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,…

March 22, 2024

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…

March 22, 2024

Novartis Reports the CHMP’s Positive Opinion for Fabhalta (iptacopan) to Treat Paroxysmal Nocturnal Hemoglobinuria (PNH)

Shots: The opinion was based on the P-III (APPLY-PNH) & (APPOINT-PNH) trials of Fabhalta (200mg, oral, BID) in PNH patients with residual anemia who switched from Anti-C5 and complement inhibitor naïve (incl. anti-C5 therapies) respectively for 24wks. In the APPLY-PNH study, 82.3% vs 2.0% had a ≥2 g/dL increase in Hb levels without transfusions while…

March 22, 2024

Pfizer’s Emblaveo (aztreonam-avibactam) Receives Positive CHMP Opinion for the Treatment of Patients with Multidrug-Resistant Infections

Shots: Pfizer’s Emblaveo has received a positive CHMP opinion for the treatment of patients with cIAI, HAP (incl. VAP), and cUTI (incl. Pyelonephritis). The MAA was supported by results from the P-III study comprising the REVISIT and ASSEMBLE studies evaluating the efficacy, safety, and tolerability of Emblaveo in treating serious bacterial infections due to Gram-negative…

March 22, 2024

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.…

March 21, 2024

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…

March 20, 2024

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…

March 19, 2024

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…

March 18, 2024

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…

March 14, 2024

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…

March 14, 2024

NEWS

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

Novartis Reports the CHMP’s Positive Opinion for Fabhalta (iptacopan) to Treat Paroxysmal Nocturnal Hemoglobinuria (PNH)

Pfizer’s Emblaveo (aztreonam-avibactam) Receives Positive CHMP Opinion for the Treatment of Patients with Multidrug-Resistant Infections

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

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