Pharmaceutical Technology Editors

FDA granted Oncoloze’s OM-301 an orphan drug designation for the treatment of acute myeloid leukemia (AML).

The collaboration will leverage Alynlam’s proprietary small interfering RNA (siRNA) technology to inhibit a target discovered by Novartis.

FDA amended it’s Emergency Use Authorization to shorten Moderna’s vaccine booster dose interval from six to five months.

Neurimmune will receive up to $760 million for NI006, an investigational human monoclonal antibody in development for the treatment of transthyretin amyloid cardiomyopathy.

FDA has cleared an IND from Poseida Therapeutics, allowing continued development of the company’s allogeneic CAR-T cell therapy candidate for treating multiple solid tumors.

The acquisition of Protein Metrics expands Insightful Science’s R&D solutions to include proteomics.

BAT has launched KBio Holdings—a biotech focused on the acceleration of research, development, and production of novel medicines that leverage plant-based technology.

BBI Solutions has completed the acquisition of BioTeZ Berlin-Buch—a Germany-based manufacturer of reagents and finished tests for the in-vitro diagnostics market.

Intravacc is partnering with Leiden University Medical Center for the development and evaluation of a new intranasal coronavirus vaccine candidate in a clinical Phase I/II study.

Pharming Group, has been granted a positive opinion by EMA for its Paediatric Investigation Plan for leniolisib.

With this investment into Yapan Bio, Piramal Pharma adds new technologies and capabilities in large molecules, including vaccines and gene therapies, to its global offering.

Thermo Fisher Scientific’s Invitrogen TrueCut HiFi Cas9 Protein offers the advantage of significantly minimizing off-target events while aiming to retain maximum on-target editing efficiency.

The partnership between OpenEye Scientific and Specifica has generated AbXtract, an antibody discovery model that is included in the Orion Antibody Suite.

The agency is expanding the use of a single booster of the Pfizer-BioNTech vaccine to children ages 12–15 and is shortening the time between primary vaccination and booster to at least five months.

Scitara’s Scientific Integration Platform (SIP) establishes a flexible, adaptable framework that facilitates a fully connected laboratory.

Thermo Fisher's Invitrogen TrueCut HiFi Cas9 Protein significantly reduces off-target events while retaining maximum on-target editing efficiency.

The MicroEDS BioWaste Treatment System can process between 150 to 500 L of waster per day.

Moderna’s vaccine is weaker against the Omicron variant, but boosters can increase neutralizing antibody levels by as much as 83-fold.

Sanofi’s acquisition of Amunix will grant access to their promising immuno-oncology pipeline.

Tezpire (tezepelumab-ckko) has been approved as an add-on maintenance treatment for severe asthma.

The agency recommended granting conditional marketing authorization for use of Nuvaxovid in people 18 years of age and older.

Amgen and Syngene International have extended their research collaboration to 2026.

Genezen has opened its new process development and analytical lab for viral vector production.

Bionique Testing Laboratories has been acquired by Asahi Kasei Medical and will join the company’s biosafety testing services unit.

Lonza plans to ensure consistent product quality by incorporating Agilent’s analytics technology into its Cocoon platform.

FUJIFILM Irvine Scientific’s new manufacturing facility in Tilburg, the Netherlands, is now fully operational.

FUJIFILM Diosynth Biotechnologies plans to invest £400 million (US$528 million) to expand its Billingham, Teeside facility in the United Kingdom.

The European Medicines Agency has accepted Sanofi’s marketing authorization application for olipudase alfa, a potential new therapy for acid sphingomyelinase deficiency, a rare disease.

FDA approved American Regent’s Injectafer (ferric carboxymaltose injection) for the treatment of pediatric patients with iron deficiency anemia.

Pfizer’s $6.7 billion acquisition of Arena will give them access to a portfolio of immuno-inflammatory therapies.