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Drug Discovery and Development
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...
FairJourney Bio delivers antibody engineering for novel tumour-conditional IL-12 therapeutic approach that unlocks the potential of localised cytokine activation
FairJourney Bio, a global antibody discovery expert, has announced the publication of a peer-reviewed study in mAbs describing a novel approach with the potential to...
Taysha Gene Therapies and Catalent expand strategic partnership to include future commercial manufacturing support of TSHA-102 gene therapy for Rett syndrome
Taysha Gene Therapies, a clinical-stage biotechnology company focused on developing adeno-associated virus (AAV)-based gene therapies for rare, monogenic diseases of the central nervous system,...
Aurisco Pharmaceutical’s Chinese manufacturing plant gets green light from US Food and Drug Administration
Aurisco Pharmaceutical announced that its manufacturing site in Yangzhou, China, has passed a US Food and Drug Administration (USFDA) pre-approval inspection, making it the first...
Veeva Vault CRM selected by Eli Lilly and Company
Veeva Systems has announced that Eli Lilly and Company (Lilly) has committed to Veeva Vault CRM globally.
Vault CRM is part of the Vault CRM Suite of applications...
Adneuris Therapeutics grants exclusive license to Maruishi Pharmaceutical to advance Cebranopadol in Japan and South Korea
Adneuris Therapeutics has entered into an exclusive license agreement with Maruishi Pharmaceutical Co., Ltd., a privately held, perioperative and pain-focused pharmaceutical company based in...
Aureka Biotechnologies raises US$100 million to build a biological world model for drug discovery
Aureka Biotechnologies has closed financing of US$100 million.
The company will direct proceeds primarily toward research and large-scale training of its next generation of biological...
Oncoinvent announces publication of normal tissue dosimetry results in Journal of Nuclear Medicine
Oncoinvent, a biotech company developing a receptor-independent alpha radiopharmaceutical to eradicate cancer cells in the abdominal cavity after surgery with a single, targeted dose,...
US FDA approves Takeda’s Orzeyful (oveporexton), the First and Only Medicine to Treat the Underlying Cause of Narcolepsy Type 1
The US Food and Drug Administration (FDA) has approved Takeda’s Orzeyful (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy...
Lilly’s olomorasib receives US FDA breakthrough therapy designation for the treatment of previously treated KRAS G12C-mutant advanced pancreatic cancer
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Eli Lilly and Company’s olomorasib as a monotherapy for the treatment...
Mediar Therapeutics enters into a collaboration and option agreement with Ono Pharma to develop novel treatments for fibro-inflammatory diseases
Mediar Therapeutics, Inc., a clinical-stage biotechnology company pioneering first-in-class therapies to halt and reverse fibrosis, has entered into a collaboration and option agreement with...
ECOG-ACRIN and NRG oncology study demonstrates multimodal AI approach to predict late distant recurrence risk in HR+ early breast cancer
Caris Life Sciences, a leading TechBio company, has published a study in Cancer Research Communications demonstrating the ability of a multimodal, multitask deep learning model to...
EpilepsyGTx partners with ClearPoint Neuro to support targeted delivery of lead gene therapy in epilepsy
EpilepsyGTx, a biotechnology company developing cutting-edge gene therapies to treat refractory epilepsy, and ClearPoint Neuro, a global therapy-enabling company offering precise navigation and delivery...
BridgeBio announces FDA acceptance of NDA for encaleret for ADH1
BridgeBio Pharma, Inc., a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, has announced the FDA has accepted for filing its...
Eli Lilly and Company’s triple agonist, retatrutide, successful in two additional phase 3 obesity trials, delivering significant improvements in weight and A1C
Eli Lilly and Company, the maker of Zepbound (tirzepatide) and Foundayo (orforglipron), today announced positive topline results from two pivotal phase 3 trials evaluating...
European Commission authorises Pfizer and BioNTech XFG-adapted COVID-19 vaccine in the European Union
Pfizer and BioNTech SE have been granted marketing authorisation by the European Commission (EC) for the companies’ 2026-2027 COVID-19 vaccine formula, targeting the XFG...
Relation unveils Morgan, the next-generation model of cellular biology
Relation has launched MORGAN (Multi-Omic Regulatory Genomics using Artificial Neural Networks), a flagship cellular foundation model, designed to transform how new biology is understood...
Clinical trial network to advance development of ATV-1601 for hereditary haemorrhagic telangiectasia
Atavistik Bio, a clinical-stage biotechnology company developing the next generation of oral selective allosteric therapeutics for the treatment of rare haematological diseases, has announced...
Clinical Trials Insights
AbbVie announces positive topline results from the phase 3 trial showing Etentamig significantly improved response rate and progression-free survival in patients with relapsed/refractory multiple...
AbbVie has announced positive topline results from a phase 3 study evaluating etentamig, an investigational BCMA x CD3 bispecific T-cell engager, versus standard available therapies (SAT)...
African Bundibugyo ebolavirus vaccine candidate advanced to clinical trials
Leading African biopharmaceutical company Minapharm Group, headquartered in Egypt with subsidiaries in Berlin, will receive up to US$16.5 million from the Coalition for Epidemic Preparedness...
NRG Therapeutics presents data on lead clinical asset NRG5051 confirming novel disease-modifying approach to ALS
NRG, an innovative clinical stage neuroscience company targeting a novel mechanism to restore mitochondrial dysfunction in neurodegenerative diseases, today presented a poster on preclinical...
