BioTech News and Headlines

Lisbon Is Calling: The BIO-Europe Startup Spotlight Returns in March 2026
NewsDec 16, 2025

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...

By Labiotech.eu
Elkedonia: Antidepressants that Act Downstream of Neurotransmitters
NewsDec 16, 2025

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...

By BioCentury
Obesity Data, Kymera and FDA Sentiment Survey Results — a BioCentury Podcast
NewsDec 16, 2025

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...

By BioCentury
Pursuing a Rare Autoimmune Disease Accelerated Kyverna’s Path to BLA
NewsDec 16, 2025

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...

By BioCentury
MHRA Deepens Global Strategy with Singapore Regulatory Pathway
NewsDec 16, 2025

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...

By BioCentury
The Busiest Biotech Seed and Series A Investors of 2025
NewsDec 15, 2025

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...

By BioCentury
Keep an Eye on These 15 Biotech Companies in 2026
NewsDec 15, 2025

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...

By Labiotech.eu
Bayh-Dole at 45: Still an Engine for Innovation
NewsDec 15, 2025

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...

By Bio.News
CEO Moves at Prolynx, Centessa, Kyowa Kirin, Enliven, Expression
NewsDec 13, 2025

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...

By BioCentury
Makary’s Embrace of Ideology, Conspiracies Puts FDA at Risk: A Perspective
NewsDec 12, 2025

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...

By BioCentury
EMA’s CHMP Backs New Medicines From Hansoh, Cytokinetics
NewsDec 12, 2025

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...

By BioCentury
BeOne Strengthens Its BTK Position at ASH
NewsDec 12, 2025

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...

By BioCentury
House Passes BIO-Backed Legislation to Increase Access to Capital
NewsDec 12, 2025

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...

By Bio.News
Fifteen Gift Ideas for a Biotech Enthusiast This Holiday Season
NewsDec 12, 2025

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...

By Labiotech.eu
Tackling Pulmonary Fibrosis: Boehringer Ingelheim’s New Drug + AI Approach
NewsDec 12, 2025

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...

By Labiotech.eu
Lilly’s Triple Agonist Contender for Best-in-Class Weight Loss
NewsDec 12, 2025

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...

By BioCentury
BioCentury’s FDA Survey Reflects an Industry in Distress
NewsDec 12, 2025

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...

By BioCentury
Front Row with BioCentury: Inside the Turbulent Ride of Cell and Gene Therapy
NewsDec 12, 2025

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...

By BioCentury
Science Spotlight: Chinese Researchers Advance PROTAC Design
NewsDec 12, 2025

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...

By BioCentury
Charlotte Emerging as a Global Leader in Health Care Innovation and Med Tech
NewsDec 10, 2025

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...

By Bio.News