Today's Pharma Pulse
CMS postpones GLP‑1 Medicare pilot, hitting Lilly and Novo shares
The Centers for Medicare & Medicaid Services indefinitely delayed its BALANCE financing model aimed at expanding Medicare coverage for GLP‑1 obesity drugs. The postponement knocked Eli Lilly’s stock down about 2% and Novo Nordisk’s by roughly 4%, with analysts projecting a near‑term revenue loss of up to $500 million for Lilly that could rise to $3.3 billion.
Also developing:
By the numbers: Asahi Kasei acquires German biotech Aicuris for $920.7M
NIMBLE Trial Shows Efficacy of Cemdisiran in gMG: Tuan Vu, MD
The phase 3 NIMBLE trial evaluated cemdisiran, an RNA‑interference therapy, in patients with generalized myasthenia gravis (gMG). Over 26 weeks, cemdisiran monotherapy and its combination with pozelimab both achieved statistically significant improvements on the MG‑ADL scale versus placebo, and met the key secondary QMG endpoint. Results were presented at the 2026 American Academy of Neurology meeting, confirming earlier Regeneron press releases from August 2025. The data position cemdisiran as a promising new option in the gMG treatment arsenal.
Boehringer Targets AI-Driven Advances in Disease Research
Boehringer Ingelheim announced a £150 million (US$203 million) AI and machine‑learning accelerator in King’s Cross, London, expanding its global computational R&D network. The new hub, part of the UK Knowledge Quarter, will focus on disease biology, target identification and predictive modeling to...
BioAge Reports Positive Phase 1 Data for BGE-102
BioAge Labs announced Phase 1 results for BGE‑102, an oral, brain‑penetrant NLRP3 inhibitor, showing up to 86% reductions in high‑sensitivity C‑reactive protein (hsCRP) in obese participants. A 60 mg once‑daily regimen over 21 days achieved biomarker improvements comparable to the previously tested...
Research Shows Nicotine May Boost Cognition, Guard Against Parkinson's
The New York Times mentioned me in an article about nicotine. They're skeptical. Here's what they didn't include... Dr. Paul Newhouse at Vanderbilt ran controlled trials showing nicotine improved concentration and cognitive function in people with mild cognitive impairment. Peer-reviewed, published...
Promising Mufemilast Results Unveiled at DDW
Strong mufemilast data being presented at DDW this week for anyone still following the $PALI story. https://t.co/Oi4WI6R0iW
Re: Alzheimer’s Drugs Targeting Amyloid Do Not Produce Clinically Meaningful Effects, Concludes Cochrane Review
A recent Cochrane review concluded that amyloid‑targeting drugs for Alzheimer’s disease do not deliver clinically meaningful benefits, prompting disappointment among researchers, investors, and caregivers. In a BMJ rapid response, emeritus professors Elaine and Robert Perry argue that cholinergic therapy—available for...
AI Accelerates Small Molecule Synthesis, Says Martin Burke
Small molecule synthesis made faster for the AI era: Listen to Martin Burke on The Long Run. Sponsors: @AlphaSenseInc and Dash Bio. https://t.co/D990phgzg8
Merck, Eisai’s Keytruda Triplet Fails to Improve Survival in Kidney Cancer
Merck and Eisai announced that their Phase 3 LITESPARK‑012 trial of a three‑drug regimen—Keytruda, Welireg and Lenvima—failed to improve overall survival or progression‑free survival in first‑line renal cell carcinoma. The control arm received the approved Keytruda‑Lenvima doublet, which also did not...
SaNOtize - 727784 - 04/17/2026
The U.S. Food and Drug Administration issued a warning letter to SaNOtize, the maker of “NOWONDER™ Nasal Cleanser,” on April 17, 2026. The agency determined the product is an unapproved new drug because its labeling and website claim nitric‑oxide‑based immune benefits, violating sections 505(a)...
Pro Numb Tattoo Numbing Spray, LLC - 722589 - 04/14/2026
The FDA issued a warning letter to Pro Numb Tattoo Numbing Spray, LLC for multiple Current Good Manufacturing Practice (CGMP) violations, including failure to test finished drug batches, inadequate raw‑material verification, and lack of stability data. The firm also marketed...
Mabwell’s T‑mab Subsidiary Clears First‑Time GMP Inspection in Jordan, Boosting Middle‑East Push
Mabwell announced that its subsidiary T‑mab successfully passed a Jordan Food and Drug Administration on‑site GMP inspection, earning a “Compliance” rating for its denosumab biosimilars. The milestone, the company’s first approval from a PIC/S member country, is expected to accelerate...
