Unten finden Sie die vollständige Liste unserer Pressemitteilungen (Seite 15 von 28):
Eminence Business Media hosts the 7th Pharma Manufacturing & Automation Convention on Oct 8–9 in Hyderabad, uniting 250+ leaders to explore lean, digital, and efficient pharma manufacturing.
The 8th Neuropsychiatric Drug Development Summit gathered 150+ leaders to advance precision psychiatry, neuroplastogens, and novel therapies shaping the future of mental health treatment.
The Pharma Manufacturing & Automation Excellence Awards 2025, themed F.A.S.T., will recognize outstanding individuals and organizations driving innovation, sustainability, automation, and talent growth in pharma.
Cell & Gene Therapy International 2025 gathered global leaders, 220+ exhibitors, and top innovators in Boston to advance cell and gene therapy R&D, manufacturing, and commercialization.
Sapu Nano starts Phase 1 trial of Sapu003 to improve Everolimus absorption and breast cancer treatment outcomes.
Invivyd adds Dr. Paul B. Bolno, CEO of Wave Life Sciences, to its Board of Directors and Compensation Committee, boosting biotech leadership.
Dr. Park CDMO teams with Thermo Fisher to equip a viral vector facility, enhancing AAV production and cell therapy capabilities.
Zealand Pharma appoints Rachel James-Owens as VP of Corporate Communications & Media Relations with 20+ years of pharma experience.
Cell & Gene Therapy International 2025 gathered global leaders, 220+ exhibitors, and top innovators in Boston to advance cell and gene therapy R&D, manufacturing, and commercialization.
Novartis' new Kesimpta study data show durable efficacy, 90%+ NEDA-3 rates, and no new safety concerns in relapsing multiple sclerosis.
Chugai seeks MHLW approval for Avastin in NF2, backed by Phase II BeatNF2 trial showing hearing improvement and disease control in patients.
Acadia reports Phase 3 COMPASS PWS trial results: intranasal carbetocin showed no efficacy over placebo but maintained a safety profile in PWS patients.
The TGA has approved LEQEMBI® (lecanemab) for early Alzheimer’s in Australia, reversing a prior rejection. Eisai and Biogen will co-commercialize the therapy.
BIOPLUS-INTERPHEX KOREA 2025, running October 15–17 at COEX, Seoul, will host 12,000+ leaders with 33 sessions, keynotes by Dr. Robert Hariri & Dr. David Berry, and 550+ exhibitors driving biopharma innovation.
Concept Life Sciences opens expanded state-of-the-art drug discovery site in Chapel-en-le-Frith, uniting chemistry, ADMET, and biology with 130 scientists to accelerate life-changing therapies.
Annovis Bio strengthens leadership with Mark Guerin as CFO to support buntanetap development for neurodegenerative diseases.
Australia approves MediWound’s NexoBrid for burn care, expanding its global presence and offering non-surgical eschar removal.
Boehringer advances Numab’s T cell engager for lung and GI cancers, triggering milestone payment and preclinical development.
Nuvectis Pharma adds biotech leader Juan Sanchez, MD, to its Board of Directors to support oncology pipeline and Phase 1b program development.
LB Pharmaceuticals appoints William Kane and Rekha Hemrajani to its Board to guide LB-102 development for schizophrenia and bipolar depression.
Sethera Therapeutics appoints Drs. Jeffery Kelly and Alexander Klibanov to the SAB, joining Dr Robert Langer to guide peptide therapeutic innovation.
Vertex Pharmaceuticals reports major progress in IgAN, AMKD, and ADPKD programs, including FDA breakthrough designation and new Phase 2/3 clinical trials.
Theratechnologies has been acquired by CB Biotechnology, a Future Pak affiliate, with shareholders receiving US$3.01 per share plus CVRs worth up to US$1.19.
CNSide Diagnostics, a Plus Therapeutics subsidiary, signs UHC deal to cover CNSide® CSF tumour cell test, boosting access for over 51M Americans.
Medicus Pharma updates on FDA Type C meeting for Skinject D-MNA, highlighting 505(b)(2) regulatory pathway support, Phase 2 trial progress, and Teverelix acquisition for advanced prostate cancer.
Alan Sandler named CDO as Revolution Medicines adds new U.S. and Europe GMs to strengthen oncology development and commercial readiness.
Usman “Oz” Azam becomes Cue Biopharma CEO, while Daniel Passeri transitions to Strategic Advisor, driving development of autoimmune and T cell therapies.
