Thu.Oct 27, 2022

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An unusual alliance opens a gene and cell therapy hub outside Boston

Bio Pharma Dive

Landmark Bio, armed with $75 million and a wide range of backers, is the latest company to emerge with plans to open a “bottleneck” slowing development of the complex medicines.

Gene 331
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What does Biden’s directive on foreign biotech investments mean for manufacturers?

Pharmaceutical Technology

The increasing regulation of biotech and manufacturing deals in the US could prompt foreign companies such as Chinese contract development and manufacturing organisations (CDMOs) to seek alternative targets in Europe or elsewhere. On 15 September, US President Joe Biden signed an executive order that targets foreign investments in US biotech, artificial intelligence (AI), semiconductors and other sensitive technologies.

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BioMarin to face FDA advisers before approval decision on hemophilia gene therapy

Bio Pharma Dive

Though the panel represents a new regulatory hurdle for Roctavian, BioMarin’s research head said the company has been preparing for such a meeting “over the last few months.

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Does Faking a Smile Make You Happier? The Latest Findings Are In

AuroBlog - Aurous Healthcare Clinical Trials blog

Does faking a smile make you feel happier? That question has been debated since famed naturalist Charles Darwin published a book on the subject in 1872. “The free expression by outward signs of an emotion intensifies it… Even the simulation of an emotion tends to arouse it in our minds,” Darwin wrote. Popular culture has […].

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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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GSK shelves filing plans for arthritis drug after trial results

Bio Pharma Dive

GSK said the drug, formerly a top prospect licensed from German biotech Morphosys, showed “limited efficacy” in a Phase 3 study of patients with rheumatoid arthritis.

Drugs 200
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AI medtech platform is aiming to tackle drug-resistant pathogens

Pharmaceutical Technology

Belfast startup AMPLY has raised £900,000 to develop a range of new products that hopes to tackle multi-drug resistent pathogens using its artificial intelligence (AI) drug discovery platform. It hopes to ensure new strains of antibiotics can still tackle global threat diseases, despite antimicrobial resistance. Antimicrobial resistance is when bacteria and viruses become resistant to medication, making previous treatments ineffective.

Drugs 147

More Trending

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Indian Ayurveda propels growth with strong industry norms & high herb quality claims: Dr. Rangesh Paramesh

AuroBlog - Aurous Healthcare Clinical Trials blog

Indian Ayurveda propels its growth supported by the industry guidelines of Good Agricultural and Collection Practice (GACP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP), said Dr. Rangesh Paramesh, director – Intellectual Property, Himalaya Wellness Company. Delving on the topic ‘Key Drivers Determining the Future of the Ayurvedic Drug and […].

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Merck reveals chairman succession as earnings beat forecasts

Bio Pharma Dive

CEO Robert Davis will take over leadership of the board from Ken Frazier on Dec. 1, one and a half years after being named the company’s chief executive.

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FDA accepts Seres’ rCDI therapeutic BLA for priority review

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted Seres Therapeutics’ Biologics License Application (BLA) for SER-109 to prevent recurrent C. difficile infection (rCDI) for priority review. A decision from the regulatory agency on approval for the therapy is anticipated on 26 April next year. Additionally, the FDA said that it is not presently planning to organise an Advisory Committee Meeting to discuss the BLA for SER-109.

Trials 130
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Grand Rounds October 21, 2022: Disinformation, Cyberthreat, and Choice: Protecting Patients and Clinical Research From the Digital Triple Threat (Eric Perakslis, PhD; Andrea Downing)

Rethinking Clinical Trials

? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?. Speakers. Eric Perakslis, PhD. Chief Science & Digital Officer. Duke Clinical Research Institute. Professor, Department of Population Health Sciences. Chief Research Technology Strategist. Duke University School of Medicine . Andrea Downing. ePatient and Security Researcher.

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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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Bayer’s CKD and type 2 diabetes therapy gets Health Canada approval

Pharmaceutical Technology

Bayer has received approval from Health Canada for finerenone as an adjunct to standard-of-care treatment for chronic kidney disease (CKD) and type 2 diabetes (T2D) in adult patients. The treatment is indicated to lower the end-stage kidney disease risk, and a sustained decline in cardiovascular mortality estimated glomerular filtration rate, non-fatal myocardial infarction and hospital admission for heart failure.

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At 18 weeks pregnant, she faced an immense decision with just days to make it

NPR Health - Shots

About halfway into her pregnancy, Karla found out her fetus had a severe genetic anomaly. As she grappled with an uncertain prognosis, she was up against North Carolina's 20-week abortion limit.

Genetics 121
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Candel and the University of Pennsylvania to assess solid tumour therapies

Pharmaceutical Technology

Candel Therapeutics has entered a partnership with the University of Pennsylvania (Penn) in the US to assess the effect of new viral immunotherapies to enhance the impacts of the latter’s CAR-T cell therapies in solid tumour models. The immunotherapies are based on the enLIGHTEN Discovery Platform of Candel. Herpes simplex virus (HSV) vectors with chosen transgenes based on the platform will be analysed along with investigational CAR-T cell therapies in tumour models.

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Birds fall to Earth from Delhi's toxic skies. Two brothers are there to save them

NPR Health - Shots

Named the best documentary at Sundance and Cannes, All That Breathes explores the mission of two Muslim brothers: saving a raptor cut down by smog and deadly kite strings.

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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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Opinion: Kids with cancer deserve more than a cure

STAT News

As an oncologist and a leader at a national cancer organization, I’ve watched countless families celebrate the incredible news that their child has defeated a pediatric cancer. But I often don’t have the heart — at least not right away — to tell them what’s coming next: a lifetime of doctor’s visits, health issues, and stress, much of it related to the treatments that were used to ensure their child’s survival.

