Fri.Oct 20, 2023

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Researchers try to tease out possible ties between long Covid and menopause

STAT

When she stopped getting her period in March 2022, Daryn Schwartz wasn’t especially concerned. At 42, she had recently come off birth control, and figured her cycles were still adjusting. When it hadn’t come back by the summer, she sought gynecological care, but was told to wait it out. So she did, with no changes. She was having other symptoms, too — fatigue, chronic pain, and difficulty focusing.

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SAEM Clinical Images Series: A Case of Painful Skin Lesions

ALiEM - Pharm Pearls

A 50-year-old Caucasian female with a history of hypertension, coronary artery disease, and insulin-dependent diabetes mellitus presents to the emergency department with a complaint of painful sores on the top of her left foot. She notes that ulcerations have formed over the past two weeks and reports a history of multiple recurrent usually non-tender skin lesions to her lower extremities, forearms, and hands over the past twenty years.

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STAT+: How biotech deal-making really works behind the scenes, according to founders

STAT

What does it feel like to run a biotech startup and then get “the call” — the one from the big pharma CEO who wants to acquire your company for billions of dollars? At the 2023 STAT Summit on Wednesday, senior biotech writer Adam Feuerstein posed this question to three people very qualified to answer it: Vlad Coric, chairman and CEO of Biohaven, which was acquired by Pfizer in 2022 for $11.6 billion; Jacob Van Naarden, former COO of Loxo Oncology , which was acquired by Eli

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Exclusive: Six in 10 pharmacists confident to deliver Pharmacy First this winter, suggests survey

The Pharmacist

More than six in 10 community pharmacists surveyed by The Pharmacist believe they have the capacity to deliver a common conditions service in England this winter. Those surveyed highlighted public and GP awareness, proper funding for the service and training for pharmacists as key enabling factors for the service. ‘More resources, clarity on payment reconciliation, […] The post Exclusive: Six in 10 pharmacists confident to deliver Pharmacy First this winter, suggests survey appeared first

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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+: Eli Lilly, riding a hot streak, expects to double planned employment in Boston research center

STAT

Eli Lilly and Co., which transformed itself from a stodgy underperformer into one of the world’s hottest pharmaceutical companies, said this week that the genetic medicine research center it plans to open in Boston in August will eventually employ twice as many workers as originally estimated. In February 2022, Lilly said that it would increase its modest Massachusetts workforce from 120 to 250 employees when it opened the $700 million Lilly Institute for Genetic Medicine along Fort Point

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MHRA finds fake Ozempic pens in UK supply chain

The Pharmacist

Pre-filled pens falsely labelled as Ozempic have been identified in the UK supply chain, the Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed. The pens were identified before reaching UK patients, and all affected pens have now been recalled and accounted for, the MHRA said. The products were imported from legitimate suppliers in Austria […] The post MHRA finds fake Ozempic pens in UK supply chain appeared first on The Pharmacist.

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Deep brain stimulation could improve memory loss in Alzheimer’s disease

Pharma Times

The new technology was safely trialled on 20 healthy volunteers for the first time ever - News - PharmaTimes

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Dobbs decision leaving broad imprint on reproductive medicine

STAT

NEW ORLEANS — The annual meeting of the American Society of Reproductive Medicine is usually a buoyant, shiny parade of new science, fresh technology products, and promises that together they will provide more people with more options than ever before for taking control of how and when, and if, they have children. This year’s event still bore the familiar trappings of hope — 8-foot-high photos of parents holding newborns bathed in rays of sunshine, a verdant “wishing

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Starvation stress key in Micrococcus luteus cleanroom survival

European Pharmaceutical Review

A paper by Tim Sandle, Head of Microbiology, Risk Management and Sterility Assurance at Bio Products Laboratory Ltd has underlined the importance of proper cleanroom disinfection practices by elucidating on the robust survival mechanism of the bacterium Micrococcus luteus (M. luteus). As “one of the most abundant organisms on the outer layer of human skin” M. luteus is a common contaminant recovered from cleanrooms, according to Sandle.

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STAT+: Pharmacists can make shortage drugs, but at what cost?

STAT

Pharmacists increasingly are being asked to make drugs in bulk for hospitals that are in short supply, and they’re even beginning to make chemotherapies. But some in the industry worry about the unintended consequences of overreliance. Hospitals’ reliance on pharmacist-made drugs, a practice called compounding, has risen in step with worsening drug shortages.

