Amneal Pharmaceuticals received ANDA approval from FDA for the generic version of TobraDex.

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.

Kadmon Pharmaceuticals selects Onco360 to be a specialty pharmacy partner for Rezurock (belumosudil).

The companies collaborate to develop and commercialize ARV-471, an investigational oral PROTAC (proteolysis targeting chimeras) estrogen receptor protein degrader.

J&J to contribute up to $5 billion to the settlement agreement to resolve opioid-related claims and litigation in the United States.

Aenova has announced plans to open a new new can and bottle filling production line in Cornu, Romania.

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

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.

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

Exscientia and GT Apeiron Therapeutics have entered into a strategic R&D oncology collaboration agreement.

Specialty pharmaceutical company, Advanz Pharma, has launched a generic version of lanreotide, MYTOLAC, in Germany.

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

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

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.

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.