NLS Pharma News

Pharma Business – September 18, 2026

AstraZeneca’s Efzimfotase alfa wins US priority review

The US Food and Drug Administration (FDA) has accepted and granted Priority Review to Alexion, AstraZeneca’s Rare Disease unit, for efzimfotase alfa as a treatment for patients with hypophosphatasia (HPP) aged 2 years and older.

Biotech Business – September 18, 2026

CHMP backs earlier use of Oncopeptides’ Pepaxti

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Pepaxti (melflufen) be extended to earlier lines of multiple myeloma treatment, a move that would significantly widen the drug’s eligible patient population.

Evotec: Where human insight meets artificial intelligence

Artificial intelligence is rapidly reshaping drug discovery and development, and the companies making real progress are those that treat AI as an accelerator, not a replacement, for scientific judgement.

Pharma Business – September 17, 2026

Independent study broadens use case for Lumito’s SCIZYS platform

A newly published, peer-reviewed study has used Lumito’s SCIZYS tissue-imaging platform to analyse biomarker expression in single immune cells, extending its validated use beyond tissue samples into cell-based research for the first time.

Pharma Business – September 16, 2026

FDA grants Orphan Drug Designation to OXC-201

Oxcia has been granted Orphan Drug Designation (ODD) by the FDA for OXC-201, its drug candidate for idiopathic pulmonary fibrosis (IPF), just weeks after a similar decision from the EMA.

Clinical Trials

Clinical Trials – September 14, 2026

Phase 2a results move ResoTher Pharma toward key efficacy trial

ResoTher Pharma has reported promising Phase 2a results for its cardioprotective drug candidate RTP-026, moving the company a step closer to a key efficacy trial and a potential pharma partnership or sale.

Clinical Trials – September 9, 2026

Novo Nordisk’s semaglutide moves obesity below threshold in nearly half of children in phase 3 trial

In the phase 3 STEP Young trial, 40.4% of children aged 6 to under 12 treated with once-weekly semaglutide were no longer classified as having obesity after 68 weeks, compared with none of those on placebo.

Clinical Trials – September 8, 2026

SynAct’s new data analysis bolsters case for Phase 3 RA trial

A post-hoc analysis of SynAct Pharma’s Phase 2b ADVANCE study confirms earlier positive results for resomelagon in rheumatoid arthritis (RA), and the company now plans to discuss Phase 3 trial design with the FDA in Q4 2026.

Clinical Trials – September 2, 2026

Cinclus Pharma completes treatment phase in Phase III trial

The company has completed the eight-week treatment period for all patients in its pivotal Phase III HEEALING1 study of linaprazan glurate in erosive gastroesophageal reflux disease (GERD), with topline results now expected in the fourth quarter of 2026.

Clinical Trials – August 31, 2026

AstraZeneca’s Tezspire hits primary endpoints in Phase III trial

AstraZeneca and partner Amgen have reported that Tezspire (tezepelumab) met both co-primary and all key secondary endpoints in the Phase III CROSSING trial in eosinophilic esophagitis (EoE), positioning the anti-TSLP antibody for a potential new indication beyond its existing approvals in severe asthma and chronic rhinosinusitis with nasal polyps.

Clinical Trials – August 31, 2026

Faron enrolls first patient in investigator-initiated Phase 1b/2 trial

Faron Pharmaceuticals has announced that the first patient has been enrolled in the BEXAR trial, testing its lead candidate bexmarilimab in combination with chemotherapy as a first-line treatment for metastatic soft-tissue sarcoma.

Biotech Business – August 26, 2026

Lytix Biopharma enters major clinical collaboration in Europe

Lytix Biopharma is joining a new investigator-initiated Phase II study, ALETTA, that will test its lead candidate ruxotemitide in combination with ipilimumab and nivolumab in patients with early-stage, resectable melanoma – a second major checkpoint-inhibitor combination alongside the company’s existing pembrolizumab work.

Clinical Trials – August 26, 2026

BioInvent’s preclinical data published in Cancer Research

Swedish biotech BioInvent has published preclinical data on its two anti-TNFR2 antibodies, BI-1808 and BI-1910, in the journal Cancer Research, showing the two candidates drive anti-tumour immunity through distinct mechanisms – including in tumour types that typically resist checkpoint inhibitor therapy.

Clinical Trials – August 20, 2026

Merck, Moderna report positive melanoma trial results

Merck and Moderna have reported positive topline results from the Phase 3 INTerpath-001 trial of intismeran autogene in combination with Keytruda in patients with completely resected, high-risk melanoma.

Clinical Trials – August 19, 2026

Pila Pharma has received regulatory approval for obesity trial

The company has received regulatory approval from the European Medicines Agency, to conduct PP-CT04, a two-part, randomized, double-blind, placebo-controlled, parallel-group, 12‑week trial investigating the safety, tolerability, pharmacokinetics and efficacy of XEN-D0501 in obese participants.

Profiles in Pharma

Profiles in Pharma – April 2, 2025

The Jalkanens: A shared thirst for knowledge

For Sirpa and Markku Jalkanen of Finland, M.D. and Ph.D., married, immunotherapy researchers, working together came as naturally as a courtship.

