Inside the Expert Network Guiding TGN-S15 to Market
Toragen’s CEO Sandra Coufal detailed the formation of a Scientific Advisory Board designed to steer the HPV‑targeted therapy TGN‑S15 through development. The board is anchored by Dr. Aldo Venuti, a leading authority on the HPV E5 protein, who supplies the rare W12 pre‑cancerous cervical cell line. Dr. Ezra Cohen, who led Keytruda’s HPV‑positive head‑and‑neck trials, adds clinical trial expertise. Together, the advisors aim to accelerate TGN‑S15’s path to market while minimizing costly missteps.
Rethinking Pharma's Go-to-Market Formula
Mike Petroutsas, president of U.S. commercial at Astellas, argues that insight‑driven commercialization is reshaping pharma’s engagement with patients, physicians, and the broader health ecosystem. In a Pharm Exec podcast, he details how Astellas leverages real‑world data, social listening, and internal...
FDA Approves Baxdrostat for Uncontrolled Hypertension in First-in-Class Entry
The FDA has granted approval to Baxfendy (baxdrostat), AstraZeneca’s first aldosterone synthase inhibitor, for adults whose blood pressure remains uncontrolled despite existing therapies. The approval is based on the phase 3 BaxHTN trial, where a 2 mg dose lowered systolic pressure by...
FDA’s New Pilot Program and Real-Time Review of Clinical Data
The FDA announced a pilot program that lets regulators review clinical trial data in real time, allowing safety signals and efficacy endpoints to be shared as they are recorded. Dr. Richard Graham explained that the initiative aims to eliminate the...
How Toragen's Alignment With The Gates Foundation Supports Global Access and Commercialization
Toragen announced a strategic partnership with the Bill & Melinda Gates Foundation to develop an oral small‑molecule therapy for cervical cancer. The collaboration builds on a 21‑year relationship that began through the Novartis Research Foundation and was accelerated by promising...
Pharmaceutical Executive Daily: FDA Approves AstraZeneca's Fasenra
The FDA has approved AstraZeneca’s Fasenra (benralizumab) for patients 12 and older with hypereosinophilic syndrome (HES), adding a rare‑disease indication to a drug already used for severe eosinophilic asthma. The approval rests on the Phase III Natron trial, which showed a...
Women’s Health Investment: Rhetoric Vs. Reality
In a Pharmaceutical Executive interview, Toragen CEO Sandra Coufal argues that despite rising investor interest, funding for women‑specific treatments remains limited because total addressable market calculations rely on male‑biased trial data. This systemic under‑representation causes the commercial potential of women’s...
Pharmaceutical Executive Daily: FDA Approves Beqalzi and Inqovi
The FDA granted accelerated approval to BeOne Medicines' Beqalzi, the first BCL2 inhibitor for relapsed or refractory mantle‑cell lymphoma, after a Phase 1/2 trial showed a 52% overall response rate and median 15.8‑month durability. Taiho Oncology also received approval for Inqovi...
Transforming Clinical Trial Design and Avoiding AI Wrappers: Q&A with Angela Schwab
Trialynx CEO Angela Schwab explains how AI is reshaping clinical trial design by moving away from manual copy‑and‑paste protocols toward data‑driven, predictive modeling. AI can scan millions of past studies to suggest optimal endpoints, procedures, and patient pathways, reducing missed...
Why E5 Was the Target Nobody Went After
Toragen CEO Sandra Coufal highlighted that the HPV E5 protein has been largely ignored in favor of the better‑studied E6 and E7 oncogenes. She explained that E5 assembles six copies into a viral ion channel that cloaks infected cells from immune...
Pharmaceutical Cybersecurity and Risk Management: Q&A with Jamie Singer & Matt Flora
In a May 12, 2026 interview, FTI Consulting’s Jamie Singer and Matt Flora explain that pharmaceutical cyber threats have moved beyond ransomware to data extortion, supply‑chain attacks, and even executive harassment, while rapid AI adoption widens the attack surface. They identify recurring...
Maximizing Drug Impact
Tris Pharmaceutical, founded by CEO Ketan Mehta, has evolved from an oral‑technology specialist to a broader portfolio that now includes pain‑management and addiction therapies. Mehta explained that the company tackles drug‑impact challenges by engineering particle‑based delivery systems that provide continuous,...
