Today's Pharma Pulse
Global drugmakers accelerate U.S. manufacturing and R&D amid looming 100% tariff threat
Pharmaceutical giants are boosting U.S. production and research investments as the Trump administration threatens 100% tariffs on branded drugs unless prices are cut or production moves domestically. Companies including Pfizer, AstraZeneca, Eli Lilly, Johnson & Johnson and Roche have pledged commitments ranging from $3.5 billion to $70 billion to secure temporary tariff exemptions.
AlzeCure Shares Soar over 300% After Eli Lilly Strikes Alzheimer’s Deal Worth over $1bn
Swedish biotech AlzeCure Pharma signed a collaboration and licensing deal with Eli Lilly, granting the pharma giant global rights to AlzeCure’s pre‑clinical gamma‑secretase modulator ACD680. AlzeCure will receive $10 million upfront and could earn more than $1 billion in milestones and royalties. The announcement sent AlzeCure’s shares up 313% to SEK 5.70. The partnership adds a novel amyloid‑production‑modulating asset to Lilly’s already extensive Alzheimer’s pipeline.
Eli Lilly Receives the US FDA Approval for Ebglyss as a Q8W Maintenance Therapy for Atopic Dermatitis
Eli Lilly has received U.S. FDA approval for Ebglyss (lebrikizumab‑lbkz) as a 250 mg subcutaneous injection administered every eight weeks for patients aged 12 years or older with moderate‑to‑severe atopic dermatitis. The decision was driven by exposure‑response modeling and eight‑week dosing data from...
Drug Safety in the Modern Age: Is It Time for a Larger-Scale Revamp of Adverse Event Case Processing?
Pharmacovigilance (PV) is at a crossroads as regulators like the EMA and FDA push for real‑time safety monitoring by 2030. The article argues that AI‑driven automation can transform adverse event case processing from a manual, reactive workflow to near‑instantaneous, end‑to‑end...
Press Release: Sanofi Provides Update on MOBILIZE Phase 3 Study of Riliprubart in Chronic Inflammatory Demyelinating Polyneuropathy
Sanofi announced that the phase 3 MOBILIZE trial of riliprubart in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) refractory to standard therapy has been stopped. An independent data monitoring committee’s interim analysis indicated the study is unlikely to meet efficacy...
Navigating the Perilous Journey From Lab to Market
Armon Sharei, founder of Portal Biotechnologies, warns that roughly 90% of pre‑clinical ideas never reach clinical trials and a similar share of those that do fail to reach market. He stresses that time is the most underestimated cost, with even...
Island Pharmaceuticals Expands USAMRIID Agreement for Galidesivir Marburg Study
Island Pharmaceuticals has broadened its Cooperative Research and Development Agreement with the U.S. Army’s USAMRIID and the Geneva Foundation to launch a dose‑optimization study of its antiviral Galidesivir against the Angola strain of Marburg virus. The study, slated to start...
BioPharm Brief: RNAi, Obesity, and Diabetes Advances
City Therapeutics secured a $99.5 million Series B round to accelerate its next‑generation RNAi platform, including the Phase 1 CITY‑FXI program for thromboembolic disease and a Stargardt disease candidate. Boehringer Ingelheim and Zealand Pharma reported that survodutide, a dual glucagon/GLP‑1 agonist, achieved significant...
Antidepressants May Offer an Unexpected Protective Effect Against Fatal MDMA Toxicity
Researchers analyzing UK coronial data found that individuals who died from MDMA‑related toxicity were 40% less likely to have antidepressants in their system compared with other drug deaths. The protective signal was strongest for SSRIs and tricyclic antidepressants, which block...
Cellectis Receives FDA RMAT Designation for Lasme-Cel, the First Allogeneic CAR-T Therapy in a Pivotal Trial for Patients with R/R...
Cellectis announced that the U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to its CD22‑targeting allogeneic CAR‑T candidate, lasme‑cel, for relapsed or refractory B‑cell acute lymphoblastic leukemia (r/r B‑ALL). The designation follows Phase 1 BALLI‑01 data that demonstrated promising efficacy and...
Biotech Rally Hits New Highs as ALVO Nears FDA Decision and Swiss Vote Threatens Talent Pool
Alvotech's interchangeable biosimilar to Entyvio cleared FDA review, pushing its stock higher, while Tango Therapeutics surged over 50% after promising pancreatic cancer data. Meanwhile, a Swiss referendum on population caps threatens biotech talent pipelines, underscoring broader market dynamics.
City Therapeutics Secures $99.5 Million to Advance Next‑Gen RNAi Drugs
City Therapeutics announced a $99.5 million financing package from U.S. banks to push its lead RNA interference candidate, CITY‑FXI, into Phase 1 trials for clotting disorders, and to prepare its second program, CITY‑RBP4, for Stargardt disease. The capital raise highlights growing market...
