Mon.Jul 10, 2023

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STAT+: The new weight loss drugs are revolutionizing our understanding of desire. Food cravings could be just the beginning

STAT

One month it was pizza. Starting in the late afternoon, while he was teaching a chem lab or grading student work, a part of Anthony Fernandez’s brain would stray to visions of steaming pies. The thought of sinking his teeth into one would tug at him as he packed up his things and walked to his car. By the time he pulled out of the Merrimack College campus, the urge would become a tractor beam, reeling him into the small shop just shy of Route 125 for a slice or three.

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Cancer R&D is shifting — here’s what’s changing most

PharmaVoice

A report from IQVIA shows China gaining ground in cancer drug R&D, and a growing industry focus on new drug targets.

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Why nearly half of Americans with Parkinson’s don’t see a neurologist

STAT

It took Richard Huckabee nine years to get a Parkinson’s diagnosis. A district manager for a convenience store chain, he first noticed symptoms in 2004 when his voice would suddenly falter while speaking to large groups of employees. “It’s probably just stress,” Huckabee remembered his doctor saying. A year later came the brain fuzziness, with Huckabee forgetting his colleagues’ names, having his thoughts freeze mid-conversation, and fully losing his ability to

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The AI Revolution Has Arrived: Shaping the Next Generation of Pharma Marketing

PharmExec

Join five industry leaders as they unpack the transformative potential of artificial intelligence in the pharmaceutical industry, offering insights into real-world applications and the future of life sciences marketing in an era shaped by rapid technological evolution.

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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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A rare disease has run through five generations of his family, so he’s built community for others

STAT

For Jack Johnson, getting diagnosed with Fabry disease at age 7 was more of a formality. He’d been experiencing symptoms for several years already, and had watched multiple family members struggle with the rare condition. But around 7 was when Johnson’s pain started — triggered by exercise or being outdoors when it was too hot. Fabry disease is characterized by a buildup of the fatty lipid Gb3, which can cause gastrointestinal issues, kidney failure, stroke, chronic pain, an

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New report shows high-impact R&D happens after cancer medicines are first approved

PhRMA

A new report showcasing nine critical oncology treatments, highlights the vital role of post-approval research and development (R&D) in advancing cancer treatment options and delivering unprecedented progress in the fight against cancer over the past 10 years.

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European regulators probe suicide risk to Ozempic, other Novo drug Saxenda

BioPharma Dive

Three reports from Iceland spurred the EMA to evaluate whether certain Novo Nordisk drugs, including Ozempic, might cause thoughts of self harm.

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STAT+: Pharmalittle: European regulator probes suicidal risks of weight loss drugs; Pfizer reports shortages of penicillin for fighting syphilis

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because that oh-so-predictable routine of meetings and online calls has returned. But what can you do? The world, such as it is, continue to spin no matter how hard we try to slow it down. So time to give it a nudge in a better direction.

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Harnessing AI for Pharma Sales

PharmExec

Artificial intelligence is steadily becoming a game changer for the pharma industry, particularly in commercialization activities, such as sales and marketing—and efforts to help highly sought treatments reach the right patients.

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STAT+: Blue Cross Blue Shield insurers keep winning from Affordable Care Act’s risk program

STAT

A program that undergirds the Affordable Care Act’s health insurance marketplaces continues to bolster the balance sheets of large Blue Cross Blue Shield companies, according to a STAT analysis of new federal data. Conversely, that same program — called “risk adjustment” — has created substantial financial burdens for startup insurers including Bright Health Group, which has now exited all health insurance markets, and Friday Health Plans, which has shut down.

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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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Crossing the Brain Barrier

PharmExec

COMPASS Pathways’ CEO, Kabir Nath, has a clear vision for psychedelics—and is leading the way with the company’s focus on psilocybin and efforts to separate the science from the hype.

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STAT+: HCA discloses massive data breach affecting 11 million patients

STAT

HCA Healthcare revealed Monday that it’s experienced what is likely the largest data breach ever reported by a health care provider, with approximately 11 million patients affected. The for-profit hospital giant said hackers stole the data from an external storage location that’s used to automate emails and then posted the data to an online forum.

