Today's Pharma Pulse
CMS to launch Medicare GLP‑1 Bridge program with $50 monthly copay for obesity drugs
The Centers for Medicare & Medicaid Services will start a short‑term demonstration on July 1 2026 offering eligible Part D beneficiaries a flat $50 monthly copay for three branded GLP‑1 obesity treatments. The program runs through December 31 2027 and aims to gather utilization data ahead of potential broader policy decisions.
NANOBIOTIX Provides Business Update and Reports Full Year 2025 Financial Results
Nanobiotix posted full‑year 2025 results showing a revenue rebound to roughly $35.5 million and a net loss of $26 million, a 65% YoY improvement. The company secured a non‑dilutive royalty financing of up to $71 million, extending its cash runway to early 2028 with $57.5 million on hand. Clinical development of JNJ‑1900 (NBTXR3) progressed across head‑and‑neck, lung, esophageal, pancreatic and melanoma indications, supported by regulatory reclassification in Europe. The Curadigm Nanoprimer platform added four new patents and launched CMC activities.
Low Placebo Response Skews Psychedelic Depression Trial Results
I was interviewed about a study of GH001, vaporized 5-MeO-DMT, for treatment-resistant depression. I commented that, while promising and encouraging, the thing that popped out to me was the almost complete lack of placebo response in the placebo group. Even...
Biogen to Acquire Apellis for $5.6 B, Shares Jump 136% on Deal
Biogen announced a definitive agreement to buy Apellis Pharmaceuticals for $41 a share in cash, valuing the transaction at roughly $5.6 billion. The deal lifts Apellis shares 135.7% to $40.28 and adds two marketed complement‑inhibitor drugs, EMPAVELI and SYFOVRE, to Biogen’s...
Frailty, Innovation, and the Future of Myeloma Treatment With Joseph Mikhael, MD
Joseph Mikhael, MD, highlights a dramatic shift in multiple myeloma care for older adults, driven by refined frailty assessments and the rise of targeted immunotherapies such as CAR‑T cells and bispecific antibodies. These advances have translated into higher survival rates...
Key Neurons Can Jumpstart Leg Movement After Spinal Injury
Researchers identified a rare subset of graft‑derived interneurons that can reconnect broken spinal circuits and trigger leg muscle activity in animal models of spinal cord injury. When these neurons were experimentally activated, 20‑30% of the subjects showed measurable leg movements,...
Pharma Goes on $25.5B, Eight-Day Acquisition Spree
Pharmaceutical companies launched an eight‑day acquisition blitz, with six firms announcing deals worth about $25.5 billion. Two of those transactions involve upfront payments exceeding $5 billion each, underscoring the aggressive pace. The deals focus on securing biotech pipelines and specialty drug assets...
TippingPoint Raises $4.5M Seed to Drug Hidden Epigenetic Targets in Deadly Pediatric Brain Cancer
TippingPoint Biosciences announced a $4.5 million seed round led by SOSV and LKS Fund to advance its epigenetic drug discovery platform. The company targets protein‑protein interfaces within disease‑specific chromatin environments, aiming at sites traditionally deemed undruggable. Its inaugural program focuses on...
First Primate Model of Congenital Deafness Created
Genetically modified marmosets lacking the OTOF gene now serve as the first primate model for human congenital deafness, offering a precise platform to advance gene therapies targeting hearing loss. genetherapy
AI Cuts Drug Discovery From Years to Months
I joined Sam Fazeli for the latest episode of Bloomberg Intelligence's Vanguards of Healthcare podcast and talk about our partnership with Eli Lilly and why I believe algorithmic approaches are reshaping the earliest stages of pharmaceutical R&D. The biggest impact...
Yuvezzi for Presbyopia Now Available in US
Tenpoint Therapeutics announced that Yuvezzi, the first FDA‑approved eye‑drop for presbyopia, is now commercially available in the United States. The formulation combines carbachol 2.75 % and brimonidine tartrate 0.1 % to induce pupil constriction within 30 minutes, providing up to ten hours...
Vanda’s Tradipitant Has Phase II Success but a Court Setback
Vanda Pharmaceuticals reported that its NK1‑receptor antagonist tradipitant achieved its primary endpoint in a Phase II trial for gastroparesis, showing a roughly 30% improvement in nausea scores versus placebo. The data suggest the drug could address a sizable unmet need in...
