Wed.Nov 15, 2023

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FDA grants approval for first time to a home test for chlamydia and gonorrhea

STAT

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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A biotech tackles drug discovery with transcription factor know-how

PharmaVoice

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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Trending Sources

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STAT+: Life scientists’ flight to biotech labs stalls important academic research

STAT

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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ACMT Toxicology Visual Pearl – Apricot Kernels: Eat or pass?

ALiEM - Pharm Pearls

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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Position Your Pharmacy for Expansion

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.

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STAT+: House moves to limit so-called gain-of-function research

STAT

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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Breaking: Pharmacy First to launch end of January

The Pharmacist

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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The power of genomics-based healthcare remains largely untapped

PharmaVoice

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

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STAT+: House panel passes PBM reforms, ratcheting up chance for passage

STAT

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.

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FDA Approves CorMedix Inc’s Treatment for Bloodstream Infections in Patients Receiving Dialysis

PharmExec

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+: More drug and device patents were invalidated for bad info than those filed by other industries, analysis finds

STAT

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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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Resource prescribing supervisors appropriately, calls RCGP

The Pharmacist

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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Opinion: Hospital systems have to decide: Do they want to be Apple or Android?

STAT

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.

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'Unwelcome' GPhC 7.5% fee increase confirmed

The Pharmacist

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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Type 2 diabetes prevention programs can work at large scale, study finds

STAT

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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2024 Pipeline Report: First-World Focus

PharmExec

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.

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Opinion: Listen: The true costs of mediocre insurance plans for medical students

STAT

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.

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Study shows how congenital heart disease affects blood supply before birth

Pharma Times

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

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STAT+: FDA’s latest reorganization puts a new emphasis on its investigations

STAT

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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A gene editing biotech’s struggles end with reverse merger

BioPharma Dive

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+: To get things done fast at FDA: ‘Don’t tell anybody,’ cancer chief says

STAT

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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CHMP recommends new immunotherapy delivery method

European Pharmaceutical Review

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+: After four patients died of gene therapy, Astellas sees possible explanation — and a way forward

STAT

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.

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Breaking Down the 2024 PRITE Blueprint

Board Vitals - Pharmacist

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+: Pharmalittle: German regulator eyes Ozempic export ban amid shortages; NIH-funded clinical trials lagging pharma’s in enrollment

STAT

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.

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Verve’s gene-editing therapy trial to lower cholesterol levels opens doors for use in CVDs: GlobalData

Express Pharma

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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The apparently strong correlation between biotech stocks and the price of eggs, explained

STAT

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.

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Medicare Part D in 2024: Mapping Large Chains' Position in 2024’s Preferred Pharmacy Networks

Drug Channels

In Medicare Part D in 2024: The Seven Largest Companies' Preferred Pharmacy Networks and the Coming Collapse of the PDP Market , I documented how those networks now dominate stand-alone Medicare Part D prescription drug plans (PDPs) and have become a major presence in Medicare Advantage prescription drug (MA-PD) plans. Today, I examine the seven largest retail chains’ participation in the 20 major 2024 Part D networks that the eight largest plan sponsors will offer.

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JCVI advises UK government on gonorrhoea and mpox vaccinations

Pharma Times

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

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Glenmark’s La Shield gets Best Consumer Healthcare Digital Marketing Campaign Award

Express Pharma

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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Gilead expands Arcellx cancer cell therapy deal

BioPharma Dive

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

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HealthPlix appoints new senior VP-Pharma, Business Development & Growth Catalyst

Express Pharma

He will also be responsible for identifying new growth opportunities in the healthcare sector and establishing new verticals HealthPlix Technologies has announced the appointment of Amitabha Mukhopadhyay as the Senior Vice President – Pharma, Business Development, and Growth Catalyst. In his new role, he will play a crucial role in fostering collaborations to enhance HealthPlix’s presence in the pharma domain.

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The evolving landscape of medicinal cannabis and its synergy with pharmaceutical giants

pharmaphorum

The evolving landscape of medicinal cannabis and its synergy with pharmaceutical giants Nicole.

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NHS sets sights on ending cervical cancer by 2040 with HPV vaccine drive

Pharmaceutical Technology

Chief executive Amanda Pritchard says vaccination and screening could make eliminating cervical cancer a reality in the next two decades.

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New health secretary calls for ‘partnership’ across settings

The Pharmacist

The new health and social care secretary has used her first speech in post to highlight the importance of general practice and pharmacy working together, alongside other settings, to help create 'strong and integrated’ care across England. Speaking at the NHS Providers conference today, Victoria Atkins also said that delivering the Urgent and Emergency Care […] The post New health secretary calls for ‘partnership’ across settings appeared first on The Pharmacist.

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Women in Science: Cynthia Pussinen, CEO of Sernova on how her career was 'written in the stars'

Outsourcing Pharma

Cynthia Pussinen knew she wanted to work in STEM fields by the time she was a teenager, she received a full scholarship to study nuclear engineering but after two years changed to chemistry for her major.

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