SELLAS Life Sciences (SLS) to Present SLS009 Data at AACR 2026
SELLAS Life Sciences announced it will present preclinical data on its CDK9 inhibitor SLS009 (tambiciclib) at the AACR 2026 meeting in San Diego. The poster highlights the drug’s ability to induce apoptosis and lower MCL‑1 levels in acute myeloid leukemia (AML) cell lines, including models with ASXL1 and TP53 mutations. Earlier this month the company began enrolling the first patient in a first‑line AML trial combining SLS009 with venetoclax and azacitidine, after meeting FDA guidance following a successful Phase 2 study that exceeded a 20% overall response rate. The data could broaden treatment options for high‑risk AML patients.
![[Comment] New Hope for Neurotrophin Targeting in Osteoarthritis Pain?](https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/754aaf1faeb0d5f3b76618daddf79401.webp)
[Comment] New Hope for Neurotrophin Targeting in Osteoarthritis Pain?
Osteoarthritis (OA) remains a massive global health challenge with no disease‑modifying drugs and only modestly effective analgesics. The anti‑NGF monoclonal antibody, introduced in 2010, delivered unprecedented pain relief but was halted in 2021 after the FDA and EMA flagged joint...
![[Editorial] Politicisation of the US FDA: Eroding Integrity and Trust](https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/2cbcac9eecf69b15e3915028747699be.webp)
[Editorial] Politicisation of the US FDA: Eroding Integrity and Trust
The editorial warns that increasing political interference is eroding the US Food and Drug Administration’s integrity and public trust. With a 2026 budget of $6.8 billion, the FDA remains the world’s most influential drug regulator, tasked with safeguarding safety while accelerating...
PMPRB Consults on Proposed Practice Directions for PMPRB Hearings
The Patented Medicine Prices Review Board (PMPRB) released seven proposed Practice Directions to modernize its hearing procedures. It proposes default paper hearings for evidentiary matters, electronic filing, standardized motions, AI disclosure, virtual oral arguments, and an expedited failure‑to‑file process with...
When Fake Supplements Work
A recent study from Università Cattolica in Milan examined how open‑label placebos affect seniors aged 65 and older. Ninety participants were divided into deceptive placebo, open‑label placebo, and control groups for a three‑week trial. The open‑label group, informed they were...
Going ‘Golden’: K-Biotech May Be Prepping for Its Moment on the Global Stage
Korean biotech is gaining global visibility after the East‑West Biopharma Summit highlighted its first‑in‑class pipelines. The Korean Ministry of Health and Welfare announced that Eli Lilly will invest $500 million over the next five years to collaborate with domestic firms. The deal...
Rubedo Announces Positive Preliminary Results for RLS-1496
Rubedo Life Sciences reported positive preliminary Phase 1 data for RLS‑1496, the first human‑tested GPX4 modulator designed to clear senescent cells. The 4‑week, double‑blind study in the EU showed the drug was well‑tolerated, produced a clear dose‑response, and reduced epidermal thickness...
CHMP Recommends Subcutaneous Form of Sanofi's Sarclisa and Four New Drugs
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions on five products: a subcutaneous formulation of Sanofi’s multiple‑myeloma therapy Sarclisa and four entirely new drugs pending approval. The subcutaneous version aims to simplify...
STAT+: In Private Meetings, White House Works to Win Pharma Companies’ Support for Drug Pricing Bill
The White House has drafted a drug‑pricing bill and is privately meeting with more than a dozen major pharmaceutical companies to secure their backing. The proposed legislation mirrors voluntary pricing agreements the administration previously struck, and notably would allow cash‑paid...
Tapinarof Shows Early, Sustained Gains in Moderate to Severe Atopic Dermatitis: Linda Stein Gold, MD
At the 2026 American Academy of Dermatology meeting, phase 3 ADORING 1 and 2 trials demonstrated that once‑daily tapinarof cream significantly improves rash and itch in moderate to severe atopic dermatitis, with effects evident by week 1 and sustained through eight weeks. The studies...
Switching Between Biosimilars and Their Reference Counterparts with Dr. Sarah Yim
In a recent FDA Q&A, Dr. Sarah Yim explained that the agency has now approved 50 biosimilars covering 15 reference biologics, spanning treatments from oncology to diabetes. She clarified the distinction between biosimilars and interchangeable biosimilars, noting that the latter...
FDA Approves Update to Neffy 1 Mg Label, Removing Age Requirement
The FDA has approved an update to the neffy 1 mg epinephrine nasal spray label, eliminating the previous age minimum of four years. The only remaining eligibility criterion is a patient weight of at least 33 lb, covering children as young as...
