Pharma News

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🔊 FDA Greenlights BridgeBio’s Heart Disease Drug, Attruby

🔊FDA Approves UI Health’s Breakthrough Therapy Lantidra for Brittle Type 1 Diabetes

🔊Canada Grants Approval for Nordisk's Wegovy to Reduce Non-Fatal Heart Attack Risk 

🔊Sarepta Partners with Arrowhead in $11B Deal for Rare Gene Therapy Innovations

🔊Roche Expands CAR-T Capabilities with $1.5B Poseida Acquisition

🔊Acadia Acquires Saniona's Tremor Asset in $582M Deal

🔊LifeArc and University of Cape Town Unite for Groundbreaking Drug Resistance Research

🔊Eton Pharmaceuticals Obtains Exclusive American Rights to Amglidia from AMMTeK

🔊Argenx's SB Efgartigimod Alfa Receives Promising Innovative Medicine (PIM) Designation from MHRA for CIDP

🔊 FDA Grants First-in-Class Approval to Syndax’s Leukemia Drug Revuforj

🔊 FDA Approves Azurity’s Reformulated Therapy Danziten for Chronic Myeloid Leukemia

🔊 FDA Clears PTC Therapeutics' Gene Therapy Kebilidi for AADC Deficiency Treatment

🔊 Jazz Pharmaceuticals’ Ziihera Wins FDA Nod for Biliary Tract Cancer

🔊 UCB Achieves FDA Approval for Bimzelx to Treat Moderate to Severe Hidradenitis Suppurativa

🔊 Samsung Bioepis Secures European Approval for Opuviz an Eylea Biosimilar for Ophthalmic Treatment

🔊 MHRA Approves Travere’s Sparsentan for Adult Patients Diagnosed with Primary IgAN

🔊 Junshi Biosciences' Toripalimab Cleared for Marketing in the UK by MHRA

🔊 Kura Partners with Kyowa Kirin in Leukemia Drug Ziftomenib Deal for $1.16B

🔊 Novartis Solidifies Radiopharma Dominance with Deal for $750M with Ratio Therapeutics

🔊 HCW Biologics Grants WY Biotech Licensing Rights for Immunotherapy Product Candidate 

🔊 Transposon’s Expands Portfolio with Acquisition of Innovative Nucleoside Analogs

🔊 CERo Receives FDA Approval for New Acute Myelogenous Leukemia Treatment Trial

🔊 Actuate’s Elraglusib Receives FDA Rare Pediatric Disease Status for Ewing Sarcoma

🔊 Vir Biotechnology Gets EMA's Orphan Drug Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta (CHD)

🔊 Ocugen Secures EMA Orphan Medicinal Product Designation for OCU410ST for Stargardt Disease

🔊 Nurix’s NX-5948 Receives Prime Designation from EMA for Lymphocytic Leukemia and Lymphoma

 18 November 2024  

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🔊 FDA Approves Autolus Cell Therapy Aucatzyl Targeting Blood Cancer

🔊PTC Therapeutics' AADC Deficiency Gene Therapy Kebilidi Gets FDA Nod

🔊Biogen Profits as Eisai’s Alzheimer’s Drug Gets EU Approval

🔊Cardinal Health Announces $3.9B Deal for Two Acquisitions

🔊Merck Strikes $3.3B Oncology Collaboration with China-Based LaNova

🔊Daiichi Sankyo Partners with Korea-based Alteogen in $300M Deal for Subcutaneous 

Enhertu

🔊ARS Pharmaceuticals Shares Climb on $145M Deal for Nasal Epinephrine

🔊UCL Spinout Trace Neuroscience Secures $101 Million for Motor Neurone Disease 

Therapies

🔊GSK Partners with Flagship Startup Vesalius Therapeutics for Parkinson’s Drug 

Discovery

🔊AE Life Sciences Partners with Stella Pharma to Broaden BNCT Therapy Reach in the 

U.S. and Europe

🔊Tempest Gains FDA Approval to Move Forward with Phase 3 Trial of Amezalpat Combo 

Therapy 

🔊Caliway Receives EMA Orphan Drug Status for CBL-514 in Dercum’s Disease Treatment

🔊NurExone’s ExoPTEN Earns EMA Orphan Status for Spinal Cord Injury in Europe

 11 November 2024  

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🔊 FDA Grants Approval for Journey Medical's Emrosi to Treat Rosacea

🔊MHRA Grants Approval for Johnson & Johnson’s Balversa in Bladder Cancer

🔊European Union Grants First Approval for Sanofi’s Pediatric EoE Treatment Dupixent

🔊EMA Greenlights Alvotech's Application for AVT05 (biosimilar golimumab) Market 

Approval 

🔊Syndax Raises $350 Million Through Royalty Funding Deal with Royalty Pharma

🔊Novo Nordisk and Ascendis Partner in $285M Deal to Develop Monthly GLP-1RA

🔊Acadia Pharmaceuticals Sells Rare Pediatric Disease Priority Review Voucher for $150M

🔊Cumberland’s Awarded FDA Orphan Drug and Rare Pediatric Disease Designations for Ifetroban

🔊FDA Grants Rare Pediatric Designation for BPGbio’s BPM31510T for Epidermolysis Bullosa

🔊FDA Awards Orphan Drug Status to Mustang Bio’s MB-108 for Malignant Glioma

🔊CytoDyn Receives FDA Green Light for Phase II Oncology Trial

🔊Phaxiam Gets FDA Approval to Begin Phase II Gloria Study in the U.S for PJI

🔊Insignis Therapeutics Receives Favorable FDA Response for IN-001 Clinical Trial

🔊Damona Pharmaceuticals Receives FDA Green Light for DPX-101 Brain Disorder Trial

