Business, energy, technology, markets and global industry news from Business News Today

Pharma & Biotech

PharmaDeviceNews Pharma & Biotech
Orum’s ORM-1153 is moving toward an approximately 42-patient Phase 1 study after FDA clearance, testing whether a CD123-targeting conjugate can selectively deliver a GSPT1 protein degrader into acute myeloid leukemia cells and translate targeted protein degradation into a new precision-oncology strategy. Representative image.
Pharma & Biotech

Orum takes ORM-1153 into human testing after FDA clears first-in-human AML study

Orum plans an approximately 42-patient Phase 1 study of ORM-1153 after FDA cleared the CD123-targeting conjugate to deliver a GSPT1 protein degrader into AML cells.

Read More
FDA written feedback supports a potential accelerated-approval strategy for Oncolytics’ REO 033 using response rate and duration, but the company must first generate supportive randomized Part A data before moving toward a pivotal expansion. Representative image.
Pharma & Biotech

Oncolytics says FDA opens a possible accelerated-approval route for pelareorep in RAS-mutant colorectal cancer

FDA written feedback supports a potential pivotal expansion of REO 033 using response rate and duration as an accelerated-approval strategy, but Oncolytics must first generate supportive randomized Part A data.

Read More
AbelZeta has regained global rights to dual CD19/CD20 CAR-T therapy prizlon-cel and secured FDA IND clearance, supported by early Chinese clinical data reporting a 91.5% response rate. Representative image.
Pharma & Biotech

Prizlon-cel reaches US clinical development as AbelZeta rebuilds its large B-cell lymphoma strategy.

AbelZeta has regained global rights to dual CD19/CD20 CAR-T prizlon-cel and received FDA IND clearance, backed by early Chinese data reporting a 91.5% response rate.

Read More
FDA approval of a single-use LEROCHOL autoinjector and revised labeling gives LIB Therapeutics a clearer US commercialization pathway, with product availability planned by January 2027. Representative image.
Pharma & Biotech

LIB Therapeutics takes its $199-a-month PCSK9 strategy into an autoinjector for 2027

FDA has approved a single-use LEROCHOL autoinjector and revised the drug’s labeling, with LIB Therapeutics planning US availability by January 2027.

Read More
Alvotech can receive up to about $150 million while retaining US commercialization rights to biosimilar candidates AVT34 and AVT87, marking a strategic shift in how the company approaches the American biosimilars market. Representative image.
Pharma & Biotech

Alvotech-Lotus $150m biosimilar deal targets nearly $12 billion of Imfinzi and Hemlibra sales

Alvotech can receive up to about $150 million while retaining the right to sell AVT34 and AVT87 itself in the United States, a first for its US biosimilar strategy.

Read More
European approval of teclistamab plus daratumumab follows MajesTEC-3 results showing an 83.4% reduction in the risk of progression or death and a significant overall-survival advantage versus established multiple myeloma regimens. Representative image.
Pharma & Biotech

Johnson & Johnson wins EU approval for TECVAYLI-DARZALEX as myeloma treatment moves earlier

Europe has approved teclistamab plus daratumumab after MajesTEC-3 showed an 83.4% reduction in progression or death and a significant overall-survival advantage versus established regimens.

Read More
Sandoz has secured ex-China commercialization rights to an initial biosimilar portfolio under a collaboration worth up to $322 million, while Henlius retains responsibility for development, manufacturing and supply. Representative image.
Pharma & Biotech

Sandoz-Henlius $322m biosimilar deal starts with three blockbusters and could expand to 10 assets

Sandoz gains ex-China commercialization rights to an initial biosimilar portfolio while Henlius retains development, manufacturing and supply responsibilities under a collaboration worth up to $322 million.

Read More
Gossamer Bio’s structured financing provides $25 million upfront, another $125 million if the FDA accepts the seralutinib NDA in 2026, and potentially $100 million more following approval, tying capital deployment directly to regulatory milestones. Representative image.
Pharma & Biotech

Gossamer Bio ties $250m financing to seralutinib FDA milestones after unusual Phase 3 result

Gossamer Bio’s structured financing provides $25 million initially, another $125 million if FDA accepts the seralutinib NDA in 2026 and potentially $100 million more following approval.

Read More
Vitruvias Therapeutics is recalling one nationwide lot of 30 mg Thyroid Tablets after testing identified potential superpotency, underscoring the narrow dosing margins and safety considerations associated with thyroid hormone replacement therapy. Representative image.
Pharma & Biotech

Why Vitruvias’ thyroid tablet recall comes at a sensitive moment for animal-derived thyroid medicines

Vitruvias Therapeutics is recalling one nationwide lot of 30 mg Thyroid Tablets after testing found potential superpotency, highlighting the narrow dosing margins of thyroid hormone replacement.

Read More
FibroBiologics is expanding its intellectual property strategy for degenerative disc disease with an Australian patent acceptance covering cannabidiol as an adjuvant to fibroblast-based regenerative therapy, although clinical validation remains the critical next step. Representative image.
Pharma & Biotech

What FibroBiologics’ Australian cannabidiol patent means for its degenerative disc disease pipeline

FibroBiologics expands its disc disease IP in Australia, but clinical validation and funding remain the bigger tests for its regenerative strategy.

Read More