#biotech-regulation

[ follow ]
NYC startup
fromFortune
11 hours ago

From drought to demand: Biotech IPOs roar back with Kailera and Alamar | Fortune

Investors are returning to biotech IPOs, as demonstrated by Alamar Biosciences and Kailera Therapeutics' successful public offerings.
#patent-law
fromPatently-O
1 day ago
Intellectual property law

Extra Credit, Not Required: Teva v. Lilly and the Limits of Amgen's Reach

fromPatently-O
3 days ago
Intellectual property law

Extraordinary by Design: How the USPTO Is Bypassing Its Own Reexamination Rules

A new procedure allows patent owners to argue against reexamination requests before the USPTO decides on substantial new questions of patentability.
Intellectual property law
fromPatently-O
1 day ago

Extra Credit, Not Required: Teva v. Lilly and the Limits of Amgen's Reach

The Teva v. Eli Lilly decision clarifies the evaluation of patent claims for methods of using known compounds under the Amgen disclosure requirements.
Intellectual property law
fromPatently-O
3 days ago

Extraordinary by Design: How the USPTO Is Bypassing Its Own Reexamination Rules

A new procedure allows patent owners to argue against reexamination requests before the USPTO decides on substantial new questions of patentability.
Cancer
fromwww.businessinsider.com
8 hours ago

Venture capitalist Ron Conway says he is starting treatment for a 'rare' cancer

Ron Conway, a prominent venture capitalist, has been diagnosed with a rare form of cancer and is stepping back from SV Angel to begin treatment.
Wellness
fromwww.businessinsider.com
12 hours ago

I visited a members-only tech hub to see the biohacking tricks Silicon Valley founders swear by. It wasn't what I expected.

Biohack Miami's wellness event in San Francisco showcased practical biohacking tips focused on immediate well-being rather than solely on longevity.
#artificial-intelligence
Artificial intelligence
fromFast Company
5 days ago

AI is rewriting the rules of biological experiments, but safety regulations aren't keeping up

AI is autonomously designing and running biological experiments, outpacing current governance systems meant to regulate these capabilities.
Artificial intelligence
fromwww.bbc.com
20 hours ago

White House and Anthropic set aside court fight to meet amid fears over Mythos model

The White House met with Anthropic's CEO to discuss collaboration on AI technology amid ongoing legal issues with the Department of Defense.
SF politics
fromSecurityWeek
1 day ago

Lawmakers Gathered Quietly to Talk About AI. Angst and Fears of 'Destruction' Followed

Lawmakers expressed significant concerns about the implications of artificial intelligence on government operations, military actions, and societal impacts.
SF politics
fromFast Company
1 day ago

At roundtable on AI, members of Congress express angst and fears of 'destruction'

Lawmakers expressed concerns about the implications of artificial intelligence on government data, military actions, and societal impacts during a congressional subcommittee roundtable.
Artificial intelligence
fromFast Company
5 days ago

AI is rewriting the rules of biological experiments, but safety regulations aren't keeping up

AI is autonomously designing and running biological experiments, outpacing current governance systems meant to regulate these capabilities.
Information security
fromHarvard Gazette
1 day ago

Time for government, business leaders to figure out AI cybersecurity regulation - Harvard Gazette

Agentic AI poses both opportunities for cybersecurity and risks to personal data, economy, and national security, necessitating regulation by leaders.
Alternative medicine
fromFast Company
1 day ago

With GLP1 drug ads everywhere, here's what to know to safely buy them online

GLP-1 medications for weight loss are increasingly advertised, raising concerns about safety and the rise of unregulated alternatives.
fromTNW | Artificial-Intelligence
1 day ago

OpenAI launches GPT-Rosalind, an AI model for life sciences research

GPT-Rosalind is designed to support evidence synthesis, hypothesis generation, experimental planning, and multi-step scientific workflows across biochemistry, genomics, and protein engineering.
Medicine
#peptides
Medicine
fromThe New Yorker
1 week ago

Are Unapproved Peptides Worth the Risk?

Peptides are short chains of amino acids that may enhance strength and recovery, but their safety and efficacy in humans are largely unknown.
Medicine
fromwww.theguardian.com
1 week ago

Traceability is vital': labs test thousands of unregulated substances amid peptide craze

The underground market for injectable peptides in the UK has surged, with thousands of unregulated substances being tested for safety and efficacy.
Medicine
fromThe New Yorker
1 week ago

Are Unapproved Peptides Worth the Risk?

