Susan Haigney

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FDA Commissioner Marty Makary, MD, MPH, released a statement on Aug. 13, 2025 commending Florida Attorney General James Uthmeier’s emergency rule filing to classify certain concentrated 7-hydroxymitragynine (7-OH) opioid drugs as Schedule 1 controlled substances in Florida. The rule makes it illegal to sell, possess, or distribute certain 7-OH drugs in the state.

“The proliferation of concentrated 7-OH products is a major concern for the FDA. I am particularly concerned with the growing availability of concentrated 7-OH products appealing to children and teenagers, such as fruit-flavored gummies, candies, and ice cream cones,” Makary said in the statement (1). “These concentrated 7-OH products have snuck into every community in America, and I'm glad to see Florida's local leaders fighting back and educating Floridian parents, law enforcement professionals, teachers and community leaders about this threat to public health. I encourage other states to act now and use common sense regulation to safeguard the well-being of our youth and Make America Healthy Again.”

In July 2025, FDA recommended a scheduling action to control certain 7-OH products under the Controlled Substances Act (2). A concentrated byproduct of the kratom plant, 7-OH has the potential for abuse, according to the agency, because it can bind to opioid receptors. FDA released a report about the health concerns (3) of 7-OH and how it differs from the kratom plant leaf. The agency also warned about vape and other products that contain 7-OH, calling these products a major concern for the agency, especially those that might appeal to children and teenagers. Labeling for these products might not be accurately labeled, the agency stated, and they might be disguised as kratom.

“Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH. After the last wave of the opioid epidemic, we cannot get caught flat-footed again,” said Makary in a press release (2).“7-OH is an opioid that can be more potent than morphine. We need regulation and public education to prevent another wave of the opioid epidemic.”

FDA also announced labeling changes in July for all opioid pain medications that emphasize the risks with long-term use of these products.Data from two large FDA-required observational studies, postmarketing requirements (PMR) 3033-1 and 3033-2, provided new data on how long-term opioid use can lead to serious side effects. These data combined with public comments, medical research, and a lack of studies on the long-term effectiveness of opioids led the agency to require the safety labeling changes so that health care professionals and patients can make more informed treatment decisions.

“The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” said Makary, in a press release (4). “This long-overdue labeling change is only part of what needs to be done—we also need to modernize our approval processes and post-market monitoring so that nothing like this ever happens again.”

“I know firsthand how devastating addiction is—not just for individuals, but for entire families and communities,” said Health and Human Services Secretary Robert F. Kennedy, Jr., in the release. “Today’s FDA action is a long-overdue step toward restoring honesty, accountability, and transparency to a system that betrayed the American people.”

Makary, M.A. Statement from FDA Commissioner Marty Makary, M.D., M.P.H., on Florida Restriction of 7-OH Opioid Products. 

https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-marty-makary-md-mph-florida-restriction-7-oh-opioid-products

FDA. FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers. Press Release. July 29, 2025. 

https://www.fda.gov/news-events/press-announcements/fda-takes-steps-restrict-7-oh-opioid-products-threatening-american-consumers

Reissig, C. J.; et al. 7-hydroxymitragynine (7-OH): An Assessment of the Scientific Data and Toxicological Concerns Around an Emerging Opioid Threat. 

FDA. FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks. Press Release. July 31, 2025. 

https://www.fda.gov/news-events/press-announcements/fda-requires-major-changes-opioid-pain-medication-labeling-emphasize-risks

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FDA Commissioner Marty Makary praised Florida's emergency rule to classify concentrated 7-hydroxymitragynine (7-OH) as a Schedule 1 controlled substance, addressing concerns over its appeal to youth. The FDA had recommended this scheduling action due to 7-OH's potential for abuse, as it binds to opioid receptors. The agency also announced labeling changes for opioid pain medications, emphasizing risks associated with long-term use. These actions aim to prevent another opioid epidemic wave and enhance public health safety by promoting informed treatment decisions and regulatory oversight.

Florida’s emergency rule will classify certain concentration forms of 7-hydroxymitragynine opioid products as Schedule 1 controlled substances in Florida, a step FDA recommended for 7-OH opioids in July 2025.