First-in-Human Trial Reports Promising Dual Lassa–Rabies Vaccine Data
Researchers at the University of Maryland reported interim data from a phase‑1 trial of LASSARAB, a novel dual vaccine targeting Lassa fever and rabies. The study enrolled 54 healthy adults and demonstrated a clean safety profile with no serious adverse...
3 New Ebola Vaccines Are Being Fast-Tracked Amid the Current Outbreak — when Could They Be Ready?
An outbreak of the Bundibugyo strain of Ebola in the DRC and Uganda has caused over 200 deaths and threatens to reach 20,000 cases within three months. Because no approved treatments exist for this strain, CEPI is fast‑tracking three vaccine...
Low Earth Orbit Emerges as a New Frontier for Pharmaceutical Innovation
The surge in commercial space activity is spilling into biotech as companies target low‑Earth orbit to produce medicines in microgravity. SpaceX’s upcoming mega‑IPO highlights investor appetite, while firms such as Varda Space Industries and Redwire are building manufacturing platforms aboard...
Novo Nordisk Puts AI at the Centre of Its Clinical Strategy
Novo Nordisk is embedding artificial intelligence across its clinical development pipeline, following an expanded partnership with OpenAI announced in April. The company is automating data‑capture specifications, using AI to process and format clinical datasets for regulator submissions, and exploring AI‑driven...
FDA Demands Extra Run, Threatens Grace Science’s Gene Therapy
Grace Science (co-founded by Carolyn Bertozzi) is running out of cash and says the FDA didn't let them use the "plausible mechanism" pathway bc, although they're developing an ultra-rare gene therapy, it's not an n-of-1 therapy. The FDA is also...
3D-Printed Nozzle Array Could Streamline Production of Drug-Delivery Microparticles
MIT researchers have unveiled a low‑cost, 3D‑printed array of triaxial electrospray emitters that can fabricate multilayered drug‑delivery microparticles at scale. The array packs 16 nozzles into a 1 cm² footprint, using vat photopolymerization to create 25 µm channels in a few hours,...
IDEAYA Biosciences Prices $300 Million Stock and Warrant Offering
IDEAYA Biosciences announced the pricing of a $300 million underwritten public offering of 5.56 million shares and an equal number of pre‑funded warrants at $27 per unit. The capital raise, backed by a syndicate led by J.P. Morgan and Jefferies, aims to...
Incyte to Acquire Vega Therapeutics for Up to $2 B, Expanding Into Bleeding Disorders
Incyte (NASDAQ:INCY) signed a definitive agreement to buy Vega Therapeutics for $1.25 billion upfront, with up to $750 million in milestone payments, bringing the potential total to $2 billion. The acquisition adds VGA039, a Phase‑3 monoclonal antibody for von Willebrand disease, to Incyte’s...
BioCardia Raises $4.4 Million in Financing for Its Heart Failure Cell Therapies
BioCardia raised $4.4 million by selling 3.509 million shares at an average price of $1.28, securing funding to advance its autologous (CardiAMP HF) and allogeneic (CardiALLO) heart‑failure cell therapies. The proceeds are expected to sustain operations through the first quarter of 2027...
FDA Clarifies Lumasiran's PH1 Approval, Keeps Givlaari as AHP Treatment
The FDA has reaffirmed that Lumasiran (Oxlumo) is approved only for primary hyperoxaluria type 1 (PH1), while Givlaari (givosiran) remains the approved RNAi therapy for acute hepatic porphyria (AHP). The clarification forces biotech business‑development teams and investors to separate the two...
Regulatory Actions for June 9, 2026
On June 9, 2026 regulators issued a wave of approvals, designations and fast‑track statuses across biopharma and med‑tech. Companies ranging from Alvotech and Artiva to Pfizer, Sanofi and Xspray saw new EU, FDA or EMA clearances for drugs, biologics and device platforms....
ADA26: Oral PCSK9 Inhibitor Enlicitide Delivers Robust LDL-C Lowering
Phase III data presented at the ADA Scientific Sessions showed that enlicitide, an oral PCSK9 inhibitor, lowered LDL‑C by 65% in participants with diabetes and 61% in those without. The integrated analysis of the CORALreef Lipids and HeFH studies found no...
ProtVar Update: A Discovery Engine for Genetic Missense Variation
EMBL‑EBI has launched a major upgrade to ProtVar, its platform for interpreting human missense variants. The revamped tool now indexes over 500 million potential missense changes and pulls together data from UniProt, AlphaFold, Open Targets, Ensembl and other resources. An AI‑powered...
