GSK’s Nucala Secures NICE COPD Endorsement
NICE has added GSK’s Nucala (mepolizumab) to its list of approved biologic add‑on treatments for chronic obstructive pulmonary disease (COPD) in patients with elevated eosinophils. The endorsement is based on three Phase III trials that demonstrated up to a 21 % reduction in yearly exacerbations when Nucala is combined with standard triple inhaled therapy. Nucala will join Sanofi’s Dupixent as the NHS’s two biologic options for this high‑risk COPD subgroup. The decision expands therapeutic choices and could lower hospitalisation rates for the NHS.
Radiopharma on the Rise: Are Supply Chains Ready?
Radiopharmaceutical therapies are moving from niche innovation to mainstream oncology, driven by a surge in approvals and a rapidly expanding clinical pipeline. GlobalData projects sales of radioligand therapies to exceed $2 billion in 2024 and climb above $10.5 billion by 2031, reflecting...
Psychedelic-Assisted Therapies Get a Boost, but Systems Struggle to Play Catch-Up
Psychedelic‑assisted therapy is gaining momentum as several biopharma firms report Phase‑III successes, while President Trump’s executive order earmarks $50 million to speed research. Compass Pathways saw its market value rise about 30% after the order, and companies such as Definium and...
FDA Oncology Roundup: AbbVie’s Rare Cancer Approval, AstraZeneca in Breast Cancer Limbo
The FDA approved AbbVie’s CD123‑targeting antibody‑drug conjugate Decnupaz for blastic plasmacytoid dendritic cell neoplasm (BPDCN), an ultra‑rare aggressive blood cancer, after the CADENZA trial reported a 69.7% composite complete response in newly diagnosed patients and 15.7% in relapsed/refractory cases. The...
Healthcare Cost Inflation Is Back in the Headlines
Blockades in the Strait of Hormuz are inflating global healthcare costs as trade disruptions raise fuel, shipping and manufacturing expenses. The resulting supply bottlenecks have already driven notable price spikes for prescription drugs in markets such as Brazil, Sweden and...
California Startup Protuoso Raises $9.5m for “Mix-and-Match” Drug Platform
California‑based Protuoso Biosciences announced a $9.5 million seed round led by Taya Venture and Darwin Ventures, with participation from NSG Ventures and SEEDS. The funding will fuel development of its MUXBODIES platform, which fuses antibodies, cytokines, peptides and other signalling modules...
Autobahn’s Elunetirom Receives FDA Fast Track Designation to Treat Adjunctive Bipolar
Autobahn Therapeutics received FDA fast‑track designation for elunetirom, an oral, brain‑penetrant thyroid hormone receptor agonist being developed as an adjunctive treatment for bipolar depression and major depressive disorder. The drug targets central nervous system thyroid receptors to boost neurobiological activity...
SK Bioscience and VECOL Partner on Colombia Vaccine Manufacturing Initiative
South Korean vaccine maker SK bioscience has signed a technology transfer and manufacturing agreement with Colombia’s state‑owned pharmaceutical company VECOL, joining the country’s $260 million vaccine localisation programme. The partnership will initially produce SK’s SKYVaricella varicella vaccine, with plans to add...
Thinning Revenues: Inside the $14bn Eliquis Patent Cliff
Eliquis, the $14.4 bn anticoagulant co‑developed by Bristol Myers Squibb and Pfizer, faces a staggered loss‑of‑exclusivity, with European patents expiring in 2026 and U.S. protection ending in 2028. Forecasts show sales plunging to $205 m by 2031, a 98.6% decline, as generics...
Next-Generation Platforms Poised to Redefine Crowded HAE Landscape
The hereditary angioedema (HAE) market has accelerated, with three FDA approvals in 2025 bringing the U.S. total to 11 marketed treatments. Nearly half of the 15 global pipeline candidates—46%—are now in Phase III, signaling a wave of imminent approvals. While most...
Pierre Fabre’s Braftovi Gains CHMP Positive Opinion for mCRC
The European Medicines Agency’s CHMP issued a positive opinion on Pierre Fabre’s Braftovi (encorafenib) combined with cetuximab and Folfox as a first‑line treatment for metastatic colorectal cancer (mCRC) harboring BRAFV600E mutations. The Phase III BREAKWATER trial demonstrated a 51% reduction in...
Q&A: How 3PLs Are Navigating the Latest Pharma Trends
Pharmaceutical 3PLs are shifting from basic warehousing to strategic commercialization support, driven by rising demand for temperature‑sensitive biologics and tighter regulations. Cencora’s senior VP Albert Cooksey highlighted the company’s push into advanced cold‑chain infrastructure, including ultra‑cold (-60°C to -80°C) storage...
Gilead Sciences Completes Tubulis Acquisition for $5bn
Gilead Sciences completed its acquisition of German biotech Tubulis in a deal valued at up to $5 bn, paying $3.15 bn upfront with $1.85 bn in potential milestones. The purchase adds Tubulis’s next‑generation antibody‑drug conjugate (ADC) platform and two clinical candidates, TUB‑040 and...
ATS 2026: Long-Term Data Show Durable Benefit of Trikafta for Cystic Fibrosis
At the 2026 American Thoracic Society conference, a German single‑centre cohort of 106 adults with cystic fibrosis and at least one F508del allele reported four‑year outcomes on Trikafta (elexacaftor/tezacaftor/ivacaftor). Patients showed a 0.5 L (15.6%) rise in FEV1, a 28.9% drop...
Quality by Design: The Impact of Disconnected Systems on Clinical Data
Clinical trials are increasingly digital, but the rapid addition of tools like EDC, ePRO, safety databases, CTMS, eTMF and RBQM often results in fragmented, poorly integrated systems. These disconnections force duplicate data entry, create inconsistent audit trails, and raise the...