Biopharma News

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

InMed Pharmaceuticals looks to expand their cannabinoid pipeline with the acquisition of BayMedica.

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.

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

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

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

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.

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.

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

Immutep was granted a Chinese patent for LAG525, a LAG-3 antagonist antibody, under evaluation for cancer treatment.

SK and GSK announce the initiation of a Phase III clinical study of SK’s COVID-19 vaccine candidate, GBP510, in combination with GSK’s pandemic adjuvant.

Merck and Ridgeback Biotherapeutics announced the initiation of the Phase III clinical trial to evaluate an investigational oral antiviral therapeutic for the prevention of COVID-19 infection.

The European Commission has granted marketing authorization to Incyte and MorphoSys for Minjuvi (tafasitamab) in combination therapy with lenalidomide to treat relapsed or refractory DLBCL.

Aadi Bioscience has closed its previously announced merger with Aerpio Pharmaceuticals and a concurrent $155-million PIPE investment.

USAntibiotics will serve as the sole American-based provider of amoxicillin and amoxil clavulanate.

Catalent’s acquisition of Bettera paves the way for growth in the softgel and oral dose formulation and manufacturing market for nutraceuticals.

After receiving the COVID-19 vaccine from a batch of Moderna vaccines that were suspected to have contaminants, two people in Japan died. Meanwhile, another one million doses have been temporarily suspended in Japan.

FSD Pharma has entered a definitive agreement to acquire all of the issued and outstanding shares of Lucid Psycheceuticals for approximately US$9 million (CAD$11.3 million) in FSD Pharma stock.

FDA has cleared QSAM Biosciences’s IND application for Samarium-153 DOTMP (CycloSam).

Japan has suspended the use of more than 1.63 million potentially contaminated doses of the Moderna vaccine.

Eli Lilly and Company and industry partners, including Ziath, are focused on speeding up the drug discovery process with a fully automated lab.

BioMed X has partnered with Janssen to start two new research programs for autoimmune diseases and drug delivery.

NGM Biopharmaceuticals has disclosed a fourth antibody drug candidate, NGM831, for development into an oncology therapeutic.

Pfizer’s proposed $2.26-billion acquisition of Trillium Therapeutics will add next-generation hematology-targeted immuno-therapeutics to its oncology pipeline.

FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.

HHS Public Health and a team of medical experts recommend that COVID-19 vaccine booster shots will soon be necessary.