Pharma News and Headlines
Pharma News and Headlines
Pharma Pulse
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Every morning
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Cumberland Pharmaceuticals reported fiscal 2025 revenue of $44.5 million, an 18% increase year‑over‑year, driven by a 31% Q4 surge to $13.7 million from Vibativ, Sancuso and the newly launched Talicia. Adjusted earnings turned positive at $1.7 million and operating cash flow rose to $4.9 million, while the balance sheet strengthened with higher equity and a $10 million reduction in its line of credit. The company secured regulatory approvals for Vibativ in China and Saudi Arabia and for an ibuprofen injection in Mexico, and obtained a CMS J‑code for Caldolor. Its pipeline advanced with ifetroban’s Phase II DMD trial showing meaningful LVEF gains and earning Fast Track, orphan and rare‑pediatric designations.
The FDA’s Center for Drug Evaluation and Research (CDER) has published its annual New Drug Application (NDA) and Biologics License Application (BLA) approval reports for calendar years 2015 through 2025, each linked in a consolidated list. These reports detail the...
A head‑to‑head study of 55 post‑prostatectomy patients compared two FDA‑cleared PSMA PET agents, Posluma (flotufolastat F‑18) and Pylarify (piflufolastat F‑18). Posluma demonstrated markedly lower bladder radioactivity, with a median bladder SUV of 10.9 versus 29 for Pylarify. This reduction translated into higher...
Scientists have identified a molecular checkpoint that guides planarian stem cells during regeneration. The roundabout A receptor (RoboA) suppresses inappropriate pharyngeal differentiation by regulating the transcription factor FoxA, while the extracellular protein Anosmin1a partners with RoboA to fine‑tune cell identity...
The FDA has mandated electronic submissions to the FAERS database using the ICH‑endorsed E2B(R3) standard, beginning January 16 2024 for post‑marketing drug and biologic reports and April 1 2024 for pre‑marketing IND safety reports. Companies have until April 1 2026 to transition fully, after which only...
The FDA Adverse Event Reporting System (FAERS) is a public database that collects adverse event, medication error, and product quality complaint reports for drugs and biologics after market approval. It follows the ICH E2B international safety reporting guidance and uses...
Arizona State University researchers quantified how water interacts with biomolecule‑coated magnetite nanoparticles, revealing that surface coatings dramatically reshape hydration energetics, immune recognition, and drug‑delivery performance. Using a calorimetry‑gas adsorption system, they measured water adsorption on particles coated with bovine serum...
Generate Biomedicines priced its IPO at $16 per share, raising $400 million to fund pivotal trials of its lead candidate GB‑0895. The antibody blocks the TSLP pathway and is engineered for six‑month dosing, a potential advantage over existing asthma biologics that...
The FDA issued a final guidance document outlining best practices for conducting and reporting pharmacoepidemiologic safety studies that rely on electronic healthcare data, such as administrative claims and electronic medical records. It prescribes how sponsors should document study design, analytical...
Alnylam Canada received a positive recommendation from Canada’s Drug Agency to list AMVUTTRA® (vutrisiran) for public reimbursement in adult patients with cardiomyopathy caused by wild‑type or hereditary ATTR amyloidosis. The therapy, approved by Health Canada in December 2025, expands the...
The European Medicines Agency’s CHMP has issued a positive opinion on Moderna’s mCombriax, a combined COVID‑19 and influenza mRNA vaccine, after a Phase III trial showed stronger immune responses than a mixed regimen of Sanofi’s flu shot and Spikevax. EMA approval...
At CROI 2026, researchers spotlighted the growing neurodegenerative burden among aging people living with HIV, emphasizing heightened risks of depression and cognitive vulnerability despite long‑term antiretroviral therapy. Parallelly, the University of Southern California announced a novel series of MAPT aggregation...
BioWorld’s “In the Clinic for March 2, 2026” page functions as a centralized gateway to the latest biopharma, med‑tech, and scientific content. It aggregates data snapshots, special reports, infographics, and market scorecards covering everything from GLP‑1 trends in China to mRNA vaccine...
On March 2, 2026 BioWorld published a regulatory snapshot covering biopharma and med‑tech firms such as AS Software, Asieris, Boehringer Ingelheim, Deephealth, Eli Lilly, Ipsen, Moderna, Neurogene, Novartis, Optellum, Photocure, Regeneron, Sanofi, Sentynl, Synergy Spine Solutions and X4. The roundup highlights...
Novo Nordisk announced a €432 million ($506 million) investment to expand its Athlone, Ireland facility, increasing capacity for oral products such as the newly launched Wegovy pill. The expansion is intended to secure supply outside the United States and help the company...
CPHI Middle East will return to Riyadh in May 2026, building on the 2024 edition that attracted over 30,000 visitors from more than 100 countries. The event promises expanded networking opportunities, direct market access, and the latest regulatory and innovation...
