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THE GOOD
Approvals & Labels

Alnylam's Amvuttra (targeting TTR mRNA) approved by FDA for transthyretin amyloidosis with cardiomyopathy, expanding label
Transthyretin amyloidosis/Transthyretin amyloid cardiomyopathy (ATTR-CM), siRNA - Read more

BrePco Biopharma and Piramal announce MHRA approval for Neoatricon, a pediatric-strength dopamine hydrochloride solution for neonatal and pediatric intensive care units
Small molecule, hypotension - Read more

AcuCort receives unlimited marketing authorization for Zeqmelit in Norway, previously granted time-limited approval in 2022.b
Small molecule, allergic reaction, nausea associated with chemotherapy - Read more

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THE GOOD
Business Development

Sanofi to pay up to $1.9B for Dren Bio's DR-0201 (targeting CD20, phagocytic receptors) for autoimmune disease treatment
Bispecific antibody, autoimmune disease - Read more

Alvotech acquires Xbrane's Swedish R&D operations and biosimilar candidate XB003 for approximately $27M
Facility sale, research center, research & development, biosimilar, monoclonal antibody fragment, Rheuma­toid arthri­tis, axial spondyloarthritis, psoriasis, psoriatic arthritis - Read more

THE GOOD
Clinical Trials

Monte Rosa's MRT-6160 (targeting VAV1), partnered with Novartis, shows 90% VAV1 degradation in Ph1 trial for immune-mediated diseases
Small molecule, inflammatory disease, molecular glue degrader, protein degrader - Read more

Kintor Pharmaceutical's KX-826 (topical androgen receptor (AR) antagonist) tincture meets Ph3 endpoint for hair loss, showing significant increases in hair count and width
Small molecule, hair loss, topical - Read more

THE GOOD
Fundraises

SV Health Investors $250M Dementia Discovery Fund, developing first-in-class therapeutics for dementia
Venture capital, dementia, biotech investing, life science investment - Read more

Akebia Therapeutics $50M public offering (with potential for $7.5M more), developing kidney disease treatments
Small molecule, chronic kidney disease anemia, chronic kidney disease - Read more

Wheeler Bio $35M Series A-1, biopharma CDMO expanding partner base, team, and capabilities to accelerate therapies
CDMO (Contract Development & Manufacturing Organization), biologics manufacturing - Read more

Brainomix £14M ($17.5M) Series C, AI imaging for stroke and lung fibrosis, expanding to US with recent FDA clearances
Fibrosis-driven disease, imaging, AI, medical device, software - Read more

9Bio Therapeutics and TransBIOTech received $450,000 ARD grant to develop next-generation oncology therapeutics
Cancer, drug development, antibody-drug conjugate (ADC) - Read more

Olio Labs $4.5M funding, AI-powered therapeutic design platform moving beyond traditional drug discovery methods
Drug discovery, drug design, AI - Read more

THE GOOD
Investments

Delpharm receives $42M from Canada to upgrade former Sandoz plant in Quebec that produces essential sterile injectables
CDMO (Contract Development & Manufacturing Organization), facility expansion, sterile manufacturing, injectables manufacturing - Read more

THE GOOD
IPOs

Visen Pharmaceuticals, Ascendis Pharma's China partner for endocrine treatments, raises $86M in Hong Kong IPO
Hormone, peptide, pediatric growth hormone deficiency, achondroplasia, hypoparathyroidism - Read more

THE GOOD
Mergers & Acquisition

Paratek acquires OptiNose for up to $330M, expanding beyond antibiotics to include Xhance, a treatment for chronic rhinosinusitis
Small molecule, chronic rhinosinusitis, drug-device combo - Read more

HCSC completes $3.3 billion acquisition of Cigna's Medicare businesses, adding 3.6 million Medicare members while Cigna plans share buybacks
Medicare Advantage, health insurance, Centers for Medicare and Medicaid Services (CMS) - Read more

THE GOOD
Partnerships

CEPI, AstraZeneca partner to develop multi-specific VHH antibody for pandemic influenza prevention with $43.5M funding
Antibody, influenza, drug development - Read more

Nvidia, Sapio Sciences partnership integrates BioNeMo platform for AI-driven drug discovery within lab informatics workflows
Drug discovery, AI, platform technology - Read more

Nvidia, ReSync Bio, partnership integrates NVIDIA BioNeMo NIM microservices into ReSync's platform for AI-powered drug discovery
Small molecule, AI, drug discovery - Read more

