Drug Patent Watch
NOVEMBER 11, 2024
Effective management of drug patent portfolios is crucial for pharmaceutical companies to maintain market exclusivity, protect revenue streams, and drive innovation. A robust patent strategy aligned with business goals is essential for maximizing value and staying competitive in the pharmaceutical landscape.
Pharmaceutical Technology
NOVEMBER 11, 2024
Aucatzyl is the first CAR-T cell therapy approved by the FDA with no requirement for a risk evaluation mitigation strategy (REMS) programme.
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Bio Pharma Dive
NOVEMBER 11, 2024
Negative drug results cost AbbVie billions of dollars in market value and convinced analysts that Bristol Myers had placed a better bet in buying Karuna Therapeutics.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 11, 2024
PET scans were used to measure protein levels in the brain. (JohnnyGreig/Getty Images) Deep sleep could be key to forestalling slow declines in brain health that may one day lead to Alzheimer’s disease, the most common form of dementia.
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
NOVEMBER 11, 2024
After an investigation, the agency concluded that a case of muscle weakness in one of Novavax’s trials was actually ALS and unrelated to vaccination.
Pharmaceutical Technology
NOVEMBER 11, 2024
AlloVir has entered into a definitive agreement for the acquisition of the complete outstanding shares of Kalaris Therapeutics, to create a new entity focused on developing therapies for retinal diseases.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Worldwide Clinical Trials
NOVEMBER 11, 2024
Jorge Araneta, Senior Director of Technical Delivery at Worldwide, served three years on active duty in the U.S. Navy and an additional four years in the reserves. Watch this interview as he shares his journey transitioning from military service to a career at Worldwide. The post Veterans Day Spotlight: Jorge Araneta’s Transition from the U.S. Navy to a Career at Worldwide appeared first on Worldwide Clinical Trials.
Bio Pharma Dive
NOVEMBER 11, 2024
Shares in AbbVie slumped Monday after the company disclosed its psychiatric medicine emraclidine didn’t best placebo in two Phase 2 trials.
Pharmaceutical Technology
NOVEMBER 11, 2024
Moderna has received Health Canada's approval for its respiratory syncytial virus messenger ribonucleic acid (mRNA) vaccine mRESVIA, designed to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals aged 60 and over.
Bio Pharma Dive
NOVEMBER 11, 2024
The formal denial comes after Cigna CEO David Cordani tried to push back on persistent speculation of a Humana merger earlier this fall.
Pharmaceutical Technology
NOVEMBER 11, 2024
Dizal has submitted sunvozertinib’s new drug application (NDA) to the US Food and Drug Administration (FDA) aiming to secure approval for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins) mutations.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 11, 2024
Raising deep concern over the partnership between Swiggy Instamart and PharmEasy for a rapid drug delivery model, the All India Organization of Chemists and Druggists (AIOCD) has apprised the Drug Controller General of India (DCGI) that this move is against the standards set under Indian law and may lead to serious health and safety problems […]
Pharmaceutical Technology
NOVEMBER 11, 2024
We explore the immense potential of gamma delta T cells, and the challenges in sourcing and scaling up sufficient volumes to treat patients.
Bio Pharma Dive
NOVEMBER 11, 2024
Innovation-without-borders philosophy seeks to bring forward only the most promising therapies.
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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
Pharmaceutical Technology
NOVEMBER 11, 2024
ALK will also pay up to $320m in milestone payments to ARS in the deal, which sees the latter keep rights in the US, Australia, and China.
Bio Pharma Dive
NOVEMBER 11, 2024
Unlock global clinical trial success with seamless sample logistics and standardized testing.
Pharmaceutical Technology
NOVEMBER 11, 2024
At the Outsourcing in Clinical Trials Conference in New England, experts shared ways to operate in a difficult clinical trials ecosystem.
Bio Pharma Dive
NOVEMBER 11, 2024
Seamlessly scale and adapt to match the rapid pace and complexity of modern science.
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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.
Pharmaceutical Technology
NOVEMBER 11, 2024
The US regulatory agency has pushed the PDUFA date by three months to 18 March 2025 to “allow for more time to review additional data”.
Fierce Pharma
NOVEMBER 11, 2024
Although ARS Pharmaceuticals’ approval for its epinephrine nasal spray came later than expected, the company ultimately received a thumbs up from the FDA in August and is now moving fast to expand | ARS Pharmaceuticals said that Denmark’s ALK-Abelló is paying $145 million upfront for the rights to market Neffy in Europe, Canada and “other geographies outside of the U.S.
Pharmaceutical Technology
NOVEMBER 11, 2024
BostonGene is a winner in four categories in the 2024 Pharmaceutical Technology Excellence Awards.
pharmaphorum
NOVEMBER 11, 2024
Mass General Brigham researchers have developed an AI that can spot hidden cases of long COVID from electronic health records
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Fierce Pharma
NOVEMBER 11, 2024
Watch out, Gilead and Novartis: there's a new CAR-T in town. | Autolus' Aucatzyl has become the first CAR-T approved by the FDA without a REMS mandate. And the company is ready to hit the ground running, facing Gilead and Novartis as its competitors.
pharmaphorum
NOVEMBER 11, 2024
Discover an expert perspective on how artificial intelligence is transforming the drug submission and approval process in the pharmaceutical industry. Explore the evolving role of AI in drug development.
XTalks
NOVEMBER 11, 2024
World Antimicrobial Resistance Awareness Week 2024, observed from November 18 to 24, 2024, centers on the theme “Educate. Advocate. Act now.” This theme addresses antimicrobial resistance (AMR), a critical issue where bacteria, viruses, fungi and parasites develop resistance to treatments, making infections harder — or sometimes impossible — to treat effectively.
pharmaphorum
NOVEMBER 11, 2024
AbbVie's $8.7bn play for Cerevel looks like a poor bet as its lead schizophrenia drug flunks two phase 2 trials, but which rival stands to benefit?
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
FDA Law Blog
NOVEMBER 11, 2024
By Deborah L. Livornese & JP Ellison — On November 8, 2024, FDA issued a proposed order to remove the oral decongestant ingredient phenylephrine (including both phenylephrine hydrochloride and phenylephrine bitartrate) (collectively, PE) from the OTC monograph on the basis of a lack of effectiveness. FDA also noted that it has concluded that no safety signal was identified for oral PE at doses permitted under the monograph.
pharmaphorum
NOVEMBER 11, 2024
FDA starts review of Unicycive's drug for hyperphosphataemia in patients with chronic kidney disease on dialysis, aiming to improve on onerous phosphate binder therapy
Fierce Pharma
NOVEMBER 11, 2024
Four months after calling for the resignation of four board members from Assertio Holdings, New York investment advisory firm Buxton Helmsley Group has flipped its long equity position into a short | Answering allegations from activist investor Buxton Helmsley that it misled investors about its acquisition of Spectrum Pharmaceuticals and its cancer drug Rolvedon, Assertio called the claims "baseless.
pharmaphorum
NOVEMBER 11, 2024
Autolus gets its first product approval, an FDA green light for anti-CD19 CAR-T Aucatzyl for B-cell acute lymphoblastic leukaemia
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
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