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Drug Discovery and Development
HanchorBio announces US FDA clearance of IND application for HCB303, a next-generation trispecific immunotherapy
The US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for HCB303 developed by HanchorBio, a global clinical-stage biotechnology...
Lundbeck presents phase 1b data for Lu AF28996 in advanced Parkinson’s disease, as phase 2 trial begins
H Lundbeck has announced results from an open-label phase 1b trial evaluating Lu AF28996, a novel, investigational, oral prodrug of D1-like/D2-like dopamine receptor agonist,...
Beactica Therapeutics selects BEA-28 as a preclinical candidate and first-in-class TEAD degrader for biomarker-selected cancers
Beactica Therapeutics AB, a Swedish precision medicine company, has selected BEA-28 as a preclinical candidate for its TEAD programme, which is aimed at developing...
Carbogen Amcis announces successful first FDA pre-approval inspection at its Vionnaz site
Carbogen Amcis, a leading pharmaceutical process development and active pharmaceutical ingredient (API) manufacturing company, announces the successful completion of the first US Food and Drug...
Thermo Fisher Scientific showcases new solutions and expanded capabilities to accelerate drug development at CPHI Milan 2026
Thermo Fisher Scientific, a world leader in serving science, is expanding its drug development, manufacturing and clinical capabilities to help pharmaceutical and biotechnology companies...
Novai publishes study supporting use of DARC imaging technology to identify patients at risk of central vision loss from macular atrophy
Novai, a medtech company combatting blindness and disability by pioneering early detection and intervention for eye and brain diseases, has announced the publication of...
nPhase.AI becomes the industry’s first AI-native enterprise platform for end-to-end clinical data management
nPhase, a clinical research technology company, has launched nPhase.ai, the life sciences industry’s first enterprise platform for end-to-end clinical data management.
The company also introduces nPhase.ai SCE (Statistical Computing...
Yourgene Health Insight DPYD assay achieves IVDR accreditation
Yourgene Health, an international molecular diagnostics company with a broad portfolio of integrated technologies and services, has announced the commercial launch of its In Vitro Diagnostic...
Takeda Receives US FDA approval of Mimrylo (rusfertide), marking a potential shift in the treatment paradigm for polycythaemia vera
Takeda has announced US FDA approval of the New Drug Application (NDA) for Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythaemia...
uniQure announces submission of biologics license application for ifezuntirgene inilparvovec (AMT-130) in Huntington’s Disease
UniQure has applied for a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the accelerated approval of ifezuntirgene inilparvovec (AMT-130), an...
FDA approves Imaavy (nipocalimab-aahu) as first-ever treatment for warm autoimmune haemolytic anaemia (wAIHA), representing a landmark advancement for patients
The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune haemolytic anaemia (wAIHA) – a...
GSK to advance mRNA seasonal flu vaccine candidate to phase 3 following positive phase 2 data
GSK presented positive phase 2 data for its mRNA seasonal influenza (flu) vaccine candidate at the Options XIII Conference for the Control of Influenza.
GSK’s...
FDA approves Gilead’s Bixlenvo, a new once-daily single tablet option for virologically suppressed adults with HIV, including those on complex regimens
The US Food and Drug Administration (FDA) has approved Gilead Sciences’ Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily single tablet regimen (STR) for...
European Commission approves Jascayd, bringing well-tolerated, novel oral treatment for IPF and PPF to the EU
The European Commission (EC) has granted marketing authorisation for Boehringer Ingelheim’s Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and...
AstraZeneca completes global license agreement for oral EGFR inhibitor Zegfrovy for lung cancer
AstraZeneca has started an exclusive licencing agreement with Dizal Pharmaceutical for Zegfrovy (sunvozertinib), an oral irreversible epidermal growth factor receptor (EGFR) inhibitor for patients with lung...
Enhertu plus pertuzumab approved in the EU as first new regimen in more than a decade for the 1st-line treatment of patients with HER2-positive...
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the European Union (EU) for the first-line treatment of adult patients...
Abbott receives FDA authorisation for world’s first dual glucose-ketone sensing technology for people with diabetes
The US Food and Drug Administration (FDA) has granted authorisation to Abbott’s Libre Duo 10 Day system, said to be the world's first dual...
