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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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