News

The Centers for Medicare and Medicaid Services took action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm (aducanumab).

The agreeement will add to Merck KGaA’s LNP and mRNA capabilities.

The agreement expands Pfizer’s access to LNP formulation technology for mRNA vaccines and therapeutics.

Bio-Rad’s new assays are designed to measure neutralizing antibodies against wild-type and significant variants of COVID-19.

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.

FDA maintained a steady pace in 2021 in approving important new therapies for market, including new vaccines and treatments for COVID-19.

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.

FDA authorized emergency use of Pfizer’s oral antiviral drug to make the drug available as quickly as possible.

An obvious theme for 2021 has been COVID-19, but the next 12 months will see industry and its people experiencing further change.

Overall, 2021 proved to be another good year for drug approvals in Europe, albeit with a slight disappointment for Alzheimer’s patients, but what should industry be watching out for in 2022?

January is the kind of month that can make your head spin.

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.

FDA has become embroiled in the debate over access to “chemical” or “medication” abortions through the prescribing and distribution of the abortifacient mifepristone.

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