2025 Q4 Job Market Report: Positive Signs Emerge for Job Seekers
The fourth quarter of 2025 marked the first quarter‑over‑quarter rise in biopharma job postings, with a 10% increase and a 4% uptick in average listings, despite a 14% year‑over‑year decline. Science/research and development roles grew 14% while clinical positions surged 23% from Q3. Layoffs, which jumped 47% year‑over‑year, fell sharply in Q4 to 3,603, the lowest figure of the year. Complementary factors such as Massachusetts tax incentives, a biotech index rally, and early‑2026 IPO activity suggest a strengthening hiring outlook.
‘Just Agree to It:’ Pazdur Said He Was Told To Cosign FDA’s Reduced Trial Requirements
Richard Pazdur, longtime FDA oncology leader, resigned after being pressured to endorse a controversial policy that would reduce required drug approval trials from two to one. He said Commissioner Marty Makary breached the traditional independence between the commissioner’s office and...
2026 Could Mark a Turning Point for American Innovation
The United States faces a potential decline in biotech leadership as recent Supreme Court decisions blur patent eligibility and congressional price‑control measures under the Inflation Reduction Act force program cancellations. Proposals to seize university licensing revenue further strain tech‑transfer offices,...
How DIA Is Helping Regulators Turn AI Principles Into Everyday Review Practice
At the 2026 DIA Global Annual Meeting, the DIA AI Consortium will showcase how regulators such as the FDA are embedding artificial intelligence into medical product review workflows. The FDA’s 2025‑2026 roadmap uses AI to automate routine tasks, accelerate timelines,...
Vertex, CRISPR Set Lofty Goal for Casgevy Gene Therapy as Patient Starts Ramp
Vertex Pharmaceuticals and CRISPR Therapeutics forecast combined Casgevy gene‑therapy and Journavx pain‑drug sales of $500 million in 2026, a 185 % jump from 2025. The therapy generated $115.8 million in 2025, with Q4 revenue of $54.8 million, and treated 111 patients that year, up...
All Eyes on Vertex’s Kidney Franchise, as Painkiller Journavx Tops Half a Million Scripts
Vertex Pharmaceuticals reported that its late‑stage RAINIER trial of povetacicept in IgA nephropathy is proceeding without safety concerns, with primary data expected in the first half of 2026. The company is leveraging a priority‑review voucher for the upcoming FDA filing...
Evommune Soars as Dermatitis Treatment Rivals Dupixent in Mid-Stage Trial
Evommune’s shares surged 75% after its Phase 2a trial showed the therapeutic protein EVO301 reduced atopic dermatitis severity by 33% versus placebo. The study enrolled 70 patients, with a 55% reduction in the treatment arm compared to 22% in the placebo...
HER2’s Digital Rebirth Is Unlocking the Full Potential of ADCs
The latest wave of antibody‑drug conjugates (ADCs) hinges on precise HER2 quantification, and digital pathology combined with AI is delivering that accuracy. By analyzing gigapixel slides, AI models can detect low and ultra‑low HER2 expression that traditional microscopy often misses,...
Facing Talent Crunch, Radiopharma Field Casts a Wide Net
Investment in radiopharmaceuticals is driving a fierce talent shortage as big‑pharma players like AstraZeneca, Novartis and Eli Lilly expand into the modality. The success of lutetium‑177 therapies such as Lutathera and Pluvicto has sparked a surge in clinical studies, intensifying demand...
Biogen’s Much Anticipated Tau Readout in Alzheimer’s Will Spur More Questions
Biogen expects Phase 2 readout for its tau‑targeting antisense oligonucleotide BIIB080 in the second or third quarter of 2026. The CELIA trial evaluates three dose levels through week 76 and uses cognition as the primary endpoint. A positive signal could lift Biogen’s...
Liver Toxicities Force Pause on Two Dose Groups of UniQure’s Mid-Stage Fabry Study
UniQure paused dosing in the mid- and high-dose arms of its Phase 1/2a Fabry gene‑therapy trial after two patients experienced grade 3 liver enzyme elevations. The affected cohorts received 4 × 10¹³ and 6 × 10¹³ genome copies per kilogram of AMT‑191, while the low‑dose group...
Ultragenyx’s Gene Therapy Shows Long-Term Efficacy in Two Sanfilippo Studies
Ultragenyx reported that its investigational AAV gene therapy UX111 delivers sustained cognitive improvements in Sanfilippo A patients, with follow‑up extending up to 8.5 years. Data from 33 dosed participants—27 receiving the highest dose—showed a 23.3‑point gain on the Bailey‑III scale...