J. Kevin Judice joins Revagenix board as Andrew McCandlish steps down, bringing biotech expertise to advance next-generation antibiotic development.
Andrew Bayliffe joins Quotient Therapeutics as CDO to lead somatic genomics-based drug development and advance breakthrough medicines.
Christophe Arbet-Engels joins Altimmune as CMO to lead clinical development of pemvidutide, advancing Phase 3 trials in liver and metabolic diseases.
The inaugural PCG 2025 Symposium in Mumbai gathered 400+ pharma leaders, regulators & innovators to shape India’s future in peptides & complex generics.
AbbVie begins construction of a new $195M API plant in North Chicago, expanding U.S. production capacity for neuroscience, immunology, and oncology medicines.
RAPT Therapeutics secures FDA clearance to launch Phase 2b prestIgE trial of RPT904, a novel anti-IgE antibody targeting food allergies and allergic diseases.
Enanta Pharmaceuticals’ Phase 2b trial of zelicapavir for RSV shows faster symptom resolution, reduced hospitalisation, and strong safety in high-risk adults.
Tonix Pharmaceuticals, an intranasal oxytocin therapy for Prader-Willi syndrome, is entering Phase 2 after FDA IND clearance and rare disease designations.
Novartis begins $48/share cash tender offer for Tourmaline Bio, with expiration set for October 27, 2025, subject to regulatory and shareholder conditions.
Novartis will launch a U.S. direct-to-patient platform on Nov 1, 2025, offering Cosentyx at a 55% discount to improve affordability and expand access.
Autonomix starts FDA-required GLP preclinical study at CBSET for its Sensing & RF Ablation System, targeting pancreatic cancer pain and broader applications.
Roche announces positive TSIX study results for its 6th-gen Troponin T test, improving heart attack diagnosis and triage in crowded emergency departments.
Nxera earns a $10M milestone from AbbVie after identifying new GPCR ‘hit’ molecules, marking the second achievement in their neurology R&D collaboration.
AbbVie has submitted a BLA to the FDA for Pivekimab sunirine (PVEK) in BPDCN, supported by Phase 1/2 CADENZA trial data and Breakthrough Therapy designation.
Tonix Pharmaceuticals appoints Ganesh Kamath as Head of Market Access, bringing extensive global experience in pricing, market access, and finance.
Pfizer signs historic deal with the Trump Administration to lower U.S. drug prices, offering up to 85% discounts via TrumpRx.gov while focusing on new cures.
Novartis’ Rhapsido gains FDA approval as the first oral BTKi for CSU, giving patients a new treatment option when antihistamines fail.
AbbVie launches $70M expansion at its Worcester Bioresearch Center, enhancing U.S. biologics manufacturing and creating new jobs.
FDA accepts Pharming’s sNDA for leniolisib in children 4–11 with APDS, granting Priority Review with a PDUFA target date of Jan 31, 2026.
SpectronRx’s Actinium-225 Trinitrate Master File receives Health Canada review, enabling Canadian clinical trials and simplifying access to this critical alpha-emitting isotope for targeted cancer therapies.
Hinge Bio partners with Kyorin to develop and commercialize HB2198 for autoimmune diseases in Japan, starting with systemic lupus erythematosus (SLE).
Disc Medicine submits an NDA to FDA for accelerated approval of bitopertin in patients 12+ with erythropoietic protoporphyria (EPP), requesting Priority Review.
EMA PDCO gives positive opinion for Acurx’s ibezapolstat in children with C. difficile infection.
Phase 3 HYPERION trial shows WINREVAIR significantly lowers risk of clinical worsening in newly diagnosed PAH patients on background therapy.
Pharma Now & Pharmig UK present Pharmig India 2025 in Ahmedabad (Dec 2) and Hyderabad (Dec 4), uniting 300+ QA/QC leaders, microbiologists, and regulators for actionable insights on contamination control and Annex 1 execution.
Starton Therapeutics elevates Rod Hartwig to Vice President of Research & Development/Manufacturing, succeeding retiring Chief Manufacturing Officer Andy Rensink, effective October 2025.
Nacuity Pharmaceuticals’ NPI-001 granted FDA Breakthrough Therapy Designation for retinitis pigmentosa, highlighting its potential to slow vision loss and accelerate development of new treatment options.
