Waters Expands Cervical Cancer Screening Access with At-Home HPV Test Approval
The U.S. FDA has cleared the Onclarity HPV Self‑Collection Kit and approved the BD Onclarity HPV Assay for at‑home cervical cancer screening. The kit detects every high‑risk HPV genotype, delivering both individual and pooled results, and is processed on the automated BD COR System. Waters is partnering with the National Cancer Institute on the SHIP trial to validate self‑collection accuracy, and plans to roll out prescription‑based kits that insurers are expected to cover nationwide.
Vanda Pharmaceuticals Initiates Thetis Study of Nereus for GLP-1–Induced Vomiting Prevention
Vanda Pharmaceuticals has launched the Phase‑III Thetis trial to test Nereus (tradipitant) against placebo for preventing vomiting in patients on GLP‑1 receptor agonists. The study’s primary endpoint is the proportion of participants who remain vomiting‑free, with topline data slated for...
Why Anti-Cancer Drugs Often Fall Short of Expectations
Recent analyses reveal that many anti‑cancer drugs underperform because they confront complex tumor biology that preclinical studies often oversimplify. Heterogeneous cell populations, rapid emergence of resistance pathways, and inadequate biomarker strategies limit clinical efficacy. Additionally, safety concerns restrict dose intensity,...
Granules India to Tighten Oversight After US FDA Warning, Exec Says
Granules India, a leading global paracetamol and API producer, is tightening oversight after the U.S. FDA cited GMP, equipment cleaning and record‑keeping violations at its Telangana plant. The company will digitise logbooks, batch records and badge cards, increase gemba walks,...
FDA Seeks Permanent Future for Rare Pediatric Priority Review Vouchers
The FDA announced plans to permanently authorize the rare pediatric disease priority‑review voucher (PRV) program as part of its $7.2 billion FY 2027 budget request. The initiative ends the cycle of four‑year reauthorizations that left the program in limbo after its 2024...
Shionogi Secures $482m BARDA Contract to Tackle AMR Crisis
Japanese pharmaceutical firm Shionogi has secured a BARDA contract worth up to $482 million to build a U.S.-based manufacturing facility for its injectable antibiotic Fetroja (cefiderocol). The agreement provides $119 million upfront and up to $363 million over several years, enabling production aimed...
BIO Coffee Chat: Price Controls Like MFN Harm Access, Increase Costs
BIO’s March Coffee Chat highlighted how recent U.S. drug‑price policies, including the Inflation Reduction Act’s out‑of‑pocket cap and proposed Most Favored Nation (MFN) pricing models, are unintentionally raising patient costs and tightening access. Evidence shows beneficiaries often pay more than...
Astellas Exercises Option to License Dyno’s AAV Capsid for AI-Designed Gene Delivery
Astellas has exercised its option to license an AI‑engineered adeno‑associated virus (AAV) capsid from Dyno Therapeutics for skeletal muscle gene delivery, marking the first licensed asset from their 2021 partnership. The capsid, created using Dyno’s large‑scale in‑vivo data‑driven AI models,...
STAT+: Biotech VCs, Used to a Winning Formula in Drug Development, Face Disruption
For decades, biotech venture capitalists have followed a formula—seed university science, add seasoned pharma executives, and invest tens of millions—to generate drugs and returns. That playbook is now under pressure as Chinese biotech firms deliver research faster and cheaper, and...
FDA Guidance May Move Goalposts For Form 483 Responses
The FDA released draft guidance that reshapes how drug manufacturers respond to Form 483 inspection observations. The guidance introduces a standardized framework for documenting, assessing and correcting systemic quality issues. While the clearer process aims to improve regulatory consistency, it...
Anumana Secures the US FDA 510(k) Clearance for Its ECG-AI Algorithm to Detect Risk of Cardiac Amyloidosis Early
Anumana has received FDA 510(k) clearance for its ECG‑AI algorithm, a software‑as‑a‑medical‑device that screens for cardiac amyloidosis using routine 12‑lead electrocardiograms. The AI model, originally developed at the Mayo Clinic, identifies subtle waveform patterns invisible to clinicians, enabling early risk...
The FDA Has Released Draft Guidance for NAMs Validation – Now What?
On March 18, 2026 the FDA issued draft guidance for validating new approach methodologies (NAMs), including complex in‑vitro models (CIVMs). The guidance centers on four validation principles—context of use, human biological relevance, technical characterization, and fit‑for‑purpose. The 11th 3D Tissue Models Summit in Boston...
