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Glass vaccine vials with silver caps and red seals on a reflective surface against a soft blue background, one vial lying on its side
Biopharma & Biotech

31-Valent Pneumococcal Vaccine Clears Phase 3, but Older-Adult Uptake Decides Its Reach

Vaxcyte's VAX-31 matched both leading adult pneumococcal vaccines in Phase 3, but most at-risk adults still get no pneumococcal shot.

October 9, 2026
An anatomical model of a human knee joint on a wooden table, with an empty hospital bed softly out of focus against a yellow wall behind it
Clinical Trials & Research

Non-Opioid Pain Pill Cuts Refills After Knee Replacement, but Coverage Decides Access

Suzetrigine patients were more likely to skip opioid refills after knee replacement, but only half could get it through insurance.

October 8, 2026
Two orange insulin injection pens lying diagonally on a plain light blue surface
FDA & Compliance

Once-Weekly Insulin Wins FDA Approval, but Dose Oversight Shifts to Care Teams

Lilly's Onswik cuts basal insulin from 365 injections a year to 52. With hypoglycemia results mixed across trials and nursing homes slow to adjust doses, the harder work shifts to the care teams managing the week between injections.

October 7, 2026
An empty adjustable bed in a long-term care room with sage green walls, an IV pole, a chart clipboard on the footboard and an armchair beside it
Clinical Trials & Research

Alzheimer's Psychosis Drug Narrowly Misses, but Nursing Homes Still Need a Safer Option

Acadia's remlifanserin missed its Phase 2 primary endpoint with a p-value of 0.0603 but matched placebo on safety. In nursing homes, where CMS now counts 16.98% of long-stay residents on antipsychotics, a safer option could matter as much as efficacy.

October 6, 2026
Rows of brain MRI scans printed on film, showing axial and sagittal views of the head
Biopharma & Biotech

Parkinson's Drug Tavapadon Wins FDA Approval, but Falls and Depression Go Untreated

AbbVie's Juvmo is the first selective D1/D5 agonist for Parkinson's disease, but in Medicare data 53% of patients had depression, only 2% saw a mental health professional and just 9% reached a movement disorders specialist.

October 5, 2026
Blurred shelves of boxed medicines in a pharmacy stockroom
Regulatory & Policy

CMS Locks In Most-Favored-Nation Pricing for Part B, but Secret Deals Cloud the Savings

CMS finalized its GLOBE model on September 30, tying Part B drug rebates to prices in 19 other countries. With private pricing deals already signed and net prices undisclosed, the savings are harder to verify.

October 2, 2026
A clear 96-well laboratory plate in close focus, with green and yellow liquid samples in its wells
Biopharma & Biotech

Gene Therapy Priced at $3.95 Million Moves the Fight to Treatment Centers and Payers

Ultragenyx's Fayuvi, approved September 18 for Sanfilippo syndrome type A, lists at $3.95 million against an estimated $8 million lifetime cost of care. The harder questions are who pays upfront and who staffs the treatment centers that deliver the dose.

October 1, 2026
A gloved hand holding an open microcentrifuge tube of green liquid beneath a pipette tip in a research laboratory
Clinical Trials & Research

FDA's Expedited IND Pilot Speeds First-in-Human Trials, but Research Site Teams Must Keep Pace

The FDA's new Expedited IND Pilot will pair sponsors with research institutions to shorten first-in-human timelines that can run up to two years, but site turnover of 35% to 61% a year could absorb the time it saves.

September 30, 2026
An older woman with grey hair and glasses holding a purple exercise ball at arm's length during a physical therapy session
Regulatory & Policy

Medicare's GLP-1 Bridge Tops 600,000 Seniors, but Muscle Loss Goes Unmanaged

Medicare's $50-a-month GLP-1 Bridge reached 600,000 seniors in two months, but its prior authorization asks only for lifestyle counseling, leaving the muscle and bone older patients lose alongside the weight unmanaged.