Profiles in Pharma – November 1, 2023

Jonina Gudmundsdottir, Coripharma

In the heart of Iceland’s life sciences industry, Jonina Gudmundsdottir, the CEO of Coripharma, is making her mark. With a deep understanding of the industry’s challenges and a relentless drive for excellence, Gudmundsdottir has steered Coripharma toward transformative success. Iceland’s life sciences industry has thrived in recent years, propelled by its unique strengths. With a […]

Profiles in Pharma – July 3, 2023

Deborah Dunsire

The CEO of Lundbeck, who announced that she will retire last week, did not initially intend to join the life science industry, but it captivated her more than 30 years ago, and the ability to transform lives still drives her to this day. For more than 100 years, Lundbeck has been at the forefront of […]

Profiles in Pharma – October 1, 2021

Malin Parkler – Passionate about science, health & leadership

Malin Parkler, CEO of Pfizer Sweden, is driven by curiosity and a passion to build knowledge and evolve the life science industry – with the ultimate goal to yield real benefits for patients. Rarely has the world been more in need of leaders. As the global community struggled with the COVID-19 pandemic last year, people […]

Profiles in Pharma – August 15, 2019

Katarina Ageborg, CEO AstraZeneca Sweden

Few companies are as synonymous with Sweden as AstraZeneca and few CEOs as visible. Yet, Katarina Ageborg, AstraZeneca Sweden’s new CEO, prefers not to think about being center stage, but instead about what her position can do for the company, Sweden and the pharmaceutical industry as a whole. “I don’t think about it that way […]

Profiles in Pharma – July 1, 2017

Embracing diversity – for the sake of true innovation

Bahija Jallal’s curiosity and passion for science have been strong driving forces throughout her entire career, as has her belief in the need for diversity to truly bring forth innovation. A view that is also deeply incorporated in her job as Head of MedImmune. Editor’s note: In 2019 Bahika Jallal left MedImmune and became the […]

Profiles in Pharma – March 22, 2017

“The scientist in me wants to make a difference”

After ten years of diabetes research and development at Novo Nordisk, Dorte X. Gram took her findings and work further to start something on her own. As founder and CEO of PILA PHARMA she hopes to bring a new oral anti-diabetic agent to the market.

Profiles in Pharma – March 8, 2017

“We have to embrace the new era of diabetes care”

Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer at Novo Nordisk, talks about the Danish pharma giant’s drug-development strategy, the new era of diabetes care and his 25 year-long passion for his job. The changing diabetes market, with increasing competition and high prices for diabetes products in the US, has made the world’s […]

Profiles in Pharma – February 16, 2017

From regulator to pharma industry specialist

Dr. Thomas Lönngren, former head of the EMA and today a pharmaceutical consultant, provides some insights on the aftermath of Brexit, describes current challenges the industry is facing and takes a short walk down memory lane on his career journey. The summer of 2016 will be remembered for many things; record temperatures, terrorist acts in […]

Profiles in Pharma – April 21, 2014

Jan Lundberg: The long view of R&D at Eli Lilly

Like sports, R&D requires team spirit, commitment, and a long view says Dr. Jan Lundberg, Lilly executive vice president for science and technology, and president of Lilly Research Laboratories. Dr. Jan Lundberg’s online bios and YouTube videos portray a steely pharmaceutical executive whose idea of fun is a 90 km ski race. It’s all true. […]

More pharma stories

Agreement - September 17, 2026

Orbis Medicines signs up to USD 1.4 billion deal with Novo Nordisk

Orbis Medicines has entered a strategic collaboration and license agreement with Novo Nordisk to discover and develop next-generation oral macrocycle therapeutics for cardiometabolic diseases, in a deal worth up to USD 1.4 billion.

Collaboration - September 16, 2026

Swedish healthcare delegation visits Kyiv as Russian attacks on civilians intensify

A Swedish healthcare delegation traveled to Kyiv on September 2–4 to strengthen cooperation on rebuilding Ukraine's healthcare system, timed to one of the most difficult periods for the city in months.

Agreement - September 15, 2026

Zealand Pharma out-licenses diabetes peptide platform to US biotech Elvinix

Zealand Pharma has signed an exclusive license agreement with newly formed US biopharmaceutical company Elvinix, granting the rights to develop and commercialize a GLP-1/gastrin dual-agonist peptide portfolio as a regenerative therapy for type 1 diabetes.

Pharma Business - September 15, 2026

FDA clears Orexo to begin trial of OX640 for anaphylaxis

The US Food and Drug Administration has approved Orexo's Investigational New Drug application for OX640, a needle-free intranasal powder formulation of adrenaline, allowing the company to begin its pivotal clinical development program for the treatment of anaphylaxis.

Pharma Diagnostics - September 14, 2026

Study finds Acarix’s CADScor platform can also detect heart failure

A peer-reviewed study led by Aalborg University has found that the seismocardiography technology behind Acarix's CADScor System can detect heart failure with diagnostic accuracy comparable to a standard blood test, and with substantially fewer false positives – a condition distinct from the coronary artery disease the device is currently cleared for.

Pharma Business - September 14, 2026

Lundbeck’s asedebart receives US orphan drug designation for Cushing’s syndrome

The US FDA has granted Orphan Drug Designation to Lundbeck's investigational anti-ACTH monoclonal antibody asedebart for the treatment of endogenous Cushing's syndrome, adding to a growing list of rare-disease designations for the candidate across three regions.

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