Pharmaceutical - Pharma Rep Focus

Syndax Pharmaceuticals Leukemia Drug Wins a First-in-Class FDA Approval

MedCity News

NOVEMBER 18, 2024

The post Syndax Pharmaceuticals Leukemia Drug Wins a First-in-Class FDA Approval appeared first on MedCity News. Approval of Syndax’s Revuforj for acute leukemia makes the twice-daily pill the first in a new class of drugs that block a cancer-driving protein called menin.

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Gene Therapy in an Implant: Neurotech Lands First FDA Approval in Rare Vision Disorder

MedCity News

MARCH 9, 2025

Neurotech Pharmaceuticals surgically implanted cell and gene therapy, Encelto, is now FDA approved to treat macular telangectasia type 2 (MacTel). Its the first therapy for this rare retinal degeneration disorder. The post Gene Therapy in an Implant: Neurotech Lands First FDA Approval in Rare Vision Disorder appeared first on MedCity News.

FDA

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Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M

MedCity News

NOVEMBER 6, 2024

Acadia Pharmaceuticals did not disclose the buyer of the priority review voucher. The biotech received the voucher last year alongside the regulatory decision that made its drug Daybue the first FDA-approved treatment for the rare disease Rett syndrome.

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The Chase for Novel Oral GLP-1 Obesity Meds Adds a New Contender

MedCity News

DECEMBER 26, 2024

Corxel Pharmaceuticals has acquired an oral small molecule GLP-1 agonist with potential applications in obesity and diabetes. The Phase 2-ready pill could compete with oral metabolic meds in development by companies such as Roche, AstraZeneca, and Structure Therapeutics.

Pharmaceutical

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Vertex Pharma’s Opioid Alternative Wins FDA Approval, First in a New Class of Pain Meds

MedCity News

JANUARY 31, 2025

Vertex Pharmaceuticals Jounavx is now FDA approved, providing patients a non-opioid option for treating acute pain. The twice-daily pill is the first in a new class of medicines that block a key pathway in the peripheral nervous system.

FDA

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It's a monster MASH for Madrigal as Rezdiffra has caught on in a flash

Fierce Pharma

OCTOBER 31, 2024

Forget about the “bumpiness” analysts expected from Madrigal Pharmaceuticals’ launch of potentia | Forget about the “bumpiness” analysts expected from Madrigal Pharmaceuticals’ launch of potential blockbuster Rezdiffra.

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Novartis, Apellis drop dueling datasets as they race for approval in rare form of kidney disease

Fierce Pharma

OCTOBER 28, 2024

Novartis and Apellis Pharmaceuticals have rolled out detailed data on iptacopan and pegcetacoplan, respectively, as they race for the prize in a type of rare kidney disease. Novartis and Apellis dropped new data on their respective meds, iptacopan and pegcetacoplan, in the rare kidney disease C3 glomerulopathy.

Pharmaceutical

The Financial Potential of Convertible Notes in the Pharmaceutical Sector

MedCity News

JUNE 26, 2024

The post The Financial Potential of Convertible Notes in the Pharmaceutical Sector appeared first on MedCity News. These notes serve not only as a means to raise capital but also as a bridge to future financing rounds or significant liquidity events.

Pharmaceutical

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AI-Powered Insights for Personalized Customer Experiences: The Art of Data-Driven Engagement

MedCity News

NOVEMBER 26, 2024

While advanced analytics and AI can unlock unprecedented insights, it’s the thoughtful application of these insights that transforms routine interactions between pharmaceutical representatives and healthcare providers into lasting relationships.

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In the Pharmaceutical Industry, Ethics are Still More Valuable Than AI

MedCity News

AUGUST 29, 2024

The post In the Pharmaceutical Industry, Ethics are Still More Valuable Than AI appeared first on MedCity News. This responsibility goes beyond mere box-ticking; it requires a deep, introspective examination of our own biases and blind spots and a genuine commitment to putting the well-being of the communities we serve first.

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European Pharmaceutical Review Issue 5 2024

European Pharmaceutical Review

NOVEMBER 21, 2024

The post <em>European Pharmaceutical Review </em> Issue 5 2024 appeared first on European Pharmaceutical Review. Register your details to access this exclusive content!