Kali Therapeutics Receives US FDA Clearance for KT501 Investigational New Drug Application
The US Food and Drug Administration (FDA) has cleared Kali Therapeutics, a clinical-stage biotechnology company pioneering next-generation immune-resetting and multi-specific therapies, Investigational New Drug...
Thryv Therapeutics licences a new class of SGK1 inhibitors from Spain’s CSIC and Universidad Autónoma de Madrid, extending its platform into neurodegenerative disease
Thryv Therapeutics has entered into an exclusive, worldwide, royalty-bearing patent and know-how license agreement with the Spanish National Research Council (Consejo Superior de Investigaciones...
Lubrizol targets drug delivery challenges at CPHI Milan
Lubrizol will showcase its portfolio of multifunctional excipients at CPHI Milan (6-8 October), and demonstrate how they solve diverse drug delivery challenges.
Visitors to stand...
Clinical Trials Insights
Anixa Biosciences announces first case of stable disease for three months in ovarian cancer CAR-T clinical trial
Anixa Biosciences, a biotechnology company focused on the treatment and prevention of cancer, has announced that a patient in its ongoing phase 1, dose-escalating,...
Vial doses first patient with asthma in phase 1b study of Vial’s IL-13 x TSLP, a bispecific antibody designed for twice-yearly dosing
Vial, a clinical-stage biotechnology company, has dosed the first patient in its phase 1b clinical study of Vial's IL-13 x TSLP in patients with mild-to-moderate...
Lundbeck presents phase 1b data for Lu AF28996 in advanced Parkinson’s disease, as phase 2 trial begins
H Lundbeck has announced results from an open-label phase 1b trial evaluating Lu AF28996, a novel, investigational, oral prodrug of D1-like/D2-like dopamine receptor agonist,...
AbbVie and Genmab announce epcoritamab in combination with R-CHOP demonstrates significant improvement in progression-free survival versus R-CHOP in patients with newly diagnosed diffuse large...
AbbVie has announced positive topline results from the phase 3 trial evaluating fixed treatment duration epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in combination with...
New partnership expands UK trial access for potential world-first vaccine against killer infection
Jane Lyons is the first person dosed in this study
Thousands of older people across the UK stand to benefit from a groundbreaking clinical trial of...
VIDEOS
Pharma in Healthcare
Abbott receives FDA approval for new CardioMEMS HF system capabilities that help patients engage in the care of their heart condition
The US Food and Drug Administration (FDA) has approved for Abbott’s updates to the CardioMEMS HF System that enable new patient-facing capabilities through the...
American Regent issues voluntary nationwide recall of three lots of epinephrine injection, due to the presence of particulate matter and lack of assurance of...
American Regent is conducting a nationwide voluntary recall of three lots of epinephrine injection, USP 30 mg/30 mL (1 mg/mL) multi dose vials to the...
Roche expands cyclospora testing portfolio to support US public health response
As a cyclospora outbreak continues to spread throughout the United States, Roche, in collaboration with subsidiary TIB MOLBIOL, has made available two new flexible and...
Sanofi’s MenQuadfi approved in the EU for use in infants from age six weeks against invasive meningococcal disease
The European Commission (EC) has approved an extension of the indication for Sanofi’s MenQuadfi (meningococcal Group A, C, W and Y conjugate vaccine) to...
Nipro Corporation receives FDA 510(k) clearance for Elisio-HX, introducing HDs to the United States
Nipro Corporation has been granted 510(k) clearance for the Elisio-HX dialyser by the United States Food and Drug Administration (FDA).
The clearance enables the introduction...
Technology and Automation
Abbott receives FDA approval for new CardioMEMS HF system capabilities that help patients engage in the care of their heart condition
The US Food and Drug Administration (FDA) has approved for Abbott’s updates to the CardioMEMS HF System that enable new patient-facing capabilities through the...
Hovione to commission world’s first ConsiGma CDC flex, bringing next-generation continuous tableting to the US
Hovione, a globally integrated pharmaceutical contract development and manufacturing organisation (CDMO), will commission the world's first ConsiGma CDC flex – a next generation continuous...
Brainomix and Endeavor present positive results from quantitative image analysis of phase2a idiopathic pulmonary fibrosis (IPF) trial
Brainomix, a leading medtech company specialising in AI-powered imaging tools for lung disease and stroke; and Endeavor BioMedicines, a clinical-stage biotechnology company, presented positive...
