FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy
Fierce Pharma
MAY 31, 2023
FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy kdunleavy Wed, 05/31/2023 - 13:02
Sat.May 27, 2023 - Fri.Jun 02, 2023
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Retailers Are Making a Big Push Into Healthcare. Is Our Sector Ready?
MedCity News
MAY 29, 2023
While retailers already have a customer service focus, there is a steep learning curve to healthcare and the nuances of how things operate. It will be critical that these brands do their due diligence and invest in innovations that work to improve the fundamentals of healthcare such as efficient provider credentialing and flexible and sustainable working practices for providers.
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Big Pharma inventory management trends revealed
European Pharmaceutical Review
MAY 31, 2023
The inventory position of 28 major pharmaceutical manufacturers in 2022 has been revealed in an annual report. Analysis explored the impact of macro-trends on inventory management from corporate reports of Big Pharma companies including Merck, AstraZeneca and Pfizer. It investigated how excessive inventories are affecting the industry and what factors could influence inventory growth in 2023.
SK Bioscience gains UK authorisation for SKYCovion Covid-19 vaccine
Pharmaceutical Technology
MAY 30, 2023
SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. SKYCovion is intended for the prevention of Covid-19 resulting from SARS-CoV-2 infection in individuals aged 18 years and above. The authorisation allows the distribution of the vaccine in Scotland, Wales and England.
AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work
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What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.
ASCO: Novartis pressures Lilly with Kisqali, targeting $3B opportunity in early breast cancer
Fierce Pharma
MAY 31, 2023
Adding Kisqali to endocrine therapy after surgery reduced the risk of invasive tumor recurrence or death by 25% in certain early-stage breast cancers.
In Therapeutic Innovation, Digital Must Be Held to the Same Rigor as Biotech
MedCity News
MAY 29, 2023
While these are key benefits of digital therapeutics and this optimism may have been laudable, this approach to market relies on promise without proof of efficacy and ignores the fact that not all digital therapeutics are created equal.
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XtalPi announces $250m AI drug discovery collaboration with Eli Lilly
Pharmaceutical Technology
MAY 31, 2023
XtalPi has made a partnership deal with US-based Eli Lilly to leverage artificial intelligence (AI) for drug discovery. XtalPi will receive $250m in upfront and milestone payments. The two companies will use XtalPi’s integrated AI capabilities and robotics platform for the de novo [without consideration of previous instances] design and delivery of drug candidates for an undisclosed target.
ASCO: Merck bills Keytruda, used around surgery, as new standard in 'messy' early lung cancer realm
Fierce Pharma
JUNE 1, 2023
As doctors weigh various immunotherapy strategies for the treatment of early-stage non-small cell lung cancer, Merck & Co. | As doctors navigate the "messy" early-stage non-small cell lung cancer landscape with various immunotherapy approaches, Merck & Co. has now unveiled new data that it hopes can establish Keytruda, used before and after surgery, as a new standard of care.
Pfizer’s RSV Vaccine Wins FDA Approval on Heels of Regulatory Nod for GSK
MedCity News
JUNE 1, 2023
Pfizer’s Abrysvo is now approved for preventing illness caused by respiratory syncytial virus, or RSV, in adults 60 and older. The regulatory decision comes weeks after GSK won approval for its RSV vaccine, Arexvy.
Pencil-on-Paper Wearable Sensor
Medgadget
JUNE 1, 2023
Researchers at Penn State have developed a low-cost, wearable sensor using pencil-on-paper technology. This approach involves depositing graphite (pencil ‘lead’) on paper that has been treated with sodium chloride, to create a conductive, low-cost sensor. Previously, these researchers had developed such sensors to detect moisture and even used them to develop a smart diaper ( yes, really ).
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
US companies drive 2023 drug launches positioned for blockbuster success by 2028
Pharmaceutical Technology
MAY 30, 2023
According to GlobalData’s Looking Ahead to 2023 – the Future of Pharma report, five drugs set for approval in 2023 are projected to attain blockbuster status or near-blockbuster status by 2028 with US company dominance. Lecanemab by Eisai Co Ltd, a monoclonal antibody therapy marketed for Alzheimer’s disease, is predicted to achieve the most significant commercial debut.
