Navigating key news stories in pharma

Featured Stories

Featured
ATMPs: At the Precipice of Success or Failure
Strategy
ATMPs: At the Precipice of Success or Failure
Strategy

With major therapeutic indications close on the horizon, the industry must urgently address the prohibitive costs and manufacturing complexities currently blocking patient access to life-changing cures.

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Strategy
News
Wilmington PharmaTech Expands U.S. API Manufacturing Capacity
Expansion
Wilmington PharmaTech Expands U.S. API Manufacturing Capacity
Expansion

The company will add new reactor suites to its Delaware campus, increasing its API reactor capacity by more than double and enabling the company to meet new demand for high-quality domestic manufacturing.

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Expansion
ATMPs: At the Precipice of Success or Failure
Strategy
ATMPs: At the Precipice of Success or Failure
Strategy

With major therapeutic indications close on the horizon, the industry must urgently address the prohibitive costs and manufacturing complexities currently blocking patient access to life-changing cures.

Read More →
Strategy
DCAT Week 2026: Aligning Science and Strategy
Strategy
DCAT Week 2026: Aligning Science and Strategy
Strategy

To secure the long-term continuity of global supply there needs to be a convergence of operational excellence and advanced chemistry, note Almac’s James Hurst and Prof. Tom Moody.

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Strategy

R&D

Featured
AbbVie Targets Obesity Market with Novel Drug
AbbVie Targets Obesity Market with Novel Drug

Phase I trial results for the company’s novel long-acting amylin analog, have demonstrated significant potential for patients to lose up to 9.79% of body weight in 12–13 weeks with no serious adverse events.

NOFLU Consortium Awarded Contract Worth Up to EUR 148 Million
NOFLU Consortium Awarded Contract Worth Up to EUR 148 Million

The funding, which is part of a larger investment commitment from the European Commission, will be used to progress Ethris’ differentiated mRNA vaccine technology as a treatment for pandemic flu.

Preclinical Study Finds Nanotrastuzumab to be Comparable with Herceptin HYLECTA
Preclinical Study Finds Nanotrastuzumab to be Comparable with Herceptin HYLECTA

The nanoparticle suspension formulation was found to mirror the reference product closely in terms of AUC, Cmax, and Tmax across a 21-day Göttingen minipig study performed by Charles River Laboratories.

Novo Nordisk Reveals Headline Phase III Trial Results Evaluating Combination Obesity Treatment
Novo Nordisk Reveals Headline Phase III Trial Results Evaluating Combination Obesity Treatment

The company’s fixed-dose combination treatment demonstrated superior efficacy to its individual components and was shown to be safe and well-tolerated, consisted with other incretin and amylin-based therapies.

Expansion

Featured
Wilmington PharmaTech Expands U.S. API Manufacturing Capacity
Wilmington PharmaTech Expands U.S. API Manufacturing Capacity

The company will add new reactor suites to its Delaware campus, increasing its API reactor capacity by more than double and enabling the company to meet new demand for high-quality domestic manufacturing.

LYOCONTRACT and Syntegon Break Ground on Freeze-Drying Facility in Germany
LYOCONTRACT and Syntegon Break Ground on Freeze-Drying Facility in Germany

The German contract manufacturer is expanding its lyophilization capacity with a complete production line from equipment supplier Syntegon, as demand for sterile freeze-dried pharmaceuticals continues to grow across the sector.

Codis Significantly Invests in UK Spray-Drying Capacity for ASDs
Codis Significantly Invests in UK Spray-Drying Capacity for ASDs

With support from LSIMF, Codis is expanding its UK facility with the addition of a GEA PSD-4 commercial-scale spray dryer, making it the only CDMO in the UK to offer such capacity.

ESTEVE Invests Millions into Chicago Facility Expansion
ESTEVE Invests Millions into Chicago Facility Expansion

The major USD 15.5 million upgrade at ESTEVE CDMO’s Morton Grove, Illinois plant, is expected to supercharge small-molecule API production for pharmaceutical and biotech clients across North America.

Dealmaking

Featured
Alliance Forms to Automate Cell and Gene Therapy Manufacturing
Alliance Forms to Automate Cell and Gene Therapy Manufacturing

San Diego-based Trenchant BioSystems has partnered with engineering firm Invetech to develop a fully automated manufacturing platform it claims could cut production costs by up to 80%.

Lifecore and Indomo Sign New Deal to Develop Drug–Device Combination Acne Treatment
Lifecore and Indomo Sign New Deal to Develop Drug–Device Combination Acne Treatment

Under this new arrangement, the companies will work together to further develop Indomo’s DT-001 candidate, which will be combined with the ClearPen device to allow self-treatment of inflammatory acne lesions.

Charles River Laboratories Signs Deals to Sell CDMO and Discovery Assets
Charles River Laboratories Signs Deals to Sell CDMO and Discovery Assets

In efforts to streamline its portfolio and prioritize core capabilities, the company has agreed two separate transactions to divest its CDMO and Cell Solutions as well as select European Discovery Services sites.