AI-Built Intrabodies Target Alzheimer’s Within
University of Essex researchers used artificial intelligence to redesign antibody fragments, creating "intrabodies" that remain stable inside human cells. By adjusting electrical charge, they converted 672 antibodies into intracellularly functional molecules that bind disease‑causing proteins linked to Alzheimer’s, Parkinson’s, Huntington’s...
Novo Nordisk Cuts Starting Price of Ozempic by 36% and Wegovy by 48%
Novo Nordisk announced that, effective April 1 2026, the starting dose of its GLP‑1 drugs Ozempic and Wegovy will be reduced by 36% and 48% respectively in India. The new price for the 0.25 mg dose is ₹202 per day (about $2.44) or...
Scientists Have Discovered an 'Achilles' Heel' In Deadly Superbugs
Scientists have identified pseudaminic acid, a sugar found only on the surface of certain Gram‑negative bacteria, as a vulnerable target. By synthesizing this sugar and creating monoclonal antibodies that bind it, researchers demonstrated in mice that the antibodies flag the...
FLAV-27 Reverses Cognitive Decline in Alzheimer Mice, Study Shows
Scientists at the University of Barcelona Institute of Neurosciences have demonstrated that the novel compound FLAV-27 can reverse cognitive decline in mice engineered to develop Alzheimer's disease. The breakthrough, which targets the brain enzyme EHMT2 to reprogram neuronal epigenetics, offers...
Modified Immune Cells Target Cancer’s Metabolic Signature
Stanford researchers engineered natural killer (NK) and cytotoxic T cells to overexpress metabolite‑sensing G protein‑coupled receptors, most notably GPR183, enabling the cells to home toward tumor‑derived metabolic cues. In mouse models of triple‑negative breast and ovarian cancer, GPR183‑enhanced NK‑92 cells...
Polysaccharide Microneedles and 3D Printing Explored for Cancer Immunotherapy Applications
Researchers reviewed polysaccharide‑based microneedles as a platform for cancer immunotherapy, emphasizing how additive manufacturing—particularly high‑resolution 3D printing—can create customizable transdermal delivery arrays. Natural polymers such as hyaluronic acid, chitosan and alginate provide biocompatibility and enable dissolvable or hydrogel‑based needles with...
Alamar Biosciences Files Nasdaq IPO After $128M Series C and 100‑Hire Surge
Alamar Biosciences, the Fremont‑based proteomics company, filed to go public on Nasdaq after raising $128 million in a Series C round and adding almost 100 employees in two years. The move marks the firm’s transition from research‑focused labs to commercial sales of...
DiaMedica Therapeutics Inc. (DMAC) Q4 2025 Earnings Call Transcript
DiaMedica Therapeutics reported Q4 2025 revenue of $45 million, a 30% year‑over‑year increase, and ended the quarter with $200 million in cash, extending its runway to 2028. The company announced that the FDA granted Fast Track designation for its DM‑101 oncology candidate, and...
AZD5004
Elecoglipron (ECC5004/AZD5004), an oral small‑molecule GLP‑1 receptor agonist, completed Phase 2 trials in type 2 diabetes and obesity, meeting primary endpoints in the SOLSTICE and VISTA studies. AstraZeneca licensed global rights from Eccogene for an upfront payment of $185 million and potential milestones...
CellCentric Initiates DOMMINO-1, a Pivotal Phase 2 Clinical Trial of Inobrodib in Combination with Pomalidomide and Dexamethasone (InoPd) in Relapsed...
CellCentric has launched the pivotal Phase 2 DOMMINO‑1 trial of inobrodib 20 mg combined with pomalidomide and dexamethasone (InoPd) in heavily pretreated relapsed or refractory multiple myeloma (RRMM) patients. The first dose was administered at The Royal Marsden in London, with additional...
ImmunityBio Strengthens Balance Sheet with $100 Million of Financing Transactions Including $75 Million of Non-Dilutive Financing to Support Global Expansion...
ImmunityBio secured $75 million of non‑dilutive financing under its existing royalty‑interest purchase agreement with Oberland Capital, raising total committed capital to $375 million. At the same time, Nant Capital converted $25 million of debt into common stock, reducing the company’s liabilities. The combined...
Enhanced Games Could Deliver Credible Data for Peptide Legitimacy
Data, data, data... The @enhanced_games are so much more than just another sports event... "The peptide community has a credibility problem and an evidence problem. Millions of people use compounds backed by rodent studies and Reddit threads. The FDA is cracking...