5 November 2024

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🔊 FDA Authorizes Iterum’s Oral Sulopenem to Treat uUTI

🔊Novartis Asciminib Secures FDA Accelerated Approval for Newly Diagnosed Myeloid Leukemia

🔊MHRA Approves CStone’s Sugemalimab for Adults with Non-Small Cell Lung Cancer

🔊Eli Lilly Receives Approval to Introduce Weight-Loss Drug Mounjaro in Hong Kong

🔊Novartis Enters Into $2.2B Molecular Glue Agreement with Monte Rosa

🔊AbbVie Expands Alzheimer's Research with Aliada Acquisition for $1.4B

🔊GSK Acquires Lupus Therapy from Chimagen Biosciences for Up to $850M

🔊EMA and MHRA Approves Rallybio's Trial for Rlyb212 in Expectant Mothers with FNAIT 

 28 October 2024 

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🔊 FDA Grants Approval to Astellas for New Gastric Cancer Drug Vyloy

🔊FDA Approved AbbVie’s Vyalev for Adults with Advanced Parkinson's Disease

🔊FDA Greenlights Pyridostigmine Bromide Extended-Release Tablets from Amneal Pharmaceuticals

🔊Lindis Biotech Receives Positive CHMP Opinion for Korjuny in Treating Malignant Ascites Intraperitoneally

🔊EU Grants Approval for J&J’s Darzalex with VRd in Newly Diagnosed Multiple Myeloma 

🔊Lilly's Alzheimer's Treatment Donanemab Deemed "Unaffordable" for Widespread Use Due to High Costs

🔊Merck Purchases Modifi, a Yale Spinout, Biosciences in $1.3B Deal 

🔊Roche Strikes Potential $1B Gene Therapy Deal with Dyno Targeting Neurological Disorders 

🔊With a $175 Million Series C Round, Alpha-9 Joins the Growing List of Funded Radiopharmaceutical Companies 

🔊MacroGenics Transfers Breast Cancer Drug Margenza to TerSera in $40 Million Deal 

🔊Ocuphire Pharma and Opus Genetics Combine to Focus on Inherited Retinal Diseases

🔊FDA Grants Fast Track Status to Protara's IV Choline Chloride for Parenteral Nutrition

🔊FDA Grants Orphan Drug Status to PYC's VP-001 for Retinitis Pigmentosa Type 11

🔊Nido Biosciences Receives Orphan Drug Designation for Its Lead Candidate Targeting Spinal and Bulbar Muscular Atrophy 

🔊Multi-Gene RNA Profile Improves Therapeutic Approaches for Triple-Negative Breast Cancer

 21 October 2024 

  🚀 Stay in the lead with last week's top pharmaceutical industry highlights! 📈💊 

🔊 AbbVie Secures FDA Approval for Parkinson's Treatment Vyalev

🔊 FDA Greenlights Pfizer's Hympavzi for Treating Hemophilia A and B

🔊 FDA Advisory Panel Endorses Stealth's Elamipretide for Barth Syndrome

🔊 Approval Granted to Merck and Astellas/Pfizer’s Bladder Cancer Combination by MHRA

🔊 Ionis’s Eplontersen Receives MHRA Approval for Treating Adults with Polyneuropathy

🔊 MHRA Approves AstraZeneca's Wainzua for Treatment of Rare Nerve Disease ATTRv-PN

🔊 Lundbeck Strengthens Epilepsy Portfolio with $2.6B Acquisition of Longboard Pharmaceuticals Amidst Rising Competition

🔊 Pfizer Enters Molecular Glue Arena with $49M Partnership with Triana Biomedicines

🔊 Sanofi Secures $326 Million Radiopharma Partnership with Orano

🔊 Viatris Secures Global Rights (Excluding U.S. and Europe) to Lexicon's Inpefa for $25M

🔊 Annovis Bio Advances Alzheimer’s Treatment with FDA Approval for Pivotal Phase 3 Studies

🔊 FDA Awards Fast Track Status to Lantern’s LP-184 for the Treatment of Glioblastoma 

🔊 Immuneering IMM-1-104 Receives Orphan Drug Designation from FDA 

🔊 Rare Pediatric Disease Status Granted by the FDA for Sellas’s GPS in acute myeloid leukemia (AML)

🔊 FDA Designates Mirum’s Volixibat as Breakthrough Therapy for Cholestatic Pruritus in PBC

🔊 Theriva Receives Orphan Drug Designation from EMA for VCN-01

🔊 Astria’s Navenibart Receives Orphan Medicinal Product Designation from European Commission

 14 October 2024 

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🔊 Genentech’s Itovebi Receives FDA Green Light for Breast Cancer Therapy

🔊Dong-A ST's Imuldosa Biosimilar for Stelara Secures FDA Approval

🔊Ipsen’s Iqirvo Becomes the First Drug Authorized by MHRA for Rare Liver Condition PCB

🔊AviadoBio Ltd signs a $2.2 billion gene therapy agreement with Astellas Pharma

🔊AstraZeneca Signs $2B Deal to License CSPC's Cardiovascular Drug

🔊MSD Expands into Fibroblast Therapies with $1.9B Partnership with Mestag

🔊Sanofi Sells Rare Autoimmune Treatment to Recordati in Up to $1B Agreement

🔊Ono Collaborates with LigaChem in a $700M Biobuck Deal for a Preclinical ADC

🔊Lilly Partners with Insitro to Create AI-driven siRNA Therapies for Metabolic Disorders

🔊Editas Sells a Segment of Its Licensing Rights for Vertex’s CRISPR Therapy for $57M

🔊FDA Awards Breakthrough Therapy Status to Boehringer's Survodutide for MASH

🔊FDA Grants Breakthrough Status to Biogen’s Kidney-Transplant Drug Felzartamab