ASCO: AstraZeneca guns for wider ovarian cancer market with Imfinzi-Lynparza combo. Will the FDA buy the plan?
Fierce Pharma
JUNE 2, 2023
Lynparza may be the most popular PARP inhibitor, but a use restriction in ovarian cancer has been a thorn in AstraZeneca’s side. | AstraZeneca is bringing on Imfinzi to potentially help Lynparza reach a broader ovarian cancer population. But the lack of evidence for contribution from Imfinzi and a regulatory concern over the use of PARP inhibitors outside BRCA-mutant tumors could make it hard for AstraZeneca to win over the FDA.
Moving up the Digital Maturity Ladder in an Evolving BioPharmaceutical Ecosystem
MedCity News
JUNE 2, 2023
Digital maturity will require shared data standards, strategies for streamlining data management and a collaborative approach that involves all players in the biopharma supply chain.
Novel PAT system could enable adaptive process control
European Pharmaceutical Review
JUNE 2, 2023
A novel refractometry-based process analytical technology (PAT) system used to monitor HEK293T cell cultures during lentiviral vector (LVV) production in real time, was able rapidly identify a relationship between bioreactor pH and culture metabolic activity, a paper has found. Using PAT in the biotechnology and biopharmaceutical industries is a radical vision” Williams et al. stated that to their knowledge, the study represents the first time that pH has been incorporated into a metabolic
EC approves Briumvi to treat relapsing forms of multiple sclerosis
Pharmaceutical Technology
JUNE 2, 2023
The European Commission (EC) has approved TG Therapeutics’ Briumvi (ublituximab-xiiy) to treat relapsing forms of multiple sclerosis (RMS) in adult patients. Briumvi is an anti-CD20 monoclonal antibody indicated for RMS adult patients with active disease which is defined by clinical or imaging features. It has been engineered to remove certain sugar molecules generally expressed on the antibody.
Alnylam sticks with aggressive litigation strategy against Pfizer and Moderna, filing yet another patent lawsuit
Fierce Pharma
MAY 30, 2023
Alnylam sticks with aggressive litigation strategy against Pfizer and Moderna, filing yet another patent lawsuit zbecker Tue, 05/30/2023 - 10:24
A Father’s Vision for New Kind of Gene Therapy Leads to a $100M Financing
MedCity News
MAY 29, 2023
Ray Therapeutics’ gene therapy is independent of the causative genes driving inherited vision disorders, which CEO Paul Bresge says is important for reaching a broad patient population. Rare disease retinitis pigmentosa is the first disease target, but the startup also plans to test its approach in more prevalent eye disorders.
Reframing Mental Health Awareness Month
InCrowd
MAY 31, 2023
Happy Mental Health Awareness Month! But wait… is it really happy? What does mental health awareness truly mean? I’ve always struggled with the idea of dedicating a single month to a specific cause. While it’s important to de-stigmatize mental illness and endeavor to provide mental health organizations with desperately needed funding, I worry that awareness will wane the moment this month ends?
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.
Janssen submits NDA to FDA for PAH combination therapy
Pharmaceutical Technology
MAY 31, 2023
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a new drug application (NDA) for its investigational single-tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) to the US Food and Drug Administration (FDA), to treat pulmonary arterial hypertension (PAH). The company is seeking approval for the combination therapy for the long-term treatment of PAH in adult patients with World Health Organisation functional class II-III.
AZ, Merck's Lynparza wins FDA nod in prostate cancer subgroup following advisory committee vote
Fierce Pharma
JUNE 1, 2023
After a panel of independent experts endorsed a narrow approval for AstraZeneca and Merck’s Lynparza in metastatic castration-resistant prostate cancer (mCRPC), the FDA has followed suit. | The drug is now approved to treat BRCA-mutated metastatic castration-resistant prostate cancer in combination with Johnson & Johnson’s Zytiga and a corticosteroid.