FDA Policy Tracker 2026: Priority Vouchers Questioned, PRVs Return
2026 regulatory landscape sees the FDA reviving the rare‑pediatric disease priority review voucher (PRV) program, launching the PreCheck manufacturing pilot, and issuing new guidance for multiple myeloma trials and GLP‑1 label warnings. The PRV reinstatement restores a $150 million voucher market,...
BMS Beats Again Despite Eliquis and Cobenfy Disappointments
Bristol Myers Squibb posted fourth‑quarter 2025 sales of $12.5 billion, topping the $12.28 billion consensus. Eliquis generated $3.4 billion, falling short of expectations, while the new schizophrenia drug Cobenfy earned $51 million, missing forecasts by 3 %. Despite the miss, BMS forecasts 10‑15 % Eliquis growth...
Novartis Cuts 6 Early Cancer Candidates, Adds 2 to Refine Oncology Strategy
Novartis announced the removal of six Phase 1 oncology candidates—including KFA115, HRO761, MGY825, and AAA802—from its pipeline and introduced two new Phase 1 assets, AMO959 for prostate cancer and GCJ904 for solid tumors. The reshuffle aligns with a strategic review aimed at...
Stem Cell Specialist PrimeGen Takes SPAC Track to Nasdaq
PrimeGen US is set to go public on Nasdaq in 2026 by merging with SPAC DT Cloud Star Acquisition Corp., valuing the stem‑cell biotech at roughly $1.5 billion. The $69 million‑raised SPAC will provide capital to advance PrimeGen’s triple‑activated mesenchymal stem cell...
Programmable RNA 2.0: Beyond the First mRNA Revolution
BioSpace’s Denatureed podcast episode "Programmable RNA 2.0" spotlights the next wave of RNA therapeutics beyond the COVID‑19 mRNA vaccine success. Host Jennifer Smith‑Parker interviews Erik Digman Wiklund of Circio and Jacob Becraft of Strand Therapeutics about emerging platforms such as circular RNA...
3 Top Challenges Facing Regulatory Professionals Right Now
Regulatory professionals are grappling with three pressing challenges: vague FDA and EMA AI guidance, the mismatch between rapidly evolving AI models and static regulatory frameworks, and a constrained supply chain for radiopharmaceuticals. Experts stress that AI‑driven submissions must rest on...
Employers Warm Up to Remote Workers Again: BioSpace Report
Biopharma employers are warming to remote hiring again, with 28% saying they will recruit candidates regardless of location in 2026 – up from 20% in 2024 and 16% in 2023. The share of firms focused solely on local talent fell...
Sarepta Saga Has 'Gone on Too Long' As Competitors Catch Up
Sarepta Therapeutics’ one‑time gene therapy Elevidys, priced at $3.2 million, is under intense scrutiny after three patient deaths in 2025 and a steep 80% stock decline. The company’s three‑year efficacy data failed to reassure analysts, and quarterly sales missed expectations, leaving...
AbbVie’s I&I Portfolio Sells $30 Billion but Execs Again Underline Other Areas
AbbVie’s immunology portfolio generated roughly $30 billion in 2025, accounting for nearly half of its $61.1 billion total sales, driven by Skyrizi, Rinvoq and residual Humira revenue. Executives used the earnings call to spotlight under‑appreciated neuroscience and oncology assets, highlighting Parkinson’s drug...
Amgen Wants MariTide To Change Obesity Paradigm With Longer Dosing Periods
Amgen is positioning its investigational bispecific antibody‑peptide, MariTide, as a differentiated obesity therapy by offering monthly, bimonthly, or quarterly dosing without compromising efficacy. Phase II data revealed an average weight loss of up to 20 % after 52 weeks, and the company...
GSK Says No to GLP-1s, Prioritizes ‘Downstream Effects’ of Obesity
GSK’s new CEO Luke Miels announced the company will not pursue GLP‑1 obesity drugs, citing a crowded market and pipeline misalignment. Instead, GSK is concentrating on the downstream complications of obesity, particularly liver disease, after acquiring Boston Pharmaceuticals’ efimosfermin alfa...
Lilly’s GLP-1s Mounjaro, Zepbound Push Revenue up 46% in Q4
Eli Lilly reported fourth‑quarter revenue of $19.3 billion, driven by a 46 % surge in volume of its GLP‑1 drugs Mounjaro and Zepbound. Earnings per share rose to $7.54, comfortably beating the $6.91 consensus. The two drugs together generated $11.7 billion, lifting the company’s...
From Awareness to Acceleration: Rare Disease Drug Development Enters a Pivotal Era
Rare disease drug development is poised for rapid expansion, with the market projected to reach $400‑600 billion by the early‑to‑mid 2030s. Recent FDA guidances, including the plausible‑mechanism approval pathway, aim to accelerate cell and gene therapy approvals for ultrarare conditions. Executives...
