Alkermes’ Richard Pops to Step Down After Three-Decade Run as CEO
Richard Pops will step down as Alkermes CEO on July 31 after a 32‑year tenure, remaining as board chair. COO Blair Jackson will succeed him and join the board during the transition. Under Pops, Alkermes shifted from drug‑delivery to commercial CNS and mental‑health medicines, and now focuses on sleep and orexin therapies. The leadership change coincides with an Avadel acquisition and a forecasted 2026 loss despite 2025 profit, prompting an 8% share dip.
Lilly to Pay CSL $100M to License Monoclonal Antibody Targeting IL-6
Eli Lilly has agreed to pay CSL Ltd. $100 million to license the monoclonal antibody clazakizumab, which targets interleukin‑6. Under the agreement, CSL will keep development rights for the drug’s use in preventing cardiovascular complications in end‑stage kidney disease patients, currently...
FDA Accepts BMS Protein Degrader for Review; Disc Rare Disease Drug Rejected
The FDA has accepted Bristol Myers Squibb’s protein‑degrading multiple myeloma candidate iberdomide for review, with a decision expected by Aug. 17 after a Phase 3 trial showed higher minimal residual disease‑negative rates. In contrast, the agency rejected Disc Medicine’s accelerated‑approval bid for...
Selecting the Optimal Cell Therapy Manufacturing Platform
Developers of cell and gene therapies must choose between fully integrated turnkey platforms and modular, multi‑device systems. Integrated solutions deliver rapid time‑to‑value and simplified workflows, ideal for low‑volume autologous products, but they restrict reagent flexibility and scale. Modular platforms provide...
How to Evaluate Prospective Diagnostic Laboratory Partners for Your Patient Support Program
The pharmaceutical industry now invests over $5 billion annually in patient support programs (PSPs), which boost adherence by roughly 30 % and lower overall healthcare costs. Diagnostic laboratory testing is a cornerstone of these programs, delivering timely data that guides dosing, monitors...
Seres to Lay Off Staff, Pause Top Program in Latest Reboot
Seres Therapeutics, a cash‑strapped microbiome drug developer, will cut about 30 % of its workforce and suspend its lead program SER‑155, which targets graft‑versus‑host disease. The company will redirect resources toward earlier‑stage immunology candidates such as SER‑603, aiming to extend its...
Gilead Dips as ‘Strong’ Earnings Outweighed by High Expectations for New HIV Drug
Gilead Sciences reported a strong fourth‑quarter, with product sales reaching $7.9 billion, a 5% year‑over‑year increase, and its flagship HIV treatments Biktarvy and Descovy surpassing analyst forecasts. The company projected full‑year sales of $29.6‑$30 billion and EPS of $8.45‑$8.85, staying within consensus...
Takeda, Iambic Partner in Latest Pharma AI Push
Japan’s largest drugmaker Takeda has signed a multiyear agreement with AI specialist Iambic Therapeutics, potentially worth more than $1.7 billion. The partnership grants Takeda access to Iambic’s AI‑driven drug discovery platform and a protein‑receptor interaction model, targeting small‑molecule treatments for cancer,...
Hengrui, Kailera Tout Positive Results for Dual-Acting Obesity Pill
Hengrui Pharma and Kailera Therapeutics reported Phase 2 results for oral ribupatide, a dual GLP‑1/GIP obesity pill. In a 166‑patient, 26‑week study the drug produced an average 12 % weight loss versus 2 % for placebo, with over half of high‑dose participants shedding...
Navigating the Complexities of Cell and Gene Therapy Supply Chains
Cell and gene therapies (CGTs) promise breakthrough treatments but demand highly complex supply chains. The process spans cell collection, manufacturing, temperature‑controlled transport, and delivery, requiring strict regulatory compliance and real‑time data integrity. Developers face challenges such as cold‑chain logistics, stakeholder...