Pharmaceutical Executive Daily: GSK Enters Collaboration to Support Launch of Bepirovirsen
GlaxoSmithKline (GSK) has signed a 5.5‑year exclusive partnership with Chia Tai Tianqing Pharmaceutical Group to launch bepirovirsen, a chronic hepatitis B candidate, across more than 5,000 Chinese hospitals. The drug is currently in priority regulatory review in mainland China, while GSK...
Adjusting Strategies Over a 25-Year-Long Career
Tris Pharmaceutical, founded by CEO Ketan Mehta 25 years ago, began as an oral‑technology platform company. Over time it broadened its focus to neurology and neuroscience, now offering a commercial ADHD portfolio and pursuing treatments for narcolepsy, spasticity, pain and...
Pharmaceutical Executive Daily: FDA Extends Review of Leqembi's sBLA
The FDA has extended the priority review of Eli Lilly's subcutaneous Leqembi by three months, delaying the agency's action date while requesting additional information. The once‑weekly injection is designed to replace the current infusion regimen for patients with early Alzheimer’s...
Factors Contributing to the Growth of Radiopharmaceuticals: Q&A with Andrea Zobel and Marco Hogenboom
Radiopharmaceuticals are poised for rapid expansion, with the market expected to grow from $9.07 billion in 2023 to $26.51 billion by 2031, driven by innovative radioligand therapies and a surge in clinical trials. World Courier’s senior directors Andrea Zobel and Marco Hogenboom...
Pharmaceutical Executive Daily: Angelini Pharma Acquires Catalyst Pharmaceuticals in $4.1 Billion Agreement
Angelini Pharma announced a definitive agreement to acquire Catalyst Pharmaceuticals for $31.50 per share in cash, representing a 21% premium to the unaffected closing price and a total equity value of roughly $4.1 billion. The transaction gives Angelini its first direct...
Strengthening the Generic Drugs Supply Chain
The API Innovation Center published a whitepaper titled “From Fragility to Resilience,” highlighting weaknesses in the U.S. generic‑drug supply chain and proposing data‑driven solutions. The report, authored by VP Natalie de Graaf, identifies the most vulnerable drug classes and quantifies supply‑chain...
What Elements Is the Conversation About Bringing Pharma Manufacturing Home Missing?
President Trump’s 100% tariff on branded drugs aims to force pharmaceutical reshoring, but industry leaders warn the focus on APIs overlooks a critical upstream layer—key starting materials (KSMs). Charlie Lyon of the API Innovation Center notes that 98% of U.S....
Winning in AI Overviews: Protecting Brand Accuracy in AI-Generated Answers
The PharmExec webinar "Winning in AI Overviews" will teach pharma marketers how AI‑generated answers reshape search discovery and how to safeguard brand accuracy. It explains the mechanics behind AI overviews, the regulatory and reputational risks of mismatched content, and practical...
Pharmaceutical Executive Daily: Zentalis Doses First Patient with Azenosertib in Phase III Trial
Zentalis Pharmaceuticals announced the first patient dosing in the Phase III Aspenova trial of Azenosertib, an oral WEE1 inhibitor for Cyclin E1‑positive, platinum‑resistant ovarian cancer. The study is run with the GOG Foundation, the European Network of Gynecological Oncology Trials (EN‑GOT), and...
From Insight to Impact: Making Real-World Evidence Actionable in Urology
Real‑world evidence (RWE) is reshaping urology, but fragmented, unstructured data limits its impact on everyday clinical decisions. In non‑muscle invasive bladder cancer, real‑world datasets reveal wide variation in BCG maintenance and treatment sequencing, while prostate cancer diagnostics suffer from inconsistent...
Pharmaceutical Executive Daily: BioNTech Reports 2026 First Quarter Results
Cellenkos secured FDA clearance to start a Phase 1b/2a trial of its off‑the‑shelf allogeneic T‑reg therapy CK0802 for steroid‑refractory graft‑versus‑host disease, with enrollment slated for late 2026. BioNTech reported first‑quarter 2026 revenue of $138 million, a 35% drop from the prior year,...
FDA Clears Investigational New Drug Application for Phase Ib/IIa Trial of CK0802 in Steroid-Refractory Graft-Versus-Host Disease
The U.S. Food and Drug Administration has cleared Cellenkos' investigational new drug application for CK0802, paving the way for a Phase Ib/IIa trial in patients with steroid‑refractory graft‑versus‑host disease (GVHD). The mid‑stage study will evaluate safety, tolerability and early efficacy, using...
