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Feliza Mirasol is the science editor for 

On July 24, 2023, Teva Pharmaceuticals, Inc., a US-based affiliate of Teva Pharmaceutical Industries, and Alvotech, an Iceland-based biotech company specializing in biosimilars, announced that they are expanding an existing strategic partnership for the development and commercialization of several biosimilar candidates. Under the expanded agreement, Teva will also acquire subordinated convertible bonds—to be issued by Alvotech—for $40 million.

With the expanded agreement, Teva will have exclusive commercialization rights in the United States for two new biosimilar candidates and line extensions of two current biosimilar candidates. Alvotech will be responsible for the development and manufacturing of these four candidates. The agreement includes milestone payments, the majority of which will be paid upon approval of the products and upon achieving significant sales milestones. Teva and Alvotech will share the profit from the commercialization of the biosimilars.

In addition, Teva will be involved in overseeing manufacturing activities and quality control at Alvotech’s manufacturing facility in Iceland. Teva is on site in Iceland to actively support Alvotech and to help ensure that the facility is fully ready for an FDA inspection, according to a company press release.

Meanwhile, the partners will continue to work closely on the pending US approval of AVT02, an interchangeable high-concentration biosimilar candidate for Humira (adalimumab). Under the existing partnership, the companies are also collaborating on four other biosimilar candidates, including AVT04, a proposed biosimilar for Stelara (ustekinumab), which is currently pending FDA approval. Furthermore, Teva’s investment under the expanded agreement (i.e., the acquisition of subordinated convertible bonds) will be used by Alvotech to fund the continued development of its biosimilars pipeline in the near-term.

“We welcome Teva’s continued partnership, and this expansion of our partnership agreement,” said Robert Wessman, chairman and CEO of Alvotech, in the press release. “We remain focused on preparing for a successful pre-approval inspection and resolving any outstanding issues identified by [FDA] to be able to bring our biosimilar candidates to patients in the US with Teva as soon as possible.”

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Teva Pharmaceuticals and Alvotech will expand their partnership for the development and commercialization of biosimilar candidates.

Teva Pharmaceuticals and Alvotech Expand Existing Biosimilars Partnership

Alnylam Pharmaceuticals, a pharmaceutical company specializing in RNA interference (RNAi) therapeutics, announced a strategic agreement with Roche on July 24, 2023. The focus of this agreement is to develop and commercialize zilebesiran, Alynlam’s investigational RNAi therapeutic intended for the treatment of hypertension. Under the agreement, Alnylam will receive $310 million in upfront payments for the rights to zilebesiran, with a total payment of approximately $2.8 billion contingent on satisfying various development, regulatory, and sales milestones.

According to a company press release, in a Phase I study, zilebesiran was associated with dose-dependent reductions in serum angiotensinogen relative to placebo. Patients achieved tonic blood pressure control with consistent and durable blood pressure reduction throughout a 24-hour period, sustained up to six months after single doses of ≥ 200 mg. The treatment is now in Phase II of clinical trial testing.

“We are thrilled to announce this collaboration, as it combines Alnylam’s proven track record in RNAi therapeutics with Roche’s global commercial reach, commitment to innovation, and desire to transform the landscape for patients with severe cardiovascular diseases,” said Yvonne Greenstreet, CEO, Alnylam, in the release. “With this collaboration, we now can develop zilebesiran in a more robust way, allowing us to have cardiovascular outcomes data in hand at launch to ensure results relevant not only for health authorities but also for access and clinical practice in order to ultimately reach as many patients as possible.”

“We are excited to work together with Alnylam and leverage our strong R&D capabilities, our leadership in cardiovascular diagnostics and our global commercial footprint to further develop and provide this promising therapy with best-in-disease potential to patients,” said Teresa Graham, CEO, Roche Pharma, in the release. “... Together with a strong partner like Alnylam, we are looking forward to making a significant impact for patients living with hypertension at high cardiovascular risk and potentially other cardiovascular indications.”

The agreement stipulates that Roche will receive exclusive rights to commercialize zilebeserian outside of the United States in exchange for low double-digit royalties on net sales of the treatment. The companies will co-commercialize the treatment in the US, splitting profits equally.

