Medicine Archives - Pauncar.com

Vorasidenib approved in UK for treating IDH-mutant brain tumours

MHRA greenlights oral therapy for patients aged 12 and over with grade 2 astrocytoma The MHRA has approved vorasidenib (Voranigo)

Imfinzi approved for NHS use in limited-stage small cell lung cance

Durvalumab becomes first immunotherapy recommended for LS-SCLC patients in England and Wales AstraZeneca’s Imfinzi (durvalumab) has been approved for NHS

Dr Christian Dowdeswell – PharmaTimes

Arcinova has appointed Dr Christian Dowdeswell as Managing Director Arcinova, a Quotient Sciences company and UK-based contract research development and manufacturing organisation

Lundbeck unveils migraine data for eptinezumab at international congress

New phase 4 results show sustained symptom relief and improved patient outcomes Lundbeck has presented new clinical data on eptinezumab

Capvaxive shows strong immune response in children at risk of pneumococcal disease

Merck presents phase 3 STRIDE-13 trial results at ESCMID conference in Lisbon Merck has announced positive phase 3 results for

George Eldridge – PharmaTimes

Abcuro has appointed George Eldridge as chief financial officer Abcuro Inc, a clinical-stage biotechnology company developing therapies for the treatment of

Rezatapopt shows promise in phase 2 trial for TP53 Y220C solid tumours

Early data reveals strong response rates in ovarian cancer cohort PMV Pharma has announced encouraging interim results from the phase

Bluejay begins phase 3 trial of brelovitug for hepatitis D

First patient enrolled in AZURE-2 study comparing brelovitug to Hepcludex Bluejay Therapeutics has enrolled the first patient in AZURE-2, a

Quotient Sciences and CPI launch RNA drug development venture

New partnership aims to fast-track mRNA therapies from lab to clinic Quotient Sciences and CPI have signed a memorandum of

Eisai unveils promising phase 1b data for narcolepsy drug E2086

Novel orexin receptor agonist shows potential to improve wakefulness Eisai has presented new clinical data for its investigational orexin 2

Sharon Curran – PharmaTimes

Sharon Curran has been appointed Chair of Rosemont’s board Sharon Curran has been appointed as the new chairperson for Rosemont Pharmaceuticals board of directors. The

AlzeCure presents phase 2 data on ACD440 at NeuPSIG 2025

Topical TRPV1 antagonist shows promise in heat-induced neuropathic pain lzeCure Pharma has presented new clinical data on its lead pain

Centre stage

Survey reveals lack of awareness need for greater clarity

Resolution Therapeutics doses first patient in EMERALD study of RTX001

Trial explores regenerative macrophage therapy for liver disease Resolution Therapeutics has announced that the first patient has been dosed and

Promised land

Blended solutions gain momentum and reveal untapped potential

eXmoor and Anthony Nolan partner to streamline cell therapy development

Collaboration offers end-to-end support from donor sourcing to manufacturing eXmoor Pharma and Anthony Nolan: Cell Therapy & Laboratory Services (CT&LS)

Polpharma Biologics and MS Pharma partner to expand biosimilar access

Deal covers biosimilars for gastroenterology, neurology and dermatology Polpharma Biologics has signed licensing agreements with MS Pharma for the commercialisation

Lilly receives UK approval for pirtobrutinib in relapsed blood cancers

MHRA grants conditional authorisation for treatment targeting mantle cell lymphoma Eli Lilly and Company has received conditional marketing authorisation from

FDA approves LEQEMBI IQLIK for maintenance dosing in early Alzheimer’s disease

New subcutaneous autoinjector offers at-home treatment option for patients Eisai and Biogen have announced FDA approval of LEQEMBI IQLIK (lecanemab-irmb)

Coya Therapeutics to progress trial of ALS treatment upon FDA approval

The US Food and Drug Administration (FDA) has accepted an Investigational New Drug (IND) application from Coya Therapeutics for COYA

Akiram advances trial of targeted radiotherapy for solid tumours

Swedish biotech company Akiram Therapeutics has announced significant progress in its first clinical trial of AKIR001, a radiopharmaceutical intended to

Johnny Cheng appointed as interim CEO of HUTCHMED

HUTCHMED has announced that Weiguo Su, CEO of the company, will take a leave of absence from his duties due

Encare’s ERAS system gains Mayo Clinic qualification, strengthening global reach

Encare’s ERAS Interactive Audit System (EIAS) has earned qualification on the Mayo Clinic Platform_Solutions Studio – a distinction rarely awarded

Anne White to retire as head of Lilly Neuroscience after three decades at company

Eli Lilly and Company has announced that Anne White, executive vice president and president of Lilly Neuroscience, will retire at

Novartis blood disorder drug shows promise in late-stage trial

Novartis has reported that its experimental drug ianalumab met the primary goal in a phase 3 trial for primary immune

Fertile ground – PharmaTimes

Top-rated pharmacies in northern Virginia for personalised fertility care Finding the right pharmacy to support your fertility journey is essential.