Peptides are short chains of amino acids that may enhance strength and recovery, but their safety and efficacy in humans are largely unknown.
Medicine
fromwww.theguardian.com
1 week ago

Traceability is vital': labs test thousands of unregulated substances amid peptide craze

The underground market for injectable peptides in the UK has surged, with thousands of unregulated substances being tested for safety and efficacy.
fromwww.nature.com
3 days ago

Editorial Expression of Concern: Creation of human tumour cells with defined genetic elements

Concerns were raised regarding a potential duplication of two bands in Fig. 1b. Due to the age of the article, the raw data were not available.
Science
fromNature
2 days ago

Quantum computers take on health care: light-sensitive cancer drugs win US$2 million contest

A team won a $2-million prize for using quantum computing to develop light-sensitive cancer drugs, but no grand prize was awarded.
Software development
fromZDNET
3 days ago

'Like handing out the blueprint to a bank vault': Why AI led one company to abandon open source

Cal is shifting from open source to proprietary licensing due to security risks posed by modern AI tools.
#ai-in-healthcare
Healthcare
fromApp Developer Magazine
3 days ago

Experts warn ai-generated health content risks misinterpretation without human oversight

AI-generated health content risks misunderstanding without human interpretation, impacting decision-making despite high technical accuracy.
Cancer
fromwww.theguardian.com
5 days ago

AI to predict how bowel cancer patients will respond to new NHS drug

A new AI method identifies effective drug responses for advanced bowel cancer patients, potentially sparing many from ineffective treatments.
Medicine
fromTNW | Opinion
1 week ago

AI health tech is booming. The cures are not.

AI in drug discovery shows promise but has not yet delivered significant breakthroughs for patients.
Medicine
fromFast Company
2 weeks ago

The AI drug revolution is real but the hype around it isn't

AI may revolutionize drug discovery, but it cannot simplify the complexities of human biology or guarantee successful treatments.
fromFortune
5 days ago

Why this Gilead Sciences exec says managing energy, not time, drives performance | Fortune

"I think about it like a piggy bank. Some meetings, tasks, and decisions draw heavily from it, particularly long discussions that go in circles..."
Women in technology
fromTNW | Startups-Technology
4 days ago

Helical closes $10M seed to turn bio foundation models into systems

Helical's thesis is that bio foundation models, AI systems trained on vast genomic, transcriptomic, and proteomic datasets, have already crossed a quality threshold that makes computational hypothesis-testing meaningful in pharma research.
Venture
#ai-governance
Artificial intelligence
fromAxios
5 days ago

The work AI boom is outrunning oversight

Companies must prioritize AI governance and compliance as agentic AI adoption increases, with many unprepared for audits and risk management.
Privacy professionals
fromEngadget
5 days ago

Meta warned by dozens of organizations that facial recognition on its smart glasses would empower predators

Civil rights organizations urge Meta to abandon facial recognition in smart glasses due to risks of empowering stalkers and predators.
Artificial intelligence
fromFuturism
1 day ago

There Are Signs of a Massive AI Backlash

Public outrage against the tech industry's AI focus is escalating, leading to protests and political backlash against data centers and AI development.
Marketing tech
fromDigiday
1 week ago

Why Pfizer and other blue-chip brands are building internal AI search hubs to reclaim control

Major advertisers are shifting SEO and AI expertise in-house due to changes in the search landscape.
#fda
Medicine
fromArs Technica
2 days ago

RFK Jr. forces FDA to reconsider 12 unproven peptides after 2023 ban

FDA plans meetings to discuss lifting restrictions on 12 unproven peptides despite safety concerns and lack of new data.
Medicine
fromArs Technica
2 days ago

RFK Jr. forces FDA to reconsider 12 unproven peptides after 2023 ban

FDA plans meetings to discuss lifting restrictions on 12 unproven peptides despite safety concerns and lack of new data.
fromTNW | Amazon
2 days ago

Amazon launches AI Bio platform to accelerate early-stage drug discovery

Amazon Bio Discovery enables scientists to run complex computational workflows through more than 40 AI-specialized foundational models, trained on a wide range of biological datasets. These models generate and evaluate potential drug molecules, alongside AI agents that help scientists to select models, optimize inputs and evaluate candidates according to their research.
Public health
#cancer-research
Cancer
fromNature
3 days ago

Four rising stars shaping the future of cancer research

A new generation of cancer researchers is focused on improving diagnostics and treatments to enhance survival rates for cancer patients.
Cancer
fromNature
3 days ago

