STAT
OCTOBER 14, 2024
It may be time to add Covid-19 infection to the list of possible risk factors for developing type 2 diabetes at a young age. An observational study published Monday in JAMA Network Open found that children and adolescents were one-and-a-half times more likely to be diagnosed with the metabolic disorder in the months after having Covid-19 compared to similar kids who weathered other respiratory infections.
PharmaVoice
OCTOBER 14, 2024
Digital therapeutics have languished in the background of traditional medicines for years, but a recent reimbursement push may have gotten the ball rolling.
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STAT
OCTOBER 14, 2024
Biotech investors have been buzzing around new areas of drug development this year, such as the red-hot obesity market. But there’s one field that has seen an even more significant amount of activity: autoimmune diseases. Companies that are developing new medicines for autoimmune conditions, as well as other immune system disorders, have brought in more money and closed more deals so far this year than most other areas, including the cardiometabolic field, data from investment bank Oppenh
PharmaVoice
OCTOBER 14, 2024
Long-time executives with a strong track record of advancing drug R&D, business savvy strategies and leadership in various sectors of pharma.
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STAT
OCTOBER 14, 2024
LONDON — The Danish pharma company Lundbeck said Monday it would buy Longboard Pharmaceuticals, which is developing treatments for neurological diseases, in a deal worth $2.6 billion. As part of the deal, which is expected to close in the fourth quarter, Lundbeck is paying $60 per share in cash for Longboard, a 54% premium on Friday’s closing price of $38.90.
pharmaphorum
OCTOBER 14, 2024
Damage to a Baxter manufacturing facility caused by Hurricane Helene, which rolled across the east US a couple of weeks ago, has led to shortages in some critical medicines.The plant in North Cove, North Carolina, was severely affected by flooding and had to be shut down at the end of September. It is Baxter's biggest manufacturing site and is also the largest supplier of intravenous and peritoneal dialysis solutions to the US market.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
Express Pharma
OCTOBER 14, 2024
Indian Council of Medical ResearchZydus Lifesciences has formalised a Memorandum of Agreement (MoA) with the Indian Council of Medical Research (ICMR) to initiate Phase 2 clinical trials of Desidustat in patients with Sickle Cell Disease. This Phase IIa, double-blind, randomised, placebo-controlled, parallel, multi-centre, proof-ofconcept study, co-funded and co-monitored by INTENT, Indian National Clinical Trial and Education Network, Clinical Studies and Trial Unit, Division of Development R
STAT
OCTOBER 14, 2024
When the U.S. health care system pivoted to meet Covid-19 in 2020, routine health visits and screenings where many cancer cases would have been caught didn’t happen. It wasn’t ideal, but many health experts thought that as the country opened back up, screenings would help “catch up” to these missed cases. A new paper published Monday in JAMA Network Open suggests that didn’t happen as quickly as experts had hoped.
pharmaphorum
OCTOBER 14, 2024
GSK's six-monthly IL-5 inhibitor depemokimab clears two phase 3 trials in chronic rhinosinusitis with nasal polyps (CRSwNP), its second indication
STAT
OCTOBER 14, 2024
A transplant to Boston from Brazil, my patient worked as a hairdresser but had developed painful rashes on her hands that peeled and cracked, making it impossible to do her job. I diagnosed her with an allergy to para-phenylenediamine, an ingredient in certain styling products she used at the salon. Her skin recovered as she avoided this chemical. A careful medical evaluation had healed her hands and allowed her to maintain her livelihood, her self-sufficiency, and the social connections with co
Speaker: Joe Sharpe and James Carlson
Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.
pharmaphorum
OCTOBER 14, 2024
Eli Lilly may invest $364m in the UK and work with the government to tackle serious public health challenges including obesity.
STAT
OCTOBER 14, 2024
When children’s hospitals around the country were subject to threats and harassment in 2022 over misconceptions about gender-affirming care services, many of them responded by stripping information about the care from their websites. Two years later, new research shows that few adult and children’s hospital websites share information about LGBTQ+ services and policies.
Express Pharma
OCTOBER 14, 2024
Jagat Prakash Nadda, Union Minister of Health and Family Welfare inaugurated the 19th International Conference of Drug Regulatory Authorities (ICDRA). The event is being hosted in India for the first time, from October 14-18, 2024 by the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, in collaboration with the World Health Organization (WHO) brings together regulatory authorities, policymakers, and health officials from over 194 WHO member states.
STAT
OCTOBER 14, 2024
Jasper Therapeutics, a biotech looking to make stem cell transplants less taxing and to treat immune-mediated diseases, reported on Monday that its experimental drug helped patients with a chronic skin condition in an initial and closely watched clinical trial. In the Phase 1/2 study, dubbed Spotlight, 14 of 15 patients given an injection of the drug, briquilimab, showed improvements in symptoms of chronic inducible urticaria, a disease defined by red, itchy welts.
Speaker: Chris Antypas and Josh Halladay
Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.
The Pharmacist
OCTOBER 14, 2024
The government intends to expand Pharmacy First to create the community pharmacy prescribing service promised in its pre-election manifesto, Community Pharmacy England (CPE) has suggested. But CPE chief executive Janet Morrison stressed that funding for the sector needed to be stabilised before the expansion could be put in place. Ms Morrison told delegates at the […] The post Prescribing service will likely build on Pharmacy First, suggests CPE appeared first on The Pharmacist.
BioPharma Dive
OCTOBER 14, 2024
The agency agreed in court to allow compounding companies to continue producing copycat versions of Lilly’s fast-selling medicines while it reevaluates its recent decision to declare the drugs back in supply.