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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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New £30m initiative launched to support innovation against antimicrobial resistance

Pharma Times

Global innovators can apply to PACE to receive up to £1m per project - News - PharmaTimes

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STAT+: After a lull, the pace of FDA authorization of AI-enabled medical devices is rising

STAT

The Food and Drug Administration on Thursday released a new accounting of artificial intelligence tools cleared for use in health care, adding scores of new products designed to reshape care in several areas of medicine. The update included 171 new products that use artificial intelligence and machine learning, including 155 authorized since August of 2022.

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CAR-TCR 2023 – Tim McGuire

pharmaphorum

At CAR-TCR last month in Boston, pharmaphorum Editor in Chief Jonah Comstock grabbed some time with Tim McGuire, director of business development at biomanufacturer Resilience.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Merck cancer drug deal caps pharma investment influx into ‘ADC’ field

BioPharma Dive

With the alliance, Merck joins Pfizer, AstraZeneca and Gilead in staking major bets on the potential for antibody-drug conjugates to reshape cancer treatment.

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STAT+: Lilly complains to the U.S. International Trade Commission about unapproved versions of Mounjaro

STAT

As demand for weight-loss treatments intensifies, Eli Lilly has filed a complaint with the U.S. International Trade Commission against nearly a dozen online pharmacies that are allegedly selling unapproved versions of the Mounjaro diabetes drug, which is frequently used to combat obesity. The drugmaker maintained the companies are marketing “low grade” versions of products purporting to contain tirzepatide, which is the active pharmaceutical ingredient in Mounjaro.

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The Most Common OTC Resource

FADIC

The Most Common OTC Resource Navigating Over-the-Counter Choices The Indispensable Guidance of Pharmacists What are Over the Counter (OTC) Medications? OTC drugs are medications that are deemed safe and effective for use by the general public without seeking treatment from a health professional. People can follow the “Drug Facts Label” directions on OTC products for proper use.

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STAT+: Pharmalittle: China arrests an Astellas exec accused of spying; weight-loss drugs are being tested in children

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda: a trip to check in on the Pharmalot ancestors, tidying up the official grounds, and some overdue promenading with the official mascots. If time permits, we may also hold a listening party and, if so, the playlist may include this , this , this and this.

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Venus Remedies gets REO Certification from CII for second consecutive year

Express Pharma

Venus Remedies has received the Responsible Export Organisation (REO) certification from the Confederation of Indian Industry (CII). This is the second consecutive year that Venus Remedies has been recognised with this certification. The Responsible Export Organisation (REO) certification is a recognition awarded by the Confederation of Indian Industry (CII) to companies for responsible and sustainable export practices, ensuring high standards of quality, ethics, and integrity in their internati

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Why Biogen is purposefully becoming more risk averse, according to Biogen’s CEO

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Lots for you today from the 2023 STAT Summit. Our podcast came live from the rollicking Boston affair, and we heard from plenty of the field’s top players. This includes Biogen CEO Chris Viehbacher, who spoke of how the company wants to move forward in a more disciplined fashion.

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Could Eli Lilly deliver first-line atopic dermatitis treatment?

European Pharmaceutical Review

In a long-term extension study, Eli Lilly and Company’s biologic lebrikizumab enabled almost 80 percent of patients with moderate-to-severe atopic dermatitis (eczema), who continued monthly maintenance dosing for up to two years, to maintain fully or almost complete skin clearance for this period. According to research highlighted by Eli Lilly, lebrikizumab is an interleukin-13 (IL-13) inhibitor that blocks signalling of IL-13.

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We wish to offer cell and gene therapy in India at one-third or one-fourth the US cost

Express Pharma

In this video, Arun Anand, COO, Immuneel Therapeutics and Dr Bruce Levine, of the University of Pennsylvania Perelman School of Medicine and member of Immuneel Therapeutics’ Scientific Advisory Board, explain to Viveka Roychowdhury how CAR-T cell therapy empowers patients to use their own immune cells as “drug factories” With promising early results from the IMAGINE study on their first product, chimeric antigen receptor T (CAR-T) cell therapy Varnimcabtagene, Bengaluru-based I

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How Centralized Prescription Fulfillment Allows Pharmacists to Better Help Patients

Drug Channels

Today’s guest post comes from Melanie Christie, VP of Product Management at CoverMyMeds. Melanie discusses how the nationwide shortage of pharmacy technicians affects pharmacists. She argues that centralized prescription fulfillment can provide pharmacists with more time to care for patients while also reducing medication errors and accelerating time-to-treatment.