Four rising stars shaping the future of cancer research

A new generation of cancer researchers is focused on improving diagnostics and treatments to enhance survival rates for cancer patients.
Science
fromNature
1 week ago

Daily briefing: CAR-T-cell therapy keeps a trio of autoimmune diseases at bay

Engineered immune cells successfully treated a woman with three autoimmune diseases, resulting in no symptoms or medication needed after fourteen months.
Intellectual property law
fromPatently-O
1 day ago

Same Problem, Same Solution: Reading Trade Secrets Across Fields

The Federal Circuit reversed a jury verdict against Texas urologists for misappropriating trade secrets related to the Penuma penile implant.
Health
fromThe Washington Post
1 week ago

One way to live longer: Win the genetic lottery

Genetic factors account for about 50% of human lifespan, significantly higher than the previously estimated 20%.
Artificial intelligence
fromTechRepublic
1 day ago

AI Upgrades, Security Breaches, and Industry Shifts Define This Week in Tech - TechRepublic

AI innovation and security threats are reshaping technology and corporate strategies across various platforms and applications.
Medicine
fromwww.bbc.com
2 days ago

'Breakthrough' Alzheimer's drugs unlikely to benefit patients, report suggests

Breakthrough Alzheimer's drugs are unlikely to significantly benefit patients despite slowing cognitive decline.
NYC startup
fromFuturism
1 week ago

AI-Powered Drug Marketer Medvi Responds After Allegations About Fake Doctors and Patients

Medvi, a drug marketing company, faces backlash for unethical practices despite a New York Times profile praising its AI-driven business model.
Cancer
fromNature
3 days ago

Improving cancer survival rates will require hard policy choices

Global cancer incidence is rising, necessitating early detection strategies and public education on risk factors.
#biotech
Business
from24/7 Wall St.
2 weeks ago

Biotech Stocks Are Up About 35% in the Past Year and Analysts Say the Biggest Gains Are Still Ahead

The biotech sector is projected to grow significantly due to lower borrowing costs and increased M&A activity.
Business
from24/7 Wall St.
2 weeks ago

Biotech Stocks Are Up About 35% in the Past Year and Analysts Say the Biggest Gains Are Still Ahead

The biotech sector is projected to grow significantly due to lower borrowing costs and increased M&A activity.
#ai
Artificial intelligence
fromFortune
1 day ago

OpenAI's policy chief says AI companies 'need to do a much better job' talking about AI as industry leaders face personal attacks | Fortune

AI's impact on labor is polarizing, with increasing backlash and violence against proponents of the technology.
Artificial intelligence
fromFortune
1 day ago

OpenAI's policy chief says AI companies 'need to do a much better job' talking about AI as industry leaders face personal attacks | Fortune

AI's impact on labor is polarizing, with increasing backlash and violence against proponents of the technology.
Medicine
fromFast Company
1 week ago

AI is coming for superbugs

AI can significantly enhance antibiotic discovery, addressing the urgent global health crisis of antibiotic resistance.
Medicine
fromBusiness Matters
2 days ago

David Ferrera on Building What Works in Medical Devices

David Ferrera is a seasoned medical device engineer and entrepreneur focused on developing innovative solutions in neurovascular and interventional medicine.
#ai-regulation
fromWIRED
4 days ago
Intellectual property law

Anthropic Opposes the Extreme AI Liability Bill That OpenAI Backed

Intellectual property law
fromWIRED
4 days ago

Anthropic Opposes the Extreme AI Liability Bill That OpenAI Backed

Anthropic opposes Illinois bill SB 3444, which would shield AI labs from liability for large-scale harm caused by their systems.
Artificial intelligence
fromFast Company
1 month ago

You can't recall AI like a defective drug

The pharmaceutical regulatory model is inadequate for AI governance because AI risks differ fundamentally from pharmaceutical risks in ways that make traditional oversight frameworks insufficient for existential threats.
from24/7 Wall St.
2 weeks ago

5 Biotechs That Big Pharma Could Snap Up as Oncology M&A Heats Up

Incyte tops this list due to its rare combination of commercial scale, cash generation, and pipeline depth. The company posted FY2025 revenue of $5.14 billion, up 21.2% YoY, anchored by Jakafi generating $828.2 million in Q4 2025 alone (+7% YoY) and Opzelura delivering $207.3 million (+28% YoY). With $3.58 billion in cash and 14 pivotal clinical trials underway, Incyte offers an acquirer immediate revenue, margin expansion potential, and a deep oncology pipeline spanning KRASG12D, CDK2 inhibition, and mutCALR.
Venture
Coronavirus
fromFortune
3 weeks ago