The Pharmacist
OCTOBER 14, 2024
Thresholds for the monthly Pharmacy First payments have been lowered until March 2025, it has been announced. NHS England’s director of pharmacy, optometry and dentistry, Ali Sparke, said the thresholds for clinical pathway consultations would be ‘revised downward’ in recognition of the ‘levels of pain going on in the sector’. He was speaking at this […] The post Pharmacy First monthly thresholds reduced until March 2025 appeared first on The Pharmacist.
pharmaphorum
OCTOBER 14, 2024
For the first time, a vaccine candidate for Rift Valley fever, developed by Oxford University, has been advanced into a phase 2 trial backed by CEPI.
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BioPharma Dive
OCTOBER 14, 2024
The deal would hand Lundbeck a treatment for a series of rare brain disorders that could, by the company's estimates, become a blockbuster product.
Big Molecule Watch
OCTOBER 14, 2024
On October 4, 2024, Amgen filed a BPCIA complaint in the District Court for the Northern District of Illinois Eastern Division against Fresenius Kabi related to Fresenius Kabi’s proposed biosimilar of Amgen’s PROLIA and XGEVA. This is the fourth BPCIA litigation regarding denosumab, following Amgen’s litigations against Sandoz, Celltrion, and Samsung Bioepis/Samsung Biologics, all filed in the District Court for the District of New Jersey.
Express Pharma
OCTOBER 14, 2024
Accord BioPharma, the US specialty division of Intas Pharmaceuticals, focused on the development of oncology, immunology, and critical care therapies, announced that the USFDA has approved IMULDOSA (ustekinumab-srlf), a biosimilar to STELARA (ustekinumab), for the treatment of chronic inflammatory conditions, including psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
Drug Patent Watch
OCTOBER 14, 2024
Risk assessment plays a crucial role in the development of generic drugs, ensuring that these products meet the required standards of safety and efficacy. The Food and Drug Administration (FDA) and other regulatory bodies have implemented various measures to ensure that generic drugs are equivalent to their brand-name counterparts in terms of quality, safety, and efficacy.
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Express Pharma
OCTOBER 14, 2024
Hemant Jain has taken charge as the new President of PHD Chamber of Commerce and Industry, effective October 10, 2024. He succeeds Sanjeev Agrawal, who now assumes the role of Immediate Former President, PHDCCI. Further, Rajeev Juneja, Vice Chairman and Managing Director of Mankind Pharma, has taken over as the Senior Vice President and Anil Gupta as Vice President, PHDCCI.
FDA Law Blog: Biosimilars
OCTOBER 14, 2024
By Steven J. Gonzalez — On September 27, 2024, in U.S. v. California Stem Cell Treatment Center, Inc., a Ninth Circuit panel unanimously held that a stem cell clinic’s Stromal Vascular Fraction (SVF) procedure constitutes a “drug” under the Food, Drug and Cosmetic Act (FDCA) and does not meet the “same surgical procedure” (SSP) exception to FDA’s regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) contained in 21 C.F.R.
Express Pharma
OCTOBER 14, 2024
Pfizer’s upcoming presentation at United European Gastroenterology Week (UEGW) 2024 will reveal the initial findings from its CULTIVATE study of its sphingosine-1-phosphate (S1P) receptor modulator Velsipity (etrasimod) in Crohn’s disease (CD), showing modest efficacy in endoscopic response and remission rates. With its in-class competitor ozanimod also underperforming in trials, the outlook for S1P receptor modulators in Crohn’s disease remains uncertain, highlighting challenges in addressing t
pharmaphorum
OCTOBER 14, 2024
Faced with lawsuit, FDA rethinks block on compounding pharmacies making Eli Lilly's diabetes and obesity drug tirzepatide
Outsourcing Pharma
OCTOBER 14, 2024
From exploring the wonders of plants as a curious teen to leading global initiatives at SCIEX, Gitte Barknowitz has carved out an exciting and unconventional career in science.
Pharmaceutical Technology
OCTOBER 14, 2024
Trends in gene therapy approvals in recent years are rapidly shaping the future of manufacturing capabilities in the pharmaceutical industry.
Pharma Marketing Network
OCTOBER 14, 2024
In the ever-evolving landscape of pharmaceutical marketing, the traditional methods of reaching healthcare professionals and consumers are gradually being supplemented by innovative digital strategies. Among these, influencer marketing has emerged as a powerful tool for pharma companies seeking to build trust and foster engagement with their target audiences.
RX Note
OCTOBER 14, 2024
Introduction Recently, during a dinner conversation, my father mentioned receiving numerous phone calls from banks inviting him to invest. Without hesitation, I replied that if the world offered free money without work and risk, it was likely a scam disguised as an investment opportunity, designed to benefit the salesperson. Historically, banks were trusted institutions where people saved money and earned interest.
Pharma Marketing Network
OCTOBER 14, 2024
The pharmaceutical industry is undergoing unprecedented changes driven by technological advancements, regulatory shifts, and a more informed patient base. As the landscape evolves, pharma executives must adapt their marketing strategies to remain competitive and effectively reach their target audiences. This article explores the key trends reshaping the industry and offers insights into innovative marketing approaches and strategies that pharma executives can employ to navigate these changes suc
PharmExec
OCTOBER 14, 2024
The Big Pharma commercialization playbook doesn’t work for emerging life sciences companies bootstrapping their way up. Exploring three strategies that could be the ingredients of a winning formula for startups.
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