STAT

NOVEMBER 15, 2023

The Food and Drug Administration granted marketing approval to a home test for chlamydia and gonorrhea on Wednesday, the first such authorization of a home test to detect the two most common sexually transmitted infections in this country. The marketing approval was granted to LetsGetChecked’s Simple 2 Test, which allows individuals to collect a sample at home that is then submitted to a laboratory for processing.

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PharmaVoice

NOVEMBER 15, 2023

Talus Bio, which developed a platform to map transcription factors, has a lead cancer candidate in the works and consults with other industry players in the complicated biology.

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STAT

NOVEMBER 15, 2023

Step inside Natasha Sheybani’s office at the University of Virginia, where she runs a bioengineering lab, and you’ll find a kaleidoscopic sea of sticky notes. She uses purple for ideas sparked by meetings, orange for future grant proposals. But she’s most excited about the yellow stickies, which Sheybani saves for moonshots: projects that are high-risk and high-reward.

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ALiEM - Pharm Pearls

NOVEMBER 15, 2023

What toxin is found in bitter apricot kernels? Cardiac glycoside Cyanogenic glycoside Dinitrophenol Lysergic Acid Reveal the Answer 2. Cyanogenic glycoside Background Apricot kernels contain a cyanogenic glycoside called amygdalin which is hydrolyzed to hydrogen cyanide in the gastrointestinal tract [1]. There are over 2,000 species of cyanogenic glycoside producing plants, including apricots, almonds, peaches, and cassava [2].

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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

Communication

STAT

NOVEMBER 15, 2023

WASHINGTON — House lawmakers late Tuesday voted to attach a U.S. ban on controversial infectious disease research to legislation that could ultimately fund federal health agencies like the National Institutes of Health. The bill would bar any federal agencies from funding so-called gain-of-function research, which involves altering a pathogen to study its spread, potentially making it more transmissible or severe in the process.

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PharmaVoice

NOVEMBER 15, 2023

23andMe co-founder and CEO Anne Wojcicki discusses ways the industry could integrate genomics into healthcare.

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The Pharmacist

NOVEMBER 15, 2023

The highly anticipated Pharmacy First common conditions service in England is set to launch at the end of January, it has been announced. The news comes as part of a series of announcements confirmed by NHS England (NHSE) and Community Pharmacy England (CPE) today, which also included updates on contraception and hypertension services. And CPE […] The post Breaking: Pharmacy First to launch end of January appeared first on The Pharmacist.

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Community Pharmacies 124

STAT

NOVEMBER 15, 2023

WASHINGTON — Panels in both the House and Senate have now passed restrictions to drug middlemen business practices, increasing the chances of those measures being included in future government spending bills. The bipartisan reforms to pharmacy benefit managers were among 21 bills that the House Energy & Commerce health subcommittee passed today.

Drug Pricing 298

Drug Pricing Biosimilars 298

PharmExec

NOVEMBER 15, 2023

Defencath is indicated for the prevention and treatment of catheter-related bloodstream infections in adults with kidney failure administered chronic hemodialysis via a central venous catheter.

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STAT

NOVEMBER 15, 2023

The patents on medicines and devices approved by the U.S. Food and Drug Administration were more frequently invalidated due to information misrepresented or withheld from patent examiners than any other industry sector, according to a new analysis. Between 2004 and 2021, a U.S. appeals court that handles patent litigation found 36 cases in which companies committed what is called inequitable conduct — failing to provide accurate or complete information to the U.S.

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European Pharmaceutical Review

NOVEMBER 15, 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC) Tecentriq ® (atezolizumab). Roche’s monoclonal antibody cancer immunotherapy was recommended for all indications in which Tecentriq intravenous (IV) has been previously approved, including certain lung, liver, bladder and breast cancer types.

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STAT

NOVEMBER 15, 2023

Convenience is rapidly becoming a guiding principle for hospital system strategy and competition. As patients demand a more convenient, integrated care experience, and new partnerships/acquisitions (for instance, CVS Health and Oak Street Health, or Amazon and One Medical) redefine what the consumer health care journey looks like, the industry will continue to see a collision between virtual, at-home, and in-person care.

Hospitals 299

Hospitals 299

PharmExec

NOVEMBER 15, 2023

Pharm Exec’s 19th annual report on the trends of the day in drug development examines the surging investment in new treatments and advances for so-called “first-world” conditions, capturing the landscape of five expanding therapeutic areas: weight loss, osteoarthritis, Alzheimer’s disease, COPD, and psychedelics.

Drug Development 110

Drug Development 110

STAT

NOVEMBER 15, 2023

LONDON — Clinical trials have shown that lifestyle programs — which include diet, exercise, and behavioral coaching — can help people in danger of developing type 2 diabetes from tipping into a diagnosis of the condition. But there’s been a nagging question of whether such intensive regimens work in the real world. A study published Wednesday backs up the idea that they can.

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Diabetes 291

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.

Pharma Times

NOVEMBER 15, 2023

CHD is a common birth defect that affects the development of the heart and brain - News - PharmaTimes

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STAT

NOVEMBER 15, 2023

For the many high-achieving perfectionists who enter medical school each year, the stakes of their success have never been higher. Becoming a doctor means lives will be in their hands — and failing to make it through med school means they’ll be stuck with an unthinkable amount of debt without a viable way to pay for it. It’s no wonder that medical students suffer greatly from burnout and mental health struggles.

Medical Schools 284

Medical Schools 284

BioPharma Dive

NOVEMBER 15, 2023

Since halting work on a sickle cell treatment early this year, Graphite Bio has laid off staff, shed assets and, now, agreed to be subsumed via a merger with Lenz Therapeutics.

