Bio/Pharma News

Novartis and Medicines for Malaria Venture have reported positive results from the Phase IIb study, evaluating a new non-artemisinin combination to treat uncomplicated malaria in children.

ViiV Healthcare has presented three-year clinical trial, reinforcing that the two-drug regimen Dovato can be used as a viable switch option for people living with HIV.

FDA granted orphan drug designation to Catalyst Biosciences’ MarzAA for the treatment of Factor VII Deficiency.

FDA approved AbbVie’s Qulipta (atogepant) as a preventative migraine treatment.

GSK has received a positive recommendation from the EMA’s CHMP for Nucala (mepolizumab) to be used as a treatment in three additional eosinophil-driven diseases.

Celltrion Group has been granted approval for regdanvimab (CT-P59) to be used as a treatment for COVID-19 by the Korean Ministry of Food and Drug Safety (MFDS).

In an amendment to their existing contract manufacturing agreement, Celsian and Poly Pharm expand GEN-1 program collaboration to add clinical and commercial batches of investigational vaccine.

New data finds J&J COVID-19 vaccine and booster to provide increased protection against COVID-19.

Celularity and Oncternal’s collaboration will focus on therapeutics targeting Orphan Receptor 1, which is linked to aggression and survival in solid tumor cells.

Lonza’s investment in its Stein and Basel facilities in Switzerland aims to expand its overall drug product development and manufacturing services.

Novartis’ acquisition of Arctos Medical could lead to significant advancements in optogenetic therapies for patients with vision loss.

Metrion’s new 12,000 ft² headquarters will significantly expand its range of services and cell lines.

The topline data from Pfizer and BioNTech’s trial suggests that a 10 µg vaccine is safe and effective among the 5 to 11 age group.

Moderna’s newest insights include an overall efficacy review, a study on breakthrough infections, and a study on long-term immunity.

Takeda’s Exkivity (mobocertinib) was approved by FDA for the treatment of patients with lung cancer.

Apellis Pharmaceuticals has announced the top-line results from two Phase III studies, evaluating intravitreal pegcetacoplan as a treatment for geographic atrophy.

GeneQuine Biotherapeutics has chosen Exothera to advance the development of its osteoarthritis gene therapy product candidate, GQ-303.

AzurRx’s acquisition of First Wave Bio grants them access to their proprietary niclosamide formulations.

Repligen and Navigo’s novel ligand could be the first to address antibody aggregation in low pH elution buffers.

HUTCHMED’s amdizalisib (HMPL-689) received breakthrough therapy designation for the treatment of a subtype of non-Hodgkin’s lymphoma.

Boehringer Ingelheim and Twist Bioscience will use Twist’s antibody libraries to discover therapeutic antibody candidates.

Janssen’s Invega Hayfera is the first six-month injectable schizophrenia treatment approved by FDA.

Moderna announced a collaboration to develop a new mRNA therapeutic for Crigler-Najjar Syndrome Type 1 at no cost to patients.

The orphan drug designation for TCR² Therapeutics’ Gavo-cel will facilitate research into a treatment for cholangiocarcinoma.

The Coalition for Epidemic Preparedness Innovations stated that developing the next generation of COVID-19 vaccines will only be possible if comparator vaccines are available for clinical trials.

Moderna’s new single-dose vaccine will be a booster for both COVID-19 and the flu.

FDA placed a clinical hold on the BMN 307 Phearless Phase I/II study, which was evaluating an investigational PAH gene therapy in adults with PKU.

Impel Neuropharma’s Trudhesa, a nasal spray, received FDA approval for treating migraines in adults with and without aura.

Orphan drug designation for Polaryx’s PLX-200 will facilitate research into its use treating Krabbe Disease, a rare lysosomal genetic disorder.

FDA clearance of trans sodium crocetinate allows Diffusion to proceed with their latest Phase II oxygenation trial.