BioSpace

BioSpace is the digital hub for life science news and jobs. They provide essential insights, opportunities and tools to connect innovative organizations and talented professionals who advance health and quality of life across the globe.

Articles: 537

BioSpace

01 May 2025, 15:07

HHS To Require Placebo-Controlled Trials for All New Vaccines in ‘Radical Departure’ From Past

Biotechnology

The new policy, revealed by the Department of Health and Human Services on Wednesday, would make vaccines “less available and less affordable,” according to vaccine expert Paul Offit. It could also further complicate the picture for companies like Novavax.

BioSpace

01 May 2025, 12:48

Immunic Talks Up Disability Gains as Phase II MS Therapy Fails on Primary Endpoint

Biotechnology

According to CEO Daniel Vitt, clinical and disability-related outcomes are more relevant than brain volume change for drug development in multiple sclerosis.

BioSpace

30 Apr 2025, 12:12

AstraZeneca’s Truqap Posts Another Pivotal Disappointment as Phase III Prostate Cancer Study Fails

Biotechnology

The drug, a small molecule protein inhibitor, brought in $132 million in the first quarter, missing consensus estimates by 17%.

BioSpace

29 Apr 2025, 12:39

HHS Unfreezes Vaxart’s COVID-19 Study, Resumes Funding as Headwinds Batter Vaccines Space

Biotechnology

While Vaxart can proceed with its study, fellow COVID-19 vaccine developers GeoVax and Novavax continue to be hamstrung by various regulatory roadblocks.

BioSpace

28 Apr 2025, 14:06

Pfizer’s Subcutaneous PD-1 Cuts Risks in Bladder Cancer but Misses OS Endpoint

Biotechnology

Pfizer’s sasanlimab, when used with standard of care, reduced the likelihood of disease recurrence or progression, death due to any cause or persistence of cancer cells by 32% in patients with high-risk non-muscle invasive bladder cancer.

BioSpace

28 Apr 2025, 13:15

J&J Declares 'Sustained Disease Control' With Bladder Cancer Drug-Device Combo

Biotechnology

The targeted drug release device TAR-200 shows promising response and disease-free survival rates in specific populations of patients with non-muscle-invasive bladder cancer.

BioSpace

28 Apr 2025, 13:13

AACR 2025 Tracker: GSK, Boehringer Ingelheim Kick Off Meeting With New Data

Biotechnology

With the American Association for Cancer Research’s annual conference now underway, oncology researchers can expect potentially practice-changing data in head and neck and lung cancer and key updates on hot modalities.

BioSpace

28 Apr 2025, 12:47

Perioperative Keytruda Cuts Risk of Negative Events by Over 25% in Head and Neck Cancer

Biotechnology

The FDA is currently reviewing Merck’s sBLA for Keytruda in head and neck cancer, with a target action date of June 23.

BioSpace

28 Apr 2025, 12:28

Summit, Akeso’s Keytruda Challenger Wins Chinese OK as US Approval Questions Linger

Biotechnology

With ivonescimab’s data coming solely from China, its prospects in the U.S., where Summit owns the rights, remain up in the air.

BioSpace

28 Apr 2025, 04:01

Cell and Gene Therapy Sector Enters ‘Critical’ Period After Marks’ FDA Exit

Biotechnology

As tariffs, HHS workforce cuts and the ouster of CBER Director Peter Marks threaten the “lifeblood” of the cell and gene therapy space, experts express wariness over the unknowns and optimism that Marks' legacy will carry on.

BioSpace

25 Apr 2025, 13:41

Vyne Crashes After Safety Signal in Dogs Puts Hold on Clinical Trial of Plaque Psoriasis

Biotechnology

The hold, placed by the FDA on an early-stage clinical trial of an experimental BET inhibitor, stems from a recent observation of testicular toxicity in canines given the treatment.

BioSpace

25 Apr 2025, 04:01

Merck, Boehringer Ingelheim, More to Present Key Data at AACR ‘25

Biotechnology

Presentations at this year’s American Association for Cancer Research meeting could have a broad impact on the treatment landscape for head and neck and lung cancer, and implications for specific drug modalities like TIGIT and VEGF.

BioSpace

24 Apr 2025, 13:02

Economic Challenges, Strategic Investments: Reshaping the Women's Health Landscape

Biotechnology

In this episode presented by DIA, BioSpace's head of insights Lori Ellis discusses the underrepresentation of women in clinical trials with Martin Hodosi, partner at Kearney and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine.

BioSpace

23 Apr 2025, 13:08

Summit’s Bispecific Beats Yet Another Cancer Med, Pressuring Keytruda’s 'Supremacy'

Biotechnology

Analysts at BMO Capital Markets expect Summit and Akeso’s HARMONi-6 readout to put some pressure on Merck and its blockbuster biologic Keytruda.

BioSpace

23 Apr 2025, 12:30

‘Strike 2?’ BMS Stumbles Again as Cobenfy Disappoints in Schizophrenia

Biotechnology

Cobenfy’s late-stage flop is BMS’ second high-profile failure in as many weeks. The pharma announced last week that Camzyos was unable to improve disease burden in non-obstructive hypertrophic cardiomyopathy.

