
India Phrama Stocks Under Pressure Due To Trump's Tariff Threat | Editors' Roundtable
The round‑table focused on rising concerns that the Trump administration could levy up to 100% tariffs on imported branded and patented medicines, a move that would directly affect Indian pharmaceutical exporters. Traders reacted by pushing the India pharma index down roughly 5% in a session where broader market indices fell even more sharply. Panelists noted that generic manufacturers appear insulated from the tariff threat, while companies with significant branded portfolios—such as Sun Pharma—could face headwinds unless they negotiate price‑guarantee deals with U.S. regulators. The sector’s relative outperformance, down only about 5% versus a 20% slump in IT, reflects its non‑cyclical nature and the recent rupee depreciation that boosts export margins. Nimsh highlighted pharma as a “new safe haven,” citing investors’ shift toward export‑oriented drug makers amid AI‑driven disruptions in the IT space and a broader business‑cycle dip. He argued that the sector’s resilience could add a few basis points to its performance, provided the tariff outlook remains ambiguous. If the tariff proposal materialises, investors may re‑allocate capital toward generics while monitoring Sun Pharma’s pricing negotiations. Conversely, a muted U.S. stance could reinforce pharma’s defensive appeal, especially as geopolitical tensions in West Asia and currency volatility persist.

Increasing Productivity in Clinical Research - Life Sciences Today Podcast Episode 48
Life Sciences Today host Danny Lieberman interviews Zena Sarif, founder of Yandu, about the chronic inefficiencies that prolong clinical‑trial timelines and how her startup aims to streamline the process. Sarif explains that up to 12‑18 months of a drug’s development are...

Session 3.1 - RISE Together: Data Sharing Across the Rare Disease Ecosystem
The RISE Together Session 3.1 convened experts to explore data‑sharing strategies across the rare‑disease ecosystem, using amyotrophic lateral sclerosis (ALS) as a pilot. Panelists Colin Hovinga of the Critical Path Institute and Natanya Kerper of the Cystic Fibrosis Foundation highlighted...

FDA Direct - Special Edition of FDA Direct
In a special edition of FDA Direct, the agency’s leadership reviewed a year of restructuring, record‑setting approvals, and a forward‑looking agenda focused on speed, safety and affordability. The discussion highlighted a near‑record 67 new drug approvals, an average review time...

Inside the Phased, Risk-Based Approach for CGT Materials
The video focuses on Bio4’s phased, risk‑based strategy for addressing particulate contamination in cell and gene therapy (CGT) raw and starting materials, a gap that has long plagued the industry. Bio4 is assembling a subgroup to draft best‑practice guidance, potentially...

Rare Disease Day 2026 | Gene Therapy in Practice
The Rare Disease Day 2026 session titled “Gene Therapy in Practice” highlighted Johns Hopkins’ emerging program to deliver gene‑based treatments for pediatric neuromuscular disorders. Speakers—Dr. Jessica Nance, nurse practitioner Maria Belellios, and pharmacy coordinator Danielle Pennock—outlined the institution’s clinical‑trial legacy,...

Poolbeg Pharma: What Are the Next Steps?
Poolbeg Pharma used the briefing to detail its strategic roadmap, focusing on two parallel tracks – expanding its intellectual‑property holdings worldwide and advancing a pivotal clinical study in relapsed‑refractory multiple myeloma. The company said it will tap the Patent Prosecution Highway...

Medicare Drug Price Negotiation: What Can We Learn From the 2027 Prices and Their Justifications?
The webinar examined the Inflation Reduction Act’s new Medicare drug‑price negotiation program, focusing on the Centers for Medicare & Medicaid Services’ (CMS) recently published explanations for the 2027 maximum fair prices (MFPs). These explanations, released before the March 1 deadline, detail...

Poolbeg Pharma: Tell Us About This Patent?
Poolbeg Pharma announced that IP Australia has issued a formal certificate of grant for its patent covering the use of any P38 MAPK inhibitor, including its lead oral candidate pod001, to prevent cancer‑immunotherapy‑induced cytokine release syndrome (CRS). The approval...

Dr. Glaucomflecken Explains: Oral PCSK9 Inhibitor Enlicitide (CORALreef Lipids)
The video features Dr. Glaucomflecken discussing a new oral PCSK9 inhibitor, Enlisticide, and its recent New England Journal of Medicine publication. The drug targets patients with familial hypercholesterolemia or elevated LDL—specifically those with prior cardiovascular events (LDL > 55 mg/dL) or at high...

