NEWS

Johnson & Johnson Reports the US FDA’s BLA Acceptance of Nipocalimab with Priority Review for Generalized Myasthenia Gravis (gMG)

Shots: The US FDA has accepted & granted priority review to the BLA of nipocalimab for treating patients with antibody positive (anti-AChR, anti-MuSK, anti-LRP4) gMG, based on P-III (Vivacity-MG3) trial. MAA in this indication has been filed with the EMA on Sep 11, 2024 The P-III study assessed safety & efficacy of nipocalimab +…

January 10, 2025

Boehringer Ingelheim Licenses Synaffix’s Technology to Boost its ADC Portfolio in Oncology

Shots: BI has entered into an agreement with Synaffix (Lonza’s company) to license the latter’s ADC technology, boosting its oncology pipeline via NBE Therapeutics (BI’s subsidiary) As per the terms, BI will access Synaffix’s platform for a specified but undisclosed number of targets, with the first target nominated & others to follow within a…

January 10, 2025

Bayer Reports Topline Data from P-III (OASIS 4) Study of Elinzanetant to Treat Vasomotor Symptoms (VMS) Associated with Breast Cancer Therapies

Shots: The P-III (OASIS 4) study assessed elinzanetant (oral, QD) vs PBO for 52wks. to treat mod. to sev. VMS caused by endocrine therapy in women (n=474) & for another 2yrs. for those with or at high risk of HR+ breast cancer The study achieved its 1EP of VMS severity reduction at 4 &…

January 10, 2025

Light Horse Therapeutics Partners with Novartis to Discover Therapies for Cancer Treatment

Shots: Light Horse has entered into a multi-target partnership with Novartis to discover & develop FIC targets for cancer treatment by using its proprietary chemical libraries & precision genetic editing platform that identifies novel functional domains in disease-critical targets As per the agreement, Light Horse is entitled to receive $25M upfront, $1B research, development…

January 10, 2025

Transcarent to Acquire Accolade for ~$621M

Shots: Transcarent to acquire Accolade with a total equity value of ~$621M, with shareholders receiving $7.03/share in cash, making Accolade private. Closing expected in Q2’25 The acquisition will yield a unified platform with Transcarent’s WayFinding (generative AI), pharmacy benefits & overall care experiences (incl. weight health, cancer & surgery care) & Accolade’s data of…

January 9, 2025

MaaT Pharma Reports Topline Data from the Pivotal P-III (ARES) Trial of MaaT013 for Acute Graft-Versus-Host Disease

Shots: The P-III (ARES) trial assesses MaaT013 as a 3L treatment of acute GI-aGvHD in patients (n=66) refractory to steroids & ruxolitinib across the EU Trial achieved its 1EP, depicting 62% GI-ORR at D28 (38% CR & 20% VGPR); 64% ORR in all evaluable organs (36% CR & 18% VGPR); 54% survival at 12mos.…

January 9, 2025

Vividion Therapeutics to Bolster its Genomic Abilities Through the Acquisition of Tavros Therapeutics

Shots: Vividion (Bayer’s subsidiary) has acquired Tavros to strengthen its genomic capabilities via Tavros’ platform. The financial terms are undisclosed The acquisition strengthens Vividion’s functional genomics expertise by adding proprietary genomic screening approaches to discover new targets & translate the known ones. Combining resources from both the companies will enable drug discovery in oncology…

January 9, 2025

AstraZeneca and RQ Biotechnology Reports the CHMP’s Positive Opinion of Kavigale (Sipavibart) to Prevent COVID-19 in Immunocompromised Individuals

Shots: The EMA’s CHMP has granted positive opinion to Kavigale for the prevention of COVID-19 in immunocompromised individuals (≥12yrs.). It was reviewed under the EMA’s accelerated pathway Kavigale consists of an antiviral human IgG1 mAb, sipavibart, as its API that offers passive protection against SARS-CoV-2 by targeting the spike protein's receptor-binding domain Sipavibart was…

January 9, 2025

ScreenPoint Medical Reports the Acquisition of Biomediq, Bolstering its Breast Cancer Risk Evaluation Capabilities

Shots: ScreenPoint has acquired Biomediq, enhancing its breast cancer risk evaluation abilities by adding Breast AI platform, Transpara, that uses Mammographic Texture Risk biomarkers to analyze 2D & 3D mammograms & predict short & long-term risk ScreenPoint has launched Transpara 2.1, with advanced features like automated breast density evaluation (BIRADS & volumetric) & temporal…

January 9, 2025

Novo Nordisk Expands its Partnership with Valo Health to Discover and Develop Novel Therapies for Cardiometabolic Diseases

Shots: Novo & Valo have expanded their partnership to discover & develop 9 more novel drugs for obesity, T2D & CV diseases, utilizing the former’s expertise in cardiometabolic diseases & Valo’s Opal computational platform plus mutual ability in human data & genetics As per the terms, Valo will get upfront, equity & near-term milestones…

January 9, 2025

NEWS

Johnson & Johnson Reports the US FDA’s BLA Acceptance of Nipocalimab with Priority Review for Generalized Myasthenia Gravis (gMG)

Boehringer Ingelheim Licenses Synaffix’s Technology to Boost its ADC Portfolio in Oncology

Bayer Reports Topline Data from P-III (OASIS 4) Study of Elinzanetant to Treat Vasomotor Symptoms (VMS) Associated with Breast Cancer Therapies

Light Horse Therapeutics Partners with Novartis to Discover Therapies for Cancer Treatment

Transcarent to Acquire Accolade for ~$621M

MaaT Pharma Reports Topline Data from the Pivotal P-III (ARES) Trial of MaaT013 for Acute Graft-Versus-Host Disease

Vividion Therapeutics to Bolster its Genomic Abilities Through the Acquisition of Tavros Therapeutics

AstraZeneca and RQ Biotechnology Reports the CHMP’s Positive Opinion of Kavigale (Sipavibart) to Prevent COVID-19 in Immunocompromised Individuals

ScreenPoint Medical Reports the Acquisition of Biomediq, Bolstering its Breast Cancer Risk Evaluation Capabilities

Novo Nordisk Expands its Partnership with Valo Health to Discover and Develop Novel Therapies for Cardiometabolic Diseases

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