NVP-INE963
Novartis and Medicines for Malaria Venture have advanced NVP‑INE963, an oral fast‑acting blood‑stage antimalarial, into Phase 2 trials. The candidate emerged from a 1.5 million‑compound phenotypic screen and shows activity against multidrug‑resistant Plasmodium falciparum, though its mechanism remains unknown. Preliminary Phase 2 data...
Some Drugs 'Fail' Because of Unrealistic Testing Conditions, Scientists Discover
Northwestern University researchers found that drug activity can flip when experiments mimic human body temperature and calcium levels. Their study showed the synthetic molecule TPPO, previously deemed inactive, robustly activates the TRPM4 channel at 37 °C with physiological calcium. Conversely, the...
The US FDA New Drug Approvals in May 2026
In May 2026 the U.S. FDA granted approvals for eight novel therapies across oncology, cardiovascular disease, infectious disease, anesthesia, and antimicrobial resistance. Highlights include Veppanu for ESR1‑mutated breast cancer, Beqalzi for relapsed mantle‑cell lymphoma, and Baxfendy for treatment‑resistant hypertension. The...
Longevity Startup Doses First Human in Bid to Reverse Age-Related Sight Loss
A longevity‑focused biotech startup announced the first human dose of its experimental therapy aimed at reversing age‑related sight loss, specifically early‑stage age‑related macular degeneration (AMD). The Phase 1 trial enrolls ten participants and will evaluate safety, tolerability, and preliminary efficacy on...
Will Obesity Drugs Save Pfizer From Its Post-COVID Slump?
Pfizer’s post‑COVID revenue surge has evaporated, and a wave of patent expirations will shave $1.5 billion off earnings this year, rising to $4.5 billion by 2027. To offset the loss, the company has poured roughly $80 billion into acquisitions and licensing, most notably...
GSK to Acquire Nuvalent for $10.6 B, Bolstering Oncology Pipeline
GSK plc agreed to buy clinical‑stage biotech Nuvalent for $10.6 billion, a deal that brings three late‑stage lung‑cancer candidates into GSK’s oncology pipeline. The transaction, priced at $124 per share, is expected to be accretive to earnings by 2029 and hinges...
Moderna Jab on Trial for Cancer-Causing Syndrome
Moderna and the University of Oxford have received clearance to begin human trials of mRNA‑4194, an mRNA‑based vaccine aimed at preventing cancers linked to Lynch syndrome. The phase 1/2 INTERCEPT‑Lynch study will start dosing patients at two Oxford clinical sites, with...
World's First WWOX Gene Therapy Given to Infant with WOREE Syndrome
An eight‑month‑old infant received the world’s first WWOX gene replacement therapy at Schneider Children’s Medical Center in Israel, marking a historic first‑in‑human treatment for WOREE syndrome. The AAV9‑based vector, developed by Mahzi Therapeutics and licensed from Hebrew University, was delivered...
DDW Highlights: 9 June 2026
In this episode, Bruno Quinney highlights four major developments: Greywolf Therapeutics' experimental oral ERAP1 inhibitor GRWD‑5769, which shrank tumors up to 55% in early trials; UK researchers warning that obesity drugs like semaglutide could widen health inequities without broader support;...
ADA: Lilly Bests Novo Again, Takes GLP-1 Pill Foundayo to FDA for Diabetes Approval
Eli Lilly’s oral GLP‑1 drug orforglipron, marketed as Foundayo, demonstrated superior blood‑sugar control and greater weight loss than Novo Nordisk’s oral semaglutide and AstraZeneca’s Farxiga in three Phase 3 ACHIEVE trials. In the 52‑week ACHIEVE‑3 study, a 9 mg dose cut HbA1c by 1.9%...
David Sinclair Enters $101 Million XPrize with Oral Rejuvenation Drug
Harvard’s David Sinclair confirmed he will launch human trials of an oral “reprogramming” drug, code‑named SL‑100, as part of the XPrize Foundation’s $101 million health‑span competition. The prize rewards teams that can demonstrate a ten‑year improvement in immune, cognitive and muscle...
Seaport Therapeutics Posts $25.4M Q1 Loss, Eyes Phase 2b BUOY‑1 Readout in H1 2027
Seaport Therapeutics announced a Q1 2026 net loss of $25.41 million, nearly double the loss a year earlier, as R&D spending surged to $21.43 million. The company also signaled that data from its Phase 2b BUOY‑1 trial are slated for the first half...
GSK to Acquire Nuvalent in $10.6 B Deal, Bolstering Lung Cancer Pipeline
GlaxoSmithKline (GSK) agreed to buy US biotech Nuvalent for $10.6 billion in cash, paying $124 per share—a 40% premium. The acquisition adds three late‑stage lung‑cancer candidates to GSK’s oncology portfolio and is expected to be accretive to earnings by 2029.
