Sat.Mar 11, 2023 - Fri.Mar 17, 2023

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Novo Nordisk follows Eli Lilly's lead, slashing insulin prices in the US

Fierce Pharma

Novo Nordisk follows Eli Lilly's lead, slashing insulin prices in the US kdunleavy Tue, 03/14/2023 - 10:56

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Top 10 Journal Articles To Read During Your Infectious Diseases Pharmacy Rotation

IDStewardship

In this post a top 10 list of journal articles to read during an infectious diseases pharmacy rotation is provided. Authored by: Timothy P. Gauthier, Pharm.D., BCPS, BCIDP Article Posted 12 March 2023 As a pharmacist serving as a preceptor to students and residents in the area of infectious diseases since 2010, I have always been on the hunt for good infectious diseases journal articles for my learners to read.

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VA To Cover Alzheimer's Drug, With Some Exceptions

Drug Topics

Per VA regulations, anyone who has had a stroke or seizure within the last year, as well as those with MRIs showing microhemmorrhages, aneurysms, lesions or tumors would be excluded from coverage of the drug, called Leqambi

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Polio cases derived from new oral vaccine reported for first time

STAT

Experts have long understood that a new polio vaccine developed to try to minimize the risks associated with the oral polio vaccine made by Albert Sabin might also cause the problem it was created to sidestep. It’s now clear that theoretical risk is a real one. The Global Polio Eradication Initiative announced Thursday that six children in the Democratic Republic of the Congo and one in Burundi have been paralyzed by viruses from the new vaccine, which is referred to as novel oral polio v

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Legal challenges put off label use of gender affirming care drugs in jeopardy

Pharmaceutical Technology

Earlier this week, the Florida Senate advanced a bill to restrict gender-affirming care for transgender minors. The bill is one of many that are currently being discussed in different states. Many politicians have cited doubts about the potential “harm” caused by puberty blockers and hormone therapies associated with gender-affirming care and concerns about incorrect treatment as major factors.

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Mass spectrometry software can link different data types

European Pharmaceutical Review

The latest version of software tool MZmine, which aids analysis of mass spectrometry data, has been released. Using this third generation software, scientists can analyse large volumes of data from mass spectrometry, processing thousands of samples within minutes to hours. [the newest version can process] thousands of samples within minutes to hours.” It is the first tool with an entire data processing pipeline that integrates liquid chromatography (LC)-ion mobility spectrometry (IMS)-MS a

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Denied by AI: How Medicare Advantage plans use algorithms to cut off care for seniors in need

STAT

An algorithm, not a doctor, predicted a rapid recovery for Frances Walter, an 85-year-old Wisconsin woman with a shattered left shoulder and an allergy to pain medicine. In 16.6 days, it estimated, she would be ready to leave her nursing home. On the 17th day, her Medicare Advantage insurer, Security Health Plan, followed the algorithm and cut off payment for her care, concluding she was ready to return to the apartment where she lived alone.

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Tapping into digital therapeutics to improve neurological outcomes

Pharmaceutical Technology

As the field of digital therapeutics continues to broaden, specific uses in mental health and neurology are increasingly making headway for patients and on the market. At the same time, experts are saying developers in the field need to double down on securing clinical data to allow for its continued maturation. Companies are testing the use of digital platforms along with pharmacological treatments.

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Surprising Gabapentin Side Effects

The People's Pharmacy

The Food and Drug Administration first approved Neurontin (gabapentin) in 1993 to treat epilepsy. Anticonvulsants are not normally blockbuster drugs. Perhaps that is why the original manufacturer, Parke-Davis, promoted the drug off-label to treat pain. You will read about the mischief that caused shortly. The marketing campaign was incredibly successful, though.

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Thoughts From the Streets: The Rise of Xylazine in Illicit Drug Use

Drug Topics

Rates of xylazine use have skyrocketed in since 2010, leading to an increase in overdoses and death.

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JAMA’s new editor settles in, bringing open access and other changes

STAT

ST. LOUIS — It’s been eight months since Kirsten Bibbins-Domingo, a general internist, cardiovascular researcher, and epidemiologist became the 17th editor in chief of the Journal of the American Medical Association and its network of journals. Bibbins-Domingo, who previously worked at the University of California, San Francisco, was named this week as a member of the 2023 STATUS List of people making a difference in health care and life sciences.

