Sat.Mar 04, 2023 - Fri.Mar 10, 2023

article thumbnail

Dawn of a new indication: how to study drugs for aging 

Pharmaceutical Technology

For a long time, aging biology and research have been enigmatic areas that biotechs hoped to capitalise on due to their market potential. Whether one refers to such research as “longevity”, “anti-aging” or “extending healthspan”, it is clear this area has evolved massively over the last few years with more scientists now eager to get drugs in this area from bench to bedside.

Drugs 363
article thumbnail

J&J-backed startup launches with $100M to build better brain drugs

Bio Pharma Dive

Rapport Therapeutics aims to find new so-called receptor-associated proteins that could serve as targets for neurological disease medicines. Its most advanced drug is already in early-stage human testing.

Drugs 362
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Study Links Artificial Sweetener to Stroke Risk, Says It Could Make Blood Stickier

AuroBlog - Aurous Healthcare Clinical Trials blog

The suspected health harms of artificial sweeteners are piling up – and now a new study has linked one kind of sugar substitute to higher risks of heart health problems.

Scientist 246
article thumbnail

Moderna opts for Oxfordshire in quest for innovation

Pharma Times

Vaccines developed at the facility will cover a wide range of respiratory diseases

Vaccine 146
article thumbnail

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

article thumbnail

New facility boosts UK’s cell and gene therapy manufacturing capacity

Pharmaceutical Technology

On 10 March, the National Health Service Blood and Transplant (NHSBT) opened a new Clinical Biotechnology Centre (CBC) with the aim of improving the UK’s ability to develop and manufacture cell and gene therapies. A £9.3 million ($11 million) grant is being used to build the facility in Bristol where therapies for currently incurable diseases, such as some forms of cancer, sickle cell disease, and cystic fibrosis can be manufactured.

article thumbnail

GPCR-targeting drugs: A renewed focus on a ubiquitous group of proteins

Bio Pharma Dive

As many as a third of FDA-approved drugs target GPCRs in some fashion, with uses ranging from treating cancer to pain. But biotech startups say there is still room to develop more.

Protein 360

More Trending

article thumbnail

STAT+: SVB, biotech’s bank of choice, just failed. It could have ripple effects

STAT News

Silicon Valley Bank, which does business with roughly half of the nation’s tech and biotech companies, failed on Friday. Now, as federal regulators step in to clean up SVB’s mess, biotech startups are left wondering: What happens to their money, and who’s going to finance the industry? On Friday morning, the Federal Deposit Insurance Corporation took control of SVB and is presiding over a sale of the firm’s assets to cover clients’ deposits.

Sales 145
article thumbnail

Eli Lilly places price cap of $35 on out-of-pocket insulin cost

Pharmaceutical Technology

Eli Lilly has announced that it will reduce the price of its most commonly used insulin, Humalog, in the US, by 70% and cap the out-of-pocket cost for those on commercial insurance at $35. This follows on from recent US federal action, the Inflation Reduction Act, that legislated reducing the Medicare beneficiary insulin out-of-pocket costs at $35 a month.

Insulin 264
article thumbnail

Lilly reaches end of the road with long-studied Alzheimer’s drug

Bio Pharma Dive

Prior trial failures hadn’t halted testing of solanezumab, once Lilly’s top Alzheimer’s drug candidate. But its final study defeat may help scientists better understand how to target the brain disease.

Drugs 317
article thumbnail

Huge New Study Shows Why Exercise Should Be The First Choice in Treating Depression

AuroBlog - Aurous Healthcare Clinical Trials blog

Exercise should be the primary treatment for depression and other common mental health conditions, according to University of South Australia (UniSA) researchers. The most comprehensive review of research to date shows that mild to moderate symptoms of depression, anxiety, and psychological distress can be alleviated with physical activity. According to their investigation, exercise is 1.

Research 233
article thumbnail

Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

article thumbnail

Digital rectal examination is not useful to early detect prostate cancers, says new research

Medical Xpress

A common method of detecting prostate cancer may not be accurate enough as a reliable screening tool by itself, scientists have warned.

Scientist 145
article thumbnail

Incannex partners with Catalent to manufacture psilocybin

Pharmaceutical Technology

Incannex Healthcare has collaborated with New Jersey-based pharma company Catalent for the development and manufacturing of a cGMP-grade psilocybin drug product for clinical trials and potential commercial use. The drug product is designed for use in the psilocybin-assisted psychotherapy drug development programme of Incannex for generalised anxiety disorder.

article thumbnail

AstraZeneca builds on study successes in early lung cancer

Bio Pharma Dive

The pharma’s drug Tagrisso extended survival in a trial that stirred debate at ASCO three years ago, while its immunotherapy Imfinzi reduced the risk of relapse in a different study.

Trials 312
article thumbnail

Children With Autism ‘See’ This Optical Illusion in a Unique Way, Experiment Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

To transform reality into the mental landscape that occupies out minds, our brain performs a multitude of operations. Some are short-cuts; assumptions that become obvious the moment we attempt to make sense of the conflict presented in an optical illusion.

article thumbnail

The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

article thumbnail

NYC Mayor Eric Adams is telling stores to have customers remove their face masks

NPR Health - Shots

"We are putting out a clear call to all of our shops: Do not allow people to enter the store without taking off their face mask," the mayor said. A flurry of questions ensued.

