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Context Therapeutics has dosed its first patient in a Phase 1 trial for CTIM-76, targeting CLDN6-positive gynecologic and testicular cancers.
Hikma teams up with Emergent for exclusive sales of KLOXXADO® 8 mg naloxone spray, expanding opioid overdose treatment options.
Acadia submits trofinetide for EMA approval as the first Rett syndrome treatment in the EU, supported by positive Phase 3 results.
Vetter's V-OVS® next closure system offers intuitive features and enhanced safety for injectable products, launching in 2027.
Sapio Sciences launches Release 24.12, adding immunogenicity automation, GMP improvements, chemistry tools, and molecular biology updates.
Enhanc3D Genomics introduces integrated 3D Multi-Omic solutions, advancing precision in drug discovery and development.
Moffitt and Cryoport partner at Speros campus, accelerating innovation in cell and gene therapies and patient care.
Keros Therapeutics halts Phase 2 TROPOS trial for PAH due to safety concerns; topline data expected by Q2 2025.
Niktimvo™, approved by the FDA, offers a new treatment option for chronic GVHD, reducing inflammation and fibrosis.
ImmunityBio shares progress with the FDA on bladder and lung cancer therapies, offering new hope for patients with limited options.
TNF Pharmaceuticals announces safety milestone for isomyosamine, advancing trials for sarcopenia, frailty, and GLP-1-induced muscle loss.
Sanabil Investments and Redesign Health team up to boost healthcare innovation in Saudi Arabia.
Piramal Pharma reduces emissions by 24,000 tCO2e yearly with biomass boiler conversion at Digwal facility.
ImmunityBio advances ANKTIVA approval in the EU and UK for bladder cancer, with potential approvals by 2026.
FDA revokes FD&C Red No. 3 for food and drugs after studies showed cancer risks in rats, though no similar effects in humans.
NORSE EIGHT trial supports Outlook Therapeutics' plan to resubmit its wet AMD therapy BLA in 2025, showcasing safety and efficacy.
Kindeva secures $129M contract to produce DuoDote® autoinjectors, aiding U.S. emergency preparedness against chemical nerve agents.
Illuccix gains European approval, revolutionizing prostate cancer imaging with superior accuracy and care.
WHO launches a $1.5B Health Emergency Appeal to address global crises, targeting urgent needs in conflict zones and severe emergencies
IDT Biologika appoints Federico Pollano as Chief Commercial Officer, leveraging his extensive experience in the biotech and CDMO industries.
Caris and Ontada team up to advance cancer research and precision medicine with integrated data solutions.
Scilex strengthens its gout treatment portfolio with ex-US rights to Gloperba®, enhancing global patient care.
Novo Nordisk’s STEP UP trial reveals 20.7% weight loss with semaglutide 7.2 mg in adults with obesity over 72 weeks.
Cormica expands into Germany with the acquisition of Zwisler Laboratorium, enhancing its European footprint in life sciences testing.
Glenmark Life Sciences, the API maker, now operates as Alivus Life Sciences after Nirma took a majority stake. What the rename means and what stays the same.
Disc Medicine to host a call on Jan 21 at 8:00 am EST to discuss FDA updates on bitopertin for severe EPP treatment.
UK advanced therapy trials grew 7% to 187 in 2024, with Phase I trials jumping 70%, per the CGT Catapult database.
Keros Therapeutics and Takeda finalize global license agreement for elritercept, marking a significant milestone in hematologic disorder treatments.
Xilio Therapeutics announces initial Phase 2 data for vilastobart (XTX101) with atezolizumab, showcasing anti-tumor activity in MSS CRC patients.
MaaT Pharma’s PHOEBUS trial progresses with strong safety backing, advancing microbiome therapies in cancer care.
Century teams up with experts for CNTY-101 trials, advancing treatment for autoimmune diseases.
Apollo™ for CRADL® speeds up research onboarding, enhancing drug discovery through digital innovation.
ARS Pharma provides free neffy® nasal sprays to schools, enhancing allergy preparedness nationwide.
Amylyx prepares U.S. and Canadian trials for AMX0114 ALS therapy after FDA hold is lifted.
