Intelligent Automation and Beyond: Dale Curtis Jr from Astrix in an Enlightening Conversation with PharmaShots

Shots: The biopharma industry faces several challenges, including digital transformation, regulatory compliance, and managing large volumes of data Intelligent automation plays a vital role in drug discovery, clinical trials, manufacturing, and commercialization, helping optimize operations and better meet customer needs Astrix CEO Dale Curtis Jr. discusses the role of AI and machine learning in global…

BySaurabh ChaubeyJanuary 31, 20250Comments

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New Drug Designations – December 2024

Shots: PharmaShots' designation report provides a concise overview of the latest drug designations by major regulatory authorities, including the FDA, EMA, MHLW and NMPA The December 2024 report covers designations granted to 43 drugs and 3 devices, encompassing 13 small molecules, 10 biologics, 7 cell and gene therapies & 3 medical devices among others Significant…

ByPrince GiriJanuary 31, 20250Comments

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Ethris Reports Topline Data from P-I trial of ETH47 for Uncontrollable Asthma

Shots:Ethris presented full topline data from P-I trial of ETH47 (nasal) in 40 healthy subjects as a potential treatment for uncontrollable asthma Study showed dose-dependent IFNλ production in nasal lining fluid above therapeutic levels & activated antiviral ISG mRNA expression in nasal brush samples, confirming ETH47’s pharmacodynamic activity & MoA. Based on this,…

ByDipanshu DixitJanuary 30, 20250Comments

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Siolta Therapeutics Enters into a Joint Research Agreement with Cowellnex

Shots:Siolta Therapeutics has entered into a preclinical research partnership with Cowellnex, a joint investment of Kirin and Kyowa Kirin, to develop an LBP focused on preventing necrotizing enterocolitis (NEC) The collaboration will utilize Siolta’s Precision Symbiotics Platform, enabling Cowellnex to expedite the discovery and development of innovative product aimed at preventing the occurrence…

ByDipanshu DixitJanuary 30, 20250Comments

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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…

ByDipanshu DixitJanuary 30, 20250Comments

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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…

ByDipanshu DixitJanuary 30, 20250Comments

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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…

ByDipanshu DixitJanuary 30, 20250Comments

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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…

ByDipanshu DixitJanuary 30, 20250Comments

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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).…

ByDipanshu DixitJanuary 30, 20250Comments

News

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…

BySenior EditorJanuary 29, 20250Comments

Intelligent Automation and Beyond: Dale Curtis Jr from Astrix in an Enlightening Conversation with PharmaShots

New Drug Designations – December 2024

Ethris Reports Topline Data from P-I trial of ETH47 for Uncontrollable Asthma

Siolta Therapeutics Enters into a Joint Research Agreement with Cowellnex

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

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