
BioCentury’s editorial warns that the current director of the FDA’s Center for Biologics Evaluation and Research (CBER) is jeopardizing patient safety and destabilizing the pharmaceutical industry. The author cites the director’s handling of Moderna’s flu vaccine as a recent example of overreach that could set a precedent for future biologics approvals. By imposing unpredictable regulatory demands, the CBER leadership is inflating development costs and delaying market entry for critical therapies. The piece urges pharma CEOs to collectively demand the director’s removal to restore regulatory stability.
More than a thousand physicians have signed a citizen petition urging the FDA to overturn its complete response letter (CRL) rejecting SYD‑101, Sydnexis Inc.'s pediatric myopia treatment. The company met the agency‑specified primary endpoint, but the FDA concluded the data...
The FDA issued a complete response letter (CRL) rejecting Regenxbio’s accelerated‑approval application for clemidsogene lanparvovec, a gene therapy targeting Hunter syndrome (MPS II). The decision underscores a growing disconnect between the agency’s public messaging on accelerated pathways and its actual regulatory...
BioCentury reports that 2025 ended a four‑year decline in biotech series A financing, with 144 companies raising $8 billion. The “BioCentury This Week” podcast highlights which venture‑capital‑backed firms attracted capital and what the trends indicate for emerging technologies. Washington editor Steve Usdin...
South Korean biotech Galux raised $29 million Series B to scale AI‑designed biologics. The company combines generative AI, high‑throughput in silico screening, and experimental validation to design proteins and antibodies. Founded in 2020 by a Seoul National University professor and...
Biotech investors have long chased scientific hype that rarely translated into commercial wins, often leaving value to large pharma. The article argues the next growth wave will stem from biotechs launching independent therapeutics that achieve meaningful sales, mirroring the early‑2010s...
South Korean biotech Galux Inc., which uses generative AI for protein and antibody design, announced a $29 million Series B financing led by Yuanta. The fresh capital will support scaling of its AI‑driven biologics platform and recent collaboration with Boehringer Ingelheim. The...
Former McKinsey senior partner emeritus Franck Le Deu has joined Aulis Capital as a venture partner. Aulis, the Hong Kong‑based fund launched by veteran Chinese VC Nisa Le Ung, will back emerging biotech and health‑tech companies across Asia and the West. Le Deu, who...
After four years of falling series A activity, biotech start‑up financing stabilized in 2025. The number of companies raising series A remained flat versus 2024, while total dollars raised increased. BioCentury’s analysis shows a broader revival, with round sizes, investor profiles, and...
Sanofi announced that its glucosylceramide synthase (GCS) inhibitor for Fabry disease failed to meet the primary efficacy endpoint in a late‑stage trial. The double‑blind study enrolled roughly 280 patients and showed no statistically significant improvement in key renal or cardiac...
Latent Labs, founded by former DeepMind researchers, has unveiled AI platforms that design drug‑like biologics in a single step. Leveraging generative foundation models inspired by AlphaFold2, the London‑based startup creates de novo macrocycles and antibodies for hard‑to‑drug targets. By addressing immunogenicity...
Steve Paul, a veteran CNS drug developer, argues that engineering breakthroughs—particularly in delivery, selectivity and tolerability—are turning long‑standing psychiatric hypotheses into viable medicines. He notes that psychiatry’s low success rates stem from polygenic disease biology and noisy trials, making human...
Angitia Biopharmaceuticals raised a $130 million Series D round, marking its second nine‑digit financing in just over a year after a $120 million Series C and following multiple nine‑figure Series B raises. New investors Frazier Life Sciences and Venrock Healthcare Capital Partners joined existing backers,...
Researchers at Sichuan University have identified distinct signaling pathways that separate the hallucinogenic and therapeutic actions of psychedelic compounds. By comparing classic psychedelics with non‑hallucinogenic analogues, they showed that 5‑HT2A‑mediated non‑canonical Gi signaling drives hallucinations, while canonical Gq signaling underlies...
The FDA has asked Amgen to withdraw its vasculitis drug Tavneos (avacopan) after re‑examining a data‑interpretation issue that was central to the advisory committee’s split vote before its 2021 approval. Amgen, which acquired Tavneos through its $4 billion purchase of ChemoCentryx...
Three leading obesity‑drug developers announced trials that met primary weight‑loss endpoints, yet their shares fell sharply. Novo Nordisk’s semaglutide extension hit its target but stock slipped amid pricing concerns. Eli Lilly’s tirzepatide data showed robust reductions, yet investors worried about market...
Representative Jake Auchincloss, a member of the House Energy and Commerce Committee, sent a formal letter to FDA Commissioner Marty Makary demanding a review of the commissioner’s national priority voucher (CNPV) program. Auchincloss argues the program, which awards expedited review...