September 29, 2026
A gloved hand holding a blood sample tube above a rack of purple-capped collection tubes in a diagnostics laboratory
FDA & Compliance

FDA Advisers Back a Multi-Cancer Blood Test, but Follow-Up Capacity Lags

An FDA panel backed GRAIL's Galleri test 7-2 on benefit and risk, but a split effectiveness vote, a failed NHS primary endpoint and scarce radiologists and endoscopists put the pressure on what happens after a positive result.

September 28, 2026
Psilocybin mushrooms growing in a clear laboratory culture container held in a gloved hand
Biopharma & Biotech

Psychedelic Depression Drugs Near Approval, but Clinic Capacity Is the Bottleneck

Compass and Definium are closing in on FDA filings, but with about 4 million Americans living with treatment-resistant depression and roughly 100,000 on Spravato, the constraint is shifting from the molecule to the clinic chair.

September 25, 2026
A printed DXA bone density report showing hip and spine scans, a T-score chart and a 10-year fracture risk summary
Clinical Trials & Research

Osteoporosis Trials Just Got Faster, but Most Fracture Patients Still Go Untreated

FDA's new hip bone density endpoint lets sponsors run smaller, shorter Phase III trials, but real-world data shows half of hip fracture patients are still untreated a year after surgery.

September 24, 2026
Three blue injection pens resting on a dark wooden table
Biopharma & Biotech

GLP-1 Evidence Is Getting Stronger Just as Employers Pull Back on Coverage

New research ties sustained GLP-1 use to thousands of avoided knee replacements and shows one-year persistence nearly doubling, yet employer coverage for obesity fell from 72% to 60% in a single year.

September 23, 2026
A clinical research nurse in scrubs reviewing patient data on a laptop in a clinic office
Clinical Trials & Research

Clinical Trial Staffing Is Stabilizing, But Patient Dropout Is Still Costing Sponsors Billions

Coordinator retention is climbing back toward pre-pandemic levels, yet life sciences remains the world's most talent-scarce industry and patient dropout still runs as high as 30%, exposing a workforce problem sponsors haven't solved.

September 22, 2026
Life sciences supply chain resilience
FDA & Compliance

Life Sciences Supply Chain Resilience: Lessons from Three Years of Disruption

Three years on, we assess which companies have genuinely rebuilt resilience versus which have made only cosmetic changes, and what a durable supply chain model actually requires.

September 18, 2026
Clinical trial design and failure risk
Clinical Trials & Research

The Hidden Cost of a Failed Phase III: New Data on Trial Design and Risk

Quantitative analysis of 900 Phase III programmes reveals that avoidable trial design flaws account for nearly 40% of late-stage failures, creating a systemic drag on industry R&D productivity.

September 14, 2026
Drug pricing reimbursement pressures
Regulatory & Policy

The Drug Pricing Puzzle: Why Reimbursement Pressures Are Behaving Differently This Cycle

Stubborn pockets of payer resistance are persisting even as biosimilar penetration increases. What the data reveals about the structural shifts driving this divergence, and how long it can last.

September 8, 2026
Real-world evidence drug approvals
HealthTech & Innovation

Real-World Evidence Is Reshaping Drug Approvals: What Sponsors Need to Know

Regulators are increasingly accepting real-world evidence to support approval and label expansion decisions. Sponsors who understand the new evidentiary standards will have a significant competitive advantage.

September 2, 2026
Life sciences talent retention crisis
Strategy & Leadership

The Life Sciences Talent Crisis: Why R&D Teams Are Struggling to Hire and Retain

Life sciences teams are losing top scientists to better-paying roles in tech and consulting at an accelerating rate. Leaders who have solved the retention problem share what actually works.

August 28, 2026
Precision medicine clinical research
Clinical Trials & Research

Precision Medicine vs. Broad Market: New Research Challenges Conventional Wisdom on Long-Term Trial ROI

A sweeping meta-analysis of two decades of clinical data asks whether the precision medicine premium has permanently compressed, and what that means for portfolio construction in 2026.

