Drug Channels
SEPTEMBER 6, 2024
Today’s guest post comes from H. John Beardsley, Senior Vice President of Corporate Strategy at CoverMyMeds John discusses how the new maximum fair prices (MFPs) published by the Centers for Medicaid & Medicare Services (CMS) will affect medication affordability, formulary negotiations, evidence-based strategies, and other aspects of the market.
Pharmaceutical Technology
SEPTEMBER 6, 2024
The US FDA has granted orphan drug designation (ODD) to Abdera Therapeutics’ ABD-147 aimed at neuroendocrine carcinoma.
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Bio Pharma Dive
SEPTEMBER 6, 2024
New trial results could offer support for an expansion of Nucala’s label after U.S. regulators rejected GSK’s submission in 2018.
Pharmaceutical Technology
SEPTEMBER 6, 2024
The US FDA has approved Amneal Pharmaceuticals and Shilpa Medicare’s oncology product BORUZU for subcutaneous administration.
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
Bio Pharma Dive
SEPTEMBER 6, 2024
OrsoBio is advancing several weight loss medicines. Elsewhere, Boehringer Ingelheim pushed forward with a geographic atrophy drug and Vaxcyte raised $1.3 billion.
Pharma Times
SEPTEMBER 6, 2024
New treatment could simplify diabetes management for millions
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Fierce Pharma
SEPTEMBER 6, 2024
GSK is heading into the weekend with a win for its respiratory blockbuster Nucala—but for now, the details are slim. | On Friday, GSK said that its IL-5 antibody Nucala plus inhaled maintenance therapy lowered the annualized rate of moderate or severe exacerbations among chronic obstructive pulmonary disease (COPD) patients for up to 2 years. Nucala is already approved in a range of respiratory conditions, but a COPD nod could present another big opportunity for the drug.
Pharmaceutical Technology
SEPTEMBER 6, 2024
The company had focused its resources on Filspari’s launch in IgAN after the US FDA snubbed the therapy in another rare kidney disorder.
Fierce Pharma
SEPTEMBER 6, 2024
Gilead Sciences has been looking for a win for Trodelvy after two surprise trial failures earlier this year. | Gilead Sciences has been looking for a win for Trodelvy after two surprise trial failures earlier this year. But it looks like that win won’t come from a triplet regimen that combines the antibody-drug conjugate with Merck’s Keytruda and chemotherapy in newly diagnosed non-small cell lung cancer.
Pharmaceutical Technology
SEPTEMBER 6, 2024
Biogen plans to apply for regulatory approval of this investigational dose regimen following positive trial data.
Bio Pharma Dive
SEPTEMBER 6, 2024
J&J did not provide Auris Health with resources to achieve regulatory milestones after acquiring the robotics company in 2019, the judge found.
Pharmaceutical Technology
SEPTEMBER 6, 2024
GSK is adding more strings to Nucala’s bow as the drug’s sales continue to grow.
pharmaphorum
SEPTEMBER 6, 2024
Financings in the biotech sector this week include an IPO filing for BioAge and private rounds for eGenesis, Navigator, and Circle Pharma.
Pharmaceutical Technology
SEPTEMBER 6, 2024
A study suggests that children may face a higher risk of harm if their father is using valproate at the time of conception.
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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
pharmaphorum
SEPTEMBER 6, 2024
GSK's severe asthma therapy Nucala could find a new lease of life as a treatment for chronic obstructive pulmonary disease (COPD) after showing a clear benefit in a phase 3 trial.
Pharmaceutical Technology
SEPTEMBER 6, 2024
German life science company Evotec has announced a collaboration with X-Chem to accelerate early-stage drug discovery-leveraging technology.
pharmaphorum
SEPTEMBER 6, 2024
The fallout from the FDA's recent decision not to approve Lykos Therapeutics' psychedelic treatment has spread to its senior management, with chief executive Amy Emerson stepping down.
Pharmaceutical Technology
SEPTEMBER 6, 2024
NImmune Biopharma and BioTherapeutics have partnered to develop new precision medicines in the field of inflammation and immunology.
XTalks
SEPTEMBER 6, 2024
Novartis announced it has broken ground on the construction of two new radioligand therapy manufacturing facilities in the US. The facilities are part of the company’s plans to expand its manufacturing and supply chain capabilities. Novartis is investing $200 million into expanding its Indianapolis, Indiana, site for in-house production of radioisotopes and constructing a brand new one in Carlsbad, California.
pharmaphorum
SEPTEMBER 6, 2024
Eli Lilly signs another genetic medicines deal, this time with Genetic Leap, a start-up that applies AI to the discovery of RNA-targeted drugs.
Pharmaceutical Commerce
SEPTEMBER 6, 2024
The enhancement—which complements the CDMO’s adeno-associated viral vector services—will be utilized at the company’s advanced therapies site in Stevenage, UK.
pharmaphorum
SEPTEMBER 6, 2024
Embracing diversity in psychiatry and neurology clinical trials is crucial for ensuring that treatments are effective for all populations. Learn about the importance of diversity in clinical trials and how to promote inclusivity in research.
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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.
Pharmaceutical Commerce
SEPTEMBER 6, 2024
In the final part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, comments on industry’s preparedness for DSCSA compliance and provides an update as to where pharma is in terms of RFID label adoption.
pharmaphorum
SEPTEMBER 6, 2024
Understanding the impact of Medtech regulations on balancing innovation and safety is crucial for the industry. Discover how compliance with regulations plays a vital role in fostering innovation while ensuring patient safety in the field of medical technology.
Fierce Pharma
SEPTEMBER 6, 2024
Astellas is closing a gene therapy manufacturing facility in South San Francisco. But, across the country, the company opened a new R&D center in Massachusetts. | Astellas is closing a gene therapy manufacturing facility in South San Francisco. But across the country, the company opened a new R&D center in Massachusetts. Chinese authorities detained several current or former AstraZeneca employees.
Pharmaceutical Commerce
SEPTEMBER 6, 2024
Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.
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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
XTalks
SEPTEMBER 6, 2024
As the co-founder of Blueprint Genetics, a proud member of the Quest Diagnostics family, I’ve witnessed firsthand the complexities and nuances involved in rare disease diagnostics and the development of orphan drugs. Our collective expertise is encapsulated in the white paper, “Rare Disease Diagnostics: Advancing Orphan Drug Development through Precision Testing,” which I am excited to introduce to you today.
Drug Discovery Today
SEPTEMBER 6, 2024
Secure your ticket to visit the biggest lab industry trade show in the UK.
WCG Clinical
SEPTEMBER 6, 2024
The use of artificial intelligence (AI) in clinical trials is a rapidly evolving area of research, and a multi-stakeholder task force led by the MRCT Center and WCG is working to address the growing need for guidance. The task force is made up of experts from various domains, including Institutional Review Boards, academia, technology, patient advocates, and regulators, all working together to ensure that AI is used appropriately in clinical research.
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