Catalyst Pharmaceuticals expands access to FIRDAPSE® in Japan, aiding LEMS patients through DyDo Pharma partnership.
Medix Biochemica acquires Germany’s CANDOR Bioscience to strengthen immunoassay solutions and support global IVD manufacturers.
Experience innovation at INTERPHEX 2025, in NYC. Join Pharma Now for expert talks, networking, and industry insights.
Cellipont Bioservices welcomes Brett Reynolds as CFO, bringing over 25 years of financial leadership experience.
AstraZeneca's C$820M investment creates 700+ jobs in Ontario, advancing life sciences and innovative medicine development.
Flagship Pioneering teams up with CUHP and MTI to drive breakthroughs in research, innovation, and biotechnology.
Veeva Systems and Zifo collaborate to integrate qcKen with Veeva LIMS, streamlining QC for biopharma with faster deployment and data workflows.
Messe München expands in India, Middle East, and Africa with Bhupinder Singh as President IMEA.
Year-two results from Roche’s EMBARK Phase III trial show Elevidys™ delivers statistically significant and clinically meaningful motor function improvements in Duchenne muscular dystrophy patients.
Pankaj R. Patel, Chairman of Zydus Lifesciences, has been awarded the Padma Bhushan for his transformative contributions to trade, industry, and healthcare in India.
The IACP Leadership Educators’ Summit 2025 in Hyderabad, supported by Pharma Now, united pharmacy educators and students to inspire innovation and excellence in the pharmaceutical sector.
FDA approves LEQEMBI® for Alzheimer’s maintenance treatment, transitioning to every four weeks.
Will Downie joins Touchlight as an adviser, driving innovation in synthetic DNA for genetic medicines.
Telix Pharmaceuticals expands U.S. operations by acquiring RLS Radiopharmacies.
Itovebi delivers significant overall survival benefits in Roche’s Phase III study for advanced breast cancer.
Study shows enobosarm helps older patients preserve muscle and improve body composition during weight loss.
Sage Therapeutics reviews strategic options after rejecting Biogen's acquisition proposal.
Merck's WELIREG sNDA for rare tumors gains FDA priority review; decision expected by May 26, 2025.
Innate Pharma launches Phase 1 trial for IPH4502, a Nectin-4-targeting ADC therapy for advanced solid tumors.
Clinigen collaborates with Tepsivo, combining expertise to enhance global Pharmacovigilance through AI-driven innovation.
The FDA accepts Alvotech and Teva’s AVT05 biosimilar for review, marking a key step in advancing treatment for inflammatory conditions.
PHARMEXCIL declares India and UAE pharmaceutical partnership, hosting the India Pavilion at Arab Health 2025 in Dubai to highlight Indian innovation and exports.
New clinical data shows cebranopadol has significantly lower intranasal abuse potential than oxycodone, reinforcing its promise in pain management.
ProductLife Group acquires Stragen Services, expanding its pharmacovigilance and clinical safety capabilities.
Lupin and Avas introduce NaMuscla® in Italy, offering the first licensed treatment for non-dystrophic myotonia.
Lupin wins FDA approval for Ipratropium Bromide Nasal Spray, a generic Atrovent® alternative for cold and allergy relief.
Argonaut and Akoya expand their partnership to produce IVD assays, advancing precision medicine with superior diagnostics.
Zentalis restructures to advance azenosertib, extending cash runway to support key trial results expected by late 2026.
Lantheus acquires Evergreen for up to $1B, strengthening radiopharmaceutical production and expanding cancer diagnostics.
Zentalis shares promising azenosertib monotherapy results in Cyclin E1+ PROC, with potential for accelerated FDA approval.
Adial Pharmaceuticals finalizes the AD04 study, confirming predictable absorption and FDA submission for AUD treatment trials.
aTyr Pharma will showcase three efzofitimod studies on pulmonary sarcoidosis at ATS 2025, sharing key trial insights.
TME Pharma teams up with Aimed Analytics to leverage AI, accelerating cancer drug research while cutting costs.
Explore cutting-edge biologics innovations, networking, and expert insights at the Biologics Workshop 2025 in Goa.
