Biocon Biologics and Civica Partner to Launch Private-Label Insulin Glargine in the US

Shots: Biocon Biologics has expanded its strategic collaboration with Civica to commercialize Insulin Glargine in the US Biocon Biologics & Civica entered into a multi-year exclusive distributorship where Biocon will manufacture & supply Insulin Glargine, & Civica will handle its commercialization in the US under its own label, incl. the CalRx brand in California No…

ByRidhi RastogiOctober 16, 2025

NEWS

Incyte Reports the Health Canada’s Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD)

Shots: Health Canada has approved Opzelura cream 1.5% for the treatment of mild to mod. AD in children (≥2yrs.), when other topical therapies are ineffective or unsuitable Approval was based on the P-III (TRuE-AD3) trial, evaluating Opzelura (BID) vs vehicle in over 300 children (≥2 to <12yrs.) with AD Trial met its 1EP with more…

ByRidhi RastogiOctober 16, 2025

NEWS

Eli Lilly Reports Topline Data from P-III (ACHIEVE-2 & 5) Trials of Orforglipron for Type 2 Diabetes

Shots: The 2 P-III (ACHIEVE-2 & 5) trials assessed orforglipron (3, 12 & 36mg; QD) vs dapagliflozin (10mg; QD) in 962 adults with T2D uncontrolled on metformin, & vs PBO in 546 adults with T2D uncontrolled on titrated insulin glargine ± metformin/SGLT2i for 40wks., respectively ACHIEVE-2 showed reduced A1C (1EP) at Wk. 40 across both…

ByRidhi RastogiOctober 16, 2025

NEWS

Novartis Highlights P-III (APPLAUSE-IgAN) Trial Findings on Fabhalta (Iptacopan) for IgA Nephropathy

Shots: Novartis has reported the P-III (APPLAUSE-IgAN) trial findings assessing Fabhalta (200mg; BID; PO) vs PBO, both on top of SoC in 477 adults with IgA nephropathy (IgAN) Trial showed that Fabhalta reduced IgAN progression measured by annualized total slope of eGFR decline over 2yrs., & demonstrated favorable safety; data to be used for 2026…

ByRidhi RastogiOctober 16, 2025

NEWS

Boehringer Ingelheim and AimedBio Partner to Advance an ADC Therapeutic in Oncology

Shots: BI has entered into a global collaboration & licensing agreement with AimedBio to develop a novel ADC for a broad range of cancers, expanding NBE Therapeutics’ portfolio (BI subsidiary) As per the deal, AimedBio will receive ~$991M, incl. an upfront, development & regulatory milestones, plus commercial milestones, as well as net sales-based royalties AimedBio’s…

ByRidhi RastogiOctober 16, 2025

NEWS

Novo Nordisk Enters ~$2.1B Deal with Omeros to Advance Zaltenibart for Rare Blood & Kidney Disorders

Shots: Novo Nordisk has entered into a definitive asset purchase & license agreement with Omeros to develop zaltenibart (MASP-3 inhibitor) for rare blood & kidney disorders, while Omeros retains certain rights to other preclinical MASP-3 programs, incl. small-molecule MASP-3 inhibitors for select indications As per the deal, Novo will receive exclusive global rights to develop…

ByRidhi RastogiOctober 16, 2025

NEWS

Vara Reports CE Mark Approval of its Breast Imaging AI for Independent Second Reading of Mammography

Shots: Vara has received the European CE Mark approval for its breast imaging AI to operate as an independent second reader for both screening & diagnostic use, with EU availability starting Oct 15, 2025 Breast imaging AI was evaluated in the PRAIM study of 460,000 women across Germany, which demonstrated significant improvements in cancer detection &…

ByRidhi RastogiOctober 15, 2025

NEWS

insitro and Bristol Myers Squibb Collaborate to Advance Drug Discovery for Amyotrophic Lateral Sclerosis (ALS)

Shots: insitro & BMS have extended their 5yr. collaboration (2020) to discover novel small molecule therapies for ALS using insitro’s AI-enabled ChemML platform The 1yr. extension will focus on developing therapies for a novel ALS target identified preclinically, with insitro receiving ~$20M in new funding & remaining eligible for discovery, development, regulatory, & commercial milestones…

ByRidhi RastogiOctober 15, 2025

NEWS

Corcept Therapeutics Reports the EMA’s MAA Submission of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Shots: The EMA has received MAA of relacorilant for the treatment of Pt-resistant ovarian cancer MAA was supported by P-III (ROSELLA) & P-II trials, where relacorilant + nab-paclitaxel demonstrated improved PFS & OS compared to nab-paclitaxel monotx., with no need for biomarker selection & showed favorable safety Relacorilant (PO) is a GR antagonist that is…

ByRidhi RastogiOctober 15, 2025

NEWS

BioCryst to Acquire Astria Therapeutics in ~$700M Cash-and-Stock Transaction

Shots: BioCryst Pharmaceuticals has entered into a definitive agreement to acquire Astria Therapeutics, strengthening its allergic & immunology portfolio As per the deal, Astria shareholders will receive $8.55 in cash + 0.59 BioCryst shares, valuing Astria at $13/share with an enterprise value of ~$700M (equity value: ~$920M), plus Astria shareholders will hold ~15% of pro…

ByRidhi RastogiOctober 15, 2025

Ridhi Rastogi

Biocon Biologics and Civica Partner to Launch Private-Label Insulin Glargine in the US

Incyte Reports the Health Canada’s Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD)

Eli Lilly Reports Topline Data from P-III (ACHIEVE-2 & 5) Trials of Orforglipron for Type 2 Diabetes

Novartis Highlights P-III (APPLAUSE-IgAN) Trial Findings on Fabhalta (Iptacopan) for IgA Nephropathy

Boehringer Ingelheim and AimedBio Partner to Advance an ADC Therapeutic in Oncology

Novo Nordisk Enters ~$2.1B Deal with Omeros to Advance Zaltenibart for Rare Blood & Kidney Disorders

Vara Reports CE Mark Approval of its Breast Imaging AI for Independent Second Reading of Mammography

insitro and Bristol Myers Squibb Collaborate to Advance Drug Discovery for Amyotrophic Lateral Sclerosis (ALS)

Corcept Therapeutics Reports the EMA’s MAA Submission of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

BioCryst to Acquire Astria Therapeutics in ~$700M Cash-and-Stock Transaction

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