145
145
article thumbnail

CNM-Au8 could address vision problems in multiple sclerosis

Pharmaceutical Technology

Clene has presented updated trial results for its Visionary MS Phase II clinical trial for its lead pipeline candidate, CNM-Au8. The trial is investigating CNM-Au8 as a treatment for patients with relapsing forms of multiple sclerosis (MS) with chronic optic neuropathy. The agent has a first-in-class mechanism of action within the MS portfolio, as it is a first drinkable treatment based on a nanocrystalline gold suspension that has reached late-stage development for MS.

article thumbnail

Merck drug data suggest ‘new direction’ for rare blood vessel disease

Bio Pharma Dive

Treatment with Merck’s sotatercept helped improve the exercise capacity of patients with pulmonary arterial hypertension, anticipated results from a Phase 3 study showed.

Drugs 312
article thumbnail

Computational chemistry helps in prediction of toxic behavior of Nitrosamine for drug safety: Experts

AuroBlog - Aurous Healthcare Clinical Trials blog

Computational chemistry is today very much required for pharmaceutical compliance including prediction of toxic behaviour of nitrosamine for drug safety, according to experts. Identification and determination of toxic behaviour of a molecule is one of the most difficult challenges faced in ensuring drug safety.

article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

article thumbnail

Activist Judy Heumann led a reimagining of what it means to be disabled

NPR Health - Shots

Heumann was instrumental in pushing to expand the civil rights of Americans with disabilities and continued to advocate for disability rights around the globe. She died on Saturday at age 75.

145
145
article thumbnail

US FDA approves Pfizer’s migraine nasal spray Zavzpret

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Pfizer ’s Zavzpret (zavegepant) for the acute treatment of migraine in adult patients with or without aura. Zavzpret is claimed to be the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray approved to treat migraine. It is a third-generation, selective and structurally unique, small molecule CGRP receptor antagonist and is currently under clinical development with oral and intranasal formulation

article thumbnail

Adaptimmune acquires struggling cell therapy rival following layoffs

Bio Pharma Dive

The planned merger between Adaptimmune and TCR2 will extend their cash runway by two years, as a biotech downturn continues to pressure companies.

299
299
article thumbnail

Health ministry to rope in state governments to establish medical devices testing laboratories

AuroBlog - Aurous Healthcare Clinical Trials blog

The ministry of health and family welfare (MoHFW) is planning to rope in state governments also to establish or designate their existing laboratories as state medical devices testing laboratories and bring in enabling rules to support setting up of more testing laboratories for medical devices across the country as the sector is experiencing major regulatory […]

article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

article thumbnail

Low-dose radiation linked to increased lifetime risk of heart disease

Medical Xpress

Exposure to low doses of ionizing radiation is associated with a modestly increased excess risk of heart disease, finds an analysis of the latest evidence published by The BMJ today.

144
144
article thumbnail

Cell One and CBM partner for cell and gene therapies

Pharmaceutical Technology

Cell One Partners has announced a strategic collaboration with the Center for Breakthrough Medicines (CBM) to expedite the development and commercialisation of cell and gene therapies. Cell One Partners offers virtual company creation and management to its clients for complete aspects of the development and commercialisation of drugs. The collaboration combines the virtual executive leadership and programme management of Cell One Partners with the technologies, capabilities, and capacity of CBM

article thumbnail

Voyager licenses gene therapy tools to Novartis

Bio Pharma Dive

The Swiss drugmaker's decision is the latest in a string of partnership announcements for the gene therapy maker, which aims to bounce back from past research failures.

article thumbnail

CRAMS and dossier submission put Indian pharma on the global market spotlight: Suresh Khanna

AuroBlog - Aurous Healthcare Clinical Trials blog

Indian pharma’s mainstay in the areas of CRAMS (contract research and manufacturing services), product development, regulatory protocol adherence, and dossiers submissions in the required CTD (Common Technical Document) format are big growth opportunities, said Suresh Khanna, chairman, Karnataka Drugs and Pharmaceutical Manufacturers Association and designated partner, Dossier Solutions LLP.

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Pfizer CEO Albert Bourla maxed out campaign contributions to Dr. Oz ahead of midterm elections

STAT News

WASHINGTON — Pfizer CEO Albert Bourla made the maximum possible campaign contribution to Mehmet Oz ahead of his failed bid last year to represent Pennsylvania in the U.S. Senate, according to federal campaign finance records. Oz is well-known for spreading medical misinformation , including touting astrology as a legitimate medical tool and the myth that apple juice contains unsafe levels of arsenic — a surprising political ally for Bourla, who runs one of the largest pharmaceutica

article thumbnail

US FDA approves Shorla’s oncology drug for T-cell leukaemia

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Shorla Oncology’s Nelarabine Injection, an oncology drug, to treat T-cell leukaemia, an aggressive blood and bone marrow cancer that progresses quickly. The oncology drug has been approved to treat T-cell Lymphoblastic Lymphoma (T-LBL) and T-cell Acute Lymphoblastic Leukemia (T-ALL).

article thumbnail

Controversial drug for preterm birth to be withdrawn, maker says

Bio Pharma Dive

The decision by Covis Pharma closes a yearslong battle over continued use of Makena, the only treatment available for prevention of early labor.

Drugs 278
article thumbnail

SEC recommends permission for Roche’s ophthalmic drug faricimab with local phase III trial waiver

AuroBlog - Aurous Healthcare Clinical Trials blog

The expert committee which advises the drug regulator on clinical trials and drug approvals has recommended for grant of permission for import and marketing of Swiss multinational pharma major Roche’s ophthalmic drug faricimab intravitreal injection in India, with waiver of local phase III clinical trial subject to conditions. The product, faricimab 6mg/0.

Trials 186
article thumbnail

The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.