Roche will pay up to $2.8 billion for the rights to Alnylam’s RNA-based hypertension therapeutic.

Roche and Alnylam Strike $2.8 Billion RNAi Deal

Tarsus Pharmaceuticals, a biopharmaceutical company developing treatments in the fields of eye care, dermatology, and infectious disease prevention, announced FDA approval of Xdemvy (lotilaner ophthalmic solutions) 0.25% for the treatment of Demodex blepharitis on July 25, 2023. According to a company press release, Tarsus’ lotilaner ophthalmic solution is the first and only FDA approved treatment that directly targets Demodex mites, the root cause of Demodex blepharitis.

According to the release, Demodex blepharitis is a common lid margin disease that is characterized by eyelid margin inflammation, redness, and ocular irritation. The disease impacts approximately 25 million adults in the United States. Lotilaner ophthalmic solution treats the condition by selectively inhibiting the Demodex mites’ gamma-aminobutyric acid-gated chlorine (GABA-Cl) channels. Lotilaner ophthalmic solution was evaluated in two pivotal trials of more than 800 patients that the met primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events.

“We are thrilled to announce the FDA approval of Xdemvy [lotilaner ophthalmic solution] for the treatment of Demodex blepharitis and look forward to making this product broadly available to the millions of patients who have not had any FDA approved therapeutics for this disease,” said Bobak Azamian, CEO and chairman, Tarsus, in the release. “This tremendous milestone was achieved through a successful collaboration of our talented Tarsus team, countless eye care providers, and the hundreds of patients who participated in our trials. We are grateful and honored for the opportunity to introduce the first and only approved therapeutic for this disease to the eye care community.”

“After years of seeing Demodex blepharitis in my practice without an effective way to target the root cause of the disease, I’m so pleased to have a new treatment to offer my patients,” said Christopher Starr, associate professor of Ophthalmology, director of Refractive Surgery, Ophthalmic Education and the Cornea Fellowship Program, Weill Cornell Medicine, New York Presbyterian Hospital, in the release. “Demodex blepharitis, easily diagnosed by the presence of eyelash collarettes, can result in ocular damage in multiple ways, including irritation, eyelash distention or loss and inflammation, which can be uncomfortable for patients. This new medicine is a positive step forward for the treatment of this disease in many patients who have been struggling for years.”

Tarsus Pharmaceuticals’ Xdemvy (lotilaner ophthalmic solutions) is designed to treat Demodex blepharitis by directly targeting Demodex mites.

FDA Approves Novel Demodex Blepharitis Treatment

The Janssen Pharmaceutical Companies of Johnson & Johnson announced on July 21, 2023 that they have received a positive opinion for two novel bispecific antibodies from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The CHMP has recommended conditional marketing authorization for TALVEY (talquetamab) and has recommended the approval of a Type II variation for teclistamab (marketed under the brand name TECVAYLI).

Janssen is seeking approval of talquetamab as a monotherapy to treat adult patients with relapsed and refractory multiple myeloma (RRMM). The indication is for RRMM patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, but who have still demonstrated disease progression on the last therapy. Talquetamab, a subcutaneous bispecific antibody, binds G protein-coupled receptor class C group 5 member D (GPRC5D), a novel target on multiple myeloma cells, and CD3, on T-cells, according to a company press release.

The CHMP’s recommendation for the Type II variation for teclistamab means that, if approved, then the dosing schedule for the therapy can be reduced to a biweekly dosing schedule in patients who have achieved a complete response or better for six months or longer. Teclistamab is a bispecific antibody that targets B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T-cells. According to the company press release, it is the first bispecific antibody with this mechanism of action to be licensed in Europe for treating adult RRMM patients who have had at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and who have demonstrated disease progression on the last therapy.

