ADA: Obesity Partners Zealand and Roche Aim for Weight Loss ‘Sweet Spot’ with Amylin Agonist
Roche and its partner Zealand reported that their amylin analog petrelintide produced a 9% weight reduction after 42 weeks in the Phase 2 ZUPREME‑1 trial, falling short of analyst expectations for 12% loss and behind Lilly’s eloralintide. The companies argue that a modest 10% loss with placebo‑like tolerability represents the “sweet spot” for a first‑line obesity therapy. Roche also highlighted its GLP‑1/GIP dual agonist enicepatide, which achieved a 22.5% placebo‑adjusted loss and is moving into Phase 3. Both drugs will advance to Phase 3 and Phase 3b later this year, emphasizing adherence and safety over maximal efficacy.
Lilly and Novo Face Off at ADA 2026 as Others Seek to Compete in Obesity
The 2026 American Diabetes Association Scientific Sessions in New Orleans will spotlight the obesity market, now projected by IQVIA to reach $92 billion this year and $200 billion by 2027. Eli Lilly will unveil Phase 3 data for its triple‑G agonist retatrutide, showing up to...
The Next FDA Commissioner Must Be a Champion for Gene Therapies
FDA Commissioner Marty Makary resigned on May 12, intensifying uncertainty for rare‑disease and gene‑therapy developers. Early 2026 data show orphan‑product rejection rates climbing to roughly 30%, up from about 10% in prior years. The volatility undermines investment decisions, prompting some...
Otsuka Energizes IgA Neuropathy Space with New Phase 3 Voyxact Data
Japanese drugmaker Otsuka Pharmaceuticals reported interim Phase 3 VISIONARY results showing its APRIL inhibitor Voyxact halted kidney function decline in IgA nephropathy patients, delivering a 0.7 mL/min/1.73 m² rise in eGFR versus a 4.8 mL/min/1.73 m² drop in the placebo arm after 12 months. The...
Stakeholders Want Makary’s Voucher Program Paused, Call for FDA Independence
Stakeholders including doctors, lawmakers and consumer groups urged a temporary pause to the FDA Commissioner’s National Priority Voucher (CNPV) program, citing opaque criteria and political influence. The program, launched by former Commissioner Marty Makary in June 2025 without public comment,...
Alnylam Hops on AI Train with up to $2B Inceptive Partnership
Alnylam Pharmaceuticals has struck a partnership with Inceptive Nucleics, committing $30 million upfront for access to the firm’s generative‑AI platform, with the agreement capable of reaching $2 billion in value through preclinical, regulatory and commercial milestones. Inceptive’s model learns disease biology and...
Rethinking Hair Loss Treatment
In a June 4, 2026 episode of BioSpace’s podcast Denatured, Pelage Pharmaceuticals CEO Daniel Gil and Eli Lilly immunology SVP Francisco Ramírez‑Valle discuss a regenerative strategy to treat hair loss. They explain why the field has seen few breakthroughs and describe early proof‑of‑concept data...
FDA Hits Medline with Warning Letter over Long-Running Contamination Problem
Medline Industries, fresh from a $6.3 billion IPO, received two FDA warning letters in early 2026 for repeated bacterial contamination at separate facilities. Between June 2023 and August 2025, inspectors documented nine instances of objectionable microorganisms, including Bacillus cereus in five...
No Longer a Bargain Pool, Chinese Biotechs Command Higher Premiums
Chinese biotech firms are shedding their low‑cost image as deal sizes surge, with average transaction values rising 74% year‑over‑year to 2025 levels. Companies like Innovent and Hengrui are securing upfront payments of $600‑$650 million, while U.S. giants such as Pfizer and...
ASCO: Pfizer Scores in Lung, Colorectal and Prostate Cancer but Key Readouts Still to Come
Pfizer entered ASCO 2026 fresh from a $10.5 billion partnership with China’s Innovent Biologics, using the deal to reinforce its oncology pipeline. The company unveiled more than 40 abstracts, including late‑breakers that showed an 81% reduction in disease‑progression risk for Lobrena in...
ASCO: A Battle of Bispecifics, Eli Lilly’s Big Win and More
At ASCO 2023, several late‑stage oncology candidates demonstrated practice‑changing potential. BioNTech and BMS reported 57‑68% response rates for their PD‑1/VEGF bispecific pumitamig in early NSCLC trials, while Johnson & Johnson’s Erleada plus ADT cut metastasis risk 20% in high‑risk localized...
Servier Frees Edgewise for Cardio Mission with $2.65B Muscular Dystrophy Deal
Servier is acquiring Edgewise Therapeutics' muscular‑dystrophy business for up to $2.65 billion, paying $1.55 billion upfront with $1.1 billion in potential milestones. The deal transfers the fast skeletal‑myosin inhibitor sevasemten, currently in Phase 3 trials for Becker muscular dystrophy and Phase 2 for Duchenne, to...