Julie Kim to succeed Christophe Weber as Takeda's CEO in June 2026, marking a new era for the pharma giant.
Cognizant earns Global Elite status in the ServiceNow Partner Program, reinforcing its leadership in AI-driven solutions.
Telix Pharmaceuticals acquires ImaginAb, adding next-generation theranostic assets, antibody technology, and a U.S. research facility to expand its oncology pipeline.
Vertex’s JOURNAVX™, a non-opioid pain reliever, gets FDA approval, offering effective, addiction-free relief for acute pain.
Cognizant And Gilead Expand Their Partnership
HOOKIPA finishes enrolling 30 participants in its Phase 1b trial for HB-500, testing safety and immunity in HIV patients.
NATCO and Breckenridge launch a generic Everolimus TFOS in the U.S., providing a cost-effective option for TSC patients.
Cognizant deepens its collaboration with Medidata, utilizing AI and expertise to streamline clinical trials and improve patient outcomes.
Experts met in Goa to explore biosimilars, gene editing, and bioprocessing innovations at Biologics Workshop 2025.
Paolo Pozzi joins Steriline as Chief Service Officer, focusing on growth, innovation, and customer satisfaction.
Roche's PATHWAY HER2 (4B5) test now identifies HER2-ultralow breast cancer patients eligible for ENHERTU® treatment, expanding its diagnostic capabilities.
Faisal G. Sukhtian is named chairman of Outlook Therapeutics’ Board, and Randy Thurman continued as lead independent director.
Lupin receives FDA approval for its generic version of Symtuza®, securing first-to-file exclusivity in the U.S. market.
Aplagon secures €7M in funding to advance its APAC therapy for thrombo-inflammatory diseases into Phase 2a clinical trials.
Sandoz announces Francisco Ballester’s retirement, with Peter Stenico succeeding him as President Region International, effective March 1, 2025.
Ocugen’s OCU400 earns EMA ATMP classification, advancing its Phase 3 trial for broad retinitis pigmentosa treatment.
PacBio appoints David Ruggiero as Global Head of Sales & Service to accelerate growth and customer engagement worldwide.
Entrada Therapeutics to begin a Phase 1/2 trial of ENTR-601-44 for Duchenne after securing MHRA authorization.
FDA supports Spur Therapeutics' Phase 3 trial of FLT201, a gene therapy for Gaucher disease, with potential for fast approval.
Serina Therapeutics closes $5M funding from JuvVentures, moving SER-252 into human trials for Parkinson’s in 2025.
uniQure's AMT-191 gene therapy for Fabry disease moves forward as the Phase I/IIa trial enters its second cohort.
Sernova seeks FDA approval to trial its Cell Pouch thyroid therapy, a potential long-term solution for hypothyroidism.
Cosette Pharmaceuticals names Brad Leonard as VP to drive generics commercial strategy and growth.
TriLink teams up with Avantor to enhance access to its nucleic acid technologies across EMEA, improving lead times.
Roche’s Susvimo gains FDA approval, providing a breakthrough treatment for diabetic macular edema with fewer injections.
Astellas Pharma is restructuring its management team, introducing new leadership roles to enhance R&D, commercialization, and compliance.
Outlook Therapeutics presents NORSE EIGHT trial data at the Virtual Investor “What This Means” segment and plans to resubmit ONS-5010 for FDA approval.
Jabil strengthens its Pharmaceutical Solutions portfolio with Pii acquisition, boosting aseptic filling and drug production capacity.
Bhavin Mehta joins Pharmexcil as Vice-Chairman, aiming to expand India’s pharmaceutical exports and MSME growth.
Astellas submits an NDA in Japan for ACP, aiming to bring the first GA treatment to patients facing progressive vision loss.
The Union Budget 2025-26 enhances India's healthcare, pharma, and medical R&D with key investments and reforms.
Eleva secures GMP production with 3PBIOVIAN, advancing Factor H (CPV-104) and expanding its moss-based expression system.
Vaxcyte's VAX-31 vaccine study progresses to Phase 2, bringing hope for preventing pneumococcal disease in infants! Data expected in 2026.
Aprea strengthens IP for ATR & WEE1 cancer therapies, securing patents till 2044, plus added exclusivity.
