News

Kriya Therapeutics completes $100 Million Series B financing to advance its platform for designing, developing, and manufacturing gene therapies.

MTBVAC has the potential to be used as an alternative to BCG vaccination in infants and for prevention of TB disease in adolescents and adults.

ImmunityBio will proceed with a Phase I/II/III trial in South Africa of their dual-antigen T-cell vaccine as a boost in participants who were previously vaccinated against COVID-19.

The Yale School of Public Health’s regulatory sciences program expansion builds on the current regulatory affairs track program, which focuses on the administrative, policy, and legal aspects of product regulation.

The US federal government awarded new funding to the National Institute for Innovation in Manufacturing Biopharmaceuticals, including funding under the American Rescue Plan that will be used to advance vaccine manufacturing.

Common stock of merged allogeneic cell therapy company to commence trading on the Nasdaq Capital Market as “CELU” on July 19, 2021.

EMA's safety committee, PRAC, has concluded that there is no evidence linking the viral vector in Zynteglo to a blood cancer known as acute myeloid leukemia (AML).

After a review of three cases, EMA's PRAC has advised against the use of Janssen’s COVID-19 vaccine in people who have a history of capillary leak syndrome.

EMA's PRAC has found a possible link to very rare cases of myocarditis and pericarditis after vaccination with Comirnaty and Spikevax COVID-19 vaccines.

A new report by Radnor Capital Partners and commissioned by the BIA has shown that international investors are being drawn toward the biotech sector of the UK.

Eli Lilly and Company has announced its acquisition of biotech firm Protomer Technologies, giving it a protein-engineering platform for next-generation protein therapeutics.

White House proposal includes measure to make drugs more affordable.

AMRI reinforces positioning as a CDMO with name change and acquires the formulation and fill/finish company, Integrity Bio, and biologics company, LakePharma.

Moderna announces supply agreement with the Argentina government for 20 million doses of Moderna’s COVID-19 vaccine.

The IND for Tevogen Bio's TVGN-489, an allogeneic COVID-19-specific cytotoxic T lymphocyte, received rapid clearance from FDA.

GEA’s plug-and-produce skids are designed for multi-product pharmaceutical and biopharmaceutical separation.

NewAge Industries is adding cleanrooms at its Pennsylvania headquarters.

FDA’s review and approval of Aduhelm triggers controversy and a call for review from within the Agency.

Sparx Therapeutics will build its first commercial manufacturing facility in Yangzhou, China, for antibody drug production.

GlaxoSmithKline and Alector have partnered to co-develop two mAbs for a range of neurodegenerative diseases, including Parkinson’s and Alzheimer’s disease.

Tezepelumab, being developed by AstraZeneca in collaboration with Amgen, reduced asthma exacerbations in Phase II and III clinical trials.

Univercells Technologies and VectorBuilder to produce custom viral vectors for cell and gene therapies as well as vaccine applications.

The collaboration continues as the companies design bioprocess impurity reagent sets to detect residual HCP from HEK 293 cells.

The recently published Life Sciences Sector Vision, from the UK government, has been welcomed by the UK BioIndustry Association (BIA).

Novasep and Exelixis have signed a manufacturing services agreement for the CGMP clinical manufacturing of a next-generation ADC candidate.

A new media panel, gene kit, and advanced resins that are now in Thermo Fisher Scientific’s gene therapy portfolio aim to reduce manufacturing costs and increase gene therapy viability.

LGM Pharma will offer contract analytical testing and stability services to pharmaceutical developers and manufacturers.

The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.