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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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.
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.
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.
Lilly’s EBGLYSS gains FDA approval for patients aged 12 and older
Pharmaceutical Technology
SEPTEMBER 16, 2024
Eli Lilly and Company has announced the FDA approval of EBGLYSS for treating atopic dermatitis in adults and children over 12.
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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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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?
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.
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.
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.
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
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.
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?
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.
Lilly's immunology unit scores another FDA nod with eczema treatment Ebglyss
Fierce Pharma
SEPTEMBER 16, 2024
Three years after establishing an immunology unit, Eli Lilly has gained its third FDA approval in the specialty area as the U.S. | Three years after establishing an immunology unit, Eli Lilly has gained its third FDA approval in the specialty area as the U.S. regulator has signed off on IL-13 inhibitor Ebglyss, or lebrikizumab, to treat atopic dermatitis.
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.
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
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.
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
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.
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