Novartis’ Sales Dip as Generics Pressure Intensifies, Radioequivalents Loom
Novartias first‑quarter net sales slipped 5% to $13.11 billion, primarily due to U.S. generic erosion of its heart‑failure drug Entresto. While earnings per share fell 11% to $1.65, growth was buoyed by double‑digit gains in Kisqali, Kesimpta and the radiopharma Pluvicto. The company faced a tentative FDA approval for Lantheus’ Lutathera generic, but a 30‑month patent stay delays market entry. CEO Vas Narasimhan stressed that the stay and strong patent portfolio will keep Lutathera’s performance largely intact.
Revolution Levels Legal Threat on Erasca as Pancreatic Cancer Rivalry Heats Up
Revolution Medicines, after its Phase 3 pancreatic cancer drug daroxinrasib showed a median overall survival of 13.2 months and lifted its share price, sent a cease‑and‑desist letter to rival Erasca demanding the U.S. halt of ERAS‑0015, alleging patent infringement and misleading...
Novartis Shares Fall as Entresto Sales Weaken
Novartis reported a 5% drop in first‑quarter net sales to $13.1 billion, driven by a 46% plunge in heart‑failure drug Entresto after U.S. patent expiry. Earnings per share fell 13% to $1.99 and the stock slipped nearly 3% as results missed...
We May Finally Have a Cure for Many Different Autoimmune Conditions
A novel cancer immunotherapy is being repurposed to eliminate rogue T‑cells that drive autoimmune diseases. Early trials show it can eradicate the pathogenic cells rather than merely suppressing symptoms, delivering faster and more durable remission. Dozens of global studies are...
Symptom-Based Approach Treats Opioid Withdrawal in Newborns with Minimal Drug Exposure
An NIH‑funded OPTimize NOW trial compared symptom‑based, as‑needed opioid dosing with traditional scheduled tapering for newborns with moderate to severe neonatal opioid withdrawal syndrome (NOWS). Among 383 infants cared for under the family‑centered Eat‑Sleep‑Console model, the symptom‑based group was ready for...
Oruka Reports Positive Data From Phase IIa Trial for Plaque Psoriasis
Oruka Therapeutics announced interim results from its EVERLAST‑A Phase IIa trial of ORKA‑001, a half‑life‑extended IL‑23p19 monoclonal antibody, in moderate‑to‑severe plaque psoriasis. Of the 63 patients receiving the 600 mg dose, 63.5% achieved PASI 100 by week 16, meeting the primary endpoint, with 83%...
Novartis CEO Warns Reality of Trump's Drug Pricing Policy Will Set in over 'the Next 18 Months'
Novartis chief executive Vas Narasimhan warned that President Donald Trump’s most‑favored‑nation (MFN) drug‑pricing rule will fully materialize within the next 18 months, tying U.S. prices to those in affluent foreign markets. The policy currently touches only 5‑10% of Novartis’s Medicaid sales...
An Octopus Probe for High-Performance >1,300 Nm NIR-II Fluorescence Molecular Imaging of Cancer
Researchers at Stanford introduced the Octopus (OCTP) probe, a modular NIR‑II fluorescence agent that emits beyond 1,300 nm and targets the folate receptor. In pre‑clinical mouse studies, OCTP delivered markedly higher tumor‑to‑background ratios and brighter tumor signals than the FDA‑approved Cytalux...
How Big Is Organon’s Biosimilar Push for Sun Pharma?
Sun Pharma’s $11.75 billion acquisition of Organon propels the Indian drugmaker into the global biosimilars market, placing it among the top ten players. Organon’s biosimilar portfolio generated $691 million in 2025, about 11 % of its total revenue, with 45 % of that coming...
Drugging the Undruggable: Cancer's Slipperiest Targets Finally Meet Their Match
Researchers at the University of British Columbia and BC Cancer have unveiled a novel drug design strategy that tightly binds intrinsically disordered proteins, long deemed undruggable. The new compounds exhibit binding affinities up to a million times stronger than previous...
CDER Proposes to Withdraw Approval of TAVNEOS
The FDA’s Center for Drug Evaluation and Research has proposed withdrawing approval of TAVNEOS (avacopan) after uncovering data manipulation in the pivotal trial and a lack of demonstrated efficacy for severe ANCA‑associated vasculitis. The agency also flagged new safety signals,...
China Races to Build Record Biobank to Rival US Drugs Research
China is constructing a national biobank that will house blood and DNA samples from 33,000 children, targeting brain‑disease research. The initiative, led by the Chinese Institute for Brain Research, seeks to create a data‑rich platform that rivals the United States’...
