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NEWS

Teva Pharmaceuticals and mAbxience Join Hands to Develop Biosimilar Candidates for Treating Oncology Indications 

Shots:  Teva Pharmaceuticals and mAbxience have signed a strategic licensing agreement across various markets incl. the EU and the US to develop a biosimilar product that is under development as a treatment for various oncology indications  As per the agreement, mAbxience will develop and produce the candidates by utilizing the knowledge of biosimilar development &…
April 4, 2024

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Insights+ Key Biosimilars Events of March 2024
INSIGHTS+

Insights+ Key Biosimilars Events of March 2024

Shots:   Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency    Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients    During March, Sandoz received the US FDA’s approval for Wyost & Jubbonti.…
April 3, 2024

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NEWS

Mabwell’s Maiweijian (Biosimilar, Denosumab; 120mg) Receives the NMPA approval for Marketing Authorization in China 

Shots:  The NMPA approved Mabwell’s Maiweijian (Biosimilar, Denosumab; 120mg), an anti-RANKL mAb, to treat unresectable giant cell tumors of the bone or resectable’s which may lead to severe functional impairment  Maiweijian vs XGEVA (original product) has shown similarity in PK, PD, clinical efficacy and safety in patients with solid tumor bone metastases  The P-I &…
April 3, 2024

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Basilea
NEWS

Basilea’s Zevtera Receives the US FDA’s Approval for Staphylococcus aureus Bloodstream Infections 

Shots:  The US FDA has approved Zevtera to treat adult patients with SAB infections such as right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSI) as well as community-acquired bacterial pneumonia (CABP) in adult & pediatric patients (3mos. to <18yrs.)   The NDA was based on efficacy & safety results from P-III trials incl.…
April 3, 2024

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NEWS

Norgine’s NPJ5008 (Dantrolene sodium hemiheptahydrate) Receives CHMP’s Positive Opinion for the Treatment of Malignant Hyperthermia 

Shots:  Norgine received a positive CHMP opinion for NPJ5008 (Dantrolene sodium hemiheptahydrate) for the treatment of Malignant Hyperthermia  With NPJ5008, dantrolene is prepared and administered quickly using novel formulation vs. Dantrolene IV (dantrolene sodium). NPJ5008 (IV) contains 120 mg of dantrolene in each vial and is reconstituted in 20 mL of water  For its final…
March 26, 2024

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MERCK
NEWS

Merck’s Winrevair (sotatercept-csrk) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension (PAH) 

Shots:  The approval was based on the results from the P-III (STELLAR) trial evaluating Winrevair (0.7mg/kg) vs PBO + stable background therapy (SC, Q3W) in patients (n=163 vs 160) with PAH. The 1EP was change from baseline at wk.24 in 6MWD  The results depicted a 41m median increase in 6MWD with Winrevair vs PBO along…
March 26, 2024

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J&J
NEWS

Johnson & Johnson’s Opsynvi (macitentan and tadalafil) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension 

Shots:   The approval was based on the results from the P-III (A DUE) clinical trial evaluating the safety & efficacy of Opsynvi vs macitentan/tadalafil monotx. in patients with PAH (WHO FC II or III). The 1EP was a change from baseline in Pulmonary Vascular Resistance (PVR) at 16wks.  The study depicted a greater reduction…
March 22, 2024

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Pfizer
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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

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Novartis
NEWS

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

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