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Pharmanovia signs licence deal for Aeterna Zentaris’ Ghryvelin

Pharmaceutical Technology

Pharmanovia and Aeterna Zentaris have entered an exclusive licensing agreement for the latter’s medicine Ghryvelin (macimorelin). Under the deal, Pharmanovia will acquire the exclusive rights and license to commercialise Ghryvelin in the EEA and the UK from Consilient Health. Ghryvelin is used for the diagnosis of Adult Growth Hormone Deficiency (AGHD), a rare and serious condition, as well as for Childhood Onset Growth Hormone Deficiency (CGHD), if approved.

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10 Favorite Wart Remedies That Work!

The People's Pharmacy

Warts are mysterious. They raise more questions than answers. We do know that warts are caused by a virus (human papilloma virus or HPV ). How that virus penetrates the skin on fingers, hands or knees is unclear. Why are children more vulnerable to warts than adults? Why are some people vulnerable and others resistant? How do warts usually disappear on their own accord and on their own timetable?

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Novo Nordisk To Cut Insulin Prices Up To 75%

Drug Topics

According to a company press release, the price reductions will go into effect at the start of 2024

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‘I’m terrified’: Patients scramble for treatment after 13 ketamine clinics shut down

STAT

Around 4:30 p.m. last Friday, Ketamine Wellness Centers CEO Kevin Nicholson sent an email: In 30 minutes, the company would no longer be in business, he said. The message went out to some patients and to all of the employees of his company’s clinics across nine states — what had, up until moments before, been one of the largest ketamine clinic chains in the country.

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Talem and Libera Bio partner for discovery of AI-driven antibodies

Pharmaceutical Technology

Talem Therapeutics, a subsidiary of Immunoprecise Antibodies, has entered a multi-target artificial intelligence (AI)-driven antibody discovery collaboration with Libera Bio. The partnership will use nanotechnology, which was proven in vivo, for providing antibodies inside tumour cells and provides a potential solution to address the medical challenge.

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Andre Persaud departs Rite Aid

Drug Store News

Bill Miller, senior vice president of central retail operations, will serve as Rite Aid's acting head of retail operations, and Karen Staniforth, chief pharmacy officer, will oversee store pharmacy operations.

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President Biden Releases Op-Ed In New York Times Outlining Future Of Medicare

Drug Topics

The President said he will make Medicare “solvent beyond 2050 without cutting a penny in benefits.

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STAT+: Moderna CEO made $398 million in 2022, but still pledges to give most to charity

STAT

Moderna CEO Stéphane Bancel is starting to reap gargantuan gains from the stock he first got when he started with the company a decade ago, although nearly all of this chunk of his fortune remains earmarked for unknown charities. Bancel made $398 million in 2022 based on the actual realized gains of stock that was exercised and sold, according to STAT’s calculations from Moderna’s annual compensation disclosure filed this week.

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Brazil’s ANVISA approves Takeda’s dengue vaccine candidate Qdenga

Pharmaceutical Technology

The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). The vaccine has received approval for preventing dengue disease in people aged four years to 60 years. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes and is designed to provide protection against any of these.

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Pfizer to acquire Seagen for $43 billion

European Pharmaceutical Review

Pfizer has announced it will acquire Seagen Inc. for a total enterprise value of $43 billion. “Together, Pfizer and Seagen seek to accelerate the next generation of cancer breakthroughs and bring new solutions to patients by combining Seagen’s antibody -drug conjugate (ADC) technology… with Pfizer’s capabilities and expertise,” shared Dr Albert Bourla, Pfizer Chairman and Chief Executive Officer.

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FDA Grants De Novo Approval to Non-Invasive Tinnitus Treatment Device

Drug Topics

The product, called Lenire, uses bimodal stimulation and will be available in April 2023

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FDA offers radio silence on question of spring Covid boosters, as other countries push ahead

STAT

Are you six months out from your Covid-19 bivalent booster and wondering when you’ll be able to get another shot? If you live in the United Kingdom or Canada, you already have your answer. The Canadian and U.K. governments, acting on recommendations from expert committees, plan to offer spring booster shots for people at highest risk of getting severely sick from Covid.

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Risk sharing agreements soar as market access risk increases

Pharmaceutical Technology

Over the last twenty years, there has been a major rise in risk sharing agreements in the pharmaceutical space, said Alex Watt, GlobalData’s principal research analyst, at a recent webinar on the same topic. These agreements have been particularly propelled by the recent rise in inflationary pressures and pharmaceutical market instability, pushing healthcare systems to find new ways to reduce risks associated with new drugs.

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Occlutech launches FROST-HF study of heart failure device

Pharmafile

Occlutech has announced that it has recruited its first patient in the FROST-HF study, which aims to investigate the company’s atrial flow regulator (AFR) device to treat patients with heart failure. The study will include patients with either preserved ejection fraction (HFpEF) or reduced ejection fraction (HFrEF), assessing the company’s AFR device for its safety and effectiveness.