FDA Commissioner Applauds Florida Restriction on 7-OH Opioids

FDA announced on Aug. 7, 2025 a new program to increase regulatory predictability and facilitate construction of drug manufacturing facilities in the United States, with the purpose of strengthening the country’s domestic drug supply chain. FDA PreCheck was created in response to an executive order directing the agency to streamline review of domestic manufacturing plants and eliminate unnecessary regulatory requirements.

According to FDA, more than half of pharmaceuticals distributed in the US are made overseas, and the US is reliant on foreign API manufacturers, with only 11% of API manufacturers located domestically. The PreCheck Program will have a two-phase approach to the development of new manufacturing facilities in the US.

The Facility Readiness Phase will allow more frequent communication between manufacturers and FDA at critical stages, such as facility design, construction, and pre-production. Companies will be encouraged to provide the agency with comprehensive facility-specific information through a Type V drug master file (DMF) that should include site operating layout and description, quality system elements, and quality management maturity practices. The DMF can be used in a drug application as appropriate.

The Application Submission Phase will focus on streamlining development of the chemistry, manufacturing, and controls section of a drug application through pre-application meetings and feedback.

“Our gradual overreliance on foreign drug manufacturing has created national security risks,” said FDA Commissioner Marty Makary, MD, MPH, in a press release (1). “The FDA PreCheck initiative is one of many steps FDA is taking that can help reverse America's reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong, and domestic drug supply.”

A public meeting, “Onshoring Manufacturing of Drugs and Biological Products", will be held on Sept. 30, 2025 that will feature a presentation of the FDA PreCheck program, stakeholder discussion, and additional considerations for overcoming onshoring challenges (2).

Pharma companies may be responding to the current administration’s push to move drug manufacturing to the US, with some major names announcing new and/or expanded locations in the US. 

 in February that it would be building four new domestic manufacturing sites in the US (3). In July, AstraZeneca announced it was investing $50 billion in US manufacturing and development, including a multi-billion-dollar facility in Virgina (4). Hikma Pharmaceuticals USA announced in June that it is investing $1 billion by 2030 to expand generic-drug manufacturing at its Ohio and New Jersey facilities (5). Also in June, BASF opened a good manufacturing practice (GMP) facility in Wyandotte, Mich., as part of the company’s commitment to providing a reliable supply of bioprocessing ingredients and excipients (6).

FDA. FDA Announces New FDA PreCheck Program to Boost US Drug Manufacturing. Press Release. Aug. 7, 2025. 

https://www.fda.gov/news-events/press-announcements/fda-announces-new-fda-precheck-program-boost-us-drug-manufacturing

FDA. Hearings, Meetings, Proceedings, etc.: Onshoring Manufacturing of Drugs and Biological Products. Federal Register. Aug. 8, 2025. 

https://www.federalregister.gov/public-inspection/2025-15083/hearings-meetings-proceedings-etc-onshoring-manufacturing-of-drugs-and-biological-products

Eli Lilly and Company. Lilly Plans to More Than Double US Manufacturing Investment Since 2020 Exceeding $50 Billion. Press Release. Feb. 26, 2025.

AstraZeneca Plans to Invest $50 Billion in America for Medicines Manufacturing and R&D

Hikma Pharmaceuticals USA Announces $1 Billion of New US Investment to Further Expand its Domestic Manufacturing and Development of Essential Generic Medicines

BASF. BASF Strengthens Its Commitment to the Biopharma and Pharmaceutical Ingredients Industries through a New Investment in North America. Press Release. June 17, 2025.

The FDA has launched the FDA PreCheck program to enhance regulatory predictability and support the construction of drug manufacturing facilities in the US, aiming to bolster the domestic drug supply chain. This initiative addresses the reliance on foreign pharmaceutical manufacturing, with only 11% of API manufacturers based domestically. The program involves a two-phase approach: the Facility Readiness Phase and the Application Submission Phase, focusing on streamlining processes and enhancing communication. Major pharmaceutical companies are responding by investing in new and expanded US manufacturing sites, aligning with the administration's onshoring efforts.

The agency’s new program is designed to increase regulatory predictability and streamline review of domestic manufacturing facilities.

FDA Moves to Strengthen Drug Supply Chain with PreCheck Program

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Bora Pharmaceuticals announced on Aug. 5, 2025 that it plans to invest in the expansion manufacturing and packaging capabilities at the company’s Maple Grove, Minn. facility that it acquired in 2024 with the acquisition of Upsher-Smith Laboratories. The expansion is part of the company’s growth to meet the demand for oral solid dose products, increasing complex formulations, novel drug delivery technologies, and the shift from solid dosage to biologic formulations.

