NEWS

Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the EC Approval for Rett Syndrome

Shots: The EC has approved Daybu (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in pts (≥5yrs.) across all 30 EEA states Approval was based on the results from the P-III (LAVENDER) study, which showed improvements in core features of Rett syndrome, as measured by RSBQ & CGI-I scale co-1EPs Daybu, a synthetic analog…

3 days ago

Alvotech and Lotus Partner to Commercialize AVT34 (Biosimilar, Imfinzi) and AVT87 (Biosimilar, Hemlibra) Across the US and 8 Asian Countries

Shots: Alvotech has entered a strategic licensing & commercialization agreement with Lotus Pharmaceutical for AVT34, a proposed Imfinzi (durvalumab) biosimilar, & AVT87, a proposed Hemlibra (emicizumab) biosimilar, in the US & selected Asian markets Under the US semi-exclusive deal, Alvotech & Lotus will jointly commercialize AVT34 and AVT87, with Lotus commercializing the products through Alvogen;…

3 days ago

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…

3 days ago

Johnson & Johnson Receives EC Approval for Tecvayli Combination for R/R Multiple Myeloma

Shots: The EMA has approved a label extension of Tecvayli (teclistamab) + Darzalex (daratumumab) for the treatment of adults with r/r multiple myeloma (RRMM) who have received ≥1 prior therapy Approval was supported by the P-III (MajesTEC-3) trial evaluating Tecvayli + Darzalex (SC) vs investigator’s choice of Darzalex (SC) & dexamethasone with either pomalidomide or bortezomib in…

3 days ago

Leads Biolabs Reports NMPA NDA Acceptance for Opamtistomig in Previously Treated Advanced EP-NEC

Shots: Chinese NMPA CDE has accepted the NDA for opamtistomig (LBL-024) as monotx. for previously treated advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) The NDA is supported by a registrational study led by Professor Shen Lin of Peking University Cancer Hospital, conducted across 34 sites; the study enrolled 96 pts with EP-NEC and completed enrollment in Aug 2025,…

August 21, 2026

IntraGel Therapeutics and UroGen Pharma Ink Strategic Collaboration & Investment to Advance TumoCure & Expand Sustained-Release Oncology Pipeline

Shots: IntraGel Therapeutics has entered into a strategic collaboration and investment agreement with UroGen Pharma to advance TumoCure for advanced head and neck cancer and expand the potential application of its SRGel biodegradable sustained-release platform As per the deal, UroGen will invest up to $7M in IntraGel to support the P-II development of TumoCure and…

August 21, 2026

Rein Therapeutics’ LTI-03 Secures the US FDA Fast Track Designation for Idiopathic Pulmonary Fibrosis

Shots: The US FDA has granted FTD to LTI-03 for the treatment of idiopathic pulmonary fibrosis The P-II (RENEW) trial is a randomized, PBO-controlled study (n=~120) evaluating the safety, tolerability, and efficacy of LTI-03 for idiopathic pulmonary fibrosis across the US, UK, Australia, Poland, and Germany. Patients will receive 1 of 2 LTI-03 doses or…

August 21, 2026

Chai Discovery and BMS Collaborate to Enhance AI-Driven Antibody Discovery

Shots: Chai Discovery has entered a collaboration with BMS to advance the discovery of therapeutic antibodies using artificial intelligence As per the deal, BMS will leveraging Chai’s AI models and platform capabilities including its molecular folding & design models to support the discovery of antibody candidates across its portfolio and to support the development of…

August 21, 2026

VarmX Enrolls First Patient in P-III (EquilibriX-S) Trial of VMX‑C001 in Urgent Surgery

Shots: VarmX has enrolled the first pt in the global registrational P-III (EquilibriX-S) study assessing VMX-C001 vs usual pharmacologic care in pts receiving FXa inhibitors who require urgent surgery/procedures EquilibriX-S, a randomized, controlled trial is expected to recruit pts across >20 countries and assess whether a single IV dose of VMX-C001 rapidly restores hemostasis, with…

August 21, 2026

Regeneron Reports US FDA Approval of Pasatru for Fibrodysplasia Ossificans Progressiva

Shots: The US FDA has approved Pasatru (garetosmab-grts) to reduce the formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP), based on the P-III OPTIMA trial assessing 10 mg/kg (n=23) & 3 mg/kg (n=19) Pasatru vs PBO (n=21) At Wk. 56, Pasatru 10 mg/kg reduced the total number…

August 21, 2026

NEWS

Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the EC Approval for Rett Syndrome

Alvotech and Lotus Partner to Commercialize AVT34 (Biosimilar, Imfinzi) and AVT87 (Biosimilar, Hemlibra) Across the US and 8 Asian Countries

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

Johnson & Johnson Receives EC Approval for Tecvayli Combination for R/R Multiple Myeloma

Leads Biolabs Reports NMPA NDA Acceptance for Opamtistomig in Previously Treated Advanced EP-NEC

IntraGel Therapeutics and UroGen Pharma Ink Strategic Collaboration & Investment to Advance TumoCure & Expand Sustained-Release Oncology Pipeline

Rein Therapeutics’ LTI-03 Secures the US FDA Fast Track Designation for Idiopathic Pulmonary Fibrosis

Chai Discovery and BMS Collaborate to Enhance AI-Driven Antibody Discovery

VarmX Enrolls First Patient in P-III (EquilibriX-S) Trial of VMX‑C001 in Urgent Surgery

Regeneron Reports US FDA Approval of Pasatru for Fibrodysplasia Ossificans Progressiva

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