George Medicines grants Biolab exclusive rights to commercialize GMRx2 in Brazil — an innovative triple combination pill for hypertension designed to improve early treatment outcomes and cardiovascular care.
Roche’s Tecentriq (atezolizumab) with lurbinectedin (Zepzelca) gains FDA approval as the first combination therapy for first-line maintenance in extensive-stage small cell lung cancer, improving survival outcomes.
Cirrus Therapeutics secures $11M seed funding to develop IRAK-M-targeted ocular gene therapy, aiming to prevent and reverse vision loss in dry age-related macular degeneration.
Health Canada approves AGAMREE (vamorolone) for treating Duchenne muscular dystrophy in patients aged 4+, marking the first authorized therapy for DMD in Canada.
Dr. Claudia Süssmuth Dyckerhoff will not seek re-election to Roche’s Board of Directors at the 2026 AGM, concluding a decade of valuable contributions to the company.
Jazz Pharma’s Zepzelca + Tecentriq combo wins FDA approval as the first maintenance therapy for ES-SCLC, showing strong survival benefits in Phase 3 trial.
Corvus Pharmaceuticals appoints Novo Nordisk EVP David Moore to its Board of Directors, bringing deep expertise in pharmaceuticals, biotechnology, and immunotherapy innovation.
Perspective Therapeutics begins second cohort dosing in Phase 1/2a trial of [212Pb]PSV359, a targeted alpha radiopharmaceutical for FAP-α solid tumors.
Astria Therapeutics opens EU sites for the Phase 3 ALPHA-ORBIT trial of navenibart, a potential long-acting treatment for hereditary angioedema (HAE).
Immunotherapeutics appoints Marc Le Bozec interim CEO as Nicolas Poirier steps down; search for a permanent CEO is underway
Roche gets CE mark for AI Kidney Klinrisk Tool, offering a CKD algorithm panel for early detection and management of chronic kidney disease.
Harness Therapeutics launches MISBA® Duo platform, partnering with Ono Venture Investment to develop dual-target therapies for neurodegenerative diseases.
Trogenix secures £70M Series A to accelerate clinical development of potentially curative therapies for aggressive solid tumours using its Odysseus® platform.
Plasmagen Biosciences names Vivek V Kamath as CEO to lead growth of its plasma-derived biopharma business.
Lonza expands TheraPEAK range with new cytokines and 293-GT medium to boost cell and gene therapy manufacturing.
PL-14 limits allergen penetration, forming a nasal barrier and showing promising preclinical results for allergy prevention.
Eccogene secures FDA clearance for MOSAIC Phase 2a trial evaluating ECC4703 and ECC0509 for MASH treatment.
Phathom Pharmaceuticals appoints Sanjeev Narula as CFO to drive financial growth and strategic expansion.
FDA clears Invivyd’s IND for VYD2311, advancing its pivotal COVID-19 antibody program as a vaccine alternative.
Hervé Hoppenot joins Maze Therapeutics as Chairman, bringing 30+ years of biotech leadership to guide growth and advance kidney and metabolic disease therapies.
Qualigen Therapeutics appoints new executives and board members, enhancing governance and positioning for long-term growth.
AstraZeneca and Daiichi Sankyo’s Datroway significantly improved OS and PFS versus chemotherapy in the Phase III TROPION-Breast02 trial for TNBC.
AbbVie reports positive Phase 2 ELATE trial results for BOTOX® in upper limb essential tremor, meeting primary and secondary endpoints.
Marker Therapeutics treats first patient in its off-the-shelf MAR-T cell program, reporting encouraging safety results from the Phase 1 RAPID trial.
Merck launches three Phase 2b trials for tulisokibart (MK-7240) in hidradenitis suppurativa, axial spondyloarthritis, and rheumatoid arthritis.
EMA accepts Alvotech and Advanz Pharma’s MAA for AVT23, a proposed biosimilar to Xolair® (omalizumab), advancing global access to allergy and asthma therapies.
Alembic and Amlan launch MinerTox-Z and MinerTox-A in India to protect poultry from toxins and boost farm productivity.
Theolytics names Dr. Matilde Saggese as Chief Medical Officer to lead clinical development of THEO-260 and strengthen oncolytic immunotherapy leadership.
Qualigen Therapeutics appoints new Co-CEO, CFO, and Board members to strengthen leadership, enhance oversight, and drive strategic growth.
CervoMed names Matthew Winton, Ph.D., Chief Commercial & Business Officer to lead late-stage development and commercialization of neflamapimod for DLB.