Flatiron Health, NRG Oncology partnering to provide data capture technology for NCI clinical trials to accelerate research
Clinical development, clinical trial data collection - Read more

Marengo Therapeutics, University of Pennsylvania exploring T cell agonist mechanisms for cancer treatment and precision T cell depletion for autoimmune diseases
Research & Development, T cell engager, bispecific antibody, cancer - Read more

Eckert & Ziegler, AtomVie global supply agreement for Lutetium-177 to support radiopharmaceutical development and manufacturing
Radiopharm, CDMO (Contract Development & Manufacturing Organization), radiopharm manufacturing, isotope supply, cancer - Read more

THE GOOD
Politics & Policy

Seven Democratic senators demand Trump reverse CDC layoffs, saying staff cuts endanger Americans and requesting details on terminated programs
Centers for Disease Control and Prevention (CDC) - Read more

THE GOOD
Public Health

Medical organizations jointly affirm vaccine safety amid misinformation and disease outbreaks, urging public adherence to vaccination schedules
Vaccine, vaccine hesitancy - Read more

CDC reschedules delayed vaccine advisors meeting for mid-April
Centers for Disease Control and Prevention (CDC), advisory committee, vaccine - Read more [Paywall]

THE GOOD
Research

Experimental drug reduces dementia risk by removing brain amyloid plaques in people genetically predisposed to early-onset Alzheimer's
Alzheimer's disease, amyloid plaque-hypothesis - Read more

University of Chicago, Insilico Medicine, and Prelude Therapeutics identify PRMT5 inhibition as potential treatment for rare adenoid cystic carcinoma
Adenoid cystic carcinoma, cancer, AI, target discovery - Read more

University of Lausanne researchers develop regulatory T-cell therapy that reduces gluten-triggered autoimmune responses in mice with celiac disease
Regulatory T-cell (Treg), cell therapy, autoimmune disease, food allergy, celiac disease - Read more

Researchers at China Pharmaceutical University discovered mandimycin, a bacterial compound effective against drug-resistant fungi listed as priority pathogens
Small molecule, antifungal, antibiotic resistance - Read more

THE GOOD
Strategic Plans

Novo Nordisk reorganizes R&D into three therapy areas, emphasizing integration of AI while focusing on diabetes and obesity treatments
Big pharma strategy, research & development - Read more

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THE BAD
Layoffs

Elevation Oncology cuts 70% of their employees
Antibody-drug conjugate (ADC), gastric cancer, gastroesophageal junction adenocarcinoma - Read more

THE BAD
Market Reports

Drugmakers warn UK's life-sciences sector faces decline due to high government drug rebate proposals compared to European counterparts
Biotech ecosystem - Read more

THE BAD
Mergers & Acquistions

Eyenovia shares fell 14% after announcing potential merger with Betaliq, creating combined ophthalmology company with Eyenovia owning 16.3%
Glaucoma, drug delivery, small molecule - Read more

THE BAD
Partnerships

BioNTech declines acting on option to co-develop Autolus Therapeutics’ duel targeting CAR-T AUTO1/22 (targeting CD19/CD22) amid pipeline prioritization
Cell therapy, CAR-T, cancer, drug development - Read more

THE BAD
Regulatory

Akero Therapeutics says FDA's regulatory guidance for accelerated approval of MASH drugs is "bizarre" despite promising cirrhosis data
"Metabolic dysfunction-associated steatohepatitis (MASH), Non-alcoholic fatty liver disease/nonalcoholic steatohepatitis (NASH)", Accelerated Approval, Regulatory guidance - Read more [Paywall]

FDA study reveals 67% of rare disease drugs approved 2020-2023 relied on single trial plus confirmatory evidence
Drug approval process, rare disease - Read more [Paywall]

THE BAD
Strategic Plans

Century Therapeutics ends cancer trial, pivots to autoimmune diseases with CNTY-101 after data fell short of expectations
Cell therapy, allogeneic cell therapy, cancer, lymphoma, autoimmune disease, pipeline strategy, stem cell-derived therapy, CAR-iNK - Read more

Elevation Oncology discontinues EO-3021 development (targeting CLDN18.2), while pivoting to HER3-targeting ADC after trial failure
Antibody-drug conjugate (ADC), gastric cancer, gastroesophageal junction adenocarcinoma - Read more

THE UGLY
Warning Letters, Form 483

FDA warns Aspen Pharmacare about microbial contamination risks and inadequate quality controls at sterile manufacturing facility
Sterility concerns, sterile manufacturing - Read more [Paywall]

You’re all caught up on the latest Pharma & Biotech News!

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