Bioxytran announced positive phase 1b/2a data for its oral antiviral ProLectin‑M in a randomized, double‑blind, placebo‑controlled trial of 39 mild‑to‑moderate COVID‑19 patients in India. The highest dose (16,800 mg/day) achieved viral clearance in 90% of participants by day 5 versus 20% on placebo,...
The large‑cap pharmaceutical sector is rebounding in 2026 after a muted 2025, buoyed by strong quarterly results, aggressive M&A, and robust pipeline activity. Zacks ranks the industry at #172, but it posted a 10.8% gain over the past year, outpacing...
The European Union has granted approval for Vueway (gadopiclenol) to be used in neonates, infants, and toddlers, marking a pivotal expansion of pediatric MRI contrast agents. Vueway delivers diagnostic‑grade imaging at half the dose of conventional macrocyclic GBCAs, thanks to...
Biotech Aardvark Therapeutics announced a voluntary pause of the Phase 3 HERO trial for its Prader‑Willi drug ARD‑101 after routine safety monitoring identified reversible cardiac observations in healthy volunteers receiving supratherapeutic doses. The pause affects both the main trial and an...
Merck and Pfizer’s Keytruda‑Padcev doublet delivered a dramatic survival advantage in the Phase 3 EV‑304 study of muscle‑invasive bladder cancer. The regimen cut the risk of disease progression, recurrence or death by 47% compared with gemcitabine‑cisplatin and lowered overall‑mortality risk by...
Chinese drugmakers, led by Jiangsu Hengrui Pharmaceuticals, are emerging as global biotech contenders. Hengrui topped 2024 trial sponsorship, boasts a pipeline of 100 investigational drugs and 400 trials, and secured a $500 million partnership with GSK that could yield $12 billion. Analysts...
The U.S. FDA granted accelerated approval to Ascendis’ Yuviwel (navepegritide) for increasing linear growth in children aged two years and older with achondroplasia and open epiphyses. Approval rests on three placebo‑controlled trials and up to three years of open‑label extension...
Cell therapy manufacturing is vulnerable to contamination because living cells cannot be terminally sterilized. Regulatory bodies such as EU GMP Annex 1 and the FDA now require risk‑based contamination control strategies that prioritize closed, sterile, and automated processes. Closing open steps...
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending Dupixent (dupilumab) for paediatric chronic spontaneous urticaria (CSU) in children aged 2‑11. The recommendation is based on robust Phase III data from the LIBERTY‑CUPID...
President Trump has pressed European nations to raise their drug spending, arguing that higher foreign prices would allow the United States to lower its own prescription costs. While no clear price hikes have materialized yet, the demand has sparked uncertainty...
Opus Genetics presented early Phase I/II data for its OPGx‑BEST1 gene therapy targeting best vitelliform macular dystrophy and autosomal‑recessive bestrophinopathy. In a sentinel 63‑year‑old participant, the treatment was well tolerated and delivered a 12‑letter gain in best‑corrected visual acuity after...
BioMarin’s enzyme substitution therapy Palynziq received FDA approval for use in adolescents aged 12 and older with phenylketonuria (PKU). The decision was based on Phase III PEGASUS trial results showing 44.4% of participants lowered blood phenylalanine below guideline levels, with a...
Eli Lilly announced a $3.5 billion life‑sciences manufacturing complex in Lehigh Valley, Pennsylvania, slated to open in 2031. The facility will produce the company’s next generation of weight‑loss drugs and employ roughly 850 engineers, scientists and technicians. The deal, the largest life‑sciences...
The article profiles 18 UK biotech firms spanning oncology, immunology, regenerative medicine and AI‑driven drug design, highlighting recent milestones such as Amphista’s $30 million upfront deal with BMS, Autolus’ FDA and EU approvals for obe‑cel, and Isomorphic Labs’ $600 million raise to...
X4 Pharmaceuticals’ Xolremdi (mavorixafor) received a positive opinion from the European CHMP, recommending approval under exceptional circumstances with an EC decision expected in Q2 2026. The recommendation is based on the global Phase III 4WHIM trial involving 31 patients aged 12 and...
European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending conditional approval of Ipsen’s Ojemda (tovorafenib) as monotherapy for pediatric low‑grade glioma with BRAF fusions, rearrangements or V600 mutations. The recommendation is based on...
The FDA will render decisions this March on five high‑profile drug applications, including two delayed from last year. Bristol Myers Squibb seeks a psoriatic arthritis label for Sotyktu, backed by Phase 3 data showing a 54.2% ACR20 response. Aldeyra, Rhythm, GSK...
Quanterix (QTRX) reported FY 2025 revenue of $16.1 million, down $11 million from the prior year, driven by steep declines in collaboration and contract‑manufacturing income. R&D spending fell modestly to $140.7 million, while SG&A rose to $65.5 million due to higher professional fees for...