Jade Biosciences launches JADE201, a half-life extended anti-BAFF-R antibody designed to deliver lasting efficacy in treating autoimmune disorders.
Relmada Therapeutics appoints Dr. Max Kates to its Clinical Advisory Board to support the development of NDV-01 for urologic oncology patients.
Bioxodes names industry leader Philippe Monteyne as Chairman to guide late-stage development of its breakthrough stroke therapy, BIOX-101.
Eli Lilly’s Omvoh (mirikizumab) becomes the first IL-23p19 inhibitor to sustain long-term remission through four years in ulcerative colitis patients.
Oragenics collaborates with Receptor.AI to utilize AI-driven receptor modeling, aiming to expand its brain-targeted therapeutics portfolio for neurological conditions.
Merck completes the $10 billion acquisition of Verona Pharma, gaining Ohtuvayre COPD therapy, to expand its cardiovascular and pulmonary pipeline.
Baxdrostat’s Phase III trial shows significant 24-hour systolic BP reduction in treatment-resistant hypertension with a consistent safety profile.
Hyderabad hosts analytica Lab India & Pharma Pro&Pack Expo 2025, uniting 650+ exhibitors and 32,000+ visitors in innovation.
Libtayo is now the first immunotherapy approved to prevent recurrence in high-risk CSCC after surgery and radiation.
Santhera partners with Biomedica to launch AGAMREE for Duchenne muscular dystrophy in Russia, expanding access for patients from Q1 2026.
Tessera Therapeutics receives $41.3M from ARPA-H to advance next-gen in vivo CAR-T therapies using Gene Writing and LNP delivery platforms.
Biomerica adds former LabCorp CEO Gary Huff to its board to drive growth, innovation, and expansion in advanced diagnostic solutions.
Ascendis Pharma seeks EMA approval for TransCon CNP to treat children with achondroplasia, backed by pivotal clinical data.
Children’s Hospital Colorado becomes newest center for ZEVASKYN gene therapy, providing FDA-approved treatment for RDEB patients of all ages.
FDA approves protocol amendment for Aardvark’s Phase 3 HERO trial, lowering age to 10 to evaluate ARD-101 in more patients with Prader-Willi Syndrome.
Charles River and Toxys announce collaboration to integrate ReproTracker®, an assay for developmental toxicity assessment in drug and chemical testing.
Astria Therapeutics launches Phase 3 ORBIT-EXPANSE trial of navenibart for hereditary angioedema, featuring flexible Q3M and Q6M dosing to enhance patient care.
Werewolf Therapeutics earns FDA Fast Track Designation for WTX-124, an IL-2 INDUKINE therapy for advanced or metastatic cutaneous melanoma post-immunotherapy.
Rigel starts Phase 1b dose expansion for R289, its IRAK1/4 dual inhibitor, in relapsed or refractory lower-risk MDS after completing dose escalation.
Thermo Fisher unveils MMDx Lung, a machine learning–based test that enhances biopsy accuracy and aids early detection of lung transplant rejection.
Gelteq teams with Melbourne Health to develop a gel-based HAMSB product aimed at reducing bowel polyp growth and lowering bowel cancer risk.
Akari Therapeutics expands its IP with two USPTO filings supporting its PH1 payload and next-gen immuno-oncology ADC therapies.
TELA Bio names Dr. Betty Jo Rocchio to its Board of Directors as Lisa Colleran steps down after five years of dedicated service.
Alex Kane joins Pyxis Oncology as Senior VP of Investor Relations & Capital Markets to strengthen capital strategy and investor engagement for ADC programs.
FDA grants Breakthrough Therapy designation to Cidara’s CD388 for preventing seasonal influenza in high-risk adults and adolescents.
Dr. Mark Hyman joins ADvantage Therapeutics to support Klothea Bio’s Klotho longevity programs and advance next-generation anti-aging therapies.
Shuttle Pharmaceuticals signs letter to acquire Molecule.ai, integrating its AI-powered drug discovery platform to accelerate therapeutic development.
Autonomix earns a new U.S. patent for its feedback-driven cardiac neuromodulation system, expanding precision treatment platform across major heart conditions.
Adial Pharmaceuticals completes analytical validation of its swab genetic test with Genomind, advancing AD04 toward FDA registration for Alcohol Use Disorder.
Acurx Pharmaceuticals earns Australian patent for DNA Polymerase IIIC inhibitors, expanding its global antibiotic IP protecting next-gen Gram-positive therapies.
