US FDA places a hold on a clinical study testing Novartis’ Zolgensma in patients with SMA Type 2, after information provided to the authorities by AveXis.
Merck announces that it has reallocated Gardasil from the US CDC stockpiles, as a surge in demand sees revenues from the vaccine rise 26% year-on-year.
Bavarian Nordic buys vaccines against rabies and tick-borne encephalitis from GlaxoSmithKline for €301m, with up to €495m more in milestones payments to follow.
Modifications on the regulatory framework and focus on funding schemes are the first steps on the path for healthcare systems to adapt to ATMPs’ ‘new ground’, says ARM head for Europe.
The pace of development in the industry sees greater demand for a trained workforce, which is leading away from ‘classroom’ to technology-assisted working environments, says training lead at Zenith.
NIH and the Gates Foundation have set themselves the goal of bringing curative gene therapies to clinical trials in the US and Africa in the next seven to 10 years.
GE Healthcare opens lab space to provide developers with access to protein and cell analysis technologies to encourage networking and partnering on R&D services.
Early dialogue with patients is ‘critical’ to design efficient clinical development programs for ATMPs and avoid ‘data gaps’, an executive from ARM says.
Novartis announces its third quarter results that show Zolgensma is outperforming sales expectations, but company notes approval in EU and Japan pushed back over manufacturing queries.
Alkermes to work collaboratively with the Fred Hutchinson Cancer Research Center on the clinical development of a drug candidate as a combination treatment alongside Keytruda.
During this year’s Festival of Biologics conference, one track saw a focus on biosimilars that brought together experts from across the industry to map the future for such treatments in the EU and US.
Ichnos will launch with a portfolio of five clinical stage assets, a proprietary platform, as well as a biologics manufacturing facility and 350 employees.
Sanofi opens its Massachusetts, US-based facility that will use digital technology for continuous biologic production, with similar plants planned in Canada, Brazil, Ireland, France, and Belgium.
An expansion to BIA Separations' Cornerstone set of processing services for viral vector development adds the use of kryptonase and CIMmultus chromatography device.
Through funding by Novo Nordisk and the NIH, researchers from MIT have come up with a microneedle containing capsule able to release drug substance into the bloodstream.
Though the utilization of biosimilars in Europe is high, a report on the practices of eight countries suggests that more can be done to foster competition and remove barriers to entry.
Novo Nordisk partners with bluebird on a three-year research arrangement looking to discover gene therapy candidates for the treatment of genetic diseases, including hemophilia.
N4 Pharma creates DNA and RNA transfection technology using silica nanoparticles with an irregular surface, which traps and protects nucleic acid during its journey to cells.
GSK taps Lyell’s technology to delay ‘exhaustion’ of T cells and will explore creating a new platform to develop cell and gene therapies for rare cancers.
Merck extends its partnership with 4D Pharma to discover and develop LBP vaccines for three undisclosed indications, adding to their Keytruda partnership.
US FDA approves AstraZeneca’s at-home autoinjector for administration of an add-on treatment for severe asthma, matching the indication of GSK’s rival product, Nucala.
J&J announces the opening of its manufacturing building in Cork, Ireland, which expands the production capacity of the biopharmaceutical supply chain facility.
The gene therapy space is a rapidly developing areas in the industry, as a result those with expertise are finding their knowledge is invaluable to companies looking to advance in the space.
The news most interesting to our readers were those featuring collaborations, whether in the production of an Ebola vaccine, biosimilars entering new markets or creating new manufacturing modalities.
Cellectis chooses Lonza to take on the clinical manufacturing of its UCART blood cancer immunotherapy candidates, intended to be marketed as industrialized, readily available CAR-T cells.
HSAC will acquire 100% of the shares of Immunovant, taking the biotech public with $100m in cash and a lead product that set to go through Phase II trials.
Shanghai Pharma and Biocad established a joint venture to commercialize the latter’s portfolio of biosimilars and biologic treatments for the Chinese market.