After the Lykos debacle, what’s next for psychedelic therapies?
Pharmaceutical Technology
SEPTEMBER 16, 2024
While Lykos Therapeutics’ MDMA therapy was rejected by the FDA, psychedelic therapy advocates remain optimistic about the sector.
Mon.Sep 16, 2024
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As Biosecure bill advances, drugmakers prepare for prospect of China pivot
Bio Pharma Dive
SEPTEMBER 16, 2024
Legislation that passed the House of Representatives passed the Biosecure Act last week would forced U.S. biotechs to cut ties with five Chinese contract partners.
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Boehringer seeks approval for lung fibrosis drug following Phase III win
Pharmaceutical Technology
SEPTEMBER 16, 2024
The Phase III trial evaluating nerandomilast as a treatment for idiopathic pulmonary fibrosis met its primary endpoint.
This Drug Shows Potential to Stop Migraines Before They Begin
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 16, 2024
(Francesco Carta Fotografo/Moment/Getty Images) Migraines and headaches affect billions of people worldwide, and a new study suggests the drug ubrogepant can put a stop to the pain even before a migraine has fully kicked in.
Bridging Innovation & Patient Care: The Growing Role of AI
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
FDA approves Roche’s Ocrevus Zunovo with Halozyme Enhanze delivery tech
Pharmaceutical Technology
SEPTEMBER 16, 2024
Roche has secured approval from the US Food and Drug Administration for Ocrevus Zunovo with Halozyme's Enhanze drug delivery technology.
Bridging science and humanity: How systems thinking should shape clinical trial execution
Bio Pharma Dive
SEPTEMBER 16, 2024
Applying a systems thinking approach can create improvements in scientific integrity, operational feasibility and scalability.
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ESMO24: A cancer cachexia drug, VEGF enthusiasm and immunotherapy’s survival impact
Bio Pharma Dive
SEPTEMBER 16, 2024
Results for Pfizer’s ponsegromab looked promising, while BioNTech and Instil Bio capitalized on momentum surrounding a kind of bispecific antibody.
NITI Aayog’s Expert Group recommends CDSCO to be made an independent regulatory authority
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 16, 2024
An expert group constituted by NITI Aayog to prepare a framework for action for emergency response and preparedness to address future pandemic, has recommended making the Central Drugs Standard Control Organisation (CDSCO) an independent regulatory authority.
Generative AI can enhance pharmaceutical innovation – but are you ready for it?
Bio Pharma Dive
SEPTEMBER 16, 2024
There’s no doubt that AI and GenAI can speed up pharmaceutical innovation. But before organizations can jump into the future, it’s crucial to understand the benefits – and the risks – of advanced technology.
September 16, 2024: Researchers Examine Feasibility of Enhanced TSOS Intervention for Trauma Survivors in Australia
Rethinking Clinical Trials
SEPTEMBER 16, 2024
Researchers in Australia examined the feasibility of implementing an enhanced version of the TSOS collaborative care intervention for patients at risk of persistent posttraumatic stress disorder (PTSD) and pain symptoms after major traumatic injury. They found the intervention was highly valued by most participants and could be implemented at low cost in the trauma system in Victoria, Australia.
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
Kyverna swaps CEOs, leaning on Kite veterans to lead ‘next chapter’
Bio Pharma Dive
SEPTEMBER 16, 2024
Warner Biddle and Christi Shaw, two prominent former executives at Gilead’s CAR-T division, will try to turn around an autoimmune cell therapy developer that’s lost most of its value since raising $319 million in a February IPO.
WHO adds first mpox vaccine to prequalification list
Pharma Times
SEPTEMBER 16, 2024
The decision is expected to facilitate timely access to Bavarian Nordic’s Imvanex
Sanofi readies to meet US demand for RSV antibody
Bio Pharma Dive
SEPTEMBER 16, 2024
With a new production line, Sanofi aims to keep it and partner AstraZeneca’s drug Beyfortus in fully supply this RSV season.
ESMO 2024: Keytruda is key to first-line treatment of HER2+ mGEJ adenocarcinoma
Pharmaceutical Technology
SEPTEMBER 16, 2024
Despite positive KEYNOTE-811 results, Merck & Co’s position in this setting is not devoid of threats from other competitors.
Easy GxP compliance for NGS data – is it even possible?
Bio Pharma Dive
SEPTEMBER 16, 2024
NGS is changing the landscape for GxP compliance. How can you adapt?
