Biopharma News

AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.

South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.

Aragen’s new 12,000 ft² facility will include various dosage form capabilities, including oral solids, liquids, topicals, and films.

Recipharm’s new high speed filling line, designed for pre-filled syringes and cartridges, is expected to be operational by May 2023.

Gilead and MacroGenics will work together on bispecific antibodies for the treatment of blood cancers.

Ebvallo (tabelecleucel) would be the first EMA-approved therapy for patients with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease.

Takeda’s dengue vaccine is designed to prevent disease caused by virus serotypes 1, 2, 3, and 4 in individuals four and older.

Merck has exercised a $250 million option with Moderna to jointly develop and commercialize cancer vaccine mRNA-4157/V940.

Alexion’s acquisition of LogicBio is designed to accelerate the company’s growth in genomic medicines.

FDA has granted Fast Track designation for CUE-101, a treatment of recurrent/metastatic head and neck squamous cell carcinoma.

Pfizer has completed its acquisition of Biohaven Pharmaceuticals for approximately $11.6 billion.

Citius and the University of Pittsburgh will investigate I/ONTAK in combination with pembrolizumab for treatment of recurrent or metastatic solid tumors.

The collaboration will use Octagon’s functional target discovery approach and novel chemistry strategy in disease areas in which Novo Nordisk has specific expertise.

The dedicated solid-state research and development suite is designed to promote discovery of novel polymorph, salt, and cocrystal forms.

Pfizer is set to supply global fund up to 6 million treatment courses of its COVID-19 oral treatment, PAXLOVID, for low-and-middle-income countries.

EC has approved Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss.

FDA granted accelerated approval to Skysona (elivaldogene autotemcel), which is designed to slow the progression of neurologic dysfunction in adolescents with CALD.

Lonza has expanded its HPAPI multipurpose suite for payload-linker manufacturing.

Boehringer Ingelheim will use Virtuosi to train employees at three aseptic sites across its network.

CytoReason has announced an expanded collaboration deal with Pfizer to deliver AI for drug discovery and development.

Civica is expanding in the greater Richmond-Petersburg region and investing $27.8 million in a new testing facility.

Ensysce Biosciences and Quotient Sciences are partnering to develop and test Ensysce’s novel opioid designed to prevent abuse and overdose.

EMA has recommended approval of Enjaymo for the treatment of hemolytic anemia in adult patients with cold agglutinin disease.

Emergence Therapeutics will work with Synaffix’s ADC technology platform to develop multiple ADCs against undisclosed targets.

MilliporeSigma’s €130 million (USD$132 million) investment is designed to increase manufacturing capacity of single-use assemblies.

WHO has awarded prequalification to GSK’s Mosquirix, an approved malaria vaccine.

Salipro has been granted patents in the United States and China for its proprietary technology to enable the development of therapeutics against challenging drug targets.

Charles River Laboratories and Cure AP-4 will collaborate on gene therapy manufacturing for AP-4 hereditary spastic paraplegia.