Susan Haigney

FDA announced on Nov. 15, 2023 that the US District Court for the District of Arizona entered into consent decree of permanent injunction that orders Smart Women’s Choice and its CEO, Jennifer A. Richard, to stop distributing unapproved contraceptive drugs in the United States until it complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The company has promoted its vaginal cream product as a safe and effective contraceptive despite the drug not being approved by FDA. The agency sent a 

 that it was unlawful to distribute the unapproved products; however, the company continued to distribute.

“The consent decree prohibits Smart Women’s Choice, Richard, and any persons or entities in active concert or participation with them who receive notice of the decree, from directly or indirectly manufacturing, preparing, processing, packing, repacking, receiving, labeling, holding and/or distributing any drug at or from their facilities unless and until they meet certain requirements to ensure they are operating in compliance with the FD&C Act, the FDA’s regulations and the decree, and they receive written notice from [FDA] that they appear to be in compliance with these requirements,” the agency stated in a press release.

“Americans expect and deserve drugs that have been scientifically proven to be safe, effective, and of high quality,” said Jill Furman, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, in the press release. “lFDA] remains fully committed to taking enforcement action against companies and executives responsible for marketing unapproved drugs in violation of federal law.”

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The US District Court for the District of Arizona entered into consent decree against Smart Women’s Choice and its CEO to stop the company from distributing unapproved contraceptive drugs.

Consent Decree Entered Against Arizona Company

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On Nov. 15, 2023, 3M announced the latest addition to its chromatographic clarifier portfolio. The Harvest RC Chromatographic Clarifier, BT500 is a 500-mL size, single-use chromatographic clarifier for monoclonal antibodies, recombinant proteins, and biologics. According to the company, the BT500 can produce predictive yield samples in 10 minutes, based on 5–8% packed cell volume (PCV) culture.

The BT500 offers a lab-scale solution for high purity and recovery “representative of a commercial scale process for clarification,” without the need for a centrifuge. The bottle-top vacuum technology delivers high product recoveries and DNA reduction (< 500ppb—based on 5–8% PCV culture) through a streamlined workflow, according to the company.

The 3M Harvest RC Chromatographic Clarifier portfolio is a set of fiber chromatography clarification devices that use proprietary fibrous chromatography media to deliver a single-stage purification solution for recombinant protein therapeutic manufacturing, which streamlines a multi-stage harvest clarification operation into a single-stage operation.

“Adding 3M Harvest RC Chromatographic Clarifier, BT500 to our product portfolio provides a much-needed solution for customers looking to maximize efficiency in the lab setting, allowing them to better keep pace with the accelerated industry demand,” said David Chau, bioprocess applications specialist at 3M Separation and Purification Sciences, in a press release.“ The Harvest RC Chromatographic Clarifier portfolio enables process intensification, yield improvements, and greater contaminant reduction compared to legacy methods. This new rapid testing capability extends even more opportunity for efficient workflows and exceptional clarity in bioprocess manufacturing.”

The 3M Harvest RC Chromatographic Clarifier, BT500 is the latest addition to the company’s chromatographic clarifier portfolio.

3M Health Care Launches New Chromatographic Clarifier

Aitia, a drug development and drug discovery technology company, announced on Nov. 13, 2023 a partnership with Charles River Laboratories, a contract development and manufacturing organization. Under the partnership, Aitia will be given access to Logica, Charles River’s artificial intelligence (AI)-powered drug solution platform. Aitia will use Logica across its portfolio of novel drug targets to create potential treatments for neurological indications, including Alzheimer’s, Parkinson’s, and Huntington’s diseases, as well as a variety of cancer treatments. The partnership also includes co-development of patient-derived xenograft (PDX) Digital Twins for 

“Unraveling the complex genetic and molecular circuitry of neurodegenerative disorders is critical to the discovery of treatments that significantly slow or reverse these devastating diseases,” said Colin Hill, chief executive officer and co-founder of Aitia, in a press release. “I do not believe we will get there without the insights from our Digital Twins, which, now combined with the advantages of Logica, positions Aitia to rapidly translate our discoveries into novel drug candidates. We are excited to join forces with Charles River, leveraging their decades of industry expertise in research to fuel our R&D efforts.”

“Combining Aitia’s Digital Twins with Logica’s next-generation solution stands to transform the discovery and development of novel therapeutics for neurological diseases and oncology,” said Professor Julie Frearson, PhD, corporate senior vice-president and chief scientific officer, Charles River, in the press release. “The research landscape for Alzheimer’s, Parkinson’s, and Huntington’s has moved slowly in recent years, and we are excited for the impact that this combined AI solution can deliver to patients.”

Logica, offered as a fully managed, risk-sharing model, uses predictive models, chemical design, synthesis capabilities, DNA-encoded libraries, 

 high throughput screening, and other capabilities to create target-to-candidate offerings. “Logica has optimized drug discovery,” said Emilio Cordova, executive director, Logica, in the press release. “Combining laboratory infrastructure, expert drug hunters, and large-scale compute capabilities, Logica eliminates whitespace and rapidly delivers results.”

Aitia will access Charles River’s Logica drug solution platform to develop therapeutic programs for neurodegenerative disease and oncology.

Charles River Laboratories and Aitia Partner on Neurodegenerative Disease and Oncology Drug Development

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The European Medicines Agency (EMA) announced on Nov. 10, 2023 that its Committee for Medicinal Products for Human Use (CHMP) has recommended approval of eight new medicines at its latest meeting. The medicines, three of which were designated as orphan medicines, include treatments for generalized myasthenia gravis, glioma, neovascular age-related macular degeneration, and more.