Xeris Biopharma reported record Q3 2025 product revenue of $74.1 million, a 40% year‑over‑year increase driven primarily by Recorlev’s 109% revenue jump. The company posted its first quarterly net income and an adjusted EBITDA of $17.4 million, reflecting strong operating leverage and...
UniQure reported a regulatory setback as the FDA now deems the Phase 1/2 external‑control data for AMT‑130 insufficient for a Biologics License Application, creating uncertainty around the U.S. filing timeline. Despite this, the high‑dose AMT‑130 achieved a statistically significant 75% slowdown...
Nuvation Bio reported $7.7 million net product revenue for Iptrozi in Q3 2025, driven by 204 new patient starts and payer coverage expanding to over 80% of U.S. lives. Clinical data showed an 89% overall response rate and a median...
UroGen Pharma reported over $127 million in cash at the end of Q4 2025, affirming sufficient liquidity to reach profitability if current plans hold. The company highlighted steady month‑over‑month growth in Zasturi enrollment, with community treatment share now around 35‑40% and institutional...
Researchers at the Innovation Center of NanoMedicine unveiled PL‑display, a cell‑free platform that immobilizes individual peptides on magnetic beads for rapid screening. The method delivers over ten‑fold efficiency gains versus traditional cell‑based displays and can operate under high‑temperature, high‑salt, or...
GoodRx introduced GoodRx Employer Direct, a new service allowing employers to directly subsidize the manufacturer‑sponsored price of high‑cost brand medications such as GLP‑1 drugs without adding them to health‑plan formularies. The model, first piloted with retailer Hy‑Vee, lets employers contribute...
Researchers at Adelaide University conducted the first in‑vivo study of salcaprozate sodium (SNAC), the absorption enhancer used in oral semaglutide tablets such as Ozempic and Wegovy. Over a 21‑day period in rats, repeated SNAC exposure reduced fibre‑degrading gut bacteria, lowered...
A phase‑2 trial of relmacabtagene autoleucel (relma‑cel), a CD19‑directed CAR‑T therapy, enrolled 59 Chinese patients with relapsed/refractory mantle‑cell lymphoma after BTK‑inhibitor failure. The study reported a 71.2% overall response rate and a 59.3% complete response rate, with median time to...
A new analysis quantifies the operational and financial benefits of using Genmab’s epcoritamab, a dual‑indication bispecific antibody, for both relapsed/refractory diffuse large B‑cell lymphoma (DLBCL) and follicular lymphoma (FL). In a community‑practice model of 100 patients, the study projects 3,110...
A phase‑2b trial enrolling 94 adults with chronic hand eczema (CHE) without etiologic pre‑selection uncovered a mixed immune signature spanning type 2, type 3 and type 1 pathways. Dupilumab, an IL‑4Rα antagonist, delivered a 59.8% mean improvement in modified Total Lesion Symptom Score...
This week’s Endpoints Weekly highlighted a surge of GLP‑1 developments, including new trial data and expanded indications that reinforce the class’s dominance in obesity and diabetes treatment. The newsletter also released its annual Top 100 venture investors list, showing a notable...
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended six new medicines, including three orphan drugs already approved by the FDA—Ojemda for pediatric low‑grade glioma, Palsonify for acromegaly, and Xolremdi for WHIM syndrome. The agency also gave a...
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![[Review] Autosomal Dominant Polycystic Kidney Disease](/cdn-cgi/image/width=1200,quality=75,format=auto,fit=cover/https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/e5c772f073be33a83118f46a1ac91f13.webp)
Autosomal dominant polycystic kidney disease (ADPKD) remains the most common hereditary cause of chronic kidney disease, imposing substantial morbidity, mortality, and healthcare costs worldwide. Recent advances in molecular genetics and high‑resolution imaging have sharpened diagnostic criteria and enabled more accurate...
![[Comment] Safeguarding Genomic Integrity in Pluripotent Stem-Cell Therapies](/cdn-cgi/image/width=1200,quality=75,format=auto,fit=cover/https://hixhlmpcokxhartfkpyi.supabase.co/storage/v1/object/public/images/thumbnails/fba52b2aab9c591bf0e059f57acce9ea.webp)
Human pluripotent stem cells (hPSCs) are emerging as a transformative platform for Parkinson’s disease, with recent phase I/II trials showing successful engraftment of hESC‑ and iPSC‑derived dopaminergic neurons. Yet extensive data reveal that cultured hPSCs frequently acquire recurrent genetic lesions—most...
Minnesota’s Department of Health reports that hospitals and clinics in the state earned at least $1.34 billion in 2024 from the 340B drug discount program. Participants received $3.045 billion in discounted medicines but paid $1.53 billion plus $165 million in administration fees. The largest...