Disease modifiers may take over PAH landscape, says Cereno CEO
Pharmaceutical Technology
SEPTEMBER 16, 2024
As more drugs approach late-stage development for PAH, Cereno Scientific’s CEO expects more successful disease-modifying therapies.
Accelerating the new wave of CAR T therapy trials
Bio Pharma Dive
SEPTEMBER 16, 2024
Applying CAR T-cell therapy in new clinical settings presents unique challenges. Worldwide Clinical Trials is at the forefront, partnering with drug development teams to map this new path forward.
Pioneering ePRO and eCOA innovations for next-generation clinical trials
Pharmaceutical Technology
SEPTEMBER 16, 2024
As clinical trials become more complex, the need for innovative solutions to capture patient data accurately and efficiently is more critical than ever.
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
AbbVie faulted for misleading ad featuring Serena Williams
pharmaphorum
SEPTEMBER 16, 2024
FDA raps AbbVie for 'misleading' ad for migraine drug Ubrelvy featuring tennis star Serena Williams
Ipsen shelves Cabometyx combo in prostate cancer after Phase III miss
Pharmaceutical Technology
SEPTEMBER 16, 2024
As Ipsen pivots away from Cabometyx in mCRPC, US rights holder Exelixis will press ahead with a submission to the FDA.
ESMO: Pfizer drug helps cancer patients gain weight
pharmaphorum
SEPTEMBER 16, 2024
Pfizer's anti-GDF-15 antibody ponsegromab was able to achieve weight gain in cancer patients with cachexia in a phase 2 trial presented at ESMO
Regeneron’s Dupixent approved as first adolescent CRSwNP treatment
Pharmaceutical Technology
SEPTEMBER 16, 2024
The FDA has expanded the approval of Dupixent to include adolescents aged 12 to 17 years with inadequately controlled CRSwNP.
How is Parkinson’s disease diagnosed?
Antidote
SEPTEMBER 16, 2024
Receiving a Parkinson’s diagnosis is a life-altering event that nearly 1 million people in the United States have experienced. Parkinson’s disease symptoms can vary from person to person. Receiving a diagnosis often requires several steps. In this blog, we’ll be sharing more details about the disease and discussing opportunities for individuals to get involved in Parkinson’s research.
Minimizing risks in pharmaceutical supply chains: what you need to know
Pharmaceutical Technology
SEPTEMBER 16, 2024
Having a specialty logistics partner that can act as lookout for pharmaceutical manufacturers is critical amid supply chain uncertainty.
ESMO: NIAGARA backs Imfinzi in bladder cancer, but will FDA?
pharmaphorum
SEPTEMBER 16, 2024
AstraZeneca reveals 'practice changing' data for Imfinzi as peri-operative therapy for bladder cancer, but will the FDA accept the study?
China grants BTD to Blenrep with BorDex for multiple myeloma
Pharmaceutical Technology
SEPTEMBER 16, 2024
China’s NMPA granted BTD for Blenrep (belantamab mafodotin) combined with BorDex for the treatment of multiple myeloma.
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.
Changing Faces: Boards of Directors appointments for August 2024
pharmaphorum
SEPTEMBER 16, 2024
Changing Faces: Discover the latest board of directors appointments for Arctoris, BioConnection, Neurocare Group, PureTech Health and more in August 2024. Stay informed and up-to-date with these industry leaders.
Vaxess' Rachel Sha - 'own the seat at the table that you have and have confidence'
BioPharma Reporter
SEPTEMBER 16, 2024
Rachel Sha has had a colorful career not without its challenges, but she urges women in the science industry to have confidence and answer hard questions.
Support app for young cancer patients launches in UK
pharmaphorum
SEPTEMBER 16, 2024
Rates of cancer among people aged 24 and below are rising fast, but health systems are often not catering well enough to the specific needs of this age group.A new partnership has been set up between the Ella Dawson Foundation, a UK-based charity for young people with cancer, and digital cancer care company Careology to try to tackle that deficit and improve their treatment and wellbeing.
Intercept's liver med Ocaliva takes heat at FDA expert meeting, as hopes for full approval dim
Fierce Pharma
SEPTEMBER 16, 2024
Following a meeting with the FDA’s Gastrointestinal Drug Advisory Committee Friday, the future of Intercept’s rare liver disease drug Ocaliva is under serious threat. | Looking to assess whether Ocaliva met its postmarketing requirements after a 2016 accelerated approval in the autoimmune disease primary biliary cholangitis, an FDA council of outside experts nearly unanimously rejected Intercept’s hopes for a full approval.
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
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