Novo Nordisk will acquire Akero Therapeutics in a $4.7B deal, strengthening its metabolic disease pipeline with Phase 3 MASH candidate efruxifermin (EFX).
Kodo Life Sciences’ Dr. Ravish Patel shares leadership insights, Gen Z lessons, and the mindset behind pharma innovation.
Teva and Medincell’s UZEDY® (risperidone) wins FDA approval as a once-monthly injectable for maintaining treatment in adults with bipolar I disorder.
Bristol Myers Squibb to acquire Orbital Therapeutics for $1.5B, gaining an AI-driven RNA platform and an in vivo CAR T-cell therapy candidate, OTX-201.
Elutia adds healthcare veteran Guido J. Neels to its Board and audit committee, bringing 40+ years of leadership from Guidant, EW Healthcare, and Eli Lilly.
AstraZeneca strikes a historic deal with the Trump administration to lower U.S. drug prices, expand manufacturing, and invest $50B in American innovation.
AbbVie gains FDA approval to expand RINVOQ’s indication for adults with ulcerative colitis and Crohn’s disease, offering more treatment flexibility.
LEQEMBI IQLIK, Eisai and Biogen’s at-home Alzheimer’s treatment autoinjector, is named among TIME’s Best Inventions of 2025 in the healthcare category.
Palisade Bio gets Canadian patent for PALI-2108, a colon-targeted PDE4 inhibitor for Crohn’s disease and ulcerative colitis, valid through 2041.
Abeona’s ABO-503 for X-linked retinoschisis selected for FDA RDEA pilot, advancing rare disease endpoints and accelerating gene therapy development.
Ardelyx names Sue Hohenleitner as CFO to drive strategic financial growth, leveraging 30+ years of industry experience in finance and operations.
Soleno Therapeutics adds Mark W. Hahn to its Board to strengthen strategic leadership and support the commercial growth of VYKAT™ XR for rare diseases.
Hinge Bio’s HB2198, a first-in-class B cell-depleting therapy for SLE and Lupus Nephritis, receives FDA IND clearance to start clinical trials.
BioCryst acquires Astria Therapeutics for $700M, adding late-stage HAE drug navenibart and strengthening its rare disease treatment pipeline.
Rocket Pharmaceuticals’ BLA resubmission for KRESLADI™, a gene therapy for severe LAD-I, accepted by FDA; PDUFA date set for March 28, 2026.
Celularity’s Phase 2 trial shows PDA-002 significantly improves healing in diabetic foot ulcers with PAD, offering a safe, regenerative treatment option.
Globus Medical unveils the ANTHEM™ Elbow Fracture System, anatomically contoured plates with polyaxial locking to simplify complex elbow fracture surgeries.
SpyGlass Pharma’s BIM-IOL System demonstrates a 42% reduction in IOP and complete independence from eye drops at 24 months, offering hope for glaucoma patients.
Cabaletta Bio names Steve Gavel as Chief Commercial Officer to drive global commercialization of rese-cel and future autoimmune therapy programs.
Arthur Golden joins Turn Therapeutics’ Board to enhance governance and support strategic growth in dermatology, wound care, and infectious disease programs.
James Rawls joins LB Pharmaceuticals as SVP of Regulatory Affairs to advance LB-102 trials for schizophrenia and bipolar depression.
Candel Therapeutics raises $130M term loan to fund CAN-2409 Phase 3 trials, clinical development, and growth initiatives in prostate cancer and NSCLC.
Robert J. Dempsey appointed Interim CEO at Ashvattha to advance migaldendranib after positive Phase 2 results and FDA guidance on pivotal trials.
Kamal Adawi joins Fate Therapeutics as CFO to drive corporate strategy and support clinical development of iPSC-derived cellular therapies.
Sheikh Dr. Khalid Al Thani joins BPGbio to guide global oncology, AI-driven programs, and strategic corporate development.
FDA grants platform technology status to Krystal Biotech’s HSV-1 vector, supporting KB801 development for neurotrophic keratitis treatment.
Quercis Pharma and founder Thomas Lines are nominated for the 2025 Prix Galien USA “Best Startup” award, honoring innovation in biopharma.
Novartis’ Fabhalta® meets Phase III endpoint, showing slowed kidney function decline in adults with IgA nephropathy (IgAN).
