Susan Haigney

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Bettersize US announced on Oct. 22, 2023 that it is showcasing three of its instruments—the BeNano Series, Bettersizer 2600, and BetterPyc 380—at the AAPS 2023 PharmSci 360 event. The company is also highlighting its FLOW MODE coupled with high-performance liquid chromatography (HPLC), “which enables high-resolution nanoparticle size testing tailored to the precise needs of pharmaceutical professionals,” according to the company.

The BeNano Series features nanoparticle size and zeta potential analysis by three light scattering techniques. The Bettersizer 2600 offers particle size analysis by laser diffraction, with wet/dry dispersions, and the BetterPyc 380 features powder analysis by gas displacement method.

Bettersize Instruments is a provider of analytical instruments for material characterization, comprehensive solutions, and exceptional customer service. In August 2023, the company opened a new facility in Costa Mesa, Calif. to support North American material scientists, researchers, and engineers.

Visit Bettersize at PharmSci 360 at booth number 2135.

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Bettersize US showcases their BeNano Series, Bettersizer 2600, and BetterPyc 380 instruments at the AAPS 2023 PharmSci 360 event. 

Bettersize Unveils New Capabilities at AAPS 2023 PharmSci 360

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On Oct. 18, 2023, the European Medicines Agency (EMA) announced that national competent authorities have notified the agency that pre-filled pens falsely labeled as Ozempic (semaglutide, 1 mg, solution for injection) have been found at wholesalers in the European Union (EU) and the United Kingdom. EMA stated in a press release that these reports of fake Ozempic follow an increase in demand for the diabetes medication, which has also created a shortage of the drug.

The pens’ labels are in German and originated in Austria and Germany. The falsified pens include genuine information from Ozempic packs including batch numbers, 2D barcodes, and unique serial numbers. According to EMA, the serial numbers came up as inactive when they were scanned. The falsified pens also differ in appearance from the genuine pens. A photo of the falsified pen can be found on the 

Regulators in the EU and police are investigating the falsified pens, and wholesalers and pharmacies have been warned of “suspicious offers of Ozempic.” German and Austrian regulators have issued statements of non-compliance with good distribution practices to wholesalers. It is recommended that wholesalers and pharmacies use caution with purchasing Ozempic from supplier and that packages be checked in the verification system.

EMA is advising patients to check the patient information leaflet that comes with the medication to be sure the pen looks correct. If they suspect the pen is fake, they should not use the medication and return the product to the pharmacy. However, the agency reports that there is no evidence that the falsified products have been given to patients from legal pharmacies.

The agency is monitoring the situation and will provide updates as they are available.

The agency is warning patients and healthcare providers about pre-filled pens falsely labeled as Ozempic.

EMA Warns About Falsified Ozempic Pens

The European Medicines Agency (EMA) announced on Oct. 13, 2023 that the agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended seven new medicines for the treatment of a variety of conditions, including Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, hyperargininemia, invasive candidiasis,menopause symptoms, and diagnostic medicines for characterizing lesions. EMA also announced two withdrawn marketing applications—for Jivadco and Sugammadex Lorien—and reexamination requests for Translarna and Blenrep. A review of the benefits and risks of Ocaliva (obeticholic acid), which treats adults with primary biliary cholangitis, was also initiated.

Among the positive opinions granted by CHMP is a treatment for Duchenne muscular dystrophy, Agamree (vamorolone), which is a genetic disorder with progressive loss of muscle function. 

for the treatment of adult patients with relapsed or refractory multiple myeloma, a rare cancer of the bone marrow.  A positive opinion under exceptional circumstances was granted to Loargys (pegzilarginase) for the treatment of a rare disease with neurological clinical signs, hyperargininemia. Rezzayo (rezafungin) was granted approval for the treatment of invasive candidiasis, a serious fungal infection caused by Candida. In addition, a treatment for moderate-to-severe hot flashes due to menopause—Veoza (fezolinetant)—was approved.

Two diagnostic medicines for the detection of central nervous system lesions—Elucirem (gadopiclenol) and Vueway—were also approved. CHMP also extended indications for Brukinsa, Imfinzi, Jemperli, Keytruda, Praluent, Prevymis, Rubraca, and Veyvondi.

The recommended medicines include treatments for Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, hyperargininemia, invasive candidiasis, menopause symptoms, and diagnostic medicines for characterizing lesions.

EMA Recommends Seven Medicines for Approval in October

The European Medicines Agency (EMA) announced on Oct. 13, 2023 that the agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a conditional marketing authorization for Elrexfio (elranatamab) as a monotherapy for patients “withrelapsed and refractory multiple myeloma who have received at least three prior therapies and whose cancer has worsened since they received their last treatment.” The treatment was supported by the agency’s PRIority Medicines (PRIME) scheme, which fosters medicines that target unmet needs.

Elranatamab is a monoclonal antibody (mAb) that simultaneously targets B-cell maturation antigen (BCMA), which is present on the surface of the multiple myeloma cells, and to CD3, a protein that is present on the T cells (cells in the immune system). The mAb activates T cells to kill the multiple myeloma cells.