August 25, 2026
Biotech M&A deal pipeline
Biopharma & Biotech

Biotech M&A Rebounds as Venture Capital Finally Unlocks the Deal Pipeline

After two years of suppressed deal flow, the biotech acquisition pipeline is opening up. Dealmakers and corporate development teams share what the next 18 months are likely to look like, and which therapeutic areas will lead.

August 20, 2026
Digital health pharma disruption
HealthTech & Innovation

Digital Health Is Eating the World, and Big Pharma Is Finally Fighting Back

Digital-native health platforms have captured $28 billion in life sciences revenue in three years. We look at which legacy pharma institutions are mounting a credible competitive response, and which are losing ground.

August 17, 2026
CSO R&D strategy AI-driven era
Strategy & Leadership

The CSO's 2026 Reckoning: How Life Sciences Leaders Are Rethinking R&D Strategy in an AI-Driven Era

As AI reshapes every function of the enterprise, chief scientific officers face a defining moment: transform the R&D model or risk being outpaced by faster-moving competitors.

August 12, 2026
CSO CEO strategic partnership
Strategy & Leadership

Beyond the Lab: How Chief Scientific Officers Are Becoming the CEO's Closest Partner

New research maps the capabilities separating the CSOs who are driving strategic transformation from those still managing pipelines, and the specific behaviours that define the difference.

August 7, 2026
Biosimilar competition patent cliffs
Biopharma & Biotech

Biosimilar Competition Intensifies as Patent Cliffs Accelerate Market Entry

A wave of blockbuster biologics is losing patent protection over the next three years. New data on biosimilar penetration rates reveals which therapeutic categories face the steepest revenue erosion.

August 4, 2026
FDA regulatory strategy pipeline planning
Regulatory & Policy

FDA's Pivot Strategy: What the Agency's Next 18 Months Mean for Pipeline Planning

Life sciences leaders need a framework for navigating the FDA's evolving approval posture. Regulatory strategists break down three scenarios and the pipeline planning implications of each.

July 30, 2026
FDA clinical trial transparency rules
FDA & Compliance

FDA's New Clinical Trial Transparency Rules: A Practical Roadmap for Regulatory Affairs Teams

The FDA's updated requirements are now in effect. Regulatory and legal teams walk through the six areas most likely to require new data infrastructure, revised submissions, and external audit support.

July 27, 2026
mRNA technology therapeutic applications
Biopharma & Biotech

mRNA Technology Beyond COVID: The Next Wave of Therapeutic Applications

The technology that powered COVID-19 vaccines is now being applied to oncology, rare disease, and infectious disease programmes at an unprecedented pace.

July 22, 2026
AI machine learning clinical trials
HealthTech & Innovation

AI in Clinical Development: How Machine Learning Is Compressing Trial Timelines

AI-powered trial design and patient recruitment tools are delivering measurable results. We analysed 80 trials and found that programmes using adaptive AI protocols completed Phase II a median of 14 months faster.

July 17, 2026
Cell and gene therapy pipeline
Clinical Trials & Research

Cell and Gene Therapy Pipeline Hits Record Highs, but Commercialisation Gaps Remain

The cell and gene therapy pipeline has never been larger, with over 1,000 active programmes globally. Yet the gap between clinical promise and commercial execution is widening.

July 14, 2026
GLP-1 manufacturing cost models
Regulatory & Policy

GLP-1 Fallout: How Life Sciences Leaders Are Rebuilding Global Manufacturing Cost Models

The ripple effects of GLP-1 demand are forcing life sciences supply teams to rebuild cost models from the ground up. Here is the analytical framework leading CSOs are using to stress-test their manufacturing assumptions.

July 9, 2026
IRA drug pricing provisions biotech
FDA & Compliance

IRA Drug Pricing Provisions Are Here, and Most Mid-Size Biotechs Aren't Ready

The IRA's Medicare drug price negotiation framework is now live. A frank assessment of where most companies stand, which gaps are most urgent to close, and what payers are likely to scrutinise first.

July 6, 2026
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