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- Biotech & Pharma Updates | April 13 - 14, 2025
Biotech & Pharma Updates | April 13 - 14, 2025
Pfizer discontinues oral obesity drug program after “review[ing]...the totality of information“, Roche's Columvi lands EC approval in lymphoma, AbbVie and Sandoz settle patent lawsuit over Rinvoq (targeting JAK), Third Harmonic Bio plans to dissolve by Q3 2025, US Commerce Secretary Lutnick confirms pharmaceutical tariffs are coming + 26 more stories
All the top Biotech & Pharma news in one daily newsletter.
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✅ The Good News ✅
THE GOOD
Approvals & Labels
EC approves Roche's Columvi (targeting CD20xCD3) for second-line diffuse large B-cell lymphoma
Bispecific antibody, lymphoma, cancer - Read more
Valneva's IXCHIQ, a single-dose chikungunya virus vaccine, receives first approval in endemic Brazil for adults 18+, enabling Ph4 trials
Vaccine, chikungunya virus - Read more
THE GOOD
Clinical Trials
Verve Therapeutics' VERVE-102 (targeting PCSK9 gene) shows 53% LDL cholesterol reduction in Ph1b for heterozygous familial hypercholesterolemia
Gene-editing, base-editing, heterozygous familial hypercholesterolemia - Read more
J&J MedTech completes first U.S. clinical cases of Ottava surgical robot, pursuing FDA clearance for multiple procedures
Medical device, surgical robotics - Read more
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✅ More Good News ✅
THE GOOD
Fundraises
AdvanCell $18M AUD ($12M USD) government grant, developing radiopharmaceutical targeted alpha therapy for prostate cancer
Radiopharm, prostate cancer, alpha therapy - Read more
Clinomic €23M ($25M) Series B, German medical tech startup expanding internationally with Mona platform for intensive care workflows
AI - Read more
HAON Life Sciences $13M DTIF grant, developing cell therapy for early brain injury via CanVas-001 platform
Cell therapy, allogeneic cell therapy, traumatic brain injury, hypoxic ischemic encephalopathy - Read more
Cue Biopharma $20M public offering, developing biologics for selective T cell modulation to treat cancer and autoimmune diseases
Fusion protein, head & neck cancer, autoimmune disease, inflammatory disease -Read more
Habitual $1.3M funding, UK healthcare company providing weight loss solutions with GLP-1 medication
Obesity, consumer health, direct-to-consumer, GLP-1 - Read more
THE GOOD
Lawsuits
AbbVie and Sandoz settle patent lawsuit over Rinvoq (targeting JAK), with Sandoz acknowledging patent validity and infringement
Small molecule, axial spondyloarthritis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, atopic dermatitis, ulcerative colitis, Crohn's disease, patent suit - Read more
THE GOOD
Mergers & Acquisitions
BayPine to acquire CenExel, a clinical trial site network specializing in complex therapeutic areas, with Webster retaining minority stake
CRO (Contract Research Organization), clinical trial sites, clinical trial enrolment - Read more
THE GOOD
Partnerships
PRISM BioLab, Elix, partnership combining peptide mimetic technology with AI platform to accelerate drug discovery for protein-protein interactions
Small molecule, drug discovery, AI - Read more
INmune Bio, Cell and Gene Therapy Catapult, partnership to scale CORDStrom manufacturing for treating RDEB and preparing commercial launch
CDMO (Contract Development & Manufacturing Organization), cell therapy, cell therapy manufacturing, dystrophic epidermolysis bullosa, allogeneic cell therapy - Read more
Reveal Genomics, Ona Therapeutics, partnering on genomic analysis for ONA-255 antibody-drug conjugate targeting resistant tumors
Antibody-drug conjugate (ADC), cancer, solid tumor, clinical development, biomarker - Read more
