10 clinical trials to watch in the first half of 2024
Bio Pharma Dive
JANUARY 2, 2024
A non-addictive pain pill faces its definitive test, while study results in ALS, a rare heart disease and lung cancer could have far-reaching implications.
Tue.Jan 02, 2024
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MRI Machines Are Perfectly Safe. But Never Do The Following Things.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 2, 2024
A 57-year-old woman from Wisconsin recently sustained a rather unfortunate injury to her buttock. She had attended the hospital for an MRI ( magnetic resonance imaging) scan and had entered the machine with a concealed firearm. The machine’s powerful magnet caused the gun to discharge.
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FDA ends busy year with three drug rejections
Bio Pharma Dive
JANUARY 2, 2024
Amgen had its bid for full approval of the cancer drug Lumakras turned back by the agency, which also issued complete response letters to Zealand Pharma and Merck & Co. in December.
Age-related macular degeneration market expected to reach $27.5bn across 7MM by 2031
Pharmaceutical Technology
JANUARY 2, 2024
The age-related macular degeneration (AMD) market is expected to grow at a compound annual growth rate of 14.1% throughout the forecast period (2021-2031), reaching $27.5bn across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) according to GlobalData’s report: Age-Related Macular Degeneration: Seven-Market Drug Forecast and Market Analysis - Update.
Tome acquires startup Replace, gaining new genome editing tools
Bio Pharma Dive
JANUARY 2, 2024
The deal is the second startup sale engineered by University of California, Berkeley scientist Shakked Halperin, and gives Tome a way to insert or delete small DNA sequences into the genome.
Truth or Myth: How Accurate Are Home DNA Test Kits?
Pharma Mirror
JANUARY 2, 2024
The popularity of at-home DNA testing is soaring in popularity and uses. When someone seeks information about paternity or genetic diseases without visiting a doctor’s chamber or laboratory, the best alternative is the at-home DNA test kit. Unless and until the paternity tests are not for legal cases, at-home test kits are an ideal choice. The question which concerns everyone is, ‘are home DNA test kits accurate?’.
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January 2, 2023: NINR Announces Funding Opportunity to Address Social Needs Through Healthcare-Community Partnerships
Rethinking Clinical Trials
JANUARY 2, 2024
The National Institute of Nursing Research (NINR) has published a funding opportunity for research to develop and expand interventions and programs that leverage existing or create new healthcare-community partnerships to address unmet social needs among individuals and families and adverse social determinants of health within communities—especially in populations that experience health disparities.
TMC and IDRS Labs introduce oral therapy for leukaemia in India
Pharmaceutical Technology
JANUARY 2, 2024
Experts from Tata Memorial Hospital and ACTREC have partnered with IDRS Labs to develop an oral suspension of 6-mercaptopurine for leukaemia.
NPPA expert committee recommends retail prices for 24 anti-diabetic drug formulations
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 2, 2024
The expert committee of the National Pharmaceutical Pricing Authority (NPPA) has recommended retail prices of 24 anti-diabetes drug combinations with components sitagliptin and dapagliflozin, which lost their exclusive patent rights for marketing in the country in recent years, as ingredients.
Gout market growth driven by entrance of novel ULTs in 2022-2032
Pharmaceutical Technology
JANUARY 2, 2024
According to GlobalData’s report, Gout: Opportunity Analysis and Forecast, the gout market is expected to see significant growth during the 2022-2032 forecast period.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Millions of doses of Pfizer's Paxlovid will go to waste in UK, EU as COVID demand plummets
Fierce Pharma
JANUARY 2, 2024
On the heels of a major Paxlovid inventory write-off in the United States, many more doses of Pfizer's COVID-fighting antiviral are going to waste overseas. | At the end of November, more than 1.5 million courses of Pfizer’s Paxlovid had expired unused in European countries, analysts at Airfinity said in a new report. The total tally of expired doses in Europe is expected to hit 3.1 million by the end of next month, representing a value of $2.2 billion.
PYC Therapeutics and Google Cloud partner for new precision medicines
Pharmaceutical Technology
JANUARY 2, 2024
PYC Therapeutics has announced plans to enter a collaboration with Google Cloud for the development of new precision medicines.
Filsuvez Topical Gel Gets FDA Approval for Epidermolysis Bullosa
XTalks
JANUARY 2, 2024
Chiesi Global Rare Diseases, a specialized division within the Chiesi Group dedicated to pioneering therapies for individuals affected by rare diseases, has received approval from the US Food and Drug Administration (FDA) for Filsuvez (birch triterpenes) topical gel. This achievement paves the way for the treatment of partial thickness wounds in patients aged six months and older diagnosed with junctional epidermolysis bullosa (JEB) and dystrophic epidermolysis bullosa (DEB).
