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.
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The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending the use of Pfizer ’s rimegepant (Vydura) to prevent migraine attacks.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.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
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.
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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.
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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?
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.
Look out, GSK. Pfizer has its adult RSV vaccine approval and is raring to launch
Fierce Pharma
JUNE 1, 2023
About a month after GSK won the world's first approval for a respiratory syncytial virus (RSV) vaccine, rival Pfizer has followed suit. | After winning FDA approvals one month apart, Pfizer and GSK are set to launch competing RSV vaccines this fall.
Burnout Continues To Crush Clinicians, But Voice Tech and AI Could Help
MedCity News
MAY 30, 2023
In addition to reducing workload, NLP and ambient voice technology can also improve the quality of care that clinicians provide. By analyzing EHRs and other patient data, NLP algorithms can identify potential health risk factors and recommend preventative measures.
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 ).
SNIPR targets antibiotic resistance with CRISPR-based gene therapy trial
Pharmaceutical Technology
MAY 31, 2023
The Danish CRISPR biotech SNIPR BIOME has released the first glimpse at the safety profile for SNIPR001, a gene therapy intended to target antibiotic resistance. Interim clinical results from a Phase I trial have demonstrated SNIPR001’s safety in healthy volunteers. Additionally, E.Coli was detected in a dose-dependent manner in feces, suggesting the therapy’s proof-of-principle targetin and removing the bacteria, including antibiotic-resistant strains.
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.
A REVIEW OF MAGNETIC NANOPARTICLES IN TARGETED DRUG DELIVERY
Pharmatutor
MAY 29, 2023
A REVIEW OF MAGNETIC NANOPARTICLES IN TARGETED DRUG DELIVERY admin Mon, 05/29/2023 - 15:04 About Authors CHETNA MODI 1 *, VINIT MODI 2 , SHWETA RAY 2 , PIYUSH NARIYA 2 , VARSHA GADHVI 2 1 Professor, Department of Pharmaceutics, Anand Pharmacy College, Anand, Gujarat, India. 2 Research Scholar, Department of Pharmaceutics, Anand Pharmacy College, Anand, Gujarat, India. * chetnamodi306@gmail.
Stealth and Pharmanovia partner for commercialisation of elamipretide
Pharmaceutical Technology
MAY 31, 2023
Stealth BioTherapeutics has made an exclusive licensing agreement with Pharmanovia for the commercialisation of its elamipretide to treat Barth syndrome. Pharmanovia will hold exclusive rights for the commercialisation of elamipretide in the EU, other European countries including Switzerland, Norway, Iceland and the UK, and the Middle East and northern Africa region.
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.
After FDA Miss in Diabetes, Lexicon Lands Long-Awaited Approval in Heart Failure
MedCity News
MAY 30, 2023
Lexicon Pharmaceuticals drug Inpefa is now FDA-approved for heart failure. Inpefa is third in its class, but the biotech says its pill can reach a specific subset of patients, enabling it to stand apart from rival medicines from AstraZeneca and partners Eli Lilly and Boehringer Ingelheim.
A glimpse into public perception of mental health care in the United States
Clarify Health
MAY 30, 2023
Addressing the mental health crisis in the United States is a complex undertaking, due to multiple factors contributing to prevalence and severity of several conditions. Recent findings from the Clarify Health Institute highlight these growing problems and speak to a need for action to combat this crisis. According to its most recent research brief, “The Kids Are Not Alright: Mental Health Utilization Among Children and Young Adults, 2016-2022,” hospital admissions for mental illnes
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: 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.
Strive Health Rakes In $166M for Value-based Kidney Care
MedCity News
MAY 31, 2023
Strive Health’s $166 million funding round was led by NEA and included participation from CVS Health Ventures, CapitalG, Echo Ventures, Town Hall Ventures, Ascension Ventures and Redpoint. In total, the company has raised more than $400 million.
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.
Amplo Biotechnology receives NIH-NIAMS grant for gene therapy AMP-201
Pharmaceutical Technology
MAY 30, 2023
Amplo Biotechnology has received a fast track phase I/II STTR grant from the NIH-NIAMS [National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases] for its gene therapy AMP-201. The company will receive substantial funding to advance AAV-ColQ gene therapy. AMP-201 addresses the severe congenital myasthenic syndrome (CMS) caused by collagen Q (ColQ) deficiency.
Carrying blockbuster sales expectations, BMS' Camyzos picks up early nod from England's NICE
Fierce Pharma
JUNE 2, 2023
As Bristol Myers Squibb braces for increasing generic competition this decade, the company is counting on its newer medicines to drive growth. | As Bristol's top-sellers creep toward the patent cliff, new launch Camzyos has picked up a key endorsement in England.
Digital Health Funding Steadied in Q1 After a Year of Decline
MedCity News
MAY 30, 2023
Global funding for digital health companies finally stabilized in Q1 of this year. The sector raised $3.4 billion — this marks the first time the digital health world didn’t experience a quarter-over-quarter funding decline since Q4 of 2021. By holding steady, digital health startups defied the dwindling fundraising totals seen across the broader venture capital landscape, where funding dropped by 13% quarter-over-quarter.
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
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.
Lexicon finally scores FDA nod for heart failure drug Inpefa
Fierce Pharma
MAY 30, 2023
Lexicon finally scores FDA nod for heart failure drug Inpefa kdunleavy Tue, 05/30/2023 - 05:46
Pfizer Hemophilia Drug Reduces Bleeding in Key Study; Regulatory Filings Are Planned
MedCity News
MAY 30, 2023
Marstacimab, a Pfizer drug for both hemophilia A and B, met the main goal of a Phase 3 study and the company now plans to discuss the data with regulators. The Pfizer drug could beat to the market a Novo Nordisk drug that addresses the same novel target.
Lonza to acquire Synaffix to strengthen ADC development
PharmaTimes
JUNE 1, 2023
Synaffix’s technology platform is intended to enhance and extend Lonza’s integrated ADC services - News - PharmaTimes
AION Labs and BioMed X launch sixth challenge for AI-driven drug discovery
Pharmaceutical Technology
MAY 30, 2023
Last week, artificial intelligence (AI) innovator AION Labs called for applications for its latest AI-powered startup. In partnership with BioMed X, the Israeli company hopes to attract top talent from across the globe to develop an AI platform capable of discovering new high-affinity small molecules. Launched back in 2021, AION Labs was formed as an alliance between AstraZeneca , Merck , Pfizer and Teva , as well as Amazon and the Israel Biotech Fund.
Persistent Sun Pharma ready to complete Taro buyout—16 years after initial offer
Fierce Pharma
MAY 30, 2023
Persistent Sun Pharma ready to complete Taro buyout—16 years after initial offer kdunleavy Tue, 05/30/2023 - 09:57
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.
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