Mon.Aug 28, 2023

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STAT+: Feds fine Medicare Advantage plans for overcharging their members

STAT

The federal government has started penalizing Medicare Advantage insurers that have one common, glaring problem: Faulty technology systems are leading to people paying more for care and coverage than they should be. The Centers for Medicare and Medicaid Services fined three different Medicare Advantage plans this month, each one getting dinged differently for the way they overcharged their members.

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Why pharma isn’t done tackling migraines

PharmaVoice

In the high-growth but competitive field of migraine treatments, CGRP drugs have changed the game — but the search is still on for more options.

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What do new weight loss drugs mean for the future of bariatric surgery?

STAT

Over the past year, weight loss drugs have captured the public’s imagination but also raised existential questions about the future of bariatric surgery. For obesity, surgery has long been — and continues to be — the most effective treatment, reducing patients’ risk of sleep apnea, diabetes, cancer, cardiovascular disease, and death.

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Are weight loss drugs a win for the global economy?

PharmaVoice

As Novo Nordisk’s drug Wegovy sways Denmark’s economy, we're examining wider implications for the weight loss market.

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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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Opinion: Psychiatrists like us cannot keep up with their inboxes

STAT

When you’re a psychiatrist, there’s no such thing as a typical day. But if you’re working in a clinic setting (like one of us, Jessi, is currently, and the other, Simone, has done previously), one thing is for sure: You’re busy. And it’s not just about seeing patients — it’s the seemingly ever-increasing electronic messages.

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FTC pulls back on legal challenge to Amgen’s $28B bid for Horizon

BioPharma Dive

Urged by a judge, the antitrust regulator said it wants to start discussions “regarding the proper resolution of this matter” — a potential prelude to a settlement.

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Superluminal draws RA Capital, Nvidia as investors in GPCR drug hunt

BioPharma Dive

GPCRs, a ubiquitous family of proteins that are prime drug targets, have drawn the interest of companies like Structure Therapeutics, Septerna and now Superluminal Medicines.

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STAT+: FDA delays enforcement of a pharmaceutical supply chain law to stop counterfeit drugs

STAT

In response to growing complaints, the U.S. Food and Drug Administration has postponed its plans to enforce a law designed to thwart counterfeit or diverted medicines passing through the pharmaceutical supply chain. The law was supposed to be fully enforced in late November, but the agency now says it will not take action until November 2024. At issue is the Drug Supply Chain Security Act, which has been implemented in steps over the past decade.

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Key Factors for Choosing the Right CDMO

Drug Patent Watch

In a guest column Kevin Wall, principal consultant and owner of Cincero Consulting, emphasizes the critical importance of selecting the right Contract Development and Manufacturing Organization (CDMO) for drug product… The post Key Factors for Choosing the Right CDMO appeared first on DrugPatentWatch - Make Better Decisions.

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ProMED issues ultimatum to striking moderators, as questions about site’s future persist

STAT

Striking moderators of the infectious diseases surveillance website ProMED have been given an ultimatum: Signal their interest in remaining with the program by Wednesday and return to work on Friday, or they will be considered to have “moved on” from the organization. The moderators, subject matter experts who are paid a nominal stipend for curating and contextualizing the numerous infectious diseases reports ProMED posts to its website and pumps out to its mailing list daily, have

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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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siRNA therapy shows long-term potential in lowering LDL-C

European Pharmaceutical Review

Novartis has announced that Leqvio ® (inclisiran) , the first and only small interfering RNA (siRNA) therapy indicated to reduce low-density lipoprotein cholesterol (LDL-C), has demonstrated promising long-term results. This is based on three-year follow up data from a Phase III trial, presented at the European Society of Cardiology (ESC) Congress 2023.

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A broad genetic test saved one newborn’s life. Research suggests it could help millions of others

STAT

CINCINNATI — Brynn Schulte nearly died twice when she was a baby, at one point needing emergency surgery for massive bleeding in her brain. No one knew what was wrong until a test that looked at her full genetic blueprint found a rare bleeding disorder called factor XIII deficiency — an early diagnosis that saved her life.

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Survivors Against TB urges immediate action to address critical anti-TB drug shortages

Express Pharma

Survivors Against TB (SATB), a collective of TB survivors, experts, and advocates, has written to Mansukh Mandaviya, the Minister of Health and Family Welfare, India, to address the alarming shortage of vital anti-TB drugs across different parts of the country. A statement from the collective informed, “Reports have surfaced indicating a severe shortage of essential anti-TB medications, including Linezolid, Clofazimine, and Cycloserine, in Government Hospitals and private pharmacies in Mumbai, U

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Artificial intelligence: The prime mover in drug discovery

BioPharma Dive

With its ability to process vast amounts of data and identify patterns, AI can significantly reduce the time and cost involved in developing new drugs.

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Researchers from Queen’s University Belfast develop 3D printed bandage to treat diabetic foot ulcers

Express Pharma

Queen’s University Belfast has designed a new 3D printed bandage which presents an innovative method of treatment to heal diabetic foot ulcers (DFUs). The new discovery combines lipid nanoparticles and hydrogels, which are used to create personalised skin-like 3D printed scaffolds. These scaffolds can release both a bulk and sustained release of antibiotic loaded molecules to treat diabetic ulcers.

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Bayer reports positive early data for Parkinson’s cell therapy

BioPharma Dive

The treatment, developed by a biotech Bayer acquired in 2019, appeared safe in a small trial and showed signs of an effect on disease progression.

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Specialised Therapeutics partners with Treeway to license ALS drug

Pharmaceutical Technology

Specialised Therapeutics has entered into a licensing agreement with Treeway for TW001, designed for treating amyotrophic lateral sclerosis.