2026 ISPE Europe Annual Conference Session: A CQV Early Engagement Checklist: BOD Thru DD
The video outlines an early‑engagement checklist for Commissioning, Qualification and Validation (CQV) that begins at the Basis of Design (BOD) and continues through due‑diligence activities. It explains why most issues surface during the CNQ phase—earlier decisions funnel problems downstream—and introduces a...

Investing In Early-Stage Oncology With Yosemite's Dan McHugh
The Business of Biotech episode spotlights Dan McHugh, head of the investment team at Yosemite, a San Francisco‑based venture firm founded by Reed Jobs and Loren Powell Jobs. Yosemite’s mandate is to fund early‑stage cancer‑therapeutics developers, leveraging a mission‑driven capital pool that grew out of...

Original Article: Atezolizumab Plus FOLFOX for Stage III Colon Cancer (ATOMIC)
The phase 3 ATOMIC trial evaluated resected stage III mismatch‑repair‑deficient (dMMR) colon cancer patients receiving modified FOLFOX6 with or without atezolizumab. Adding atezolizumab improved three‑year disease‑free survival compared with chemotherapy alone. However, grade 3‑4 adverse events increased, driven primarily by fatigue. The findings...

Theravance's Strategic Review with Andy Summers $TBPH
Theravance Biopharma (TBPH) entered a strategic review after its sole pipeline candidate failed a pivotal Phase‑III trial, prompting a sharp stock drop from the low $20s to $13‑$14. The company, a single‑product pharma spun out a decade ago, relies on...

BREAKTHROUGH CURES By The Thousands: LigandForge Is Here.
The video spotlights three AI‑driven breakthroughs reshaping biomedicine: a tech‑entrepreneur in Australia used publicly available AI tools to design a custom mRNA cancer vaccine that reduced his dog Rosie’s tumor by 75%, researchers identified the circulating protein HMGB1 as a...

Healey Community Q&A Webinar: March 12, 2026 | CNM-Au8 Expanded Access Update
The Healey Community Q&A webinar on March 12, 2026 featured Dr. Jinsey Andrews presenting interim results from the NIH‑funded CNM‑AU8 expanded access program (EAP) for amyotrophic lateral sclerosis (ALS). The program targets patients ineligible for traditional clinical trials, offering them...

Healey ALS MyMatch
The Shaun M. Healey and AMG Center for ALS at Massachusetts General Hospital unveiled ALS MyMatch, a precision‑medicine platform designed to overhaul early‑phase clinical trials for amyotrophic lateral sclerosis. By integrating a unified screening protocol that evaluates multiple biomarkers and...

PMDA Washington D.C. Office Initiatives
The video outlines the launch of the PMDA Washington DC office, the agency’s first permanent base in the United States, under its 2024‑2029 mid‑term plan. Located near the White House, the office serves as a physical gateway for Japanese regulators...

Abridged Regulatory Pathways
The video explains the concept of bridged regulatory pathways, a reliance‑based model that lets national regulatory authorities (NRAs) base decisions on assessments performed by a reference agency such as Japan’s PMDA. The World Health Organization defines reliance as a means...

It Takes a Community to End Tuberculosis
A new phase‑three trial of the M72 tuberculosis vaccine is underway across Africa and Asia, with roughly 20,000 volunteers, aiming to halt the progression from infection to disease. The effort is anchored in South Africa, where TB mortality remains among...

Media Briefing: MRNA Vaccines
The Johns Hopkins Bloomberg School of Public Health hosted a media briefing to explain how messenger RNA (mRNA) vaccines work, their safety profile, and their expanding role beyond COVID‑19. Professors Andrew Pekosch and Gigi Granvall outlined the technology’s core advantage:...

IXICO CEO Says Milestone Medidata Collaboration Supports Growth Strategy
IXICO’s chief executive Bram Goorden announced a strategic partnership with Medidata, the multibillion‑dollar leader in electronic data capture and clinical‑trial services. The deal is presented as the first step in IXICO’s “tech‑bio” growth plan, aiming to blend the company’s proprietary...

What Does MDMA Therapy Actually Look Like? | Rachel Yehuda
Rachel Yehuda explains that MDMA‑assisted psychotherapy for PTSD is a structured, multi‑phase program rather than a one‑off drug experience. Patients undergo extensive preparation, discussing stuck points, hopes, and readiness before any medication is administered. The protocol currently approved for FDA...

Nyrada Phase 2 Trial Targets Heart Attack Damage
Nyrada Inc announced it will commence a Phase 2 trial of its lead candidate Zoltrip in Australia, enrolling 100 patients who have experienced a STEMI heart attack across seven sites. The study’s primary objective is to confirm safety while seeking...

