Thu.Feb 29, 2024

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India’s Tata Institute develops tablet for cancer recurrence prevention

Pharmaceutical Technology

India’s Tata Institute has developed a tablet combining resveratrol and copper that has the potential to prevent the recurrence of cancer.

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Tiny Doses of LSD Boost Unique Signals in The Human Brain

AuroBlog - Aurous Healthcare Clinical Trials blog

Even small doses of LSD could have therapeutic benefits for mental health and task performance, a new study shows. Researchers from the US and Germany gave 21 adults either a placebo or 13 or 26 micrograms of LSD – small doses that rarely lead to hallucinatory effects.

Research 181
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Lutris wins FDA orphan drug tag for EGFR inhibitor-induced rash candidate

Pharmaceutical Technology

LUT014 is being investigated in an ongoing Phase II trial as a first-line treatment for EGFR inhibitor-induced acneiform rash, for which there is no approved drug.

Drugs 264
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Abingworth invests in Trodelvy development in deal with Gilead

Bio Pharma Dive

The unusual deal will see one of the investment firm’s startups work with Gilead to expand the cancer drug’s label, with Abingworth receiving payment if successful.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Shifting the paradigm – novel approaches to amyotrophic lateral sclerosis therapy

Pharmaceutical Technology

Amyotrophic lateral sclerosis (ALS) is a swiftly advancing, fatal neurodegenerative condition marked by muscle weakness, atrophy, and spasticity.

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Cure Ventures backs a cell therapy startup targeting Parkinson’s

Bio Pharma Dive

The startup, Kenai Therapeutics, has raised $82 million and will be chaired by Jeff Jonas, a new Cure partner and former CEO of Sage Therapeutics.

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CDSCO declares around 5% of drug samples tested in January as NSQs

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has declared almost 5 per cent of the total drug samples it tested during the month of January, 2024 as Not of Standard Quality (NSQ). The number of samples tested, however, has declined during the month compared to the previous months.

Drugs 151
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HHS advocates for health equity through sickle cell initiative

Pharmaceutical Technology

The US HHS Secretary called for state collaboration on a project to improve gene therapy access for sickle cell disease.

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With BlossomHill, former Turning Point execs take aim at cancer, autoimmune disease

Bio Pharma Dive

Less than two years after Bristol Myers bought Turning Point for $4.1 billion, Jean Cui and Peter Li have built a new startup that’s brought in more than $170 million in funding.

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Indena’s CDMO services: Health is a joint project

Pharmaceutical Technology

For Indena, the leading company dedicated to the identification, development and production of high-quality active principles derived from plants, custom services have been a key area of expertise for some time now.

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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

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Scaling innovation across hospitals and nations

pharmaphorum

Explore how innovation in healthcare can be scaled across hospitals and nations, driving transformation through research & development, biotech collaborations, and fostering start-ups in the industry.

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The health risks of ultra-processed foods (UPFs) are worse than we think

Pharmaceutical Technology

Research published by the British Medical Journal on 28 February 2024, has found that ultra-processed foods (UPFs), including cereals, chocolate bars, and ready meals, are linked to 32 negative health outcomes.

Research 130
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With J&J settlement, Biocon Biologics gets a license to challenge Stelara in the US

Fierce Pharma

As Johnson & Johnson's U.S. exclusivity period on its immunology blockbuster Stelara ticks away, another biosimilar player has lined up for the piece of the drug's sales pie. | As Johnson & Johnson's U.S. exclusivity period on Stelara ticks away, another biosimilar player has lined up for the piece of the blockbuster's sales pie.

Licensing 101
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CDMO: Indena’s Long-Term Vision

Pharmaceutical Technology

Indena CDMO origin: Founded in 1921 by Carlo Boccaccio Inverni and Biagio Alberto Della Beffa and headquartered in Milan, Indena…

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Pfizer's Abrysvo maintains strong efficacy through 2nd RSV season, study finds

Fierce Pharma

Pfizer’s respiratory syncytial virus (RSV) vaccine Abrysvo has shown its staying power in older adults who received a single dose before the previous virus season. | Pfizer’s respiratory syncytial virus vaccine Abrysvo has shown its staying power in a trial of patients who received a single dose before the previous virus season. In season two, Abrysvo provided efficacy of 78% against lower respiratory tract disease in adults 60 and older, according to trial results released Thursday.

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MHRA streamlines approval process for established medicines

Pharmaceutical Technology

The UK MHRA has announced new process changes in its latest guidance for enhancing the efficiency of assessing established therapies.

