BMS Brings the Buzz Around Late-Stage Readouts Amid a So-So Q1
Bristol Myers Squibb’s Q1 earnings showed modest 1% revenue growth to $11.5 bn, beating forecasts, while its growth portfolio surged 9% to $6.2 bn. The company highlighted late‑stage readouts for milvexian, a next‑generation anticoagulant, and Cobenfy, a schizophrenia therapy, as potential blockbuster drivers. Camzyos posted a 97% revenue jump, underscoring the impact of newer assets. BMS reaffirmed its 2026 revenue guidance of $46‑$47.5 bn despite looming Eliquis patent expiry.
EU’s Joint Clinical Assessment System Still Finding Its Footing
The European Union’s Joint Clinical Assessment (JCA) system, launched in January 2025, saw its first activation with Ipsen’s Ojemda approval, initiating a 30‑day countdown for a centralized clinical report. Designed to replace duplicated health‑technology assessments across member states, the JCA currently...
Regeneron Q1 2026 Net Income Falls 10% to $727m
Regeneron reported GAAP net income of $727 million for Q1 2026, a 10% decline from the prior year, while non‑GAAP net income rose 12% to $1.04 billion. Total revenue jumped 19% to $3.6 billion, driven by an 8% increase in net product sales and...
The Strategic Investments Expanding CDMO Capabilities for HPAPIs and ADCs
Contract development and manufacturing organisations (CDMOs) are accelerating investments to meet soaring demand for highly potent active pharmaceutical ingredients (HPAPIs) and antibody‑drug conjugates (ADCs). The focus is on backward integration, high‑containment infrastructure, and advanced processing such as chromatography and lyophilisation...
Arcera and Fosun Sign MoU for Neuroscience Innovation
Arcera Life Sciences and Fosun Pharma have signed a memorandum of understanding to create a long‑term strategic partnership focused on licensing, technology sharing, and neuroscience innovation. The deal taps Fosun’s research and manufacturing capabilities and Arcera’s access to international markets,...
Rocket to Sell PRV for $180m to Advance Gene Therapy Pipeline
Rocket Pharmaceuticals has agreed to sell its rare‑pediatric disease priority review voucher for $180 million after the FDA granted accelerated approval for its Kresladi gene therapy. The voucher, issued for addressing a rare paediatric condition, can be used to speed up...
Seaport and Hemab Target $180m IPOs as Biotech Listings Accumulate
Seaport Therapeutics and Hemab Therapeutics announced IPO pricing on the Nasdaq, each targeting roughly $180 million in net proceeds. Seaport will sell 11.8 million shares at $16‑$18, estimating $183.5 million at the midpoint, while Hemab will offer 11.7 million shares in the same range...
Early Detection of Bowel Cancer in the UK Represents Success of Screening Program
The UK’s bowel‑cancer screening programme, launched in 2006, is delivering measurable gains. NHS data show 7 million people screened in 2025, up from 4.7 million in 2015, and 70,000 cancers detected among 85 million tests. The rollout of home‑based faecal immunochemical kits and...
Pharma Meets AI Conference 2026: AI in Pharma Begins Delivering Measurable ROI
At the Pharma Meets AI conference in Barcelona, industry leaders highlighted that artificial intelligence is finally moving beyond pilot projects to deliver quantifiable returns in pharmaceutical commercial and field‑medical operations. Exeevo showcased its Ask‑Nova platform, which embeds AI into routine...
Pharma Meets AI Conference 2026: AI Governance Shifts to Embedded Practice
At the Pharma Meets AI conference in Barcelona, industry leaders announced a pivot from standalone AI policy frameworks to embedded governance models. Novartis presented an “integrated assurance” approach that fuses risk management, compliance, and internal controls directly into business processes....
ESCMID Global 2026: Pritelivir Excels in Immunocompromised Refractory HSV Patients
Aicuris presented Phase III data for its oral helicase‑primase inhibitor pritelivir at ESCMID Global 2026. In the PRIOH‑1 trial of 101 immunocompromised adults with acyclovir‑refractory HSV, pritelivir achieved significantly higher lesion‑healing rates than investigator‑chosen IV or topical therapies. The drug also...
MFN Changing the Rules of the Game for the Nordic Countries
GlobalData’s Price Intelligence analysis links the U.S. Most Favored Nation (MFN) policy to a 35% decline in pharmaceutical product launches across Europe within ten months of its introduction. In the Nordics, oncology drugs are priced roughly 5% below the European...
Novartis Secures Pair of Regulatory Wins for Skin Disease and Malaria Treatments
Novartis won two regulatory milestones: the European Commission approved its oral BTK inhibitor Rhapsido for adults with chronic spontaneous urticaria who have failed antihistamines, and the World Health Organization granted prequalification to Coartem Baby, an artemether‑lumefantrine formulation for infants weighing 2‑5 kg....
