The <a href="https://www.cdc.gov/drugresistance/tatfar/index.html">Transatlantic Taskforce on Antimicrobial Resistance</a> (TATFAR) has enhanced synergy and communication between its member agencies resulting in strengthened domestic and global efforts in the fight against the urgent threat of antimicrobial resistance (AMR). The progress of TATFAR and its achievements in addressing AMR were reviewed at a conference held on 14/15 September, and are summarised in the <a href="https://www.cdc.gov/drugresistance/pdf/2021-progress-report-508.pdf">2016-2020 progress report</a>.
The report outlines the actions to fight AMR in three key areas: appropriate therapeutic use of antimicrobials in human and veterinary medicine, prevention of drug-resistant infections, and strategies for improving the pipeline of new antimicrobial medicines.
As member of the taskforce, EMA has contributed to the implementation of strategies to encourage responsible use of antimicrobials in veterinary medicines, and to foster research and development of new safe and effective human antibiotics.
The joint fight against the global challenge of AMR continues. TATFAR has identified 18 actions for the <a href="https://www.cdc.gov/drugresistance/tatfar/tatfar-recomendations.html">2021-2026 work plan</a>, which is expected to be formally adopted before the end of 2021.
From 2016 to 2020, EMA and the <a href="https://www.fda.gov/">US Food and Drug Administration</a> (FDA) discussed recommendations on <a href="https://www.ema.europa.eu/en/glossary/clinical-trial">clinical trial</a> designs for new antibacterial medicines, feasible approaches to facilitate trials and regulatory options available to medicines developers. In addition, guidance for medicines developers has been updated or developed to reflect the evolutions in the area.
AMR is a public health problem of increasing magnitude and importance, with actions needed for human and veterinary medicines at global and national level. New antimicrobial agents are urgently required for a number of human pathogens and to this date very few new classes of antibiotics are under development. The EU and the US established TATFAR in 2009 to intensify cooperation in the fight against AMR. In October 2015, Canada and Norway became partners of the taskforce and the UK joined in 2021.

Sterile Processing

Transatlantic Taskforce

The Transatlantic Taskforce on Antimicrobial Resistance (TATFAR) has enhanced synergy and communication between its member agencies resulting in strengthened domestic and global efforts in the fight against the urgent threat of antimicrobial resistance (AMR). The progress of TATFAR and its achievements in addressing AMR were reviewed at a conferenc

Transatlantic Taskforce continues international fight against antimicrobial resistance

Advent of a new era of collaboration
2 July 2025, Brussels Hybrid conference
Speakers’ Bios
Olivér VÁRHELYI COMMISSIONER
Sandra GALLINA
Olivér Várhelyi is a Hungarian lawyer and diplomat who has served as European Commissioner for Health and Animal Welfare since December 1, 2024, in the second von der Leyen Commission. His mandate focuses on advanc

EU health technology assessment:

The HERA Info Days aim to present the main strands of work of the European Commission’s Health Emergency Preparedness and Response Authority, showcase its success stories, and pinpoint funding opportunities in the field.
By participating in HERA’s Info Day in Nicosia, you will get the chance to interact with HERA, learn more about funding schemes o

Health Emergency Preparedness and Response Authority: Connecting stakeholders for a safer future

By Barbara Obstoj-Cardwell. Editor
US biotech major Amgen, a late comer to the growing obesity treatment space, released new data showing that its MariTide reduced weight by 20%. In deal-making news last week, US drugmaker Amarin struck a deal with Italy’s Recordati for the marketing of its cardiovascular drug Vazkepa in 59 countries, mostly Europe

The week in pharma: action, reaction and insight – week to June 27

July 15, 2025, Institut Pasteur du Maroc, Casablanca
Single-use technologies offer a streamlined and flexible approach to biopharmaceutical manufacturing. But to find the right solutions for your process, it’s critical to consider factors like compliance, sustainability, and efficiency — all of which can have a large impact on design, cost, and fea