Belite Bio’s Tinlarebant receives China NMPA priority review for Stargardt disease based on positive interim Phase 3 DRAGON trial results.
Taysha Gene Therapies regains full global rights to TSHA-102 for Rett syndrome, following Astellas agreement expiry, advancing toward pivotal REVEAL trial.
Galapagos NV appoints Fred Blakeslee as Executive VP and General Counsel to enhance its global legal and corporate strategy during its transformation.
Candel Therapeutics appoints Dr. Bali Pulendran, a leading systems immunology expert, to its Research Advisory Board to advance CAN-2409 and CAN-3110 programs.
Merck reports positive final results from its KEYNOTE-B96 trial, showing improved survival for ovarian cancer patients treated with KEYTRUDA-based therapy.
Praxis Precision Medicines announces successful Phase 3 Essential3 trial results for ulixacaltamide, showing strong efficacy and durability in essential tremor.
Thermo Fisher Scientific partners with OpenAI to integrate AI across research, clinical trials, and operations, accelerating drug development and boosting innovation.
Aligos Therapeutics announces the USAN Council has adopted “pevifoscorvir sodium” as the official generic name for its investigational HBV therapy, ALG-000184.
Genentech introduces its first Direct-to-Patient program for Xofluza, offering $50 flu treatment, home delivery, and expanded savings to improve U.S. patient access.
Disc Medicine secures FDA Commissioner’s National Priority Voucher for bitopertin, a potential new therapy for erythropoietic and X-linked protoporphyria (EPP/XLP).
AstraZeneca and Amgen’s Tezspire was approved by the FDA for CRSwNP, the first TSLP-targeting biologic for adults and adolescents with uncontrolled nasal polyps.
Novartis’ Scemblix receives a positive CHMP opinion for EU approval in all lines of Ph+ CML-CP, showing superior efficacy compared to other TKIs in trials.
Oryzon Genomics received FDA feedback on its Phase III vafidemstat BPD trial, plans to revise and resubmit protocol; other CNS programs continue as scheduled.
AstraZeneca’s Saphnelo wins CHMP backing for EU approval as a once-weekly self-injectable treatment for systemic lupus erythematosus, expanding patient access.
SystImmune and Bristol Myers Squibb’s bispecific ADC iza-bren shows promising antitumor activity and manageable safety in global Phase I NSCLC study.
AbbVie completes acquisition of Gilgamesh’s bretisilocin, a next-gen short-acting 5-HT2A agonist in Phase 2 trials for major depressive disorder.
AstraZeneca’s Imfinzi plus BCG therapy cut the risk of recurrence or death by 32% in BCG-naïve, high-risk NMIBC patients, per Phase III POTOMAC results.
Valitor appoints biotech and ophthalmic veteran Gregory D. Kunst as CEO to advance next-gen eye therapies and clinical programs.
Roche’s evERA trial shows giredestrant plus everolimus boosts PFS by 44% in ITT and 62% in ESR1-mutated ER+ advanced breast cancer.
Novartis Kisqali® shows 28% lower recurrence risk in high-risk early breast cancer in 5-year NATALEE trial.
FDA awards Achieve Life Sciences a priority voucher for cytisinicline, supporting nicotine e-cigarette and vaping cessation.
Katina Dorton joins Prelude Therapeutics’ Board, bringing 30+ years of healthcare and finance expertise to advance the precision oncology pipeline.
FDA grants Orphan Drug Designation to Kiniksa’s KPL-387 for pericarditis, supporting development of a monthly self-injection therapy; Phase 2/3 data expected H2 2026.
CHMP gives positive opinion for PYRUKYND® (mitapivat) to treat anemia in adults with alpha- or beta-thalassemia, pending EU approval.
India’s biggest life sciences pitch stage returns Nov 14 at ISB Hyderabad with $5M capital, investor access & biomanufacturing scale-up support.
Pharma leaders convened at PM&AC 2025, Hyderabad, to spotlight digital transformation, sustainability, AI, and award industry trailblazers.
PM&AE Awards 2025 recognized India’s top pharma companies and leaders for innovation, sustainability, automation, and visionary manufacturing.
Novartis to buy Avidity Biosciences for $12B, adding AOC RNA tech and late-stage neuromuscular programs to boost its neuroscience pipeline.
Kura Oncology earns $30M from Kyowa Kirin as Phase 3 KOMET-017 trials begin for ziftomenib, a menin inhibitor targeting AML treatment.
