Aspire Biopharma and Microsize Collaborate for Alprazolam Powder Formulation
Aspire Biopharma has teamed with particle‑engineering specialist Microsize to develop a sublingual powder formulation of alprazolam, aiming for faster anxiety relief than traditional tablets. The partnership leverages Microsize’s micronisation expertise and Pace’s excipient compatibility and stability services to accelerate development. The sublingual route bypasses the gastrointestinal tract, delivering the drug directly into the bloodstream for a more rapid and predictable onset. Aspire targets a Phase I clinical trial by mid‑2026 and hopes to launch the first market‑ready alprazolam sublingual product.
Extracellular Vesicles: The Next Frontier in Regenerative Medicine and Drug Delivery?
Extracellular vesicles (EVs) are emerging as a versatile platform for regenerative medicine and targeted drug delivery. Researchers highlight their ability to transfer proteins, RNA, and lipids between cells, mimicking natural signaling pathways. Recent advances in isolation, engineering, and loading techniques...
Navigating Uncertainty and Building Resilient Supply Chains: The Case for US-Based CDMO Partnerships
Pharmaceutical firms are accelerating onshoring efforts, with more than $270 billion pledged for U.S. manufacturing since early 2025 and 80% of global producers weighing domestic or near‑shore options. Legislative moves such as the BIOSECURE Act and incentives like BARDA Project NextGen are...
Europe’s Pharma Trade with the US Remains Critical Despite Tariff Turmoil
U.S. pharmaceutical tariffs on EU imports have risen to 15% after a brief 10% measure, reviving trade tensions despite a prior MFN deal. Europe is pursuing alternative markets, notably a new EU‑India free‑trade agreement that could eliminate up to 11%...
Dermatology Trials by the Numbers: Key Trends and Benchmarks for 2026
Dermatology research is booming, with more than 16,000 trials completed, ongoing, or planned by the end of 2025. The Asia‑Pacific region now hosts roughly 8,000 studies, a five‑fold increase over the past decade, matching North America and Europe combined. Low...
Moderna’s Dual Covid-Flu Vaccine Poised for EMA Approval on Positive CHMP Take
The European Medicines Agency’s CHMP has issued a positive opinion on Moderna’s mCombriax, a combined COVID‑19 and influenza mRNA vaccine, after a Phase III trial showed stronger immune responses than a mixed regimen of Sanofi’s flu shot and Spikevax. EMA approval...
Sanofi Receives CHMP Recommendation for Dupixent Expansion in Europe
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending Dupixent (dupilumab) for paediatric chronic spontaneous urticaria (CSU) in children aged 2‑11. The recommendation is based on robust Phase III data from the LIBERTY‑CUPID...
BioMarin Receives FDA Approval for Palynziq Use in Adolescents
BioMarin’s enzyme substitution therapy Palynziq received FDA approval for use in adolescents aged 12 and older with phenylketonuria (PKU). The decision was based on Phase III PEGASUS trial results showing 44.4% of participants lowered blood phenylalanine below guideline levels, with a...
How America’s Former Steel Heartland Secured a $3.5bn Eli Lilly Facility
Eli Lilly announced a $3.5 billion life‑sciences manufacturing complex in Lehigh Valley, Pennsylvania, slated to open in 2031. The facility will produce the company’s next generation of weight‑loss drugs and employ roughly 850 engineers, scientists and technicians. The deal, the largest life‑sciences...
Podcast: Rare Disease Day: FDA Guidance Allowing Advancement
The FDA issued a suite of new guidance documents in early 2026 aimed at easing development of therapies for rare diseases, including the Rare Disease Evidence Pathway, Plausible Mechanism Pathway, and innovative trial designs for cellular and gene therapies. The...
Quotient and Ipsen Extend Partnership for Ultra-Rare Disease Therapy
Quotient Sciences has extended its commercial partnership with Ipsen to manufacture Sohonos (Palovarotene), the approved therapy for fibrodysplasia ossificans progressiva (FOP), an ultra‑rare disease affecting fewer than 1,000 people worldwide. The deal includes Ipsen's investment in a pneumatic closed‑transfer system...
NorthX Biologics and Demeetra Collaborate on GMP Manufacturing and CLD
NorthX Biologics and Demeatriz have formed a strategic alliance to deliver an end‑to‑end platform that couples Demeatriz’s CleanCut CHO cell line development with NorthX’s GMP manufacturing capabilities. The partnership leverages a high‑titre GS‑knockout CHO cell line that carries no royalty...
FDA Accepts Beren Therapeutics’ NDA for Niemann-Pick Disease
Beren Therapeutics announced that the U.S. Food and Drug Administration has accepted its New Drug Application for adrabetadex, an investigational therapy aimed at treating infantile‑onset Niemann‑Pick disease type C (NPC). The agency set a target action date of 17 August 2026 under the...
EU Pledges €225m to Develop Next Generation of Flu Vaccines
The European Commission has pledged €225 million through a pre‑commercial procurement model to accelerate the development of next‑generation influenza vaccines. Ten entities, including Sanofi and Bavarian Nordic, will receive eight‑year contracts that cover clinical testing through market authorisation. The funding targets...
Podcast: Which Pharma and Medtech Companies Came Out on Top in 2025 Revenues?
The 2025 earnings season highlighted a clear hierarchy among healthcare giants, with Eli Lilly and AstraZeneca leading pharma revenue growth and Medtronic and Edwards Lifesciences topping medtech sales. The podcast hosted by Robert Barrie and Ross Law breaks down the financial results, noting...
Boehringer Ingelheim and NIPER Sign MoU on Pharmaceutical Research
Boehringer Ingelheim India has signed a memorandum of understanding with the National Institute of Pharmaceutical Education and Research (NIPER) in Raebareli to deepen collaboration on pharmaceutical technologies and novel drug delivery systems. The agreement grants NIPER access to Boehringer’s opnMe...
Valneva’s Lyme Disease Vaccine Offers Beacon of Hope Amid 2025 Sales Dip
Valneva reported a 3.3% decline in product sales to €157.9 million in 2025, driven primarily by regulatory suspensions of its chikungunya vaccine Ixchiq in the US and UK. Despite the sales dip, total revenue rose to €174.7 million, buoyed by a licensing...
MSD and Mayo Clinic Team up to Advance AI in Drug Development
Merck & Co (MSD) and Mayo Clinic have launched a research partnership that leverages AI, advanced analytics, and multimodal clinical‑genomic data to accelerate drug discovery and precision medicine. The collaboration merges Mayo’s Platform architecture and de‑identified datasets—including imaging, labs, molecular...
FDA to Review Moderna’s Flu Jab on Agency Pivot
The FDA has reversed its earlier refusal and will now evaluate Moderna’s mRNA‑1010 seasonal flu vaccine using a two‑track approach: a full Biologics License Application review for adults 50‑64 and an accelerated approval pathway for those 65 and older, contingent...
