NEWS

Accord BioPharma Reports Commercial Availability of Osvyrti and Jubereq (Biosimilars, Prolia & Xgeva) in the US

Shots: Accord BioPharma has reported the launch of Osvyrti & Jubereq, interchangeable biosimilars to Amgen’s Prolia & Xgeva (denosumab), in the US Osvyrti (60mg PFS) treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & increases bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer…

July 24, 2026

Lundbeck Secures the US FDA Fast Track designation for Lu AH69593 to Treat Narcolepsy

Shots: The US FDA has granted Fast Track designation to Lu AH69593 for the treatment of patients with narcolepsy Lu AH69593 is a small-molecule orexin 2 receptor agonist being developed by Lundbeck for narcolepsy to regulate arousal, wakefulness, & sleep-wake stability Lu AH69593 is being evaluated in a P-Ib clinical program, with Lundbeck continuing to…

July 24, 2026

Nuvectis Pharma Reports NMPA Approval of Ciprocopan for Paroxysmal Nocturnal Hemoglobinuria (PNH)

Shots: The NMPA has approved ciprocopan (NXP100, QD, PO) for the treatment of pts with PNH previously untreated with Complement inhibitors. Application for PNH pts previously treated with anti-C5 therapies is under review in China Approval was based on a P-III trial of ciprocopan vs Soliris in the above-mentioned pts, which met all 1 &…

July 24, 2026

Outlook Therapeutics Reports the US FDA Approval of Lytenava for Wet AMD

Shots: The US FDA has approved Outlook’s Lytenava (Bevacizumab-vikg) for wet AMD Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized IgG1 MAb targeting VEGF Additionally, the approval is expected to provide LYTENAVA with 12 years of Reference Product Exclusivity under the BPCIA Ref: Outlook Therapeutics | Image: Outlook Therapeutics | Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications.…

July 24, 2026

Eli Lilly Reports P-III (TRIUMPH-2 and TRIUMPH-3) Results on Retatrutide for Obesity

Shots: TRIUMPH-2 assessed retatrutide (4, 9, or 12mg, QW) vs PBO in 1152 pts with T2D & obesity/overweight, while TRIUMPH-3 assessed retatrutide (9 or 12mg, QW) in 1949 pts with severe obesity & CV disease; trials used a stepwise dose-escalation approach at Q4W In TRIUMPH-3, 12mg reduced TGs, non-HDL cholesterol, systolic BP, waist circumference, &…

July 24, 2026

AstraZeneca Receives the EC Approval for Etcamah (Camizestrant) to Treat Advanced Breast Cancer

Shots: The EC has approved Etcamah + a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for adults with ER+, HER2- locally advanced or metastatic breast cancer with an ESR1 mutation & no progression on 1L endocrine therapy + CDK4/6 inhibitor; regulatory review is ongoing in the US Approval was based on the P-III (SERENA-6) trial assessing…

July 24, 2026

Pfizer Receives the US FDA Priority Review for Talzenna + Xtandi to Treat HRR-Gene Mutated mCSPC

Shots: The US FDA has accepted sNDA & granted priority review to Talzenna (talazoparib) + Xtandi (enzalutamide) to treat men with HRR gene-altered mCSPC, with PDUFA action date in Q4’26. Regulatory review is ongoing in the EU sNDA was supported by the P-III (TALAPRO-3) trial data assessing Talzenna (talazoparib; 0.5mg/day) + Xtandi (160mg/day) vs PBO + Xtandi…

July 24, 2026

Dassault Systèmes to Acquire ArisGlobal for ~$2B

Shots: Dassault Systèmes has entered into a definitive agreement to acquire ArisGlobal, creating the industry’s first unified intelligence platform As per the deal, Dassault will acquire ArisGlobal for ~$1.8B at closing in cash & ~$200M in additional payments linked to multi-year AI-related revenue milestones; closing is expected in H2’26 Acquisition will advance Dassault Systèmes’ ambition to…

July 23, 2026

Revolution Medicines Reports the US FDA NDA Acceptance of Daraxonrasib for Previously Treated Metastatic PDAC

Shots: The US FDA has accepted the NDA for Revolution Medicines’ daraxonrasib to treat pts with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), plus daraxonrasib was selected for the FDA CNPV pilot program NDA was backed by P-III (RASolute 302) trial assessing daraxonrasib (300mg, QD, PO) vs CT, in above-mentioned pts, regardless of RAS mutation, which…

July 23, 2026

Arrowhead Reports P-III (SHASTA-3 & SHASTA-4) Results on Plozasiran in Severe Hypertriglyceridemia (sHTG)

Shots: Arrowhead has reported topline P-III (SHASTA-3 & 4) trial results assessing plozasiran (25mg, SC, Q3M) vs PBO in sHTG pts (n=~750), where both trials met their 1EP of reduced median TGs by 79% & 81%, respectively, at 12mos. vs ~27% Pooled analyses showed significant reductions in AP event rates & total incidence rate, with…

July 23, 2026

NEWS

Accord BioPharma Reports Commercial Availability of Osvyrti and Jubereq (Biosimilars, Prolia & Xgeva) in the US

Lundbeck Secures the US FDA Fast Track designation for Lu AH69593 to Treat Narcolepsy

Nuvectis Pharma Reports NMPA Approval of Ciprocopan for Paroxysmal Nocturnal Hemoglobinuria (PNH)

Eli Lilly Reports P-III (TRIUMPH-2 and TRIUMPH-3) Results on Retatrutide for Obesity

AstraZeneca Receives the EC Approval for Etcamah (Camizestrant) to Treat Advanced Breast Cancer

Pfizer Receives the US FDA Priority Review for Talzenna + Xtandi to Treat HRR-Gene Mutated mCSPC

Dassault Systèmes to Acquire ArisGlobal for ~$2B

Revolution Medicines Reports the US FDA NDA Acceptance of Daraxonrasib for Previously Treated Metastatic PDAC

Arrowhead Reports P-III (SHASTA-3 & SHASTA-4) Results on Plozasiran in Severe Hypertriglyceridemia (sHTG)

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