Bio-Rad launches PTC Harmony 96 and PTC Harmony Deepwell thermal cyclers
Bio-Rad Laboratories has launched the PTC Harmony Thermal Cycler line, designed to offer broader access to optimised workflows for PCR applications such as sequencing,...
PCI Pharma Services announces US$1 billion expansion of US sterile fill-finish and drug-device delivery combination capabilities
PCI Pharma Services, a world-leading integrated global contract development and manufacturing organisation (CDMO) focused on innovative biologic and small molecule therapies, has announced a...
Drug delivery and supply chain
Dr Oregonin completes US FDA registration for Oltis Dental-X, unveiling oral-care innovation rooted in trans-Pacific alder research
Dr Oregonin Inc has completed US Food and Drug Administration (FDA) registration for OLTIS DENTAL-X, paving the way for its official commercial entry into...
Esteve CDMO expands US capacity with additional $17.5 million investment in Morton Grove
Esteve CDMO, a global pure-play CDMO specialising in the development and manufacture of small-molecule APIs and pharmaceutical intermediates, is to spend $17.5 million on...
Hovione to commission world’s first ConsiGma CDC flex, bringing next-generation continuous tableting to the US
Hovione, a globally integrated pharmaceutical contract development and manufacturing organisation (CDMO), will commission the world's first ConsiGma CDC flex – a next generation continuous...
West to highlight industry leadership in packaging and containment at CPHI worldwide
West Pharmaceutical Services, a global leader in innovative solutions for injectable drug administration, will highlight its leadership and expertise in addressing industry challenges at...
Yourgene Health Insight DPYD assay achieves IVDR accreditation
Yourgene Health, an international molecular diagnostics company with a broad portfolio of integrated technologies and services, has announced the commercial launch of its In Vitro Diagnostic...
Conferences and events
Thermo Fisher Scientific showcases new solutions and expanded capabilities to accelerate drug development at CPHI Milan 2026
Thermo Fisher Scientific, a world leader in serving science, is expanding its drug development, manufacturing and clinical capabilities to help pharmaceutical and biotechnology companies...
CPHI Milan 2026: The Must-Attend Event for Pharma Professionals
Fiera Milano, Italy
October 6-8, 2026 in Milan, Italy.
Pharma Press Global and Drug Discovery and Development are proud to support CPHI Milan 2026, the pharmaceutical...
World Health Expo (WHX) in Dubai 2027
25–28 January 2027 at the Dubai Exhibition Centre, Expo City and Dubai World Trade Centre.
World Health Expo (WHX) 2027 is a leading B2B healthcare...
2026 PharmSci 360 launches two innovator-curated tracks, developed by leading scientific experts
AAPS has launched two innovator-curated tracks at the 2026 PharmSci 360.
These tracks address the current state of scientific research integrity and disruptive technologies in...
LSX Investival Showcase London
16 November, London, UK
LSX Investival Showcase London brings together biotech innovators, medtech pioneers, healthcare investors and corporate strategics fromacross Europe and beyond, creating a...
Finance, mergers and appointments
Consano Bio raises more than US $15 million in oversubscribed financing to advance C-1101 in chronic painful lumbosacral radiculopathy (chronic sciatica)
Consano Bio, a clinical-stage biotechnology company advancing novel therapeutics designed to address serious, painful orthopaedic conditions, has completed an oversubscribed financing, raising more than its...
CellCarta establishes strategic partnership with Waters to advance companion diagnostics development
CellCarta, a leading global CRO laboratory to the biopharmaceutical industry, today announced a strategic partnership with Waters Corporation, a global leader in life sciences...
Ontario contributes $1.7 million investment to advance life sciences innovation at Piramal Pharma’s Aurora facility
Piramal Pharma Solutions (PPS), a leading global contract development and manufacturing organisation (CDMO) has announced that its Aurora, Canada drug substance site has received a...
Evotec announces Chief Scientific Officer transition
Chief Scientific Officer of Evotec SE, Dr Cord Dohrmann, will step down effective 30 September.
The decision for Dr Dohrmann to step down from his...
Alcami strengthens commercial operations with appointment of Will Isom as Vice President of laboratory services sales
Alcami, a leading contract development and manufacturing organisation (CDMO), has appointed biologics industry veteran Will Isom as Vice President of Laboratory Services Sales.
The creation...
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