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Increased prescribing across four out of five kinds of mental health drug

The Pharmacist

The number of mental health medicines prescribed in 2022/23 in England has increased since last year across antidepressants, central nervous system and ADHD drugs, antipsychotics and drugs for dementia. But hypnotics and anxiolytics items and the number of patients using these items both decreased by 2% since last year, according to recent figures from the […] The post Increased prescribing across four out of five kinds of mental health drug appeared first on The Pharmacist.

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EMA revises guidance on nitrosamine impurities

European Pharmaceutical Review

As of 7 July 2023, the European Medicines Agency (EMA) has updated its guidance on nitrosamine impurities. The regulatory body has amended Q&A 10 to include the Carcinogenic Potency Categorization Approach (CPCA) and the enhanced Ames test (EAT) for establishing acceptable intakes (AIs) for N -nitrosamines. The assessment report of the Committee for Medicinal Products for Human Use (CHMP)’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal produ

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Dr Reddy’s selects AWS as cloud provider to develop pharma therapies

Express Pharma

Dr. Reddy’s Laboratories has selected Amazon Web Services (AWS) as its cloud provider to help provide access to affordable and innovative medicines. As part of the collaboration, the company has migrated it’s SAP platform entirely on to AWS. A company release from AWS informed, “By centralising the platform on the world’s leading cloud, Dr. Reddy’s will accelerate the development of new healthcare applications, grow its digital platform to help the organisation serve more than 1.5 billion patien

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Janssen reveals new Spravato data

Pharma Times

Period to remission was shortened with esketamine nasal spray in both sub-groups within study - News - PharmaTimes

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On the clock: a collaborative approach to advancing adoption of RMM

European Pharmaceutical Review

Traditional methods for assessing microbial contamination in pharmaceutical products can take weeks: sterility testing for final product requires 14 days of incubation (per USP <71> and Ph. Eur. 2.6.1), while mycoplasma determination in cell cultures can take up to 28 days (USP <63>, Ph. Eur. 2.6.7). Given their short shelf-life, there is a need for methods that generate more rapid results for emerging advanced therapy medicinal products (ATMPs) such as cell and gene therapies.

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GSK’s Arexvy authorised by MHRA

Pharma Times

Therapy is the first respiratory syncytial virus vaccine specifically developed for older adults - News - PharmaTimes

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Teeth brushing at night lowers risk of adverse cardiovascular events

The Pharmacist

Night-time teeth brushing is associated with a significantly lower risk of developing an adverse cardiovascular event, according to the findings of a recent Japanese study. Infrequent teeth brushing is associated with severe forms of periodontal disease. While patients with cardiovascular disease require special considerations, particularly in regard to dental treatment, it is also recognised that the […] The post Teeth brushing at night lowers risk of adverse cardiovascular events appeare

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The power of rapid methods for fungal ID

European Pharmaceutical Review

Fungal contamination in pharmaceutical products represents a potential hazard for two reasons. First, it may cause product spoilage; the metabolic versatility of fungi is such that any formulation ingredient may undergo chemical modification in the presence of a contaminating organism. Spoilage not only affects the therapeutic properties of a product but may also discourage the patient from taking the medication.

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Labetalol batch recalled due to wrong dosage labelling

The Pharmacist

A batch of Labetalol 200mg tablets has been recalled as they are incorrectly labelled as 100mg tablets on the foil blister packaging. But the Medicines Healthcare Products Regulatory Agency (MHRA) said that the actual tablets were 200g strength, consistent with the information on the outside of the box. Pharmacists have been instructed to immediately stop […] The post Labetalol batch recalled due to wrong dosage labelling appeared first on The Pharmacist.

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Titanium dioxide (E171) and its role in formulation

European Pharmaceutical Review

The ability to uniquely identify oral solid dosage (OSD) forms has been recognised by regulatory authorities worldwide as one of the mechanisms to reduce medication errors and to detect falsified medicines. Changes in the appearance of medicines has been identified as a factor in patient compliance and, therefore, clinical outcomes. In the development of a new drug product, it is necessary that each dosage form or strength incorporates mechanisms that enable its unique identification.