Medicine 130
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In atypical Big Pharma-VC pact, Gilead secures $210M from Abingworth to fund Trodelvy trials

Fierce Pharma

Venture capital firms pitching in on drug development isn’t exactly a new way of doing business for the biopharma industry. | Venture capital firms pitching in on drug development isn’t exactly a new way of doing business for the biopharma industry. But a new funding pact between Carlyle’s Abingworth and Gilead Sciences is somewhat unconventional.

Trials 105
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Obesity cost US businesses $425.5bn in 2023

Pharmaceutical Technology

An Eli Lilly-sponsored GlobalData report finds that obese workers had $6,472 higher annual in medical and economic costs.

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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.

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CoreRx strikes $130M deal to snap up struggling small-molecule specialist Societal CDMO

Fierce Pharma

Several months after Societal CDMO launched a restructuring campaign that led to 26 layoffs, the small molecule contract manufacturer has announced it’s being bought by one of its production peers | Several months after Societal CDMO launched a restructuring campaign that led to 26 layoffs, the small molecule contract manufacturer has announced it’s being bought by one of its production peers in Florida.

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Every Cure receives ARPA-H grant for drug repurposing

Pharmaceutical Technology

Every Cure has received $48.3m contract from the ARPA-H, marking a significant federal investment in drug repurposing.

Drugs 130
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Seizing the moment: The life sciences industry at the threshold of change

pharmaphorum

Explore the impact of the Inflation Reduction Act (IRA) on drug prices and negotiations within the life sciences industry, as it stands on the threshold of change. Gain insights into the potential outcomes and implications of this legislation.

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The state of the diagnostic industry: cautious optimism for the coming years

Pharmaceutical Technology

After a challenging few years post-pandemic, industry professionals believe diagnostic testing is back on track

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Rare Disease Day: Understanding the power of diagnosis and connection

Antidote

Rare Disease Day, typically observed on February 28th, will be celebrated this year on February 29th! Rare Disease Day is an awareness holiday intended to generate change for the 300 million people who are diagnosed with a rare disease worldwide, as well as their families and caregivers.

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The 2024 biopharma M&A landscape: An overview

pharmaphorum

It’s been a couple of months since pharma’s annual JP Morgan Chase Healthcare Conference, where the mood around pharma M&A this year was optimistic, albeit with a few caveats. On today’s podcast, host Jonah Comstock is joined by Cody Powers, principal of portfolio and business development at ZS Associates, to discuss those trends and predictions and how they’re shaking out so far.

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After setting out on its own, Sandoz inks $265M deal to resolve 'legacy' price-fixing lawsuit

Fierce Pharma

Sandoz, after inking a new settlement in a price-fixing case inherited from its former parent Novartis, says it’s taken an encouraging step on its quest to leave “allegations of legacy conduct” in | Sandoz, after inking a new settlement in a price-fixing case inherited from its former parent Novartis, says it’s taken an encouraging step on its quest to leave “allegations of legacy conduct” in the past.

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Palatin pummelled as dry eye therapy underwhelms in phase 3

pharmaphorum

Palatin Technologies’ therapy for dry eye disease (DED) missed its primary endpoints in a phase 3 trial, knocking investor confidence as it tries to chart a way forward.

Trials 107
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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.

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GI-targeted ROCK inhibitor for fibrostenotic Crohn’s disease in phase 1 study

Outsourcing Pharma

Yesterday, (February 28), a clinical-stage biotechnology company, Redx, announced that the first participant has been dosed in a phase 1 clinical trial for RXC008.

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GSK avoids trial with another Zantac settlement in California

Fierce Pharma

For the second time in four weeks, GSK has settled a personal injury lawsuit in California sta | For the second time in four weeks, GSK has settled a personal injury lawsuit in California state court over the heartburn drug Zantac. The company revealed the dismissal of the case and the agreement in a release Thursday.

Trials 100
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Lifebit unlocks the potential of diverse data to accelerate pharmaceutical R&D

Outsourcing Pharma

Lifebit, a progressive biomedical data technology and services company, has reached a huge milestone, boasting a catalog of 100 million patients in its multi-omic and health data repository.

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In U-turn, NICE backs first drug for AL amyloidosis

pharmaphorum

Almost four years after it was approved in Europe to treat the incurable rare disease systemic amyloid light-chain (AL) amyloidosis, Johnson & Johnson’s Darzalex has been given the go-ahead for routine use by the NHS in England and Wales.

Drugs 103
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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.