Cardiff Craters Amid Executive Exits, Mixed Mid-Stage Data
Cardiff Oncology announced the departure of its CEO and CFO while releasing mixed Phase II data for its PLK1 inhibitor onvansertib. In the CRDF‑004 trial, the 30 mg dose combined with FOLFIRI + bevacizumab achieved a 72.2% objective response rate and a 62% reduction in progression‑free survival risk, though statistical significance was not reached due to the small cohort. The company’s share price fell 32% to $2, and analysts warn that with $60 million cash on hand, Cardiff will likely need dilutive financing to fund a pivotal registrational study. The firm will advance only the 30 mg regimen with FOLFIRI for a forthcoming frontline RAS‑mutated mCRC trial.
Roche Makes Obesity Splash, Moderna Cans Vaccine Trials, Sarepta’s New Data, More
Roche announced that its GLP‑1/GIP candidate CT‑388 achieved a 22.5% average weight loss in a Phase II study and will launch a Phase III trial early this year, pairing the drug with a Zealand Pharma therapy to curb gastrointestinal side effects. Baseline...
FDA Lifts One of Two Clinical Holds on Intellia’s ATTR Gene Editing Program
The U.S. Food and Drug Administration lifted its clinical hold on Intellia Therapeutics' MAGNITUDE‑2 Phase III trial of the CRISPR‑based therapy nex‑z for hereditary transthyretin amyloidosis with polyneuropathy (ATTRv‑PN). The company announced that patient enrollment will resume, prompting a 10 % rise...
Baseline Debuts To Challenge GLP-1 Giant Lilly in Alcohol Use Disorder
Baseline Therapeutics, a San Francisco biotech, has launched its GLP‑1 analog BT‑001 to treat alcohol use disorder (AUD). The company has secured FDA alignment and will begin two randomized, placebo‑controlled Phase III trials this year. Baseline also plans to expand BT‑001 into...
Big Pharma Tight-Lipped on Details of API Stockpile Deals
Pharma giants Bristol Myers Squibb, GSK and Merck have agreed to contribute large quantities of active pharmaceutical ingredients (APIs) to the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) as part of the Trump administration’s supply‑chain resilience push. The deals, sealed at...
FDA Inspections Should Not Be Source of Stress
FDA inspections often trigger frantic, short‑term fixes that hide deeper operational flaws. A reactive approach can lead to costly citations, product recalls, and even multi‑million‑dollar losses, as illustrated by a pump‑contamination incident. Proactive inspection readiness ties asset reliability, documentation, and...
Sarepta’s DMD Gene Therapy Staves Off Disease Three Years After Treatment
Sarepta Therapeutics reported three‑year data from the Phase III EMBARK trial showing that Elevidys, its gene therapy for Duchenne muscular dystrophy (DMD), continues to stabilize disease progression in ambulatory patients. Motor function measures improved, with a 73% slowdown in time‑to‑rise and...
Merck Backs Off Revolution After Failing To Agree on Price: WSJ
Merck and Revolution Medicines ended acquisition talks after failing to agree on a purchase price, with proposals hovering between $28 billion and $32 billion. The biotech’s lead drug, daraxonrasib, has generated strong early‑stage data and earned an FDA priority voucher, making it...
To Accelerate Rare Disease Progress, Take a Sandbox Approach
A sandbox framework is proposed to overhaul rare‑disease drug development, allowing regulators, sponsors, patients and academics to collaborate in real time. The model groups therapies into small‑molecule, biologic and complex sandboxes, enabling a continuous IND that spans Phase 1‑3 and eliminates...
Rare Disease Vouchers Caught in Political Abyss. It Didn’t Have To Be This Way
The Mikaela Naylon Give Kids a Chance Act, which would re‑authorize the rare pediatric disease priority‑review voucher (PRV) program, is stuck in a $1.2 trillion appropriations bill, jeopardizing its passage despite bipartisan support. The PRV program, created in 2012, grants vouchers...
BMS Bets $850M on Janux’s Tumor-Activated Drugs, Deepening Cancer Investments
Bristol Myers Squibb has signed a partnership with San Diego‑based Janux Therapeutics, committing up to $850 million in upfront payments and milestone funding to co‑develop a tumor‑activated immunotherapy. The investigational drug targets an undisclosed solid‑tumor antigen and employs a proprietary masking...
FDA Sets Feb. 1 Launch Date for PreCheck Pilot To Strengthen Domestic Supply Chain
The FDA will begin accepting applications for its PreCheck pilot on Feb. 1, 2025, with a one‑month window to submit proposals for new domestic drug‑manufacturing facilities. The program, slated for a June 30 selection deadline, offers early regulatory feedback and a streamlined...