The BioPharm Brief: FDA Advances Autoimmune Pipeline with New Delivery Options and Priority Review
The FDA cleared a subcutaneous autoinjector for anifrolumab, allowing at‑home treatment of moderate‑to‑severe systemic lupus erythematosus. It also granted Priority Review to nipocalimab for warm autoimmune hemolytic anemia, a rare blood disorder, accelerating its path to market. AbbVie submitted a...
April 30, 2026: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement - 04/30/2026
The FDA’s Oncologic Drugs Advisory Committee will meet on April 30, 2026 to evaluate two AstraZeneca submissions: NDA 220359 for camizestrant tablets combined with CDK4/6 inhibitors in ESR1‑mutated hormone‑receptor‑positive breast cancer, and sNDA 218197/S‑004 for Truqap (capivasertib) plus abiraterone in PTEN‑deficient metastatic hormone‑sensitive prostate...
Intellia’s Data Reveal Tees Up FDA Filing for CRISPR-Based In Vivo Gene-Editing Med
Intellia Therapeutics filed a rolling FDA submission for lonvo‑z, its CRISPR‑based in‑vivo gene‑editing therapy for hereditary angioedema (HAE). In a placebo‑controlled Phase 3 trial of 80 patients, a single infusion cut swelling attacks by 87% versus placebo and left 62% of...
SBIA Resources in Chinese 中文信息
The FDA’s Small Business and Industry Assistance (SBIA) program has released Chinese-language versions of six recent webinars, covering critical topics such as the Drug Supply Chain Security Act, establishment registration, electronic submission requirements, eCTD data standards, GDUFA II, and generic drug...
FDA Grants Breakthrough Designation for Efimosfermin for MASH
GSK’s investigational liver drug efimosfermin received FDA breakthrough therapy designation for metabolic dysfunction‑associated steatohepatitis (MASH). A phase‑2 trial showed 45.2% of patients achieved at least one‑stage fibrosis improvement versus 20.6% on placebo, and 67.7% attained MASH resolution compared with 29.4%...
STAT+: Erasca Touts Strong, Though Preliminary, Results in Trial of Pancreatic and Lung Cancer Therapy
Erasca announced that its oral RAS‑targeting drug ERAS‑0015 produced tumor shrinkage in 40% of patients with advanced pancreatic cancer and 62% of those with advanced non‑small‑cell lung cancer. The early‑stage data, gathered from trials in the United States and China,...
Federal Circuit Clarifies Written Description and Enablement Standards for Method-of-Treatment Patent Claims Using a Well-Known Antibody Genus
On April 16, 2026, the Federal Circuit reversed a district‑court ruling and held that Teva’s method‑of‑treatment patents for treating headache with anti‑CGRP antagonist antibodies met the written‑description and enablement requirements of 35 U.S.C. § 112. The court distinguished the Supreme Court’s Amgen decision,...
Pencil Beam Laser Could Help Researchers Design Brain-Targeted Therapies
MIT researchers have demonstrated that laser light can self‑organize into a tightly focused "pencil beam," enabling a new bioimaging modality that is both faster and high‑resolution. In proof‑of‑concept experiments the team captured three‑dimensional images of the human blood‑brain barrier 25...
FDA May Be Poised To Collaborate With Paradigm On AI Model
The FDA is reportedly preparing an announcement on real‑world evidence (RWE) that could involve a partnership with Paradigm on its new SPIRAL artificial‑intelligence model. SPIRAL is designed to generate RWE for post‑approval and late‑stage clinical studies, leveraging large‑scale health‑data sources....
Internet Pharmacy Warning Letters
The FDA has intensified its crackdown on unsafe online pharmacies, issuing more than 40 warning letters between 2023 and early 2026 to sites such as Beauty of Aztlan, RxGoodUSA and OnlineRxMedz. The letters cite violations like selling unapproved drugs without...
Randomized Radical Reaction Leads to Selective Cyclizations
A new “radical sampling” strategy reported in JACS (2026) enables selective formation of six‑membered nitrogen heterocycles such as piperidines and morpholines from simple aldehyde and amine precursors. The method uses a light‑activated catalyst to generate radicals that compete between rapid...
Withdrawn | Cancer Accelerated Approvals
The FDA has withdrawn 31 cancer drugs that were granted accelerated approval, spanning indications from lung and breast cancer to rare lymphomas. The most recent removal was Trodelvy for metastatic urothelial carcinoma on November 22, 2024. Withdrawals typically follow failed...