Scaling Innovation Without Losing Executional Rigor: Q&A with Mark Thierer
EVERSANA CEO Mark Thierer says pharmaceutical manufacturers have moved past uncertainty and are now focused on scaling execution. He highlights a demand for integrated commercialization models that combine strategy, data, and real‑world performance across the product lifecycle. EVERSANA is investing...
Pharmaceutical Executive Daily: UCB to Acquire Candid Therapeutics
UCB signed a definitive agreement to acquire privately held Candid Therapeutics for $2 billion upfront with up to $200 million in milestones. The deal, slated to close by late Q2 or early Q3 2026 pending antitrust clearance, adds a suite of T‑cell engager...
Asembia ASX26: The ‘Entirely Pass-Through’ Business Model
At the Asembia ASX26 Summit, Aradigm Health CEO Will Shrank outlined the company’s “entirely pass‑through” business model, which charges only a transparent administrative fee and returns any surplus to purchasers as a dividend. The approach targets the opacity and waste...
Pharmaceutical Executive Daily: FDA Approves Auvelity
The FDA approved Axsome Therapeutics’ Auvelity for agitation associated with Alzheimer’s disease, marking the first non‑antipsychotic and only the second drug cleared for this indication. Earlier, the FDA’s Oncologic Drugs Advisory Committee gave AstraZeneca’s Truqap a 7‑1 favorable benefit‑risk vote,...
Global Disruptions to the Pharma Supply Chain: Q&A with Jeff Golfman
Jeff Golfman, founder of Send 123, warned that rising geopolitical tensions—particularly around Iran and the Strait of Hormuz—are tightening global pharmaceutical and medical supply chains. Shipping bottlenecks and shrinking capacity are driving up prices and threatening access to critical therapies such...
Alternative Supply Chain Strategies Companies Should Prioritize
Jeff Golfman, founder of Send 123, urges companies to move beyond merely adding suppliers and adopt data‑driven, structural supply‑chain reforms. He recommends a detailed audit of product origins to build geographic risk profiles, longer lead times with strategic inventory buffers, and...
Asembia ASX26: The Strain on the Development of Infrastructure for Sustainable C&G Therapy
Cell and gene therapies promise transformative treatments but remain hampered by steep costs across research, manufacturing, and delivery. At the Asembia ASX26 Summit, Aradigm Health CEO Will Shrank highlighted the fragmented U.S. payment landscape as a core barrier to sustainable...
Pharmaceutical Executive Daily: Rocket Pharmaceuticals Sells Pediatric Disease Priority Review Voucher
Rocket Pharmaceuticals agreed to sell its rare‑pediatric disease priority‑review voucher for $180 million in cash, providing non‑dilutive funding as the PRV program was reauthorized in early 2026. Teva Pharmaceutical announced a definitive agreement to acquire Emalex Biosciences for up to $900 million,...
Teva Enters $900 Million Agreement to Acquire Emalex
Teva Pharmaceutical Industries announced a $900 million acquisition of Emalex Biosciences, securing the late‑stage pediatric Tourette syndrome candidate ecopipam. The deal includes a $700 million upfront payment and up to $200 million in milestone fees, with the transaction slated to close in Q3 2026....
Which Supply Chains Are Most Exposed by Disruptions in The Strait of Hormuz?
Jeff Golfman, founder of Send 123, warns that disruptions in the Strait of Hormuz expose a wider contraction in global supply chains, affecting not only oil but also critical medicines. The narrow waterway, a key conduit for cargo from India, Pakistan,...
Pharmaceutical Executive Daily: FDA Approves Breztri
Sun Pharmaceutical Industries agreed to buy Organon for $11.75 billion, propelling the combined entity into the top‑25 global pharma ranks. IMG Pharmaceutical announced the acquisition of Japan’s Matsumoto Pharmaceutical, adding a portfolio with more than 50 OTC approvals. The FDA granted...
Asembia AXS26 Summit: The Future of High-Cost Specialty Drugs
At the Asembia AXS26 Summit, Clarivate’s Dee Chaudhary warned that U.S. drug‑pricing policy is moving from theory to real‑time execution, reshaping payer behavior and market volatility. The Inflation Reduction Act’s Medicare price negotiations, the new One Big, Beautiful Bill Act, and renewed Most Favored...
Asembia ASX26: Adjusting Strategies to Adapt to an Uncertain Global Political and Regulatory Market
At the Asembia ASX26 Summit, Jessica Lovett, VP of Commercial Strategy and Innovation at Innomar, outlined how the company is reshaping its commercial approach amid heightened geopolitical and regulatory uncertainty. She stressed that disciplined scenario planning—covering tax, payer, and regulatory...