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Teva and Sanofi Mid-Stage Data Reveal Shows Best-in-Class Potential for IBD Drug

MedCity News

DECEMBER 17, 2024

The Teva Pharmaceuticals and Sanofi drug, duvakitug, showed statistically significant and clinically meaningful results in a Phase 2b study in ulcerative colitis and Crohns disease. The drug is part of an emerging class of therapies that target TL1A, a protein involved in signaling that drives inflammation.

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Generative AI: Revolutionizing Pharmaceutical Industry and Driving Precision Medicine With Innovation, Equity and Ethics

MedCity News

SEPTEMBER 20, 2023

In the realm of pharmaceuticals, where innovation can be the difference between life and death, the emergence of generative AI, has been nothing short of transformative. By harnessing the capabilities of AI, the pharmaceutical industry is unlocking novel possibilities that were once deemed unattainable.

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FDA Nod for BridgeBio Brings New Competition to Blockbuster Pfizer Cardio Drug

MedCity News

NOVEMBER 25, 2024

But new competition to both products could come soon from Alnylam Pharmaceuticals, now set to receive an FDA decision in this indication by late March. BridgeBio Pharma claims its drug, Attruby, has an edge over a Pfizer drug as a treatment for cardiomyopathy caused by transthyretin-mediated amyloidosis.

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Axsome Aims for FDA Filing in Alzheimer’s Agitation Despite Mixed Bag of Phase 3 Data

MedCity News

DECEMBER 30, 2024

Axsome Therapeutics aims to offer an alternative to Rexulti, a Lundbeck and Otsuka Pharmaceutical product that is the only FDA-approved Alzheimers agitation drug. One Phase 3 test of Auvelity met its main goal in Alzheimers agitation while the drugs other pivotal trial showed numerical improvement that fell short of statistical significance.

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Building Resilience: CDMO Strategies for Drug Supply Chain Stability

MedCity News

FEBRUARY 2, 2025

As the pharmaceutical landscape evolves, small-molecule CDMOs will be essential in balancing supply and demand, driving innovation, and improving patient outcomes. They must continue embracing innovation and strategic agility to survive and thrive in this complex environment.

Pharmaceutical

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Trends shaping the pharmaceutical industry in 2024

PharmaVoice

DECEMBER 18, 2023

Advancements in cloud and AI technology will transform clinical trial efficiency and engagement.

Pharmaceutical

Bain Capital Broadens Its Biotech Reach With $3.3B Deal for Mitsubishi Tanabe Pharma

MedCity News

FEBRUARY 7, 2025

This business is the pharmaceuticals division of Japanese conglomerate Mitsubishi Chemical Group. Bain Capitals buyout of Mitsubishi Tanabe Pharma brings a company with a drug portfolio and pipeline in areas such as immunology, central nervous system disorders, and metabolic disease. The post Bain Capital Broadens Its Biotech Reach With $3.3B

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Kura Oncology Gets $330M to Kick Off Global Leukemia Drug Pact With Kyowa Kirin

MedCity News

NOVEMBER 21, 2024

Ziftomenib is in the same class of medicines as Syndax Pharmaceuticals’ Revuforj, which won FDA approval last week. Kura Oncology already had a broad development plan for ziftomenib in leukemias, but the agreement with Kyowa Kirin provides the cash to execute it and a partner to commercialize the drug globally.

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Bristol Myers Squibb’s Sotyktu Meets Goals in Two Pivotal Psoriatic Arthritis Studies

MedCity News

DECEMBER 23, 2024

Bristol Myers Squibb is trying to add new indications for the drug and stay ahead of competitors including Takeda Pharmaceutical. Sotyktu, which became the first TYK2 inhibitor to reach the market after its 2022 FDA approval in plaque psoriasis, now has positive data from two pivotal tests in psoriatic arthritis.

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Sustainable method converting waste into pharmaceuticals developed

European Pharmaceutical Review

MARCH 3, 2025

A team of researchers in Japan have developed a novel artificial photosynthesis method that transforms waste organic compounds into valuable pharmaceuticals and energy using sunlight and water. The APOS technique also demonstrated its ability to modify existing pharmaceuticals, such as a drug used to treat high lipid levels.

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Scilex's Semnur Pharmaceuticals to go public through $2.5B SPAC merger as it advances sciatica prospect

Fierce Pharma

SEPTEMBER 3, 2024

Semnur Pharmaceuticals, which is working on a non-opioid prospect for sciatica, has agreed to merge with special purpose acquisition company Denali Capital Acquisition Corp. Semnur Pharmaceuticals is following in its parent company Scilex's footsteps with a special purpose acquisition company (SPAC) merger.

