Christopher Cole

In this new PharmTech video feature, we highlight the week’s industry news in an easy-to-consume, fun format

PharmTech Weekly News Roundup - Week of September 1, 2025

In this new PharmTech video feature, we’ll highlight the week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week. And be sure to check the links below for more in-depth coverage of each story.

Cytokinetics' Aficamten, a cardiac myosin inhibitor, 

significantly outperformed metoprolol in a Phase III trial

 (MAPLE-HCM) for obstructive hypertrophic cardiomyopathy, demonstrating superior efficacy in improving exercise capacity, symptoms, and left ventricular outflow tract gradients.


The European Medicines Agency and the World Health Organization are 

celebrating a decade of successful collaboration

 aimed at enhancing global regulatory capacity and public health.


The University of Oxford and the Ellison Institute of Technology launched the 

Correlates of Immunity—Artificial Intelligence program

, a £118 million (US$158 million) initiative focused on understanding immune responses and vaccine protection against antibiotic-resistant pathogens.


Concerns are rising in the US over the removal of key advisory figures, including 

Paul Offit, from FDA vaccine advisory committee

 under HHS Secretary Robert F. Kennedy Jr.


Finally, the Pistoia Alliance announced an 

 to establish standards and protocols for the safe and responsible adoption of "agentic AI" in the life sciences.

Videos

Aficamten beat metoprolol for oHCM, EMA/WHO hit 10 yrs, Oxford and EIT collaborated on AI vaccine, Offit's FDA exit stirred policy, and Pistoia set agentic AI rule.

PharmTech Weekly Roundup – Week of September 1, 2025

Silver Spring, MD, USA - June 25, 2022: Closeup of the FDA sign seen at its headquarters campus in Silver Spring, Maryland. FDA is a federal agency of the Department of Health and Human Services | Image Credit: © Tada Images - stock.adobe.com.

Major shifts in federal vaccine policy under Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. are reshaping the advisory landscape that underpins US vaccine approvals and immunization strategy (1). These developments could signal a more unpredictable regulatory environment with direct implications for vaccine development, manufacturing, and commercialization.

Paul Offit, pediatrician and co-inventor of the rotavirus vaccine, was recently removed from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC)—a panel central to evaluating vaccine safety and efficacy data for approval (1). Although Offit had previously agreed to a two-year term extension at the agency’s request, his position was abruptly terminated. HHS stated that approximately a dozen advisory members across eight FDA panels were removed after their service terms expired, but no clarity was provided on renewals.

Offit’s removal follows a series of high-profile exits driven by policy changes:

CDC Director Susan Monarez was dismissed last week after pressure from Kennedy (2).

Three senior CDC officials resigned in protest of Monarez being forced out, warning that systematic dismantling of scientific advisory structures jeopardizes evidence-based policymaking (3).

Vinay Prasad exited his position as head of the FDA

’s Center for Biologics Evaluation and Research amid tumult in biologics oversight, and then 

All 17 members of CDC’s Advisory Committee on Immunization Practices were fired

 in June, eliminating the independent body that sets national vaccination recommendations.

 in March, citing interference and misinformation.

For vaccine developers, these shifts raise several critical issues:

Regulatory Uncertainty: The removal of independent scientific advisors creates ambiguity around how future vaccine candidates will be assessed. Developers may face greater unpredictability in approval timelines, safety evaluations, and market authorization pathways.

Market Dynamics: Offit and others have argued that Kennedy’s approach could restrict vaccine availability and affordability (1). If this leads to reduced public uptake or changes in reimbursement structures, it could directly impact revenue models for manufacturers.

Erosion of Scientific Oversight: The sidelining of established experts could weaken confidence among investors, healthcare professionals, and international stakeholders in the rigor of the US vaccine regulatory system—a reputation that has historically underpinned global trust in pharmaceutical innovation.

Policy Misalignment: Offit’s willingness to critique certain broad immunization strategies (such as universal annual coronavirus vaccination) highlights that expert debate has been suppressed alongside anti-vaccine policymaking (1). Industry stakeholders may face a regulatory body less receptive to evidence-based nuance, which is typically critical for guiding clinical trial design and targeted rollout strategies.

