FDA approves Teva Pharmaceuticals’ AUSTEDO XR for TD and HD chorea
Pharmaceutical Technology
MAY 30, 2024
The US FDA approved Teva Pharmaceuticals’ AUSTEDO XR as a once-daily treatment option for tardive dyskinesia and Huntington’s disease chorea.
Thu.May 30, 2024
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CinCor’s ‘hub-and-spoke’ parent nabs new funding to build its next biotechs
Bio Pharma Dive
MAY 30, 2024
The $73 million round for CinRx Pharma, which created a startup AstraZeneca bought last year, will help fund subsidiaries making drugs for obesity, irritable bowel syndrome and gastroparesis.
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DoP launches portal and constitutes ICPMR for implementation of R&D policy
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 30, 2024
The Department of Pharmaceuticals (DoP) has said that it has developed a portal for monitoring the implementation of the research and development (R&D) policy and has constituted the Indian Council for Pharmaceuticals and Medtech Research and Development (ICPMR), as envisaged in the National Policy on Research and Development and Innovation in the Pharma-Medtech Sector in […]
Immunovant changes up plans for closely watched autoimmune drugs
Bio Pharma Dive
MAY 30, 2024
The company is prioritizing development of an earlier so-called FcRn inhibitor, a type of medicine that’s shown promise treating multiple inflammatory conditions.
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
Mysterious Viral DNA in Human Genome Linked With Psychiatric Disorders
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 30, 2024
Around 8% of human DNA is made up of genetic sequences acquired from ancient viruses. These sequences, known as human endogenous retroviruses (or Hervs), date back hundreds of thousands to millions of years – with some even predating the emergence of Homo sapiens.
Otsuka defies digital health downturn with new company
Bio Pharma Dive
MAY 30, 2024
With “no playbook out there” to fall back on, the new company is taking a long-term approach as it develops its portfolio, an Otsuka Precision Health exec told MedTech Dive.
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COVID-19 vaccinations now ‘alarmingly low’ in Europe
pharmaphorum
MAY 30, 2024
COVID-19 vaccination rates have fallen precipitously in Europe and should be ramped up this autumn so they are at least in line with influenza vaccine uptake.
Agios sells vorasidenib US royalties for $905m
Pharmaceutical Technology
MAY 30, 2024
Royalty Pharma will receive 15% on US sales of vorasidenib, up to $1bn, and at a 12% rate beyond that.
BioNTech, flush with $145M from CEPI, looks to expand mRNA vaccine production in Africa
Fierce Pharma
MAY 30, 2024
As various efforts to produce next-generation vaccines in Africa are being carried forward by the likes of the World Health Organization (WHO) and the Bill & Melinda Gates Foundation, BioNTech | Under an expansion of the partners’ existing deal, the Coalition for Epidemic Preparedness Innovations (CEPI) is committing up to $145 million to bolster BioNTech’s efforts to establish vaccine R&D and manufacturing capabilities at the German company’s facility in Kigali, Rwanda.
Interview: Has Cybin hit the biggest breakthrough in 40 years to treat psychiatric disorders?
Outsourcing Pharma
MAY 30, 2024
In an intriguing interview with Cybinâs CEO, Doug Drysdale, OSP senior editor, Liza Laws found out how second-generation psychedelics could be the biggest breakthrough in psychiatry in 40 years.
CSL Seqirus scores 4th award from US government for bird flu pandemic preparedness
Fierce Pharma
MAY 30, 2024
The United States Department of Health and Human Services has expanded its avian flu pandemic preparedness partnership with CSL Seqirus, lining up the vaccine specialist to
Gilead urged to improve access to HIV drug by public figures and celebrities
Pharmaceutical Technology
MAY 30, 2024
Several personalities, including a Nobel-winning scientist who helped discover HIV, have written to Gilead in an open letter about fairer access to Sunlenca.
Gilead's Trodelvy suffers double whammy as failed bladder cancer trial raises flag over early deaths
Fierce Pharma
MAY 30, 2024
In the span of half a year, Gilead Sciences' Trodelvy has flopped a second phase 3 trial. | Following a high-profile lung cancer setback in January, Gilead said Thursday that Trodelvy also failed to move the needle in a bladder cancer study. The flop threatens the ADC's accelerated approval in the tumor type.
Sanofi completes the $1.7bn acquisition of Inhibrx
Pharmaceutical Technology
MAY 30, 2024
With the completed acquisition, Sanofi will gain access to SAR447537, Inhibrx’s human recombinant protein in development for AATD.