Moderna Partners with CEPI on Ebola Vaccine Efforts Amid Outbreak in Africa
Moderna and the Coalition for Epidemic Preparedness Innovations (CEPI) have struck a partnership that allocates up to $50 million to advance an experimental mRNA vaccine targeting the Bundibugyo ebolavirus (BDBV). The funding will support preclinical work, Phase 1 trials and manufacturing capacity...
Lilly Maintains Deal Streak with $1.2B Pact for Hanmi's GLP-2 Candidate
Eli Lilly signed a licensing deal with South Korean biotech Hanmi Pharm worth up to $1.2 billion to develop the GLP‑2 agonist sonefpeglutide. The agreement provides Lilly exclusive worldwide rights, except in Korea, with an upfront $75 million and milestone payments tied to...
ASCO: Biopharma Has Pancreatic Cancer ‘Surrounded’ as Immuneering’s Drug Adds 9 Quality Months
Immuneering reported that its MEK inhibitor atebimetinib combined with modified gemcitabine/nab‑paclitaxel (mGnP) produced a 17.3‑month median overall survival in a Phase 2a trial of 55 first‑line metastatic pancreatic‑cancer patients, nearly doubling the 8.5‑month benchmark from the historic MPACT study. The regimen...
Biohaven Looks to Obesity to Bounce Back From Run of Clinical and Regulatory Failures
Biohaven is repurposing its myostatin‑activin blocker taldefgrobep alfa for obesity after a failed Phase 3 spinal muscular atrophy trial. The drug showed weight‑loss benefits while preserving lean muscle and bone density, prompting a Phase 2 obesity study that began enrollment in March....
Cracked Gaskets and Rust-Like Residues Trigger FDA Warning Letter to Alchymars
The U.S. Food and Drug Administration issued a second warning letter to Indian API maker Alchymars ICM SM Private Limited after an unannounced inspection uncovered cracked gaskets, rust‑like residues and wet paint on equipment used for U.S. drug production. The...
Replimune Gives Cancer Immunotherapy a Third Try After FDA Leadership Shakeup
Replimune is filing a third biologics license application for its oncolytic melanoma therapy RP1, now paired with Bristol Myers Squibb’s PD‑1 inhibitor Opdivo. The FDA has labeled the resubmission an urgent matter and will prioritize its review. Earlier submissions were rejected...
11 Companies Hiring in New Jersey Now
New Jersey’s life‑sciences sector, home to over 3,000 firms and 61,100 employees, saw BioSpace job postings jump 73% year‑over‑year, now exceeding 300 openings. The surge is driven by hiring sprees at 11 major pharma and biotech companies, including AbbVie, Daiichi...
FDA Accepts BridgeBio’s Application for Potential First Limb-Girdle Muscular Dystrophy Drug
BridgeBio’s oral therapy BBP‑418 has received FDA priority review, with a target action date of Nov. 27, 2025, positioning it for a potential launch in late 2026 or early 2027. The Phase 3 FORTIFY trial met all primary and secondary endpoints, showing...
Lilly Just Bought Renowned Regulator Peter Marks a Pipeline to Play With
Eli Lilly has spent $3.8 billion acquiring Curevo, LimmaTech Biologics and Vaccine Company, giving the company a fledgling vaccine pipeline. The deals were driven in part by the hiring of former FDA CBER chief Peter Marks, who left the agency amid concerns over...
FDA Assembles Vaccine Experts to Update COVID-19 Formulation
The FDA will convene its Vaccines and Related Biological Products Advisory Committee on May 28 to evaluate a reformulated COVID‑19 vaccine that targets the XFG subvariant, which now accounts for the majority of U.S. cases. CDC surveillance confirms XFG’s dominance,...
Kura’s Encouraging Cancer Drug Data Could Unlock $2B Market Opportunity
Kura Oncology reported that its experimental farnesyltransferase inhibitor darlifarnib, combined with Bristol Myers Squibb’s KRAS inhibitor Krazati, shrank tumors in 77% of the 26‑patient FIT‑001 cohort. Objective response rates reached 67% in pancreatic cancer, 50% in non‑small cell lung cancer,...
Makary’s Reforms Will Live on at FDA Even as Leadership Turns Over
Former FDA Commissioner Marty Makary’s reforms, especially the Commissioner’s National Priority Voucher (CNPV) program, will continue unchanged despite his resignation and a broader leadership vacuum at the agency. The CNPV, launched in July 2025, grants accelerated review to drugs that...
Germany Can Produce Biotech Winners. Europe Must Back Them Better.
Germany’s robust science, capital and talent ecosystem produced a headline‑making deal when U.S. drugmaker Gilead Sciences agreed to acquire Munich‑based Tubulis GmbH. The transaction values the clinical‑stage antibody‑drug conjugate developer at $3.15 billion in cash with up to $1.85 billion in milestone...