White House’s Online Service for Drug Sales Debuts with Limited Impact on Prices
The White House launched TrumpRx, an online portal selling about 40 prescription drugs from manufacturers such as Pfizer, Eli Lilly, and Novo Nordisk at discounted rates. The platform targets cash‑pay consumers, offering "most‑favored‑nation" pricing that mirrors low overseas prices. While the service...
Novo Combination Obesity Shot Meets Goal in Diabetes Trial
Novo Nordisk announced Phase 3 results for its combination injection CagriSema, showing superior glycemic control and greater weight loss than Wegovy in patients with type 2 diabetes and obesity. In the 68‑week trial of more than 2,700 participants, CagriSema lowered HbA1c by...
Amgen Gives up on Its Once-Prized Eczema Drug
Amgen has terminated its collaboration with Kyowa Kirin on the OX40‑targeting eczema drug rocatinlimab, returning all rights to the Japanese partner. The decision follows Phase 3 trials that met primary endpoints but failed to demonstrate superiority over established therapy Dupixent and showed...
Politicization Runs Deeper than Ever at FDA, Risking Long-Term Impacts
The FDA has undergone an unprecedented wave of politicization in the past year, marked by mass staff departures, early retirements, and a surge of political appointees across senior roles. This shift has altered advisory committees, review processes, and introduced the...
Express Scripts Considering Settlement in FTC Insulin Price Lawsuit
Cigna’s pharmacy‑benefit manager Express Scripts is reportedly close to a settlement with the Federal Trade Commission over allegations that the PBM helped inflate insulin prices. The FTC has paused the broader case to allow settlement talks with Express Scripts, CVS...
From Detection to Prevention: How Sponsored Testing Can Transform Patient Outcomes
Diagnostic testing is evolving from a purely detection tool to a preventive strategy, especially in Canada where provincial coverage varies. Pharmaceutical sponsors are launching paid testing programs that eliminate cost barriers, granting patients access to advanced risk‑identification assays for conditions...
The Crucial Role of Raw Material Selection for Success in Cell Therapy Manufacturing
Cell therapy’s promise hinges on manufacturing consistency, which is driven by the quality of raw (ancillary) materials such as media, cytokines, scaffolds, and disposables. Variability in these inputs can cause fluctuations in cell potency, safety, and regulatory compliance, especially when...
FDA Lays Out New Path to Speed Development of Multiple Myeloma Drugs
The FDA released new guidance allowing accelerated approval of multiple myeloma therapies based on minimal residual disease (MRD) or complete response endpoints. This shift lets sponsors use single‑arm or randomized trials focused on deep molecular responses, reducing the need for...
J&J Eyes $100B in Sales Amid Gains for Cancer, Immune Drugs
Johnson & Johnson reported a 9.1% rise in fourth‑quarter sales to $24.6 billion and projected full‑year revenue of $100‑101 billion for 2026, up from $94.2 billion. The company’s growth is driven by strong cancer and immune‑therapy sales, offsetting a steep decline in its...
When Every Day Counts: Building CRO Partnerships on a Foundation of Trust, Care and Precision
Almac Clinical Services positions its "Supply with Care" model as a trust‑based solution for CROs facing costly clinical‑supply delays. The firm highlights a global depot network, real‑time visibility tools, and dedicated CRO operational leads to keep medicines on schedule. By...
The Patient Retention Crisis Is Happening Before Enrollment Even Begins
A new State of Enrollment 2026 report reveals that most patient loss happens before enrollment, with 48% dropping out during pre‑screening, 38% at phone screening, and 36% during eligibility review. This upstream attrition is invisible on traditional enrollment dashboards, shifting the...
Boston Scientific to Acquire Penumbra for $14.5B
Boston Scientific announced a $14.5 billion acquisition of Penumbra, paying $374 per share in cash and stock. Penumbra’s portfolio of clot‑removal and embolization devices will broaden Boston Scientific’s reach into fast‑growing thrombectomy and vascular bleeding markets. The deal values Penumbra at...