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Novartis Nabs First FDA Nod in Rare Kidney Disease, But Apellis Pharma Is on Its Heels

MedCity News

MARCH 23, 2025

But Apellis Pharmaceuticals Empaveli has superior clinical data, and that drug has been submitted for FDA review in the same rare kidney disease as well as another one that does not yet have an approved therapy. Novartiss Fabhalta is the first FDA-approved therapy for C3 glomerulopathy.

FDA

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Supernus Wearable Device for Dosing Parkinson’s Drug Lands Long-Awaited FDA Approval

MedCity News

FEBRUARY 4, 2025

Supernus Pharmaceuticals Onapgo provides a continuous infusion of apomorphine to manage off periods experienced by Parkinsons disease patients. Approval of Onapgo comes after the FDA twice turned back applications for the drug/device combination product.

FDA

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After prior trial flop, EyePoint's Duravyu bounces back with promising data in DME

Fierce Pharma

OCTOBER 28, 2024

Earlier this year, EyePoint Pharmaceuticals’ drug-device combo Duravyu missed the mark in a non-proliferative diabetic retinopathy (NPDR) study, raising doubts about the product’s potential in seve | EyePoint released new diabetic macular edema data Monday that a Mizuho Securities analyst described as "very promising."

Leads

Leads Pharmaceutical

AI IN PHARMACEUTICAL MARKETING: Optimizing Automation and Expertise

PM360

JANUARY 24, 2025

AI drives automation and optimization that empower pharmaceutical marketers to rapidly scale commercialization-oriented content and activities. The transformative impact of AI on pharmaceutical marketing is significant, with much to consider regarding its promise and how its reshaping the industry.

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Novartis falls short in legal effort to undo FDA approval of MSN's Entresto generic

Fierce Pharma

OCTOBER 17, 2024

As a host of generics circle the gates, Novartis has lost another bid to waylay MSN Pharmaceuticals’ copycat of the Swiss pharma’s top-selling drug Entresto. | In a court decision filed in Washington, D.C., District Judge Dabney Friedrich rejected Novartis’ position that the FDA’s approval of MSN’s Entresto generic was unlawful.

FDA

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Teva hands over $450M to resolve kickback lawsuits involving MS drug Copaxone and generics

Fierce Pharma

OCTOBER 11, 2024

Teva Pharmaceuticals USA and Teva Neuroscience have agreed to pay a combined $450 million to resolve claims that the company violated the United States' Anti-Kickback Statute and the False Claims Act, the U.S.

Pharmaceutical

Regeneron Bets $100M That Mammoth’s CRISPR Tech Can Deliver on Next Wave of Genetic Medicines

MedCity News

APRIL 25, 2024

Regeneron Pharmaceuticals is collaborating with CRISPR technologies startup Mammoth Biosciences to develop in vivo gene-editing therapies. The deal marks the third pharmaceutical industry partnership for Mammoth, which initially focused on developing CRISPR-based diagnostics.

Medicine

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CDMO Samsung Biologics bags $1.2B production contract, bringing total 2024 deal value to $3.3B+

Fierce Pharma

OCTOBER 22, 2024

billion contract with an unnamed Asia-based pharmaceutical company that’s expected to run through December 2037. With multiple high-profile production pacts already in the books for 2024, CDMO Samsung Biologics has hooked another big one. Following a string of high-profile deals, Samsung Biologics has locked down a $1.2

Pharmaceutical

Pharmaceutical training boost: how the growth and skills levy could shape industry development

European Pharmaceutical Review

FEBRUARY 17, 2025

For the pharmaceutical industry, where rapid innovation requires continuous upskilling and reskilling of employees, this reform could significantly improve access to tailored training opportunities.

Training

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Cozadd's coda: Jazz unveils succession plan as longtime CEO and co-founder plots retirement

Fierce Pharma

DECEMBER 17, 2024

Its the end of an era at Jazz Pharmaceuticals as the drugmakers co-founder and CEO, Bruce Cozadd, eyes his exit after nearly 22 years with the companysome 15 of which were spent at the helm. Current helmsman Bruce Cozadd plans to retire from his role at Jazz Pharmaceuticals in the next 12 months, the company said Monday.