Friends of Cancer Research and MMS partner to improve interpretation of cancer trial survival data

Friends of Cancer Research has announced a new collaboration with global clinical research organisation, MMS, to develop decision frameworks that

ANGLE partners with Myriad Genetics to explore blood-based cancer testing

ANGLE has announced a collaboration with Myriad Genetics to assess whether circulating tumour cell (CTC) DNA harvested from blood samples

FDA grants Breakthrough Therapy Designation to lung cancer therapy

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to izalontamab brengitecan (iza-bren), an investigational drug

Upperton Pharma Solutions awarded grant to develop oral vaccine delivery with University of Oxford

Upperton Pharma Solutions has been awarded funding under the first VaxHub Sustainable Platform Funding Call to support the development of

Upperton and Oxford join forces to develop oral vaccine formulation

Project aims to improve global immunisation through needle-free delivery Upperton Pharma Solutions has secured funding from the first VaxHub Sustainable

Ogsiveo approved in EU for treatment of desmoid tumors

Merck’s therapy becomes first authorised option for aggressive soft tissue tumours Merck has announced that the European Commission has granted

Mounjaro shows cardiovascular benefit in head-to-head diabetes trial

Lilly’s study finds tirzepatide delivers broader health improvements Eli Lilly has announced positive topline results from its phase 3 SURPASS-CVOT

Vedanta’s ulcerative colitis candidate misses phase 2 efficacy target

Company shifts focus to phase 3 VE303 trial in recurrent C. difficile infection Vedanta Biosciences has announced that VE202 failed

Genmab’s epcoritamab combination meets key endpoints in phase 3 lymphoma trial

Promising results support global submissions and priority review by US FDA Genmab has announced that its phase 3 EPCORE FL-1

FDA approves AJOVY for paediatric migraine prevention

Teva’s CGRP therapy becomes first approved option for children and adolescent Teva Pharmaceuticals has received US FDA approval for AJOVY

Lilly and UK Government launch £85 million obesity care innovation programme

Nationwide competition to pilot new models of obesity support Eli Lilly and Company and the UK Government have announced a

Lilly’s Jaypirca shows positive results in phase 3 trial

Pirtobrutinib meets primary endpoint in CLL/SLL study Eli Lilly and Company has announced positive topline results from its phase 3

Scotland approves zanubrutinib for relapsed mantle cell lymphoma

New treatment option now available across all UK nations Patients in Scotland with relapsed or refractory mantle cell lymphoma (MCL)

Sever Pharma expands work on ketamine implant with Silo Pharma

New phase of development targets chronic pain and fibromyalgia Sever Pharma Solutions has deepened its partnership with Silo Pharma to

FDA expands AVTOZMA IV approval to include cytokine release syndrome

Celltrion’s biosimilar now fully aligned with ACTEMRA IV indications in US Celltrion has received US Food and Drug Administration approval

NICE backs KEYTRUDA combination for advanced endometrial cancer

New first-line option for patients with pMMR and dMMR tumours in England NICE has recommended KEYTRUDA (pembrolizumab) with carboplatin and

Porosome Therapeutics unveils breakthrough Alzheimer’s research

FDA validation and AI-designed therapies mark major shift in treatment strategy Porosome Therapeutics has announced major advances in Alzheimer’s disease

Nxera unveils proprietary pipeline targeting obesity and metabolic disorders

New oral GLP-1 agonist aims to reshape chronic weight management Nxera Pharma has launched a broad proprietary pipeline focused on

Gedeon Richter launches Nalvee in UK to expand HRT options for menopause

Dydrogesterone-only tablet returns after 17-year absence to support personalised care Gedeon Richter UK has launched Nalvee (10mg dydrogesterone) in the

Bath researchers develop pill-based alternative to injections

New drug delivery system could transform treatment for chronic conditions Scientists at the University of Bath have developed a new

Microbiotica completes recruitment for phase 1b ulcerative colitis trial

MB310 study investigates safety and efficacy of precision microbiome therapy Microbiotica has completed patient recruitment for its phase 1b trial,

US$30.9 million strategic equity deal strengthens Everest’s oncology platform

US$30.9 million strategic equity deal strengthens oncology platform Everest Medicines has announced a strategic equity investment of US$30.9 million in

Moderna wins EU approval for updated COVID-19 vaccine

Spikevax authorised to target LP.8.1 variant ahead of 2025-2026 season Moderna has received marketing authorisation from the European Commission for

