Patient Advocates Urge Action on PPRV to Help Fight Rare Disease
Patient advocates at BIO’s December Coffee Chat urged Congress to reauthorize the Pediatric Priority Review Voucher (PPRV) program before year‑end. The voucher scheme, which expired in 2024, has awarded 63 vouchers for 47 rare pediatric diseases, turning four treated conditions into dozens of approved therapies. Advocates highlighted personal stories and noted the House passed the Mikaela Naylon Give Kids a Chance Act on Dec 1, while urging the Senate to act swiftly. Reauthorization is portrayed as essential to keep pipelines for ultra‑rare children’s drugs alive.
Weekly TechBio News
The episode highlights four major tech‑bio developments: LatchBio’s launch of agent.bio, an interactive sandbox for spatial biology analysis across five platforms; Chai Discovery’s $130 M Series B raise to build an AI‑driven CAD suite for drug design, backed by OpenAI; Accenture Ventures’...
RTW Leans Into NewCo Model with GenSci Deal for Ocular Autoimmune Therapy: Deals Report
RTW Therapeutics announced a strategic partnership with GenSci to form a new joint‑venture focused on developing an ocular autoimmune therapy. The collaboration adopts a NewCo model, with both parties contributing capital and expertise to accelerate drug discovery for non‑infectious uveitis....
The Evolving BTK Story in Multiple Sclerosis: Clinical Report
Sanofi’s Bruton’s tyrosine kinase (BTK) inhibitor failed to meet its primary endpoint in a pivotal trial for primary progressive multiple sclerosis, while the company awaits an FDA decision on a secondary progressive indication. Roche, meanwhile, reported encouraging efficacy and safety...
Measuring Drug Target Success
The episode explores how drug targets are identified and validated, highlighting genetic, animal, and in‑vitro evidence as key sources. It discusses the limited predictive power of pre‑clinical data, noting that genetically validated targets double the odds of clinical success while...
$12B-Plus in New Life Sciences Funds This Year
Venture capital activity in life sciences has surged in 2025, with at least 27 firms announcing new funds. Collectively, these vehicles have attracted more than $12 billion in capital, marking a record inflow for the sector. Notably, four of the funds...
Who Invented What? BIO IP Panel Tackles Joint Inventorship
The BIO IP panel highlighted that joint inventorship is now the norm in biotech, replacing the lone‑inventor myth. It outlined the legal elements—conception, collaboration, corroboration—and illustrated them with real and hypothetical cases, including AI‑driven research. Panelists warned that mis‑attributing inventors...
Fenebrutinib (GDC-0853)
Fenebrutinib (GDC‑0853) is an oral, reversible Bruton’s tyrosine kinase (BTK) inhibitor that entered Phase 3 trials for multiple sclerosis in a November 2025 press release. The drug was discovered through ATP‑site‑directed compound library screening and subsequently optimized by Roche and Genentech. Its...
UltraMarathonRT: When Your Reverse Transcription Must Go Long
RNAConnect has launched a new kit for Oxford Nanopore direct‑RNA sequencing that uses UltraMarathonRT, a group II intron‑derived reverse transcriptase. Unlike traditional AMV or M‑MLV enzymes, UltraMarathonRT is highly processive, can copy RNA longer than 30 kb, and works at a gentle...
VIDO – Five Ways Our Research Strengthened Animal Health in 2025
In 2025 the University of Saskatchewan’s Vaccine and Infectious Disease Organization (VIDO) tackled five critical animal‑health challenges, from a first‑record H5N1 outbreak in dairy cattle to a world‑first chlamydia vaccine for endangered koalas. Researchers demonstrated natural immunity in infected cows,...
Biotech in 2025: A Retrospective
2025 marked a phase shift in biotech as metabolic health, AI, and radiopharmaceuticals moved from hype to mainstream impact. GLP‑1 and related incretin drugs expanded into broader cardiometabolic indications, with over 40 candidates in development and major licensing deals reshaping...
Lisbon Is Calling: The BIO-Europe Startup Spotlight Returns in March 2026
BIO‑Europe’s Startup Spotlight, the premier European biopharma pitch competition, announced its 2025 champion, German spin‑out Fusix Biotech, which secured the trophy in Vienna with its InFUSE chimeric oncolytic virus platform. The contest selects eight early‑stage companies—fewer than 25 employees and...
Elkedonia: Antidepressants that Act Downstream of Neurotransmitters
Elkedonia, a seed‑funded French biotech, is developing a novel class of antidepressants that target the transcription factor ELK1 to reboot neuroplasticity downstream of classic neurotransmitter pathways. The company announced a €5 million seed round led by European venture partners and presented...