America is handing its mRNA lead to China-and RFK Jr. is to blame | Fortune

The U.S. mRNA vaccine sector faces political challenges, impacting investment and development despite strong clinical data.
Medicine
fromThe Atlantic
3 days ago

How to Fix a Diagnosis Crisis

Diagnostic errors are common, affecting 5% of Americans annually, leading to significant disability and death.
Cancer
fromwww.theguardian.com
6 days ago

GSK reports promising early results in ovarian and womb cancer drug trial

GSK's Mo-Rez treatment shows promising results in shrinking tumors for ovarian and endometrial cancers, leading to plans for late-stage trials.
Science
fromFuturism
2 weeks ago

A Startup Has Been Quietly Pitching Cloned Human Bodies to Transfer Your Brain Into

Cloning efforts have evolved from animals to controversial human embryo models, with ambitions for brainless human clones for organ transplants.
Medicine
fromInsideHook
5 days ago

CAR T Therapy Shows Promise Against Autoimmune Diseases

CAR T therapy shows promise in treating autoimmune conditions, providing significant relief for patients previously unresponsive to traditional treatments.
Artificial intelligence
fromAbove the Law
4 days ago

What Lawyers Need To Know About Anthropic's Mythos - Above the Law

Anthropic's new AI model, Claude Mythos, uncovers significant security vulnerabilities, raising concerns about its potential impact on cybersecurity.
Artificial intelligence
fromForbes
5 days ago

The Hottest Debate In Tech: Ads In AI

The debate in AI centers on the introduction of advertising in chatbot interactions and the financial implications of running AI systems.
fromNextgov.com
1 month ago

Tech bills of the week: Improved biological data for research; Section 702 reform; and more

Ushering in the Golden Age of Innovation is about more than just winning the global tech race - it's about securing the safety and prosperity of our country for generations to come. Our bill is an important step in this effort and will better ensure the United States has the infrastructure in place to lead the 21st century.
EU data protection
Medicine
from24/7 Wall St.
2 weeks ago

These 5 Biotechs Could Be the Next Big GLP-1 Acquisition Target

The GLP-1 revolution is driving biopharma M&A strategies, with companies like Viking Therapeutics and Structure Therapeutics as prime acquisition targets.
Silicon Valley
fromKqed
1 month ago

How South San Francisco Became the Birthplace of Biotechnology | KQED

South San Francisco transformed from an industrial meatpacking and steel manufacturing hub into the world's biotechnology capital, hosting over 250 biotech companies including Genentech.
Healthcare
fromFast Company
1 month ago

Responsible compounding could close the innovation gap

Compounding can responsibly accelerate patient access to needed therapies when grounded in rigorous data, filling genuine clinical gaps while pursuing FDA approval, particularly in underserved areas like women's health.
Venture
from24/7 Wall St.
1 month ago

Forget AI. This Biotech Stock's Taking Off Right Now

AI stocks face correction risk due to rising capital expenditures without proportional profits, making biotech an undervalued alternative for AI-driven growth exposure.
fromMail Online
1 month ago

Outrage as cancer-fighting drug in US patent echoes hidden CIA file

According to the patent, a specific crystalline form of the drug known as polymorph C may be more effective than other versions because it is absorbed more efficiently by the body. The patent also notes that laboratory studies showed the drug reduced tumor growth and helped mice with brain tumors live longer, prompting early clinical trials to test whether the treatment is safe and effective in humans.
Cancer
Left-wing politics
fromTruthout
1 month ago

Reproductive Tech That Promises Smart Babies Is Peddling Soft Eugenics

Reproductive tech companies now offer embryo genetic screening for intelligence and disease, raising concerns about eugenics, disability discrimination, and wealth-based genetic enhancement.
Fundraising
fromMedCity News
2 months ago

The 4 Biotech Companies on Track to IPO this Week Despite the Government Shutdown - MedCity News

Several biotech companies can proceed with IPOs this week because the SEC filed notices of effectiveness before a partial government shutdown halted agency operations.
Medicine
fromWIRED
3 weeks ago

A Billionaire-Backed Startup Wants to Grow 'Organ Sacks' to Replace Animal Testing