Curse of the Straight-A Student
The article describes how high‑performing "straight‑A" employees excel by delivering flawless work, earning trust and reliability. Over time, that same execution focus can stall career growth because senior leaders value judgment more than relentless effort. To break the ceiling, professionals...
Niowave, Fresh From Novartis Deal, Starts Building $75M Radioisotope Plant
Niowave announced the construction of a new $75 million actinium‑225 production facility in Lansing, Michigan, slated to begin operations in 2028. The plant will house proprietary superconducting linear accelerators and create about 70 high‑skill jobs in research, engineering, and quality assurance....
4 Troubled Targets that Have Thwarted Biopharma
Biopharma’s pursuit of high‑profile targets—TIGIT, RIPK1, MYC, STING and alpha‑synuclein—has hit a series of setbacks. Gilead and Arcus dropped domvanalimab after a disappointing Phase 3 readout, while GSK, Sanofi, Eli Lilly and Roche have all abandoned RIPK1 programs. MYC remains structurally undruggable,...
REGENXBIO, Novartis, Dyne Near FDA Submissions in Muscular Dystrophies
A wave of near‑term regulatory activity is reshaping the muscular dystrophy landscape. REGENXBIO reported mixed Phase 3 data for its gene therapy RGX‑202, achieving 93% microdystrophin expression but raising safety flags, while targeting a 2027 launch. Novartis’ $12 billion acquisition of Avidity...
Moderna’s Once-Rebuffed mRNA Flu Shot to Face Scrutiny From FDA Adcomm
The FDA will hold its Vaccines and Related Biological Products Advisory Committee on June 18 to evaluate Moderna’s investigational mRNA flu vaccine, MFLUSIVA, aimed at adults 50 and older. Earlier this year the agency issued a refusal‑to‑file letter, arguing the...
FDA Sends Warning Letter After Chinese Supplier Breaks GLP-1 Import Restrictions
The FDA issued a warning letter to Harbin Jixianglong Biotech after inspectors found the Chinese API maker importing semaglutide from a non‑green‑list source and mislabeling it as produced in‑house. Jixianglong had been added to the FDA’s newly created “green list”...
Beam One-Ups Wave as Both Show Promise of Editing for AATD
Beam Therapeutics presented Phase 1/2 data for its DNA editor BEAM‑302, showing an 80% drop in mutated alpha‑1 antitrypsin (AAT) protein and lifting total AAT above the 11 µM protective threshold, with effects lasting 12 months. Wave Life Sciences reported its RNA editor...
AbbVie’s New Immunology Standard-Bearer Skyrizi Kneels to UCB’s Bimzelx in Psoriatic Arthritis
UCB’s Bimzelx outperformed AbbVie’s Skyrizi in a Phase 3 head‑to‑head trial for psoriatic arthritis, achieving 49.1% ACR50 versus 38.4% for Skyrizi at week 16. While Bimzelx also showed numerically higher minimal disease activity (43% vs 39.9%), the difference missed statistical significance. Skyrizi...
J&J’s Duato Makes 358 Times His Median Employee; Vertex CEO Makes Just 80 Times
Johnson & Johnson chief Joaquin Duato earned $32.6 million in 2025, creating a 358‑to‑1 pay ratio with the median employee who earned $91,000—the widest gap among the ten pharma firms studied. Eli Lilly’s David Ricks followed with a $36.7 million package and a 293‑to‑1...
Relay Doubles the Bar, Outpacing Novartis with a 60% Response in Rare Disease
Relay’s oral PI3Kα inhibitor zovegalisib posted a 60% volumetric response in a Phase 2 trial of patients with vascular malformations, far outpacing Novartis’ 11% result with Vijoice. The data, presented at the ISVAA World Congress 2026, came from 20 evaluable patients,...
BioMarin Suffers Another Blow to Rare Disease Portfolio in Phase 3 Flop
BioMarin’s investigational enzyme replacement therapy BMN 401 lowered plasma inorganic pyrophosphate (PPi) in the Phase 3 ENERGY 3 trial for ENPP1 deficiency, but it did not translate into clinical benefit. The study enrolled almost 30 children aged 1‑12 and missed the primary Radiographic...
Regeneron, Parabilis Set Out to Create New Drug Class in Deal Worth up to $2.3B
Regeneron is committing $75 million upfront and up to $2.3 billion in milestones to partner with peptide‑focused biotech Parabilis Medicines. The collaboration will merge Regeneron’s antibody‑drug conjugate (ADC) platform with Parabilis’ Helicon peptide technology to create a new class called antibody‑helicon conjugates...
