BioPharm International Editors

EMA's CHMP has taken the decision to start a rolling review of Vidprevtyn—Sanofi Pasteur’s COVID-19 vaccine.

Summa Equity has acquired a majority stake in science tools business Axion BioSystems with the intent of further entering the CGT market.

Thermo Fisher Scientific has added a new suite of immune repertoire assays that offers high detection rates of malignant clones, allowing researchers to better assess blood cancers.

Byondis and Glycotope have formed an agreement to discover and develop antibodies that target specific glyco-epitopes.

Following a deal struck in mid-2018, 908 Devices’ ZipChip and REBEL technology have proven instrumental in facilitating Transcenta’s efficiency and volumetric production.

Avantor’s newly unveiled J.T.Baker robotic tips is the latest in their line of automated precision plastics.

Cytiva and Pall reinforce recent expansion efforts with a $1.5-billion dollar investment in new manufacturing facilities.

Sciex’s recently launched accurate mass instrument, the ZenoTOF 7600 system, offers novel ion fragmentation and increased sensitivity for life science research and biotherapeutic development.

Merck announced that FDA approved Vaxneuvance for active immunization for the prevention of invasive pneumococcal disease.

Meissa Vaccines’s MV-014-212, an intranasal recombinant live attenuated COVID-19 vaccine, induced mucosal and systemic antibodies against SARS-CoV-2 and two variants of concern.

PerkinElmer has entered into an agreement to acquire BioLegend, a global developer and manufacturer, in a deal valued at $5.25 billion.

The EMA’s CHMP has adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older.

Sinovac Biotech’s Eupolio vaccine, a Sabin inactivated poliovirus vaccine (sIPV), has gained marketing authorization in China.

The European Commission has granted marketing authorization to bluebird bio for its gene therapy SKYSONA for the treatment of early CALD.

Catalent commences the first phase of a $100-million expansion program Anagni site to increase its manufacturing capabilities for biologics drug substance.

Summa Equity has acquired a majority stake in G-CON Manufacturing, a prefabricated cleanroom provider.

Pfizer Inc. and BioNTech SE announced the signing of a letter of intent with The Biovac Institute Ltd to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union.

Catalent Biologics has launched its new cell line expression technology, GPEx Lightning, which aims to shorten drug substance development timelines by up to three months.

Samsung Biologics and Kineta have entered into a strategic partnership for drug product manufacturing services and to support an IND filing of a novel antibody therapeutic.

BioNTech will acquire a TCR cell therapy R&D platform as well as a manufacturing facility in Gaithersburg, Md., from Kite, a Gilead company.

Nkarta will establish a new combined scalable NK cell therapy manufacturing facility and corporate headquarters in South San Francisco, Calif.

Cellares has entered into a strategic relationship with Poseida Therapeutics to advance a closed, automated, and scalable cell therapy manufacturing system.

Pall has secured a manufacturing contract with Exothera for the suspension-based manufacture of gene therapies and viral vector-based vaccines.

In combination with etoposide and either carboplatin or cisplatin, Imfinzi has been approved in the first-line setting of ES-SCLC by China’s National Medical Products Administration.

The companies work to develop and supply advanced cell models that better reflect an in-vivo environment to improve drug discovery accuracy and efficiency.

The GMP facility is designed to maximize bioprocessing efficiency of newborn stem cells and manufacturing at scale.

MorphoSys completes the acquisition of Constellation, a clinical-stage biopharmaceutical company.

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.