VarmX enrols first participant in global phase 3 trial evaluating VMX‑C001 in urgent surgery
VarmX, a biotech company developing innovative approaches to bypass direct oral anticoagulants targeting activated factor Xa (FXa inhibitors), enrolled the first participant in its global phase 3...
Novo Nordisk provides update on a phase 3 trial in people with ASCVD, CKD and inflammation
Novo Nordiskhas announced headline results from the cardiovascular outcomes from a phase 3 trial.
While ziltivekimab demonstrated target engagement and inhibition of the IL-6 pathway,...
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Pharma in Healthcare
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...
European Commission authorises Pfizer and BioNTech XFG-adapted COVID-19 vaccine in the European Union
Pfizer and BioNTech SE have been granted marketing authorisation by the European Commission (EC) for the companies’ 2026-2027 COVID-19 vaccine formula, targeting the XFG...
Technology and Automation
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...
Ledger Run first to bring AI-powered automation to clinical trial payments
Ledger Run, a leader in clinical trial financial management solutions, has announced significant upgrades to its ClinRun platform, including intelligent automation and expanded flexibility to accelerate...
Trelleborg strengthens quality compliance with ISO certification in Costa Rica
Trelleborg Medical Solutions’ manufacturing site in Costa Rica has earned ISO 13485:2016 certification, helping ensure product consistency and compliance.
ISO 13485:2016 is a process-focused quality framework...
Liebherr expands UK lab portfolio
Commercial refrigeration specialist Liebherr has introduced seven high performance countertop and fully integrated under bench models in their UK lab and healthcare range.
These include...
Drug delivery and supply chain
InnovHeart announces first US Saturn transseptal TMVR system implant, reaching 15 patients globally
InnovHeart, a medical device company developing the Saturn Transseptal Transcatheter Mitral Valve Replacement (TMVR) System, today announces the successful implantation of the first US...
Cipla announces exclusive partnership with Qilu Pharmaceutical for the licensing and supply of biosimilar to Keytruda (Pembrolizumab) in the US
Invagen Pharmaceuticals has entered into a strategic partnership with Qilu Pharmaceutical Co, for the exclusive licensing and supply of QL2107, a biosimilar to Keytruda (pembrolizumab), for...
ENA Respiratory awarded Biointelect Venturer funding to support new study in asthma patients of INNA-051 nasal spray designed to protect against symptomatic viral respiratory infections
ENA Respiratory, a clinical-stage pharmaceutical company developing host defence enhancers for the prevention of complications associated with respiratory viral infections in at-risk populations, has been awarded AUD...
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...
Aurora Cannabis furthers global medical cannabis growth with accretive acquisition of Internode Pharma and HAP Pharma
Aurora Cannabis, the Canadian-based leading global medical cannabis company, has acquired Internode Pharma, a licensed importer and wholesaler and HAP Pharma, a licensed pharmacy.
Strategic rationale
• The UK...
Conferences and events
NextGen Biomed 2027 conference: the next generation of biotherapeutics takes shape in London
NextGen Biomed 2027 brings together biologics, immunotherapy and vaccine specialists across four connected programmes in London, 18–19 March.
From next-generation antibodies and ADCs to...
Cell 2026 conference: the whole ecosystem assembles in London, UK
Cell 2026 brings together bioprocessing specialists, advanced therapy developers and CGT manufacturing leaders across three connected programmes in London, 12–13 November.
From cell line...
CPHI & PMEC Shenzhen 2026 attracts unprecedented international interest as demand for AI-driven innovationgrows
CPHI & PMEC Shenzhen 2026 is set to welcome its most international audience to date, reflecting growing global interest in South China's rapidly evolving pharmaceutical market...
US Pharmacopeia to host sessions at 2026 AAPS PharmSci 360
AAPS and the United States Pharmacopeia (USP) have announced a collaboration taking place at the 2026 PharmSci 360, to be held 25-28 October, in...
Sustainability, AI and resilience take centre stage at CPHI Milan 2026
This year’s CPHI conference in Europe will introduce a new sustainability summit, as well as exhibitor zones focusing on AI, contamination control and logistics.
CPHI...
Finance, mergers and appointments
Aurora Cannabis furthers global medical cannabis growth with accretive acquisition of Internode Pharma and HAP Pharma
Aurora Cannabis, the Canadian-based leading global medical cannabis company, has acquired Internode Pharma, a licensed importer and wholesaler and HAP Pharma, a licensed pharmacy.
Strategic rationale
• The UK...
Thermo Fisher Scientific completes sale of its microbiology business to Astorg
Thermo Fisher Scientific Inc., a world leader in serving science, has completed the sale of its microbiology business to Astorg, a leading pan-European private...
Adneuris Therapeutics grants exclusive license to Maruishi Pharmaceutical to advance Cebranopadol in Japan and South Korea
Adneuris Therapeutics has entered into an exclusive license agreement with Maruishi Pharmaceutical Co., Ltd., a privately held, perioperative and pain-focused pharmaceutical company based in...
Aureka Biotechnologies raises US$100 million to build a biological world model for drug discovery
Aureka Biotechnologies has closed financing of US$100 million.
The company will direct proceeds primarily toward research and large-scale training of its next generation of biological...
Schrödinger announces strategic collaboration and software agreement with Bristol Myers Squibb to deploy Bunsen, an AI co-scientist
Schrödinger, Inc. has entered a strategic agreement with Bristol Myers Squibb (BMS) to deploy Bunsen, Schrödinger's agentic AI co-scientist, within its research organisation.
Building on a...
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