Eli Lilly to Acquire Kelonia Therapeutics in $7 B Cash Deal
Eli Lilly agreed to acquire Cambridge‑based Kelonia Therapeutics for up to $7 billion in cash, including an undisclosed upfront payment. The deal adds Kelonia’s in‑vivo gene‑delivery platform and its lead candidate KLN‑1010 to Lilly’s oncology portfolio, and sent Lilly’s shares up 2.5%...
Chinese Researchers Propose Saliva Test to Detect Stomach Cancer Early
Researchers from Shanghai Jiao Tong University School of Medicine have pinpointed 20 bacterial species that appear in both the mouths and stomachs of gastric‑cancer patients. Their study, published in Cell Reports Medicine, proposes a non‑invasive saliva test that could identify...
BBOT Secures FDA Fast Track for Pan-KRAS Inhibitor BBO-11818 in KRAS‑Mutant Pancreatic Cancer
BridgeBio Oncology Therapeutics (BBOT) announced that the FDA granted Fast Track designation to its pan‑KRAS inhibitor BBO-11818 for advanced KRAS‑mutant pancreatic ductal adenocarcinoma. The designation accelerates development of a drug that showed a confirmed partial response in early data and...
Neolaia Synthesizes New CD38 Inhibitors
Biohaven disclosed detailed preclinical data on BHV‑2100, a TRPM3 calcium‑channel modulator aimed at neuropathic pain. A new meta‑analysis concluded that anti‑amyloid therapies for Alzheimer’s have not demonstrated clinically meaningful benefits, intensifying debate over the approach. Jiangsu and Shanghai Hengrui patented...
Incyte Discloses New TYK2 And/Or JAK1 Inhibitors
Incyte announced the discovery of a new series of small‑molecule inhibitors that selectively target TYK2 and JAK1, two kinases central to cytokine signaling in autoimmune disorders. The compounds demonstrated sub‑nanomolar potency in cell‑based assays and favorable safety margins in early...
Regulatory Hurdles, Not Tech, Slow Biotech Breakthroughs
"We need 6 'AlphaFold' moments to compress the drug delivery timeline from 10yrs to a few months" -Demis Yes and the FDA will still take 10yrs to approve it. Safetyism has throttled biotech unnecessarily and the only way to accelerate is to...
Pharma Exporters Facing Issues with Online National Drug Licensing System
Indian pharmaceutical exporters are encountering technical problems with the Online National Drug Licensing System (ONDLS), which issues Certificates of Pharmaceutical Products (COPP) under the WHO Good Manufacturing Practices scheme. The Pharmaceuticals Export Promotion Council (Pharmexcil) has launched a feedback drive...
This Biotech Firm Has Room to Run Despite Surging Nearly 500% in Past Year, Morgan Stanley Says
Arrowhead Pharmaceuticals’ stock has rocketed 473% over the past year, prompting Morgan Stanley to upgrade the shares to overweight and lift its price target to $100 from $78, indicating roughly a 44% upside. The firm is set to release Phase‑3...
Rethinking When to Start Long-Acting HIV Therapy
Real‑world data from the OPERA cohort of over 5,000 patients show that starting long‑acting cabotegravir plus rilpivirine (CAB+RPV LA) in individuals with detectable viral loads—about 11% above 50 copies/mL—can still achieve virologic suppression comparable to patients who begin treatment already...
Tortugas Neuroscience Launches to Develop Brain Disorder Drugs
Tortugas Neuroscience launches with hopes to develop drugs for brain disorders, other conditions https://t.co/zoM69VEQtV via @ADeAngelis_bio
Trump Order Boosts Psychedelic Biotech Stocks
Trump executive order lifts psychedelics biotechs https://t.co/3H00cxuF4A by @realJacobBell $GHRS $HRELP $DFTX $ENVB $COMP $ATAI #biotech
Patients Stay Cancer-Free Three Years After Clinical Trial
A phase II trial at UCL tested pembrolizumab as neoadjuvant therapy for 32 patients with stage II‑III MMR‑deficient/MSI‑high bowel cancer. After up to nine weeks of immunotherapy before surgery, 59% showed no detectable tumor and none experienced recurrence over a median...