Kennedy is set to appear before the Senate Finance Committee this week, where lawmakers are expected to question his vaccine policy decisions (1). The outcome may provide early signals on whether Congress could intervene or push back against the erosion of traditional scientific advisory mechanisms.

As the regulatory climate continues to shift, bio/pharma companies should prepare for greater political volatility in vaccine policy, with implications for development pipelines, regulatory strategy, and long-term commercial planning.

Offit’s VRBPAC Departure Raises Questions About Another HHS Panel Revamp

CDC Director Susan Monarez fired by Trump administration after refusing to resign, citing 'reckless directives'

CDC leaders fight back in wake of attack on agency, public health

Articles

Recent changes in federal vaccine policy under HHS Secretary Robert F. Kennedy Jr. are altering the advisory framework for US vaccine approvals and immunization strategies. The removal of key figures like Paul Offit from the FDA’s VRBPAC and other advisory bodies has led to concerns about regulatory uncertainty, market dynamics, and the erosion of scientific oversight. These shifts could impact vaccine development, manufacturing, and commercialization. As Kennedy faces scrutiny from the Senate Finance Committee, the bio/pharma industry must brace for increased political volatility in vaccine policy.

Paul Offit removed from FDA vaccine panel as RFK Jr. reshapes US immunization policy, raising concerns for bio/pharma and regulation.

Pharma Implications of Paul Offit’s Removal from Vaccine Advisory Committee

Cereno's PAH drug got FDA Fast Track. Novo plant cited for contamination. Gilead's HIV PrEP approved in EU. Nelson Labs expanded testing.

PharmTech Weekly Roundup – Week of August 24, 2025

In this first installment of a new PharmTech feature, we’ll highlight the week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week. And be sure to check the links below for more in-depth coverage of each story.

Our news stories from this week collectively discuss significant developments in the pharmaceutical industry, highlighting both advancements in drug therapies and critical manufacturing challenges. We detail Cereno Scientific's 

PAH treatment receiving FDA fast-track status

 due to promising trial results, indicating accelerated development for a much-needed therapy. We also report that Gilead Sciences' 

HIV PrEP injectable gained European Commission approval

, offering a novel, less frequent dosing option for HIV prevention. In contrast to these positive strides, we revealed this week that an FDA inspection uncovered 

serious contamination and safety issues at a Novo Nordisk plant

, raising concerns about quality control in drug manufacturing. Finally, we highlighted 

Nelson Labs' expansion of its German and US facilities

, signifying a growing demand for enhanced laboratory and sterility assurance services within the pharmaceutical sector.

Digital Transformation in Pharma Manufacturing: Industry Perspectives Survey

The bio/pharmaceutical manufacturing and development industry is at a critical turning point (1-8). As new modalities move toward commercialization, traditional manufacturing approaches are under intense pressure (5,7-12). At the same time, such technologies as automation, advanced analytics, digital twins, and artificial intelligence are rapidly evolving and promising to transform how medicines are developed, produced, and delivered.

Yet adoption has been uneven. While some organizations are piloting cutting-edge digital tools across their operations, others are still navigating legacy systems, limited resources, or regulatory uncertainty (2-6,10,11,13-18). And even for those further along in the journey, questions remain about integration, workforce readiness, cost, and ultimately, the measurable impact on efficiency, quality, and speed to market (1,2,7,9-12,19-23).

That’s why we’re focusing this survey on digital transformation and technology adoption. We want to understand where the industry truly stands today, what barriers professionals are facing, and what opportunities are most within reach. Your perspective—whether from development, manufacturing, quality, engineering, or regulatory—will help build a clearer picture of the challenges and successes shaping digital change.

By sharing your experiences, you’ll help highlight what’s working, where support is needed, and how the industry can collectively move forward. The insights gathered will inform a broader discussion within the community and provide valuable benchmarks for organizations navigating their own transformation.

