Know What's Happening in BioTech
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Kobe University researchers have devised a cryopreservation protocol that freezes induced pluripotent stem cells (iPSCs) directly in their 2‑dimensional culture dishes. The method uses the inexpensive amino acid D‑proline combined with a synthetic polymer and a brief enzymatic step to weaken cell‑cell adhesion, achieving near‑perfect viability and retained pluripotency after three months of storage. This breakthrough eliminates the need for detachment and animal‑derived cryoprotectants, paving the way for automated, large‑scale iPSC banking. The approach promises to accelerate personalized medicine, drug screening, and regenerative‑therapy pipelines.
In the year‑end episode, GEN editors review six headline biotech stories, highlighting AI’s expanding role in drug discovery, a landmark success for Baby KJ in cell‑gene therapy, and the turbulent year for Sarepta’s DMD gene therapy Elevidys, including patient deaths...
GOP Representative Diana Harshbarger, a pharmacist, wrote FDA Commissioner RFK Jr. urging the agency to use enforcement discretion to loosen restrictions on six unapproved wellness peptides, including BPC‑157 and CJC‑1295. The request echoes a similar appeal from Senator Tommy Tuberville, signaling...
UC San Diego engineers have created a water‑based spray polymer coating that shields plant leaves from bacterial infection and improves drought tolerance. The polynorbornene polymer carries positive charges that disrupt bacterial membranes while remaining gas‑permeable for normal leaf respiration. Laboratory...
The article reviews the NLRP3 inflammasome inhibitor DFV890, highlighting its Phase 2 data in acute coronary syndrome and its mechanism of selectively blocking NLRP3 activation. It also examines emerging NLRP3‑targeted programs, including covalent inhibitors and PROTAC degraders, and discusses the broader...
The post outlines ALS as a progressive neurodegenerative disease with no cure and only modestly effective drugs such as riluzole and edaravone. It highlights how multidisciplinary ALS clinics deliver the greatest survival benefit, while a booming market of unproven supplements...
Researchers from Marshall University and the University of Missouri unveiled G2PDeep, a web‑based deep‑learning platform that fuses six major omics data streams to predict complex health outcomes. The peer‑reviewed study in *Biomolecules* demonstrates the tool’s ability to identify molecular markers,...
Researchers at the IGTP demonstrated that delafloxacin inhibits intracellular Legionella replication more effectively than levofloxacin in a macrophage model. The fluoroquinolone achieved bacterial killing at concentrations five to ten times lower than the current standard, except for L. longbeachae where...
Xtalpi announced that veteran biotech executive Tam Man Hong will assume the role of President, Business Development, effective immediately. The appointment comes as the company finalizes a $150 million Series B financing round to expand its AI‑driven protein therapeutics platform. Hong, who...
Two independent research groups have pinpointed reduced expression of the mitochondrial protein FDX2 as a novel therapeutic axis for Friedreich ataxia, publishing their findings in Nature. The studies argue that frataxin (FXN) and FDX2 function as a stoichiometric pair, and...
Addition Therapeutics, a newly launched biotech, is deploying engineered retrotransposons to insert therapeutic payloads into a single ribosomal DNA (rDNA) locus, a recognized genomic safe harbor. By concentrating multiple genes at this highly transcribed, repetitive site, the platform promises stable...
Springworks Therapeutics and Pfizer announced FDA approval of mirdametinib (PD0325901), an oral, brain‑penetrant MEK1/2 inhibitor for treating neurofibromatosis type 1‑associated plexiform neurofibromas (NF1‑PN) in both adults and children. The drug was optimized from an earlier in‑vitro tool compound to improve potency...
In 2025 the immunology and inflammation sector saw eight blockbuster partnerships, each worth between $1.7 billion and $4 billion. Deals ranged from AstraZeneca’s $175 million upfront, $4.4 billion‑potential collaboration with Harbour BioMed to Vor Bio’s surprising $4 billion licensing of telitacicept despite a massive wind‑down....
St. Jude researchers unveiled Combocat, an open‑source platform that merges acoustic liquid handling with machine‑learning models to screen drug combinations at unprecedented scale. The system tested 9,045 drug pairs on a neuroblastoma cell line, identifying multiple synergistic hits that were...
The BIO IP Counsel Committee Conference addressed growing skepticism toward patents in biopharma, amplified by pandemic‑era messaging that frames IP as a barrier to care. Panelists argued that patents remain vital incentives for costly research and development, despite public concerns...
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...
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 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....
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...
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...
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...
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) 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...
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...
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,...
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...
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, 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 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...
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...
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...
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...
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...
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...
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...
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 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...
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...
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...
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 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...
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...
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...
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...
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...
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...
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 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...
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...
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...