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Health Care Hiring Trends For 2023 And Beyond

Drug Topics

How are hiring trends shaping up for the future of health care?

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Large network of clinics offering ketamine for depression shuts down

STAT

One of the largest operators of ketamine clinics in the country abruptly closed its facilities this week, leaving patients in the dark and out of treatment for depression and other chronic conditions. Ketamine Wellness Centers spanning nine states were shuttered, leaving laid-off employees and patients with more questions than answers. Interest in ketamine to treat depression and other conditions has grown in recent years.

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GOSH and Leucid to manufacture novel CAR T therapy

European Pharmaceutical Review

In a first-of-its-kind commercial agreement, Great Ormond Street Hospital NHS Foundation Trust (GOSH) will work with Leucid Bio to manufacture LEU011, a lateral Chimeric Antigen Receptor (CAR) targeting NKG2D ligands. The CAR T therapy will be used in clinical studies for solid tumours and haematological malignancies. Under the agreement the parties will work together at state-of-the-art cleanroom facilities at the Zayed Centre for Research into Rare Disease in Children.

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Sandoz to build new biologics production plant in Slovenia to support biosimilars

Drug Store News

The Sandoz investment is expected to be at least $400 million, supporting the company’s ambition to drive the future growth of its global biosimilars portfolio.

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Can you drink while taking Mounjaro?

The Checkup by Singlecare

Similar to Ozempic, Mounjaro (tirzepatide) is a medication approved to treat Type 2 diabetes. It is prescribed alongside exercise and a balanced diet to manage high blood sugar levels. After its approval in 2022, healthcare providers also prescribed Mounjaro off-label for weight loss. When living with diabetes or trying to lose weight, there are special considerations around alcohol—how it affects your blood sugar and your waistline.

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STAT+: U.K. trade group suspends Novo Nordisk for ‘serious breaches’ in promoting obesity drug

STAT

In a rare move, a U.K. pharmaceutical industry trade group suspended Novo Nordisk for two years due to “serious breaches” involving the promotion of a weight-loss drug that violated a code of practice and discredited the entire sector. The Association of the British Pharmaceutical Industry took this step after receiving a complaint alleging the company had sponsored courses on weight management on LinkedIn for health professionals, without making clear that it was involved in the s

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LCRF, Daiichi Sankyo and AstraZeneca enter research collaboration

Pharmaceutical Technology

The Lung Cancer Research Foundation (LCRF) has announced a new research partnership with Daiichi Sankyo and AstraZeneca. This collaboration is intended to fund up to three research grants that are focused on antibody-drug conjugates (ADCs) for improving the outcomes for lung cancer patients. ADCs are designed for targeting cancer cells specifically and selectively provide a highly potent payload that may limit healthy cells’ damage.

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Barilla celebrates Mikaela Shiffrin with limited-edition pasta pack

Drug Store News

Barilla is celebrating Mikaela Shiffrin’s 87th World Cup victory with a pasta pack that features the brand’s iconic blue box pasta recipe made into 8 and 7 shapes.

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How to treat itchy eyes

The Checkup by Singlecare

If you’ve ever experienced dry, red, burning, itchy, or watery eyes, you know you need fast relief when this allergy symptom hits. Thankfully, there are many effective treatments. In fact, there are so many options that it can be overwhelming to narrow it down to the best allergy medicine for itchy eyes. Here, learn what your options are, along with expert advice on how to pick the most effective itchy eye medication for you.

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Opinion: The staggering financial burden of a proposed HIPAA rule

STAT

The already beleaguered U.S. health care system is facing a new and costly threat that will affect patient care and ultimately may lead to hospital closures : paying for and processing a torrent of medical record requests. While the news media in 2022 focused on hospitals’ billions of dollars of losses , negative operating margins, and other daunting post-pandemic challenges , a set of costly modifications to the HIPAA Privacy Rule proposed by the Department of Health and Human Services m

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New Trends & Requirements from Digitalization, Annex 1, Continuous Manufacturing & High Potent Manufacturing

ISPE

New Trends & Requirements from Digitalization, Annex 1, Continuous Manufacturing & High Potent Manufacturing Trudy Patterson Thu, 03/16/2023 - 08:00 iSpeak Blog iSpeak New Trends & Requirements from Digitalization, Annex 1, Continuous Manufacturing & High Potent Manufacturing Natalia Nikolaevna Vtyurina, PhD Dany SHAMI Richard Denk Amjad Wahbeh 16 March 2023 The pharmaceutical industry is rapidly evolving.