It’s Time for Healthcare To Embrace Patient-Friendly Language
MedCity News
JUNE 1, 2023
Recent regulations from the Office of the National Coordinator for Health IT (ONC) and Centers for Medicare & Medicaid Services (CMS) have, respectively, focused on prohibiting information blocking and increasing price transparency. Together, these two regulations have put a third issue into the spotlight as well: Reducing the complexity of clinical terminology.
CHMP meeting highlights – May 2023
European Pharmaceutical Review
MAY 29, 2023
A neurosteroid drug was one of two medicines recommended for approval at the Committee for Medicinal Products for Human Use (CHMP) ’s May 2023 meeting. Ztalmy (ganaxolone) received a positive opinion for epileptic seizures associated with cyclin-dependent kinase-like 5 deficiency disorder. This genetic condition is defined by seizures starting during infancy.
How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales
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Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten
Lexicon gets FDA approval for Inpefa to treat heart failure
Pharmaceutical Technology
MAY 29, 2023
Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. Inpefa is a once-daily oral tablet indicated as an inhibitor of sodium-glucose co-transporter type 2 (SGLT2) and type 1 (SGLT1). It is intended to lower the risk of cardiovascular death, urgent heart failure visit, and hospitalisation for heart failure.
Former Novartis execs cleared of Greek bribery charges after yearslong investigation
Fierce Pharma
MAY 31, 2023
After a yearslong investigation involving politicians and medical professionals alike, Novartis is looking to close the books on its Greek bribery imbroglio. | After an investigation that dates back to 2017, four former Novartis executives and a Greek politician were cleared of bribery charges. But 15 doctors were charged for their alleged involvement.
Interoperability: Past, Present, and Future
MedCity News
JUNE 1, 2023
A new decentralized network of the future exists and is in operation today. Large payers and providers are already beginning to use it for administrative transactions, although clinical transactions are also envisioned.
CRISPR-based microbial gene therapy delivers promise
European Pharmaceutical Review
MAY 31, 2023
The novel CRISPR-Cas therapeutic selectively targets antibiotic-resistant E. coli which can cause life-threatening bloodstream infections” Positive interim results from a Phase I trial have demonstrated that the first CRISPR-armed phage microbial gene therapy can reduce Escherichia coli ( E. coli ) levels in the GI tract. “With the combined killing effects of bacteriophages and CRISPR-Cas technology, SNIPR001 has demonstrated the ability to target and eliminate antibiotic-resistant E
How to Stay Competitive in the Evolving State of Martech
Advertiser: ZoomInfo
Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr
UK’s NICE recommends Pfizer’s rimegepant to treat migraine
Pharmaceutical Technology
JUNE 1, 2023
The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending the use of Pfizer ’s rimegepant (Vydura) to prevent migraine attacks. The therapy has been recommended as an option to prevent episodic migraines in adult patients, who have between four and 15 migraine attacks per month, and where a minimum of three preventive treatments have previously failed.
As Sandoz prepares to spin off from Novartis, the company sets sights on new crosstown headquarters
Fierce Pharma
JUNE 1, 2023
As Sandoz prepares to spin off from Novartis into its own generics and biosimilars business, the company has settled on a location for its new headquarters. | After spinning off from Novartis later this year, generics and biosimilars giant Sandoz plans to move into its new headquarters by the middle of 2024.
How Employers Can Get Started in the Food as Medicine Movement
MedCity News
MAY 30, 2023
Employers have a responsibility to support the food as medicine movement and help employees who are food insecure, said Jay Bhatt, managing director of Deloitte Services and managing director of the Center for Health Solutions and Health Equity Institute. He made these comments last week at the MedCity INVEST conference in Chicago.
NICE recommends oral migraine treatment for first time
European Pharmaceutical Review
JUNE 1, 2023
An oral treatment for preventing migraines has been recommended by the National Institute for Health and Care Excellence (NICE) for the first time. Rimegepant (Vydura) is recommended as an option for episodic migraine in adults after having at least three previous failed preventive treatments. The NICE final draft guidance recommends rimegepant in individuals who have at least four migraine attacks per month but less than 15, stated the UK regulatory body.
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