UK Biotech Could Be Bound for Recovery, BIA Report Reveals
UK biotech venture financing rebounded in Q1 2026, with total equity raised climbing 18% to £552 m ($746 m). Venture‑capital inflows also rose 17% to £516 m ($699 m), and 25 companies secured funding, up from 15 a year earlier. While public‑market activity stayed flat—no...
The Slow March of Clinical Biomarkers to Become Surrogate Endpoints
Clinicians are urging the FDA to recognize more clinical biomarkers as surrogate endpoints, hoping to accelerate drug approvals and reduce trial durations. Regulators remain cautious, approving only six biomarkers through the 2007 Biomarker Qualification Programme and often demanding definitive clinical...
AAN 2026: Tavapadon Post-Hoc Analysis Strengthens Its D1/D5 Agonist Pitch
At the 2026 American Academy of Neurology meeting, AbbVie unveiled post‑hoc results from its Phase III TEMPO‑1 and TEMPO‑2 trials of tavapadon, a once‑daily oral D1/D5 partial agonist for early Parkinson’s disease. The analysis showed statistically significant improvements in seven of...
AAN 2026: Head-to-Head Trial Shows Superiority of Qulipta for Migraine Prevention
AbbVie presented Phase IIIb TEMPLE trial data at AAN 2026, showing its oral gepant Qulipta outperforms topiramate in migraine prevention. Over 24 weeks, Qulipta had a 12.1% discontinuation rate versus 29.6% for topiramate and achieved a 73.7% responder rate (>50% reduction in...
Biogen Seeks Darzalex Rivalry in China for Multiple Myeloma with Felzartamab Deal
Biogen has secured exclusive rights to TJ Biopharma’s anti‑CD38 antibody felzartamab in Greater China for up to $850 million, including control of a pending biologics licence application for relapsed and refractory multiple myeloma. The drug will be manufactured domestically at TJ...
Regulatory Round-Up: Novartis, Sanofi and Arrowhead Secure CHMP Blessings
The European Committee for Medicinal Products (CHMP) issued positive opinions on three therapies: Sanofi's BTK inhibitor cenrifki for non‑relapsing secondary progressive multiple sclerosis, Arrowhead's siRNA drug redemplo for familial chylomicronemia syndrome, and Novartis' gene‑replacement therapy itvisma for spinal muscular atrophy....
Cardiometabolic Trials: Using Expertise to Turn Complexity Into Robust Results
Nucleus Network’s Minneapolis site has emerged as a benchmark for early‑phase cardiometabolic trials, leveraging AI‑driven recruitment, rigorous PI oversight, and advanced imaging to deliver decision‑grade data. In the Rivus RIV‑HU6‑203 study the team screened 506 candidates, randomised 80 participants and...
Cumberland to Sell Drug Portfolio to Apotex for $100m
Cumberland Pharmaceuticals has agreed to sell its branded commercial drug portfolio to Canadian generic giant Apotex for $100 million in cash, subject to shareholder approval. The transaction lets Cumberland retain its pipeline assets, including the thromboxane antagonist ifetroban, and its majority...
ESCMID Global 2026: Zelicapavir Demonstrates Benefits for High-Risk Adults with RSV
At ESCMID Global 2026, Enanta Pharmaceuticals presented Phase IIb data for zelicapavir, an oral once‑daily N‑protein inhibitor, in high‑risk adults with RSV. The double‑blind study of 186 participants missed the primary endpoint but demonstrated faster symptom resolution—up to 7 days quicker in...
Pharma Meets AI Conference 2026: Key Barriers to Scaling AI in Drug Development
At the Pharma Meets AI conference in Barcelona, industry leaders warned that trust and governance are the biggest obstacles to scaling artificial intelligence in drug development. While AI is delivering gains in prediction, personalization and productivity, concerns over data quality,...
ESCMID Global 2026: Adibelivir Emerges as Potential Disease-Modifying Therapy for HSV
Innovative Molecules presented Phase I/Ib data on adibelivir (IM‑250), a novel helicase‑primase inhibitor, at ESCMID Global 2026. The drug demonstrated nanomolar potency against clinical and acyclovir‑resistant HSV‑1/2 isolates and showed a favorable safety profile up to 200 mg with no dose‑limiting toxicities....
AbbVie Opts for North Carolina to House $1.4bn Manufacturing Site
AbbVie announced a $1.4 bn investment to build a new 185‑acre manufacturing campus in North Carolina, the largest single‑site spend in the company’s history. The facility will produce oncology, immunology and neuroscience therapies and incorporate AI‑driven advanced manufacturing technologies. Construction is...