Your voice is essential to capturing this moment in the industry’s evolution. We appreciate your time and perspective, and we look forward to sharing the results with you and your peers.

The Importance for CDMOs of Partnering With a Sponsor’s Mindset

How Rare Diseases Shape Drug Manufacturing and Development Innovation (Part 1

MHRA Approves Sanofi’s Teplizumab to Delay Onset of Stage III T1D

Biopharma Development Hurdles: Lessons from Vedanta’s Live Bacteria Cocktail Failure

Sustainability Becomes Essential: Green Manufacturing and Supply Chain Resilience in Bio/Pharma

FDA Approves Precigen’s Immunotherapy to Treat Recurrent Respiratory Papillomatosis

Onshoring’s Unexpected Benefits: Quality, Efficiency, and Supply Chain Resilience

EMA Grants Orphan Designation to Rilzabrutinib for IgG4-Related Disease

ElevateBio BaseCamp Achieves First Multi-Modality ICMC Certification in Commercial CGT Manufacturing

ProBio Launches End-to-End AAV Production at NJ Manufacturing Site

Strand’s Programmable mRNA Pipeline Advances on $153 Million in New Funding

After mRNA Rollback, BARDA Pulls Plug on Vaxart Oral COVID Vaccine Trial

Merck and Daiichi Sankyo’s I-DXd Earns FDA Breakthrough Therapy Status in Small Cell Lung

FDA Grants Breakthrough Therapy Designation to Bispecific ADC for EGFR-Mutant Lung Cancer

FDA Releases Guidance on Oncology Therapeutic Radiopharmaceuticals

Telstar to Showcase Integrated GMP Services at Farmaforum

The Impact of Reclassifying 7-OH Products

Kratom and the Impact of 7-OH Reclassification

FDA Commissioner Applauds Florida Restriction on 7-OH Opioids

Lilly Statement: MFN Pricing Targeted for September 1, Pushback on Pharma Tariffs

Intellectual Property as a Core Strategy in Drug Formulation and Development

Iterum's UTI Drug Launches as First Commercial Oral Penem Antibiotic in US

Bio/Pharma's Tariff Response: Key Insights from Industry Survey Results

The bio/pharmaceutical manufacturing and development industry is undergoing a significant transformation as new modalities approach commercialization, challenging traditional manufacturing methods. Emerging technologies like automation, advanced analytics, digital twins, and AI are poised to revolutionize drug development, production, and delivery. However, adoption varies across organizations, with some embracing digital tools while others face challenges with legacy systems and regulatory uncertainties. A survey aims to capture industry perspectives on digital transformation, identifying barriers and opportunities to inform broader discussions and provide benchmarks for organizations navigating this evolution.

At a critical turning point in the adoption of digital tools across the bio/pharma industry, we want to hear to industry professionals on where things actually stand.

This video clips offers topline findings from our survey of nearly 90 bio/pharma professionals on the impacts of Trump-era tariffs and trade policy.

Tariffs & Trade Policy: Results of a Bio/Pharma Peer Survey

Spanning the first two weeks of August 2025, 

® conducted a survey on the impacts of Trump-era tariffs and trade policies on the organizations at which you and your peers in the bio/pharmaceutical industry work. Responses reveal that most perceive tariffs as a major influence on their operations and supply chains, with nearly half reporting significant effects and another large segment anticipating moderate impacts. In navigating these challenges, companies are actively adapting their strategies, primarily by increasing investment in trade compliance and diversifying supply bases, to mitigate risks rather than relying on a single approach, such as reshoring.

This video clip summarizes our key findings. 

Click here to access our full, extensive results

*Editor’s Note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.


 Welcome to the explainer. If you're in the bio slash pharma industry, you really don't need me to tell you that tariffs and trade policy have been a bit of a roller coaster lately, but how are companies actually handling it all? Well, we're about to jump into a new survey to see exactly what your peers are thinking and doing.