Eisai data shows sustained benefit of lecanemab in early Alzheimer’s disease

Four-year treatment slows cognitive decline with consistent safety profile Eisai has presented new clinical data showing that patients with early

NICE backs AstraZeneca’s dual immunotherapy for advanced liver cancer

Imfinzi and Imjudo combination recommended as first-line treatment AstraZeneca has received a positive recommendation from NICE for the use of

Filgotinib meets phase 3 endpoint in axial spondyloarthritis trial

Alfasigma to seek regulatory approval following OLINGUITO study success Alfasigma has announced positive topline results from its OLINGUITO phase 3

PharmaTimes Clinical Researcher of the Year – The Americas

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Exonate to launch phase 2b trial of EXN407 for diabetic eye disease

CLEAR-DE study to assess topical therapy for non-proliferative diabetic retinopathy Exonate has announced plans to initiate a phase 2b clinical

Elizabeth Rebeil – PharmaTimes

Veranova has appointed Elizabeth Rebeil as VP of Supply Chain Excellence Veranova has appointed Elizabeth Rebeil as Global Vice President of Supply Chain and Operational Excellence.

Moderna’s updated COVID-19 vaccine receives positive EMA opinion

CHMP recommends authorization for LP.8.1-targeting vaccine ahead of 2025-2026 season Moderna has received a positive opinion from the European Medicines

Kling Bio partners with Sanofi to accelerate antibody discovery

Collaboration aims to advance next-generation therapeutics and vaccines Kling Bio has announced a new collaboration and licence option agreement with

Akari Therapeutics advances research on novel PH1 payload for targeted cancer therapy

Akari Therapeutics has reaffirmed its commitment to advancing research on PH1, a novel spliceosome modulator payload used in its antibody

Ovagen breakthrough boosts yellow fever vaccine yields

Irish biotech’s germ-free egg platform could help close global shortfall Irish biotech Ovagen has announced a major advance in vaccine

4TEEN4 begins trial of antibody therapy for cardiogenic shock

First patient dosed in phase 1b/2a study of procizumab 4TEEN4 Pharmaceuticals has dosed the first patient in a phase 1b/2a

PharmaTimes Clinical Researcher of the Year – The Americas

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PhoreMost unveils platform to streamline molecular glue drug discovery

GlueSEEKER enables rational design of targeted protein degraders PhoreMost has published new data validating its GlueSEEKER platform, a high-throughput technology

Ezmekly becomes first approved EU therapy for NF1-PN in children and adults

EC grants conditional marketing authorisation to Merck and SpringWorks Therapeutics The European Commission has approved EZMEKLY (mirdametinib) for treatment of

AlzeCure to present promising pain therapy ACD440 at NeuPSIG 2025

Clinical results from phase 2 study highlight analgesic effects in neuropathic pain patients AlzeCure Pharma will present new clinical data

MHRA approves first oral treatment for hereditary angioedema attacks

Sebetralstat offers injection-free relief for patients aged 12 and over The MHRA has approved sebetralstat (Ekterly) as the first oral,

Proximie and HistoSonics partner to transform liver tumour treatment in US

Digital operating rooms and histotripsy therapy combine to improve outcomes Proximie has announced a new partnership with HistoSonics to support

North East NHS launches digital platform to tackle chronic kidney disease

Healthinote rollout aims to improve early detection and patient self-management North East and North Cumbria NHS has begun a year-long

One Biosciences raises €15 million to advance single-cell oncology platform

Funding to accelerate development of AI-driven tumour profiling tool OneMap One Biosciences has secured €15 million in Series A financing

Seaport Therapeutics begins phase 2b trial of GlyphAllo for major depression

First patient dosed in BUOY-1 study targeting MDD with or without anxious distress Seaport Therapeutics has dosed the first patient

NHS England secures access to new cystic fibrosis treatment ALYFTREK

Vertex’s once-daily triple therapy approved for eligible patients aged six and over Vertex Pharmaceuticals has announced a broad reimbursement agreement

Imperial study reveals DNA structure that could reverse ovarian cancer resistance

Researchers at Imperial College London have discovered that an unusual DNA structure could be key to reversing chemotherapy resistance in

Pierre Fabre secures China approval for BRAFTOVI combination in colorectal cancer

New treatment targets BRAFV600E-mutant mCRC after prior therapy Pierre Fabre Laboratories have received marketing authorisation in China for BRAFTOVI (encorafenib)

Osivax publishes phase 2a results supporting dual flu vaccine approach

OVX836 shown to be safe and effective alongside seasonal Fluarix Tetra Osivax has released phase 2a trial data confirming that