Congress approved a $48.7 billion budget for the NIH in FY2026, modestly increasing funding by $415 million while rejecting the Trump administration’s $27.9 billion request that would have cut the agency by roughly 40 percent. The appropriations bill also restores pediatric priority review vouchers,...

The BioCentury podcast outlines the most consequential biotech catalysts slated for 2026, highlighting over thirty late‑stage trials that could reshape therapeutic landscapes. It also examines China’s newly enacted orphan‑drug regulations, which lower approval thresholds and introduce tax incentives for rare‑disease...

In January 2026 the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued positive opinions on six new medicines, marking a busy month for European regulators. Among the approvals, Sanofi’s Rezurock (benedosudil) secured a conditional marketing authorization...
The FDA’s February docket lists at least nine PDUFA submissions, including five prospective new products and four indication extensions. Four of the entries are gene‑therapy candidates targeting rare lysosomal disorders, highlighting the sector’s reliance on AAV platforms. RegenxBio’s RGX‑121 for...
The Phase III HORIZON trial of pelacarsen, an antisense oligonucleotide that lowers lipoprotein(a), will deliver its first readout in early 2026. Ionis Pharmaceuticals and Novartis are awaiting results that could confirm whether Lp(a) reduction translates into fewer heart attacks, strokes, and...
Renal disease is emerging as a hotbed for pharmaceutical investment after surrogate endpoints for IgA nephropathy (IgAN) were validated, simplifying trial designs and regulatory reviews. This year’s pipeline sees Phase III results expected from at least two IgAN candidates, with a...
A BioCentury and Advarra survey of oncology sponsors and CROs reveals pervasive operational friction slowing cancer trials. Nearly all respondents report post‑start protocol amendments, which add several months to study timelines and cascade into staffing and data delays. The study...
AstraZeneca has struck a landmark partnership with China’s CSPC Pharmaceutical, paying $1.2 billion upfront and committing to a total potential value of $18.5 billion. The agreement grants AZ ex‑China rights to eight obesity and diabetes programs, highlighted by SYH2082, a once‑monthly dual...
AstraZeneca announced a partnership with China's CSPC Pharmaceutical Group, paying $1.2 billion upfront for exclusive ex‑China rights to eight obesity and diabetes programs, including the GLP‑1R/GIPR agonist SYH2082. The total deal value is projected at $18.5 billion, marking one of AZ's largest...
RNA‑interference (RNAi) therapies are moving from experimental to mainstream, with dozens of antisense and siRNA programs slated for pivotal data releases and regulatory decisions in 2026. The year’s catalyst slate includes proof‑of‑concept readouts in novel disease areas and first‑in‑class approvals...
Cardiff Oncology announced a reshuffle of its senior leadership as it accelerates a late‑stage oncology candidate toward market. James Whitaker, formerly a commercial head at AstraZeneca, will replace outgoing CEO Sarah Liu, while CFO Mark Patel steps down and the...
Effective May 15, China will grant orphan drugs a seven‑year market exclusivity and provide a two‑year exclusivity period for pediatric indications. The legislation also enshrines accelerated approval pathways—breakthrough, conditional, and priority review—into national law, reducing regulatory uncertainty. While many implementation details...
Corvus Pharmaceuticals reported Phase I efficacy for its oral ITK inhibitor soquelitinib in 24 atopic dermatitis patients who had failed prior therapies. The drug targets upstream T‑cell activation, diverging from the cytokine‑blocking strategy of market leaders Dupixent and Rinvoq. Investors...
The 2026 catalyst calendar for neuroscience highlights a surge of late‑stage readouts in psychedelics, epilepsy, and genetically driven neurodegeneration. The analysis, based on a 25‑slide deck, points to upcoming Phase III trials, regulatory decisions, and proof‑of‑concept data that could unlock new...
Miles Gerson and Sofia Guerra, two prominent venture capitalists in the life‑science sector, have announced new senior positions at leading biotech‑focused firms. Gerson is joining XYZ Ventures as Managing Partner, while Guerra moves to ABC Capital as General Partner. Both...
China has introduced new rules that overhaul investigator‑initiated trials, speeding the development and commercial launch of cell and gene therapies. BioCentury’s latest podcast breaks down how the framework creates stronger incentives for Chinese biotech firms to bring advanced therapies to...
China’s health authorities will implement new regulations on May 1 that overhaul investigator‑initiated trials for gene and cell therapies. The rules create a unified governance framework, permit medical centers to charge patients for investigational treatments, and allow limited commercial rollout of...
A quartet of public biotech companies announced enlarged follow‑on offerings, collectively raising $665 million. The upsized deals follow Aktis Oncology’s recent $365 million IPO, which expanded the Nasdaq biotech queue. Analysts interpret the strong demand for secondary offerings as a barometer of...