“With talquetamab, a novel bispecific antibody targeting GPRC5D, we look to … bring forward a vital new treatment option for patients with relapsed and refractory multiple myeloma, who have a poor prognosis,” said Edmond Chan, senior director EMEA Therapeutic Area Lead Hematology, Janssen-Cilag, in the press release. “Today’s recommendation from the CHMP marks an exciting step for patients who continue to face the challenges of this difficult-to-treat blood cancer. We look forward to working with health authorities to bring talquetamab to patients in need across the region as soon as possible, while we continue our focus on enhancing a robust multiple myeloma portfolio of therapeutics and regimens.”

“Pending approval, this variation for teclistamab will be an important step forward for this first BCMA bispecific therapy, offering flexible, less frequent dosing depending on a patient’s response,” said Sen Zhuang, vice president, Clinical Research and Development, Janssen Research & Development, in the release.

Janssen has received a positive opinion from the EMA for two novel bispecific antibodies, TALVEY (talquetamab) and TECVAYLI (teclistamab), which the company is developing to treat blood cancer.

EMA Gives Positive Opinion on Two of Janssen’s Bispecific Antibodies

MilliporeSigma, the US and Canada Life Science business of Merck KGaA, Darmstadt Germany, has invested $25 million to expand its cell culture media production facility in Lenexa, Kan. With the investment, the company intends to add 98,000 ft2 of lab space and cell culture media production capability, the company announced in a July 12, 2023 press release.

Counting its Lenexa site, the company has a total of three centers of excellence for dry powder cell culture media manufacturing. The other two centers are in Nantong, China, serving the Asia Pacific region, and Irvine, Scotland, serving Europe, the Middle East, and Africa region.

“This expansion makes Lenexa the company’s largest dry powder cell culture media facility and [c]enter of [e]xcellence in North America,” said Darren Verlenden, head of Process Solutions, Life Science, MilliporeSigma, in the press release. “Investing in the region reflects our strategy to expand and diversify our supply chain to ensure we meet current and future demand for cell culture media.”

“The new production line represents the company’s vision for our Lenexa site, as it was initially constructed for three manufacturing lines for dry powder cell culture media,” Verlenden said in the release. “The new production line is the culmination of multiple years of planning, and now we are able to offer greater flexibility and faster cell culture media manufacturing for our customers.”

MilliporeSigma has invested $25 million to expand its cell culture media production facility in Lenexa, Kan.

MilliporeSigma Expands Production Facility for Cell Culture Media

AbbVie and Calibr announced an expanded strategic collaboration to continue to advance several innovative preclinical and early-stage clinical assets on July 26, 2023. The partnership is an extension of the collaboration from AbbVie and Scripps Research that was formed in 2019, according to the press release.

"We've made significant progress to advance rapidly many preclinical and clinical development programs across small molecule, biologics and CAR-T modalities," said Thomas Hudson, MD, senior vice president, research and development, chief scientific officer, AbbVie, in a press release. "Working together with Calibr, AbbVie is excited to explore and further develop the potential of novel technologies and new clinical indications to bring breakthrough medicines to patients."

Further, Calibr will present AbbVie with a certain number of new discovery targets and preclinical assets of mutual interest for option considerations, according to the press release.

"AbbVie has been a trusted partner to Scripps Research for many years, as proven by our successful ongoing R&D collaborations spanning numerous disease areas that have yielded four clinical stage programs," said Peter Schultz, PhD, president and chief executive officer of Scripps Research and Calibr, in a press release. "This expansion represents an important step forward in our mission of translating scientific insights and discoveries into innovative, clinically validated drugs, and we believe it is a model for biomedical industry-nonprofit R&D partnerships."

AbbVie plans to provide Calibr with research option payments over the course of five years to obtain a first-exclusive option to develop and commercialize candidates from independent preclinical research conducted by Calibr. In addition, Calibr is able to receive additional payments from AbbVie, such as option exercise fees, success-based development and commercial milestone payments.

The partnership is an extension of the collaboration from AbbVie and Scripps Research that was formed in 2019, according to the press release.

AbbVie Expands Collaboration with Calibr to Advance Clinical Assets

The biopharmaceutical industry has seen a lot of change in recent years, between new collaborations with supplier and contract development and manufacturing organizations (CDMOs) and accelerated drug delivery times. According to recent research, biopharmaceutical figures are already using digital and analytics for their benefit, with an increase of up to 40% in plant capacity, 20% in lead time, and 15% reduction in conversion costs (1).