Amgen & Accumulus launched the first digital CMC dossier, revolutionizing global drug approvals with real-time access.
Myriad & Lumea integrate Prolaris and MyRisk tests into BxLink, cutting errors & delivering results in under 10 days.
Codexis welcomes Arthur Levin, PhD, a pioneer in RNA therapeutics, to its Strategic Advisory Board to support the expansion of its ECO Synthesis™ platform for enzymatic oligonucleotide manufacturing.
Lipella’s LP-310 gains FDA approval for expanded access, providing relief for oral lichen planus patients in need.
Tonix’s TNX-1500 demonstrates strong safety and efficacy in Phase 1, paving the way for Phase 2 kidney transplant trials.
Healthcare and pharma leaders applaud Union Budget 2025-2026; the pharma chiefs also appreciate the step towards healthcare, startups, and medical tourism.
FDA extends PDUFA date for Eton Pharmaceuticals’ ET-400 NDA, with approval expected by May 28, 2025.
BioMed X and Merck complete an oncology project on ecDNA, with findings acquired for potential cancer therapy development.
Senseonics files for CE Mark approval of Eversense 365, the only one-year continuous glucose monitor, aiming to bring long-term CGM benefits to European diabetes patients.
Alumis and ACELYRIN will merge, creating a $737M-backed immunology powerhouse with funding secured through 2027.
Pharma Now partners with PharmaTech Expo 2025, fostering pharma innovation in Bengaluru with 156 exhibitors and 4,000 attendees.
Santhera Pharmaceuticals appoints Catherine Isted as CFO, leveraging her expertise in biotech finance and corporate strategy.
Preliminary HLA data from the FLAMINGO-01 trial strengthens the outlook for GLSI-100 in breast cancer immunotherapy.
Dr. Joshua Bleharski joins IDEAYA as CFO, bringing years of biopharma finance expertise to fuel company growth.
GTx-104 reduced hypotension and improved outcomes in aSAH patients compared to oral nimodipine in Phase 3 trial.
Dr. Douglas Faller joins IMUNON as CMO to advance IMNN-001 for advanced ovarian cancer, with a Phase 3 trial set for early 2025.
Clearside unveils ODYSSEY Phase 2b results, guiding its Phase 3 trials for wet AMD treatment.
Achieve Life Sciences advances its NDA plans as the DSMC confirms strong safety data in its ORCA-OL smoking cessation trial.
Tempest’s amezalpat earns FDA Fast Track for liver cancer, showing strong survival benefits in trials.
ImmixBio’s NXC-201 earns FDA RMAT designation, accelerating development for relapsed AL amyloidosis therapy.
Dan Kirby joins Iovance as CCO, bringing decades of expertise to expand TIL therapy and Proleukin sales globally.
Medera’s CTScreen™ installed at UMC Utrecht, advancing cardiac disease modelling and drug screening with human-based tech.
Ashvattha’s subQ MGB shows promising Phase 2 data, cutting treatment burden in wet AMD & DME with strong safety results.
Palisade Bio’s PALI-2108 reduces UC symptoms in preclinical studies, showing strong potential for clinical use.
Oragenics and BRAINBox Solutions collaborate to create a breakthrough intranasal therapy and diagnostic platform for concussions.
Novartis is acquiring Anthos Therapeutics, strengthening its cardiovascular pipeline with abelacimab, a next-generation anticoagulant for stroke prevention.
PathAI and Rede D’Or collaborate to introduce AI-driven digital pathology, enhancing diagnostics and research in Brazil.
60 Degrees Pharma gains FDA approval to import KODATEF, ensuring continued malaria prophylaxis amid rising ARAKODA demand.
Bolt and Toray's collaboration targets Caprin-1, aiming to improve cancer treatments with innovative therapies.
Kiora Pharmaceuticals' KIO-104 approved for Phase 2 trial, aiming to treat retinal macular edema with fewer side effects.
Voyager shifts SOD1 ALS gene therapy focus, delaying IND filing to explore new payloads; cash runway to mid-2027.
FDA accepts Regeneron’s BLA resubmission for linvoseltamab in relapsed/refractory multiple myeloma; decision due July 2025.