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Venus Remedies gets Saudi marketing approval for Enoxaparin in PFS

Express Pharma

Venus Remedies has received marketing approval from Saudi Arabia for its product Enoxaparin in pre-filled syringes. A company statement informed that Venus Remedies has an annual capacity of producing more than five million units of Enoxaparin, a widely used anticoagulant that prevents blood clots, at its robotic line. Having secured marketing authorisations from Saudi Arabia for six antibiotics meant for intensive care units and three oncology products, Venus Remedies has so far sold more than

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Novartis completes acquisition of Chinook Therapeutics

World Pharma News

Novartis announced that it has completed its acquisition of Chinook Therapeutics, Inc., a Seattle, WA, based biopharmaceutical company focused on the discovery, development, and commercialization of precision medicines for kidney diseases, in a transaction valued at up to USD 3.5 billion.

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Exciting line-up and speakers for the IPF 7th annual summit in Boston next month

Outsourcing Pharma

With more than 63 biopharma companies attending and 15 event partners sharing solutions, the 7th annual IPF Summit being held in Boston next month (September 2023) is not to be missed.

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New patent for Accord drug CAMCEVI KIT

Drug Patent Watch

Annual Drug Patent Expirations for CAMCEVI+KIT Camcevi Kit is a drug marketed by Accord and is included in one NDA. It is available from one supplier. There are three patents… The post New patent for Accord drug CAMCEVI KIT appeared first on DrugPatentWatch - Make Better Decisions.

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Menopause and eye health softgels from Sirio to showcase at CPHI Barcelona

Outsourcing Pharma

CDMO, Sirio Europe, is launching two new softgels aimed at those who want to develop in the pharmaceutical consumer health space at this yearâs CPHI in Barcelona.

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New patent for Genentech Inc drug GAVRETO

Drug Patent Watch

Annual Drug Patent Expirations for GAVRETO Gavreto is a drug marketed by Genentech Inc and is included in one NDA. It is available from one supplier. There are two patents… The post New patent for Genentech Inc drug GAVRETO appeared first on DrugPatentWatch - Make Better Decisions.

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Wearables, Sensors, and Apps Part 2 – Development and Qualification of Digital Health Technologies in Drug and Biological Product Development

FDA Law Blog: Biosimilars

By Adrienne R. Lenz, Principal Medical Device Regulation Expert — Following up on our first post discussing Digital Health Technologies (DHTs) ( here ), this post will focus on development and qualification of DHTs for use in clinical trials for drug development. Earlier this year, FDA hosted a public meeting, Understanding Priorities for the Use of Digital Health Technologies to Support Clinical Trials for Drug Development and Review , intended to bring together key stakeholders, such as patie

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New patent for Cody Labs drug NUMBRINO

Drug Patent Watch

Annual Drug Patent Expirations for NUMBRINO Numbrino is a drug marketed by Cody Labs Inc and is included in one NDA. It is available from one supplier. The generic ingredient… The post New patent for Cody Labs drug NUMBRINO appeared first on DrugPatentWatch - Make Better Decisions.

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Could #MedThreads become the new #MedTwitter?

pharmaphorum

Could #MedThreads become the new #MedTwitter? Mike.

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Allucent to expedite Covid-19 booster vaccines development

Pharmaceutical Business Review

These candidates are being developed to offer better protection, extend the duration in preventing illness and transmission, as compared to the current vaccine technologies. As part of the contract, Allucent will initiate a Phase IIb clinical trial of 10,000 participants under BARDA’s Clinical Studies Network. The study will compare the relative efficacy of next-generation vaccines against approved vaccines to prevent symptomatic, PCR-confirmed SARS-CoV-2 infection.

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New Video Series: Are You at Higher Risk for COVID-19?

Putting Patients First Blog

New Video Series: Are You at Higher Risk for COVID-19? August 28, 2023 By: Jennifer Schleman, Senior Vice President, Communications & Governance Today, the National Health Council (NHC) announced a new digital video series that features discussions with prominent health care experts and advocates about the importance of measuring and reducing personal risk associated with COVID-19.

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Manage Stress and Support Adrenal Health with Adreset

Welltopia Pharmacy

Find relief from adrenal fatigue and stress with Adreset. Learn how to incorporate this natural supplement into your holistic stress management plan for optimal adrenal health and improved resilience to stress.

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Warehouse material handling for pharmaceutical industry

GMPSOP

Warehouse material handling for pharmaceutical industry Pharmaceuticals quality assurance & validation procedures GMPSOP Warehouse material handling for pharmaceutical industry Prev PREVIOUS POST Table of Contents Warehouse plays a significant role in ensuring pharmaceutical product quality. Warehouse material handling activities are at the heart of providing such high-level assurance.

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Menopause and eye health softgels from Sirio to showcase at CPHI Barcelona

Outsourcing Pharma

CDMO, Sirio Europe, is launching two new softgels aimed at those who want to develop in the pharmaceutical consumer health space at this yearâs CPHI in Barcelona.

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Danaher to buy antibody supplier Abcam for $5.7B

BioPharma Dive

The acquisition gives Danaher ownership of a producer of research tools, such as antibodies and reagents, that are used in drug discovery experiments.

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GC Biopharma and Eubiologics enter deal to produce cholera vaccine

Pharmaceutical Technology

GC Biopharma has signed a memorandum of understanding (MOU) with Eubiologics to jointly manufacture oral cholera vaccine, Euvichol.

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The intelligent content ecosystem is here. Is your organization ready?

BioPharma Dive

Is pharma up to the challenge of delivering the personalized and contextual experiences doctors have come to expect? Too often, the answer is no.

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Phebra, University of Wollongong partner to develop cancer therapies

Pharmaceutical Technology

Pharmaceutical firm Phebra has reached a new six-year collaboration agreement with Australia’s University of Wollongong (UOW)

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