With more growth comes more responsibilities, and processes like cell and gene therapy are on the forefront for the latest strategies to overcome the challenges in the manufacturing space.

Reimagining the future of biopharma manufacturing

. October 11, 2022. https://www.mckinsey.com/industries/life-sciences/our-insights/reimagining-the-future-of-biopharma-manufacturing

has more than 25 years of experience in the science and business of taking molecules through the entire drug development process and currently serves as the global head of technical and scientific affairs, pharma services, Thermo Fisher Scientific. His extensive knowledge spans early-stage development to scale-up and commercial manufacturing and includes technical transfers between global sites and drug life cycle management.

has held leading roles in consulting, healthcare and technology companies for nearly 20 years in the US, UK and Europe. He also serves as a Non-Executive Director of London-based healthtech start-ups gripAble and Credentially, as well as Auxita Pty, an Australian healthcare data platform and hystrix medical AG, a Swiss B2B marketplace for medical products. As the Managing Director of Health Equity Consulting, he has advised private equity & venture capital funds, family offices, accelerators and healthTech start-ups.

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 editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

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In this episode of Drug Digest, Pharmaceutical Technology editors discuss what happens in the manufacturing space from a CDMO and a cell/gene therapy perspective. 

Drug Digest: Accelerating Biopharma Development and Manufacturing through CDMOs and CGT

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FDA released a press statement on July 21, 2023, to update the public on the damage to Pfizer’s facility at Rocky Mount, NC. “Importantly,” FDA wrote, “we do not expect there to be any immediate significant impacts on supply given the products are currently at hospitals and in the distribution system, but this is a dynamic situation and FDA staff are in frequent communication with Pfizer and other manufacturers.” FDA wrote it will work with its partners in government, industry, and the broader health care system to minimize impact on patient care.

As Pfizer has one third of the total sterile injectable drug market for US hospitals, and this facility produces 25% of Pfizer’s total product for this market, 8% of US consumption is supplied by this site. FDA’s analysis identified fewer than 10 drugs for which this plant is the sole source for the US market, but many of these are specific formulations that have substitutes available or where many weeks’ worth of stock should be housed in Pfizer’s other warehouses. For products produced at this facility that are in or may be at risk of shortage, FDA has started mitigating the impact on the market, through steps such as finding additional sources and asking other manufacturers to prepare to increase production.

To keep fair product distribution and maintain availability to those in most need, as well as to avoid hoarding, Pfizer has put strict allocation on the inventory of many of their products. This could impact localized suppliers depending on contractual relationships for supplies. FDA advised health care systems struggling to obtain specific drugs to contact their distributor or Pfizer directly.

“More broadly, this incident underscores that a robust, resilient, and safe drug supply chain is essential for public health and national security,” FDA wrote. The redundancy of manufacturing locations and suppliers is crucial to alleviate risks to supply that can occur from less predictable events such as natural disasters or geopolitical conflicts.

The damage to the facility, which produces 8% of US injectable drug consumption, should not significantly affect the current supply.

Update on Storm Damage to Pfizer Facility in North Carolina

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On July 20, 2023, the European Medicines Agency (EMA) announced their expansion of the OPEN initiative from COVID-19 vaccines and treatments to a wider range of medicines. These medicines can potentially address respiratory syncytial virus (RSV) infections, antimicrobial resistance (AMR), or newly diagnosed myelodysplastic syndromes (and other hereditary diseases). The new extended scope includes marketing authorization applications for medicines targeting AMR, medicines through EMA’s PRIority MEdicines scheme (not including advanced therapy medicinal products), medicines for RSV infections or newly diagnosed myelodysplastic syndromes and other hereditary diseases, and medicines responding to health threats or public health emergencies.

The first product under OPEN assessment is an messenger RNA (mRNA) vaccine against RSV, which is being assessed alongside Swissmedic. To be eligible for OPEN assessment, medicines require EMA’s human medicines committee (CHMP) and at least one OPEN partner to agree to conduct parallel assessments. Discussions will continue with OPEN partners to select other products for the OPEN framework, and the agency will continue engagement with stakeholders as more experience is gained.