Biogen, with $5.6B Apellis Buy, Builds Out Immunology Offerings
Biogen announced a $5.6 billion cash acquisition of Apellis Pharmaceuticals, paying $41 per share—a 140% premium—and issuing contingent value rights worth up to $4 per share. The deal brings two recently launched products, the eye‑disease therapy Syfovre and the rare‑kidney drug...
Short-Acting Psychedelic DMT Shows Promise as a Rapid Treatment for Major Depressive Disorder
A phase IIa trial published in Nature Medicine found that a single intravenous dose of dimethyltryptamine (DMT), paired with structured psychotherapy, produced a rapid and sustained reduction in major depressive disorder symptoms. Participants receiving 21.5 mg of DMT showed an average...
AN2 Therapeutics Announces Initiation of Phase 2 Investigator-Initiated Clinical Trial of Epetraborole for Mycobacterium Abscessus Complex Lung Disease
AN2 Therapeutics has begun a Phase 2 investigator‑initiated trial of epetraborole, an oral leucyl‑tRNA synthetase inhibitor, for pulmonary disease caused by Mycobacterium abscessus. The randomized, double‑blind study will enroll 84 patients across roughly 10‑15 U.S. sites and is led by Dr. Kevin...
Is AI Ready to Transform COA Development?
Artificial intelligence is reshaping clinical development by augmenting, not replacing, human expertise. AI already accelerates medical imaging, compound discovery and COVID‑19 vaccine modeling, compressing timelines from years to months. In clinical outcome assessment (COA) translation, AI can support draft translation...
Tirzepatide Plus Hormone Therapy Boosts Weight Loss 35% in Post‑Menopausal Women
Mayo Clinic and Wayne State scientists report that post‑menopausal women who combined tirzepatide with hormone therapy lost 35% more body weight than those on tirzepatide alone. The retrospective analysis of 120 women showed an average 19.2% loss versus 14%, prompting...
Henan Lvyuan Pharmaceutical Co. Ltd. - 722497 - 03/26/2026
The FDA issued a warning letter to Henan Lvyuan Pharmaceutical after a September 2025 inspection uncovered multiple Current Good Manufacturing Practice (CGMP) violations. Inspectors cited severe facility maintenance issues, including corrosion and water leaks that could compromise API potency and...
Microbiological Testing & Consulting, LLC - 720374 - 03/16/2026
The FDA issued Warning Letter 320‑26‑53 to Microbiological Testing & Consulting, LLC after a September 2025 inspection uncovered multiple Current Good Manufacturing Practice (CGMP) violations. The firm failed to maintain adequate laboratory controls, documentation, media qualification, and a functional quality‑control unit,...
FDA Green List Lets Chinese Firms Dominate GLP‑1 Supply, US Safety at Risk
The FDA’s recent “green list” designation has cleared more than 50% of Chinese manufacturers of GLP‑1 obesity drugs, effectively handing China a dominant role in the U.S. supply chain. Critics warn the move could expose American patients to substandard products...
FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos (Avacopan) for Severe Active Anti-Neutrophil Cytoplasmic Autoantibody (ANCA)-Associated Vasculitis
The FDA issued a drug safety communication warning that Tavneos (avacopan) is linked to 76 post‑marketing cases of drug‑induced liver injury, including eight fatalities. Seven patients developed biopsy‑confirmed vanishing bile duct syndrome, a severe cholestatic condition, with three deaths. Median...
Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts
The CARES Act, enacted in March 2020, added new authorities to the FDA to curb drug shortages by requiring manufacturers to notify the agency of permanent discontinuances and production interruptions. It also mandates the creation of site‑specific risk‑management plans and...
Companies that Have Not Submitted Drug Amount Reports
The FDA has released two public lists identifying registrants that failed to submit required drug amount reports for calendar year 2024. One list covers entities with active drug listings, the other captures those with inactive listings. Registrants must certify or...
October - December 2025 | New Safety Information or Potential Signals of Serious Risks Identified by the FDA Adverse Event...
The FDA’s Adverse Event Monitoring System (AEMS) released a slate of new safety signals for a range of products covering October‑December 2025. Alerts include heightened hypersensitivity reactions for certain lots of Alyglo, hypogammaglobulinemia linked to multiple bispecific T‑cell engager therapies,...
