STAT

MARCH 13, 2023

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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Nursing Homes 364

LifeProNow

MARCH 12, 2023

March 10, 2023 : “LEO Pharma, a global leader in medical dermatology, and ICON plc announced a strategic partnership that will enable LEO Pharma to scale clinical trial execution that is patient-centric and cost effective, and which will support the company’s overall ambition of building one of the most effective and efficient clinical portfolio execution organisations in the industry.

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PharmaVoice

MARCH 14, 2023

To expand its reach, Christiane Langer, the company’s head of medical affairs, is leaning on connections and singularity over fitting in a box.

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BioPharma Dive

MARCH 17, 2023

The regulator will convene a panel of advisers to consult on an approval decision for the biotech’s Duchenne treatment, a change from just a few weeks ago when Sarepta had said a meeting wouldn’t be held.

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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.

STAT

MARCH 15, 2023

In the summer and fall of 2021, West Nile virus spread rapidly through Arizona’s Maricopa County and other areas of the state. The outbreak, with more than 1,700 cases reported and 127 deaths. was the largest in the United States since the mosquito-borne virus first emerged in this country in 1999. But with the nation facing a far larger public health crisis with the Covid-19 pandemic, it went almost unnoticed.

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Pharmaceutical Technology

MARCH 14, 2023

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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European Pharmaceutical Review

MARCH 14, 2023

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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STAT

MARCH 17, 2023

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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Pharmaceutical Technology

MARCH 17, 2023

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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PharmaVoice

MARCH 15, 2023

Welcome to the Woman of the Week podcast, a weekly discussion that illuminates the unique stories of women leaders who are catalyzing change throughout the life sciences industry. You can check out all our podcast episodes here. When Novartis acquired AveXis and its spinal muscular atroph.

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Pharmacy Management

European Pharmaceutical Review

MARCH 17, 2023

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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Immunity Immunization Hospitals 105

STAT

MARCH 17, 2023

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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Pharmaceutical Technology

MARCH 16, 2023

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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Compounding 104

PharmaVoice

MARCH 16, 2023

The recent departure of neurodegenerative development head Samantha Budd Haeberlein is just the latest sign of a changing tide among Biogen’s post-Aduhelm leadership.

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Pharmafile

MARCH 14, 2023

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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STAT

MARCH 17, 2023

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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Vaccines 275

Express Pharma

MARCH 17, 2023

India is set to become a major player in the global nutraceutical industry, with a projected $100 billion valued market by 2030. But nutraceuticals lack the oversight of pharmacovigilance, a practice that is commonplace in pharmaceutical studies to ensure safety and efficacy of products before they are launched to retail consumers. NutrifyToday’s NutrifyGenie, a ground-breaking AI-powered engine designed to facilitate the development of ethical nutraceutical formulations, hopes to cut time to ma

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PharmaVoice

MARCH 14, 2023

Priyanka Dutta-Passecker, head of wound-care specialist Healiva, discusses the importance of tapping her network in starting and running a biotech.

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European Pharmaceutical Review

MARCH 15, 2023

New targeted drug revumenib facilitated complete response in around 40 percent of patients with acute leukaemia subtypes, according to data in a new pair of studies ( 1 ) and ( 2 ) published in Nature. The two genetic subtypes of acute leukaemia involved in this research are “driven by a rearrangement of the MLL1 gene or a mutation in the NPM1 gene.

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STAT

MARCH 16, 2023

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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Pharmaceutical Technology

MARCH 17, 2023

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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PharmaVoice

MARCH 13, 2023

Across therapy areas, GoodRx Assist is a proven point-of-sale rebate program for cash-paying patients.

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Med Ed 101

MARCH 15, 2023

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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STAT

MARCH 16, 2023

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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FDA Law Blog: Biosimilars

MARCH 13, 2023

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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PharmaVoice

MARCH 17, 2023

Dr. Ryan Saadi, CEO of Tevogen Bio, is making good on a lifelong goal of bringing T cell therapies to people who need them.

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Digital Pharmacist

MARCH 14, 2023

Allergy season comes every year and pharmacies need to ensure that patients know how to identify and treat their symptoms accurately. Nearly 15% of Americans (over 24 million) deal with diagnosed hay fever, according to the CDC. Close to 10% of children have some sort of respiratory allergy. Altogether, seasonal allergies cause around 12 million primary care visits each year.

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STAT

MARCH 13, 2023

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 Law Blog: Biosimilars

MARCH 12, 2023

The COVID-19 pandemic emergency forced federal regulators to take extraordinary measures to ensure that patients were permitted continued access to important medicines. These government measures included granting temporary exemptions from certain FDA and DEA legal requirements. When the public health emergency ends on May 11, 2023 , so do these exemptions.

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Controlled Substances 98

PharmaVoice

MARCH 16, 2023

A $43 billion deal that doubles the pharma giant's cancer pipeline shows that M&A is back on the table in pharma.

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Digital Pharmacist

MARCH 13, 2023

Purchasing software can seem like a daunting task for pharmacy owners to tackle on top of all their other day-to-day tasks – but purchasing the right software can automate those tasks and thus free up so much valuable time in the long run. Today we will discuss some pain points to avoid in the process to help you choose wisely the first time and get to the end goal… a more efficient team and happier patients.

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STAT

MARCH 16, 2023

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.

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Drug Pricing 246

Pharmafile

MARCH 15, 2023

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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PharmaVoice

MARCH 15, 2023

What we’re looking for in each new class of honorees.

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Pharma Times

MARCH 15, 2023

Lyophilized PCR reaction bead reduces the cost of transport and extends shelf life for the test

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