Virica Biotech and FUJIFILM Biosciences Collaborate Under the Canada-Japan Co-Innovation Program to Advance AAV Production Enhancers
Virica Biotech secured advisory services and funding from NRC IRAP under the Canada‑Japan Co‑Innovation Program to partner with FUJIFILM Biosciences. The joint effort will optimize Virica’s Viral Sensitizer (VSE) formulation for FUJIFILM’s BalanCD® HEK293 media, aiming to boost adeno‑associated virus (AAV)...
GLP-1 Drugs Shown to Fight Arthritis Independent of Weight Loss
A Chinese study found that semaglutide, a GLP‑1 drug best known for diabetes and weight‑loss treatment, can halt cartilage degradation and even thicken cartilage in osteoarthritis patients, independent of weight loss. In mice, only the semaglutide‑treated group showed reduced joint...
Long-Term Follow-Up Results of Topical Imiquimod for High-Grade Cervical Intraepithelial Neoplasia in Young Women: An Original Research
A retrospective single‑arm cohort studied topical imiquimod in nulliparous women under 35 with CIN 2/3 to avoid cervical excision. After eight weekly applications, 96% of lesions regressed to at least CIN 1 and 47% cleared high‑risk HPV. Long‑term follow‑up showed 81.6% complete...
Daily Briefing: A Treatment to Reverse Cellular Ageing Is About to Be Tested in People
Researchers are preparing the first human trial of a "partial reprogramming" therapy that uses targeted protein expression to reverse cellular ageing. The approach, derived from stem‑cell reprogramming techniques, has shown organ‑level rejuvenation in mice and could, if safe, reshape how...
One Woman, Three Autoimmune Diseases: CAR-T Therapy Vanquishes Ultra-Rare Disease Trio
German researchers used a single dose of engineered CAR‑T cells to treat a 47‑year‑old woman suffering from three ultra‑rare autoimmune diseases—autoimmune haemolytic anaemia, immune thrombocytopenia, and antiphospholipid syndrome. After previous failures with steroids and nine other therapies, her own T...
Nxera Pharma Achieves Second Development Milestone in Collaboration with Eli Lilly Targeting Metabolic Diseases
Nxera Pharma announced it has reached a second development milestone in its multi‑target collaboration with Eli Lilly, triggering an undisclosed payment. The achievement validates Nxera’s NxWave™ GPCR structure‑based platform for identifying small‑molecule binders. Under the 2022 agreement, Lilly will now lead...
Hong Kong: Leading the Way in Smart Biopharmaceutical Innovation
The University of Hong Kong has signed a strategic research agreement with a leading pharmaceutical company to fast‑track drug discovery in Hong Kong. The partnership centers on anti‑infective therapies, leveraging advanced synthetic chemistry and chemical biology to create novel candidates...
Organ-on-Chip Integrated Into Preclinical Glioblastoma Research
German biotech Dynamic42 and oncology firm EPO have formed a strategic partnership to embed organ‑on‑chip technology into preclinical glioblastoma research. The collaboration merges Dynamic42’s human‑based blood‑brain barrier‑on‑chip platform with EPO’s tumor models and translational expertise, targeting more predictive drug testing....
Malaysia, Australia Empower Women to Lead in Biotechnology Innovation
Malaysia and Australia launched an inaugural biotechnology session aimed at boosting women’s leadership in high‑growth sectors such as vaccine manufacturing and bioprocessing. The partnership aligns with Malaysia’s 2021‑2030 STI policy and Biotechnology Policy 2.0, leveraging Australia’s life‑science expertise and Malaysia’s strong...
Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination
Blaine Labs, Inc. announced a voluntary nationwide recall of three lot numbers of its Revitaderm® and Tridergel™ wound‑care gels after detecting the environmental bacterium Lysinibacillus fusiformis. The affected products, 1‑oz and 3‑oz bottles containing 0.1% benzalkonium chloride, were distributed to...
Tackling Translation: The Parker Institute Model
The Parker Institute for Cancer Immunotherapy marks its tenth anniversary by spotlighting a deliberate approach to translating scientific discoveries into medicines. Founder Karen Knudsen notes that while U.S. discovery remains strong, the nation struggles with moving breakthroughs through development pipelines....
Life Bio’s Trial: Is the FDA Warming to Rejuvenation?
Life Biosciences received FDA clearance for its ER-100 investigational new drug, marking the first human trial of a cellular reprogramming therapy aimed at the eye. The Phase 1 study will enroll patients with glaucoma or non‑arteritic anterior ischemic optic neuropathy, emphasizing...
