UCB’s Bimzelx Receives CHMP’s Positive Opinion to Treat Moderate to Severe Hidradenitis Suppurativa

Shots: The recommendation was supported by the P-III studies (BE HEARD I and BE HEARD II) assessing the safety and efficacy of Bimzelx 1014 patients with PsA evaluating bimekizumab vs. PBO at week 16 Both trials met their 1EPs & 2EPs measured by HiSCR50 and HiSCR75 respectively at wk. 16. Clinical responses were sustained up…

ByDipanshu DixitMarch 22, 2024

NEWS

Outlook Therapeutics’ Lytena Gains the CHMP’s Positive Opinion for the Treatment of Wet AMD

Shots: Outlook’s Lytenava has received CHMP’s positive opinion to treat Wet AMD. If approved Lytenava expected to gain 10 yrs of market exclusivity in EU The opinion was supported by 3 wet AMD clinical programs (NORSE ONE, NORSE TWO & NORSE THREE) assessing ONS-5010 along with retrospective bibliographic literature Lytenava, an ophthalmic formulation of bevacizumab,…

ByDipanshu DixitMarch 22, 2024

NEWS

Italfarmaco’s Duvyzat Obtains the US FDA’s Approval to Treat Duchenne Muscular Dystrophy

Shots: The US FDA has granted approval to Italfarmaco’s Duvyzat (givinostat), histone deacetylase (HDAC) inhibitor, to treat Duchenne muscular dystrophy (DMD) patients (6yrs. or above) The approval was supported by the P-III (EPIDYS) study assessing the safety & efficacy of Duvyzat (BID) vs PBO in DMD ambulant male patients (n=179, 6yrs. or above) The trial…

ByDipanshu DixitMarch 22, 2024

NEWS

Novo Nordisk’s Awiqli Receives the CHMP’s Positive Opinion for the Treatment of Diabetes

Shots: Novo Nordisk’s Awiqli (QW basal insulin icodec) has received CHMP’s positive opinion and recommending it for the final approval which is anticipated in next ~67days/ ~2mos The opinion was supported by the six P-IIIa (ONWARDS) study assessing the safety & efficacy of Awiqli in type 1 & type 2 diabetes adults (n= >4,000) incl.…

ByDipanshu DixitMarch 21, 2024

NEWS

Idorsia’s Tryvio Receives the US FDA’s Approval for the Treatment of Hypertension

Shots: The US FDA has approved Tryvio (12.5mg, oral, QD, with/without food) in addition with antihypertensive drugs to treat hypertensive adults not controlled on other drugs The P-III (PRECISION) trial assessed the efficacy of Tryvio for hypertensive adults with SBP ≥140 mmHg receiving at least 3 antihypertensive therapies with the 1EP as change in SiSBP…

ByDipanshu DixitMarch 20, 2024

NEWS

Dr. Reddy’s Laboratories Expects the Launch of Versavo (biosimilar, bevacizumab) for the Treatment of Several Cancer Indications Across the UK

Shots: The company has developed Versavo as a biosimilar of Avastin, approved for the treatment of various cancer indications incl. metastatic colorectal cancer, advanced non-squamous NSCLC, recurrent glioblastoma, mRCC, advanced cervical cancer, ovarian cancer & metastatic breast cancer Based on the clinical evaluation, Versavo is expected to be approved and launched across the UK as…

ByDipanshu DixitMarch 19, 2024

NEWS

Bio-Thera Solutions and SteinCares Collaborate for Marketing Biosimilars Across LATAM

Shots: Bio-Thera Solutions and SteinCares have entered into a new licensing agreement for marketing two biosimilars as per which SteinCares gains exclusive distribution and marketing rights to Bio-Thera's products across Brazil and the rest of the region Under the agreement, Bio-Thera will handle the biosimilars’ development & regulatory submissions with the US FDA & the…

ByDipanshu DixitMarch 18, 2024

NEWS

Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) Receives the US FDA’s Approval to Treat NASH with Liver Fibrosis

Shots: The US FDA has granted accelerated approval to Rezdiffra for treating noncirrhotic NASH with moderate to advanced liver fibrosis (F2 to F3) supported by the P-III (MAESTRO-NASH) study assessing its safety & efficacy at 100mg & 80mg dosing vs PBO in NASH patients (n=1,759) The results after 52wks. showed improved NASH resolution (incl. a…

ByDipanshu DixitMarch 14, 2024

NEWS

The US FDA Grants Approval to BeiGene’s Tevimbra to Treat Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Shots: BeiGene’s Tevimbra has received the US FDA’s approval as a monotx. to treat unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic chemotherapy (CT) excl. PD-(L)1 inhibitor. The US availability is anticipated in H2’24 The approval was supported by the P-III (RATIONALE 302) study assessing the safety & efficacy of Tevimbra vs…

ByDipanshu DixitMarch 14, 2024

NEWS

Celltrion Submits BLA to the US FDA for CT-P39 (Biosimilar, Xolair)

Shots: Celltrion has reported BLA submission for CT-P39, biosimilar version of Xolair (omalizumab), to the US FDA for all indications as of the reference product incl. asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy (US only) & CSU The submission was supported by the data, showing comparable efficacy & safety, from P-III study…

ByDipanshu DixitMarch 10, 2024

Dipanshu Dixit

UCB’s Bimzelx Receives CHMP’s Positive Opinion to Treat Moderate to Severe Hidradenitis Suppurativa

Italfarmaco’s Duvyzat Obtains the US FDA’s Approval to Treat Duchenne Muscular Dystrophy

Novo Nordisk’s Awiqli Receives the CHMP’s Positive Opinion for the Treatment of Diabetes

Idorsia’s Tryvio Receives the US FDA’s Approval for the Treatment of Hypertension

Dr. Reddy’s Laboratories Expects the Launch of Versavo (biosimilar, bevacizumab) for the Treatment of Several Cancer Indications Across the UK

Bio-Thera Solutions and SteinCares Collaborate for Marketing Biosimilars Across LATAM

Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) Receives the US FDA’s Approval to Treat NASH with Liver Fibrosis

The US FDA Grants Approval to BeiGene’s Tevimbra to Treat Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Celltrion Submits BLA to the US FDA for CT-P39 (Biosimilar, Xolair)

Contact US

FOLLOW US