NEWS

Alvotech and Teva Pharmaceuticals Collaborate to Expand Access for Adalimumab-ryvk (Interchangeable Biosimilar, Humaira) in US

Shots: Alvotech entered into a long-term agreement with Teva Pharmaceuticals to expand access to newly US FDA-approved higher concentration Adalimumab-ryvk, an interchangeable biosimilar to Humaira in US market The partnership agreement aims to broaden access and further availability assurance of biologics for patients at affordable prices in the US and globally Following commercialization collaboration between…

April 16, 2024

Fresenius Kabi Launches Tyenne (Biosimilar, Actemra; IV) to Treat Chronic Autoimmune diseases

Shots: The company has launched Tyenne (biosimilar, Actemra) in the US, to treat chronic autoimmune diseases; got approved on Mar 05, 2024 Tyenne, an Interleukin-6 (IL-6) receptor antagonist developed by using Fresenius’ analytical & manufacturing technologies to treat several autoimmune diseases incl. rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis & systemic juvenile idiopathic…

April 15, 2024

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

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

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

Akebia’s Vafseo (Vadadustat) Tablets Gains the US FDA’s Approval to Treat Anemia Due to CKD

Shots: The US FDA has approved the company’s Vafseo (vadadustat) tablets as a treatment of anemia associated with chronic kidney disease (CKD) in adults on dialysis for at least 3mos. The company, in collaboration with CSL Vifor, will commercialize Vafseo across the US The approval was based on the safety and efficacy results from INNO2VATE…

March 27, 2024

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

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

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

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…