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STAT

NOVEMBER 15, 2023

WASHINGTON — There’s about to be a new acronym in town. The Food and Drug Administration is in the final stages of cementing sweeping changes to the Office of Regulatory Affairs, which oversees inspections and compliance for all its regulated products, according to three people familiar with the planning. That overhaul includes a new name: Meet the Office of Inspections and Investigations.

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Advertisement

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

The Pharmacist

NOVEMBER 15, 2023

The General Pharmaceutical Council (GPhC) fees will increase by 7.5% from April 2024, it has confirmed, following agreement from its council earlier this month. GPhC also defended its decision to have headquarters in London’s Canary Wharf, following calls from members that the organisation should seek to cut its running costs. And the regulator said it […] The post 'Unwelcome' GPhC 7.5% fee increase confirmed appeared first on The Pharmacist.

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STAT

NOVEMBER 15, 2023

WASHINGTON — The Food and Drug Administration’s top cancer drug regulator doesn’t always ask for permission before taking on big initiatives. Richard Pazdur, director of the FDA Oncology Center of Excellence, hates bureaucracy. It stifles his ideas for getting treatments to cancer patients faster — of which there are many.

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Board Vitals - Pharmacist

NOVEMBER 15, 2023

One crucial milestone in a psychiatric resident’s training is the Psychiatry Resident-In-Training Examination, commonly known as the PRITE. The PRITE covers a broad range of topics within the field of psychiatry. While the specific content may vary from year to year, here is a sampling of some of the areas you can expect to see on the exam. What is the PRITE ?

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STAT

NOVEMBER 15, 2023

A gene therapy study, halted when four children with a rare neuromuscular disorder died after treatment, showed enough promise to merit finding a path forward, according to the medicine’s manufacturer. The treatment, made by the Japanese pharmaceutical company Astellas, led to severe and fatal liver problems for four of the 24 treated children with X-linked myotubular myopathy, or XLMTM, a genetic disease that severely degrades muscle function and kills most patients before the age of 10.

Pharmaceutical Companies 273

Pharmaceutical Companies Pharmaceutical Companies 273

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.

European Pharmaceutical Review

NOVEMBER 15, 2023

Researchers have demonstrated the feasibility of on-line mass spectrometry (MS) measurement using an on-line micro simulated moving bed chromatography (µSMB)- mass spectrometry system. It provides a versatile process analytical technology (PAT) tool by combining the detection power of mass spectrometry for various product attributes with the advantages of continuous on-line analytics.

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STAT

NOVEMBER 15, 2023

Good morning, everyone, and how are you today? We are doing just fine, thank you. Given that this is already the middle of the week and we have survived this far, no reason not to continue, yes? Just consider the alternatives. In fact, this modest accomplishment calls for celebration. So please join us in quaffing a ritual cup of needed stimulation.

Diabetes 247

Diabetes Labelling 247

European Pharmaceutical Review

NOVEMBER 15, 2023

Two new production facilities have opened in Europe, Sandoz announced on 10 November 2023. The €150 million facility in Kundl, Austria will produce the antibiotic penicillin, while the new €25 million facility in Holzkirchen, Germany will be Sandoz’s new Biosimilar Development Center. Launch of these new facilities help to ensure sustainable access to quality antibiotics and spearhead development of biosimilars, Sandoz noted.

Biosimilars 93

Biosimilars 93

STAT

NOVEMBER 15, 2023

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello, everyone. Damian here with some annoyingly good news for the biotech market, a look at the plight of the Ph.D., and the perils of an ill-timed shopping spree.

Drug Pricing 194

Drug Pricing Drug Development 194

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Pharmacy Management

Express Pharma

NOVEMBER 15, 2023

The first human clinical trial of a novel gene-editing technique known as base editing has shown promising results in maintaining healthy levels of cholesterol. In the trial by Verve Therapeutics , physicians injected patients with a Clustered Regularly Interspace Short Palindromic Repeats (CRISPR)-based gene editing therapy called VERVE-101, which inactivated the liver gene PCSK9 that typically contributes to higher levels of low-density lipoprotein (LDL)—a key contributor to heart disease.

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Compounding 98

BioPharma Dive

NOVEMBER 15, 2023

The deal gives Gilead an estimated 13% ownership in Arcellx and extends the company’s cash runway into 2027.

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Express Pharma

NOVEMBER 15, 2023

Glenmark Pharmaceuticals received the “Best Consumer Healthcare Digital Marketing Campaign” award at the recently concluded Organization of Pharmaceutical Producers of India (OPPI) OTC Health and Wellness Conference 2023. This accolade recognised La Shield’s innovative and impactful digital marketing strategy. The campaign ‘Be Sun wise’ leveraged the available online information through dynamic creative optimisation to provide consumers with relevant, real-time, city-specific UV inde

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Pharma Times

NOVEMBER 15, 2023

Both programmes will be offered to those most at risk of developing STIs - News - PharmaTimes

Vaccines 120

Vaccines 120

The Pharmacist

NOVEMBER 15, 2023

The Royal College of General Practitioners (RCGP) has called for pharmacist training and supervision to be resourced appropriately as the profession takes on more responsibility. This follows comments made by a GP panellist at the recent Royal Pharmaceutical Society (RPS) conference who suggested that training pharmacist prescribers was becoming a ‘burden’ on GPs tasked with […] The post Resource prescribing supervisors appropriately, calls RCGP appeared first on The Pharmacist.

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