FDA Approves Breztri for Patients 12 Years and Older with Asthma
The FDA has approved Breztri Aerosphere, a single‑inhaler triple‑combination of budesonide, glycopyrrolate, and formoterol, for maintenance treatment of asthma in patients aged 12 and older. This marks the first U.S. approval of a triple therapy that adds a long‑acting muscarinic...
Asembia's AXS26 Summit: How Is Digital Innovation Transforming Programs for Patient Access?
At Assembia’s AXS26 Summit, Syneos Health’s VP Kim Plesnarski explained how digital tools—wearables, sensors, smart pills—are reshaping patient access programs by feeding real‑time data into EMRs and clinician workflows. She emphasized that integrating these solutions early is critical to personalize...
Why Ireland Has Become a Strategic Hub for the Global Pharmaceutical Industry
Ireland has cemented its status as a global pharmaceutical hub, boasting over 90 FDA‑approved facilities, a workforce of 50,000, and $133 billion in annual pharma exports. The country’s regulatory track record and stable policy environment have attracted $16.3 bn of biopharma investment...
How RFID Is Reshaping Health and Wellness Supply Chains: Q&A with Suresh Palliparambil
Impinj’s SVP Suresh Palliparambil explains how the latest RAIN RFID Gen2X chips deliver true item‑level visibility across health‑and‑wellness supply chains. The Gen2X standard, launched in December 2024, improves tag sensitivity, read range and filtering, enabling reliable reads of small, liquid‑filled...
How Can Pharma Prices Be Reduced for Americans Without Impacting Innovation?
President Trump announced a sweeping plan to impose 100% tariffs on branded pharmaceuticals, while offering exemptions to companies that sign most‑favored‑nation (MFN) agreements. The policy is framed as a way to force lower drug prices for American patients and to...
Pharmaceutical Executive Daily: FDA Issues CRL to AbbVie
The U.S. Food and Drug Administration issued a complete response letter to AbbVie, rejecting its biologics license application for trenibotulinumtoxinE due to manufacturing and CMC deficiencies. The setback delays AbbVie’s entry into the lucrative neurotoxin market, a segment dominated by...
Lessons Learned in the Current Biotech Funding Environment
MaxCyte CEO Maher Masoud says the recent lumpy biotech funding climate has forced companies to sharpen their focus on lead assets rather than spreading resources across multiple programs. He notes that leaner financing is sufficient to advance cell and gene...
The Long Wait for Rare Disease Treatment Approval: Q&A with Dr. Patricia E. Greenstein
In early 2026 the FDA issued draft guidance that elevates real‑world data (RWD) to a primary evidentiary role in rare and ultra‑rare disease drug approvals. The agency now accepts a single pivotal trial supported by high‑quality RWD, reducing the need...
Pharmaceutical Executive Daily: FDA Expands Approvals for Tzield and Dupixent
The FDA broadened Tzield’s approval to treat children as young as one year with stage 2 type 1 diabetes, aiming to delay progression to stage 3 disease. It also expanded Dupixent’s label to cover young patients with uncontrolled chronic spontaneous urticaria, adding another...
Pharmaceutical Executive Daily: Idvynso Receives FDA Approval
The FDA granted approval to Idvynso, a new oral therapy for HIV‑1 infection in adults, citing trial data that showed sustained viral suppression and a safety profile on par with existing regimens. The drug adds to a shifting HIV market...
How Compounding Has Become a Permanent Bridge for Healthcare Access: Q&A with Dr. Nicole Snow
Compounding pharmacies are positioning themselves as a permanent bridge to healthcare access by delivering highly individualized therapies when commercial products fall short. Dr. Nicole Snow of Wesley Pharmaceuticals explains how custom dosing, alternative dosage forms, and allergen‑free excipients close care...
Top Drugs at Risk of Supply Shortages: Report
The U.S. Pharmacopeia’s new vulnerable medicines report flags 100 drugs—half of which depend on a single‑country key starting material—as prone to supply shocks. While only 30 of these are in active FDA shortage, the list highlights injectables, ICU sedatives, IV...
Pharmaceutical Executive Daily: UnitedHealth Raises Full-Year Profit Forecast
UnitedHealth Group reported adjusted earnings of $7.23 per share in Q1, well above analyst expectations, and used the momentum to raise its full‑year profit outlook. The boost reflects tighter medical‑cost controls and higher government reimbursement rates across its insurance operations....