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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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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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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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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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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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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Continued Antidepressant Use Helps Pregnant Women Manage Severe Mental Illness

Drug Topics

There was a lower probability of initiating psycholeptics and experiencing postpartum psychiatric emergencies in study patients who continued using antidepressants

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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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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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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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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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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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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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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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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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‘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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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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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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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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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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Badass Staff Meetings: Here is the Formula

DiversifyRx

Let’s talk about all things staff meetings We don’t have a choice. Running staff meetings is a necessity we can not ignore if we want to create a badass pharmacy team. Staff meetings are an opportunity to gain more team engagement, discuss new and upcoming initiatives, collaborate on ideas, learn what’s working and what’s not, and uncover any customer service issues that need attention.

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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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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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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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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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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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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.

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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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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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Publix associates help the environment during 2023 Publix Serves Week

Drug Store News

More than 7,500 associates will volunteer at over 200 organizations, including Keep America Beautiful affiliates, parks, zoos, gardens and other nonprofits focused on environmental sustainability.

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Novo Nordisk to cut insulin prices by up to 75% in 2024

Pharmafile

Danish pharmaceutical company Novo Nordisk has announced that it will cut its prices for insulin products by up to 75%, beginning in January 2024. The price of Novolog and Novolog Mix 70/30 will be cut by 75%, with Novolin and Levemir seeing a 65% reduction in price. Novo’s cuts will take effect around the same time that the American Rescue Plan will be introduced.

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STAT+: Veterans Health Administration will cover the newest Alzheimer’s drug

STAT

In an unexpected move, the Veterans Health Administration decided that it will widely cover a new Alzheimer’s treatment , even as Medicare has decided to wait for additional data about the medicine before taking the same step. The VA will provide coverage to veterans who meet agency criteria for using the medicine — called Leqembi — as well as stipulations on the product labeling, according to a statement from Eisai, which is partnering with Biogen to market the treatment.

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FDA approves nasal spray to treat migraine

The Checkup by Singlecare

On March 10, the U.S. Food and Drug Administration approved Zavzpret, the first calcitonin gene-related peptide (CGRP) antagonist nasal spray to treat acute migraine (with or without aura) in adults. This could mean faster—and more effective—treatment for many of the 40 million people in the U.S. who experience migraine. Read on to see what we know about this new medication and when it will be available.

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Inhaled Fluticasone and CYP3A4 Interactions

Med Ed 101

Fluticasone is one of the most commonly used inhaled corticosteroids for the management of asthma and other respiratory conditions. I’ve encountered drug interactions frequently with fluticasone because it is metabolized by CYP3A4. I’ve seen this interaction flagged on many drug interaction programs. In this article, I’ll discuss the practical implications of dealing with inhaled fluticasone […] The post Inhaled Fluticasone and CYP3A4 Interactions appeared first on Med Ed

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What Do Patients Have to Say about Gene Therapy Trials? An Upcoming FDA Public Meeting to Hear from Patients and Caregivers

The FDA Law Blog

By Larry J. Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision ab

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STAT+: Sanofi becomes the third leading insulin maker to lower list prices, cutting Lantus price by 78%

STAT

Following the lead of its rivals, Sanofi will cut the price of its most widely prescribed insulin in the U.S. by 78% and also place a $35 cap on out-of-pocket costs for commercially insured patients who take the treatment, which is called Lantus. The moves will go into effect on Jan. 1, 2024. The change comes after Eli Lilly and then Novo Nordisk announced plans this month to reduce list prices for some of their own insulin products by similar amounts.