Lexicon Opens Path to $1B+ Opportunity as FDA Greenlights Phase III for Non-Opioid Pill
Lexicon Pharmaceuticals received FDA clearance to advance its non‑opioid analgesic pilavapadin into Phase III trials for diabetic peripheral neuropathic pain, following a smooth end‑of‑Phase II meeting. The agency raised no additional study requirements and agreed on a 12‑week, placebo‑controlled design using a...
‘Almost Like a Religion’: Pfizer CEO Slams RFK Jr.’s 'Anti-Science' Vaccine Policies
Pfizer CEO Albert Bourla publicly denounced U.S. Health Secretary Robert F. Kennedy Jr. as "anti‑science" for his vaccine rhetoric, a remark made at the World Economic Forum in Davos. Since Kennedy assumed the HHS role in February 2025, he has questioned...
From Sound Bites to Signals: Editors Parse Executive and Investor Chatter at JPM
BioSpace’s Denatured podcast released a post‑JPM episode where senior editor Annalee Armstrong and news editor Dan Samorodnitsky dissect conversations with pharma and biotech executives and investors. Hosted by Jennifer Smith‑Parker, the discussion highlights emerging industry themes and offers forecasts for...
Increasingly Competitive Job Market Worries, Frustrates Biopharma Professionals
BioSpace’s 2026 U.S. Life Sciences Employment Outlook reveals a sharp rise in job‑search activity among biopharma professionals. In the latest survey, 52 % of employed or contract respondents are actively looking, up from 46 % in 2024, while 93 % of the unemployed...
The New Gold Rush in Brain Science
Venture capitalists are aggressively targeting the brain, with billions flowing into CNS drug development and neurotechnology after breakthroughs in biomarkers, imaging and patient stratification. Big‑pharma deals—Johnson & Johnson’s $14.6 billion acquisition of Intra‑Cellular Therapies and Sanofi’s $470 million purchase of Vigil Neuroscience—signal...
JPM26: Filling C-Suites, Union Square—And Elevators—With Pink
The Biotech CEO Sisterhood’s pink‑themed gathering at the J.P. Morgan Healthcare Conference drew up to 1,000 participants, underscoring a growing movement to spotlight women executives in biopharma. Since its 2022 launch, the group has expanded to about 350 members and...
JPM26: KalVista’s HAE Win Is a ‘Tale of Two Markets’
KalVista secured FDA approval for its oral on‑demand hereditary angioedema drug Ekterly after a delayed PDUFA review and reported political pressure. The pill is positioned as the only oral option in a market dominated by injectable therapies, targeting the $3.8‑6.5 billion...
Roche Raises NC Manufacturing Investment to $2B To Support Obesity Challenge
Roche, through Genentech, is boosting its North Carolina manufacturing commitment from $700 million to roughly $2 billion to expand a 700,000‑square‑foot facility in Holly Springs. The plant, slated to be operational by 2029, will add about 100 jobs, bringing total staffing to over...
GSK Joins Growing PD-1 SubQ Push With Alteogen Alliance Worth up to $285M+
GSK has committed $20 million upfront and up to $265 million in milestones to partner with South Korea’s Alteogen, aiming to create a subcutaneous version of its PD‑1 cancer drug Jemperli. Alteogen will supply its Hybrozyme recombinant hyaluronidase (ALT‑B4) to enable under‑skin...
JPM26 Recap, Novo’s Oral Wegovy Soars as Lilly’s Orforglipron Is Delayed, IPOs Return
At the JPMorgan Healthcare Conference, Novo Nordisk’s oral Wegovy quickly reached roughly 3,100 patients within its first week, underscoring strong demand for oral obesity therapies. Eli Lilly’s competing oral candidate, orforglipron, saw its FDA decision pushed back to April 10, despite...
Going With the Flow: Finding Success in Academic and Biotech Research Cultures
The piece contrasts academic and biotech research cultures, highlighting how each handles uncertainty. Academic labs prioritize deep exploration and iterative validation, treating ambiguous results as opportunities for further inquiry. Biotech startups focus on data that can drive decisions quickly, balancing...
Pfizer Makes $530M Vaccine Play With Novavax Deal After Rumors of BioNTech Pullback
Pfizer has committed $30 million upfront and up to $500 million in milestone payments to partner with Novavax, gaining a non‑exclusive license to the Matrix‑M adjuvant technology. The agreement allows Pfizer to apply the adjuvant to up to two disease areas, though...
Moderna, Merck Show Long-Term Survival For mRNA-Keytruda Combo
Moderna and Merck reported that their mRNA neoantigen vaccine intismeran autogene combined with Keytruda cut the risk of melanoma recurrence or death by 49% at the five‑year mark, matching the three‑year result. The data come from the Phase IIb KEYNOTE‑942 trial...
