Nitinotes Reports the US FDA’s IDE Approval of EndoZip System for Endoscopic Sleeve Gastroplasty

Shots: Nitinotes has received the FDA’s IDE approval to begin a pivotal trial of its EndoZip System for endoscopic sleeve gastroplasty; enrollment is set to start by Q3’25 The trial will assess the safety & efficacy of the EndoZip System for obesity pts. (n=184) across up to 10 US and additional international sites. As a…

ByDipanshu DixitJune 25, 2025

INSIGHTS+

New Drug Designations – May 2025  

Shots:    PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA  The May 2025 report covers designations granted to 44 drugs and 5 medical devices, spanning 15 small molecules, 7 biologics, 13 cell and gene therapies & 5 medical devices among others  …

ByDipanshu DixitJune 24, 2025

NEWS

Johnson & Johnson launches ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM Contact Lens in the US and Canada

Shots: Johnson & Johnson launched ACUVUE OASYS MAX 1‑DAY MULTIFOCAL for astigmatism daily disposable lens in the U.S. and Canada for people with both astigmatism and presbyopia A study showed 95% of people wearing ACUVUE OASYS MAX 1-DAY MULTIFOCAL for ASTIGMATISM contact lenses reported clear vision during daily activities, while 87% saw clearly while driving…

ByPrince GiriJune 24, 2025

NEWS

Purpose Pharma’s Attrogy Receives the CHMP’s Positive Opinion for the Treatment of Hereditary Transthyretin-mediated Amyloidosis

Shots: The CHMP has recommended Attrogy (diflunisal) to treat hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult pts. with stage 1 or stage 2 polyneuropathy The EC will make decision within 67 days, and if approved, Attrogy will be authorized in all EU & EEA countries Iceland, Lichtenstein and Norway Diflunisal has received EU ODD for…

ByDipanshu DixitApril 25, 2025

NEWS

AVITA Medical Launches Cohealyx for Wound Healing in the US

Shots: AVITA Medical has launched Cohealyx, collagen-based dermal matrix in the US Cohealyx is currently being evaluated in the post-market Cohealyx I trial (enrolment ongoing) to further assess clinical outcomes, wound bed preparation for definitive closure, & patient recovery timelines Cohealyx, developed by AVITA & Regenity Biosciences, is designed to support cellular migration & revascularization, allowing…

ByRidhi RastogiApril 4, 2025

NEWS

Organon Acquires Regulatory and Commercial Rights of Tofidence IV Infusion (Biosimilar, Actemra) from Biogen

Shots: Organon has acquired the US regulatory & commercial rights for Tofidence, a biosimilar version of Actemra (tocilizumab), from Biogen, which retains manufacturing rights in the US As per the deal, Biogen will receive upfront, while Organon will assume Biogen's obligation to pay Bio-Thera tiered annual net sales royalties & milestones Tofidence is a humanized…

ByRidhi RastogiApril 2, 2025

NEWS

Zealand Pharma and Roche enter a ~$5.3B Deal to Co-Develop and Commercialize Petrelintide for Weight Management

Shots: Zealand Pharma & Roche will develop & market petrelintide & its products incl. petrelintide + CT-388 (Roche’s asset) in the US & EU for weight loss, with Roche obtaining exclusive marketing rights in the rest of the world Zealand will handle ~50% marketing in the US & EU with opt-in/out rights under specific…

ByRidhi RastogiMarch 12, 2025

NEWS

Biocon Biologics Partners with Civica to extend access of Insulin Aspart in the US

Shots: Biocon Biologics has entered into strategic collaboration agreement with Civica to extend access & affordability of Insulin Aspart in the US As per the deal, Biocon will supply Insulin Aspart drug substance to Civica, which will manufacture prefilled pens & vials of insulin at its Petersburg, Virginia facility. Civica will commercialize it in the US…

ByRidhi RastogiMarch 7, 2025

NEWS

Fresenius Kabi Launches Otulfi (Biosimilar, Stelara) in the US

Shots: Fresenius Kabi has launched Otulfi (ustekinumab- aauz) injection, a biosimilar to Stelara, developed by Formycon AG to treat mod. to sev. Crohn’s disease, ulcerative colitis, and plaque psoriasis & active psoriatic arthritis (age ≥ 6 yrs.) across the US Otulfi will be available in the US in 45 mg/0.5 mL and 90 mg/mL prefilled…

ByDipanshu DixitMarch 3, 2025

NEWS

Biocon Biologics Launches Yesintek (Biosimilar, Stelara) in the US

Shots: Biocon Biologics has launched Yesintek (ustekinumab- kfce), a biosimilar to Stelara, to treat psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis across the US. The available presentations are 45 mg/0.5 mL PFS, 90 mg/mL PFS, 45 mg/0.5 mL vial, and 130 mg/26 mL vial The approval was…

ByRidhi RastogiFebruary 24, 2025

Nitinotes Reports the US FDA’s IDE Approval of EndoZip System for Endoscopic Sleeve Gastroplasty

New Drug Designations – May 2025

Johnson & Johnson launches ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM Contact Lens in the US and Canada

Purpose Pharma’s Attrogy Receives the CHMP’s Positive Opinion for the Treatment of Hereditary Transthyretin-mediated Amyloidosis

AVITA Medical Launches Cohealyx for Wound Healing in the US

Organon Acquires Regulatory and Commercial Rights of Tofidence IV Infusion (Biosimilar, Actemra) from Biogen

Zealand Pharma and Roche enter a ~$5.3B Deal to Co-Develop and Commercialize Petrelintide for Weight Management

Biocon Biologics Partners with Civica to extend access of Insulin Aspart in the US

Fresenius Kabi Launches Otulfi (Biosimilar, Stelara) in the US

Biocon Biologics Launches Yesintek (Biosimilar, Stelara) in the US

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