Commercializing CAR T Cell Therapy With Legend Biotech's Alan Bash
In a Business of Biotech interview, Legend Biotech’s President Alan Bash discusses the commercial trajectory of Carvykti, the J&J‑partnered CAR‑T therapy for multiple myeloma that received FDA approval in 2022 and now generates blockbuster revenues. Bash highlights the product’s Q4 2025...

HEALEY ALS Platform Trial Webinar: March 19, 2026 | Regimen I (NUZ-001) Science
The webinar introduced Regimen I of the Healy ALS platform trial, the next phase of a community‑driven effort to evaluate new therapies. Led by Dr. James Barry and partners from New Horizon, the session focused on the investigational mTOR inhibitor NUZ001,...

2026 ISPE Europe Annual Conference Session: Implementing Data Integrity: Real-World Lessons
The ISPE Europe 2026 conference session focused on practical strategies for implementing data‑integrity controls across pharmaceutical manufacturing and quality systems. Presenter emphasized closing the gap between rapid technology adoption and sustainable regulatory compliance. Attendees learned how to replace paper‑heavy audit reviews...

New Evidence Suggests Medicinal Cannabis Does Not Treat Mental Illnesses
The video examines a new Lancet Psychiatry review that concludes medicinal cannabis offers no therapeutic benefit for anxiety, depression, or PTSD and may even exacerbate these conditions. The analysis arrives amid a surge in Australian prescriptions, with more than 700,000...

Atrial Fibrillation Therapy in Patients with Stents (ADAPT AF-DES)
The New England Journal of Medicine’s ADAPT AF‑DES trial examined whether a non‑vitamin K antagonist oral anticoagulant (NOAC) alone could safely replace the conventional dual antithrombotic regimen of NOAC plus clopidogrel in patients with atrial fibrillation who had received a...

NEJM Clinician: Apixaban Vs. Rivaroxaban for Acute VTE
The New England Journal of Medicine published a head‑to‑head trial evaluating apixaban (Eliquis) against rivaroxaban (Xarelto) in 2,800 patients with acute pulmonary embolism or deep‑vein thrombosis. The study provides the first direct comparative safety and efficacy data for these two...

They Call It a Lottery Ticket. The Data Says Otherwise | The Hidden Alpha of Biotech
Biotech investing is portrayed as a lottery ticket, yet specialist investors argue persistent alpha exists. The conversation with DA Wallak explores how early‑stage biotech firms are valued using a “bag of options” framework that sums the net present value of...

Radiotherapeutics For CNS Cancers With Plus Therapeutics' Marc Hedrick, M.D.
In a recent Life Science Leader interview, Marc Hedrick, M.D., President and CEO of Plus Therapeutics, outlined the company’s strategic shift toward radiotherapeutics targeting central nervous system (CNS) malignancies. The discussion centered on the lead asset, Rayobic, a Re‑186 beta‑emitting...

Health Reporters React to "The Fugitive"
The video features health journalists using the 1993 thriller “The Fugitive” as a springboard to explore how a fictional pharmaceutical scandal would be reported today. They walk through the plot’s central drug, Provasic—originally called RDU90—described as a revolutionary, side‑effect‑free arterial...

FDA & Rare Disease Drugs: Why Policy and Politics Are Heating Up
The episode focuses on the FDA’s new draft guidance designed to streamline approval pathways for ultra‑rare, often single‑patient, therapies. Host Jeff Buyers and guest Leslie Erlac discuss the policy shift against the backdrop of recent leadership turmoil, notably the departure...

Vaccines and Related Biological Products Advisory Committee Meeting
The FDA's Vaccines and Related Biological Products Advisory Committee convened in open session to discuss and recommend strain composition for the 2026–2027 U.S. influenza vaccines. The meeting opened with roll call introductions from committee members and guest speakers—experts from academia,...

Navigating Private Equity Ownership in the CDMO Space
The Outsourced Pharma Live segment dissected how pharmaceutical companies can evaluate a CDMO’s financial resilience when owned by private‑equity firms. Panelists Jana Spes and Christine Sheaffer outlined precise questions to uncover sponsors’ reinvestment intentions and to confirm that leadership remains...

The BioSecure Act & Unfiltered Supply Chain Realities
The Outsourced Pharma Live panel highlighted the urgent need for supplier‑level visibility of raw materials and packaging as geopolitical tensions threaten supply continuity. Speakers emphasized that transferring technology to established U.S. CDMOs is a capital‑intensive, time‑consuming process. Jana Spes and...

