Pharmaceutical Technology Editors

Pfizer has expanded its voluntary recall to include all lots of varenicline (Chantix), but FDA allows continued distribution of the drug product to continue due to drug shortages.

Health Canada approved the new drug submission for Spikevax—more commonly known as the Moderna COVID-19 vaccine—for active immunization to prevent COVID-19 in individuals 12 years of age and older.

FDA revised the emergency use authorization for bamlanivimab and etesevimab (administered together) to include emergency use as post-exposure prophylaxis (prevention) for COVID-19.

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

The new FDA office will reorganize IT, data, and cybersecurity functions to an agency level.

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

BMG Pharma has signed an agreement with HTL for the development and commercialization of injectable products with sodium hyaluronate lipoate formate.

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

Symbiosis Pharmaceutical Services has successfully completed an on-site inspection, performed by the MHRA, of its expanded facility in Stirling, UK.

SGS has selected the European Centre for Clinical Research Training (ECCRT) for the provision of good manufacturing practice (GMP) training of its pharmacy team.

Exscientia has entered into a four-year agreement with the Bill & Melinda Gates Foundation for the development of small-molecule therapeutics that can tackle coronavirus and other viruses with pandemic potential.

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

The joint venture with OSTHUS will expand PharmaLex’s IT consulting and system integration expertise.

CPC’s MicroCNX Series Connectors provide an alternative to tube welding at small tubing sizes.

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

FDA and EMA will provide scientific advice to applicants concerning complex generic and hybrid products.

Pharmaceutical Technology checked in with AAPS and IPEC-Americas to get an update on how the organizations are navigating the pandemic and planning for the future.

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

AGC Biologics is expanding manufacturing capacity at its Heidelberg, Germany, facility for plasmid DNA and messenger RNA.

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

Both Marion Gruber and Phillip Krause, FDA officials, co-authored a document disputing the need for COVID-19 boosters for most people.

The memorandum of understanding between ABITEC and Luca AICell will work to advance ultra-high purity lipidic chemistries.

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.

Vector Laboratories has completed a $124 million cash buyout backed by Thompson Street Capital Partners and will begin an acquisition strategy to expand protein detection capabilities.

ABPI has announced that eight leaders from the patient and health charity sector have been chosen to join its new Patient Advisory Council.

ILC Therapeutics, has successfully closed a £3.5 million (US$4.9 million) pre-initial public offering (IPO) funding round.

NICE has reconsidered its decision on Janssen's Erleada (apalutamide), issuing two positive final appraisal determinations (FADs) on the therapy.

NICE has recommended tofacitinib (Xeljanz, Pfizer)as an option for treating active polyarticular juvenile arthritis and juvenile psoriatic arthritis.

Sterling Pharma Solutions has invested in a center of excellence for research into commercial applications of continuous flow chemistry at its site in Dudley, UK.