Bayer Reports US FDA sNDA Acceptance for Kerendia to Treat Non-Diabetic CKD

Shots: The US FDA has accepted sNDA of Kerendia (finerenone) for the treatment of adults with chronic kidney disease (CKD) without diabetes sNDA was supported by the P-III (FIND-CKD) trial assessing Kerendia (10 or 20mg) vs PBO, both on top of maximum tolerated labeled doses of a RAS-blocking therapy, in >1,500 adults with non-diabetic CKD …

ByRidhi Rastogi1 day ago

NEWS

The NMPA Accepts The United Laboratories’ Marketing Application for IDegLira Biosimilar

Shots: China’s NMPA has accepted marketing registration application for insulin degludec & liraglutide injection (IDegLira), developed by TUL’s wholly owned subsidiary Zhuhai United Bio-Pharmaceutical IDegLira is a once-daily fixed-dose combination of basal insulin degludec and the GLP-1 analogue liraglutide for type 2 diabetes, designed to provide complementary glucose-lowering effects while simplifying treatment Through complementary and…

ByRidhi RastogiSeptember 24, 2026

NEWS

Genentech Reports Topline P-II (CT-388-104) Trial Data on Enicepatide in T2D and Overweight or Obesity

Shots: Genentech has reported topline P-II (CT-388-104) trial data assessing enicepatide (CT-388; QW, SC) vs PBO in 447 adults living with type 2 diabetes and overweight or obesity for 48wks. Enicepatide met both 1EPs, with dose-dependent reductions in blood glucose & body weight at 48wks. At 24 mg, HbA1c fell 2.65% from 8.1% baseline, while…

ByRidhi RastogiSeptember 23, 2026

NEWS

Hanmi Pharm Licenses HM17321 to Genentech in ~$2.3B Deal

Shots: Hanmi Pharm has entered into an exclusive licensing agreement with Genentech for the development, manufacturing, & commercialization of HM17321, for obesity & associated conditions such as T2D & CV diseases, globally, excl. South Korea As per the deal, Hanmi will receive ~$190M upfront, with additional development, regulatory & commercial milestones representing the total deal…

ByRidhi RastogiAugust 24, 2026

INSIGHTS+

Key Biosimilars Events of July 2026

Shots: July 2026 witnessed strong momentum across the biosimilars landscape with major regulatory approvals, including Ennumo (US FDA), Garzulys (US FDA), Yesintek Autoinjector (Health Canada), and FDA/EMA acceptance of PB016, alongside commercial launches of Byooviz, Osvyrti, and Jubereq, expanding treatment options across oncology, ophthalmology, immunology, osteoporosis, diabetes, and inflammatory diseases. Strategic collaborations and licensing agreements between Orion Pharma–Shilpa Biologicals, Polpharma–Teva, Samsung Bioepis–Teva, Formycon–OneSource Specialty Pharma, and Organon–Samsung Bioepis strengthened…

ByDipanshu DixitAugust 4, 2026

NEWS

FiberSense Receives CE Mark for its Continuous Glucose Monitoring (CGM) System

Shots: FiberSense has received the CE Marking for its CGM System as a Class IIb medical device, with the company planning to launch in select markets, with initial orders confirmed & first deliveries expected in late 2026 The company is preparing manufacturing scale-up, logistics, customer support, & market access activities for launch, while advancing its…

ByRidhi RastogiJune 17, 2026

NEWS

Eli Lilly Reports P-III (TRIUMPH-1) Trial Data on Retatrutide for Weight Management

Shots: Trial assessed Lilly’s retatrutide (4, 9 & 12mg) with dose escalation vs PBO in adults with obesity/overweight & ≥1 weight-related comorbidity & without diabetes, meeting 1EP of 19% (4mg), 25.9% (9mg) & 28.3% (12mg) weight loss at 80wks. In 2EPs, retatrutide reduced waist circumference by 16.3cm (4mg), 21.8cm (9mg), & 24.1cm (12mg) vs 3.6cm.…

ByRidhi RastogiMay 21, 2026

NEWS

Novo Nordisk Reports the US FDA Approval of Wegovy HD for Weight Management

Shots: FDA has approved Wegovy HD (7.2mg semaglutide, QW) under CNPV along with lifestyle intervention for chronic weight management in adults with obesity; Wegovy HD will be launched as a single-dose pen by Apr 2026 Backed by STEP UP trial (~1,400 adults without T2D) & STEP UP T2D trial (~500 obese adults with T2D), based…

ByRidhi RastogiMarch 23, 2026

NEWS

Novo Nordisk and Vivtex Partner in ~2.1B Metabolic Deal to Develop Oral Therapies

Shots: Novo Nordisk has partnered with Vivtex to develop next-generation oral biologics for obesity, diabetes, & related comorbidities, leveraging Vivtex’s GI screening & formulation platform Vivtex will license select oral drug-delivery techs to Novo, which will lead global development, regulatory, manufacturing & commercialization, while Vivtex will receive an upfront, research funding, & milestone payments totalling…

ByRidhi RastogiFebruary 26, 2026

NEWS

Sciwind Biosciences and Pfizer China Partner to Commercialize Ecnoglutide in China

Shots: Sciwind Biosciences has granted Pfizer China exclusive commercialization rights to Ecnoglutide injection in Mainland China As per the deal, Sciwind will retain the MA & will be responsible for R&D, registration, manufacturing, & supply, plus is eligible to receive ~$495M in upfront, regulatory, & sales milestones Independently developed by Sciwind, Ecnoglutide is a cAMP-biased…

ByRidhi RastogiFebruary 24, 2026

Bayer Reports US FDA sNDA Acceptance for Kerendia to Treat Non-Diabetic CKD

The NMPA Accepts The United Laboratories’ Marketing Application for IDegLira Biosimilar

Genentech Reports Topline P-II (CT-388-104) Trial Data on Enicepatide in T2D and Overweight or Obesity

Hanmi Pharm Licenses HM17321 to Genentech in ~$2.3B Deal

Key Biosimilars Events of July 2026

FiberSense Receives CE Mark for its Continuous Glucose Monitoring (CGM) System

Eli Lilly Reports P-III (TRIUMPH-1) Trial Data on Retatrutide for Weight Management

Novo Nordisk Reports the US FDA Approval of Wegovy HD for Weight Management

Novo Nordisk and Vivtex Partner in ~2.1B Metabolic Deal to Develop Oral Therapies

Sciwind Biosciences and Pfizer China Partner to Commercialize Ecnoglutide in China

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