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The Power of Rebranding: How Website Rebranding Drives Increased Traffic

Pharma Marketing Network

In today’s digital landscape, a website serves as a vital touchpoint for businesses to connect with their target audience. However, over time, a website can become outdated, lose relevance, or fail to resonate with visitors. When done strategically, rebranding a website can breathe new life into your online presence and significantly boost traffic.

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Capsule formulation: future trends

European Pharmaceutical Review

What recent advancements have been made in pharmaceutical capsules? Gelatine also poses potential long-term performance challenges” Several major trends have emerged in recent years in the capsule space. First, we are seeing growing demand for new materials to replace the traditional gelatine capsule shell. One of the reasons for this is the growing importance of offering an alternative vegan capsule for patients who, for dietary reasons, do not want to consume animal products.

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Astellas buys rights to 4D Molecular’s technology in latest gene therapy deal

BioPharma Dive

The licensing agreement for the biotech’s viral vector platform follows recent Astellas agreements with Taysha Gene Therapies and Kate Therapeutics.

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CluePoints: 'there is true recognition risk-based quality management is not just monitoring'

Outsourcing Pharma

Updated guidelines for risk-based quality management (RBQM) are much more than just for monitoring purposes and can show quality by design concepts, save immeasurable time on manpower and shows there has been a complete mindset shift within the last 15 years, CluePoints says.

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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog: Biosimilars

By Philip Won & Adrienne R. Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. But that is only the beginning. After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% t

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New patent for Pharmacyclics Inc drug IMBRUVICA

Drug Patent Watch

Annual Drug Patent Expirations for IMBRUVICA Imbruvica is a drug marketed by Pharmacyclics Inc and is included in three NDAs. It is available from one supplier. There are fifty-five patents… The post New patent for Pharmacyclics Inc drug IMBRUVICA appeared first on DrugPatentWatch - Make Better Decisions.

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Ways to Spice Up Your Sponsorships in the Pharmaceutical Industry

Pharma Marketing Network

Sponsorships are a great way for pharmaceutical companies to connect with their target audience and promote their products or services. However, traditional sponsorships can be somewhat stale. If you want your sponsorships to stand out, you need to find ways to spice them up. Here are a few ideas: Get creative with your event sponsorships: Instead of just sponsoring a generic trade show booth, get creative with your event sponsorships.

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J&J snaps up Nanobiotix cancer radiotherapy in $2.5bn+ deal

pharmaphorum

J&J snaps up Nanobiotix cancer radiotherapy in $2.5bn+ deal Phil.

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Pharma Computer Software Assurance 2023 conference held in Mumbai

Express Pharma

The Pharma Computer Software Assurance 2023 conference’s third edition was recently held at Novotel Mumbai, Juhu Beach, on 22-23 June, 2023. The conference commenced with a Keynote address from Guneet Kaur Hayer, MD, Eminence Business Media. It was follwed by a panel discussion titled “CSV or CSA? CSV to CSA? CSV is CSA?”, moderated by Ken Shitamoto.

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Overcoming AAV manufacturing challenges

BioPharma Dive

Overcome issues with AAV vector scalability and reproducibility. Enable a wider application of gene therapies in a cost-effective and sustainable way.

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Bayer extends partnership with Peking University to foster pharmaceutical innovation in China

World Pharma News

Bayer and Peking University (PKU) will collaborate to foster the translation of basic pharmaceutical research into drug discovery and development, while accelerating scientific research on cutting-edge technologies across the pharmaceutical value chain. The collaboration will focus on selected key areas of interests, such as oncology, cardiorenal, immunology, as well as cell and gene therapy.

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AI-based heart disease tool wins Future NHS Award

pharmaphorum

AI-based heart disease tool wins Future NHS Award Phil.

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The Best 24 Easy-to-Use AI Tools

FADIC

Artificial intelligence (AI) has become indispensable for businesses and individuals in today’s fast-paced, technology-driven world. From automating mundane tasks to enhancing decision-making capabilities, AI revolutionises how we live and work. However, choosing the right one can be daunting with the plethora of AI tools available. Fret not; we have compiled a list of the best 24 easy-to-use AI tools that cater to a wide range of applications.