The first phase of the contract development and manufacturing organization’s (CDMO’s) investment will be a Gerteis Macro-Pactor at the site that will be followed by a broader buildout of 100,000 square feet of dedicated shell space to streamline high-volume production. The FDA-inspected manufacturing site will have on-site quality control laboratories and a dedicated development team.

“With pharmaceutical companies relying more heavily on specialized CDMO partners to scale production and maintain quality, top-tier manufacturing capacity and technical expertise are at a premium,” said J.D. Mowery, president of Bora’s CDMO business, in a press release (1). “Bora’s Maple Grove facility offers a unique opportunity for innovators to secure space in a state-of-the-art site staffed by experts in formulation development, tech transfer, and commercial manufacturing.”

“As we complete our transition from Upsher-Smith, we’re creating the infrastructure to deliver integrated manufacturing, packaging, and analytical services with the speed and quality our clients need,” shared Dennis Hall, vice president and general manager of the Maple Grove site, in the release. “As we expand our capabilities, we look forward to tapping into all the experience and talent in the area.”

In July 2025, Bora announced the installation of a high-performance filling line at its Mississauga, Ontario, Canada manufacturing facility to expand the company’s production capabilities, especially for dermatologic products in response to projected growth in the dermatologic market. The new tube-filling line can produce approximately 7 million to 15 million units pers year and can handle metal, plastic, and ABL tubes. The line can accommodate fill volumes from 2g to 150g and supports scalability in manufacturing vessels, specifically for semi-solid manufacture, that range in size from 2.5Kg to 3600Kg. Laser printing capabilities are suited for dermatologic applications, and the line, which is PODA and Track and Trace serialization qualified, can pack tubes into a wide range of cartons, then bundle, and automatically pack into shipping cases.

“This filling line complements our deep expertise in semi-solid formulations and strengthens our ability to help customers scale up efficiently,” John Lawrie, vice-president of Operations for Bora Pharmaceuticals, said in a press release (2). “The upgrade significantly expands our capacity, allowing us to address growing demand for high volume production not just from our current partners, but from the marketplace as a whole.”

Bora Pharmaceuticals. Bora Pharmaceuticals Announces Multi-Year Expansion for Midwest Manufacturing Site, as Upsher-Smith Entity Split is Finalized. Press Release. Aug. 5, 2025. 

https://bora-corp.com/bora-pharmaceuticals-announces-multi-year-expansion-for-midwest-manufacturing-site-as-upsher-smith-entity-split-is-finalized/

Bora Pharmaceuticals. Cutting-Edge Technology to Accelerate High-Volume Production; Mississauga Site to be Outfitted with Tube Filler this July. Press Release. July 16, 2025. 

https://bora-corp.com/bora-pharmaceuticals-adds-new-filling-line-to-canadian-manufacturing-facility/

Bora Pharmaceuticals is expanding its manufacturing and packaging capabilities at its Maple Grove, Minnesota facility, acquired from Upsher-Smith Laboratories in 2024. This expansion aims to meet the growing demand for oral solid dose products and novel drug delivery technologies. The first phase includes installing a Gerteis Macro-Pactor and developing 100,000 square feet of production space. Additionally, Bora is enhancing its Mississauga, Ontario facility with a high-performance filling line to boost dermatologic product production. These expansions will support increased production capacity and technical expertise to meet market demands.

The investment will expand the company’s manufacturing and packaging capabilities at its Maple Grove, Minn. site, which Bora acquired in 2024 with its acquisition of Upsher-Smith Laboratories.

Bora Pharmaceuticals to Expand Midwest Manufacturing Site

ESTEVE CDMO (actively operating under the Esteve Química brand) announced on July 31, 2025 that it has acquired Regis Technologies, an API contract development and manufacturing organization (CDMO) in Chicago. The acquisition expands ESTEVE’s API contract development and manufacturing services in the United States from pre-clinical to commercial manufacturing.

ESTEVE CDMO, headquartered in Barcelona, is a global pure-play CDMO that specializes in small-molecule APIs, intermediates, spray drying technologies, and high-potency API manufacturing. To these services, Regis Technologies brings process R&D; analytical and stability; current good manufacturing practice (GMP) API manufacturing; chemistry, manufacturing, and controls support; and chromatography products.