Government to adopt EU standards for high-risk diagnostic devices

New regulations aim to simplify processes and strengthen patient safety The Government is set to amend UK medical devices regulations

Actithera closes $75.5m Series A to advance radioligand therapy platform

Funding to support lead candidate targeting FAP and pipeline expansion Actithera has secured $75.5 million in an oversubscribed Series A

BiomX phage therapy shows potent effect in cystic fibrosis trial

BX004 achieves 500-fold bacterial reduction with no resistance in phase 1b/2a study BiomX has published promising phase 1b/2a trial results

Clinical Researcher of the Year – The Americas

Enter the 2025 PharmaTimes Clinical Researcher of the Year – The Americas Enter The 2025 PharmaTimes Clinical Researcher of the

VarmX secures US approval to begin phase 3 trial of urgent surgery treatment

New trial to test VMX-C001’s effectiveness in restoring coagulation in FXa DOAC patients Biotech company VarmX has received clearance from

Eladynos recommended for osteoporosis treatment in Scottish NHS

SMC approval provides option for postmenopausal women at risk of fractures The Scottish Medicines Consortium has recommended Eladynos (abaloparatide) for

First patient dosed in trial for novel dry AMD treatment PST-611

PulseSight begins phase 1 safety study of gene therapy for geographic atrophy PulseSight Therapeutics has announced that the first patient

First German haemophilia B patient receives gene therapy HEMGENIX

CSL Behring marks new era in treatment with milestone reimbursement model The first haemophilia B patient in Germany has been

Paul Carter – PharmaTimes

Clinigen has appointed Paul Carter as Non-Executive Chair of its Board Clinigen, the global pharmaceutical services Group, has appointed seasoned biopharma

Neumifil shows promise in treating influenza with positive phase 2 dat

Pneumagen’s intranasal antiviral demonstrates reduced infection Pneumagen has announced the publication of phase 2 data showing its antiviral therapy, Neumifil,

Dr Dietrich Stephan – PharmaTimes

Enhanced Genomics appoints Dr Dietrich Stephan as Chair of the Board Enhanced Genomics has appointed Dr Dietrich Stephan as Chair of the Board of

Moderna flu vaccine shows superior results in phase 3 study

Data shows mRNA-1010 could better protect adults aged 50 and above Moderna has reported positive phase 3 results for its

Kate Woolland – PharmaTimes

Closed Loop Medicine has appointed Kate Woolland as CEO Closed Loop Medicine (CLM) has appointed Kate Woolland as Chief Executive Officer. Previously serving

Cidara and hVIVO report positive results in flu prevention study

New data show strong efficacy of CD388 in phase 2b trial Cidara Therapeutics and hVIVO have announced encouraging topline results

UCB reports success in phase 3 study of fenfluramine for CDD

Positive trial results offer hope for those with ultra-rare epileptic disorder UCB has announced that its phase 3 trial evaluating

Future prescribed – PharmaTimes

Transforming community prescribing through innovation As the NHS places an increasing focus on strengthening primary care and enhancing community-based prescribing,

Talking the talk

Why supporting representative trial participation matters

NHS ConfedExpo 2025: a platform for change in UK health and care

This year’s event took place on 11 to 12 June at Manchester Central This year’s NHS ConfedExpo took place on

Jessica Atkinson – PharmaTimes

VectorY Therapeutics has appointed Jessica Atkinson as Chief Business Officer VectorY Therapeutics has appointed Jessica Atkinson as Chief Business Officer. In this newly created role, she

2025 PharmaTimes Clinical Researcher of the Year

Enter this year’s famous competition Enter The 2025 PharmaTimes Clinical Researcher of the Year – The Americas! Introducing the Novice

Excellence in Healthcare Partnerships Awards launched by PMGroup and Visions4Health

The programme was unveiled at this year’s NHS ConfedExpo in Manchester PMGroup Worldwide and Visions4Health have launched the Excellence in

Ben Svarczkopf – PharmaTimes

Biocartis has appointed Ben Svarczkopf as Senior Vice President of Global Marketing Biocartis Group of Companies (Biocartis) has announced the

NHS rolls out new initiative to identify pancreatic cancer earlier

The pilot will see GP practices look at patient records to identify those most at risk The NHS has announced

Chris Brett – PharmaTimes

Kallikor has appointed Chris Brett as Chief Technology and Product Officer Kallikor has announced the appointment of Chris Brett as

eXmoor and Signadori Bio enter cell therapy partnership

Signadori is advancing a platform designed to overcome the challenges of treating solid cancers eXmoor Pharma and Signadori Bio have