JPM26: Galapagos' New CEO Is Here to Finally Turn The Ship Around
Galapagos appointed Henry Gosebruch as CEO, inheriting a €3 billion cash war chest and a mandate to reset the biotech’s direction after a series of clinical setbacks and a failed cell‑therapy push. Gosebruch has halted the cell‑therapy program and is reassessing...
Bonus Episode: Q3 2025 Job Market Update
BioSpace released a bonus podcast episode featuring Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel, reviewing Q4 2025 job‑market performance in the life‑sciences sector. The hosts highlighted a modest hiring uptick, rising salaries, and stronger diversity hiring,...
2026 IPO Train Keeps Chugging as AgomAb, SpyGlass Eye Nasdaq Debut
California‑based SpyGlass Pharma and New York‑based AgomAb Therapeutics filed IPOs this week, targeting Nasdaq listings under the symbols SGP and AGMB respectively. SpyGlass’s lead candidate is a Phase III bimatoprost‑eluting intraocular lens aimed at treating ocular hypertension and open‑angle glaucoma, with enrollment...
AbbVie, Genmab’s Bispecific Misses Key Overall Survival Endpoint in Phase III Lymphoma Study
AbbVie and Genmab reported that their bispecific antibody Epkinly failed to achieve a statistically significant overall survival benefit in the Phase III EPCORE DLBCL‑1 trial, showing only a 4% OS gain versus standard chemotherapy. The study, which enrolled 483 relapsed/refractory DLBCL patients...
LOTTE Biologics Tightens Global Quality as Syracuse ADC Hub Ramps for 2026
LOTTE Biologics is ramping its Syracuse ADC hub for 2026 while extending a unified global quality culture across its organization. The company emphasizes a proactive contamination‑control strategy that relies on closed, functionally closed and single‑use systems, validated cleaning, and rigorous...
Report: U.S. Life Sciences Job Market Report Q4 2025
BioSpace’s Q4 2025 U.S. Life Sciences Job Market Report shows early signs that biopharma hiring is stabilizing after a turbulent period. Job postings increased modestly, while layoffs slowed markedly, and hiring sentiment edged higher heading into 2026. The report highlights...
After the JPM Hype, a Reality Check: Why Your 2026 Strategy Hinges on Your Manufacturing Toolkit
After the J.P. Morgan Healthcare Conference, biotech firms face a reality check: manufacturing, not just discovery, will determine whether 2026 promises are fulfilled. The article argues that flexible CDMO toolkits, combining legacy platforms like AGC Biologics’ CHEF1 with high‑speed systems...
Vedanta ‘Significantly’ Reduces Staff, Focuses on Phase III Study of C. Diff Drug
Vedanta Biosciences announced a major headcount reduction, cutting roughly half of its workforce to preserve cash for a Phase III trial of its oral C. difficile candidate VE303. The layoffs follow earlier cuts after a failed Phase II study of VE202 and reflect...
JPM26: Protagonist Has a $400M Decision To Make. It’s a No-Brainer
Protagonist Therapeutics faces a pivotal choice on its rusfertide partnership with Takeda. The company is leaning toward opting out of the 50‑50 co‑development deal, which would trigger a $400 million opt‑out payment and tiered royalties up to 29% on sales exceeding...
JPM26: Deal Hungry Novo Moves With ‘Intention’ To Put Metsera in the Rearview
Novo Nordisk is revamping its business‑development approach under new CEO Mike Maziar Doustdar, emphasizing intentional M&A and licensing to accelerate its obesity and diabetes pipeline. The company recently closed a $5.2 billion acquisition of Akero Therapeutics and secured a China partnership...
Former Emergent CEO Hit With Insider Trading Lawsuit
The New York Attorney General sued former Emergent BioSolutions CEO Robert Kramer for alleged insider trading, claiming he sold stock based on nonpublic knowledge of vaccine contamination. Kramer reportedly profited over $10.1 million from trades executed between November 2020 and early 2021....
JPM26: Korro Bio Looks To Save Itself Despite Unenviable Position
Korro Bio’s lead RNA‑editing candidate KRRO‑110 failed its Phase I/IIa trial for alpha‑1 antitrypsin deficiency, prompting an 80% stock plunge and a one‑third staff layoff. A root‑cause analysis revealed the lipid nanoparticle delivery vehicle achieved only about 25% of the...
FDA Delays Decision for Lilly’s Obesity Pill Orforglipron, Other Priority Voucher Awardees: Report
The FDA announced it will postpone its action date for Eli Lilly’s oral obesity drug orforglipron to April 10, 2026, extending the review timeline for the medication. The agency also delayed decisions for three other Commissioner’s National Priority Voucher recipients—Sanofi’s Tzield, Disc Medicine’s...