Obesity Data, Kymera and FDA Sentiment Survey Results — a BioCentury Podcast
Obesity therapeutics dominated the latest BioCentury podcast, with Eli Lilly unveiling new top‑line data for its triple‑agonist retatrutide, positioning it as a best‑in‑class weight‑loss candidate. Structure Therapeutics reported strong Phase IIb results for its oral GLP‑1, reigniting interest in non‑injectable options, while...
Pursuing a Rare Autoimmune Disease Accelerated Kyverna’s Path to BLA
Kyverna Therapeutics announced that its lead autoimmune CAR‑T, mivocabtagene autoleucel (miv‑cel), achieved both primary and secondary endpoints in a registrational Phase II trial for stiff person syndrome. The data positions the therapy as the first autoimmune CAR‑T to pursue a Biologics...
MHRA Deepens Global Strategy with Singapore Regulatory Pathway
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a regulatory innovation corridor with Singapore’s Health Sciences Authority, offering companies coordinated scientific advice from both regulators. Flagship Pioneering is the first industry partner, giving its biotech portfolio a...
The Busiest Biotech Seed and Series A Investors of 2025
In 2025 more than a dozen venture capital firms have each disclosed at least five seed or Series A biotech investments, making them the busiest early‑stage investors of the year. BioCentury’s data shows that capital is flowing into a wide range...
GAS41 Revisited: A Chemical Probe
Researchers at the University of Michigan have refined a fragment‑based series into DLG‑41, a monomeric chemical probe targeting the YEATS domain of GAS41. The probe exhibits ~1 µM affinity by ITC and nanomolar potency in a NanoBRET cellular assay, confirming both...
Keep an Eye on These 15 Biotech Companies in 2026
Labiotech’s 2026 "biotechs to watch" list spotlights fifteen companies across gene therapy, cell therapy, base editing, radiopharma and metabolic disease, each with pivotal clinical or regulatory milestones slated for the coming year. Highlights include AAVantgarde’s $141 million Series B and proof‑of‑concept trials...
Bayh-Dole at 45: Still an Engine for Innovation
The Bayh‑Dole Act, celebrating its 45th anniversary, has turned federally funded university research into a powerhouse of commercial innovation. Between 1996 and 2020 it generated up to $1.9 trillion in economic output, created 6.5 million jobs and spurred 19,000 startups, resulting in...
Patenting Strategies for Small Molecule Drugs
The article reviews patenting strategies for small‑molecule drugs, emphasizing the need for early and comprehensive protection. It outlines the typical patent lifecycle—from provisional filings through PCT applications to national‑phase prosecution—and the legal standards of utility, novelty, and non‑obviousness. Real‑world examples...
The FDA Under MAHA Control: Weakening the Quack Miranda Warning on Supplements
The FDA, under the Make America Healthy Again (MAHA) agenda, is considering a rule change that would let supplement manufacturers place the DSHEA disclaimer on a single panel instead of every claim‑bearing panel. The proposal follows a December 11 letter...
CEO Moves at Prolynx, Centessa, Kyowa Kirin, Enliven, Expression
BioCentury reports a wave of CEO appointments across five life‑science firms. Prolynx named a former biotech COO to steer its next growth phase, while Centessa tapped a veteran pharma executive to accelerate its pipeline expansion. Kyowa Kirin promoted its internal R&D...
Makary’s Embrace of Ideology, Conspiracies Puts FDA at Risk: A Perspective
FDA Commissioner Marty Makary is openly endorsing debunked conspiracy theories while linking drug approvals to political pricing deals and onshoring incentives. His recent podcast remarks claimed Lyme disease and AIDS originated from government labs, blurring the line between science and...
EMA’s CHMP Backs New Medicines From Hansoh, Cytokinetics
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for five new drugs and vaccines in its December meeting. Two products originate from Chinese biotech Hansoh, while three are from U.S. firm Cytokinetics. The...
BeOne Strengthens Its BTK Position at ASH
BeOne Medicines presented six‑year follow‑up data for its BTK inhibitor Brukinsa (zanubrutinib) at the ASH meeting, showing roughly 75% of treatment‑naïve chronic lymphocytic leukemia (CLL) patients remain progression‑free. The company also shared early results from a novel BTK degrader that...
House Passes BIO-Backed Legislation to Increase Access to Capital
The U.S. House of Representatives approved the Incentivizing New Ventures and Economic Strength Through Capital Formation (INVEST) Act on Dec. 11, passing it 302‑123 with bipartisan support. The legislation, championed by BIO, aims to remove regulatory hurdles and expand capital access...