Operational Lessons From Global Nephrology Trials
The article outlines four operational lessons drawn from the surge of global nephrology trials, noting that GlobalData tracks 888 CKD studies with only 56 multinational efforts. It argues that traditional site selection in Europe and the U.S. limits enrollment speed...
MSD Teams up with Google Cloud on Agentic AI Transformation
Merck & Co (MSD) and Google Cloud have signed a multi‑year, up‑to‑$1 bn partnership to embed agentic AI across the pharma giant’s R&D, manufacturing, commercial and corporate functions. The deal centers on deploying Google’s Gemini Enterprise platform, enabling predictive analytics, automation and enhanced...
Immunotherapy in Locally Advanced HNSCC: Is There Still Room for New Agents?
In June 2025 the FDA approved MSD’s Keytruda (pembrolizumab) for resectable locally advanced head‑and‑neck squamous cell carcinoma (LA HNSCC) with PD‑L1 CPS ≥ 1, based on the KEYNOTE‑689 trial. A separate adjuvant nivolumab study (NIVOPOSTOP) showed promising results, though regulatory filing is...
MSD-Backed Ray Locks in $125m to Back Eye Drug Pipeline
Ray Therapeutics announced a $125 million Series B round, led by Janus Henderson Investors with participation from Merck’s venture arm, MRL Ventures and Novo Holdings. The capital will fund late‑stage clinical work and commercial preparation for RTX‑015, its lead gene‑therapy candidate for...
FDA Approves MSD’s Once-Daily HIV Combo Idvynso
Merck’s Idvynso (doravirine/islatravir) received FDA approval, marking the first tenofovir‑free, non‑INSTI two‑drug regimen for HIV. The decision follows Phase III trials that demonstrated non‑inferior viral suppression compared with Gilead’s three‑drug standard Biktarvy. Idvynso targets virologically suppressed patients without prior treatment failure...
BioAegis and Prenosis Partner for Inflammatory Disease Therapies
BioAegis Therapeutics has teamed up with AI‑focused startup Prenosis to accelerate precision‑medicine approaches for inflammatory diseases. The partnership will analyze biospecimens from BioAegis’s Phase II BTI‑203 trial of recombinant human plasma gelsolin in 600 ARDS patients across Europe, Canada and the...
The Definitive Infrastructure for Modern Drug Development
Paradigm Health has launched an AI‑powered clinical research platform that operates across a national network of more than 800 community and academic sites in the United States, Japan and Israel. The platform embeds trial design, patient identification and data capture...
Eli Lilly Doubles Down on in Vivo with $7bn Kelonia Buyout
Eli Lilly announced a deal to acquire Kelonia Therapeutics for up to $7 bn, securing its lentiviral‑based in vivo gene‑therapy platform iGPS and an early‑stage multiple‑myeloma asset, KLN‑1010. The transaction includes a $3.25 bn cash payment upfront and up to $3.75 bn in milestone payments...
British Patients Risking “Fake” Weight Loss Drugs, Despite Safety Concerns, Survey Says
British patients are increasingly turning to unregulated weight‑loss drugs, with a Zava survey revealing that 21% lack a prescription and many purchase them online. One in six respondents bought doses from e‑commerce platforms, while 11.75% sourced drugs through social‑media channels...
Beyond GLP-1Rs: Emerging Targets Poised to Gain Share of Obesity Market
The global obesity drug market is projected to reach $172.6 bn by 2031, up 139% from 2026, driven by GLP‑1R giants like Wegovy and Zepbound. Non‑GLP‑1R therapeutics, currently a niche at $310 m, are forecast to surge 50‑fold, hitting $15.5 bn by 2031....
Magazine: Digital Twins Become the New Battleground for CDMOs
The latest issue of Pharmaceutical Technology highlights how knowledge‑graph digital twins are becoming a strategic weapon for contract development and manufacturing organisations (CDMOs) tackling complex biologics, gene therapies and advanced products. By creating a virtual replica of the entire manufacturing...
The Future of Quality in CDMOs: The Five-Stage Journey to an Advanced Pharmaceutical Quality System (PQS)
Sharp, a leading contract development and manufacturing organization (CDMO), outlined a five‑stage journey to an advanced Pharmaceutical Quality System (PQS) that shifts quality from basic compliance to a strategic, performance‑driven function. The roadmap progresses through foundational compliance, strategic direction, integrated...
Four Ways to Build a Secure and Scalable CGT Distribution Network
Cell and gene therapies (CGTs) are expanding rapidly, with 34 US products approved and a projected $80 bn global market by 2029, driven largely by oncology. Successful commercialization now hinges on building secure, scalable distribution networks that protect fragile, cryogenic products...
