STAT
NOVEMBER 6, 2023
When Christian Pulcini was a pediatric emergency fellow at Children’s Hospital of Philadelphia, he witnessed firsthand the ways that gun violence affected children who survived it. He still remembers one young boy who had been shot in the neck while playing outside his home. Pulcini did not remove the bullet — a routine practice, often safer than removal.
PharmaVoice
NOVEMBER 6, 2023
Bioethics guru Arthur Caplan of NYU gives his outspoken and frank opinion on the industry’s minefield of ethical challenges.
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STAT
NOVEMBER 6, 2023
As weather starts to cool in much of the country, the heat-baked cement and sweaty afternoons from this summer fade from collective memory. But activists and labor groups representing outdoor workers haven’t forgotten. They are pushing lawmakers and regulators to keep facing the heat. On Tuesday, the Miami-Dade Board of County Commissioners will take a final vote on a proposed heat standard to protect outdoor workers.
ALiEM - Pharm Pearls
NOVEMBER 6, 2023
A 55-year-old female with a history of hyperlipidemia presents after a syncopal episode. She had mild nausea and diarrhea on the morning of presentation but otherwise had no prodromal symptoms before suddenly losing consciousness in a grocery store. Of note, she recalls a similar syncopal episode in the remote past, also preceded by gastrointestinal symptoms at that time.
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.
STAT
NOVEMBER 6, 2023
Harm reduction is having its moment in America. The doors of drug-related harm reduction have swung wide open after years of federal funding bans. Extensive opioid settlement payouts combined with an urgency to address the overdose crisis have allowed for harm reduction approaches to catch on like wildfire. But as renowned addiction author William White muses, “The fastest way to kill anything in America is to turn it into a superficial fad that dies from distortion and over-exposure.
PharmaVoice
NOVEMBER 6, 2023
Investor concerns that interest in GLP-1s will slow demand for medical devices and procedures have shaved roughly $370 billion in value from stocks across the medtech sector, according to research by Mizuho.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
The Pharmacist
NOVEMBER 6, 2023
The Pharmacists’ Defence Association (PDA) has warned pharmacy students that the use of artificial intelligence (AI) technology risks charges of plagiarism and misconduct. In its October 2023 student newsletter, the PDA highlighted a ‘concerning rise’ in the number of students using AI programmes – such as ChatGPT and QuillBot – to write or enhance assessments. […] The post PDA sounds alarm over AI use by pharmacy students appeared first on The Pharmacist.
STAT
NOVEMBER 6, 2023
The fast-evolving world of digital therapeutics offers the promise of lowering barriers to accessing health care, but the companies behind these software-based tools face an uphill battle in convincing clinicians and insurers that their products can complement traditional medicine. That debate has largely focused on the quality of evidence backing these prescription digital therapies.
Pharma Times
NOVEMBER 6, 2023
The device successfully diagnosed COPD in patients with 90% accuracy - News - PharmaTimes
STAT
NOVEMBER 6, 2023
Astellas on Saturday presented study results showing an increased treatment effect over time for its approved medicine for a common type of vision loss. The new data are probably enough to convince the Food and Drug Administration to remove restrictions on the drug’s use, but they still don’t measure up to a competing treatment from Apellis Pharmaceuticals.
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Drug Patent Watch
NOVEMBER 6, 2023
A paper titled “Analysis of Strategy for Extending Patent Protection of Rucaparib” by Zhifeng Wang. discusses the strategies employed by pharmaceutical companies to extend the patent protection period of the… The post Maximizing Intellectual Property Value in the Biomedical Sector: A Case Study on Rucaparib Patents appeared first on DrugPatentWatch - Make Better Decisions.
STAT
NOVEMBER 6, 2023
An experimental treatment that delivers an electrical current to the spinal cord appeared to notably improve the ability of a man with Parkinson’s to keep his balance and walk without freezing up, a development that experts say could be a dramatic advance if it is found to deliver similar benefits in larger studies. The volunteer, identified as Marc, a 62-year-old who has had Parkinson’s for 30 years, spoke on a call with reporters last week.
FDA Law Blog: Biosimilars
NOVEMBER 6, 2023
By Douglas B. Farquhar & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections.
STAT
NOVEMBER 6, 2023
The federal government is proposing to rein in health insurance companies that entice brokers with lavish bonuses to sell their Medicare Advantage plans by placing a firmer cap on broker compensation. However, even with new guardrails in place, agents and brokers will still have strong financial incentives to move people into Medicare Advantage plans instead of pitching supplemental coverage for the traditional Medicare program.
Pharma Times
NOVEMBER 6, 2023
The image helps researchers understand how heart muscles operate in disease - News - PharmaTimes
STAT
NOVEMBER 6, 2023
SAN DIEGO — Ventyx Biosciences reported on Monday that it was ending development of an experimental drug for treating plaque psoriasis though it proved safe and moderately effective in a mid-stage trial. Within hours, the company’s stock tanked by more than 80%. That’s because the company announced that the small molecule, VTX958, had not met the biotech’s internal goals to advance to the next phase of clinical development.
PharmaTech
NOVEMBER 6, 2023
Pharmaceutical Technology Europe® spoke with Ole Wiborg from Zerion Pharma, a Danish pharmaceutical development company, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.