Silo Pharma announces promising preclinical results for SP-26, a ketamine implant for chronic pain and fibromyalgia; final data due March.
Charles River and Deciphex deepen partnership to enhance AI tools, streamline toxicologic pathology workflows, and boost efficiency.
Experts at the 8th Annual Pharma Project & Portfolio Management 2025 explore AI, strategy, and industry innovation.
AbbVie and Xilio collaborate to develop novel tumor-activated immunotherapies, aiming for safer, more effective cancer treatments.
Genentech’s Evrysdi tablet gains FDA approval, providing a flexible and non-invasive treatment option for SMA patients.
MMS expands its expertise with the acquisition of Exploristics, enhancing biostatistics, data science, and clinical trial design.
HEJJE adds Dr. Prabhavathi R., a leading pediatrician specializing in neurodevelopmental disorders, to its expert healthcare team.
Synexa Life Sciences achieves the highest My Green Lab Certification, driving sustainability in lab operations and clinical research.
Robin Kenselaar is Orchard's new CCO, set to drive global strategy as the company advances gene therapies.
UK approves Telix’s Illuccix, a next-gen PET imaging agent that enhances prostate cancer detection and management.
NYBCe researchers identify immune pathways in Sickle Cell Disease, opening doors to innovative treatment approaches.
Theratechnologies has resumed EGRIFTA SV® distribution in the U.S. after FDA clearance, ensuring continued patient access.
Dr. Navin Saxena awarded Russia’s 'Order of Friendship' and 'Memorial Medal' for his contributions to science and Indo-Russian relations.
Lacutamab earns FDA Breakthrough Therapy status for relapsed Sézary syndrome, advancing treatment for rare T-cell lymphoma.
Dupixent gains FDA Priority Review for treating bullous pemphigoid, offering hope for patients with this severe skin condition.
Mukhtar Ahmed joins BC Platforms as CEO, bringing extensive expertise to advance real-world data innovation in life sciences.
AlgoTx’s ATX01 Phase 2 trial for neuropathic pain reports encouraging efficacy signals despite high placebo response.
Zymeworks appoints Oleg Nodelman, Founder of EcoR1 Capital, to its Board of Directors, reinforcing strategic leadership in biotech innovation.
Merck’s WELIREG receives EU approval for treating advanced RCC and VHL disease, bringing new hope to patients.
Biogen teams up with Stoke to develop zorevunersen, a potential first-in-class treatment for Dravet syndrome.
Cabaletta Bio reveals new data on rese-cel, highlighting its potential to treat autoimmune diseases without steroids.
Dr. Vivek Reddy to lead Orchestra BioMed’s BACKBEAT study, advancing AVIM therapy for patients with uncontrolled hypertension.
Opus Genetics doses first pediatric patient in its OPGx-LCA5 trial for Leber congenital amaurosis, with initial data expected by Q3 2025.
Supernus' SPN-820 misses primary and secondary endpoints in Phase 2b trial for treatment-resistant depression but remains safe.
Lexicon's study confirms sotagliflozin reduces MACE, heart attack, and stroke risk in T2D and CKD patients per SCORED trial.
Tiziana doses four more na-SPMS patients in expanded access for foralumab; 10 early patients show stability or improvement.
Queensland advances biotech, AI-driven healthcare, and clinical research partnerships with India at BioAsia 2025.
Acurx Pharmaceuticals earns a Japanese patent for DNA Polymerase IIIC inhibitors, advancing its innovative antibiotic research.
Amneal launches mesalamine tablets for ulcerative colitis and secures FDA approval for generic lenalidomide in the U.S.
ImmunityBio’s FDA-approved EAP offers a new BCG source to tackle bladder cancer drug shortages, effective in EU trials.
Adial wins a U.S. patent for genetic-based addiction treatment, enabling personalised therapy for alcohol and opioid disorders.
Milestone gains a U.S. patent for CARDAMYST’s repeat dose regimen, extending IP protection and awaiting FDA approval.
Chugai Pharmaceutical’s Tecentriq® (atezolizumab) gains Japan’s MHLW approval as the first immune checkpoint inhibitor for treating unresectable alveolar soft part sarcoma.