The "Bad News" Stress Test: How CDMOs Handle Escalation
The Outsourced Pharma Live segment highlighted a "bad news" stress test for evaluating CDMOs during due diligence. Panelists Jana Spes and Christine Sheaffer explained how to map escalation pathways by pinpointing key decision‑makers and probing the partner’s problem‑solving culture. They...

What Great CDMO Selection Looks Like In 2026
The Outsourced Pharma Live panel redefines what makes a great CDMO in 2026, shifting focus from raw capacity and technical capability to how partners execute under uncertainty. Christine Sheaffer emphasizes the importance of managing change without triggering contract disruptions, delivering...

The One Quality Metric That Actually Matters
During the Outsourced Pharma Live event, panelists Jana Spes and Christine Sheaffer highlighted three internal quality metrics that cut through marketing hype to reveal a CDMO’s true quality culture. They emphasized deviation closure times, batch record cycle times, and CAPA...

AI Meets Cell Therapy Manufacturing
Senti Biosciences executives Tim Lu and Claire Aldridge told Cell & Gene Live that artificial intelligence is reshaping cell‑therapy manufacturing by speeding up, not replacing, wet‑lab steps. They highlighted robust validation data that demonstrates AI‑driven processes are reliable. The speakers...

Unlocking AI's Potential in Cell Therapy Through Robust Data
In the closing session of Cell & Gene Live, Senti Biosciences executives Tim Lu and Claire Aldridge argued that a high‑quality, diverse data infrastructure is the cornerstone for applying AI and synthetic biology to cell and gene therapies. They stressed...

Why Programmable Logic-Gated Cell Therapies Matter
Senti Biosciences executives Tim Lu and Claire Aldridge argued that next‑generation cell and gene therapies must employ programmable, logic‑gated designs to address diseases where traditional small molecules and biologics fall short. By integrating AI‑driven design and synthetic biology, these therapies...

Safer, Smarter Cell Therapies with AI
In a Cell & Gene Live segment, Claire Aldridge, Ph.D., emphasized that AI and synthetic biology breakthroughs depend on proprietary, well‑annotated experimental data that continuously train models. Tim Lu, M.D., Ph.D. of Senti Biosciences explained how logic‑gated designs combined with...

AI-Designed Logic Circuits for Smarter Cancer Targeting
Senti Biosciences unveiled an AI‑guided workflow that designs paired activating and inhibitory chimeric antigen receptors (CARs) to create logic‑gated circuits for cell therapies. The system automatically optimizes CAR combinations, enabling more precise discrimination between cancerous and healthy cells and delivering...

Faron Pharmaceuticals CEO on €40M Raise for Key Bexmarilimab Trial
Faron Pharmaceuticals announced a €40 million rights offering to finance a pivotal, blinded, randomised phase II trial of its lead immunotherapy, bexmarilimab, in higher‑risk myelodysplastic syndromes (MDS). The earlier open‑label phase I/II study delivered encouraging efficacy signals, prompting the company to focus on...

Peter Fedichev on AI, Longevity & the Future of Anti-Aging Drugs MedTech World Middle East 2026
Peter Fedichev, speaking at MedTech World Middle East 2026, outlined how his company merges biotechnology with artificial intelligence to decode massive clinical and genetic datasets, aiming to uncover targets for drugs that address aging itself. He positioned anti‑aging therapeutics as...

Dr Alireza Daneshvar on Precision Oncology | MedTech World Middle East Dubai 2026
Dr. Alireza Daneshvar highlighted at MedTech World Middle East Dubai 2026 that precision oncology is evolving toward "GPS‑guided" immune cells that can locate and destroy cancer lesions, marking a next‑generation frontier in personalized medicine. He emphasized that the Middle East’s life‑science...

The Tradeoffs Of Continuous Processing
The panel addressed a recurring audience query about whether continuous processing—specifically harvesting antibody‑producing bioreactors and loading directly onto Protein A chromatography—can be implemented under GMP conditions. The discussion framed the issue as a balance between upstream output and downstream handling, asking...

Medicus Pharma Provides Additional Phase 2 Data for SkinJect Cancer Therapy
Medicus Pharma presented additional Phase 2 results for its SkinJect microneedle therapy, aimed at treating basal cell carcinoma without surgery. The data, discussed by CEO Dr. Raza Bokhari, focus on a non‑invasive approach that could alleviate the roughly one‑million annual Mohs...