The Innovators Working to Make in Vivo Cell Therapy a Reality
First‑in‑human trials of in‑vivo CAR‑T therapies are now underway, delivering therapeutic genes directly inside patients via viral or lipid‑nanoparticle vectors. Big‑pharma interest is evident after AstraZeneca’s $1 bn purchase of EsoBiotec and Eli Lilly’s $2.4 bn acquisition of Orna Therapeutics, despite limited clinical...
Developers Back Alzheimer’s Drugs Despite Report Suggesting Lack of Efficacy
A new Cochrane review of 17 trials involving 20,342 patients concludes that anti‑amyloid drugs for Alzheimer’s disease deliver only trivial or no clinically meaningful cognitive benefit and may increase the risk of amyloid‑related imaging abnormalities (ARIA). Eli Lilly’s donanemab (Kisunla) and...
Nucleai and Sirona Dx to Provide New Proteomics Solution for Pharma Companies
Nucleai and Sirona Dx have formed a partnership to deliver an end‑to‑end spatial proteomics solution for pharmaceutical and biotech companies. The joint offering unifies assay design, high‑quality imaging, and AI‑driven analytics to turn complex tissue data into actionable biological insights....
Boehringer Ingelheim and Zai Lab Team up for Dual DLL3 Therapy Study
Boehringer Ingelheim and Zai Lab have launched a Phase Ib/II trial that pairs Boehringer’s DLL3‑directed T‑cell engager obrixtamig with Zai Lab’s DLL3‑targeting ADC zoci. The study will evaluate safety, tolerability and early efficacy in patients with extensive‑stage small‑cell lung cancer and other neuroendocrine...
EU Sees 2025 Pharma Export Uptick Amid Competitiveness Concerns
EU pharmaceutical exports surged 16% in 2025, reaching €366.2 bn (≈$429 bn) and generating a record trade surplus of €220.5 bn (≈$257 bn). The United States remained the top destination, accounting for 44% of shipments – roughly €160.6 bn (≈$188 bn). Tariff pressures, including a 15%...
Pharma 5.0, Sustainability & Security: PHARMAP 2026 Brings Pharma’s Future Into Focus
PHARMAP Congress 2026 will convene pharma leaders in Amsterdam on April 20‑21 to address digital transformation, sustainability, and security. The event highlights the shift from Pharma 4.0 to Pharma 5.0, focusing on AI‑human collaboration and Quality 5.0’s integrative approach. Speakers will showcase circular packaging...
AbbVie Bets on Chinese Biopharma’s Pain Pipeline in $745m Bid
AbbVie has struck a deal worth up to $745 million with Chinese biopharma Haisco, securing development, manufacturing and commercialization rights to several early‑stage pain‑relief compounds outside China, Hong Kong and Macau. The agreement includes a $30 million upfront payment and up to $715 million...
Telix and Regeneron Sign $4.3bn Deal to Co-Develop Radiopharmaceutical Therapies
Telix and Regeneron Pharmaceuticals have signed a partnership valued at up to $4.3 billion to co‑develop radiopharmaceutical therapies for solid tumours. Regeneron will pay $40 million upfront for access to Telix’s manufacturing platform and can expand to four additional programmes, while Telix...
BMS and Oxford BioTherapeutics Join Forces in TCE Discovery Pact
Bristol Myers Squibb has entered a discovery partnership with Oxford BioTherapeutics to develop T‑cell engager (TCE) therapies for solid tumours. BMS will pay an undisclosed upfront fee to access OBT’s OGAP‑Verify platform, while OBT will design and deliver pre‑clinical candidates....
Emerging Therapies Bring Hope for Frail HNSCC Patients Unfit for Standard Treatment
Head and neck squamous cell carcinoma (HNSCC) cases are projected to rise to 273,000 by 2034, with frail and elderly patients expected to comprise 44% of the market. Standard curative regimens are often intolerable for this group, creating a sizable...
Advancing Single-Cell Transcriptomics Into the Mainstream of Biomedical Research
Single‑cell transcriptomics is transitioning from a niche method to a core biomedical tool, offering cell‑level gene‑expression detail that fuels advances in cancer, immunology and cell‑therapy research. Manual library‑preparation steps limit throughput to about 24 samples per day, creating bottlenecks for...
Precision Medicine in Early Oncology Trials: Biomarkers as Strategic Drivers
Oncology drug development is shifting toward precision immunotherapies, with biomarkers driving patient selection and trial efficiency. Experts at a Caidya webinar highlighted two trends: novel combination regimens and early integration of biomarker strategies, including companion diagnostics. Early biomarker adoption can...