Amgen’s Rare Disease Drug Tavneos Tied to 20 Deaths in Japan
Amgen’s rare‑disease drug Tavneos has been linked to 20 deaths among roughly 8,500 Japanese patients, primarily due to vanishing bile duct syndrome, a severe form of drug‑induced liver injury. The Japanese distributor Kissei Pharmaceutical has warned doctors against initiating new...
Regeneron Misses Again as Melanoma Combo Bows to Merck’s Keytruda in Phase 3
Regeneron reported that its investigational LAG‑3 antibody fianlimab, combined with the PD‑1 blocker Libtayo, failed to show statistically significant survival benefits versus Merck’s Keytruda in a Phase 3 first‑line melanoma trial. Median progression‑free survival was 11.5 months for the high‑dose combo...
The Future of Radiopharma Is Being Built by Nuclear Geeks in SLC
Nusco, a Salt Lake City physics firm, is building a 190,000‑sq‑ft radioisotope production facility featuring a novel ion‑source linear accelerator capable of producing up to 12 isotopes simultaneously. The plant, designed for 24/7 operation and earthquake resilience, aims to meet...
Can Revolution’s 'Miracle' Pancreatic Cancer Drug Be Topped? Immuneering, Actuate Say Yes
Revolution Medicines reported Phase 3 data showing its oral RAS inhibitor daraxonrasib more than doubled median overall survival for advanced pancreatic cancer to 13.2 months versus 6.7 months on chemotherapy. The results triggered a 40 % share surge and will support global regulatory filings,...
4 Spaces Primed for the Next Wave of Gene Therapies
The FDA’s recent approval of Regeneron’s Otarmeni for hereditary hearing loss marks the first non‑oncology gene‑therapy clearance, underscoring a shift toward treating central‑nervous‑system, ophthalmic, cardiovascular and muscular disorders. Companies such as Lexeo, Lilly/AskBio, uniQure, REGENXBIO/AbbVie, Tenaya, Medera and Sarepta are...
Genmab Drops 2 Antibody Assets, Including Another ProfoundBio ADC
Genmab has scrapped two recent antibody‑drug conjugate programs after acquiring ProfoundBio for $1.8 billion, citing safety and efficacy concerns. The discontinued assets include GEN1286, which failed to meet enrollment targets and showed an unfavorable benefit‑risk profile, and GEN1057, a DuoBody bispecific...
Sun Pharma Recalls Cancer Drug After Finding Glass Particles in some Vials
Sun Pharma is recalling 675 vials of its doxorubicin hydrochloride liposome chemotherapy drug in the United States after glass particles were found in the vials. The batch, manufactured at Sun's Halol, India facility, has not generated any adverse event reports,...
Biogen’s Alzheimer’s Results Bolster Tau Theory—And Denali’s Next Gen Candidate
Biogen’s Phase 2 trial of the tau‑targeting agent BIIB080 showed modest cognitive gains and biomarker improvements but failed to meet its primary endpoint of dose‑dependent disease‑severity change at 76 weeks. The mixed results nonetheless validated the intracellular tau hypothesis, prompting Biogen...
GPCRs, Radiopharma and the Rise of Functional Peptide Screening
Functional peptide screening is emerging as a key differentiator in GPCR and radiopharmaceutical drug discovery. High‑throughput platforms that measure signaling, rather than just binding, enable identification of true agonists for both known and orphan receptors. Big Pharma is backing the...
Biogen Takes Tau Alzheimer’s Therapy to Phase 3 Despite Mid-Stage Fail, Prompting Cautious Optimism
Biogen is advancing its tau‑targeting Alzheimer’s drug diranersen (BIIB080) to Phase 3 despite a failed primary endpoint in the Phase 2 CELIA trial. The study of over 400 early‑stage patients showed a strong reduction in cerebrospinal‑fluid tau and modest slowing of cognitive...
BeOne Wins Mantle Cell Lymphoma Approval, Opening New Therapy Class
The FDA granted accelerated approval to BeOne Medicines’ BCL2 inhibitor sonrotoclax, marketed as Beqalzi, for patients with relapsed or refractory mantle‑cell lymphoma who have failed at least two prior therapies, including a BTK inhibitor. The drug is the first BCL2...
From MSCs to iPSCs: Building the Cell Therapy Future
In a live session at the ISCT annual meeting, Miguel Forte and Jon Ellis discussed the evolving roles of mesenchymal stem cells (MSCs) and induced pluripotent stem cells (iPSCs) in cell‑therapy development. They examined the scientific advantages of each platform, highlighted persistent...
Makary’s Reported FDA Removal Could Be 'Broad Positive' For Biopharma
President Donald Trump reportedly agreed to remove FDA Commissioner Marty Makary, a move confirmed by the Wall Street Journal and echoed by anonymous sources. The announcement follows the recent departure of CBER director Vinay Prasad and adds to a pattern of...