Alexandra Murphy

Pfizer to ration key syphilis treatment amid supply shortage

Pfizer is warning physicians that it expects a new shortage of Bicillin L-A, a long-acting penicillin injection that is currently the single recommended treatment for syphilis during pregnancy, CNN reported July 16. 

The drugmaker’s alert follows a July 10 recall of certain lots found to contain floating particles, which Pfizer traced to faulty stoppers from an outside vendor. The company said no adverse reactions have yet been reported. 

“We have identified the root cause to be associated with stoppers supplied from an external vendor and are implementing the appropriate corrective and preventative actions,” the company said in a statement to the news outlet. “We fully recognize the importance of this medicine for patients and are working as quickly as possible to resolve the matter.”

Bicillin L-A most recently saw a shortage in 2023. As a result, the FDA allowed imports of two equivalent products, Extencilline and Lentocillin, which were imported from Portugal and sold by Mark Cuban’s Cost Plus Drugs. 

For now, Pfizer has advised customers that it will give an update on the Bicillin supply no later than mid-August and said until stock is recovered, it will ration the available supply for the shots. Providers will be asked to fill out medical request forms and the company will send supplies on a per-patient system. 

“We’re in the midst of a congenital syphilis crisis, and we’ve been calling for an emergency declaration for congenital syphilis for years,” said Jeffrey Klausner, MD, a professor of clinical population and public health sciences at the Los Angeles-based University of Southern California’s Keck School of Medicine. “This threatens to make that even worse.”
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ASHP urges Congress to approve pharmacy access, Medicare coverage bills

Hospital pharmacists are urging Congress to act on a number of their priorities, including Medicare coverage for pharmacist services and protections for residency funding. 

In a July 9 letter, Tom Kraus, vice president for the American Society of Health-System Pharmacists, called on lawmakers to advance bills designed to improve access to pharmacy services, reduce medication costs and protect funding of critical residency programs, according to a July 11 news release from the organization. 

Among the bills cited in the letter is the Ensuring Community Access to Pharmacist Services Act. It would allow Medicare to reimburse pharmacists for services such as testing, vaccination and treatment for respiratory infections. 

The ASHP is also advocating for the Rebuild America’s Health Care Schools Act, which would clarify reimbursement rules for pharmacy, nursing and allied health residency programs under Medicare and Medicaid. 
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WHO advises caution when using AI in traditional medicine: Report

The World Health Organization, alongside the International Telecommunication Union and the World Intellectual Property Organization, has released a technical report warning of risks associated with applying artificial intelligence to traditional medicine without safeguards. 

The report was presented at the ITU’s 2025 AI for Good Global Summit and outlined how AI is being used in traditional, complementary and integrative medicine, with concerns raised about data ownership and lack of legal protections, according to a July 11 news release from WHO. 

:AI must not become a new frontier for exploitation,” said Yukiko Nakatani, PhD, WHO assistant director-general for health systems. “We must ensure that Indigenous Peoples and local communities are not only protected but are active partners in shaping the future of AI in traditional medicine.”

The report also recommends national policies to regulate AI in traditional medicine, better data standards, training for practitioners and community-led approaches to digital knowledge sharing. 
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UC Health opens outpatient pharmacy center

Cincinnati-based UC Health has opened its fifth outpatient pharmacy, located inside the new UC Blood Cancer Healing Center on the UC Medical Center campus. 

The new pharmacy offers same-day access to medications, clinical pharmacist guidance and close coordination with care teams, enhancing convenience and continuity of care for patients and families, Jeffrey Akers, PharmD, vice president of pharmacy, told Becker’s. 

The pharmacy is integrated with the UC Specialty Pharmacy, allowing it to deliver advanced medications and support patients undergoing treatment for blood cancers such as leukemia, lymphoma and myeloma, he said. 
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Sun Pharma plant fails another inspection

U.S. inspectors have found new breakdowns at a Sun Pharmaceuticals plant in India that produces medications for U.S. customers, ProPublica reported July 16. 

The FDA found the factory failed to identify the source of bacterial contamination in test samples and did not address damaged equipment that had caused drugs to be contaminated with metal particles, according to the June inspection report. 

The findings come roughly two and a half years after the FDA allowed the facility to continue exporting selected drugs to the U.S., even after the factory was officially banned from the U.S. market. 

Inspectors also cited that workers improperly handled vials and stoppers meant for sterile medications, and in some instances, there were lapses in disinfecting both the equipment and production areas, the report said. Investigators also said they saw liquid dripping through ceiling cracks, and that fungus and mold appeared to be present in a storage area for samples used for testing. 

