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 prostate cancer. Incyte’s Monjuvi‑lenalidomide‑R‑CHOP combo improved three‑year progression‑free survival to 67.3% in diffuse large B‑cell lymphoma, and Gilead’s TUB‑040 ADC achieved 60.9% tumor shrinkage in platinum‑resistant ovarian cancer. Eli Lilly’s RET inhibitor Retevmo raised two‑year event‑free survival to 91.5% as adjuvant therapy for RET‑fusion positive NSCLC, marking a landmark for targeted adjuvant treatment.
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...
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...