"We are proud to strengthen our CDMO solutions for pharmaceutical innovators through this acquisition, while welcoming around 70 skilled professionals to our US team," said Joan Petit, chief industrial operations officer of ESTEVE and general manager of Esteve CDMO (Esteve Química), in a press release (1).

"This acquisition enhances our early-stage development capabilities, and expands our global manufacturing footprint, allowing us to have an integrated service offering to better respond to our customers' needs," Andrea Oro, global head of Commercial Operations and Strategy, added.

"We are happy to join a company that shares our same values, a company that is also family-owned, with more than 90 years of experience, that is committed to people and focused on delivering long-term value to customers," said Scott Aladeen, president and CEO of Regis Technologies, in the release.

ESTEVE acquires symptomatic medullary thyroid cancer treatment

In June 2025, ESTEVE, the company’s pharmaceutical development division, acquired the rights to Caprelsa (vandetanib) in more than 50 countries from Sanofi. Caprelsa (vandetanib) is a treatment for adults and children five years of age and above with aggressive symptomatic medullary thyroid cancer.

"Medullary thyroid carcinoma is a rare neuroendocrine tumor that can produce calcitonin from parafollicular cells. The treatment of resectable disease is surgery (2). When the disease is not technically resectable, this treatment provides a long-lasting slowdown of disease progression. We at ESTEVE are proud to join the fighting effort of the patients diagnosed with this carcinoma and their healthcare professionals, with the ambition to continue improving patient's health and lives," José María Giménez-Arnau, chief scientific & medical officer of ESTEVE, said in a press release (3).

Other recent acquisitions by the company include the purchase of a business specializing in rare and ultra-rare endocrinology and onco-endocrinology diseases in April 2024 and a license for a biologic treatment for children and adolescents aged 2–18 years old with severe primary insulin-like growth factor 1 deficiency in April 2025.

"We are proud to announce that we are increasing our portfolio of highly specialized therapies. Caprelsa will help us improve the lives of patients all around the world. This is a step forward in ESTEVE's international journey focused on highly specialized treatments for high unmet medical needs of patients," Jacob Tolstrup, chief commercial officer of ESTEVE, said in the press release (3).

ESTEVE CDMO. ESTEVE CDMO Acquires Regis Technologies, Expanding US Presence and Capabilities. Press Release. July 31, 2025. 

https://www.esteve.com/global/media/news/esteve-acquires-regis-technologies-expanding-u-s-presence-and-capabilities

American Thyroid Association. Cancer of the Thyroid. Thyroid.org (accessed Aug.6, 2025). 

https://www.thyroid.org/medullary-thyroid-cancer/

ESTEVE. ESTEVE to Acquire Medicine to Treat Medullary Thyroid Cancer. Press Release. June 30, 2025. 

https://www.esteve.com/global/media/news/esteve-to-acquire-medicine-to-treat-medullary-thyroid-cancer

ESTEVE CDMO, operating under the Esteve Química brand, has acquired Regis Technologies, enhancing its API contract development and manufacturing services in the US. This acquisition strengthens ESTEVE's capabilities from pre-clinical to commercial manufacturing, adding process R&D, GMP API manufacturing, and more. Additionally, ESTEVE's pharmaceutical division acquired Caprelsa (vandetanib) for treating aggressive symptomatic medullary thyroid cancer, expanding its portfolio of specialized therapies. These strategic moves align with ESTEVE's focus on highly specialized treatments for unmet medical needs, reinforcing its global presence and commitment to patient care.

The acquisition expands the CDMO’s small-molecule API development and manufacturing services in the US.

ESTEVE CDMO Acquires Regis Technologies

The Evolving Field of Radiopharmaceuticals

Radiopharmaceuticals have been traditionally used to treat superficial tumors, according to Mike Ritchie, CCO at 

. As they have evolved, they have been used to treat internal tumors, and now the technology is transforming to be directed specifically so that they only impact the tumor and not other cells in the body.