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PERMIT PARALYSIS: How a Single Administrative Error Sparked 10 Months of Critical Medication Shortages in Eswatini
An administrative error in November 2023 led Eswatini’s Ministry of Health to suspend Fortunate Bhembe, the sole official authorized to sign import permits for controlled medicines. With no successor appointed, the country’s primary supplier, SwaziPharm, could not secure new imports,...
Key Differences Between Biotechnology and Pharmaceutical Industries
The article clarifies that biotechnology firms develop medicines using living organisms, while pharmaceutical companies rely on synthetic chemical processes. It highlights the rapid growth of the biotech sector, projecting a global market of $6.34 billion by 2035, and notes that biotech...
Neuroblastoma Tumor Growth in Mice Suppressed by Blocking Enzyme to Inhibit mTOR Signaling
Researchers at The Hebrew University of Jerusalem identified neuronal nitric oxide synthase (nNOS) as a driver of neuroblastoma growth and showed that its inhibition suppresses mTOR signaling. Using the selective inhibitor BA-101 and siRNA knock‑down, they reduced nitric oxide production,...
AbbVie Files Lawsuit to Address ‘Outdated’ Drug Discount Eligibility Program
AbbVie has filed a lawsuit against the U.S. Health and Human Services Department seeking updated guidance on the 340B drug discount program. The company argues that current rules allow hospitals and clinics to claim discounts for patients with minimal or...
Lupin Shares to Be in Focus on Thursday as USFDA Approves Dapagliflozin and Metformin Tablets
Lupin announced U.S. FDA approval of its dapagliflozin and metformin hydrochloride extended‑release tablets, covering four dosage strengths and matching the brand Xigduo XR in efficacy. The approval follows the company’s recent acquisition of European eye‑care specialist VISUfarma, which contributed roughly $58 million...
Subcutaneous Tepezza Demonstrates Phase III Efficacy in Thyroid Eye Disease
Amgen reported that its subcutaneous formulation of teprotumumab‑trbw (Tepezza) met the primary endpoint in a phase III trial for moderate‑to‑severe active thyroid eye disease, with 76.7% of patients achieving a ≥2 mm proptosis reduction versus 19.6% on placebo. The study also showed...
Umary and Related Products
The U.S. Food and Drug Administration has issued a warning that Umary and Amazy dietary supplements contain undeclared prescription‑drug ingredients, including dexamethasone, diclofenac, and omeprazole. Laboratory testing confirmed these hidden drugs, prompting voluntary nationwide recalls by several distributors. Parallel alerts...
High-Dose Wegovy Debuts at $399 for Self-Paying Patients
Novo Nordisk has launched Wegovy HD, a 7.2‑mg semaglutide injection, priced at $399 per month for self‑paying patients. The FDA approved the higher‑dose formulation in March, expanding the company’s weight‑loss portfolio beyond the previous 2.4‑mg limit. The new price is...
PhRMA Head Steve Ubl to Step Down at End of Year
Steve Ubl, who has led the pharmaceutical lobbying coalition PhRMA for more than a decade, announced he will step down at the end of the year. Under his stewardship, the group amplified its influence on Capitol Hill, championing policies that...
Forecasting Protein Aggregation with an Improved Algorithm
Scientists at the Autonomous University of Barcelona have released the fourth generation of their protein‑aggregation forecasting algorithm, which leverages AlphaFold structural data and molecular‑dynamics simulations. The tool lets users evaluate aggregation risk, explore mutations, scan protein families, and assess pH...
Faster Process Development via “Transfer Learning”
Transfer learning—a form of AI that reuses models trained on historic data—promises to accelerate biopharmaceutical process development. By applying existing predictive models to new, related fermentations, companies can forecast critical metrics such as viable cell density and product titre from...
Trump’s New Pharmaceutical Tariffs Will Hit Small Drugmakers Hardest
The Trump administration revived pharmaceutical tariffs, imposing a 100% base duty on imported patented drugs and their active ingredients. While generic medicines and UK imports are exempt, firms with Most Favored Nation (MFN) agreements—such as Pfizer and Eli Lilly—are shielded, and...
Redefining Bioprocessing Using Reservoirs of Biochemical Diversity
Scientists have uncovered a trove of heat‑tolerant glycosyltransferase enzymes in the rhizosphere soils of desert plants in Saudi Arabia. These extremophile enzymes, identified through metagenomic analysis, could improve glycosylation steps in biologics manufacturing by operating under high‑temperature, low‑moisture conditions. The...