The recommendation was based on an open-label, single arm, multicenter, Phase II clinical trial that investigated the treatment’s efficacy “in 123 participants with refractory multiple myeloma who had received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, but who had not received prior BCMA-directed therapy. 61% of patients enrolled in the trial responded to the treatment with Elrexfio and more than 70% of the responding patients have a probability to live without their disease getting worse for an average of 15 months,” EMA stated in a press release. The safety of the mAb was shown after data from 265 participants were analyzed. Common side effects included a decrease in blood cells, infections, and cytokine release syndrome (CRS). According to EMA, “One of the main risks associated with elranatamab use is neurological toxicity including immune effector cell-associated neurotoxicity (ICANS), as these events have the potential to be life-threatening or fatal if not properly managed. Monitoring and mitigation strategies for CRS and ICANS are described in the product 

 and in the risk management plan that is an integral part of the authorization.”

The maker of Elrexfio (elranatamab) will have to submit data from a randomized Phase III trial to confirm the results of previous studies. Submission of final results of the pivotal Phase II clinical trial will also need to occur.

CHMP’s recommendation will be sent to the European Commission for adoption in the European Union.

The agency recommended conditional marketing authorization for Elrexfio (elranatamab) as a monotherapy for adult patients with relapsed and refractory multiple myeloma.  

EMA Recommends Multiple Myeloma Treatment

FDA published draft guidance on Oct. 11, 2023, 

Quality Considerations for Topical Ophthalmic Drug Products

, that discusses quality considerations for topical ophthalmic drug products used in and around the eye. These types of products include solutions, suspensions, emulsions, gels, ointments, and creams.

The document specifically outlines approaches for evaluating visible particulate matter, extractables and leachables, and impurities and degradation products. It also discusses 

 drug release/dissolution testing for certain ophthalmic dosage forms. FDA also offers recommendations for design, delivery, and dispensing features of container closure systems (CCSs) and stability studies.

Regarding visible particulate matter, the guidance states, “For topical ophthalmic drug products packaged in opaque containers, appropriate technologies (e.g., X-ray spectroscopy) or destructive testing should be used to identify particulates within the accepted visible size range.”

In discussing extractables and leachables, the document states, “Leachables have the potential to interact with the formulated drug product, which could compromise product quality and therapeutic effect. The assessment of extractables and leachables should consider the primary, secondary, and tertiary packaging components of the CCS, including the labeling components.”

 drug release and dissolution testing, FDA states, “One approach that applicants can consider as part of the quality control strategy for certain ophthalmic dosage forms (e.g., suspensions, emulsions, semi-solids) is the use of 

 drug release/dissolution testing. Other approaches are also acceptable, such as using one or more critical quality attributes (CQAs) that are sensitive to the formulation and process variants. The applicant should provide scientific justification for how the control strategy will ensure consistent product quality.”

In addition, the guidance document provides information about United States Pharmacopeia criteria and recommendations for documentation of chemistry, manufacturing, and controls information for new drug applications, abbreviated new drug applications, and biologics license applications. However, the guidance does not apply to biological products regulated by the Center for Biologics Evaluation and Research.

The draft guidance document discusses quality considerations for topical ophthalmic drug products.

FDA Issues Guidance for Topical Ophthalmic Drugs

FDA announced on Oct. 11, 2023 that it has established the Digital Health Advisory Committee to advise the agency on the scientific and technical issues surrounding digital health technologies (DHTs) such as artificial intelligence (AI), machine learning (ML), augmented reality, virtual reality, digital therapeutics, wearables, and remote patient monitoring. The committee, which expects to be fully operational in 2024, will provide expertise and perspective on FDA’s understanding of the benefits and challenges of DHTs.

The development of the committee is in response to the rapidly evolving DHT space that covers a range of technologies. These technologies also include decentralized trials, patient-generated health data, and cybersecurity, according to FDA.

“As one of our strategic priorities, our goal is to advance health equity in part through expanding access by bringing prevention, wellness, and healthcare to all people where they live—at home, at work, in big cities, and rural communities,” said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, in a press release. “Digital health technologies are critical for achieving this transformation in care delivery. As digital health technologies advance, [FDA] must capitalize on knowledge from inside and outside of the agency to help ensure we appropriately apply our regulatory authority in a way that protects patient health while continuing to support innovation.”

“Technology moves at an incredible pace, and we’re excited to have a committee of experts throughout the field who can help ensure our regulation of these exciting tools maintains an appropriate pace while working within parameters of safety and effectiveness standards,” said Troy Tazbaz, director of FDA’s Digital Health Center of Excellence. “Many of these technologies are novel and tend to rapidly change; it’s our duty to seek as much knowledge on them as possible as we determine and implement appropriate regulation to encourage innovation while protecting public health.”

There will be nine core voting members on the committee including the committee chair. FDA is requesting that those interested in serving on the committee submit nominations electronically to the 

FDA Advisory Committee Membership Nomination Portal 

The new Digital Health Advisory Committee will advise the agency on issues related to technologies such as AI, virtual reality, and machine learning.