, validate and optimize antibodies in its pipeline.
Dewpoint and Merck in $305m deal for HIV ‘cure’ 14-Jul-2020 By Ben Hargreaves The two partners will use Dewpoint’s platform, focusing on biomolecular condensates, to treat the disease.
Webinar delves into drug delivery innovations 09-Jul-2020 By Jenni Spinner Innovations in Drug Delivery Part II, a free online event on July 15, will feature novel technologies and innovative solutions to current challenges.
Rentschler and Vetter cooperate to integrate services 09-Jul-2020 By Ben Hargreaves The CDMOs will launch pilot projects to determine where collaboration may help streamline drug development.
Operation Warp Speed delivers $2bn to scale COVID-19 solutions 08-Jul-2020 By Ben Hargreaves Novavax is the principle recipient of the funding, as US government provides capital in return for guaranteed access to doses.
Regeneron COVID-19 antibody cocktail enters late-stage trials 07-Jul-2020 By Ben Hargreaves Regeneron’s potential coronavirus treatment enters Phase III and US government provides capital injection for manufacture.
Sarepta licenses therapy to boost gene therapies 06-Jul-2020 By Ben Hargreaves Sarepta signs agreement with Hansa to use its treatment as part of a gene therapy treatment schedule.
Pfizer posts positive vaccine results and capacity for 1.2bn doses 02-Jul-2020 By Ben Hargreaves Pfizer and BioNTech release positive results from Phase I/II trials investigating their mRNA vaccine against COVID-19.
Inovio posts positive COVID-19 vaccine results but few details 30-Jun-2020 By Ben Hargreaves The biotech reveals positive results of Phase I trials but does not provide a fuller picture of data.
Stevanato partners with CEPI for 2 billion vaccine vials 29-Jun-2020 By Ben Hargreaves CEPI signs agreement for supply of glass vials to speed up COVID-19 vaccine development timeline.
Moderna secures fill-finish capabilities for COVID-19 vaccine 29-Jun-2020 By Ben Hargreaves Moderna signs deal with Catalent for fill-finish services, shortly after AZ announced the same move.
WHO seeks $31bn in next 18 months to combat COVID-19 29-Jun-2020 By Ben Hargreaves The organization wants to raise the sum to support its ‘three pillar’ approach to the pandemic: vaccines, therapeutics, and diagnostics.
Cytiva expands Massachusetts biomanufacturing site 25-Jun-2020 By Ben Hargreaves The facility has been expanded to cater to the growing number of small- to mid-size biotechs looking to contract manufacture.
AstraZeneca makes another vaccine supply agreement 25-Jun-2020 By Ben Hargreaves AZ enters a supply agreement with Symbiosis as it continues to work on bolstering supply for its COVID-19 vaccine.
Hired & Retired: From big pharma to mid-sized leadership 24-Jun-2020 By Ben Hargreaves This month featured executives making the switch from big pharma to take on leadership positions at mid-sized companies.
Novo Nordisk provides €100m for sustainable cell factories 22-Jun-2020 By Ben Hargreaves Novo Nordisk Foundation donates funds to DTU Biosustain to continue its work to develop methods for sustainable biotechnologies.
Emergent in $75m expansion into viral vectors and gene therapy 22-Jun-2020 By Ben Hargreaves The company will buildout its Massachusetts facility to provide CDMO services for viral vector and gene therapies.
Sanofi to invest €610m in vaccine production site 18-Jun-2020 By Ben Hargreaves The company will create both a vaccine site and an R&D center in France.
Catalent to fill and package AZ’s COVID-19 vaccine 18-Jun-2020 By Ben Hargreaves The CDMO seals a deal to provide vial filling and packaging services for the commercialization of AZ’s potential COVID-19 vaccine.
Gavi backed with $8.8bn to support immunization plans 17-Jun-2020 By Ben Hargreaves The Vaccine Alliance given funds to support the immunization of 300 million children and to develop measures against COVID-19.
TreeFrog opens stem cell manufacturing facility 16-Jun-2020 By Ben Hargreaves The startup completes work on facility to produce stem cell therapies in-house.
WuXi Biologics signs lease for US clinical-stage facility 16-Jun-2020 By Ben Hargreaves The CDMO announces the lease of its third site in the US, the latest being focused on clinical supply.
Moderna’s COVID-19 vaccine set for Phase III trial 15-Jun-2020 By Ben Hargreaves The company will begin a late-stage trial for its potential vaccine in July, with 30,000 individuals to receive mRNA-1273.