STAT+: Tortugas Neuroscience Launches with Hopes to Develop Drugs for Brain Disorders, Other Conditions
Tortugas Neuroscience launched with a $106 million financing round led by Cure Ventures, The Column Group and AN Ventures. The startup has licensed two schizophrenia and tinnitus candidates from China’s Jiangsu Hansoh and two additional therapies for focal epilepsy and encephalopathies...
STAT+: BioAge Says Experimental Pill Aimed at Reducing Heart Risks Significantly Reduced Inflammation
BioAge Labs reported that its investigational cardiovascular‑risk pill BGE‑102 dramatically lowered inflammation in a Phase 1 trial. A 60‑mg dose cut high‑sensitivity C‑reactive protein (hs‑CRP) by 85% after one week, with the effect persisting through three weeks. The same reduction was...
Serif Targets Revolutionary Genetic Medicine Platform
Serif, Flagship’s latest biotech, aims to make a new kind of genetic medicine https://t.co/kvmbF3xYKu by @gwendolynawu #biotech #startups @FlagshipPioneer
A Pivotal Year for Regulatory Reform and Innovation
Britain’s Medicines & Healthcare products Regulatory Agency (MHRA) is advancing its MedTech regulatory reform, introducing a pre‑market statutory instrument that adds an international reliance scheme, updated classification, mandatory UDIs and stricter claim rules. The agency also plans an Early Access...
AtaiBeckley Shares Jump 21% After Trump Orders Faster Psychedelic Drug Reviews
AtaiBeckley Inc. (ATAI) surged more than 21% in Monday trading after President Donald Trump issued an executive order to accelerate FDA reviews of psychedelic treatments. The move lifted the biotech’s market cap to roughly $1.8 billion and put its Phase 2‑tested nasal...
Akeso's Cadonilimab Shows Survival Gain in Phase II Pancreatic Cancer Trial
Akeso announced that its bispecific antibody cadonilimab combined with chemotherapy delivered a median overall survival of more than 23 months in a Phase II study of advanced pancreatic ductal adenocarcinoma, marking a notable efficacy signal for a disease with limited options.
How the Depo-Provera Brain Tumor Lawsuit Works
The Depo‑Provera brain tumor lawsuit alleges that the contraceptive shot’s manufacturer failed to warn users of an increased risk of meningiomas, a type of brain or spinal‑cord tumor. Plaintiffs must demonstrate a causal link through medical records, expert testimony, and...
Judge Poised to Order Purdue Pharma to Forfeit $225 M, Unlocking Opioid Settlement
A federal judge is expected to sentence Purdue Pharma to forfeit $225 million to the Justice Department, clearing the way for a multi‑billion‑dollar settlement that requires the Sackler family to contribute up to $7 billion. The move follows a 2020 plea agreement...
PEPITEM as a Potential Therapy for Autoimmune Arthritis
Researchers at the University of Birmingham have identified a decline in the anti‑inflammatory peptide PEPITEM as a key driver of worsening inflammatory arthritis with age. Laboratory tests showed that adding synthetic PEPITEM restores white‑blood‑cell responsiveness to adiponectin in early‑stage rheumatoid...
Kailera Therapeutics Raises $625 Million in Record Biotech IPO
Kailera Therapeutics, a RTW Bio portfolio company, completed a $625 million Nasdaq IPO on April 17, upsizing from an initial $500 million target and sending its shares soaring 62.5% on debut. The offering set a new record for biotech IPO proceeds and...
Trump Signs Executive Order to Fast‑Track Psychedelic Drugs for Serious Mental Illness
President Donald Trump signed an executive order that compels the FDA to issue National Priority Vouchers to psychedelic drugs with Breakthrough Therapy designations for serious mental illness. The move is intended to eliminate regulatory bottlenecks and speed patient access to...
CPC Biotech Debuts Unified Bioprocess Fluid Portfolio
CPC Biotech, a new brand under Dover’s Pump Solutions Group, launched by merging CPC’s sterile connector expertise with PSG Biotech’s low‑shear pumps, flow meters and sensors. The unified portfolio offers biopharma manufacturers a single source for connectors, pumps, and measurement...
Atsena Secures DMC Approval for LIGHTHOUSE Trial
Atsena Therapeutics received a recommendation from its independent data monitoring committee to launch the pivotal Part C of the LIGHTHOUSE Phase I/II/III trial for ATSN‑201, its gene‑therapy candidate targeting X‑linked retinoschisis (XLRS). Part C will enroll 76 patients across Europe and North America,...