How Real-World Data Is Reshaping the NSCLC Patient Journey
Pharma firms are leveraging real‑world data (RWD) to map the patient journey of non‑small cell lung cancer (NSCLC) and uncover social determinants of health that hinder care. The new eBook highlights how gaps in biomarker testing, socioeconomic barriers, and incomplete...
Agentic AI, Virtual Cell, LNP Vaccine Boosters, Engineered Organs, and Mergers
Agentic AI is emerging as a pivotal technology in healthcare, building on generative AI momentum. Xaira Therapeutics unveiled the largest virtual cell model to date, enhancing complex biology simulations. Researchers redesigned lipid nanoparticles to avoid the liver and concentrate in...
Regulatory Actions for March 27, 2026
On March 27, 2026 BioWorld reported a flurry of regulatory actions affecting a broad swath of biopharma and med‑tech companies. The snapshot lists approvals, designations and submissions for firms such as 3D Systems, Agilent, Deciphera, Royal Philips and several others....
J&J’s Darzalex Nets First Self-Administered Cancer Injectable Approval
Johnson & Johnson’s Darzalex (daratumumab) received European Medicines Agency approval for self‑administration, becoming the first oncology injectable cleared for home use. The Type II label change allows patients or caregivers to give the subcutaneous injection after the fifth dose, covering all...
Drug Trials Snapshots: CARDAMYST
Milestone Pharmaceuticals received FDA approval on December 12, 2025 for CARDAMYST, a 70 mg nasal spray of etripamil designed to rapidly convert acute paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm. The pivotal RAPID trial enrolled 255 adults across eight countries, showing...
Drug Digest: Examining the Growing Role of Partnerships in Modern Bioprocessing and Biopharma R&D with Bristol Myers Squibb's Dr. Manisha...
In a debut interview for BioPharm Drug Digest, Bristol Myers Squibb’s senior vice‑president of Product Development, Manisha P. Desai, explains how strategic, end‑to‑end partnerships are reshaping bioprocessing and biopharma R&D. She highlights a shift from traditional fee‑for‑service outsourcing to deep collaborations that integrate...
Celldex Reports Quality of Life Gains in Urticaria Trials
Celldex Therapeutics reported Phase 2 data showing its KIT‑targeting antibody barzolvolimab dramatically improves quality‑of‑life scores for chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU). At Week 52, 94 % of CSU patients achieved a Dermatology Life Quality Index (DLQI) of 0‑1, and...
Blocking TIE2 Protein May Prevent Blood Vessel Defects in the Brain
Researchers at the University of Pennsylvania identified the endothelial receptor TIE2 as a pivotal link between the MEKK3‑KLF2/4 and PI3K signaling cascades that drive cerebral cavernous malformations (CCMs). In mouse models, oral inhibition of TIE2 with the tyrosine‑kinase inhibitor rebastinib...
FDA Approves Novo Nordisk's Once-Weekly Insulin
The U.S. Food and Drug Administration has approved Novo Nordisk’s once‑weekly insulin, the first longer‑acting basal therapy for type‑2 diabetes in the United States. The product, insulin icodec, demonstrated non‑inferior HbA1c reduction and comparable safety to daily basal insulins in...
EU Regulator Backs Sanofi’s Injectable Version of Blood Cancer Drug
The European Medicines Agency has issued a positive opinion on Sanofi’s subcutaneous version of Sarclisa, a drug for multiple myeloma, citing late‑stage trials that proved non‑inferior efficacy to the intravenous formulation. If the European Commission follows the EMA’s recommendation, the...
Webinar: Aligning With the FDA on a Regulatory Pathway To Avoid Decision Day Surprises
A BioSpace webinar highlighted how biotech firms can close the expectation gap with the FDA to avoid last‑minute decision‑day setbacks. Speakers emphasized the FDA’s recent pledge—led by Commissioner Marty Makary and CBER Director Vinay Prasad—to provide regulatory navigation for small companies,...
GSK Reports the EMA’s MAA Acceptance of Bepirovirsen to Treat Chronic Hepatitis B
GlaxoSmithKline announced that the European Medicines Agency has accepted the marketing authorization application for bepirovirsen, an antisense oligonucleotide targeting chronic hepatitis B. The acceptance follows positive Phase III data from the B‑Well 1 and B‑Well 2 trials, which enrolled patients...
AstraZeneca’s in Vivo CAR-T Led to Early Responses, but One Death in China Trial
AstraZeneca’s in‑vivo CAR‑T platform, acquired last year, has entered a Phase I/II trial in China for relapsed/refractory multiple myeloma. Early data show a 33% overall response rate with several partial remissions, but the study also reported one death due to severe...