2021 Sparked a Banner Year for Biotech IPOs. Where Are They Now?
In 2021 a pandemic‑driven gold rush produced 99 biotech IPOs that raised $15.6 billion, dwarfing the combined proceeds of 2023‑24. The surge created a “logical gap,” with many companies going public before their science was mature, leading to bankruptcies, pivots, and...
Novo Slides 14% as Early Q4 Results Predict Sales Decline for 2026
Novo Nordisk previewed its early Q4 results, showing a 5% sales decline forecast for 2026 driven by lower U.S. drug prices. The company beat analyst expectations in the quarter, with Ozempic and Wegovy outperforming by 9% and 3% respectively. Shares...
Pfizer’s Early Metsera Data Leaves Analysts Wanting More
Pfizer disclosed early Phase IIb data for its Metsera‑acquired obesity drug PF’3944, showing a 12.3% average weight loss at week 28 in the 3.2‑mg and 4.8‑mg monthly dosing arms. Analysts noted the placebo‑adjusted loss is roughly 12%, trailing Eli Lilly’s Zepbound 16%...
Merck Bats Away ‘Modest Growth’ Accusations, Touts Broad Pipeline
Merck met its 2025 sales guidance, reporting fourth‑quarter revenue of $16.4 billion, slightly above expectations. The company’s HPV vaccine Gardasil saw a 35% global decline, driven by weak demand in China and Japan. CEO Robert Davis countered modest‑growth criticism by highlighting...
BioNTech’s Multi-Modality Play Outpaces Moderna’s mRNA-Focused Pipeline
BioNTech is outpacing Moderna by expanding beyond mRNA into a multi‑modality oncology pipeline, highlighted by its $3.5 billion pumitamig partnership and several Phase III candidates. Moderna, still anchored to mRNA, has seen COVID‑19 vaccine revenues plunge from $18.4 billion in 2022 to $3.1 billion...
As Amgen and Lilly Recommit, Puerto Rico Seeks To Regain Manufacturing Momentum
Amgen and Eli Lilly have pledged more than $1.8 billion to expand their Puerto Rico facilities, with Amgen allocating $650 million to its Juncos biologics plant and Lilly committing over $1.2 billion to modernize its Carolina site for oral GLP‑1 production. These investments arrive as...
Wave To Work Alone on RNA Editor as AATD Picture Becomes Clearer
Wave Life Sciences will continue developing its RNA‑editing candidate WVE‑006 for alpha‑1 antitrypsin deficiency (AATD) after GSK relinquished its stake, aiming for accelerated regulatory feedback by mid‑2026. The AATD market, valued at $2.6 billion today, is projected to reach $6.2 billion by...
GSK Hands RNA Editor Back to Wave After Underwhelming Early AATD Data
GSK has returned Wave Life Sciences' RNA‑editing oligonucleotide WVE‑006 after a modest Phase Ib/IIa readout for alpha‑1 antitrypsin deficiency. The September data showed 11.9 µM AAT, slightly below analyst expectations, prompting GSK to refocus on larger indications like COPD. Despite the...
FDA Warned Corcept of ‘Significant Review Issues’ for Rejected Drug in Early Meetings
The FDA issued a complete response letter rejecting Corcept Therapeutics' relacorilant for hypercortisolism, citing significant review issues identified early in the submission process. While the Phase III GRACE trial met its primary endpoint, the agency questioned the hypertension data and warned...
Opinion: Pricing Transparency Is Coming to the Pharma Industry
The article argues that the pharmaceutical sector must abandon its long‑standing secrecy on drug pricing as recent U.S. executive orders intensify pressure for transparency. While companies cite R&D costs and complex payer negotiations, they rarely disclose how individual drug prices...
Psychedelics Space at a ‘Tipping Point’ as Compass, Definium Gear Up To File for Approval
Compass Pathways and Definium (formerly MindMed) are poised to file FDA applications for their psychedelic therapies—Compass' psilocybin‑based COMP360 for treatment‑resistant depression and Definium's LSD‑based MM120 for anxiety—following late‑stage Phase III readouts. Analysts predict filings by Q3 2025 and potential approvals by 2027,...
Despite Wide Support for Rare Disease, Voucher Program Caught Up in Senate's ICE Fight
The Senate’s failure to pass the omnibus spending bill left the rare‑pediatric priority review voucher (PRV) program without reauthorization, prompting biotech CEOs to intensify lobbying. Without a renewal, about 200 rare‑disease therapies could lose eligibility, threatening up to $4 billion in...