Sartorius at Institut Pasteur, Casablanca

(20 µg/ml salmon gonadotropin releasing hormone analog + 10 mg/ml domperidone) Injectable Solution Spawning aid for intraperitoneal or intramuscular injection FOR USE IN FINFISH BROODSTOCK ONLY
LEGAL STATUS -- In order to be legally marketed, a new animal drug intended for a minor species must be Approved, Conditionally Approved, or Indexed by the

(20 µg/ml salmon gonadotropin releasing hormone analog + 10 mg/ml domperidone)

1.375 in
User Safety Warnings: Before use, read package insert for complete product information Not for use in humans. Keep out of the reach of children. May damage fertility. Pregnant women should exercise caution because exposure may damage the unborn child. Use in a well-ventilated area. Wear gloves, goggles, and suitable protective clothing. Ca

CAUTION: FOR USE IN FINFISH BROODSTOCK ONLY.

Aenova, a contract development and manufacturing organization, announced on June 27, 2025 that it is expanding its sterile manufacturing facility in Latina, Italy with a new cold chain warehouse that will be connected to the existing facility. The new warehouse will support a wide range of cold chain products without the need for special adaptation

Aenova Adds Cold Chain Warehouse to Latina, Italy Site

Pharmaceutical Technology® Group was able to interview more than a half dozen executives in the biopharmaceutical industry as part of its coverage of the Biotechnology Innovation Association (BIO) International Convention, which took place in Boston June 16–19, 2025.
The conference was bookended by major developments with impacts to healthcare with

At BIO 2025, As Political Shifts Continue, Key Leaders Respond

Mark Foster, General Manager of Oliver Design, shares insights on balancing patient needs, manufacturability, and sustainability in biopharma packaging.
Pharmaceutical packaging is no longer just about containment and compliance—it’s about enabling patients, streamlining manufacturing, and accelerating time to market. In this Q&A, Mark Foster, Gene

Design with Purpose: How Oliver Design is Shaping the Future of Pharma Packaging

Salvador Alvarado, Senior Product Manager at Thermo Fisher Scientific shares the DynaDrive single-use bioreactor, which offers scalability from one liter to five thousand liters. Its square design maximizes efficiency in mixing and ensures optimal performance, aligning with leading family vessels. The bioreactor features both microsparger and macro

Now available: 5L Thermo Fisher Scientific DynaDrive Single-Use Bioreactor

Vetter continues to expand in the US, breaking ground on a clinical production facility in Des Plaines.
Vetter celebrated the start of construction on its new clinical manufacturing site in the Chicago area with an official groundbreaking ceremony. The state-of-the-art facility, which is being built in Des Plaines, Illinois, is expected to be ready

CDMO Vetter Pharma Breaks Ground On New Clinical Manufacturing Aseptic Filling Facility In Illinois

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Calling our Risk Assessment Experts

Friday, June 27, 2025
Invetech, a global leader in solving complex manufacturing and product development challenges in the advanced therapies and diagnostics markets, today announced a strategic collaboration with AiCella, a company focused on harnessing the power of artificial intelligence (AI) to optimize the development of cell therapy productio

Invetech and AiCella Announce Strategic Collaboration to Advance Cell Therapy Innovation

Bristol Myers Squibb (BMS) received U.S. Food and Drug Administration (FDA) approval for label updates for its CAR T cell therapies, Breyanzi (lisocabtagene maraleucel; liso-cel) to treat large B cell lymphoma (LBCL) and other lymphomas, and Abecma (idecabtagene vicleucel; ide-cel) to treat multiple myeloma.
These label updates reduce certain patie

FDA Approves REMS Programs in BMS Cell Therapy Labels

ProBio, a global contract development and manufacturing organization (CDMO), has opened its flagship Cell and Gene Therapy Center of Excellence at the Princeton West Innovation Campus in Hopewell, New Jersey.
The 128,000 sq ft GMP facility is purpose-built for manufacturing high-quality plasmid DNA and viral vectors, including adeno-associated viru

ProBio Opens Flagship Cell & Gene Therapy Center of Excellence in Hopewell, NJ

Sachin Maled (Senior Manager - Presales) will present the webinar Achieving Regulatory Readiness: How to Minimize Audit Stress on Jul 16, at 8:00 AM EDT. There is a second session at 12:00 PM EDT.
Transform audit preparation from months of stress into continuous confidence with ValGenesis Smart GxP™. Discover how the world's first AI-enabled digita