Doctors 119
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Concussion protocols are based on research of mostly men. What about women?

NPR Health - Shots

Some concussion experts hope that a major meeting in Amsterdam could lead to a consensus statement that could improve research on how concussions impact women.

Research 118
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STAT+: Drugmaker raises the price of an old chemo medicine tenfold amid persistent shortages

STAT News

Amid sporadic shortages of a drug that is essential in preparing patients for lifesaving, cancer-fighting treatments, one manufacturer has returned to the market — but is selling its medicine for 10 to 20 times the prices offered by the only other companies with available supplies. Over the past week, Areva Pharmaceuticals began marketing vials of fludarabine at a wholesale price of $2,736, a much steeper cost than the $272 charged for the same dosage by Fresenius Kabi and the $109 price

Medicine 111
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FDA Adds Additional Q&As in the Final CMC Postapproval Changes Guidance

FDA Law Blog

By Holly N. Brevig, Senior Regulatory Device and Biologics Exper & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — FDA recently published the final guidance document “ Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.” This final guidance provides recommendations to original applicants and holders of approved applications for human drugs and certain biological products on implementing chemi

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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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STAT+: A new suite of RNA-sensing tools could help scientists target cancerous cells, and much more

STAT News

Sure, you’ve heard of CRISPR. But it’s 2022. The acronym you need to know now is ADARs. That stands for “adenosine deaminases acting on RNA.” Catchy it may not be. But this RNA-editing class of proteins, made by all multicellular organisms, is starting to have its moment in the bioengineering sun.

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Deep Dive: Patients and Partnerships 2022

pharmaphorum

The concept of patient centricity has been a key talking point across the healthcare ecosystem for years. Having recognised the tangible benefits that their unique insights and experiences can bring to the table, decision-makers are increasingly seeking new opportunities to partner with patients across a product’s lifecycle. However, fostering lasting and meaningful partnerships is not a simple task for life science companies.

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‘If I were a hospital, I’d be reading the tea leaves’: Pressures grow on the health care industry to reduce its climate pollution

STAT News

Flooding, heat waves, wildfires, and other climate-driven weather extremes in recent years have catapulted hospitals into emergency mode and devastated the communities they serve, with Hurricane Ian’s deadly rampage through central Florida only the most recent example.  But while hospitals might seem to be the unwitting victims of climate disasters, the U.S. health care system — and hospitals in particular — shoulder a good deal of the blame.

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UK lags behind other nations in research and development

Pharma Times

UK only places 11th in terms of total R&D investment as a percentage of GDP

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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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Opinion: Allocate opioid settlement dollars to real addiction-ending solutions

STAT News

The crisis of opioid overdose deaths that sparked the multitude of lawsuits leading to a historic settlement continues to rage, with overdose deaths at an all-time high despite heightened national awareness and more resources than ever dedicated to treatment and overdose prevention. The persistence of this crisis underscores the dire need for well-informed and sustainable solutions that work — and funding for them.

Drugs 105
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In Knoxville, the burden of medical debt reinforces a long history of segregation

NPR Health - Shots

Black communities in the U.S. suffer disproportionately from health care debt. The reasons go back to segregation and a history of racist policies that have limited Black wealth.

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Montana may be moving away from its innovative plan for setting hospital prices for public workers

STAT News

Montana is signaling it might step away from an innovative way of setting the prices its public employee health plan pays hospitals for services, an approach that has saved the state millions of dollars and become a model for health plans nationwide. The plan gained national renown among employers and health care price reform advocates when, in 2016, it established maximum amounts the health plan would pay for all inpatient and outpatient services.

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Stem cell rejuvenation startup secures investment 

Drug Discovery World

Biotech company Mogling Bio has successfully has completed its first seed investment round with a sole investor, Kizoo Technology Capital. Mogling Bio is developing new pharmacological approaches to rejuvenate old stem cells of the hematopoietic (blood cell formation) system. Ageing causes stem cells to lose their normal structure by increased activity of the protein CDC42. [.].

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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.

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Listen: Anti-science at the polls, a biotech odd couple, & the stakes of the midterms

STAT News

Can Covid denialism get you elected? How is the music business like biotech investing? And what’s at stake for science in the midterms? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Sarah Owermohle joins us to discuss how pandemic shutdowns, Covid-19 vaccines, and the prospect of arresting Anthony Fauci have become campaign rallying cries in midterm elections.

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Santhera seeks speedy FDA review of Duchenne drug vamorolone

pharmaphorum

Santhera has completed a rolling application for its Duchenne muscular dystrophy (DMD) therapy vamorolone in the US, setting up a possible approval and launch in the latter half of 2023. The Swiss biotech is seeking a priority review for vamorolone, which was licensed from US biotech ReveraGen BioPharma in 2020 after Santhera its former DMD therapy candidate idebenone failed clinical testing and was abandoned.

Drugs 95
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STAT+: Pharmalittle: Italy probes Pfizer over profit transfers; FDA postpones meeting for OTC birth control pill

STAT News

Rise and shine, another busy day is on the way. However, this is also shaping up as a beautiful day as well, given the clear and sunny skies — and delicious breezes — enveloping the Pharmalot campus this morning. This calls for celebration with a cup of stimulation, and we are opening a new package of Pumpkin Spice for the occasion. Autumn, after all, is in full swing.

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New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry

pharmaphorum

On 28 September 2022, the international and European self-regulatory bodies for the research-based pharmaceutical industry ( IFPMA , the International Federation of Pharmaceutical Manufacturers and Associations, and EFPIA , the European Federation of Pharmaceutical Industries and Associations) published a Note for Guidance to assist member companies with their use of social media and digital channels and to help ensure they stay within the regulations on promotion of medicines to the public.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.