Obatala Sciences, Ainnocence partner to combine AI drug discovery with human testing models to replace animal testing and accelerate development
Drug discovery, AI, non-animal models, organoid, stem cell models - Read more
Boehringer Ingelheim, Cue Biopharma partnering to develop CUE-501 B cell depletion therapy for autoimmune and inflammatory diseases
Fusion protein, autoimmune disease, inflammatory disease - Read more
THE GOOD
Patient Access
NHS partners with Scancell to provide melanoma patients access to needle-free cancer vaccine trial that boosts immune response
Cancer vaccine, drug access, bowel cancer, melanoma - Read more
THE GOOD
Politics & Policy
FDA union preparing negotiations with HHS over potential reinstatement of some laid-off employees after 2,453 received notices
Food & Drug Administration (FDA), US Department of Health & Human Services (HHS), public agency layoffs - Read more [Paywall]
THE GOOD
Regulatory
CDC vaccine advisors meet Tuesday to discuss immunization schedule after two-month delay amid scrutiny from RJK JR.’s HHS
Centers for Disease Control and Prevention (CDC), vaccine, vaccine hesitancy, influenza, respiratory syncytial virus (RSV), meningitis, COVID-19, chikungunya virus, meningococcal disease - Read more
UK launches new clinical trial regulations with one-year rollout to reduce bureaucracy and accelerate study approvals
Drug approval process, clinical trial-focused, Medicines and Healthcare products Regulatory Agency (MHRA) - Read more
❌ The Bad News ❌
THE BAD
Approvals & Labels
Ironwood Pharmaceuticals’ stock plunged after FDA required additional Ph3 trial for apraglutide, a GLP-2 analogue treating short bowel syndrome with intestinal failure
Peptide, short bowel syndrome with intestinal failure - Read more
THE BAD
Clinical Trials
Bristol Myers Squibb's Camzyos (cardiac myosin inhibitor) fails Ph3 trial for non-obstructive hypertrophic cardiomyopathy
Small molecule, hypertrophic cardiomyopathy - Read more
Bridge Biotherapeutics' BBT-877 (autotaxin inhibitor) flops in Ph2 trial for treating idiopathic pulmonary fibrosis
Small molecule, idiopathic pulmonary fibrosis - Read more
THE BAD
Company Shutdown
Third Harmonic Bio plans to dissolve by Q3 2025, sell assets, and return cash to shareholders after stopping clinical study due to liver toxicities
Small molecule, chronic inducible urticaria - Read more
THE BAD
Lawsuits
Sandoz sues Amgen for allegedly extending Enbrel (targeting TNF) market exclusivity, preventing Sandoz's biosimilar Erelzi from reaching US patients
Small molecule, biosimilar, biosimilar suit, anticompetitive, rheumatoid arthritis, arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis - Read more
THE BAD
Research
Transplanted pig kidney removed after 130 days due to rejection, patient now back on dialysis.
Gene-edited organs, kidney transplant - Read more [Paywall]
THE BAD
Strategic Plans
Pfizer discontinues obesity drug danuglipron (targeting GLP-1), despite promising efficacy in trials, after “review[ing]…the totality of information“ and after one patient experienced potential drug-induced liver injury
GLP-1, small molecule, obesity, pipeline strategy - Read more
👹 The Ugly News 👹
THE UGLY
Patient Access
Novo Nordisk warns of counterfeit Ozempic as FDA investigates seized units amid high demand
GLP-1, obesity, counterfeit drugs - Read more
THE UGLY
Politics & Policy
US Commerce Secretary Lutnick confirms pharmaceutical tariffs coming soon as Trump administration targets drug imports to encourage domestic manufacturing
Tariffs, drug pricing, biotech ecosystem - Read more
CDC's closure of the main viral hepatitis lab threatens US ability to combat 4 million hepatitis cases
Centers for Disease Control and Prevention (CDC), hepatitis - Read more [Paywall]
You’re all caught up on the latest Pharma & Biotech News!

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