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Tracy Beth Høeg, the newly appointed head of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), outlined her priorities in a Thursday address to staff, signaling increased scrutiny of antidepressants used during pregnancy and respiratory syncytial virus (RSV) protective shots for infants, STAT reported.

Høeg, who assumed her position in December following the retirement of Richard Pazdur, indicated she would revisit issues she previously focused on, including the safety profile of antidepressants taken by pregnant women and the monoclonal antibodies designed to safeguard infants against RSV. She too expressed an intention to integrate her existing interest in vaccine policy into her role at the CDER.

Prior to her appointment, Høeg had taken steps to limit access to Covid-19 shots and assumed control of vaccine surveillance efforts, shifting responsibilities from career staff. Her arrival at the CDER marks the fifth leadership change at the drug center since the beginning of 2025, a period marked by concerns regarding the politicization of FDA scientific processes, as reported by STAT.

In separate news, pharmaceutical company Roche announced its plans to seek a buyer for one of its key antibiotics, Rocephin, and to cease manufacturing operations by 2030, according to Euractiv. The decision, attributed to rising production costs, declining prices, and increased competition from generic alternatives, impacts a drug listed as essential by both the World Health Organization and the European Union.

Rocephin is utilized in the treatment of severe bacterial infections, including meningitis, and pneumonia. Roche’s move occurs as the European Union intensifies efforts to reduce its reliance on Asian generic drug manufacturers and encourage production within the bloc, including Switzerland, under the new Critical Medicines Act. The antibiotic market has proven unprofitable for European companies due to the high volume of production required. Last year, Danish manufacturer Xelia halted production of several key antibiotic ingredients, signaling a broader trend within the industry.

The Food and Drug Administration is poised to significantly alter its drug approval process and expand access to medications currently requiring prescriptions, according to FDA Commissioner Marty Makary. The agency aims to create changes this year that would allow more companies to offer prescription medicines over the counter, or OTC.

Makary told CNBC that the FDA is undertaking a review of existing regulations, specifically focusing on updating OTC monographs – the rulebooks governing which drugs can be sold without a prescription. He indicated the agency is prioritizing “basic, safe” prescription drugs, citing nausea medications and vaginal estrogen, used to treat menopausal symptoms, as potential candidates for over-the-counter availability.

The move aligns with a key priority of the Trump administration: lowering drug costs. Makary framed expanded OTC access as a means to achieve that goal, removing layers of prescription-related expenses.

Alongside the OTC push, the FDA is also revising its standard for approving new drugs. Traditionally, the agency has required two rigorous studies to demonstrate safety and efficacy. Yet, Makary and a top deputy, Vinay Prasaid, announced in a New England Journal of Medicine article that the FDA’s “default position” will now be to require only one study for new drugs and other novel health products.

According to the article, this shift reflects advancements in drug research that have made the process “increasingly precise and scientific.” Makary and Prasaid predict the change will “lead to a surge in drug development.”

The changes are the latest in a series of adjustments to longstanding FDA standards and procedures under Makary’s leadership, all with the stated intention of reducing bureaucracy and accelerating the availability of new medicines.

The Trump administration also recently revived a pilot program aimed at reworking drug pricing within the 340B program, a controversial federal drug discount program, according to Stat News. This program provides discounted drugs to hospitals and clinics serving vulnerable populations.

Meanwhile, a lawsuit has been filed alleging that pharmacy benefit managers, including CVS and Express Scripts, negotiated large rebates from Mylan for the EpiPen device, benefiting the PBMs rather than consumers, Yahoo News reported.

Merck recently received FDA approval for Enflonsia, a shot to protect infants against RSV, the leading cause of hospitalization among babies. The wholesale price is set at $556 a dose, the same as Sanofi and AstraZeneca’s Beyfortus, though the two products differ in dosage requirements, according to STAT.

As the work week concludes, weekend plans beckon. Our agenda remains flexible due to a potential storm, but we intend to prioritize essentials like caffeine, reading, films, and a listening party featuring tracks like this, this, this, this, and this. Perhaps you’ll cook, connect with loved ones, or organize your space. A trip to Greenland is always an option. Whatever your choice, prioritize safety and enjoyment.

Moderna CEO Stéphane Bancel announced the company will not invest in new late-stage vaccine trials due to increasing opposition to immunizations from U.S. officials, according to Bloomberg News. Bancel’s statement represents his most direct commentary yet on the challenges vaccine manufacturers face under the current administration. He joins other pharmaceutical leaders expressing frustration with the government’s stance on immunizations. Led by U.S. Health and Human Services Secretary Robert F. Kennedy Jr., a known vaccine critic, officials have restricted eligibility for Covid vaccines and created conf

The U.S. Food and Drug Management asked drugmakers to remove warnings about a potential risk of suicidal thoughts from widely used GLP-1 weight loss drugs, including Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. This request, also covering Novo’s older weight loss drug Saxenda, follows an agency review that found no evidence linking GLP-1 receptor agonists to an increased risk of suicidal thoughts or behavior. The move could ease a key safety concern for this fast-growing class of medicines, which are being tested or used for conditions beyond weight loss, including cardiovascular issues, fatty liver disease, and sleep apnea. The warnings were originally based on reports with older weight loss medicines. Labels for these drugs in the European Union do not carry such warnings.

Illumina, a leader in genomics, is focusing on helping customers better understand and apply genetic data to drug progress. The company unveiled the Billion Cell Atlas, which it claims is the world’s largest dataset of its kind. this atlas details the results of turning genes on or off across 200 cell lines, including those used to study heart disease, neurologic disorders, immune conditions, and cancer. Data from these genetic changes could help drug companies validate drug targets or create AI-powered models of cell behavior. Illumina is offering the atlas to pharmaceutical companies, with Merck, AstraZeneca, and Eli Lilly as initial customers.

And so, another working week will soon draw to a close. Our agenda is, so far, rather modest. We plan to catch up on our reading, promenade with the official mascots, and hope to hold another listening party, featuring this, this, this, this and this. Depending on your location, staying cozy indoors with a book or watching a moving picture show may be ideal. Perhaps this is an possibility to stimulate the economy and visit an eatery or two.Or you could simply plan the rest of your life.Whatever you do, have a grand time, but be safe. Enjoy,and see you soon.

Merck is in talks to acquire cancer drug developer Revolution Medicines in a deal potentially worth $28 billion to $32 billion, Reuters reports. Other large pharmaceutical companies also express interest in Revolution,and another suitor could emerge. Merck aims to bolster its late-stage pipeline, which has nearly tripled as 2021 through internal progress and acquisitions, as it prepares to loose patent exclusivity for its blockbuster cancer treatment Keytruda later this decade. Acquiring Revolution would grant Merck access to daraxonrasib, an experimental drug in late-stage trials that received a fast-track review voucher from the U.S. food and Drug Management. This drug targets multiple mutations in the RAS genes, common drivers of cancers like pancreatic, lung, and colorectal cancers.

Eli Lilly found that combining its weight loss drug Zepbound with its immunology therapy Taltz provided greater benefits for obese patients with an autoimmune condition causing joint pain than Taltz alone, according to STAT. The data suggest zepbound, already proven effective for obesity and sleep apnea, may also help with psoriatic arthritis (PsA). However, the notable demand for Zepbound due to its weight loss effects may limit the impact on prescribing patterns. Lilly positions the trial as a way to highlight Taltz, stating it is “now the first and only biologic for PsA with data supporting a potential comprehensive treatment approach alongside” a GLP-1 drug. Several other immunology drugs remain popular among patients and doctors.