Compounder Sues Lilly, Novo, Claims Coordinated Crackdown
Arizona‑based Strive Compounding Pharmacy has filed an antitrust lawsuit in Texas against Eli Lilly and Novo Nordisk, accusing the two giants of coordinating with telehealth firms to block compounders from filling GLP‑1 prescriptions. The complaint alleges that the pharma companies restrict payment...
Jazz Sells Priority Review Voucher for $200M as Program’s Renewal Languishes in Senate
Jazz Pharmaceuticals sold a priority review voucher for $200 million, the highest price in nearly a decade, during its J.P. Morgan Healthcare Conference presentation. The voucher stemmed from the FDA’s August 2025 approval of Modeyso, a rare‑brain‑tumor drug acquired through Chimerix. While...
JPM Day 3: Rare Disease in the Spotlight
Rare‑disease therapeutics dominated day three of J.P. Morgan Healthcare, with five companies outlining 2026 roadmaps. Rocket Pharmaceuticals announced it will resume dosing three Danon disease patients in the first half of 2026 after an FDA hold, while also awaiting a...
JPM26: As Capital Concentrates, VCs Scrutinize Founder Pedigree and CEO Fit in Early Biotech
At the J.P. Morgan Healthcare Conference, venture capitalists highlighted a tightening funding environment for early‑stage biotech firms, driven by a hyper‑concentration of capital among a few investors. VCs now scrutinize founder and CEO attributes, emphasizing regulatory know‑how, market insight, and...
11 Companies Hiring Manufacturing Professionals Now
Big Pharma is accelerating domestic manufacturing hiring as 2026 begins, highlighted by Johnson & Johnson’s plan to add 500 jobs at a new North Carolina plant and AbbVie’s $100 billion ten‑year commitment to U.S. R&D and capital projects. The surge creates...
JPM26: Sanofi’s CEO Keen To Buy the Dip as Vaccine Rhetoric Impacts Short-Term Sales
Sanofi’s CEO Paul Hudson said the firm will acquire Dynavax for $2.2 billion, targeting its adult hepatitis B vaccine Heplisav‑B, as vaccine sentiment wanes under U.S. political rhetoric. Legacy vaccine sales fell 8 % in Q3 2025, prompting a long‑term focus on adult‑focused products...
JPM26: Gilead Captures Sunny JPM Mood With Yeztugo Numbers, HIV Vibes
Gilead’s new HIV therapy Yeztugo is gaining rapid market traction, achieving 85% payer coverage six months after its June 2025 approval and hitting the $150 million revenue target for the year. CEO Daniel O’Day highlighted voluntary licensing of the drug’s active ingredient,...
AstraZeneca’s Path to $80B by 2030 Paved With ADCs, Cell Therapies, Near-Term Product Launches
At the J.P. Morgan Healthcare Conference, AstraZeneca reaffirmed its ambition to generate $80 billion in revenue by 2030, a target now seen as attainable. The company highlighted three near‑term product launches—baxdrostat for hypertension, camizestrant for breast cancer, and gefurulimab for myasthenia...
Novartis Doesn’t Have a GLP-1. They Don’t Miss It In a World Of Me-Toos
Novartis chief strategy officer Ronny Gal told BioSpace at J.P. Morgan that the Swiss giant will not pursue a GLP‑1 acquisition, citing the high commercial risk of me‑too products. He emphasized that existing GLP‑1s such as Eli Lilly’s Zepbound and Novo Nordisk’s...
After Mortality-Marred Year, Sarepta Looks Ahead to Catalyst-Rich 2026
Sarepta Therapeutics is shifting focus from a troubled DMD gene‑therapy portfolio to a robust siRNA pipeline partnered with Arrowhead. Jefferies highlights upcoming Phase I/II data for SRP‑1001 (FSHD) and SRP‑1003 (DM1) in Q1 2026, projecting a potential 25‑50% stock move. The...
Lung Cancer Trial to Proceed After FDA Releases Hold on Merck, Daiichi’s ADC
The U.S. Food and Drug Administration has lifted the partial clinical hold on Merck and Daiichi Sankyo’s antibody‑drug conjugate ifinatamab deruxtecan (I‑DXd) in the Phase III IDeate‑Lung02 trial for relapsed small‑cell lung cancer. The companies can now resume enrollment and data...
AbbVie, Amgen, Lilly Lead Calls for FDA To Update Post-Approval Change Rules
Big‑pharma leaders including AbbVie, Amgen and Eli Lilly urged the FDA to decouple pre‑approval inspections from marketing applications and modernize its post‑approval change framework. They argue the 1990s SUPAC guidance treats all biologics as high‑risk, slowing domestic facility transfers. The coalition...