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Pfizer to price COVID treatment Paxlovid at $1,390 per course

Express Pharma

Paxlovid, the most commonly prescribed at home treatment for COVID19 in the U.S., will remain available for free to patients there until the the end of the year, Pfizer said Pfizer on Wednesday said it will set the U.S. price for its COVID-19 antiviral treatment Paxlovid at nearly $1,400 per five-day course when it moves to commercial sales after government stocks run out, more than double what the government currently pays for it.

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A Comprehensive Guide to Vitamins

FADIC

A Comprehensive Guide to Vitamins What are vitamins and minerals?   Vitamins and minerals are micronutrients the body requires to carry out a range of standard functions. However, these micronutrients are not produced in our food but are derived from our food. Vitamins are organic substances generally classified as fat-soluble or water-soluble.

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Interview: CRO Emmes on the unique challenges of clinical trials using psychedlics and the FDA guidance

Outsourcing Pharma

Feedback has been submitted to the US Food and Drug Administration (FDA) with guidelines intended for sponsors of clinical trials related to psychedelic compounds.

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Roche Pharma launches clinical trial excellence project in India

Express Pharma

Program partners with government hospitals to strengthen drug development in the country Roche Pharma India has announced the launch of its clinical trial excellence project in India with an objective to strengthen the capabilities of public health institutions to do clinical trials and drug research in the country. This will also enable these government hospitals to become the centres of excellence for clinical research in the country and move up the value chain.

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Amylyx Pharmaceuticals hopes to launch largest PSP trial to date by the end of 2023

Outsourcing Pharma

The treatment of rare brain disease, progressive supranuclear palsy (PSP), that has no disease modifying therapies, has been given a glimmer of hope by Amylyx Pharmaceuticals.

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NVIDIA banks on generative AI to pursue partnerships with biotechs

Pharmaceutical Technology

NVIDIA’s vice-president of healthcare, Kimberly Powell, discussed GenAI in pharma and the importance of partnerships.

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Center focused on finding cure for glioblastoma reveals AstraZeneca drug may be a success

Outsourcing Pharma

A small molecule kinase inhibitor has been trialed in humans for the first time as part of a glioblastoma treatment study.

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Axplora appoints Dr Stephan Haitz as President of Novasep CDMO Business Unit

Express Pharma

Axplora has appointed Dr Stephan Haitz as President of the Novasep CDMO Business Unit and member of the company’s Executive Committee, effective November 1, 2023. He will take over from Jean Bléhaut, who leaves the company after a career spanning more than 25 years. Haitz has a 20+ years’ business career in the pharma industry where he held various management positions within global CDMOs such as Solvias, Lonza and Cambrex.

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New tentative approval for Sandoz drug sugammadex sodium

Drug Patent Watch

Sugammadex sodium is the generic ingredient in two branded drugs marketed by Msd Sub Merck, Aspiro, Mylan, and Sandoz and, and is included in four NDAs. There is one patent… The post New tentative approval for Sandoz drug sugammadex sodium appeared first on DrugPatentWatch - Make Better Decisions.

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New deep brain stimulation could improve memory loss in Alzheimer’s patients

Outsourcing Pharma

Researchers at the UK Dementia Research Institute have developed a new form of deep brain stimulation that does not require surgery and could provide an alternative treatment option for debilitating brain diseases such as Alzheimerâs.

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New tentative approval for MYLAN drug sugammadex sodium

Drug Patent Watch

Sugammadex sodium is the generic ingredient in two branded drugs marketed by Msd Sub Merck, Aspiro, Mylan, and Sandoz and, and is included in four NDAs. There is one patent… The post New tentative approval for MYLAN drug sugammadex sodium appeared first on DrugPatentWatch - Make Better Decisions.

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Health Canada grants NOC to Sumitomo and Pfizer’s MYFEMBREE

Pharmaceutical Technology

Health Canada has granted a Notice of Compliance (NOC) to Sumitomo Pharma Canada and Pfizer Canada’s MYFEMBREE.

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