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
Bristol Myers secures another FDA go-ahead for Breyanzi, this time in mantle cell lymphoma
Fierce Pharma
MAY 30, 2024
In the years since gaining an initial FDA approval for Breyanzi, Bristol Myers Squibb has worked hard to expand the reach of its cell therapy. | In the years since gaining an initial FDA approval for Breyanzi, Bristol Myers Squibb has worked hard to expand the reach of its cell therapy. For the third time in as many months, those efforts have yielded a label expansion at the FDA.
How cell and gene therapy are evolving
Pharmaceutical Technology
MAY 30, 2024
The cell and gene therapy market is accelerating in its evolution, as well as commercial approvals, with new therapeutic options for patients
NHS announces hospitals will roll out ‘Martha’s Rule’ as part of patient safety initiative
Pharma Times
MAY 30, 2024
The first phase of the programme will be in place in hospitals across the UK by March 2025
Ikena further sheds staff and pipeline in bid to maximise value
Pharmaceutical Technology
MAY 30, 2024
The company has fired 53% of its workforce and is shutting down the development of a Phase I pipeline candidate.
Verona's ensifentrine will be a 'paradigm shift in COPD treatment,' GlobalData says
Fierce Pharma
MAY 30, 2024
With a target date for FDA approval less than a month away, Sanofi and Regeneron’s megablockbuster Dupixent has gained much attention as it is on the verge of becoming the first biologic to treat c | With Verona Pharmaceuticals' COPD candidate ensifentrine approaching its FDA decision date, GlobalData has referred to it as a “paradigm shift in COPD treatment.
AIFA’s horizon scanning 2024 predictions suggest an influx of ATMPs
Pharmaceutical Technology
MAY 30, 2024
In May 2024, Italy’s medicines agency AIFA published a strategic overview, detailing all new active substances that are potentially advancing towards EU marketing authorisation.
Short reads, big impact: How genomics is revolutionising cancer research
pharmaphorum
MAY 30, 2024
Discover how genomics is transforming cancer research through the study of DNA, RNA, and ctDNA. Learn about the latest breakthroughs in the field in this insightful short read.
BIOSECURE “grandfather” amendment softens impact of US-China trade ban
Pharmaceutical Technology
MAY 30, 2024
The US BIOSECURE bill aims to prevent US companies from working with Chinese biotechs, but is softened with a "grandfather" clause.
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.
Researchers identify genetic changes responsible for rare childhood immune disorders
Pharma Times
MAY 30, 2024
Affecting the immune system, various forms of SCID are estimated to affect one in 75,000 to 100,000 newborns
MSD agrees to acquire EyeBio for up to $3bn
Pharmaceutical Technology
MAY 30, 2024
MSD has announced a definitive agreement to acquire EyeBio, through a subsidiary, for a total of up to $3bn.
Who decides whether you get into a clinical trial?
Antidote
MAY 30, 2024
One may choose to participate in a clinical trial for many reasons. Volunteering often has multiple benefits, from advancing medical research to gaining access to cutting-edge medical care. However, deciding to enroll in a clinical trial is only one part of the process.
Untapped opportunities: Fulfilling the promise of decentralized clinical trials
Pharmaceutical Technology
MAY 30, 2024
Decentralized clinical trials are driving new complexities in data collection. The right solutions provider can make all the difference.
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
US Congress passes bill to end Parkinson’s disease
pharmaphorum
MAY 30, 2024
The US Congress has passed the first-ever federal bill dedicated to ending Parkinson’s disease, modelled on similar legislation for Alzheimer’s enacted in 2011
EC grants orphan medicinal product status to Rocket’s RP-A601
Pharmaceutical Technology
MAY 30, 2024
The EC has granted orphan medicinal product designation for Rocket Pharmaceuticals’ RP-A601 for PKP-2 related arrhythmogenic cardiomyopathy.
May 30, 2024: Workshop Materials Now Available From ‘Patient-Centered Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials’
Rethinking Clinical Trials
MAY 30, 2024
Complete materials are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Patient-Centered Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials.” The 1-day workshop, held on May 19 at the 45th annual Society for Clinical Trials meeting in Boston, introduced concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems.
Merck agrees to acquire EyeBio for up to $3bn
Pharmaceutical Technology
MAY 30, 2024
Merck has announced a definitive agreement to acquire EyeBio, through a subsidiary, for a total of up to $3bn.
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.
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