Louise Peacock – PharmaTimes

Aravax has appointed Louise Peacock as Chief Regulatory and Quality Officer Aravax has announced the appointment of Louise Peacock as

Teva and Fosun Pharma partner on early-stage oncology drug

The candidate is being evaluated as both a monotherapy and in combination pembrolizumab Teva Pharmaceutical Industries and Shanghai Fosun Pharmaceutical

Steven Sciuto – PharmaTimes

iOnctura has appointed Steven Sciuto as Chief Financial Officer iOnctura has announced the appointment Steven Sciuto as its new Chief

FDA approves UroGen’s Zusduri to treat recurrent bladder cancer

Approximately 59,000 LG-IR-NMIBC patients experience recurrent disease every year in the US The US Food and Drug Administration (FDA) has

Investigational treatment shows promise for aggressive multiple myeloma

Results suggest bispecific antibody combination could improve outcomes A new investigational treatment has shown strong and lasting responses in multiple

EDX medical partners with spire healthcare to advance disease diagnostics

Collaboration aims to improve rapid detection and personalised treatments EDX Medical Group has entered into an agreement with Spire Healthcare

Dr Jason Slingsby – PharmaTimes

Tozaro has appointed Dr Jason Slingsby as Chief Executive Officer Tozaro has announced the appointment of Dr Jason Slingsby as Chief Executive Officer. Jason will lead

Argenx presents new efgartigimod data at EULAR 2025

Rheumatology studies show promising results for Sjogren’s disease Argenx has presented positive phase 2 results for efgartigimod in myositis and

Migraine takes the spotlight at European Parliament

EMHA calls for its inclusion in EU neurological health strategy The European Migraine and Headache Alliance (EMHA) has urged EU

Levicept presents new LEVI-04 data at EULAR

Biotech firm shares phase 2 findings on novel osteoarthritis treatmen Levicept has presented new data from its phase 2 trial

Bimekizumab shows lasting efficacy at EULAR 2025

Three-year data highlights inflammation control in psoriatic arthritis UCB has announced new three-year data from phase 3 trials and their

Unique journey

Personalisation is the future of cancer care

Tagomics secures £860k grant for colorectal cancer test

Biotech firm to collaborate with NHS on early detection study Tagomics has been awarded £860k in funding from Innovate UK’s

Nihad Hasagic – PharmaTimes

Clinigen has appointed Nihad Hasagic as SVP for CLS Clinigen has appointed Nihad Hasagic as Senior Vice President for Clinigen Lifecycle Services (SVP CLS). CLS plays

PharmaTimes Clinical Researcher of the Year – The Americas

Enter The 2025 PharmaTimes Clinical Researcher of the Year – The Americas! Enter The 2025 PharmaTimes Clinical Researcher of the

Dr Jason Slingsby – PharmaTimes

Tozaro has announced the appointment of Dr Jason Slingsby as Chief Executive Officer. Jason will lead the company’s long-term strategy, including commercialisation of

Linear Diagnostics awarded £1m to develop rapid STI test

New funding supports development of diagnostic platform Birmingham spin-out Linear Diagnostics has secured £1m funding to advance a rapid test

EC approves Santen’s Ryjunea to slow progression of paediatric myopia

Therapy indicated for children aged 3 to 14 at treatment initiation Santen has announced that the European Commission has granted

NICE recommends Sogroya for growth hormone deficiency in children

Treatment provides option for children with growth failure The National Institute for Health and Care Excellence (NICE) has recommended Sogroya

Patient puzzle – PharmaTimes

Last month, I had the privilege of hosting a webinar for the National Institute for Health and Care Research (NIHR)

Leading lights

Richard Condon, CEO Aspire Pharma, discusses successful leadership

PharmaTimes Clinical Researcher of the Year – The Americas

Enter The 2025 PharmaTimes Clinical Researcher of the Year – The Americas! Enter The 2025 PharmaTimes Clinical Researcher of the

AstraZeneca’s Forxiga recommended for chronic kidney disease treatment

Updated guidance from NICE expands eligibility for dapagliflozin us The National Institute for Health and Care Excellence (NICE) has published

NICE recommends mirikizumab for Crohn’s disease treatment

New guidance expands treatment options for eligible patients The National Institute for Health and Care Excellence (NICE) has issued final

Stephen Rayda – PharmaTimes

Worldwide Clinical Trials has appointed Stephen Rayda as Chief Digital and Information Officer Worldwide Clinical Trials has appointed Stephen Rayda

Lumanity and Parker Institute partner to support delivery of new immunotherapies

The alliance combines Lumanity’s commercial and development strategy capabilities with PICI’s translational research expertise Lumanity and the Parker Institute for