Valneva adjusts 2023 financial guidance after priority voucher sale delay
Pharmaceutical Technology
JANUARY 2, 2024
Valneva’s CFO said the company is waiting to sell the voucher, which it received upon approval of its chikungunya vaccine, for €90m-€110m.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Bristol Myers Squibb buys Karuna Therapeutics for $14 billion in a deal that includes schizophrenia treatment
Outsourcing Pharma
JANUARY 2, 2024
Bristol Myers Squibb has announced it has acquired Karuna Therapeutics, Inc., for a total equity value of $14 billion or $12.7 billion net of estimated cash acquired.
China NMPA approves AstraZeneca-Sanofi’s RSV antibody for infants
Pharmaceutical Technology
JANUARY 2, 2024
The Chinese NMPA approved AstraZeneca and Sanofi’s Beyfortus to prevent respiratory syncytial virus (RSV) in neonates and infants.
Talk of the Towne episode 09: BrightFocus Foundation
Antidote
JANUARY 2, 2024
The latest episode of Antidote’s quarterly podcast series Talk of the Towne is available now! Talk of the Towne is focused on bridging the gap between clinical discussion and patient centricity, hosted by Antidote’s Senior Clinical Informatics Manager, Dr. Richard Towne, PharmD.
Apollo secures funds to advance pipeline programmes
Pharmaceutical Technology
JANUARY 2, 2024
Apollo Therapeutics has secured a further $33.5m in a second round of its Series C funding to advance its pipeline programmes.
The New Age of Decentralized Clinical Trials
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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.
Inside AbbVie's $10B buyout of ImmunoGen—and the bidding war it swooped in on
Fierce Pharma
JANUARY 2, 2024
AbbVie is entering 2024 with a foothold in the antibody-drug conjugate (ADC) field thanks to its late-2023 buyout of ImmunoGen worth more than $10 billion. | According to a recent securities filing, AbbVie only entered the ImmunoGen bidding war after other buyout interest led the ADC specialist to widen its pool of potential purchasers. When it came down to the final three players, AbbVie's offer blew the others out of the water.
ImmunityBio inks $320m deal to advance bladder cancer drug and boost pipeline
Pharmaceutical Technology
JANUARY 2, 2024
The deal will see ImmunityBio receiving an upfront $210m combination of equity and royalty financing from Oberland.
Verona cuts $400m loan deal as it preps COPD drug for market
pharmaphorum
JANUARY 2, 2024
Verona Pharma has agreed a new $400 million debt facility with Oxford Finance and Hercules Capital designed to help the company navigate the possible approval and launch of ensifentrine, its therapy for chronic obstructive pulmonary disease (COPD). The Anglo-US company has already tapped $50 million of the funding and can take another $100 million if an ongoing review of ensifentrine by the US FDA results in regulatory approval.
TiumBio raises $12m to advance clinical pipeline development
Pharmaceutical Technology
JANUARY 2, 2024
South Korea-based TiumBio plans to use the funds to advance the development of endometriosis therapy, merigolix.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
Beacon of hope for IgA nephropathy community as full approval granted to Tarpeyo
Outsourcing Pharma
JANUARY 2, 2024
The US Food and Drink Administration (FDA) has approved Calliditas Therapeutics' Tarpeyo (budesonide) delayed-release capsules to reduce the loss of kidney function in adults with IgAN.
AstraZeneca Reaches Agreement to Acquire Cell Therapy Specialist Gracell Biotechnologies
Pharmaceutical Commerce
JANUARY 2, 2024
Agreement includes novel cell therapy for hematology that has the opportunity to bring a potential best-in-class treatment to patients with blood cancers.
KCLA to host Q&A to dispel ketamine myths following Friends actor Matthew Perry's death
Outsourcing Pharma
JANUARY 2, 2024
A Los Angeles clinic is holding a free webinar covering the facts and myths about ketamine following the death of late actor, Matthew Perry.
AstraZeneca, Sanofi win nod in China for RSV antibody Beyfortus
Fierce Pharma
JANUARY 2, 2024
AstraZeneca and Sanofi have scored first in | AstraZeneca and Sanofi have scored first in China with an approval for their respiratory syncytial virus (RSV) immunization Beyfortus for infants, with the companies expecting the shot to be available there for the 2024-25 season. Beyfortus is the only immunization approved for babies entering their first RSV season to protect them against lower respiratory tract infection.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Digital training programme improves quality of life for dementia patients living in care
Pharma Times
JANUARY 2, 2024
The programme is the only remote, digital delivery nursing home training programme for dementia
Interview: The major changes AI will bring to the clinical landsacpe in 2024
Outsourcing Pharma
JANUARY 2, 2024
Over the last year, weâve seen how rapid technology adoption, namely AI, can impact clinical trials.
Novo Nordisk will open AI hub in London
pharmaphorum
JANUARY 2, 2024
Novo Nordisk is planning to open an AI research facility in London, UK, as part of a drive to place the technology at the heart of its drug discovery operations
Nearly three million people received urgent NHS cancer checks in 2023
Pharma Times
JANUARY 2, 2024
The number of people getting tested over the last decade has increased by 133%
Accelerating Clinical Supply Through Integrated Drug Development
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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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