NEWS

Bayer Submits MAA of Finerenone to Japan’s MHLW for Heart Failure (HF)

Shots: Japan’s MHLW received MAA of finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Regulatory review is ongoing in the US, EU & China, with global filings planned Application was backed by P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n>15000)…

February 14, 2025

Pfizer Reports Data from P-III (TALAPRO-2) Trial of Talzenna + Xtandi for Metastatic Castration Resistant Prostate Cancer (mCRPC)

Shots: The P-III (TALAPRO-2) trial assessed Talzenna + Xtandi vs PBO + Xtandi in mCRPC ± HRRm pts for >4yr. (mFU: 52.5mos.) that were randomized into 2 Arms (A1: no genetic selection & A2: HRRm pts) A1 showed reduced death risk by 20% & mOS of 45.8 vs 37mos. while A2 depicted death risk…

February 14, 2025

CSL Behring Receives the EC Approval for Andembry as a Prophylactic Treatment of HAE

Shots: EC has approved Andembry for HAE pts (≥12yrs) in 30 EEA states (incl. Iceland, Liechtenstein & Norway) following UK’s MHRA & Australia’s TGA approval in Jan 2025. Although, regulatory review is ongoing for the US, Switzerland, Japan & Canada Approval was based on the P-III (VANGUARD) trial (Data published in The Lancet) assessing Andembry vs PBO & OLE…

February 14, 2025

Boehringer Ingelheim Launches Semintra in the EU to Treat Feline Hypertension

Shots: BI has launched Semintra (4mg/mL) in the EU for the treatment of systemic hypertension in cats Semintra has shown clinical efficacy in reducing proteinuria & blood pressure, which may help restore kidney balance while also promoting cat’s appetite, activity levels, & QoL Semintra (QD) is a telmisartan solution administered orally or on top…

February 13, 2025

Johnson & Johnson MedTech Launches Cereglide 92 Catheter System in the US for Acute Ischemic Stroke

Shots: J&J MedTech has launched the Cereglide 92 Catheter System with the Innerglide 9 delivery aid in the US to ease insertion & guidance of interventional devices in the neurovascular system Cereglide 92 features a .092” inner diameter with Innerglide 9 delivery aid, Brite-line tech for complete catheter visibility, & TruCourse for flexibility to…

February 13, 2025

Dalan Animal Health Unlocks the Potential of Innate Immunity with its Vaccine Platform

Shots: Dalan Animal Health has developed shrimp vaccine for white spot syndrome virus (WSSV) & early mortality syndrome (EMS) using its innate immunity platform, extending its validation from honeybee vaccine to aquaculture Dalan’s shrimp vaccine (administered via the broodstock) will offer non-GMO as well as non-chemical alternative to conventional vaccines & has shown 62% &…

February 13, 2025

Pfizer Reports the US FDA Approval of Adcetris Regimen to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Shots: The US FDA has approved sBLA for Adcetris + lenalidomide + Rituxan to treat adults with r/r LBCL (incl. DLBCL NOS, indolent lymphoma associated DLBCL, or HGBL), previously treated with ≥2L of therapy & are not eligible for auto-HSCT or CAR-T therapy Approval was based on P-III (ECHELON-3) trial assessing Adcetris with lenalidomide +…

February 13, 2025

Royalty Pharma Partners with Biogen to Develop Litifilimab

Shots: Royalty Pharma & Biogen have entered into an agreement for the clinical development of litifilimab in SLE & CLE As per the agreement, Biogen will receive ~$250M R&D funding over 6 quarters to support the development, whereas Royalty Pharma is entitled to receive regulatory milestones & mid-single digit royalties on global sales …

February 13, 2025

AbbVie Collaborates with Xilio Therapeutics to Develop Next-Generation Tumor-Activated Immunotherapies

Shots: AbbVie & Xilio have entered into a collaboration & option-to-license agreement to leverage Xilio's proprietary tech for developing tumor-activated Abs As per the deal, Xilio will get $52M upfront (incl. $10M equity investment), & is entitled to receive ~$2.1B in contingent payments for option-related fees, milestones, & tiered royalties Xilio’s platform develops…

February 13, 2025

Alloy Therapeutics Enters into a Multi-Year Strategic Collaboration with Pfizer to Develop New Antibody Discovery Platform

Shots: Alloy Therapeutics has entered into a strategic collaboration with Pfizer to develop a platform designed to improve Pfizer’s capability to discover potent, specific, and effective antibodies for targets that are challenging to address with current antibody discovery technologies, including the use of Alloy’s ATX-Gx platform As per the agreement, Alloy will receive an…

February 12, 2025

NEWS

Bayer Submits MAA of Finerenone to Japan’s MHLW for Heart Failure (HF)

Pfizer Reports Data from P-III (TALAPRO-2) Trial of Talzenna + Xtandi for Metastatic Castration Resistant Prostate Cancer (mCRPC)

CSL Behring Receives the EC Approval for Andembry as a Prophylactic Treatment of HAE

Boehringer Ingelheim Launches Semintra in the EU to Treat Feline Hypertension

Johnson & Johnson MedTech Launches Cereglide 92 Catheter System in the US for Acute Ischemic Stroke

Dalan Animal Health Unlocks the Potential of Innate Immunity with its Vaccine Platform

Pfizer Reports the US FDA Approval of Adcetris Regimen to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Royalty Pharma Partners with Biogen to Develop Litifilimab

AbbVie Collaborates with Xilio Therapeutics to Develop Next-Generation Tumor-Activated Immunotherapies

Alloy Therapeutics Enters into a Multi-Year Strategic Collaboration with Pfizer to Develop New Antibody Discovery Platform

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