NEWS

Scholar Rock Reports the US FDA’s BLA Submission for Apitegromab to Treat Spinal Muscular Atrophy (SMA)

Shots: The US FDA received BLA, plus a request for a priority review of apitegromab to improve motor function in pts with SMA who are on SMN-targeted therapy. The EMA’s MAA to be filed in Q1’25 The BLA was supported by the P-III (SAPPHIRE) & P-II (TOPAZ) trial, where SAPPHIRE met its 1EP of…

January 30, 2025

Vertex Receives the US FDA Approval for Journavx (Suzetrigine) to Treat Acute Pain

Shots: The FDA has approved Journavx (50mg; BID) to treat moderate-to-severe acute pain in adults JOURNAVX is an oral, non-opioid pain signal inhibitor that selectively targets NaV1.8 relative to other NaV channels The company is also testing suzetrigine for peripheral neuropathic pain (PNP), with ongoing P-III trial for diabetic neuropathy and plans for…

January 30, 2025

Amgen Receives EC’s Approval for Blincyto to Treat Philadelphia Chromosome-Negative CD19-Positive B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)

Shots: The EC has approved Blincyto monotherapy as a part of consolidation therapy to treat 1L philadelphia chromosome-negative CD19+ B-ALL adults based on P-III (E1910) trial Blincyto + CT showed improved OS with 4.5yrs. median follow up vs CT alone, whereas 5-yrs. mFU demonstrated 82.4% vs 62.5% OS in 112 pts The trial was led by…

January 30, 2025

Life Spine Receives US FDA’s 510(k) Clearance for ProLift Pivot Expandable Spacer System

Shots: The US FDA has granted 510(k) clearance to Prolift Pivot expandable spacer system, expanding Life Spine’s Micro Invasive tech portfolio The system provides full articulation for precise spinal fusion, while reducing tissue disruption & nerve retraction, allowing surgeons to restore patient alignment with superior control & efficiency. It also features OSSEO-LOC surface tech that promotes osseointegration & long-term…

January 30, 2025

Roche Reports Topline Data from P-III (INAVO120) Trial of Itovebi (Inavolisib) to Treat HR-Positive Breast Cancer

Shots: The P-III (INAVO120) trial evaluated Itovebi + Ibrance + fulvestrant vs matching PBO in PIK3CA-mutated, HR+/HER2-, endocrine-resistant, 1L LA/M breast cancer pts (n=325); ongoing regulatory review in EU & other regions Study met its 2EP of significant OS demonstrating 57% reduction in risk of disease worsening or death (mPFS: 15 vs 7.3mos.; HR=0.43).…

January 30, 2025

Pet Honesty Introduces Urinary Tract Health for Cats

Shots: Pet Honesty launched Urinary Tract Health, a supplement to promote cats' urinary health, expanding its feline wellness product portfolio Urinary Tract Health chews contain cranberry, glucosamine, & probiotics to support normal urinary function, gut health & maintain urine pH This is a dual-texture cat supplement to increase palatability in cats, plus provide…

January 29, 2025

The EMA Accepts MAA for ImmunityBio’s Anktiva to Treat BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

Shots: The EMA has accepted MAA of Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS, & with/without papillary tumors, based on an ongoing QUILT 3.032 study. Application covers 27 EU countries, plus Iceland, Norway & Liechtenstein, with submission also made to the UK's MHRA As of the data cut-off on Jul…

January 29, 2025

Lantheus Holdings to Acquire Evergreen Theragnostics for ~$1B

Shots: Lantheus will acquire Evergreen Theragnostics for $250M upfront plus ~$752.5M development & sales milestones related to Octevy & other assets in an all-cash transaction, with closing anticipated in H2’25 pending regulatory approvals The acquisition will add Evergreen’s Octevy (registrational-stage PET imaging agent for somatostatin receptor +ve NETs in adults & pediatrics) complementing Lantheus'…

January 29, 2025

Zimmer Biomet to Acquire Paragon 28 for ~$1.2B

Shots: Zimmer Biomet has agreed to acquire Paragon 28 for $13.00/share in cash with an equity value of ~$1.1B & enterprise value of ~$1.2B. Closing is expected in H1’25 As per the terms, shareholders will also get a non-tradeable CVR of $1/share on achieving revenue milestones, which is payable from $0 to $1 (calculated linearly)…

January 29, 2025

Fresenius Kabi Reports the US FDA’s 510(k) Clearance for Adaptive Nomogram, Improving Plasma Collection Efficiency

Shots: The US FDA has granted 510(k) clearance to Adaptive Nomogram algorithm in the Aurora Xi Plasmapheresis System to improve plasma collection efficiency Clearance was based on a trial of Adaptive Nomogram in Aurora Xi Software Version 2.0 vs the existing Optimized Nomogram involving >52,400 procedures that met its 1EP, depicting increased plasma volume…

January 29, 2025

NEWS

Scholar Rock Reports the US FDA’s BLA Submission for Apitegromab to Treat Spinal Muscular Atrophy (SMA)

Vertex Receives the US FDA Approval for Journavx (Suzetrigine) to Treat Acute Pain

Amgen Receives EC’s Approval for Blincyto to Treat Philadelphia Chromosome-Negative CD19-Positive B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)

Life Spine Receives US FDA’s 510(k) Clearance for ProLift Pivot Expandable Spacer System

Roche Reports Topline Data from P-III (INAVO120) Trial of Itovebi (Inavolisib) to Treat HR-Positive Breast Cancer

Pet Honesty Introduces Urinary Tract Health for Cats

The EMA Accepts MAA for ImmunityBio’s Anktiva to Treat BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

Lantheus Holdings to Acquire Evergreen Theragnostics for ~$1B

Zimmer Biomet to Acquire Paragon 28 for ~$1.2B

Fresenius Kabi Reports the US FDA’s 510(k) Clearance for Adaptive Nomogram, Improving Plasma Collection Efficiency

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