Joint Venture Between BioDuro and Cenra Set to Increase Commercial API Manufacturing Capacity
Joint Venture Between BioDuro and Cenra Set to Increase Commercial API Manufacturing Capacity

The companies will integrate their strengths from early-stage development and commercial-scale GMP API manufacturing to offer clients an end-to-end API solution.

Strategy

Featured
ATMPs: At the Precipice of Success or Failure
ATMPs: At the Precipice of Success or Failure

With major therapeutic indications close on the horizon, the industry must urgently address the prohibitive costs and manufacturing complexities currently blocking patient access to life-changing cures.

DCAT Week 2026: Aligning Science and Strategy
DCAT Week 2026: Aligning Science and Strategy

To secure the long-term continuity of global supply there needs to be a convergence of operational excellence and advanced chemistry, note Almac’s James Hurst and Prof. Tom Moody.

DCAT Week 2026: Solving the Complexity Crisis
DCAT Week 2026: Solving the Complexity Crisis

According to Maja Pedersen from FUJIFILM Biotechnologies, modularity, AI-driven compliance, and harmonized global networks are necessary to resolve complexity challenges in downstream processing.

Navigating the Strategic Imperatives of DCAT Week 2026
Navigating the Strategic Imperatives of DCAT Week 2026

In this brief guide to DCAT Week 2026, The Pharma Navigator explores some of the critical dialogues’ attendees can look forward to participating in during their stay in Manhattan.

Future Biopharma

Featured
Opening the Door: The Technology Scaling the Next Era of Emerging Therapies
Opening the Door: The Technology Scaling the Next Era of Emerging Therapies

As emerging therapies target increasingly niche genetic pathways, the adoption of AI modeling, organoids, and advanced AAV delivery is becoming essential to ensure successful clinical progression and patient access.

Transforming the Treatment Landscape with Tailored Therapies
Transforming the Treatment Landscape with Tailored Therapies

Patient outcomes are transforming, thanks to innovative, curative, tailored therapies; however, industry needs to address a few pressing issues to ensure the huge promise of these drugs can be achieved.

Unlocking Potential in Pulmonary and Nasal Drug Delivery
Unlocking Potential in Pulmonary and Nasal Drug Delivery

While advancements are unlocking new possibilities in inhaled drug delivery and the pipeline is strong, the regulatory landscape is still challenging, highlighting the need for specialized partners to unlock future success.

The Role of Artificial Intelligence in Antibody Drug Discovery
The Role of Artificial Intelligence in Antibody Drug Discovery

Traditional antibody discovery is notoriously slow and resource-intensive, but a new wave of AI tools is enabling optimization of candidates prior to them reaching the clinic, accelerating development timelines. 

Regulatory

Featured
Roche's pMN Therapy Meets Primary Endpoint in Phase III Trial
Roche's pMN Therapy Meets Primary Endpoint in Phase III Trial

The company has revealed that its humanized, glycoengineered Type II anti-CD20 mAb has achieved superior complete remission rates versus tacrolimus in the MAJESTY study.

Rilzabrutinib Gains Regulatory Nods in the U.S. and Japan
Rilzabrutinib Gains Regulatory Nods in the U.S. and Japan

The U.S. FDA has granted breakthrough therapy designation and Japan’s MHLW has designated orphan drug status to Sanofi’s BTK inhibitor, rilzabrutinib (Wayrilz), as a treatment for wAIHA.

CBER Issues RTF for Moderna’s Investigational Flu Shot
CBER Issues RTF for Moderna’s Investigational Flu Shot

According to Moderna, the reasoning for the refusal to review the BLA by the regulatory authority is inconsistent with previous feedback, leading the company to request a Type A meeting.

FDA Grants Priority Review of sBLA for Datopotamab Deruxtecan
FDA Grants Priority Review of sBLA for Datopotamab Deruxtecan

If the application is successful, the therapy will become the first-line treatment for patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.

Upcoming Events

Featured
analytica 2026

World's leading trade fair with a long tradition: since 1968, analytica has been your guarantee of success for the successful presentation of innovative laboratory technology, pioneering analysis and future-oriented biotechnology.

World Vaccine Congress Washington 2026

The World Vaccine Congress Washington 2026 is one of the world’s leading events dedicated to vaccines, bringing together experts from across the global life sciences and healthcare ecosystem.

Fierce Drug Development and Delivery Day 2026

Join Drug Development Day, a free virtual event where industry leaders will explore the latest innovations in drug delivery and development.

LNP Formulation & Process Development Summit 2026

Returning to Boston in April 2026, the 5th LNP Formulation & Process Development Summit is an industry-led end-to-end meeting providing the latest scientific content to advance LNP development for a variety of payloads and therapeutic applications, from mRNA vaccines to next-generation cell and gene therapies.