Novartis CEO Vas Narasimhan says the company is de‑risking its platform bets by adding RNA interference (RNAi) to its portfolio. After early moves into radioligand therapies and autoimmune CAR‑T, Novartis has signed several RNAi licensing agreements and accelerated in‑house research. The...
Corcept Therapeutics reported positive Phase III results for relacorilant in platinum‑resistant ovarian cancer, meeting the overall survival endpoint. The data lifted the stock after a steep decline following a complete response letter that had cut the company's market value by half...
Corxel Pharmaceuticals announced a $287 million Series D‑1 financing round aimed at advancing its oral GLP‑1 therapy into late‑stage clinical trials. The capital will enable the company to move beyond its China‑only data and pursue a global development strategy. Existing backers RTW...
Astellas CEO Naoki Okamura argues that Japan’s biotech sector is constrained more by the ability to translate scientific discoveries into market‑ready products than by a lack of capital. He outlines Astellas’ strategic focus on cell and gene therapies, a menopause...
The FDA released draft guidance endorsing measurable residual disease (MRD) negativity as a surrogate endpoint for accelerated approval in multiple myeloma. The guidance implements the unanimous 2024 recommendation from the Oncologic Drugs Advisory Committee. By formalizing MRD negativity, the agency...
After more than four years of a biotech bear market, investors are now seeing a genuine bullish turn. Lower interest rates, clearer policy signals and strengthening fundamentals are aligning to revive capital flows. BioCentury’s survey of 15 buyside investors and...
Next‑generation targeting chimeras (TACs) are moving from research labs to early clinical programs, signaling a new wave of induced‑proximity therapeutics beyond PROTACs. GSK’s $2.2 billion acquisition of Rapt Therapeutics adds a China‑origin allergy platform to its pipeline, highlighting strategic biotech buyouts....
In the fourth quarter of 2025, biotech megacap companies—those valued at $10 billion or more—delivered a median stock price increase of 10%, adding $138.4 billion in market value. Over the full year, these megacaps posted the strongest performance, with a median gain...
Parabilis Medicines has secured a $305 million crossover financing round after demonstrating proof of concept for its lead candidate, zolucatetide, in desmoid tumors. The company now targets a Phase III trial while evaluating broader indications and combination‑first strategies. CEO Mathai Mammen highlighted...
Parabilis Medicines announced a $305 million crossover financing round, giving the biotech company line of sight to Phase III trials for its lead candidate zolucatetide. The funding will support expansion of its Helicon platform into degrader, RIPTAC and radiopharmaceutical formats. The announcement...
Congress is moving a bipartisan spending package that would reauthorize pediatric priority review vouchers, safeguard NIH funding, and extend Medicare coverage to multi‑cancer early‑detection tests. The House Appropriations Committee released a bill to fund the government through September and avoid...
ImmunityBio announced a first‑in‑human readout of its off‑the‑shelf CD19 t‑haNK CAR‑NK therapy combined with rituximab, delivering a durable 15‑month complete response in four Waldenstrom lymphoma patients. The data propelled the stock to $5.52, up 137% from the prior week and added...
Ildong Pharmaceutical promoted Chae Joon Lee from COO to co‑CEO while retaining his president role, and he will continue overseeing affiliates such as Yunovia, ILeadBMS, and Idience. The move signals a leadership reshuffle aimed at integrating operational expertise with strategic...
During the J.P. Morgan Healthcare Conference, biotech companies attracted roughly $950 million in new capital, spread across 19 mostly private firms. The influx followed an early‑2026 surge of venture deals that pushed total private biotech funding to about $3 billion. Most of...
The J.P. Morgan Healthcare Conference ignited a surge of financing, the strongest in years for biotech. In a special BioCentury This Week podcast recorded at the conference, analysts and investors examined Asia’s burgeoning biotech ecosystems. Discussions covered deal pricing in China, the...
The article forecasts that the United States will adopt a most‑favored‑nation (MFN) drug‑pricing model, tying domestic prices to international reference benchmarks. Policymakers view MFN as a tool to curb soaring prescription costs, while industry groups warn it could compress profit...
The latest generation of intracellular PROTACs now offers precise spatial activation, tunable persistence, and expanded ubiquitin‑ligase recruitment, addressing the pharmacokinetic and toxicity hurdles of earlier candidates. Chinese research groups have pioneered formulations that release the degrader only within target cells...
Eli Lilly announced it will acquire Ventyx in a $1.2 billion transaction, expanding its neuroscience and immunology pipeline. The deal is driven by Ventyx’s NLRP3 programs with potential applications in pericarditis, Parkinson’s disease, and obesity‑associated cardiometabolic disease.
Amgen announced a deal to acquire an acute myeloid leukemia (AML) drug candidate from UK-based biotech Dark Blue. The terms of the transaction were not disclosed. The deal expands Amgen's oncology pipeline.