BioSpace

22 Apr 2025, 12:39

Gilead’s Trodelvy, With Keytruda, Slows Disease Progression in Triple-Negative Breast Cancer

Biotechnology

Combining Trodelvy with Keytruda and pushing it into the frontline setting could “potentially double” the ADC’s market in metastatic triple-negative breast cancer, according to analysts at Truist Securities.

BioSpace

22 Apr 2025, 12:23

AstraZeneca, Daiichi Sankyo Push Enhertu to Frontline Breast Cancer With Phase III Data

Biotechnology

Analysts at Leerink Partners said in a Monday note that DESTIN-Breast09’s findings “could support an approval” for Enhertu in first-line HER2+ metastatic breast cancer.

BioSpace

21 Apr 2025, 14:15

Regulatory and Economic Turmoil Is More Familiar in Other Countries

Biotechnology

Disruptive conditions are typical in non-Western markets. The U.S. industry, thrown into a period of significant change as the Trump administration overhauls HHS and considers implementing tariffs, could learn a thing or two by looking overseas.

BioSpace

18 Apr 2025, 12:31

FDA’s User Fee Negotiation Teams Gutted by Layoffs: Reuters

Biotechnology

Losing the FDA’s senior negotiators would slow the renewal of the user fee programs “considerably,” according to policy and regulatory expert Steven Grossman.

BioSpace

18 Apr 2025, 04:01

Here Today, Gone Tomorrow: Trump’s Policies Give Biopharma Whiplash

Biotechnology

Like they say about the weather in Iceland, if you don’t like an action taken by the new administration, wait five minutes; it’ll probably change. The markets, it seems, don’t react kindly to that kind of policymaking.

BioSpace

17 Apr 2025, 15:11

Biotech’s Next Phase Will Be All-American: Pitchbook

Biotechnology

With tariffs pushing manufacturing home to the U.S., Pitchbook warns of reduced M&A activity and venture capital funding.

BioSpace

17 Apr 2025, 14:59

Sanofi Bets More Than $1.8 Billion in Biobucks on AI-Developed Bispecifics

Biotechnology

The French pharma giant has made multiple trips to the artificial intelligence well over the past few years, this time with Delaware-based Earendial Labs.

BioSpace

17 Apr 2025, 13:15

Lilly Skyrockets on ‘Injectable-Like Efficacy’ for Oral GLP-1 in Phase III Diabetes Trial

Biotechnology

Eli Lilly’s shares shot up 11% pre-market on Thursday after orforglipron became the first small-molecule GLP-1 drug to ace a late-stage study in type 2 diabetes, eliciting significant reductions in body weight and improvements in glucose control.

BioSpace

16 Apr 2025, 13:49

Sanofi’s $1.4B Kymab Bet Falters as Asthma Drug Stumbles in Phase II

Biotechnology

Analysts at Leerink agreed with Sanofi that, despite falling short of statistical significance in the Phase II TIDE-Asthma trial, amlitelimab warrants further development in this indication.

BioSpace

15 Apr 2025, 13:09

Merck Eyes Oral Peptide Delivery With Cyprumed Deal Worth up to $493M

Biotechnology

Merck has not disclosed which of its peptide therapies it plans to develop oral formulations for.

BioSpace

15 Apr 2025, 12:13

BMS’ Camzyos Fails to Show New Cardiomyopathy Benefit in Phase III

Biotechnology

According to analysts at BMO Capital Markets, non-obstructive hypertrophic cardiomyopathy would have meant a $1.3 billion opportunity in a label expansion Camzyos.

BioSpace

14 Apr 2025, 15:11

Verve’s Base Editor “Numerically Beats” Other Cholesterol-Lowering Drugs

Biotechnology

In a Phase Ib trial, VERVE-102 showed it could lower bad cholesterol across doses, setting up an opt-in decision for Eli Lilly and a showdown with Novartis.

BioSpace

14 Apr 2025, 13:22

Pfizer Drops Lead Obesity Asset After Liver Safety Concerns, Overall Review

Biotechnology

Pfizer's discontinuation of danuglipron brings the company down to a single molecule in its obesity pipeline.

BioSpace

14 Apr 2025, 10:00

Beyond the Breakthrough: Industry Leaders Address Key Hurdles Facing Cell and Gene Therapies

Biotechnology

At the GenScript Biotech Global Forum 2025, industry leaders celebrated CAR T cell therapy achievements while discussing ongoing challenges in manufacturing, distribution, treatment center capacity, and global payment structures for cell and gene therapies.

BioSpace

14 Apr 2025, 04:01

Opinion: Smart Antibodies Will Transform Our Fight Against Solid Tumors

Biotechnology

AI is enabling the development of a next generation of drugs that can more precisely target cancer cells while sparing healthy tissues.

BioSpace

11 Apr 2025, 14:26

Trump’s Whiplash Tariffs and HHS Layoffs Set Biopharma Industry Ablaze

Biotechnology

As the biopharma industry grapples with the uncertain macro environment brought on by the new administration, CEOs, regulators and many others speak out.

BioSpace

10 Apr 2025, 13:25

Breaking Down Barriers: The Nuanced Approach to Women's Representation in Medical Research

Biotechnology