Bio/Pharma News

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.

Novo Nordisk will pay up to $700 million for the exclusive rights to develop and commercialize candidates from Ventus Therapeutics NLRP3 inhibitor portfolio.

FDA has approved Relyrio as a once-to-twice daily treatment for patients with ALS.

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.

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.

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

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.

In partnership with the University of Pittsburgh, ElevateBio will open its next manufacturing center in the city.

Roche’s acquisition of Good Therapeutics grants them rights to the company's conditionally activated PD-1-regulated IL-2 program.

Lynparza has been approved in Great Britain as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.

Sanofi’s Xenpozyme (olipudase alfa-rpcp) is now the only approved treatment for acid sphingomyelinase deficiency.

Touchlight will expand Lonza’s end-to-end offering for mRNA manufacturing with an additional, differentiated source of DNA raw material.

The patent applications are for programs concerning lupus, idiopathic pulmonary fibrosis, and chronic kidney disease.

Novo Nordisk’s $1.1 billion acquisition of Forma Therapeutics is intended to expand its sickle cell and rare blood disorder portfolio.

Thermo Fisher Scientific’s new 300,000 ft² facility, located in Plainville, Mass., will specialize in manufacturing viral vectors.

Scientists have developed a mouse model that could be a promising model system for research into factors affecting mammalian embryonic development and disease.