Exercise, Ibuprofen Reduce Cancer-Related Cognitive Impairment
A phase‑2 randomized trial of 86 chemotherapy patients found that a six‑week home‑based exercise program markedly improved cognitive performance, cutting Trail Making Test times by over 21 seconds compared with placebo. Low‑dose ibuprofen (200 mg twice daily) also yielded modest gains,...
TrumpRx Has Signed Deals With Nearly Every Major Drugmaker. Are Prices Actually Falling?
President Trump launched TrumpRx, a direct‑to‑consumer portal that leverages most‑favored‑nation (MFN) pricing agreements with drugmakers. The administration has signed 17 MFN deals covering about 86% of the branded market, granting tariff exemptions to participants. Discounts are steep—Pfizer’s cuts range from...
How Does Integrated Fluid Management Enable Flexible Bioproduction Across Modalities?
At INTERPHEX 2026, Avantor senior vice president Jerry Keybl highlighted how integrated fluid management underpins scalable bioproduction across cell, gene and other therapeutic modalities. He argued that consistent, well‑characterized fluid paths from early development through commercial scale reduce variability and...
Veradermics Soars on Positive Data for Baldness Treatment
Veradermics announced that its experimental oral minoxidil pill, VDPHL01, achieved the primary endpoint in a Phase 3 trial, delivering a 30‑33 hair‑per‑cm² increase over six months versus placebo. The drug was well tolerated, with side‑effect rates matching placebo and no cardiac...
Lilly to Acquire Ajax Therapeutics
Eli Lilly announced a definitive agreement to acquire Ajax Therapeutics for up to $2.3 billion in cash. Ajax’s lead candidate, AJ1-11095, is a first‑in‑class Type II JAK2 inhibitor currently in a Phase 1 study (AJX‑101) for myelofibrosis patients who have failed Type I JAK2...
Compass Shares Crash as ‘Confounding’ Survival Data Raise Approvability Questions for Bispecific
Compass Therapeutics reported that its bispecific antibody tovecimig failed to meet the secondary overall survival (OS) endpoint in the Phase 2/3 COMPANION‑002 trial, though it achieved a 56% reduction in progression risk, extending progression‑free survival (PFS) to 4.7 months versus 2.6...
University of Southampton and UCB to Develop Digital Antibodies with AI
The University of Southampton and biopharma firm UCB have launched the Digital Antibody Research Collaboration (DARC), a three‑year AI‑driven platform for in‑silico therapeutic antibody design. DARC aims to compress the typical ten‑to‑twelve‑year development timeline by automating molecule modeling, testing and...
ESCMID Global 2026: Pritelivir Excels in Immunocompromised Refractory HSV Patients
Aicuris presented Phase III data for its oral helicase‑primase inhibitor pritelivir at ESCMID Global 2026. In the PRIOH‑1 trial of 101 immunocompromised adults with acyclovir‑refractory HSV, pritelivir achieved significantly higher lesion‑healing rates than investigator‑chosen IV or topical therapies. The drug also...
The Bad Ad Program
The FDA’s Bad Ad Program, run by the Office of Prescription Drug Promotion, educates clinicians on spotting false or misleading prescription‑drug advertising and provides a streamlined way to report violations. It targets a broad audience of physicians, nurses, pharmacists and...
MFN Changing the Rules of the Game for the Nordic Countries
GlobalData’s Price Intelligence analysis links the U.S. Most Favored Nation (MFN) policy to a 35% decline in pharmaceutical product launches across Europe within ten months of its introduction. In the Nordics, oncology drugs are priced roughly 5% below the European...
Missouri Analytical Laboratories Inc - 615319 - 10/09/2024
The U.S. Food and Drug Administration issued a closeout letter to Missouri Analytical Laboratories Inc., confirming that the company’s corrective actions have addressed the violations cited in a 2021 warning letter. The FDA noted that while the immediate issues appear...
Lilly to Buy Startup Ajax in Bid for a Better JAK Drug
Eli Lilly announced it will acquire New York‑based biotech Ajax Therapeutics for up to $2.3 billion. The deal centers on Ajax’s experimental JAK inhibitor AJ1‑11095, which binds an inactive JAK2 conformation to overcome resistance seen with existing therapies for myelofibrosis and...
Fathom Therapeutics Scores $47 Million Series A
Fathom Therapeutics, previously known as Atommap Corp., announced an oversubscribed $47 million Series A round. The financing was led by Sutter Hill Ventures with participation from Chemistry, Alexandria Venture Investments, and NY Ventures. Fathom leverages quantum chemistry and artificial intelligence to design...
A Single Dose of Psilocybin Outperforms Nicotine Patches for Quitting Smoking
A Johns Hopkins pilot trial found that a single, weight‑adjusted dose of psilocybin combined with cognitive‑behavioral counseling helped 40% of smokers remain abstinent for six months, far surpassing the 10% quit rate achieved with standard nicotine patches. The psychedelic group...