Plant Molecular Farming Comes of Age
Plant molecular farming (PMF) has evolved into a scalable, GMP‑compatible platform for producing complex biologics, leveraging low‑energy plant growth and advanced transient‑expression systems. Recent advances in sensor technology, AI‑enabled host engineering, and digital manufacturing have lowered infrastructure costs and accelerated...
FDA Recommends Health Care Professionals Discuss Naloxone with All Patients when Prescribing Opioid Pain Relievers or Medicines to Treat Opioid...
The FDA has mandated that manufacturers add naloxone guidance to the prescribing information for all opioid pain relievers and medications for opioid use disorder (OUD). Health‑care professionals must now discuss naloxone availability with every patient receiving an opioid prescription or...
Bayesian Statistical Analysis (BSA) Demonstration Project
The FDA’s CDER Center for Clinical Trial Innovation (C3TI) has launched a Bayesian Statistical Analysis (BSA) demonstration project to encourage the use of Bayesian methods in simple phase 3 trials. The program lets sponsors collaborate with FDA statisticians to apply Bayesian...
FDA Warns About Risks of Dental Problems Associated with Buprenorphine Medicines Dissolved in the Mouth to Treat Opioid Use Disorder...
The FDA has issued a new safety warning that buprenorphine tablets and films dissolved under the tongue or against the cheek can cause dental problems such as cavities, abscesses, and even tooth loss. The alert applies to both single‑ingredient buprenorphine...
FDA Issues Series of Guidances Under Drug Competition Action Plan
The FDA released three new guidances under its Drug Competition Action Plan to streamline generic drug reviews. A final guidance clarifies the use of Information Requests and Discipline Review Letters, a revised draft updates procedures for aligning ANDA labeling with...
Approved First Generic for Apokyn Injection Cartridges Requires Separately Packaged Pen
The FDA approved Sage Chemical’s generic apomorphine hydrochloride cartridges, the first generic version of Apokyn for treating "off" episodes in advanced Parkinson’s disease. The generic cartridges work only with the proprietary Apokyn Pen, which must be obtained separately through specialty...
FDA Announces Evusheld Is Not Currently Authorized for Emergency Use in the U.S.
The FDA revised Evusheld's Emergency Use Authorization on Jan. 26, 2023, limiting its use to situations where susceptible SARS‑CoV‑2 variants comprise 90% or less of national cases. With current CDC data showing over 90% of circulating variants are resistant, Evusheld...
FDA Updates Sotrovimab Emergency Use Authorization
The U.S. Food and Drug Administration revoked the Emergency Use Authorization for sotrovimab on April 5, 2022, after CDC data showed the Omicron BA.2 sub‑variant accounted for more than 50 % of cases in every HHS region. Earlier in the year the agency...
Advancing Novel Surrogate Endpoints For Rare Disease Drug Development Workshop - 05/18/2026
The FDA is hosting a virtual workshop on May 18, 2026 to advance novel surrogate endpoints for rare disease drug development. The event is part of the Rare Disease Endpoint Advancement (RDEA) Pilot Program, mandated by PDUFA VII and FDORA, which requires up...
FDA Works to Protect Consumers From Potentially Harmful OTC Skin Lightening Products
The U.S. Food and Drug Administration issued warning letters to twelve companies for selling over‑the‑counter skin‑lightening products that contain hydroquinone, an ingredient not approved for OTC use. The agency highlighted serious adverse events such as rashes, facial swelling, and permanent...
New Nasal Flu Vaccine Shows Promise in Mice
Researchers at Georgia State University have engineered an intranasal influenza vaccine that uses cell‑derived extracellular vesicles (EVs) to display inverted hemagglutinin (HA) proteins. The upside‑down HA exposes the conserved stalk region while masking the variable head, prompting cross‑protective immunity. In...
Merck Adjusts Its Vaccine Supply Deal in China; Soleno Withdraws EU Application
Merck and its Chinese partner Zhifei have revised their COVID‑19 vaccine supply agreement, lowering the committed volume and adding a flexible delivery schedule to reflect waning demand. The updated contract preserves Zhifei’s exclusive distribution rights but shifts risk back to...
Jeito Capital, Prominent Biotech Investor, Raises $1.2B for Next Fund
Jeito Capital announced the close of its Jeito II fund, raising €1 billion (about $1.2 billion) – the largest capital raise ever for an independent European biopharma fund. The fund will back 15‑20 clinical‑stage drugmakers, allocating up to €150 million ($162 million) per company across...