Digital Health Funding Increases in 2025, Spurred by AI: Report
Digital health funding jumped to $14.2 billion in 2025, the highest level since 2022, driven largely by artificial‑intelligence startups. AI‑focused firms secured 54% of total capital and enjoyed a 19% premium in average deal size versus non‑AI peers. Although the total...
What Sanofi’s Multiple Sclerosis Troubles Could Mean for the Space
Sanofi’s BTK inhibitor tolebrutinib failed pivotal late‑stage trials in both relapsing and primary progressive multiple sclerosis, prompting the FDA to reject its approval over liver toxicity concerns. The setback highlights the challenges of BTK‑targeted therapies, even as competitors like Roche’s...
Building More Sustainable Cold Chain Packaging Through Innovation
The pharmaceutical cold‑chain still depends on single‑use expanded polystyrene (EPS) for reliable temperature control, but that reliance generates a massive waste stream and high carbon emissions. Global EPS production exceeds 5 million metric tons annually, yet recycling rates linger below 30 percent,...
5 Questions Facing Biopharma in 2026
The 2026 J.P. Morgan Healthcare Conference highlighted five critical questions for biopharma: whether the 2025 recovery will sustain, if the recent surge in M&A will continue, how the U.S. will counter China’s fast‑growing biotech sector, whether FDA leadership turmoil will...
Best Practices for COA Selection: Building a Stronger Foundation for Clinical Trials
Selecting the right clinical outcome assessment (COA) is now a pivotal determinant of trial success, influencing regulatory acceptance and data relevance. A Pearson Research survey shows 91% of investigators feel under‑prepared, with licensing, translation, and rater training cited as the...
Eikon, a High-Profile Startup Led by Merck Vets, Seeks an IPO
Eikon Therapeutics, a biotech founded in 2019 by former Merck executives, has raised more than $1 billion and announced plans for an initial public offering. The company’s pipeline includes four clinical candidates, with its lead asset EIK1001 advancing in a Phase 2/3...
Aurora Sets Out to Capitalize on FDA’s New Framework for Bespoke Drug Therapies
Biotech startup Aurora Therapeutics, co‑founded by Nobel laureate Jennifer Doudna and genetic‑medicine pioneer Fyodor Urnov, announced a $16 million seed round from Menlo Ventures. The company plans to leverage the FDA’s newly introduced “plausible mechanism” regulatory pathway to fast‑track multiple CRISPR‑based...
Diagonal Banks Another $125M for ‘Clustering’ Antibody Drugs
Biotech startup Diagonal Therapeutics secured $125 million in a Series B financing, bringing its total capital raised since 2024 to over $250 million. The funding will advance its lead candidate, DIAG723, a clustering antibody designed to reactivate the ALK1 pathway...
Lilly Snaps up Ventyx for $1.2B in Pursuit of Oral Immune Drugs
Eli Lilly agreed to acquire Ventyx Biosciences for $1.2 billion, paying a 62 % premium to secure the oral NLRP3 inhibitor VTX3232. The drug showed a 64 % reduction in a cardiac‑risk biomarker and synergistic effects with semaglutide in obesity‑related trials. The purchase expands...
5 FDA Decisions to Watch in the First Quarter of 2026
Eli Lilly’s oral GLP‑1 candidate orforglipron received a national‑priority voucher, accelerating its FDA review and threatening Novo Nordisk’s recent oral Wegovy launch. Disc Medicine’s repurposed schizophrenia drug bitopertin is on the brink of approval for the rare disease erythropoietic protoporphyria,...
Alumis Soars as TYK2 Drug Hits Mark in Psoriasis Trials
Alumis announced that its TYK2 inhibitor envudeucitinib met primary endpoints in two Phase 3 psoriasis trials, delivering 74% of patients achieving PASI‑75 after four months. The data suggest efficacy comparable to leading oral candidates and injectable biologics, prompting the stock to...