Leaders in Life Sciences

Glenmark Pharmaceuticals has recalled nearly 1.5 million bottles of generic atomoxetine (ADHD medication) due to unacceptable levels of a potential carcinogen, N-nitroso atomoxetine. This recall, from January 2024, adds to a series of recent recalls by Glenmark, including potassium chloride capsules (June 2024), diltiazem hydrochloride (December 2024), and various other drugs in 2023 and 2022, due to manufacturing and impurity issues. These repeated recalls raise concerns about Glenmark's quality control, and patients taking Glenmark's atomoxetine are advised to consult their healthcare providers.

Novo Nordisk is strategically expanding into rare diseases, shifting from its traditional focus on common chronic conditions, by significantly increasing R&D investment and executing key acquisitions to build a strong portfolio in blood, endocrine, and hemato-renal disorders. The company aims to achieve long-term leadership in this space through internal innovation, strategic partnerships, and further mergers and acquisitions.

The FDA is updating the labeling for all FDA-approved testosterone products (oral, topical gel, transdermal patch, buccal system, and injection) based on the TRAVERSE trial and ABPM studies. The results of the TRAVERSE trial are being added to all testosterone product labels, and the language in the Boxed Warning related to an increased risk of adverse cardiovascular outcomes will be removed from all testosterone products. The TRAVERSE trial found no increased risk of adverse cardiovascular outcomes in men using testosterone for hypogonadism. However, the "Limitation of Use" language for age-related hypogonadism is being retained. A new warning about increased blood pressure is being added to products without such a warning. Furthermore, product-specific information on increased blood pressure will be included for products with completed ABPM studies. ABPM studies confirmed an increase in blood pressure with the use of all testosterone products. These actions follow prior FDA warnings about the risks of stroke, heart attack, and death in men taking testosterone products. Testosterone is only approved for use in men with low testosterone levels in conjunction with an associated medical condition.

A study by Phreesia demonstrated that point-of-care messaging significantly increases vaccine uptake. Patients who received vaccine information prior to their appointments were more than twice as likely to get vaccinated compared to a control group. The study, which ran from March 2020 to May 2024, also found that many patients found the information new and were more likely to discuss vaccines with their doctor. This approach could help counteract declining vaccine confidence and improve vaccination rates.

In 2024, Moderna faced financial challenges including $739 million in cost of sales for the fourth quarter, which factored in $193 million in inventory write-downs, $259 million in production wind-down costs, and a $238 million charge from a cancelled contract. The company's total revenue for 2024 was $3.2 billion, a 72% decrease from the previous year. Moderna is working to resize its production footprint to meet post-pandemic needs and has struggled to accurately gauge vaccine demand in the current market. Moderna anticipates revenue between $1.5 billion and $2.5 billion in 2025.

The pharmaceutical and life sciences sector anticipates a surge in merger and acquisition activity in 2025. Driving this trend are expected interest rate reductions by the Federal Reserve and the resolution of post-election uncertainties. While deal values and volumes are projected to rise, transactions in the $5 billion to $15 billion range are forecasted to be the most common. However, geopolitical issues could present obstacles to this growth.

The FDA is alerting the public to the risk of anaphylaxis, a rare but serious allergic reaction, associated with glatiramer acetate (Copaxone, Glatopa), a drug used to treat multiple sclerosis (MS). Anaphylaxis can occur at any time during treatment, even after doses administered months or years after starting the medicine, and has sometimes resulted in hospitalization and death. Symptoms typically appear within one hour of injection.To communicate this risk, the FDA is adding a Boxed Warning to the prescribing information and patient Medication Guide. Patients should stop taking glatiramer acetate and seek immediate medical attention if they experience symptoms of anaphylaxis such as wheezing, difficulty breathing, swelling of the face, lips, or throat, or hives. While early symptoms of anaphylaxis can be similar to a temporary post-injection reaction, they are typically more severe and worsen over time. If symptoms are more than mild, worsen, or do not go away quickly, patients should seek immediate medical attention