Celastrol Disrupts Hsc70‑Bim to Boost Longevity, Reduce Fibrosis
Celastrol Targets Hsc70-Bim Interaction as a Novel Senolytic to Extend Lifespan and Mitigate Organ Fibrosis https://t.co/Iv51QlhH5l
Eli Lilly to Acquire Kelonia Therapeutics for ~$7B
Eli Lilly announced a definitive agreement to acquire Kelonia Therapeutics for roughly $7 billion in cash, including an upfront payment of $3.25 billion. The deal brings Kelonia’s in‑vivo gene placement system (iGPS0) and its lead candidate, KLN‑1010, a one‑time IV gene therapy that...
Probiotics Shown to Relieve Constipation in Kids: Vietnam RCT
A Vietnam‑based randomized, double‑blind trial found that two Bacillus spore probiotic liquids, LiveSpo Kids and LiveSpo Preg‑Mom, significantly eased functional constipation in preschool children. Over four weeks, the probiotic groups experienced a 3.6‑ to 4‑fold reduction in low‑frequency bowel movements,...
Long‑time Applicants Finally See Chance for Rigorous Testing
Been applying to her office and others (eg welcome trust, nimh, arpa) for years asking to test/demonstrate that this isn’t magical thinking or snake oil. Glad to see things might change.
APC-Deficient Cancer Cells Rely on Single Enzyme for Survival
Researchers have identified aldehyde dehydrogenase 2 (ALDH2) as a critical survival factor for colorectal cancer cells lacking functional APC. Computational screening and lab experiments show that pharmacological inhibition of ALDH2, using agents such as disulfiram, sharply reduces proliferation and induces...
Trial Shows Safety of Novel KIR-CAR T Therapy in Solid Tumors
A Phase I dose‑escalation trial of SynKIR‑110, a novel KIR‑CAR T therapy, demonstrated safety in nine patients with advanced ovarian cancer, mesothelioma or cholangiocarcinoma. The multi‑chain design uses NK‑cell receptors to provide an on/off switch, reducing T‑cell exhaustion and side...
Dr. Kaeberlein's Optispan Podcast Series - Rapamycin and More
The Optispan podcast hosted by Dr. Kaeberlein outlines a translational protocol for 3‑hydroxyanthranilic acid (3HAA), a mouse‑tested longevity molecule. Using FDA BSA scaling, the human equivalent dose (HED) is calculated at roughly 1.1 g per day for a 70‑kg adult. Safety...
When a Text Message Tries to Short-Circuit the FDA
A text exchange between Joe Rogan and Donald Trump suggesting a quick FDA green‑light for ibogaine sparked concern about bypassing the rigorous drug‑approval process. The post explains that FDA approval is deliberately methodical, requiring phased clinical trials and safety data,...
AHA Calls on HRSA to Drop 340B Rebate Pilot, Warns of $1B Cost Hit
The American Hospital Association (AHA) has formally asked the Health Resources and Services Administration (HRSA) to abandon its proposed 340B rebate‑model pilot, arguing it would impose more than $1 billion in annual costs on safety‑net hospitals and jeopardize care for millions....
Tozorakimab Hits Primary Endpoint in Phase III MIRANDA COPD Trial
AstraZeneca announced that tozorakimab met the primary endpoint in the Phase III MIRANDA trial, delivering a statistically significant and clinically meaningful drop in moderate‑to‑severe COPD exacerbations. The result positions the IL‑33‑targeting biologic as a potential first‑in‑class therapy for a disease with...
CRISPR Screens Map Human T‑Cell Genes That Promote or Block HIV Infection
Researchers at Gladstone Institutes and UCSF used genome‑wide CRISPR activation and knockout screens in primary human CD4+ T cells to map host genes that either promote or restrict HIV infection. By optimizing infection rates to about 70%, they could perturb...
Trump’s Psychedelic Order Tests Review Norms
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Four Overlooked AACR Early-Stage Agents Worth Watching
While everyone was watching KRAS, some of AACR’s promising early stage pipeline agents were easy to miss. Here's an analysis on four examples which caught my eye and are well worth watching to see how they develop in the...
New RAS Cancer Drugs Aim to Beat RevMedicines’ Success
April20: Which RAS-based cancer drug developers are working to improve upon the dazzling pancreatic cancer results of @RevMedicines' daraxonrasib, whose stock surged 54%? Read about $RVMD plus updates on $MGTX and $TVTX in my latest StockWatch for @GENbio: https://t.co/9wQA7XsuLW