FDA’s Multiple Myeloma Guidance Highlights Decade of Success
The FDA released draft guidance urging sponsors of multiple myeloma drugs to use minimal residual disease (MRD) negativity as the primary endpoint for accelerated approval, moving beyond traditional overall response rates. The agency defines MRD‑negative as one cancer cell per...
TrumpRx Delayed Amid Potential Anti-Kickback Concerns
The White House postponed the rollout of TrumpRx, the federal direct‑to‑consumer drug marketplace. Officials cite potential violations of the federal anti‑kickback statute as a key factor, prompting HHS to issue a guidance bulletin outlining required safeguards. Major manufacturers including Pfizer,...
Moderna Teams With Recordati on Rare Disease mRNA Therapy for up to $160M
Moderna has signed a partnership with Italy’s Recordati to advance mRNA‑3927, a therapy for the rare metabolic disorder propionic acidemia. The agreement provides up to $160 million, including a $50 million upfront payment and milestone fees, with Recordati taking charge of commercialization....
Sanofi Moves Away From mRNA Flu Vaccine as CEO Projects Confidence
Sanofi announced it has deprioritized its SP0237 mRNA‑based seasonal flu vaccine, removing the candidate from near‑term launch plans. The hexavalent shot was in a Phase I/II safety and immunogenicity trial for adults over 50, which remains active but is not recruiting...
Summit’s Potential Keytruda Rival Gets November FDA Decision Date
The U.S. Food and Drug Administration has set a November 14 deadline to rule on Summit Therapeutics’ bispecific antibody ivonescimab, which targets PD‑1 and VEGF in EGFR‑mutant non‑small cell lung cancer. Summit’s Phase III HARMONi trial demonstrated a roughly 50% improvement in...
Biotech’s Next Chapter: Asset-Centric Deals and Shifting Alpha at JPM 2026
Biotech is emerging from a multi‑year slump into a new cycle driven by late‑stage, asset‑centric deals, as highlighted at JPM 2026. While headline megadeals were scarce, rumors around Revolution Medicines and Abivax and announced transactions such as Eli Lilly‑Ventyx and GSK‑RAPT underscored...
AstraZeneca Pledges $15B More in Chinese Investments for Cell Therapies, Radiopharma
AstraZeneca announced a $15 billion investment in its China operations through 2030, aimed at bolstering capabilities in cell therapies and radioconjugates. The funding will support the full drug development chain, from design to manufacturing, and expand existing production sites in Wuxi,...
Sanofi Suffers Another Sales Dip For 'Gift to Public Health' Vaccines
Sanofi reported a 2.5% decline in 2025 vaccine revenue to €2 bn, marking a continued sales dip amid rising U.S. vaccine skepticism. The drop was offset by a 31.5% surge in flu and COVID‑19 vaccine sales, driven by higher virus circulation...
Lilly Establishes up to $2.7B Repertoire Deal in Second Immune Play of 2026
Eli Lilly has signed a strategic alliance with Repertoire Immune Medicines, providing $85 million upfront and up to $1.84 billion in milestone payments to develop T‑cell‑targeted therapies for autoimmune diseases. The collaboration will use Repertoire’s DECODE platform to pinpoint T‑cell antigen interactions, aiming...
10 Companies Hiring IT Professionals Now
Biotech firms are aggressively recruiting IT talent as the sector’s digital transformation accelerates. After a mid‑year dip in 2025, job postings rebounded in the last four months and January 2026 listings already surpass December’s total. Ten companies—including AbbVie, Amgen, Lilly...
REGENXBIO Delay Could Put Denali in Pole Position for Hunter Syndrome Approval
The FDA placed a clinical hold on REGENXBIO’s RGX‑111 and RGX‑121 after a tumor was found in a five‑year‑old patient potentially linked to the AAV vector. The hold jeopardizes REGENXBIO’s Feb. 8, 2026 PDUFA deadline for its Hunter syndrome gene therapy. Denali...
J&J’s Darzalex Faspro Notches Another Multiple Myeloma Indication, Pushing Into Frontline
The FDA approved Johnson & Johnson’s Darzalex Faspro as part of a four‑drug regimen for newly diagnosed multiple myeloma patients who cannot undergo stem cell transplantation. This is the drug’s twelfth overall and fifth frontline indication. Phase III CEPHEUS data showed 52.3%...
Advanced Therapies Week 2026: ‘Solving for Science’ and Weathering Global Complexity
Advanced Therapies Week 2026 in San Diego will spotlight the accelerating yet turbulent landscape of cell and gene therapies. New FDA guidance, including the plausible‑mechanism pathway, promises faster approvals, while recent U.S. cuts to mRNA projects and a wave of...