Pharmaceutical

FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains

Fierce Pharma

NOVEMBER 12, 2024

In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval for its liver disease drug Ocaliva has come up short.

FDA

FDA Pharmaceutical

Recursion Pharma Accelerator Steps In to Fill Some of the Funding Gap Amid NIH Tumult

MedCity News

FEBRUARY 19, 2025

Accepted applicants will be admitted to Altitude Lab, the Salt Lake City biotech accelerator formed by Recursion Pharmaceuticals. Altitude Lab Fund will provide pre-seed funding for early-stage startups affected by changes to grant programs administered by the National Institutes of Health.

Pharma

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Choosing the Right Pharmaceutical Marketing Company: Strategies for Pharma Success

Pharma Marketing Network

FEBRUARY 17, 2025

Introduction: Choosing the right pharmaceutical marketing company is like picking a strategic partnerit can make or break your brands success. This article will guide you through the strategies for selecting a pharmaceutical marketing company that aligns with your goals, understands your audience, and delivers measurable results.

Marketing

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Big Servier Acquisition Pays Off as FDA Approves Drug for Two Types of Rare Brain Cancer

MedCity News

AUGUST 6, 2024

The FDA approved Servier Pharmaceuticals’ Voranigo as a treatment for two types of low-grade gliomas. billion acquisition of Agios Pharmaceuticals’ oncology business. The drug, which is projected to become a blockbuster product, comes from Servier’s $1.8

FDA

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Protecting Temperature-Sensitive Pharmaceuticals, Without Unnecessary Plastic Waste

Pharmaceutical Commerce

MARCH 24, 2025

Advances in the life sciences are driving a significant increase in the number of temperature-sensitive pharmaceuticals.

Pharmaceutical

Neuro Drug Passed Up by Biogen Posts Positive Data for Ionis, Setting Stage for Phase 3 Test

MedCity News

JULY 22, 2024

Ionis Pharmaceuticals is looking ahead to a Phase 3 study for an antisense medicine it is developing to treat Angelman syndrome, a rare neurodevelopmental disorder with no FDA-approved therapies. Its main competition is an Ultragenyx Pharmaceutical drug set to begin pivotal testing later this year.

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Seeing a Better Way for Eye Drug R&D, Character Bio Lands $93M for Two Trials in Dry AMD

MedCity News

MARCH 25, 2025

Apellis Pharmaceuticals and Astellas Pharma have the first two FDA-approved therapies for geographic atrophy, but Character Biosciences claims its approach could be best in class for treating this advanced form of dry age-related macular degeneration.

Ionis Rare Disease Drug Is Headed to FDA, But Forthcoming Data Will Decide Competitive Profile

MedCity News

JANUARY 22, 2024

In its Phase 3 test, Ionis Pharmaceuticals drug donidalorsen reduced the frequency of swelling attacks caused by the rare disease hereditary angioedema. If Ionis can commercialize this drug, competition would include products from Takeda Pharmaceutical and BioCryst Pharmaceuticals.

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Pfizer moves to settle more than 10,000 Zantac cases in state courts: Bloomberg

Fierce Pharma

MAY 8, 2024

Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U. state courts, according to Bloomberg.

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Leads Pharmaceutical

Heartburn Drug from Phathom Pharma Expands Its Approval to Cover More GERD Patients

MedCity News

JULY 18, 2024

Expanded FDA approval of Phathom Pharmaceuticals drug Voquezna now includes patients with non-erosive gastroesophageal reflux disease (GERD). Phathom licensed its flagship product from Takeda Pharmaceutical. The post Heartburn Drug from Phathom Pharma Expands Its Approval to Cover More GERD Patients appeared first on MedCity News.

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Novo Nordisk Expands Cardio Reach by Buying Heart Drugs Biotech Cardior

MedCity News

MARCH 25, 2024

Acquiring Cardio Pharmaceuticals adds a novel RNA-based therapy that is a potential heart failure treatment. Novo Nordisk’s strategy to grow beyond metabolic diseases includes expanding into adjacent areas such as cardiovascular disease.