The inspection in June was the first time the FDA had been back to the factory since it imposed the import ban and Sun Pharma began shipping exempted medications to the U.S.
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Trump threatens pharma tariffs this month: 4 notes

President Donald Trump said he will most likely impose tariffs on pharmaceuticals as soon as the end of the month, along with tariffs on semiconductors, Bloomberg reported July 15. 

Here are four notes: 

President Trump said the additional tariffs could hit along with broader additional rates set for August 1. “Probably at the end of the month, we’re going to start off with a low tariff and give the pharmaceutical companies a year or so to build, and then we/re going to make it a very high tariff,” he told reporters July 15.

At a cabinet meeting in early July, President Trump announced plans to impose a 50% tariff on copper and suggested that pharmaceutical tariffs could reach 200% within a year unless companies bring manufacturing back to the U.S. He also invoked investigations under Section 232 of the Trade Expansion Act of 1962, citing national security threats due to a flood of imports.

This comes after President Trump sent letters to trading partners dictating new import duties while maintaining a willingness to negotiate. One negotiation with Indonesia resulted in a revised tariff rate of 19%, down from 32% in exchange for commitments to buy $15 billion in U.S. energy and $4.5 billion in agriculturale products.

Smaller nations that did not receive custom tariff rates from the Trump administration will face a flat tariff of 10%, while other trading partners, such as the European Union, face a much higher levy of 30%.

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FDA to review myeloma drug after mixed trial data, eye safety concerns

The FDA is reevaluating GlaxoSmithKline’s blood cancer drug Blenrep following mixed results from two phase 3 trials and mounting concerns about eye-related side effects and dosing. 

The agency is meeting with its Oncologic Drugs Advisory Committee July 17 to discuss whether the drug’s proposed doses are appropriate given the high rates of ocular toxicity seen in the clinical trials, according to a briefing document. The studies tested Blenrep in combination with standard therapies for relapsed or refractory multiple myeloma. 

Though Blenrep combinations improved progression-free survival for multiple myeloma patients, more than 75% of patients experienced severe eye toxicity, including blurred vision and corneal damage. 

The panel will weigh whether revised dosing schedules could improve safety without compromising efficacy. 
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CMS reaches outcome-based deal with drugmakers to treat sickle cell disease

CMS has reached agreements with drug manufacturers to provide gene therapies to treat sickle cell disease to Medicaid recipients under a new outcomes-based model. 

A total of 33 states, including the District of Columbia and Puerto Rico, have joined a program that ties Medicaid payments to patient outcomes, according to a July 14 news release shared with Becker’s. Under the arrangement, drugmakers will provide discounts and rebates if the treatments do not achieve expected results. 

This marks the first time the federal government has negotiated these contracts on behalf of state Medicaid programs. The participating states account for about 84% of Medicaid enrollees living with sickle cell disease. 

The program provides up to $9.55 million per state with flexible start dates beginning January 2025, the release said.
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Federal judge tosses AbbVie lawsuit over Missouri 340B law

A federal court in Missouri has dismissed a legal challenge by drugmaker AbbVie to the state’s new 340B contract pharmacy law, which aims to regulate how pharmaceutical companies interact with contract pharmacies. 

The order, filed July 11 in the U.S. District Court for the Eastern District of Missouri, sided with Missouri Attorney General Andrew Bailey who had moved to dismiss the case, according to court documents reviewed by Becker’s. 

AbbVie filed the lawsuit earlier this year, alleging that Missouri’s 340B law conflicted with federal 340B program regulations and was unconstitutional. However, the court ruled that AbbVie lacked standing, finding insufficient justification for moving the case forward. 
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GLP-1s may boost testosterone: Study

Weight loss drugs like Ozempic and Mounjaro may help reverse low testosterone levels in men with obesity or Type 2 diabetes, according to research presented at the Endocrine Society’s annual meeting in San Francisco, NBC News reported July 14.

Researchers at SSM Health St. Louis University Hospital analyzed EHRs from 110 men with obesity or Type 2 diabetes who were taking GLP-1s. Testosterone levels were measured before starting the medications and up to 18 months afterward. Nearly half of the participants began with low to low-normal testosterone levels. However, most reached normal levels after treatment. 

“The increases we observed were more modest than what you would typically see with testosterone replacement therapy,” said lead author Shellsea Canales, MD, endocrinologist at SSM Health St. Louis University Hospital, in an email to the news outlet. “However, they occurred naturally, without testosterone replacement therapy, and likely reflect the body recovering its normal hormone production as weight and insulin resistance improved.”

The study also highlighted a potential need to lower or discontinue testosterone therapy in men whose levels normalize from GLP-1s. Researchers did not assess testosterone levels after stopping the medication, and outcomes may vary if the weight is regained. 
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