OPEN was created by EMA in December of 2020 initially as a pilot, meant to provide a framework for international collaboration on the evaluation of COVID-19 vaccines and therapeutics. It is used by regulators from Australia, Brazil, Canada, Japan, Switzerland, and the World Health Organization (WHO) to conduct near-concurrent reviews of new medicines and exchange views and reports on product assessments. This collaboration both accelerates and aligns regulatory decisions, leading to more clarity in the industry and more unity on product labeling while keeping regulator’s decision-making independence. “The collaboration with WHO means that OPEN can accelerate regulatory decisions and availability of medicines in low- and middle-income countries,” the agency states in a press release.

The extension of the OPEN framework is based on the positive findings and recommendations, which can be found in a report on the OPEN pilot. EMA wrote that it “has bilateral agreements with all regulatory authorities involved in OPEN. Standard EMA requirements for EU experts participating in the assessment of medicines (e.g., confidentiality and absence of conflicts of interest) also apply to OPEN experts.” Medicines assessed under OPEN will be labeled in publicly available CHMP agendas and minutes, and on EMA’s website.

The framework is now expanded beyond COVID-19 vaccines and treatments.

EMA Extends OPEN Framework to More Medicines

The European Medicines Agency (EMA) published a draft reflecting paper on July 19, 2023 detailing the agency’s current outlook on the use of artificial intelligence (AI) “to support the safe and effective development, regulation and use of human and veterinary medicines.” The paper, now open for public discussion, outlines recommendations for the use of AI and machine learning (ML) during any step of a medicines’ lifestyle, from drug discovery to the post-authorization setting.

“AI and ML tools have the potential to effectively support the acquisition, transformation, analysis, and interpretation of data across the medicinal product lifecycle,” wrote EMA in a press release. “Their application can include, for example, AI/ML modelling approaches to replace, reduce, and refine the use of animal models during the preclinical development.”

During clinical trials, AI/ML systems may also assist with data recording and analyses that can be submitted to regulators in marketing-authorization procedures. During the marketing-authorization stage, AI has tools to draft, compile, translate, or review data that are used in the product information of a medicine. During the post-authorization stage, these tools could potentially support pharmacovigilance activities.

The reflection paper emphasizes that a human-centric approach should be at the forefront of all development and deployment of AI and ML. All use of AI should comply with existing legal requirements and take ethics and the respect of fundamental rights into consideration.

“The use of artificial intelligence is rapidly developing in society, and as regulators, we see more and more applications in the field of medicines. AI brings exciting opportunities to generate new insights and improve processes. To embrace them fully, we will need to be prepared for the regulatory challenges presented by this quickly evolving ecosystem” said Jesper Kjær, director of the Data Analytics Centre at the Danish Medicines Agency and co-chair of the joint HMA-EMA Big Data Steering Group (BDSG), in an EMA press release.

EMA recommends that developers seek early regulatory support for AI/ML systems expected to impact the benefit-risk balance of a medicine. “With this paper, we are opening a dialogue with developers, academics, and other regulators, to discuss ways forward, ensuring that the full potential of these innovations can be realized for the benefit of patients’ and animal health,” said Peter Arlett, EMA’s head of Data Analytics and Methods, co-chair of the BDSG, in an EMA press release.

The paper is part of BDSG initiatives to “to develop the European Medicines Regulatory Network’s capability in data-driven regulation.” It was creative collaboratively by the BDSG, EMA’s Committee for Medicinal Products for Human Use and its Committee for Veterinary Medicinal Products.

All stakeholders are invited to comment on the draft reflection paper. The public consultation will be open until Dec. 31, 2023. The HMA and EMA will hold a joint workshop on Nov. 20–21, 2023 to discuss the topic further.

The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it. 

Featured Content

Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

Behind the Headlines Episode 28

Ask the Expert

Drug Digest December 2025

A “Plan, Prevent, Prove” Approach