The Expanding Role of Checkpoint Inhibitors in CSCC Management
The NCCN has revised its guidelines to place checkpoint inhibitors at the forefront of cutaneous squamous cell carcinoma (CSCC) treatment, extending their use beyond metastatic disease to neoadjuvant and adjuvant settings. PD‑1/PD‑L1 agents such as cemiplimab, cosibelimab and pembrolizumab are...
Do GLP-1s Have a Future in Europe?
GLP‑1 receptor agonists are booming in the United States, where roughly 12 % of patients use them, but European uptake lags at about 2 % across the EU and UK. Consumer skepticism—especially in France, Italy and Spain—and the dominance of public‑health reimbursement...
Novartis to Spend up to $2B on Excellergy and Its Next-Gen Xolair Candidate
Novartis announced it will pay up to $2 billion upfront to acquire Excellergy Inc., securing the biotech’s next‑generation anti‑IgE candidate. The move comes as Xolair, Novartis’ blockbuster allergy drug, prepares for imminent biosimilar competition that could erode its market share. By...
Triple Pre-Surgery Therapy May Boost Immunity Against Soft Tissue Sarcoma
Researchers at UCLA Health and Stanford Medicine reported that a neoadjuvant regimen combining hypofractionated radiation, the experimental immunomodulator BO‑112, and anti‑PD‑1 therapy (nivolumab) can reshape the tumor microenvironment of soft‑tissue sarcoma. Preclinical mouse work and a Phase I trial in 14...
‘Milestone’ Research Method Measures Gene Activity Across Whole Mice
Researchers at the University of Chicago have unveiled a whole‑body spatial transcriptomics method that slices frozen mice and maps gene expression across millions of cells in a single cross‑section. Using a cryomacrotome and 600,000 spatial spots, the technique captured activity...
AstraZeneca’s COPD Antibody Gets Phase 3 Wins in Broader-than-Expected Population
AstraZeneca announced that its investigational COPD antibody achieved positive results in two Phase 3 trials, marking a turnaround after a previous mid‑stage failure. The studies demonstrated statistically significant improvements in lung function and exacerbation rates across a broader patient population...
Microbiome-Activated Nanogel Successfully Delivers Butyrate in Mice
A preclinical study in Small describes an inulin‑butyrate nanogel that releases butyrate directly in the inflamed colon of mice, markedly improving colitis outcomes. The nanogel remains stable through the upper GI tract and is enzymatically activated by colonic microbes, delivering...
Simulations Plus and Three Pharma Companies Collaborate on AI-Driven Drug Development
Simulations Plus has launched strategic partnership programmes with three pharmaceutical companies to embed AI‑driven modelling into the drug development lifecycle. The collaborations will integrate Simulations Plus platforms—ADMET Predictor, GastroPlus, Thales and MonolixSuite—into model‑informed drug development (MIDD) workflows, enabling natural‑language interaction and automated...
HaemaLogiX – Precision Immunotherapy for Multiple Myeloma
HaemaLogiX, an Australian clinical‑stage biotech, is developing precision immunotherapies for multiple myeloma by targeting novel antigens KMA and LMA that appear only on malignant plasma cells. Peer‑reviewed research validates these targets, allowing the company to spare healthy plasma cells and...
Novartis Agrees to Acquire Excellergy, Building on Allergy Leadership With Next-Generation Anti-Ige Innovation
Novartis announced a definitive agreement to acquire Excellergy, a private biotech developing next‑generation anti‑IgE therapies. The deal values Excellergy at up to $2 billion in upfront and milestone payments, with closing targeted for the second half of 2026. Exl‑111, Excellergy’s lead...
Insilico Medicine Expands AI-Driven CNS Collaboration with Tenacia in a ~$94.75M Deal
Insilico Medicine and Tenacia Biotechnology have expanded their AI‑driven partnership to create a second central‑nervous‑system (CNS) candidate, now advancing to the preclinical stage. The original March 2025 collaboration combined Insilico’s Pharma.AI platform with Tenacia’s expertise in blood‑brain‑barrier‑permeable small‑molecule inhibitors. Under...
Abcuro Presents the P-II/III (MUSCLE) Study Data on Ulviprubart for Inclusion Body Myositis at GCOM 2026
Abcuro presented Phase II/III MUSCLE trial data for ulviprubart (ABC008) in inclusion body myositis (IBM) at the GCOM 2026 meeting. The study enrolled 272 patients who received either 0.5 mg/kg, 2 mg/kg, or placebo. Across the entire cohort the drug showed only...
