Bio/Pharma News

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.

SpringWorks Therapeutics and the Dana-Farber Cancer Institute will conduct further research into the therapeutic potential of combination therapy with nirogacestat and anti-BCMA agents for multiple myeloma.

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

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

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

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.

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

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).

FDA granted orphan drug designation for imatinib in AER-901 for the treatment of patients with pulmonary arterial hypertension.

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.

FDA approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty.

Novartis' Cosentyx has been granted further approval from the China National Medical Products Administration for use in pediatric patients.

FDA granted orphan drug designation to Paratek Pharmaceuticals for NUZYRA (omadacycline), an investigational antibiotic.

Bristol Myers Squibb has exercised the option to in-license an immune-modulating drug candidate developed by Exscientia.

Merck KGaA has partnered with Telix Pharmaceuticals to conduct combination clinical studies for cancer therapy.

The collaboration will focus on the interactions between WTX-124 indukine and KEYTRUDA (pembrolizumab).

A new method developed by the NIH bypasses genetic RNA extraction, simplifying the testing process.

WHO’s solidarity plus trial will enroll hospitalized patients to test artesunate, imatinib, and infliximab in hospitalized COVID-19 patients.

Lilly’s insulin, lyumjev, receives FDA approval for an expanded label.

The Cleveland, Ohio facility will produce critical anti-infective drug products for US hospitals.

Artiva Biotherapeutics’s new R&D and GMP manufacturing center in San Diego, Calif., for NK cell therapies is expected to open in 2022.