Multiple GLP-1 Drugs Linked to Lower AFib Risk
A retrospective analysis of 13,034 patients who started GLP‑1 receptor agonist therapy between 2020 and 2024 found a significant reduction in atrial fibrillation (AFib) incidence compared with a propensity‑matched cohort of over 385,000 untreated individuals. The benefit persisted regardless of...
FDA Clears Subcutaneous Anifrolumab Autoinjector for Moderate to Severe SLE
The FDA has cleared AstraZeneca’s subcutaneous anifrolumab autoinjector (Saphnelo) for adults with moderate to severe systemic lupus erythematosus (SLE) on standard therapy. The new formulation mirrors the approved intravenous product but allows weekly self‑administration at home. Approval rests on the...
FDA Priority Review Advances Nipocalimab for Adults With Warm Autoimmune Hemolytic Anemia
The FDA has granted priority review to Johnson & Johnson’s nipocalimab‑aahu (IMAAVY) for adults with warm autoimmune hemolytic anemia (wAIHA), a rare disease lacking any approved U.S. therapy. The designation compresses the review clock to roughly six months, marking the...
STAT+: Astellas Retries XLMTM Gene Therapy After Deaths
Astellas Pharma announced it will restart its next‑generation gene therapy trial for X‑linked myotubular myopathy (XLMTM) after pausing the program following two patient deaths. Meanwhile, Intellia Therapeutics reported its one‑time CRISPR treatment lonvo‑z reduced hereditary angioedema attacks by 87% in...
STAT+: Pharmalittle: We’re Reading About a Lilly Deal, an Intellia CRISPR Rare-Disease Treatment, and More
Intellia Therapeutics reported that a single dose of its CRISPR‑based therapy lonvo‑z dramatically reduced swelling attacks in hereditary angioedema patients during a Phase 3 trial, positioning it for a rolling FDA submission as the potential second approved CRISPR drug. The treatment...
FDA Review Sought for Subcutaneous Risankizumab Induction in Crohn Disease
AbbVie has filed a supplemental NDA with the FDA to add subcutaneous (SC) risankizumab induction for adults with moderate‑to‑severe Crohn disease. The request relies on the phase 3 AFFIRM trial, which enrolled 289 patients—65% of whom had failed prior advanced therapies—and...
Gilead’s Pipeline Strategy in 2026: A Broadening Focus Beyond HIV
Gilead Sciences is accelerating a diversification push in 2026, adding $12.6 billion of oncology and immunology assets to a portfolio still dominated by HIV drugs. The company completed three major acquisitions—Arcellx for $7.8 billion, Tubulis for $3.15 billion, and Ouro Medicines for $1.67 billion—bolstering...
Eli Lilly to Acquire Ajax Therapeutics for ~$2.3B
Eli Lilly has signed a definitive agreement to acquire Ajax Therapeutics for roughly $2.3 billion in cash, covering an upfront payment and future clinical and regulatory milestones. Ajax’s lead candidate, AJ1‑11095, is a Type II JAK2 inhibitor currently in a Phase‑I trial (AJX‑101)...
CureVac Takes Moderna to Court over mRNA Vaccine Patents
CureVac has filed a lawsuit against Moderna alleging infringement of its mRNA‑stabilisation and delivery patents that underpin Spikevax. The case, backed by BioNTech after its 2025 acquisition of CureVac, seeks a share of the multibillion‑dollar revenues from COVID‑19 mRNA vaccines....
FDA’s Need for Speed Could Strain Small Biotechs. Here’s How They Can Keep Up.
The FDA is accelerating drug approvals through the National Priority Voucher pilot, which can shrink review timelines from ten months to as little as two, and a new plausible mechanism pathway for niche therapies lacking large trial data. While the...
Motif Neurotech Receives FDA IDE Approval to Initiate RESONATE Trial of Motif XCS System in Treatment-Resistant Depression
Motif Neurotech has secured FDA Investigational Device Exemption (IDE) to launch the RESONATE early feasibility study of its Motif XCS System in patients with treatment‑resistant depression who have failed at least two medications. The trial will monitor 12‑month safety, symptom...
GSK/Tesaro Claim Denied in Jemperli Lawsuit with AnaptysBio
A Delaware court rejected GSK and its Tesaro unit's attempt to terminate the 2014 licensing agreement with AnaptysBio, preserving the existing royalty rate for the PD‑1 cancer drug Jemperli. The ruling affirms that AnaptysBio has not breached the contract, while...