AstraZeneca Drug Reduces Flare-Ups of Chronic Lung Disease in Late-Stage Trials
AstraZeneca’s experimental antibody tozorakimab cut moderate‑to‑severe COPD flare‑ups in two phase‑III trials, meeting its primary endpoint. The drug showed a statistically meaningful reduction across both current and former smokers, including those with varying lung damage. The positive data lifted AstraZeneca...
Top HHS Official Makes Impassioned Pitch to Take on China Biotech
Senior HHS official and Medicare administrator Chris Klomp warned that competition with China’s rapidly advancing biotech sector is “a war,” signaling heightened urgency in U.S. policy circles. He highlighted gaps in domestic research funding, manufacturing capacity, and talent pipelines that...
Innovent Shares Jump on First Profit, Obesity Drug Momentum
Innovent Biologics reported its first annual profit, propelled by strong demand for its weight‑loss medication. The Hong Kong‑listed company’s shares surged as much as 7.75%, the biggest jump since late October. The profit milestone underscores the rapid growth of China’s...
STAT+: FDA Approves Rocket Gene Therapy for Rare Immune Disorder
The FDA has granted approval to Rocket Pharma's gene therapy Kresladi for severe leukocyte adhesion deficiency type 1 (LAD‑1), an ultra‑rare immune disorder. The therapy was previously rejected in 2024 due to manufacturing concerns, but the agency cleared it after the...
Eye Drops Made From Pig Semen Deliver Cancer Treatment to Mice
Scientists at Shenyang Pharmaceutical University have engineered eye drops using exosomes derived from pig semen, loaded with a carbon‑dot nanozyme, to breach the retinal barrier in mice. The formulation halted retinoblastoma tumor growth and preserved normal vision over a 30‑day...
Implications of the Rules of the Pharmaceutical Investment Promotion Committee in México.
Mexico published the Rules of the Pharmaceutical Investment Promotion Committee on February 23, 2026, implementing a 2025 decree aimed at boosting pharmaceutical investment and domestic health‑supply production. The rules tie participation in certain public procurement procedures, such as direct awards...
Clarity Secures Large-Scale Manufacturing Agreement for Copper-64
Clarity Pharmaceuticals has signed a manufacturing supply agreement with Theragenics to scale up production of copper‑64, a radiometal used in its investigational prostate‑cancer tracer 64Cu‑SAR‑bisPSMA. The deal leverages Theragenics’ Atlanta‑area facility, which houses 14 cyclotrons capable of producing roughly 100...
Beyond Lipid Nanoparticles: How Custom Polymers and AI May Reshape Gene Therapies
Researchers at Helmholtz‑Zentrum Hereon and partners propose a payload‑driven approach to nucleic‑acid delivery, designing polymeric carriers that are chemically tuned to each DNA, RNA or mRNA payload. The strategy contrasts with the one‑size‑fits‑all lipid nanoparticles that dominate current vaccines and...
LeonaBio Reports Full Year 2025 Financial Results and Provides Business Update
LeonaBio announced it has secured an exclusive global license for the Phase 3 lasofoxifene program, a novel selective estrogen receptor modulator aimed at ESR1‑mutated metastatic breast cancer, and raised $90 million in a private placement that could expand to $236 million with warrant...
Egg-Based Biologics Drive Neion Bio Pharma Deal
Neion Bio, fresh from stealth mode, signed its first co‑development and supply agreement with a major global pharmaceutical company to produce recombinant biologics using its egg‑based Raptor™ platform. The deal provides upfront and milestone payments plus profit‑sharing after commercialization, delivering...
Bulk Drug Substances Used in Compounding
The FDA issued guidance clarifying how compounding pharmacies may use bulk drug substances, also known as active pharmaceutical ingredients. Under section 503A, state‑licensed physicians and pharmacists can compound with bulk substances that meet USP/NF monographs, are components of FDA‑approved drugs, or...
Pinnacle Medicines Raises $89M Series B
Pinnacle Medicines announced the closing of an oversubscribed $89 million Series B financing, co‑led by LAV and Foresite Capital. The biotech firm leverages a proprietary platform that blends physics‑based molecular simulations, AI‑driven design, and advanced peptide chemistry to create oral peptide therapeutics....
Biopharma Industry Pushes Back on FDA's 'America First' User Fee Proposals
The FDA’s upcoming user‑fee framework, dubbed "America First," seeks to tighten eligibility for the small‑business waiver, limiting it to U.S.‑based applicants. Industry groups argue the change politicizes fee policy and could disadvantage foreign‑owned biotech firms that rely on the waiver...