Omjjara (momelotinib), an orphan medicine, was recommended for treating the rare blood cancer, myelofibrosis, which affects the bone marrow.Another orphan drug, Rystiggo (rozanolixizumab), was recommended for approval to treat generalized myasthenia gravis, which is a chronic autoimmune neuromuscular condition. The third orphan drug, Spexotras (trametinib), was given a positive opinion for treating glioma, a brain tumor that develops in glial cells, in pediatric patients aged one year and older.

Two biosimilars and two generic drugs were also recommended for approval. The biosimilar Rimmyrah (ranibizumab) was recommended for treating the retinal macular disease, neovascular age-related macular degeneration. The second biosimilar, Uzpruvo (ustekinumab), was recommended to treat plaque psoriasis, psoriatic arthritis, and Crohn’s disease. The generic drugs that received a positive CHMP opinion include Azacitidine Kabi (azacitidine), for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukemia, and acute myeloid leukemia; and Naveruclif (paclitaxel), which treats metastatic breast cancer, metastatic adenocarcinoma of the pancreas, and non-small cell lung cancer.

CHMP also granted conditional marketing authorization after a re-examination to Krazati (adagrasib) for the treatment of advanced non-small cell lung cancer with a G12C mutation in the KRAS gene in adults whose disease has worsened after at least one systemic treatment. The committee also extended recommendations for nine previously authorized medicines: Ayvakyt (avapritinib), Evkeeza (evinacumab-dgnb), Fluad Tetra (influenza vaccine [surface antigen, inactivated]), Jardiance (empagliflozin), Keytruda (pembrolizumab), Mounjaro (tirzepatide), NexoBrid (anacaulase-bcdb), Talzenna (talazoparib), and Veltassa (patiromer).

Two applications for recommendation were withdrawn. Vijoice (alpelisib), an orphan drug, which would have been for the treatment of PIK3CA-related overgrowth spectrum, was withdrawn. Bylvay (odevixibat), also an orphan drug, had an application for extension of use to include treatment of cholestatic pruritus in Alagille syndrome in patients aged six months or older withdrawn.

Recommended medicines include treatments for generalized myasthenia gravis, glioma, neovascular age-related macular degeneration, and more.

EMA Recommends Rare Blood Cancer Treatment and Seven Other Medicines

The European Medicines Agency (EMA) announced on Nov. 8, 2023 that the Heads of Medicines Agencies (HMA), the European Commission, and EMA have published electronic product information (ePI) for selected medicines that have been harmonized across the European Union. The published ePIs are part of a one-year pilot program, under the Pharmaceutical Strategy for Europe, for the transition of information to an electronic system. Companies participating in the program create and submit the ePI as part of a regulatory application. The published ePIs include medicines that were evaluated by EMA or national authorities in Denmark, the Netherlands, Spain, and Sweden. The pilot program includes 25 medicines and will conclude in July 2024.

A Product Lifecycle Management Portal is available to view the ePIs in English for centrally approved drugs and in the local language of nationally approved medicines. ePI data can also be accessed via a public application programming interface.

According to EMA, medicine product information is provided for each authorized drug in the EU and includes a summary of characteristics, labeling, and a package leaflet. The information can also be found on EU regulator websites. “Digital platforms open new possibilities to share this information electronically, keep it constantly updated and make it more accessible to end users such as healthcare professionals and patients,” EMA stated in a press release.

“These ePIs were created following the EU ePI Common Standard adopted by the European medicines regulatory network to provide a consistent structure throughout all Member States and ensure the information works across different e-health platforms. This should facilitate the use of product information to meet individual needs and access requirements. Future developments could include functionalities such as automatic update notifications, access to supportive videos or audio content and online adverse-reaction reporting tools,” the agency stated in the release.

Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time.

Europe Publishes Electronic Product Information for Selected Medicines

On Nov. 7, 2023, FDA issued final guidance that includes recommendations for reporting post-approval changes of some common changes to container closure system (CCS) components consisting of glass vials and stoppers for approved sterile drug products and biologics. The recommendations apply to approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs). Pathways available to application holders to obtain feedback from FDA are also presented. Risk-based tools for implementation of changes to CCSs consisting of glass vials and stoppers are provided. This guidance does not apply to CCS types other than glass vials and stoppers.

According to FDA, many COVID-19 products use glass vials and stoppers as their CCS, and the supply of these products may be constrained. Manufacturers, therefore, may need to update approved applications to reflect changes made to CCS components to fill demand. The agency will consider risk-based approaches to implementation of chemistry, manufacturing, and controls (CMC) changes to a CCS so that supply of products is not impeded.

The guidance details common changes related to glass vials and stoppers and provides information on tools that can facilitate changes to CCS components. “FDA may expedite the assessment of a supplement or determine that a different reporting category is appropriate, taking into account public health priorities and the applicant’s rationale and associated risk assessment and mitigation strategy for the proposed change. Should a different reporting category be determined to be appropriate, FDA will notify the applicant and convey its rationale for the determination,” the agency states in the document.

The policy remains in effect until Aug. 7, 2024 unless a revised final guidance is published before then. More information can be found in the 

https://www.federalregister.gov/documents/2023/03/13/2023- 05094/guidance-documents-related-to-coronavirus-disease-2019-covid-19

The document includes recommendations for the reporting and implementation of changes to container closure system components.