R3 Bio proposes nonsentient organ sacks as an ethical alternative to animal testing in biotechnology.
US politics
fromNature
1 month ago

Biotech investor set to lead US National Science Foundation

Donald Trump plans to nominate biotechnology investor Jim O'Neill to lead the National Science Foundation.
fromFast Company
2 months ago

Most scientific inventions don't leave the lab. This VC firm is changing that

But he'd been considering an idea for new technology-an autonomous, wind-powered cargo ship. Then, while on paternity leave in 2024, he discovered a free program that helps scientists and engineers launch businesses for the first time. Weeks after finishing the program, called 5050, Cymbalist had launched a startup called Clippership. The company's first ship is being built in the Netherlands this year. Without the accelerator, he says, the company likely wouldn't exist.
Startup companies
Healthcare
fromFuturism
1 month ago

Government Handing Out Cash Bonuses to Drug Researchers Who Rush Through Regulatory Approvals

The FDA introduced a cash bonus program for drug reviewers who complete work ahead of schedule, creating potential conflicts of interest with accelerated approval processes.
Cancer
fromMail Online
1 month ago

CIA backlash after hidden document hints at possible cancer cure

A declassified 1951 CIA document summarizes Soviet research identifying biochemical similarities between parasitic worms and cancerous tumors, suggesting potential shared treatment approaches.
Medicine
fromwww.bbc.com
4 weeks ago

Lab-grown food pipe offers new hope for young patients

Scientists have successfully grown and transplanted fully functioning food pipes in mini pigs, offering hope for patients with oesophageal conditions.
fromArs Technica
1 month ago

Have we leapt into commercial genetic testing without understanding it?

Martschenko's argument is largely that genetic research and data have almost always been used thus far as a justification to further entrench extant social inequalities. But we know the solutions to many of the injustices in our world-trying to lift people out of poverty, for example-and we certainly don't need more genetic research to implement them. Trejo's point is largely that more information is generally better than less.
Science
Medicine
fromThe Atlantic
1 month ago

Everyone Is a Biohacker Now

Vyleesi, a prescription female libido drug, is being purchased off-label by men through online retailers exploiting 'research use only' disclaimers to circumvent prescription requirements.
fromNature
1 month ago

AI tools can design genomes. Will they upend how life evolves?

Biology is undergoing a transformation. After centuries of studying life as it evolves naturally, researchers are now using a combination of computation and genome engineering to intervene, generating new proteins and even whole bacteria from scratch. The use of artificial-intelligence tools to design biological components, an approach known as generative biology, is set to turbocharge this area of research. Just last year, scientists used AI-assisted design to produce artificial genes that can be expressed in mammalian cells.
Science
Intellectual property law
fromPatently-O
1 month ago

Parts vs. Whole: Federal Circuit Corrects District Court's Component-Level Section 101 Analysis in Gene Therapy Case

The Federal Circuit reversed ineligibility of genetically engineered host cells under patent law, establishing that such cells are not natural phenomena and therefore patentable subject matter.
Artificial intelligence
from24/7 Wall St.
2 months ago

2 Biotech Stocks to Buy as AI Drug Discovery Lifts Off

AI-assisted drug discovery is emerging as a promising way to accelerate novel treatments, potentially reducing biotech risk and unlocking value despite skepticism.
Medicine
fromNature
2 months ago

China's biotech boom: why the nation must collaborate to stay ahead

China leads in drug manufacturing and biotech innovation, but geopolitical scrutiny and moves toward a closed biotech ecosystem threaten scientific collaboration and global medicine access.
fromNature
2 months ago

My 'detective' job as a competitive-intelligence consultant for pharma

We provide thought partnership. When a company is developing a drug, there's a lot of work involved, such as understanding the science, designing a study and generating good data. We come in and explain what the standard of care looks like today for their patient population, and what we think it will look like in five to eight years or whenever they plan to launch their therapy.
Medicine
fromNature
2 months ago

NIH rolls back red tape on some experiments - spurring excitement and concern

Many researchers are surprised and relieved over an unusual step taken by the US National Institutes of Health (NIH): the agency is rolling back the red tape on a host of basic-science experiments that involved human participants and had been classified as clinical trials. The decision, which was announced on 29 January and is part of a broader NIH effort to reduce administrative burden, should free such research from the heavy bureaucratic requirements that are designed for clinical trials but are sometimes ill-suited to other fields, such as basic psychology and behavioural studies.
Medicine
[ Load more ]