“There's so much [that goes] into pharmaceutical development into making something that can be manufactured at scale. It can sit on a shelf for a while. We can administer it to a patient, and it behaves in the way that we want,” says Ritchie. “We're just learning how to apply what we learn from anybody drug conjugatesinto radio drug conjugates, so the chemistry of how to link this radio ligand to an antibody, something that will continue to evolve, and there's a real opportunity there to improve that, to improve the therapeutic activity.From the biology perspective, again, we're in our infancy and understanding what are the tumor types, or the molecular cohorts within a tumor that are more sensitive to radio ligands. Like any chemotherapy or any therapy, certain tumors will respond. Others will not. They'll develop resistance. And so really understanding the right cohorts of patients to treat is something that we're still learning, and I think we'll continue to learn as the clinical development of these programs evolves.”

Click the video above to watch the interview.

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Radiopharmaceuticals are moving from their standard use of treating superficial tumors into radio drug conjugates that target tumors without impacting other cells in the body.

FDA announced on July 31, 2025, that it is requiring changes to the safety labeling of all opioid pain medications so that the risks associated with the long-term use of these types of drugs are emphasized and explained. This change comes after FDA reviewed data showing the serious risk of misuse, addiction, and overdose.

Data from two large FDA-required observational studies, postmarketing requirements (PMR) 3033-1 and 3033-2, provided new data on how long-term opioid use can lead to serious side effects. These data combined with public comments, medical research, and a lack of studies on the long-term effectiveness of opioids led the agency to require the safety labeling changes so that health care professionals and patients can make more informed treatment decisions.

Clearer risk information, including a summary of study results showing the estimated risks for addiction, misuse, and overdose during long-term use

Stronger warnings that higher doses come with greater risks that remain over time

The removal of language that may be misinterpreted to support using opioid pain drugs indefinitely

Guidance reinforcing that long-acting or extended-release opioids should only be considered when other treatments, including shorter-acting opioids, are inadequate

A reminder that opioids should not be stopped suddenly in patients who may be physically dependent, to avoid serious harm

Additional information on drugs that can reverse an opioid overdose

Enhanced warning about combining opioids with other drugs that slow down the nervous system

New information about a serious brain condition that may occur after an overdose (toxic leukoencephalopathy)

Updates about opioid-related impacts on the esophagus.

Relevant drug manufacturers have 30 days to submit their labeling updates to FDA for review.The agency is also requiring an additional prospective, randomized, controlled clinical trial to examine the benefits and risks of long-term opioid use.

“The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” said FDA Commissioner Marty Makary, MD, MPH, in a press release (1). “This long-overdue labeling change is only part of what needs to be done — we also need to modernize our approval processes and post-market monitoring so that nothing like this ever happens again.”

“I know firsthand how devastating addiction is—not just for individuals, but for entire families and communities,” said Health and Human Services Secretary Robert F. Kennedy, Jr., in the release. “Today’s FDA action is a long-overdue step toward restoring honesty, accountability, and transparency to a system that betrayed the American people.”

 that 7-hydroxymitragynine (7-OH) products be classified under the Controlled Substance Act (2). A concentrated byproduct of the kratom plant, according to FDA, binds to opioid receptors and, therefore, has the potential for abuse. While there are no 7-OH drugs approved by FDA, the agency has stated that approximately 1.7 million Americans aged 12 and older have used products to self-treat pain, coughing, diarrhea, anxiety, and depression that are prepared from the leaves of Mitragyna speciosa, a tropical tree native to Southeast Asia (3).

Biopharma developers exploring kratom-based therapeutics are being urged to be cautious. Enhanced 7-OH products may raise concern over abuse liability and may face future regulatory scheduling, which could impact clinical research and investigational drug approval. The Drug Enforcement Administration, which has final scheduling authority, is reviewing FDA’s recommendation on 7-OH.

FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers.

 FDA.gov, last updated July 29, 2025 (accessed July 30, 2025).

The FDA has mandated changes to the safety labeling of opioid pain medications to highlight the risks of long-term use, including addiction, misuse, and overdose. This decision follows data from observational studies and public input. The new labeling will include clearer risk information, stronger warnings, and guidance on opioid use. Additionally, the FDA is requiring a clinical trial to further assess long-term opioid use. The agency also recommended classifying 7-hydroxymitragynine products under the Controlled Substance Act due to their potential for abuse, impacting kratom-based therapeutic development.

The changes, required for safety labeling of all opioid drugs, will emphasize the risks with long-term use to combat misuse and addiction.