Korsana, a biotech focused on Alzheimer’s disease, announced a $150 million Series A funding round to advance its next‑generation amyloid‑targeting antibody. The capital will fund clinical development and expansion of its pipeline. Investor identities were not disclosed.
California-based biotech PrimeGen US announced a merger with SPAC DT Cloud Star Acquisition Corporation, valuing PrimeGen at approximately $1.5 billion in equity. The transaction, disclosed in a February 4 SEC filing, is expected to close in the second half of 2026 pending...

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 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...

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...

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...

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,...

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...

The FDA released draft guidance urging sponsors of multiple myeloma drugs to use minimal residual disease (MRD) negativity as the primary endpoint for accelerated approval, moving beyond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...

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 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 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...

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...

Moderna and Italy’s Recordati announced a partnership to develop and commercialize mRNA‑3927 for propionic acidemia. Recordati will pay up to $160 million in upfront and milestone payments and receive royalties, while Moderna will lead clinical development and manufacturing and Recordati will...

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 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 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...

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...

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...

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...

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 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...

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...

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...

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 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...

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...

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...

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 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...

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...

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...

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...

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 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...

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...

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...

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...

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...
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...

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, 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 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...

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...

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...

Novo Nordisk announced an expanded partnership with Aspect Biosystems, transferring its stem‑cell‑derived islet cell and hypoimmune cell‑engineering technologies. As part of the deal, Novo will make an equity investment and provide research funding to Aspect, though financial terms were not...

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 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...

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...

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,...

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...

California‑based SpyGlass Pharma and New York‑based AgomAb Therapeutics announced the launch of their Nasdaq IPOs last week, joining the 2026 IPO class. Both firms have not disclosed the amount they expect to raise. SpyGlass will list on the Nasdaq Global Select...

Eli Lilly announced a $1.2 billion cash acquisition of California‑based Ventyx Biosciences, gaining its oral drug pipeline targeting inflammatory diseases. The deal, expected to close in the first half of 2026 pending approvals, expands Lilly’s portfolio beyond its obesity drugs.

Amgen announced on Tuesday that it will acquire England‑based Dark Blue Therapeutics in a deal valued at up to $840 million, aiming to bolster its oncology pipeline with Dark Blue’s pre‑clinical protein‑degradation assets. The acquisition will integrate Dark Blue into Amgen’s...

Cardiovascular biotech Corsera Health announced an $80 million Series A round co‑led by Forbion and Population Health Partners to advance its siRNA therapeutics, including the COR‑1004 program now entering Phase I trials. The funding will support the development of AI‑enabled tools for ASCVD...

Crinetics Pharmaceuticals announced a $350 million public offering of 7.6 million shares, with an underwriters’ option for an additional $52 million, to fund the development of its atumelnant drug after strong Phase II results that outperformed Neurocrine’s Crenessity. The offering was announced on Monday,...