Astellas to Establish Joint Venture with YASKAWA for Cell Therapy Manufacturing

Shots: Astellas has entered into definitive agreement with YASKAWA to establish a joint venture for the development of a cell therapy product manufacturing platform based on previously signed MoU (May 21, 2024) In joint venture, Astellas will own 60% & YASKAWA 40% with $30.14M (¥4.5B) capital & expected to establish in Sept 2025, subject…

ByRidhi RastogiMarch 6, 2025

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Johnson & Johnson MedTech Launches Shockwave Javelin Peripheral IVL Catheter in the US

Shots: Shockwave Medical (J&J MedTech’s company) has launched Shockwave Javelin peripheral IVL catheter in the US to modify calcium & cross extremely narrowed vessels in pts with peripheral artery disease (PAD) Shockwave Javelin was studied in FORWARD PAD IDE trial that demonstrated similar safety & effectiveness compared to balloon-based Shockwave IVL catheters, regardless of…

ByRidhi RastogiMarch 6, 2025

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Jazz Pharmaceuticals to Acquire Chimerix for ~$935M

Shots: Jazz Pharmaceuticals to acquire Chimerix for ~$935M at a price of $8.55 per share in cash. Upon completion in Q2’25, Jazz will acquire remaining shares via second-step merger Acquisition will strengthen Jazz’s rare oncology presence through development & launch of Chimerix’s lead asset, dordaviprone, while adding durable revenue potential with patent protection through…

ByRidhi RastogiMarch 6, 2025

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Contineum Therapeutics Initiates Patient Dosing in P-Ib Study to Evaluate PIPE-791 in Chronic Pain

Shots: Contineum Therapeutics reported the initiation of patient dosing in exploratory P-Ib study of PIPE-791 for chronic pain associated with two separate indications, osteoarthritis (OA) and low back pain (LBP) The company expects to enroll approx. 40 pts. for a treatment duration of 28 days and anticipates topline data in early 2026 PIPE-791…

ByRidhi RastogiMarch 5, 2025

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Bioheng Therapeutics Secures the FDA Clearance of IND Application for CTD402 in T-ALL/LBL

Shots: The US FDA approved Bioheng’s IND application for CTD402 to treat pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) CTD402 will be evaluated in a P-Ib/II single-arm, open-label, dose-finding study to optimize dosing and accelerate clinical development CTD402 is a CD7-targeted universal CAR-T (UCAR-T) cell therapy that is genetically…

ByRidhi RastogiMarch 5, 2025

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Genentech Reports the FDA’s sBLA Acceptance for Gazyva to Treat Lupus Nephritis

Shots: Based on positive results from P-III (REGENCY) study, the US FDA has accepted sBLA of Gazyva in Lupus Nephritis; FDA's approval decision is expected by Oct’25 The P-III (REGENCY) study demonstrated improved CRR with Gazyva + standard therapy vs standard therapy alone, along with improvements in complement levels & reductions in anti-dsDNA, markers…

ByRidhi RastogiMarch 5, 2025

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Inspira Technologies Reports Positive Results from Clinical Study of HYLA Blood Sensor

Shots: The clinical study of AI-powered clip-on HYLA blood sensor (n=6) showed 96% accuracy vs. traditional blood test analyzers in open-heart surgery pts. The study was also used to test indicator for identifying oxygen deficiencies with 92.3% accuracy The study was conducted at Sheba Hospital, and Inspira plans to gather more patient data to…

ByRidhi RastogiMarch 5, 2025

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Celltrion Reports the US FDA approval for Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

Shots: The US FDA has approved Stoboclo & Osenvelt (CT-P41, denosumab), a biosimilar to Prolia & Xgeva for all indications of the reference products Approval is based on P-III trial results in postmenopausal women with osteoporosis, which showed equivalent efficacy & PD of CT-P41 to reference denosumab, with similar PK and comparable safety, and…

ByRidhi RastogiMarch 5, 2025

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KYORIN and Novartis Sign a $832.5M Global License Agreement for KRP-M223

Shots: KYORIN and Novartis entered into a global license agreement for KRP-M223 and its back-up compounds discovered by KYORIN As per the agreement, Novartis gets an exclusive global license to develop, manufacture, and commercialize KRP-M223, where KYORIN retains an option to commercialize and manufacture product for the Japanese market, with Novartis retaining an option to co-promote…

ByRidhi RastogiMarch 4, 2025

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The US FDA Accepts GSK’s Depemokimab Review Application for Asthma with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Shots: The FDA has accepted review application for BLA of depemokimab as an add-on maintenance therapy for inadequately controlled asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as CRSwNP (PDUFA: Dec 16, 2025), based on P-III (SWIFT & ANCHOR) trials, respectively SWIFT-1 (n=382) & SWIFT-2 (n=380) studies assessed…

ByRidhi RastogiMarch 4, 2025

Ridhi Rastogi

Astellas to Establish Joint Venture with YASKAWA for Cell Therapy Manufacturing

Johnson & Johnson MedTech Launches Shockwave Javelin Peripheral IVL Catheter in the US

Jazz Pharmaceuticals to Acquire Chimerix for ~$935M

Contineum Therapeutics Initiates Patient Dosing in P-Ib Study to Evaluate PIPE-791 in Chronic Pain

Bioheng Therapeutics Secures the FDA Clearance of IND Application for CTD402 in T-ALL/LBL

Genentech Reports the FDA’s sBLA Acceptance for Gazyva to Treat Lupus Nephritis

Inspira Technologies Reports Positive Results from Clinical Study of HYLA Blood Sensor

Celltrion Reports the US FDA approval for Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

KYORIN and Novartis Sign a $832.5M Global License Agreement for KRP-M223

The US FDA Accepts GSK’s Depemokimab Review Application for Asthma with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

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