Zai Lab Reports the NMPA Approval of Tivdak (Tisotumab Vedotin) for Recurrent or Metastatic Cervical Cancer
Zai Lab’s antibody‑drug conjugate Tivdak has secured approval from China’s National Medical Products Administration for adults with recurrent or metastatic cervical cancer who have progressed after chemotherapy. The decision follows the global Phase III innovaTV 301 trial, which showed a 45 % reduction...
Scientists Use Inactive Virus to Safe-Deliver Spasticity-Reversing Spinal Genes
A preclinical study used an inactive AAV9 vector to deliver GAD65 and VGAT genes directly into the spinal cord of rats with chronic injury‑induced spasticity. The single subpial injection restored GABAergic inhibition, leading to progressive reductions in muscle stiffness and...
FDA Expands Hympavzi to Children 6+, Boosting Hemophilia Care
The FDA has broadened approval of Pfizer's Hympavzi (marstacimab-hncq) to include all patients aged six and older with hemophilia A or B, with or without inhibitors. The once‑weekly subcutaneous treatment showed a 92% drop in annualized bleeding rates in trials,...
David Sinclair Plans to Test Whole-Body Rejuvenation Drugs in the XPrize Competition
Harvard biologist David Sinclair plans to test an oral epigenetic reprogramming drug, code‑named SL‑100, in the XPRIZE Healthspan competition, which offers $101 million for teams that can demonstrate a ten‑year functional improvement after a year of treatment. The trial would be...
Bial Drops Pariceract After Phase IIb Failure in GBA-Associated Parkinson’s
Portuguese drugmaker Bial has halted development of pariceract (BIA 28‑6156) after its Phase IIb ACTIVATE trial failed to meet primary and key secondary endpoints in 273 GBA‑associated Parkinson’s patients. The oral GCase activator was well tolerated but showed no significant difference from...
GSK Pursues $10.6bn Takeover of Cancer Biotech Nuvalent
GSK announced a $10.6 billion tender offer for Boston‑based Nuvalent, paying $124 per share—a 40 % premium. The deal brings two late‑stage lung‑cancer drugs, the ROS1 inhibitor zidesamtinib and the ALK inhibitor neladalkib, into GSK’s oncology pipeline, both under FDA review with...
Pfizer Receives the US FDA Approval for Hympavzi to Treat Hemophilia A or B in Two Populations
Pfizer’s Hymnavzi (marstacimab) received U.S. FDA approval for subcutaneous weekly treatment of hemophilia A or B patients aged 12 and older who have inhibitors, and for children aged 6‑11 with or without inhibitors. The approval rests on Phase III BASIS data...
Pharma in Spain: Why Global Investors and Innovators Are Moving In
Spain has emerged as a European pharma hub, ranking third in EU scientific output and ninth worldwide. Its robust research ecosystem—anchored by institutions like CSIC, CNIO and CNIC—feeds a dense network of 848 public hospitals that support over 1,000 annual...
Scientists Found a New Alzheimer’s Trigger and a Drug that Stops It
Researchers at ETH Zurich have pinpointed the inactive form of the regulatory protein GRK2 as a new trigger of Alzheimer’s disease. In mouse studies, GRK2 aggregates block mitochondrial pores, reducing cellular energy and boosting amyloid‑beta production. The team’s experimental Compound 10...
SGLT2 Inhibitor Cuts Heart‑failure Hospitalizations >80% in Variant Carriers
A sodium-glucose cotransporter 2 drug (SGLT2) was linked to >80% reduction of hospitalization for heart failure in people who carried a disease-causing (pathogenic or likely pathogenic) genomic variant. Compared with placebo in a randomized trial with subsequent exome sequencing...
Target Trial Does Not Suggest Major Adverse Outcomes with Early GLP-1 Use in Pregnancy
A target‑trial emulation of 3,572 U.S. pregnancies examined the safety of continuing glucagon‑like peptide‑1 receptor agonists (GLP‑1RAs) into the first trimester. The analysis, published in Annals of Internal Medicine, found no statistically significant increase in non‑live birth, abnormal fetal growth,...
Left-Handed DNA Tubes Double Cancer Drug Killing by Boosting Cell Uptake
Researchers at the Cancer Center at Illinois have shown that left‑handed DNA origami tubes loaded with the chemotherapy drug Daunorubicin achieve more than twice the cell‑killing efficacy of right‑handed tubes. The tubes display aptamers that target the CD117 protein on...
Regimen ‘Extremely Encouraging’ in Metastatic Pancreatic Cancer
Tango Therapeutics and Revolution Medicines reported that the oral PRMT5 inhibitor vopimetostat combined with the pan‑RAS inhibitor daraxonrasib produced a 92% objective response rate in patients with MTAP‑deleted, RAS‑mutant metastatic pancreatic ductal adenocarcinoma. At six months, 90% of those responders...