A Compendium of Pharmaceutical Salts to Help Flavor Your Drug Formulation
The article presents a comprehensive list of pharmaceutical salts that can be leveraged to enhance the taste, solubility, and overall patient acceptability of oral drug formulations. It outlines the physicochemical properties, regulatory status, and typical applications of both traditional inorganic...
Fifteen Gift Ideas for a Biotech Enthusiast This Holiday Season
The article curates fifteen holiday gift ideas tailored for biotechnology enthusiasts, ranging from playful items like the Viral board game to advanced tools such as portable DNA sequencers. It highlights novelty products—including glow‑in‑the‑dark mushrooms, DNA‑shaped cookie cutters, and personalized DNA...
Fed Rate Cut Tailwind, Lilly’s Triple Agonist Delivers Big, Vaccine Policy Turmoil — This Week in Biotech #81
The episode highlights how the Fed’s recent rate cut creates a macro‑tailwind for biotech, reviving valuations and financing opportunities. It discusses mixed public‑health signals around COVID‑19 vaccination in children and warns that U.S. skepticism could erode its mRNA leadership. Landmark...
Tackling Pulmonary Fibrosis: Boehringer Ingelheim’s New Drug + AI Approach
Boehringer Ingelheim has launched the first new pulmonary‑fibrosis medicine in more than a decade, an oral PDE4B inhibitor that secured FDA approval and will be rolled out globally. The company also introduced eLung, an AI‑driven imaging tool that spots microscopic...
Lilly’s Triple Agonist Contender for Best-in-Class Weight Loss
Eli Lilly announced Phase III TRIUMPH-4 data for its triple‑agonist retatrutide, showing a 26.6% placebo‑adjusted weight loss after 68 weeks at the 12 mg weekly dose. The study enrolled 445 obese adults with knee osteoarthritis, and the highest dose translated to...
BioCentury’s FDA Survey Reflects an Industry in Distress
BioCentury’s 2025 FDA survey paints a picture of deep distress across biopharma, flagging “inconsistency” as the sector’s most pressing worry. Respondents praised FDA staff effort but argued senior leadership decisions appear driven by political agendas rather than science. The perceived...
Front Row with BioCentury: Inside the Turbulent Ride of Cell and Gene Therapy
Cell and gene therapy continues to attract attention despite a recent wave of setbacks that have slowed commercial momentum. Manufacturing complexities, heightened regulatory scrutiny, and pricing debates are creating a turbulent environment for developers. Nevertheless, breakthrough scientific data and expanding...
Science Spotlight: Chinese Researchers Advance PROTAC Design
Chinese scientists have unveiled a next‑generation PROTAC scaffold that delivers oral bioavailability and heightened target selectivity. The platform successfully degrades previously undruggable proteins, including KRAS(G12C), and demonstrates tumor‑growth inhibition in mouse models. By integrating AI‑guided linker optimization, the researchers mitigated...
GLP Podcast: Ketamine—Miracle Depression Treatment, or Recreational Nightmare?
The episode examines ketamine’s rise from a battlefield anesthetic to an FDA‑approved treatment (esketamine) for treatment‑resistant depression, highlighting its rapid antidepressant effects and potential to reduce suicidal thoughts. Experts discuss the drug’s significant risks—including addiction, dissociation, blood‑pressure spikes, bladder damage,...
Extracorporeal Blood Oxygenation and Ozonation
Extracorporeal Blood Oxygenation and Ozonation (EBOO) is marketed by the wellness industry as a high‑end anti‑aging therapy that removes, oxygenates, ozonates, and filters a patient’s blood before reinfusion. The procedure is invasive, involving two IV lines and large‑volume blood processing,...
Inside NImmune’s Phase 3 Push in Ulcerative Colitis
In this episode, Dr. Josep Bassaganya‑Riera discusses NImmune's strategy to launch omilancor, a gut‑restricted LANCL2 agonist, into Phase 3 for ulcerative colitis, emphasizing its mechanism as an immune “thermostat” that rebalances gut immunity rather than broadly suppressing it. He highlights...
Charlotte Emerging as a Global Leader in Health Care Innovation and Med Tech
Charlotte, long known as a U.S. financial hub, has launched The Pearl—a $75 million health‑care innovation district—in midtown in June 2025. The campus brings together IRCAD North America, Wake Forest University School of Medicine, global med‑tech firms, startup labs, and an AI‑driven clinical‑trial...
Determining the Cause and Severity of Sepsis with a Point-of-Care Test
In this episode of The Bio Report, host Daniel Levine interviews Tim Sweeney, CEO of Inflammatix, about the company's TriVerity point‑of‑care test that rapidly distinguishes bacterial from viral infections and gauges immune response severity in sepsis patients. Sweeney explains how...