Eli Lilly acquires SiteOne Therapeutics to advance treatment for chronic pain

Global biopharma Eli Lilly will acquire SiteOne Therapeutics, a biotech dedicated to the development of non-opioid medicines to treat pain

TQ Therapeutics acquires Juno GmbH to support decentralised cell therapy platform

TQ Therapeutics (TQx) has acquired Juno Therapeutics GmbH, the German subsidiary of Juno Therapeutics, through a share purchase agreement. Juno

Oxford Brain Diagnostics to launch groundbreaking dementia diagnosis technology

Company secures regulatory approvals for commercial rollout in UK and US With over 55 million people worldwide living with dementia,

NICE recommends sparsentan for IgA nephropathy

First non-immunosuppressive dual-action therapy approved for eligible patients The National Institute for Health and Care Excellence (NICE) has recommended FILSPARI

Sonrai and AOA Dx partner to accelerate ovarian cancer test development

Strategic collaboration aims to improve early diagnosis Sonrai Analytics and AOA Dx have announced a partnership to accelerate the development

MHRA Board meets in Scotland for first time, reinforcing UK-wide health priorities

The Board of the Medicines and Healthcare products Regulatory Agency (MHRA) has met in Scotland for the first time, marking

Bee Koen Low – PharmaTimes

Kelso Pharma has appointed Bee Koen Low as Chief Operating Officer Kelso Pharma has announced the appointment of Bee Koen

Ionis shares phase 3 results for olezarsen in moderate hypertriglyceridaemia

The drug was recently approved in the US for familial chylomicronaemia syndrome Ionis Pharmaceuticals has shared positive top-line results from

Elizabeth Rebeil – PharmaTimes

Veranova has appointed Elizabeth Rebeil as Global Vice President of Supply Chain and Operational Excellence Veranova has announced the appointment

FDA approves Amneal’s self-administered migraine drug Brekiya

Brekiya is now the first DHE auto-injector to be approved by the regulator The US Food and Drug Administration (FDA)

Massalia Therapeutics launches to advance novel treatments for complex conditions

Biotech spin-off targets fibrosis, neoplasm and neovascularization Massalia Therapeutics, a biotechnology spin-off from the C2VN Institute, has officially launched with

MHRA approves guselkumab for Crohn’s disease and ulcerative colitis

Regulator confirms safety and efficacy of new treatment option for patient The Medicines and Healthcare products Regulatory Agency (MHRA) has

AviadoBio opens UK trial for FTD gene therapy

Aspire-FTD study aims to stop disease progression with one-time treatment AviadoBio has launched its phase 1/2 Aspire-FTD trial in the

Shane Olwill – PharmaTimes

Asgard Therapeutics has appointed Shane Olwill as Chief Development Officer Asgard Therapeutics, a privately held biotech company pioneering in vivo direct cell

Kaerus Bioscience secures orphan drug designation for fragile x syndrome treatment

FDA recognises KER-0193 as a potential therapy for rare paediatric disease Kaerus Bioscience has received orphan drug and rare paediatric

Herantis Pharma doses final cohort in phase 1b trial of HER-096 for Parkinson’s disease

Trial progresses towards topline data expected later in the year Herantis Pharma has dosed the first patients in the final

Rein Therapeutics initiates renew phase 2 trial for IPF treatment

Screening begins for study evaluating LTI-03 in idiopathic pulmonary fibrosi Rein Therapeutics has begun screening and recruiting patients for its

Gergely Sved – PharmaTimes

Ellab has appointed Gergely Sved as its new Chief Executive Officer Ellab, the provider of validation, monitoring and calibration services and solutions,

Apiary invests in life sciences marketing specialist performance-io

Private equity firm Apiary Capital backs rapid growth of performance-i Apiary Capital has completed its investment in performance-io (PIO), a

Fiona Smith-Laittan – PharmaTimes

Fiona Smith-Laittan has been appointed Chair of Cambridge Global Health Partnerships Fiona Smith-Laittan, Vice President of Global Health Strategy and

iOnctura starts randomised phase 1/2 trial in lung cancer treatment

Study explores whether PI3Kδ targeting could combat resistance iOnctura has begun a randomized phase 1/2 study investigating its lead asset,

Amgen’s Tepezza granted marketing authorisation in the UK

Teprotumumab approved as first targeted treatment for thyroid eye disease The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has

PharmaTimes Clinical Researcher of the Year – The Americas Awards

Demonstrate your skill and prowess by entering this year’s awards! For 2025, The 2025 PharmaTimes Clinical Researcher of the Year

MHRA grants Promising Innovative Medicine designation to UCB’s DoxTM for TK2d

UCB’s developmental treatment may be eligible for patient access UCB has announced that its developmental treatment DoxTM, a combination of

