Abbvie Reports the US FDA Approval for Emblaveo to Treat Complicated Intra-Abdominal Infections (cIAI)

Shots: The US FDA has approved Emblaveo (IV) + metronidazole for pts (≥18 yrs) with few or no therapy options for cIAI caused by susceptible gram -ve bacteria, incl. E. coli, K. pneumoniae, K. oxytoca, ECC, C. freundii complex, & S. marcescens; commercially available in Q3’25 Approval was based on prior aztreonam’s efficacy & safety data…

ByRidhi RastogiFebruary 10, 2025

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Novo Nordisk Reveals Interim Data from P-III (FRONTIER3) Trial of Mim8 for Haemophilia A with or without Inhibitors

Shots: The P-III (FRONTIER3) trial assessed Mim8 (SC) in 70 pts (1-11yrs.) with hemophilia A ± FVIII inhibitors in 2 parts: P1 involves Q1W prophylaxis therapy until 26wks. after which pts can stay on Q1W or switch to QM for further 26wks.; regulatory filings expected in 2025 P1 data showed 0.53 mean & 0 median…

ByRidhi RastogiFebruary 7, 2025

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Bain Capital to Acquire Mitsubishi Tanabe Pharma for ~$3.3B

Shots: Bain Capital has signed to acquire Mitsubishi Tanabe Pharma in a carve-out deal from Mitsubishi Chemical Group at ~510 billion JPY (3.3 billion USD), is led by Bain Capital’s Private Equity teams in Asia, North America, and its Life Sciences team. The transaction is expected to close in Q3’25, pending regulatory approval, shareholder…

ByRidhi RastogiFebruary 7, 2025

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Senseonics Seeks the CE Mark Approval for Eversense 365 System

Shots: Senseonics has filed for the CE Mark Approval of its Eversense 365 CGM system. If approved, it will be distributed in the EU (Germany, Italy, Spain, Poland, Switzerland, Sweden, & Andorra) by Ascensia Diabetes Care (Senseonics' commercial partner) Eversense offers longevity (1yr. vs 10-14 days for traditional CGMs), features a removable smart transmitter…

ByRidhi RastogiFebruary 7, 2025

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Alumis Signs a Definitive Merger Agreement with ACELYRIN to Develop Novel Therapies for Immune-mediated Diseases

Shots: Alumis & ACELYRIN have entered into a definitive agreement to merge, with ACELYRIN stockholders receiving 0.4274 Alumis shares/share, owning 45% of the combined entity - "Alumis"; closing expected in Q2’25 As of Dec 31, 2024, Alumis & ACELYRIN had ~$289M & ~$448M in cash as well as investments, respectively, with a pro forma…

ByRidhi RastogiFebruary 7, 2025

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Relmada Therapeutics Acquires Sepranolone from Asarina Pharma for ~$3.12M

Shots: Relmada acquired the Sepranolone from Asarina for $3.12M via an asset purchase agreement to develop it as a potential treatment for Tourette syndrome (TS) & other compulsive disorders Sepranolone (10mg, BIW, SC) is a GABAA-modulating steroid antagonist that is being investigated in a P-IIa trial, assessing it with SoC vs SoC alone in…

ByRidhi RastogiFebruary 7, 2025

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Merck Initiates P-III (waveLINE-010) Trial of Zilovertamab Vedotin to Treat Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL)

Shots: Merck initiated P-III (waveLINE-010) trial to assess zilovertamab vedotin (ROR1- ADC) + R-CHP (Rituximab, cyclophosphamide, doxorubicin & prednisone) vs R-CHOP (R-CHP + vincristine) to treat pts with previously untreated DLBCL; global enrolment is ongoing Trial will enrol ~1,046 pts to assess PFS as the 1EP, with 2EPs incl. OS, event-free survival, duration of…

ByRidhi RastogiFebruary 7, 2025

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The US FDA Approves Supernus’ Onapgo (Apomorphine Hydrochloride) for Parkinson’s Disease

Shots: The US FDA has approved Onapgo injection (SPN-830; SC infusion device) to treat motor fluctuations in adults with advanced Parkinson’s disease; commercially available in Q2’25 Approval was based on a 12wk P-III trial assessing Onapgo (n=53) vs PBO (n=51) in Parkinson’s pts (N=107), evaluating 1EP of mean change in total daily OFF time…

ByRidhi RastogiFebruary 7, 2025

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Adicet Bio’s ADI-001 Secures the US FDA’s Fast-Track Designation for Treating Refractory SLE with Extrarenal Involvement

Shots: The US FDA has granted FTD to ADI-001 for treating adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement Adicet Bio is advancing ADI-001 in six autoimmune indications, with patient enrollment ongoing in the P-I LN study. Enrollment in SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM, or myositis), and stiff…

ByRidhi RastogiFebruary 6, 2025

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AstraZeneca Reports CHMP Positive Opinion for Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Shots: The CHMP has recommended Imfinzi for the treatment of LS-SCLC pts whose disease has not progressed after receiving Pt-based CRT; regulatory review underway in Japan & other regions Opinion was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by Imfinzi…

ByRidhi RastogiFebruary 6, 2025

Ridhi Rastogi

Abbvie Reports the US FDA Approval for Emblaveo to Treat Complicated Intra-Abdominal Infections (cIAI)

Novo Nordisk Reveals Interim Data from P-III (FRONTIER3) Trial of Mim8 for Haemophilia A with or without Inhibitors

Bain Capital to Acquire Mitsubishi Tanabe Pharma for ~$3.3B

Senseonics Seeks the CE Mark Approval for Eversense 365 System

Alumis Signs a Definitive Merger Agreement with ACELYRIN to Develop Novel Therapies for Immune-mediated Diseases

Relmada Therapeutics Acquires Sepranolone from Asarina Pharma for ~$3.12M

Merck Initiates P-III (waveLINE-010) Trial of Zilovertamab Vedotin to Treat Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL)

The US FDA Approves Supernus’ Onapgo (Apomorphine Hydrochloride) for Parkinson’s Disease

Adicet Bio’s ADI-001 Secures the US FDA’s Fast-Track Designation for Treating Refractory SLE with Extrarenal Involvement

AstraZeneca Reports CHMP Positive Opinion for Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

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