Pharmaceutical Technology Editors

The organizers of Pharmapack Europe have released the results of its global drug delivery and packaging survey, demonstrating the continuation of the United States’ lead in innovation.

Celltrion Group has been granted approval for regdanvimab (CT-P59) to be used as a treatment for COVID-19 by the Korean Ministry of Food and Drug Safety (MFDS).

ProductLife Group (PLG) and Juuka Advisory have teamed up to form a new consulting offering, ProductLife Consulting.

The first and only approved antibody-drug conjugate for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy receives accelerated approval by FDA.

Boehringer Ingelheim to develop novel cancer therapies by leveraging Abexxa’s breakthrough antibody-based drugs.

In an amendment to their existing contract manufacturing agreement, Celsian and Poly Pharm expand GEN-1 program collaboration to add clinical and commercial batches of investigational vaccine.

Verrica Pharmaceuticals receives CRL from FDA identifying deficiencies at a facility of a CMO for its NDA for VP-102.

The research collaboration between AstraZeneca and VaxEquity aims to discover and develop self-amplifying RNA therapeutics.

The FDA has amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to allow a single booster dose to several high-risk populations.

New data finds J&J COVID-19 vaccine and booster to provide increased protection against COVID-19.

Celularity and Oncternal’s collaboration will focus on therapeutics targeting Orphan Receptor 1, which is linked to aggression and survival in solid tumor cells.

Lonza’s investment in its Stein and Basel facilities in Switzerland aims to expand its overall drug product development and manufacturing services.

Novartis’ acquisition of Arctos Medical could lead to significant advancements in optogenetic therapies for patients with vision loss.

Metrion’s new 12,000 ft² headquarters will significantly expand its range of services and cell lines.

US District Court for the Middle District of Florida entered a consent decree of permanent injunction prohibiting Florida-based Premier Pharmacy Labs from producing or distributing drugs because of insanitary conditions.

The agency approved Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab injection), for the treatment of several eye diseases.

AstraZeneca will establish an API manufacturing facility near Dublin, Ireland.

The topline data from Pfizer and BioNTech’s trial suggests that a 10 µg vaccine is safe and effective among the 5 to 11 age group.

UCR scientists are researching whether a plant-based messenger RNA vaccine can be created and aim to eliminate the need for the refrigeration of mRNA vaccines during transport and storage.

People with ulcerative colitis who are taking statins were found to have a 50% decreased risk of colectomies and hospitalization, according to a Stanford Medicine study.

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.