Longer-Term Real-World Data Needed to Compare Leqembi and Kisunla Opposing Treatment Strategies for Alzheimer’s
Eisai/Biogen’s Leqembi and Eli Lilly’s Kisunla are the only FDA‑approved disease‑modifying Alzheimer’s therapies, but they follow opposite treatment models—continuous dosing versus a finite course after amyloid clearance. Four‑year data presented at AD/PD 2026 showed Leqembi delayed disease progression by roughly 9.8 months, with...
Telomir's IND Filing Sparks Speculative Long On
Telomir filed IND for oral Telomir‑1 in TNBC. Data: clean GLP safety; Phase1/2 planned. Risk: pre‑revenue, weak balance sheet, stock -65%. Trade: speculative long on IND clearance. — Viktor Kopylov, PhD, CFA. More insights: t.me/si14Kopylov
NVIDIA’s Healthcare Stack Is the Picks and Shovels Play You’ve Been Waiting For
NVIDIA has assembled a comprehensive AI infrastructure stack for healthcare, encompassing BioNeMo, MONAI, Isaac for Healthcare, Holoscan, Parabricks, Clara and NIM. Its 2026 State of AI in Healthcare survey shows 70% of organizations actively using AI, with generative models now...
Diabetes Drug Empagliflozin Shows Promise for Early Alzheimer’s
As a medical school professor, I've long suspected that Alzheimer's disease is metabolic at its core. Now we have clinical proof. A Wake Forest trial tested empagliflozin -- a common diabetes drug -- in NON-DIABETIC Alzheimer's patients for the first time. The...
Add Biotech to Strategic Tech List, Stop China Outsourcing
We need to add biotech to the COINS Act list of strategic technologies alongside chips, AI, quantum, and drones. It is insane to outsource the genetic engineering industry to China with US VC's leading the way.
Killer Cells Eradicate Superbugs in a Single Day
Forget Antibiotics: These Killer Cells Wipe Out Deadly Superbugs in a Day by @ShellyFan https://t.co/KVAaK61555 https://t.co/cXP8loNRHn
Nature-Inspired Drug Discovery Discussed on The Long Run
Inspired by Mother Nature, Discovering New Drugs. @viswacolluru of @lifeschemistry is the latest guest on The Long Run. Sponsored by @AlphaSenseInc and Dash Bio. https://t.co/F01HMam6Ul
Telehealth Gets Discounted GLP‑1 Service, Outsmarts Weightwatchers
GLP-1 as a service and at a massive discount. Entire distribution now massively and exclusively advantaging telehealth providers. Of course Mr efficient thinks that’s a nothing burger for Weightwatchers. Can’t make this up https://t.co/62IYen2o3b
Regulators Lag as AI Accelerates Drug Discovery
AI in drug discovery is moving faster than any other sector right now. Eli Lilly. Computational pharma. FDA timelines under pressure. The bottleneck isn't the AI. It's whether regulatory frameworks were designed for a world where drug candidates get identified in months.
Viral Research Reveals Immune Secrets for Vaccine Design
Here is my talk on how studying viral infections can teach us a lot about the immune system, and how we can use those insights to develop vaccines against viruses. "Night science moments" make science so exciting 🌓 @NightScienceIns @ItaiYanai...
FDA Standards Threaten Affordable Academic Gene Therapies
The scientists behind treating Baby KJ say the FDA is imposing standards that could make it too expensive for them — or any academics — to bring such bespoke therapies to approval. https://t.co/OrxMXBVev4
FDA Hurdles Stall Academic Scaling of Custom Gene Editor
Baby KJ scientists hit speed bump in quest to scale custom gene editor. Stringent FDA requirements could prove stumbling block for academics https://t.co/HsaK7lSuh1 via @Jasonmmast
US VCs Embed in Chinese Labs, Courting Scientists Early
U.S. venture capital firms are no longer waiting for Chinese biotech assets to surface before investing in them — they’re moving upstream, embedding themselves inside labs and courting scientists before they publish their research https://t.co/7kOlGh0sbu
Hype Undermines Science, Fuels Unfounded Doubt
"This kind of hype is dangerous. It undermines more serious science and brings into play doubt about data that’s yet to be presented.” https://t.co/43glXqCyx9
Mental‑health Biotech Will Outgrow Disease‑focused Pharma
Consumer biotech and pharma will ultimately be a much bigger business than sickness-focused biotech and pharma. And what people crave even more than being sexy is being happy. Hence, I believe #mentalhealth will be the largest subsector and companies like my @ataibeckley...