Pharmaceutical

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FDA Reconsideration Leads to Approval of Takeda Drug for Rare Esophagus Disorder

MedCity News

FEBRUARY 12, 2024

FDA approval of Takeda Pharmaceutical drug Eohilia introduces a new therapeutic option for patients with eosinophilic esophagitis, inflammation of the esophagus that causes swallowing difficulty. It will compete against Dupixent, a Sanofi and Regeneron Pharmaceuticals drug already approved for this disorder.

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Syndax Pharmaceuticals Leukemia Drug Wins a First-in-Class FDA Approval

Gene Therapy in an Implant: Neurotech Lands First FDA Approval in Rare Vision Disorder

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Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M

Webinars

The Chase for Novel Oral GLP-1 Obesity Meds Adds a New Contender

Vertex Pharma’s Opioid Alternative Wins FDA Approval, First in a New Class of Pain Meds

It's a monster MASH for Madrigal as Rezdiffra has caught on in a flash

Novartis, Apellis drop dueling datasets as they race for approval in rare form of kidney disease

The Financial Potential of Convertible Notes in the Pharmaceutical Sector

AI-Powered Insights for Personalized Customer Experiences: The Art of Data-Driven Engagement

In the Pharmaceutical Industry, Ethics are Still More Valuable Than AI

European Pharmaceutical Review Issue 5 2024

Teva and Sanofi Mid-Stage Data Reveal Shows Best-in-Class Potential for IBD Drug

Generative AI: Revolutionizing Pharmaceutical Industry and Driving Precision Medicine With Innovation, Equity and Ethics

FDA Nod for BridgeBio Brings New Competition to Blockbuster Pfizer Cardio Drug

Axsome Aims for FDA Filing in Alzheimer’s Agitation Despite Mixed Bag of Phase 3 Data

Building Resilience: CDMO Strategies for Drug Supply Chain Stability

Trends shaping the pharmaceutical industry in 2024

Bain Capital Broadens Its Biotech Reach With $3.3B Deal for Mitsubishi Tanabe Pharma

Kura Oncology Gets $330M to Kick Off Global Leukemia Drug Pact With Kyowa Kirin

Bristol Myers Squibb’s Sotyktu Meets Goals in Two Pivotal Psoriatic Arthritis Studies

Sustainable method converting waste into pharmaceuticals developed

Scilex's Semnur Pharmaceuticals to go public through $2.5B SPAC merger as it advances sciatica prospect

Novartis Nabs First FDA Nod in Rare Kidney Disease, But Apellis Pharma Is on Its Heels

Supernus Wearable Device for Dosing Parkinson’s Drug Lands Long-Awaited FDA Approval

After prior trial flop, EyePoint's Duravyu bounces back with promising data in DME

AI IN PHARMACEUTICAL MARKETING: Optimizing Automation and Expertise

Novartis falls short in legal effort to undo FDA approval of MSN's Entresto generic

Teva hands over $450M to resolve kickback lawsuits involving MS drug Copaxone and generics

Regeneron Bets $100M That Mammoth’s CRISPR Tech Can Deliver on Next Wave of Genetic Medicines

CDMO Samsung Biologics bags $1.2B production contract, bringing total 2024 deal value to $3.3B+

Pharmaceutical training boost: how the growth and skills levy could shape industry development

Cozadd's coda: Jazz unveils succession plan as longtime CEO and co-founder plots retirement

FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains

Recursion Pharma Accelerator Steps In to Fill Some of the Funding Gap Amid NIH Tumult

Choosing the Right Pharmaceutical Marketing Company: Strategies for Pharma Success

Big Servier Acquisition Pays Off as FDA Approves Drug for Two Types of Rare Brain Cancer

Protecting Temperature-Sensitive Pharmaceuticals, Without Unnecessary Plastic Waste

Neuro Drug Passed Up by Biogen Posts Positive Data for Ionis, Setting Stage for Phase 3 Test

Seeing a Better Way for Eye Drug R&D, Character Bio Lands $93M for Two Trials in Dry AMD

Ionis Rare Disease Drug Is Headed to FDA, But Forthcoming Data Will Decide Competitive Profile

Pfizer moves to settle more than 10,000 Zantac cases in state courts: Bloomberg

Heartburn Drug from Phathom Pharma Expands Its Approval to Cover More GERD Patients

Novo Nordisk Expands Cardio Reach by Buying Heart Drugs Biotech Cardior

FDA Reconsideration Leads to Approval of Takeda Drug for Rare Esophagus Disorder

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