Health Canada approves LEQEMBI, the first treatment targeting Alzheimer’s cause, slowing cognitive decline in early-stage patients.
Syndax gains FDA approval for Revuforj to treat relapsed or refractory NPM1-mutated AML in adults and children, expanding its leukemia therapy reach.
Medera begins Phase 2 of the MUSIC-HFrEF trial, dosing the first patient with SRD-001 gene therapy for heart failure with reduced ejection fraction.
Clearmind Medicine appoints Mary-Elizabeth Gifford as Chief of Global Impact to lead U.S. partnerships, advocacy, and ethical advancement in psychedelic medicine.
Immatics appoints Amie Krause as Chief People Officer to lead HR strategy and drive growth as the company transitions to a commercial-stage enterprise.
Cellectar receives FDA Rare Pediatric Disease Designation for iopofosine I-131, advancing its mission to treat pediatric high-grade glioma brain cancer.
Evaxion appoints Dr. Helen Tayton-Martin as CEO to lead growth, leveraging her biotech expertise and leadership to advance AI-Immunology™-powered vaccines.
Biomea Fusion begins Phase I trial of BMF-650, its next-gen oral GLP-1 receptor agonist for obesity, after strong preclinical results showing significant weight loss.
Cocrystal Pharma secures a $500K SBIR Phase I grant from NIH/NIAID to develop an oral broad-spectrum antiviral targeting the influenza polymerase complex.
FDA expands Merck’s WINREVAIR approval to include reduced risk of death, hospitalization, and transplant in pulmonary arterial hypertension patients.
BridgeBio’s BBP-418 delivers positive Phase 3 results in limb-girdle muscular dystrophy, showing strong safety, with an FDA filing planned for 2026.
Artelo Biosciences appoints Mark Spring as Chief Financial Officer, strengthening its financial leadership, advancing its clinical pipeline and growth plans.
RAPT Therapeutics begins its Phase 2b prestIgE trial evaluating ozureprubart for IgE-mediated food allergies to assess efficacy and safety.
Amneal introduces Brekiya, the first ready-to-use DHE autoinjector for acute migraine and cluster headaches in adults, now available via specialty pharmacies.
Step Pharma names Dr. Karen L. Smith as CMO to advance CTPS1 inhibitor dencatistat in cancer and blood disorder treatment.
ORYZON names Dr. Iman Barilero as Senior Advisor for Regulatory Affairs to strengthen global strategy and support Phase III trials of vafidemstat in BPD.
AC Immune names Dr. Catherine Mummery as Chair of its Clinical Advisory Board to guide clinical strategy and advance neurodegenerative drug development.
CervoMed names David Quigley to its Board of Directors to guide growth and Phase 3 plans for neflamapimod in dementia with Lewy bodies.
Palisade Bio names Sharon Skare, PhD(c), as VP, Global Head of Clinical Operations to advance PALI-2108 and strengthen its precision therapy pipeline.
Roche’s Elecsys® Dengue Ag test earns CE mark, enabling early and accurate dengue diagnosis amid record global infections.
The EU has approved Alexion’s Koselugo for adults with NF1 and inoperable plexiform neurofibromas, backed by strong Phase III KOMET trial results.
Merck and Eisai’s WELIREG + LENVIMA combo significantly improves PFS and ORR in advanced RCC, showing promise beyond current anti-PD-1/L1 therapies.
Merck’s KEYTRUDA + WELIREG combination shows significant disease-free survival benefit in Phase 3 adjuvant RCC trial, a key milestone in kidney cancer care.
Novartis finalizes its $48-per-share acquisition of Tourmaline Bio, delisting it from Nasdaq and making it an indirect wholly owned subsidiary.
Jazz Pharmaceuticals adds Dr. Ted Love, former GBT CEO, to its Board effective Dec 1, 2025, as long-time member Kenneth O’Keefe announces retirement.
PDS Biotech requests FDA meeting for expedited approval of PDS0101 after strong VERSATILE-002 results in HPV16-positive head and neck cancer.
Avalo Therapeutics completes Phase 2 LOTUS trial enrollment for AVTX-009 in hidradenitis suppurativa; topline results expected by mid-2026.
Dewpoint Therapeutics receives FDA Orphan Drug Designation for DPTX3186, a novel condensate modulator targeting gastric cancer, with trials set for 2025.
AnaptysBio reports durable efficacy and strong safety for rosnilimab in Phase 2b rheumatoid arthritis trial at ACR 2025.