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How Next-Gen Lyophilization is Redefining Formulation Integrity
Conventional drying will remain useful, but it does not have to set the limits of formulation. Lyophilization offers a way to reduce risk, protect value and build products that are ready today — and ready for the future. read more
FDA Grants Two More National Priority Vouchers
An oral drug for lowering LDL cholesterol and a treatment for advanced cancers will have shortened review times. read more
Shionogi Inks $2.5B Buyout for ALS Drug
The Japan-based company will acquire Radicava ORS and IV Radicava along with a subsidiary in the U.S. read more
BioMarin to Acquire Amicus for $4.8B, Expanding Rare Disease Capabilities
The deal will give BioMarin Amicus’s lead oral drug, Galafold, approved in 2018 for Fabry disease. read more
Gilead Single-Tablet HIV Combo Meets Late-Stage Endpoints
A single-tablet regimen combining bictegravir and lenacapavir could potentially transform the HIV treatment landscape. read more
North American Ambitions
Driven by persistent supply chain disruptions, shifting trade dynamics, evolving customer expectations and the accelerating growth of the nutraceutical sector, the pharma ecosystem is rewiring where — and how — it operates. read more
USAntibiotics Gets First FDA 'National Priority' Nod for XR Antibiotic
Augmentin XR received approval after just two months via the CNPV pilot program, marking the first drug to win approval using the new pathway. read more
Sanofi Oral Multiple Sclerosis Drug Hit With FDA Delay, Trial Failure
The FDA has delayed its decision about tolebrutinib for a second time and Sanofi will not pursue approval in primary progressive multiple sclerosis. read more
Qualicaps to Close North Carolina Plant
The closure will eliminate 91 jobs, with some workers being offered transfers to positions within Roquette. read more
Lilly to Build $6B API Plant in Alabama for Oral Obesity Drug
The facility is one of nine U.S. manufacturing sites that Lilly has announced since 2020. read more
Roche Oral SERD Reduces Breast Cancer Reoccurrence in Phase 3 Trial
Giredestrant the first SERD to demonstrate superior invasive disease-free survival in early breast cancer, suggesting a new standard of care. read more
The Critical Role of Granulation in Optimizing Drug Formulation
Although not a routine manufacturing step, granulation plays a central role in determining the quality, consistency and performance of modern OSD products. This article explores how granulation can effectively underpin formulation... read more
Pfizer Continues Obesity Push with YaoPharma Deal
In a deal that could exceed $2B, Pfizer will pick up YaoPharma’s small molecule GLP-1 receptor agonist currently in trials for chronic weight management. read more
Digital Twin-Driven Scale-Up of Tablet Film Coating
Scaling up a tablet coating process from work performed with a small-scale unit to a full-scale production plant raises critical questions: Which controls and product attributes must remain unchanged, and which can or must be ... read more
Structure Advances Oral GLP-1 into Phase 3 Trials
In the phase 2b trial, a 120 mg dose led to a mean weight loss of 11.3% and a 240 mg dose to 15.3% at 36 weeks. read more
Kymera Oral STAT6 Degrader Matches Blockbuster’s Efficacy in Atopic Dermatitis Trial
The drug demonstrated efficacy on par with Sanofi and Regeneron's blockbuster drug, Dupixent. read more
Praxis Stops Oral Epilepsy Drug Trial Early Over Efficacy
Relutrigine treats developmental and epileptic encephalopathies, which have an extremely high mortality rate due to seizure burden. read more
Belite Preps Regulatory Submissions for Oral Stargardt Drug
Tinlarebant reduced lesion growth compared to placebo, marking the first therapeutic candidate to demonstrate clinical efficacy for STGD1. read more
Lupin in Talks to Buy UK’s Largest Nutra Company
Lupin will partner with two global private equity firms to acquire Vitabiotics in a deal that could be worth $1.25 billion. read more
Protego Closes $130M Series B to Advance AL Amyloidosis Drug
The orally bioavailable small molecule targets protein misfolding to attack the root cause of the disease rather than treating the resulting symptoms. read more

January/February 2026

2026 Annual Buyer’s Guide
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