So here's our game plan. We're gonna start with just how big this disruption really is. Then we'll look at the strategic playbook companies are using to adapt. We'll hear directly from your peers about their biggest hurdles, and finally, we'll see what the industry is actually asking for to make things better.

Alright, first up, tariffs as a major disruption. Let's really dig into the scale of this challenge. Let's just start with the headline number, the one that tells you pretty much everything you need to know. 86.2%. That's how many of your peers are saying that tariffs are gonna have a moderate to significant impact on their supply chain.

So, yeah, this isn't some minor headache, right? This is a huge sector-wide issue, and when you break that number down, the story gets even clearer. Just look at this, almost half, nearly 50% are preparing for a significant effects. That tells you that for a lot of companies, probably just like yours, tariff policy isn't just noise in the background.

It's now a primary driver of their operational strategy. So where is this pressure actually being felt the most? Is it just one specific area? Not even close. You can see things like equipment procurement and API sourcing are definitely feeling the heat. But look at that massive 72% pointing to finished product trade.

The impact is being felt all the way across the value chain from getting raw materials right through to the final product, leaving the warehouse. So with this kind of widespread disruption, you have to wonder what are companies actually doing about it. Let's take a look at their strategic playbook.

While for the long haul, the main play seems to be a defensive one. You've got almost half of companies doubling down on trade compliance, basically just trying to navigate these incredibly complex rules, and close to 40% are working to diversify their supplier base, which is a classic move to hedge against risk.

Now, in the immediate short term, things are a little different. It's more of a mixed bag of tactics. You see this blended approach of trying to get regulatory relief through exclusions. Shifting sourcing to countries that aren't tariffed, and for a decent chunk actually investing in domestic manufacturing.

So what's the big takeaway here? It's that there's no single magic bullet. Your pairs are building out this really flexible blended playbook. It's part compliance, part diversification, and part targeted investment, all designed to manage this ongoing uncertainty. But you know, numbers and charts, they only tell half the story.

What does all this disruption actually feel like for the people on the ground day in and day out? The survey's, open-ended responses. They really paint a picture. The first major theme that comes through loud and clear is the direct hit to the wallet. We're talking rising costs and finding it harder to compete in a global market.

It's a straight shot to the bottom line. The second theme, it's the sheer exhaustion. It's trying to plan for the long term. When you're dealing with constant policy, whiplash, the ground is always shifting beneath your feet, and that makes strategic planning almost impossible. And this one, wow. This is a story where that uncertainty turns into a real, tangible and super expensive failure.

A $2 million loss and six weeks of loss production, all because a last minute policy change forced a risky supply chain decision. So given all these challenges, what does the industry actually expect from the future? And maybe more importantly, how prepared do they feel for whatever is coming next?

There's a really strong consensus here. 70% of your peers believe that future administrations will probably soften tariffs, but not get rid of them completely. It really suggests that everyone is settling in for this being the new normal. But here's the catch. Even with that expectation, there's a clear confidence gap.

The vast majority feel they're only partially prepared. That leaves a pretty significant chunk of the industry, nearly one in five, admitting they're just not ready for future policy shifts, leaving them vulnerable. And what's really fascinating is that there's a lot of skepticism that tariffs are even the right tool for the job.

Most of your peers see them as a pretty weak or insufficient policy lever. If the goal is actually to encourage reshoring manufacturing. Okay, so if tariffs aren't the answer, what is. Well, your peers were very, very clear about the kinds of policy changes that would actually help them out. All the responses really boil down to two main ideas.

First, give us policies that make it easier to innovate and do r and d. And second, for goodness sake, create a trade environment that is stable, predictable, and doesn't rely so heavily on tariffs. And this translates into some pretty specific asks. Things like getting rid of tariffs on critical materials like APIs, making customs more efficient.

Protecting intellectual property and making sure that big investments in r and D are actually rewarded long-term. You know, this one response really just ties it all together perfectly. It's a call for a coherent strategy that combines stability with real incentives for domestic innovation. That's what the industry is asking for.

