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THE GOOD
Approvals & Labels

Bristol Myers Squibb's Opdivo (targeting PD-1) plus Yervoy (targeting CTLA-4) approved by FDA for first-line unresectable or metastatic hepatocellular carcinoma
Monoclonal antibody, combo therapy, liver cancer, hepatocellular carcinoma - Read more

Biocon Pharma receives FDA approval for Everolimus (targeting mTORC1) an organ rejection prevention drug for adult kidney and liver transplant patients
Small molecule, transplant rejection, prophylaxis - Read more

AstraZeneca's Truqap (AKT protein inhibitor) approved by NHS for hormone receptor-positive HER2-negative breast cancer with PIK3CA/AKT1/PTEN alterations
Small molecule, breast cancer - Read more

AstraZeneca's Tagrisso (targeting EGFR) receives NICE recommendation for first-line treatment of advanced non-small-cell-lung cancer alongside chemotherapy
Small molecule, lung cancer - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Amgen's Imdelltra (targeting DLL3) significantly improved survival in Ph3 trial for small-cell lung cancer versus standard chemotherapy
Bispecific T-cell engager, lung cancer - Read more

Kelun-Biotech publishes detailed data for sacituzumab tirumotecan (targeting TROP-1), Ph3 in advanced triple-negative breast cancer and Ph1/2 with advanced non-small-cell lung cancer
Antibody-drug conjugate (ADC), breast cancer, lung cancer - Read more

THE GOOD
Fundraises

Oncolytics Biotech $20M share purchase agreement, funds clinical development of pelareorep cancer immunotherapy
Oncolytic virus, cancer, solid tumor - Read more

illumicell AI raises $2M pre-seed to develop portable "lab scanner" and AI platform for rapid fluid-based diagnostics
AI, techmed, diagnostics, biomarker - Read more

Olaris (undisclosed amount) Series-B1, leverages metabolomics and machine learning for myOLARIS diagnostics with Labcorp investment
Precision medicine, metabolomics, -omics, machine learning, diagnostics - Read more

Okeiro (Predict4Health) raises €10M (approximately $10.8M), funding precision medicine platform for transplantation and chronic disease diagnostics
Precision medicine, chronic disease, AI, diagnostics, transplant rejection - Read more

Titan Pharmaceuticals $1M private placement, convertible preferred stock issued to Blue Harbour
Small molecule, chronic pruritus, drug delivery, opioid use disorder - Read more

THE GOOD
Investments

Kyowa Kirin completes $118M biologics plant in Japan for early-stage development as North Carolina facility progresses
Biologics manufacturing, biologic, specialty pharmaceuticals, new facility, drug substance manufacturing - Read more

THE GOOD
Mergers & Acquisitions

Future Pak submitted proposals to acquire Theratechnologies, offering $3.51-$4.50 per share, totalling up to $255 million
CDMO (Contract Development & Manufacturing Organization), pharmaceutical packaging, specialty pharmaceuticals, consumer health, neutraceuticals - Read more

THE GOOD
Politics & Policy

Bipartisan bill proposes new office to coordinate biotech initiatives, streamline regulations, and counter China's growing biotech dominance
Biotech ecosystem, geopolitics - Read more

THE GOOD
Research

Scientists develop STITCHR, a programmable tool using "jumping genes" linked to CRISPR to precisely insert DNA sequences
Gene-editing, CRISPR, retro­trans­posons - Read more

THE GOOD
Strategic Plans

GSK CEO Walmsley confident company can withstand potential US tariffs due to strategic supply chain restructuring after Haleon spinoff
Supply chain, big pharma strategy, tariffs - Read more

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THE BAD
Lawsuits

Vanda Pharmaceuticals sues FDA for right to promote Hetlioz (targeting MT1, MT2) off-label for jet lag disorder after FDA rejected its application for expanded use
Small molecule, jet lag disorder, regulatory approval suit - Read more

THE BAD
Mergers & Acquisition

Keensight Capital withdraws £345.8m offer to acquire British medical device manufacturer Niox Group due to economic concerns
Medical device, medtech, asthma, biomarker - Read more

THE BAD
Politics & Policy

Trump administration ends federal funding for non-medical services in Medicaid, reversing Biden-era health initiatives
Federal funding, Centers for Medicare and Medicaid Services (CMS) - Read more [Paywall]

White House directs NIH to research "regret" among transgender individuals post-transition, raising further concerns about political influence over scientific research
National Institute of Health (NIH), transgender - Read more

THE UGLY
Politics & Policy

Biotech industry warns FDA's staff reductions and hiring freeze threaten US drug development leadership, causing regulatory delays and pushing companies overseas
Public agency layoffs, Food & Drug Administration (FDA), drug approval process - Read more

Novavax shares dropped 20% after health secretary Kennedy criticized its COVID vaccine's efficacy amid FDA approval delays
Vaccine, vaccine hesitancy, COVID-19 - Read more

RFK Jr. claims single-antigen respiratory vaccines don't work, contradicting scientific consensus and puzzling experts
US Department of Health & Human Services (HHS), vaccine hesitancy - Read more [Paywall]

THE UGLY
Public Health

Measles surges in Texas due to funding cuts and vaccine hesitancy, with two child deaths and nationwide risk rising
Measles, infectious disease, infectious disease outbreak, vaccine hesitancy - Read more

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

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