Search Results

Highlights M3DICINES™ 3D-printed medicines platform. One platform for PharmaTher’s proprietary products, its network of CraftMake™ placements and partner services: CDMO, white-label products, formulation licensing and clinical trial supply. Commercial launch of M3DICINES™. Initial orders of the CraftMake™ pharmaceutical 3D printer, the platform’s entry point, are planned for Q4 2026. Near-term products. First proprietary 503A peptide products are planned for Q4 2026, followed by a ketamine dissolvable tablet for telehealth in Q1 2027. Rare pediatric NDA with voucher potential. Orphan drug and rare pediatric disease designation applications are planned for October 2026, with a pre-IND meeting in Q1 2027 and an NDA submission targeted for Q4 2028. Approval could earn a priority review voucher; recent vouchers have sold for US$100–155 million. Pipeline expansion into underserved markets. PharmaTher is evaluating three underserved markets where small-batch production is an advantage: ultra-rare diseases with no FDA-approved treatment, psychedelic medicines for clinical trials and special access, and discontinued medicines that mass manufacturing no longer serves. National emergency network. Every CraftMake™ placement can become a node that prints medical countermeasures on demand. PharmaTher plans to pursue readiness contracts with U.S. and Canadian agencies. New website and brand. PharmaTher has launched its new corporate website at PharmaTher.com, and PERSONALIZ3D™ is now M3DICINES™ (M3DICINES.com).

Big Pharma companies including Bristol Myers Squibb, Johnson & Johnson and Novartis are among those that made or planned layoffs in Q3. Those cuts could affect over 1,800 employees, with New Jersey the hardest-hit state.

Amgen is awaiting another Phase 3 readout for the investigational Sjögren’s disease therapy, set for later this year. William Blair anticipates that at least two trials will be needed to support an FDA application.

Potential near-term commercialization through two synergistic business units: (i) a telehealth platform connecting patients with independent licensed healthcare providers and (ii) a North American network of pharmacy-based pharmaceutical 3D-printing systems for compounding medications, together forming a personalized medicine ecosystem

Bristol Myers Squibb’s $2.3 billion Houston manufacturing campus is part of the company’s larger $40 billion investment designed to bolster American innovation and manufacturing.

With weight loss topping 20% at 80 weeks in the Phase 3 TRIUMPH-2 and TRIUMPH-3 trials, Eli Lilly plans to file for retatrutide’s approval in the first quarter of 2027. Previously a filing was expected later this year.

EloraTZP—a combination of an amylin asset and Eli Lilly’s approved obesity drug Zepbound—made a clean sweep of the primary and secondary endpoints in a mid-stage trial of adults with obesity and type 2 diabetes, setting up the launch of a Phase 3 trial before the end of the year.

Moderna’s norovirus vaccine failed in a Phase 3 trial, but the company still has faith in an ambitious revenue growth target thanks to ex-U.S. vaccine sales and a unanimous FDA adcomm win for mFLUSIVA.

In briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor’s assertion that a Phase 3 trial met its primary outcome measures.