Achieving Regulatory Readiness: How to Minimize Audit Stress

Union, NJ-based Prokaryotics has entered into a licensing agreement with Finnish company Northern Antibiotics that will give Prokaryotics global rights to develop, manufacture, and commercialize a treatment currently known as NAB741, formerly SPR741 (1). NAB741 is a non-bioactive polymyxin that acts as a Gram-negative antibiotic potentiator, design

Prokaryotics Licenses Gram-Negative Antibiotic Potentiator from Northern Antibiotics

Biotech company, Invivyd, announced on June 26, 2025 that Phase I/II clinical data for the company’s next-generation monoclonal antibody (mAb), VYD2311, shows promise for use in the prevention and treatment of COVID-19 (1).
Engineered by Invivyd’s proprietary integrated technology platform, VYD2311is designed to generate an antibody that will neutr

Positive Early Data Seen in COVID-19 Monoclonal Antibody Treatment

The CDC’s Advisory Committee on Immunization Practices (ACIP) has blessed Merck’s new respiratory syncytial virus (RSV) shot Enflonsia, but the decision was hardly resounding from Robert F. Kennedy Jr.’s newly formed panel of advisors.
The ACIP signed off on recommending Merck’s newly approved monoclonal antibody by a vote of 5 to 2. The committee

CDC immunization advisory panel endorses Merck's new RSV shot, but not without dissent

Pharmaceutical Contract Packaging: Top Trends in Outsourcing
From serialization and sustainability to patient-centric design, experts reveal the trends shaping the contract packaging outsourcing market.
Read More>>
Survey Says: Contract Packaging on the Rise
Contract packaging industry survey highlights growing demand, evolving expectations, and in

Beyond Protection: Evolving Trends In Secondary Packaging

This webcast features: Ashley Bell, Associate Director Key Accounts & FAS, Scott Miller, PhD, Director of Instrument Development, Jérémie Barbau, Senior Application Scientist, Repligen.
Precise characterization of amino acid profiles in cell culture media is fundamental to understanding and controlling upstream performance. Amino acids play a centr

Next-Generation At-Line Cell Culture Media Analysis Enables Real-Time Data-Driven Optimization

It’s a large and universally recognizable CDMO, so this matters.
Going forward, Swiss-based powerhouse Lonza will increase its focus on biologics, and “advanced synthesis” such as complex modalities including antibody-drug conjugates (ADCs), cell and gene therapies (CGT), and mRNA-based therapeutics.
Lonza will exit its Capsules & Health Ingredient

Lonza Bets On Biologics. What's It Mean For You?

Hi Dear All members,
Need guidance on below topic,
We have recently received the regulatory query for our one of the product regarding Specificity parameter on LCMS method.
“Conduct specificity studies using samples spiked with known drug substance-related impurities. These studies should demonstrate that the presence of other impurities does not i

Analytical Procedures and Validation_Specificity parameter requirment

Thursday, June 26, 2025
Valneva SE, a specialty vaccine company, today announced an exclusive agreement with CSL Seqirus, one of the world’s largest influenza vaccine companies, for the marketing and distribution of Valneva’s three proprietary vaccines in Germany.
Under the agreed terms, CSL Seqirus will start commercializing Valneva’s single-dose

Valneva Announces Exclusive Vaccine Marketing and Distribution Agreement for Germany with CSL Seqirus

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
• Given the established management guidelines and extensive experience of the medical hematology/oncology community in diagnosing and managing the risks
Page 2 – STN BL 125736/488 – Kasem Khan
of cytokine release syndrome (CRS) and neurologic toxicities a

June 26, 2025 Approval Letter - ABECMA

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Lessons from a cross-functional roundtable at PDA Week 2025
Peter Makowenskyj, MEng, G-CON Manufacturing and Toni Manzano, PhD, Aizon
The pharmaceutical industry stands at a pivotal moment as advanced digital technologies, particularly artificial intelligence (AI), are increasingly integrated into manufacturing environments.
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