Terns Pharmaceuticals appoints Robert Azelby to its board, strengthening leadership in oncology and obesity research.
Elixirgen’s gene therapy EXG-34217 gains FDA Orphan Drug Designation for Telomere Biology Disorders treatment.
Roche’s SBX technology sets a new standard in high-speed, high-accuracy sequencing, transforming genomics and disease research.
Neurona advances NRTX-1001 to Phase 3, aiming to revolutionize treatment for drug-resistant epilepsy with cell therapy.
Inventiva and Hepalys launched a Phase 1 trial in Japan to assess the lanifibranor’s safety and support future MASH treatments.
Discover AI-driven drug discovery, compliance trends, and sustainability in Pharma Now’s Feb-Mar 2025 edition.
Dr. Gregory George joins Mesoblast’s Board, bringing expertise in medical innovation and commercial expansion.
Sandoz introduces Pyzchiva®, a biosimilar to Stelara®, expanding treatment access for chronic inflammatory diseases in the US.
Phase 2 trial data reveal Lusvertikimab’s efficacy in ulcerative colitis, achieving key remission and healing milestones.
Cellectis presents a breakthrough CAR T-cell strategy using IL-2 to boost solid tumor treatment at AACR-IO 2025.
Takeda’s new 2 mL pre-filled pen for TAKHZYRO® offers greater flexibility for hereditary angioedema patients in the EU.
NGM Bio’s Phase 2 trial of NGM120 aims to provide a breakthrough therapy for hyperemesis gravidarum by blocking GDF15.
Atea Pharmaceuticals appoints Arthur Kirsch to its Board, enhancing financial strategy for antiviral drug development.
BioMarin adds Timothy Walbert to its Board, leveraging his biotech leadership to advance innovative rare disease treatments.
ElevateBio’s LETI-101 achieves over 80% reduction of mutant huntingtin protein, showing promise for HD treatment.
PDS Biotech’s Versamune® HPV clears HPV16-positive tumor DNA, showing promise for HPV-related cancer treatment.
Calidi Biotherapeutics launches a new trial for CLD-101, aiming to improve treatment for high-grade glioma patients.
Kevin Springman joins Avadel Pharmaceuticals as VP of Sales to expand LUMRYZ’s reach in the sleep medicine market.
Russell Bradley joins CNSide Diagnostics as President to drive growth and market introduction for CNS cancer diagnostics.
Regeneron's DB-OTO trial shows improved hearing in children with genetic deafness, with near-normal results in some cases.
Inhibikase appoints top pharma executives, strengthening leadership in PAH research, development, and corporate strategy.
Bavarian Nordic and Biological E. partner to boost chikungunya vaccine access in LMICs through manufacturing expansion.
Oragenics’ Dr. James Kelly joins The Leigh Steinberg Foundation’s Medical Board to drive concussion research.
Andrew Gengos joins Terns Pharmaceuticals as CFO, bringing 25 years of biotech finance and strategy expertise.
ORIC Pharmaceuticals accelerates clinical plans for ORIC-944 and ORIC-114, extending its cash runway into 2027.
Celularity secures FDA TRG recommendations for Natalin and Acelagraft™, advancing its regenerative medicine portfolio.
Austria approves VAZKEPA® reimbursement, expanding access to cardiovascular care and strengthening Amarin’s European presence.
CAN-2409 trial shows long-term survival benefits for pancreatic cancer patients, offering new hope for treatment.
UZEDY’s sNDA accepted by FDA, marking a step toward long-acting treatment options for bipolar I disorder.
Telix’s TLX250-CDx for kidney cancer imaging gets FDA Priority Review, with a PDUFA date set for August 27, 2025.
Adial gains FDA support for AD04’s bridging strategy, advancing toward Phase 3 trials in 2025 for addiction therapy.
Allogene and Foresight partner to develop an MRD assay as a companion diagnostic for LBCL patients in the ALPHA3 trial.
Actuate enrolls 56 patients in its Phase 2 trial evaluating elraglusib, FOLFIRINOX, and losartan for metastatic pancreatic cancer.