Johnson & Johnson submits application for subcutaneous Rybrevant dosing

Company seeks approval for new schedules to improve patient convenience Janssen-Cilag International NV, a Johnson & Johnson company, has submitted

Chiesi partners with Wirral Primary Care to improve COPD detection

New initiative aims to accelerate diagnosis and ease NHS pressures Chiesi UK and Ireland and Wirral Primary Care Collaborative (WPCC)

Mosaic therapeutics expands pipeline with Astex deal

Cambridge firm in-licenses two oncology programmes Mosaic Therapeutics a UK-based oncology company has announced it has in-licensed two clinical-stage oncology

Nice recommends first AI medical device for skin cancer diagnosis in the NHS

Approval marks milestone for AI use in frontline care NICE has endorsed DERM, an autonomous AI medical device developed by

Leqembi dosing proposal for Alzheimer’s treatment validated by MHRA

Application seeks reduced infusion frequency to support patient flexibility Eisai Europe and Biogen Idec have announced the validation of a

Hundreds of genetic links to osteoarthritis unlocked

Study paves the way for personalised therapies for osteoarthritis sufferer Groundbreaking research has identified over 900 genetic links to osteoarthritis,

Lynozyfic receives EU approval for relapsed multiple myeloma treatment

New therapy offers hope for patients with limited option Regeneron Pharmaceuticals has announced that the European Commission has conditionally approved

Shaping tomorrow

Today’s leaders are building a stronger, more inclusive future for the industry

Takeda’s Adcetris receives positive opinion for Hodgkin lymphoma treatment

CHMP recommendation brings new hope for patients Takeda has announced a positive opinion from the Committee for Medicinal Products for

Katharina Pink – PharmaTimes

Aspire Pharma has appointed Katharina Pink as Chief Commercial Officer Aspire Pharma has announced the appointment of Katharina Pink as

Argenx receives positive CHMP opinion for CIDP treatment

VYVGART could be the first CIDP drug with a novel mechanism in 30 years Argenx has announced that the Committee

Noah Goodman – PharmaTimes

Kymera Therapeutics has appointed Noah Goodman as Chief Business Officer Clinical-stage biopharma Kymera Therapeutics has announced the appointment Noah Goodman

Patrick Daly – PharmaTimes

Terumo BCT has appointed Patrick Daly as Chief Business Officer Terumo Blood and Cell Technologies (Terumo BCT) has announced the

Acoramidis approved for heart condition treatment

MHRA authorises drug for adults with rare heart muscle damage The Medicines and Healthcare products Regulatory Agency (MHRA) has given

Mosaic therapeutics expands pipeline with Astex deal

Mosaic Therapeutics a UK-based oncology company has announced it has in-licensed two clinical-stage oncology programmes from Astex Pharmaceuticals. The agreement

All systems go! – PharmaTimes

Where to purchase reliable pharmacy automation systems Technological advancements propel the pharmaceutical industry into the future. Better equipment makes it

Genomics study launches to optimise childhood cancer care in Ireland

It is hoped that the MAGIC-I study will support earlier diagnosis and personalised treatment A five-year clinical study aiming to

UCL researchers launch congenital muscular dystrophy research programme

The university has been awarded a £1m grant from LifeArc and Muscular Dystrophy UK Researchers from University College London (UCL)

Russell Abberley – PharmaTimes

ABPI has appointed Russell Abberley as President-elect The Association of the British Pharmaceutical Industry (ABPI) has appointed Russell Abberley, Vice

Novavax shares positive real-world results for JN.1-adapted COVID-19 vaccine

The SHIELD-Utah study compared Novavax’s vaccine to the Pfizer/BioNTech mRNA 2024-2025 vaccine Novavax has shared positive preliminary results from a

Aidan Synnott – PharmaTimes

Oncodesign Services has appointed Aidan Synnott as CEO Oncodesign Services has announced the appointment of Aidan Synnott as its new

FDA approves Click’s digital therapeutic for episodic migraine

More than 37 million adults in the US are affected by migraine The US Food and Drug Administration (FDA) has

Pepaxti shows effectiveness in heavily pretreated multiple myeloma patients

New real-world data reinforce treatment benefit Real-world data from the University of Catania, Italy, suggest that Pepaxti, a treatment for

Leqembi approved as first treatment to slow early Alzheimer’s progression

European Commission grants authorisation for Eisai and Biogen therapy The European Commission has granted marketing authorisation for Leqembi (lecanemab), making

Global data highlights effectiveness of romosozumab

Studies show improved bone mineral density and healthcare cost reductions New data from multiple countries confirm the effectiveness of romosozumab,