That really leaves us with the final crucial question. This survey shows a clear disconnect between the policy tools being used and what the industry actually needs. It leaves the path forward pretty uncertain, and makes you wonder, will future policy reflect the playbook of the past, or will it finally adapt to the needs of the future?



Silver Spring, MD, USA - June 25, 2022: Closeup of the FDA sign seen at its headquarters campus in Silver Spring, Maryland. FDA is a federal agency of the Department of Health and Human Services | Image Credit: © Tada Images - stock.adobe.com

A recent FDA inspection has identified significant quality concerns at a Novo Nordisk pharmaceutical manufacturing plant in Bloomington, Indiana (1). The site, which was acquired in late 2024 through Novo Nordisk’s purchase of Catalent facilities (2), received an FDA Form 483 following findings of contamination and unresolved equipment problems.

Inspectors documented cases of “atypical extrinsic particles,” including cat and human hair in vial stoppers, along with pest infestations in classified areas (3). These observations were made between late June and mid-July 2025.

Unresolved contamination complaints and equipment failures

The plant, which produces therapies for Regeneron and Scholar Rock, has faced recurring complaints of contamination dating back several years. According to the FDA’s inspection report obtained by 

, “Your investigation failed to determine a root cause for the contamination, assess the potential impact to the rest of the lot, or evaluate whether similar issues may have occurred in upstream batches” (4).

The report noted that the company’s review “was limited to a one-year time frame, and no complaints were assessed. Although components were considered a potential root cause, no corrective or preventative actions were taken to address this.” The agency added that since then, “approximately 20 additional deviations related to hair contamination during 100% manual visual inspection have occurred,” along with 14 deviations uncovered through a gap analysis.

Client concerns extend back to June 2022, when reports of “foreign matter” and “particles” were raised (1). In 2024 and 2025, roughly 10 work orders were logged for “recurrent leaks and other failures” in a key system, with some repairs delayed for extended periods.

Acquisition expanded US fill-finish capacity

The Bloomington facility became part of Novo Nordisk’s network in December 2024, when Novo Holdings completed its $16.5 billion purchase of Catalent’s operations (3). At the time, company leadership emphasized the importance of adding US fill-finish capacity to strengthen its supply chain for diabetes and obesity treatments.

“We are very pleased with the agreement to acquire the three Catalent manufacturing sites which will enable us to serve significantly more people living with diabetes and obesity in the future,” said Lars Fruergaard Jorgensen, president and CEO of Novo Nordisk, in the acquisition announcement (3). “The acquisition complements the significant investments we are already doing in active pharmaceutical ingredients facilities, and the sites will provide strategic flexibility to our existing supply network.”

Broader workforce shifts in gene therapy manufacturing

Separately, Catalent recently announced it will reduce its workforce by 350 employees at its Baltimore gene therapy site, citing changes in customer demand (5). “Our gene therapy business continues to see strong growth and we look forward to working on behalf of customers to deliver novel therapies for patients with genetic diseases/disorders,” a company spokesperson told Endpoints News. “It is never easy to see talented colleagues leave Catalent and we remain committed to providing them transition support as they manage this change.”




Major US Drug Manufacturing Plant Did Not Properly Investigate Cat Hair, Pests, and Other Problems, FDA Finds

Catalent to Lay Off 350 Workers at Baltimore Gene Therapy Plant

Novo-Acquired Catalent Plant Plagued by Unresolved Pest, Contamination Issues, FDA Finds

The FDA inspection of a Novo Nordisk plant in Bloomington, Indiana, revealed significant quality issues, including contamination and equipment failures. Acquired in 2024 from Catalent, the facility faced unresolved contamination complaints, with inspectors finding atypical particles like hair in vial stoppers and pest infestations. Despite previous contamination reports, corrective actions were lacking. Novo Nordisk's acquisition aimed to enhance US fill-finish capacity for diabetes and obesity treatments. Concurrently, Catalent announced workforce reductions at its Baltimore gene therapy site due to shifting customer demand.

FDA cites Indiana drug plant for contamination, pest issues, and unresolved equipment failures, raising concerns over pharma manufacturing quality.