STAT
NOVEMBER 6, 2023
Moonlake Immunotherapeutics, a Swiss biotech, was buried Monday under an avalanche of its own data spin. It’s been awhile since I encountered a management team that speaks so arrogantly about the supposed supremacy of its own drug, but then fails to back up the talk with real data. Moonlake claimed its experimental antibody called sonelokimab delivered “landmark” results in a mid-stage study of psoriatic arthritis.
The Pharmacist
NOVEMBER 6, 2023
The Royal Pharmaceutical Society (RPS) has backed government plans to impose regulations on high-risk non-surgical cosmetic procedures to ensure they can only be undertaken by qualified and regulated healthcare professionals. Responding to a government consultation on how to make non-surgical cosmetic procedures – such as botox and fillers – safer for the public in England, […] The post RPS supports government proposals to regulate cosmetic procedures appeared first on The Pharmacist.
STAT
NOVEMBER 6, 2023
Good morning, everyone, and welcome to another working week. We hope the weekend respite was somehow relaxing and invigorating, because that oh-so familiar routine of online calls, meetings, and deadlines has predictably returned. But what can you do? The world, such as it is, continues to spin. So time to nudge it in a better direction with a cup or three of stimulation.
PioneerRx
NOVEMBER 6, 2023
It pays to be safe. Pharmacy security is an understated but essential aspect of pharmacy ownership. Whether you’re stocking medications, testing supplies.
STAT
NOVEMBER 6, 2023
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Happy Monday. So, we’ve got a welcome bump in the XBI, see that European regulatory conditions are prompting Ozempic maker Novo Nordisk to look stateside for growth, and more.
Express Pharma
NOVEMBER 6, 2023
Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg, the generic version of Prolixin Tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, of Apothecon. Glenmark’s Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg, will be distributed in the US by Glenmark Pharmaceuticals US.
European Pharmaceutical Review
NOVEMBER 6, 2023
A new medicine to treat adults with non-small cell lung cancer (NSCLC) with a rare mutation called KRAS G12C has been authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA). According to the MHRA, Mirati Therapeutics B.V.’s Krazati ® (adagrasib) can be used in this indication in individuals who have an advanced form of the disease, or it has spread to other parts of the body.
Express Pharma
NOVEMBER 6, 2023
University of Dundee researchers have developed a new molecule that is able to target and bind to a protein class previously considered undruggable by using a masking technique to enter the cell. A team in the laboratory of Professor Alessio Ciulli, at the University’s new Centre for Targeted Protein Degradation (CeTPD), have unlocked a class of proteins known as suppressor of cytokine signalling (SOCS).
European Pharmaceutical Review
NOVEMBER 6, 2023
The global cell line development industry is expected to value $4,674.8 million by 2033, according to a report by Future Market Insights. Total cell line product sales are expected to reach $3,124.4 million in 2023, with a predicted compound annual growth rate (CAGR) of 4.1 percent through the next decade. Advancements in biotechnology, pharmaceutical research, and biomanufacturing processes are key factors in driving the market, the author acknowledged.
The Pharmacist
NOVEMBER 6, 2023
Negotiations on the £645m funding for a common conditions service in England, as well as other pharmacy services, have now concluded, Community Pharmacy England (CPE) has said. Speaking at a conference hosted by Sigma Pharmaceuticals this weekend, Janet Morrison, CPE chief executive, told delegates that an announcement about the new common conditions service could be […] The post Pharmacy First announcement due ‘very shortly’ as negotiations conclude appeared first on The Pharmacist.
PharmExec
NOVEMBER 6, 2023
Healthcare organizations can lower their risk of drug diversion by strengthening staffing, employee training, and technology.
Express Pharma
NOVEMBER 6, 2023
Zydus Lifesciences announced that the US Food and Drug Administration (FDA) approved its New Drug Application (NDA) for ZITUVIMET (Sitagliptin and Metformin hydrochloride) tablets, 50 mg/500 mg and 50 mg/1000 mg. ZITUVIMET contains active ingredients sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
European Pharmaceutical Review
NOVEMBER 6, 2023
IZERVAY ( avacincaptad pegol intravitreal solution) induced a year-over-year reductions in the rate of geographic atrophy lesion growth in patients with geographic atrophy secondary to age-related macular degeneration (AMD) in a Phase III trial, Astellas Pharma has announced. The findings presented at the American Academy of Ophthalmology (AAO) 2023 Annual Meeting, revealed that the treatment continued to reduce the rate of geographic atrophy lesion growth for both every month and every-other-mo
pharmaphorum
NOVEMBER 6, 2023
How over-investment is killing digital health companies Mike.
Outsourcing Pharma
NOVEMBER 6, 2023
Life sciences investment group and part of global investment firm Carlyle, Abingworth announced last week it had exceeded its $300 million target by $56 million.
pharmaphorum
NOVEMBER 6, 2023
Anthropy23, part one: The future of AI, the future of Britain Mike.
Pharmaceutical Technology
NOVEMBER 6, 2023
GlobalData uncovers the leading innovators in rAAV production technology for the pharmaceutical industry.
World Pharma News
NOVEMBER 6, 2023
A new targeted drug, studied by researchers at The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC - James), may offer a new treatment option for patients with blood cancers, including chronic lymphocytic leukemia (CLL) and Non-Hodgkin lymphoma (NHL) whose disease has stopped responding to standard treatments.
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