New data reinforce daratumumab as standard of care for multiple myeloma

Long-term survival projections suggest improved outcomes for patients New data from Janssen-Cilag International NV suggest that subcutaneous DARZALEX (daratumumab) quadruplet

New test prototype for monitoring MGUS patients funded

Birmingham researchers to make MGUS monitoring more efficient Birmingham researchers have received £230k from Cancer Research Horizons to develop a

UK clinical trials regulations signed into law

Major update aims to accelerate research and strengthen patient safety New UK clinical trials regulations have been signed into law,

Lab-grown lung cancer cells show potential to revolutionise treatment

The model could lead to more targeted treatments for the disease Cancer Research scientists have developed a new cell-based model

First treatment for common bladder cancer recommended by NICE

Johnson & Johnson’s Balversa was found to extend the lives of urothelial cancer patients with a genetic alteration Balversa (erdafitinib)

SkyCell and Microsoft partner to improve pharma supply chains

AI-powered SkyMind is designed to improve efficiency, compliance and decision-making SkyCell has partnered with Microsoft to launch SkyMind, an artificial

NHS launches spring COVID-19 booster campaign

An estimated 7.5 million people will be invited to receive the booster The NHS has started delivering its spring COVID-19

Regina Hodits – PharmaTimes

Angelini Ventures has appointed Regina Hodits as managing director Angelini Ventures has announced the appointment of Regina Hodits as its

MHRA approves prostate cancer imaging agent trofolastat

Approximately 55,100 new cases of prostate cancer are diagnosed every year in the UK The Medicines and Healthcare products Regulatory

SMC approves bimekizumab for hidradenitis suppurativa treatment

The Scottish Medicines Consortium (SMC) has approved bimekizumab for adults with active moderate to severe hidradenitis suppurativa (HS) who have

Endlyz Therapeutics emerges with pipeline for Parkinson’s disease

Research targets lysosomal function restoration for neurodegeneration Endlyz Therapeutics has launched from stealth, unveiling its pipeline of small molecule modulators

Aspire and inspire – PharmaTimes

Women are shaping new dimensions throughout industry Having women in the pharmaceutical industry is crucial because it brings diverse perspectives

Elekta and Azra AI partner to advance cancer registry operations with AI

Collaboration introduces automation to enhance efficiency Elekta has announced a partnership with Azra AI to improve cancer registry workflows using

European Commission approves ustekinumab for paediatric Crohn’s disease

Approval extends ustekinumab’s use to younger patients The European Commission (EC) has approved ustekinumab for the treatment of moderately to

Visionaries

Women in healthcare and pharma – progress, challenges and outcomes

4basebio receives MHRA licence for synthetic DNA manufacture

GMP certification enables 4basebio to supply DNA for clinical trials 4basebio PLC has been granted Good Manufacturing Practice (GMP) certification

NICE recommends brentuximab vedotin plus AVD for Hodgkin lymphoma

Advancing care for stage 3 or 4 Hodgkin lymphoma patients The National Institute for Health and Care Excellence (NICE) has

Bio matters

Are biotechs underestimating regulatory groundwork

Diagnexia and Stratipath link up brings AI breast cancer diagnostics to UK

Collaboration expands AI-based risk profiling tools Diagnexia has announced a partnership with Stratipath AB to bring Stratipath Breast, an AI-based

Gene team – PharmaTimes

When Integrated DNA Technologies (IDT) launched its Collab Network in February 2023, the goal was to speed up the pace

One Health – PharmaTimes

The vital link between human and animal well-being The next pandemic will require crucial collaboration between veterinarians and medical professionals.

Amivantamab plus lazertinib shows survival benefit in lung cancer

Janssen drug combination extends life expectancy during trial Janssen-Cilag International NV has announced results from the phase 3 MARIPOSA study,

Genome editing offers hope for genetic hearing loss

New therapy developed to repair GJB2 R75W mutation Scientists from Juntendo University and The University of Tokyo have created an

Nouscom reveals promising results for lynch syndrome immunotherapy

NOUS-209 shows potential to intercept cancer in its early stages Nouscom has announced full safety and immunogenicity results from its

Linda Härmark – PharmaTimes

Drug Safety Research Unit appoints Linda Härmark as its Director The Drug Safety Research Unit has announced Linda Härmark as its new Director. She succeeds

Kieron Hall – PharmaTimes

Sygnature Discovery has appointed Kieron Hall as Chief Commercial Officer Sygnature Discovery has announced the appointment of Kieron Hall as its new Chief Commercial Officer (CCO)

Seth Benson – PharmaTimes

Nuclera has appointed Seth Benson as Chief Financial Officer Nuclera, the biotechnology company accelerating protein expression and optimisation through its benchtop eProtein