Pharmafile

NOVEMBER 21, 2023

AstraZeneca has announced that it has launched Evinova, its new health-tech business, which it is hoped will become a leading provider of digital health solutions for healthcare professionals, regulators and patients.

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STAT

MAY 13, 2024

The company was accused of providing skewed and incomplete cost information and did so before regulators issued marketing authorization, according to a report by the Prescription Medicines Code of Practice Authority. However, Sandoz rejected the findings.

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STAT

JUNE 30, 2023

Regulators must approve the deal. But the pending sale of its Medicare Advantage business means the financially distressed Bright has exited the health insurance market that the company was founded on. Molina said in a news release that Bright’s current book of business generates $1.8

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Insurance 101

STAT

APRIL 10, 2024

And what better way to make the time fly than to keep busy. Now, though, the time has come to get busy. Novartis currently employs around 12,500 in development, which includes handling drug regulations, analytics, and support functions like quality assurance. So grab that cup of stimulation and get started.

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STAT

JANUARY 26, 2023

A loophole in prescription drug regulation exposes American consumers to false and misleading claims of drug ads via on-line businesses promoting potent drugs without accurate information about their risks and benefits. Many countries prohibit direct-to-consumer advertising of prescription drugs.

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Pharmaceutical Companies Pharmaceutical Companies 107

STAT

MARCH 10, 2023

Silicon Valley Bank, which does business with roughly half of the nation’s tech and biotech companies, failed on Friday. Now, as federal regulators step in to clean up SVB’s mess, biotech startups are left wondering: What happens to their money, and who’s going to finance the industry?

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Insurance 145

Pharma Marketing Network

JULY 19, 2023

Content Marketing as a Sales Driver: Unlocking Your Business Potential in the Pharmaceutical Industry Content marketing is a long-term strategy that can help businesses of all sizes generate leads, increase brand awareness, and drive sales. Make sure that all of your content is compliant with all applicable regulations.

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Pharmaceutical Companies Pharmaceutical Companies 98

STAT

DECEMBER 27, 2023

Their increasingly ubiquitous use is having a huge impact not only on patients and the companies that manufacturer these drugs — Novo Nordisk and Eli Lilly — but also investors , doctors, employers, insurers, regulators, and businesses in a variety of industries. Continue to STAT+ to read the full story…

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Insurance 113

Pharma Marketing Network

JULY 13, 2023

In the pharmaceutical industry, where trust and credibility are essential, it’s especially important to choose a web development company that understands the specific needs of your business. Compliance: The pharmaceutical industry is heavily regulated. Scalability: Your business is likely to grow over time.

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Pharmaceutical Companies Pharmaceutical Companies Communication 97

The FDA Law Blog

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance. Truly, these are complex considerations.

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Fierce Healthcare

JULY 27, 2023

The Federal Trade Commission (FTC) and Surescripts have reached a settlement over the regulator’s claims that the health tech company was excluding competitors from certain e-prescribing markets an | The regulator highlighted new restrictions that would be imposed on the health tech company's e-prescribing business.

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ISPE

JUNE 26, 2023

Regulators and Industry Discuss Digital Transformation and Pharma 4.0™ ™ Trudy Patterson Mon, 06/26/2023 - 10:37 iSpeak Blog iSpeak Regulators and Industry Discuss Digital Transformation and Pharma 4.0™ Overall, this can also lead to a harmonization of the way we view digitization as a business process.

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BioPharm

MAY 10, 2023

EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.

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STAT

MARCH 29, 2023

As the health impacts of climate change become harder to ignore, biotechnology and pharmaceutical companies are facing increasing pressure from investors, employees, and government regulators to reduce their carbon emissions, and to make environmental sustainability a core part of their business.

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Pharmaceutical Companies Pharmaceutical Companies 107

STAT

APRIL 27, 2023

Andrew Joseph, STAT’s Europe correspondent, joins us to explain the EU’s sweeping proposal to overhaul how new drugs are regulated on the continent — and why the pharmaceutical industry is fighting it. Read the rest…

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STAT

MAY 16, 2023

During an extraordinary hearing Tuesday, members of a Senate subcommittee called for aggressive regulation of generative AI tools — and the makers and users of the technologies themselves urged the senators to quickly follow through. Continue to STAT+ to read the full story…

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STAT

JANUARY 26, 2024

business, who is responsible for U.S.  In its lawsuit, the Association for Accessible Medicines argued the law gives the state the power to regulate interstate commerce. At issue is the Dormant Commerce Clause, a constitutional principle that bars individual states from regulating trade beyond their own borders.

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European Pharmaceutical Review

FEBRUARY 21, 2023

Short discussed the heavy workload involved in navigating the regulations associated with a controlled drug. Good manufacturing practice registration was one of the hardest lifts I’ve had in my 30 years of building businesses. ” Our approach has always been to work with regulators. What were the key lessons?

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Pharmaceutical Companies Pharmaceutical Companies Compounding 125

Fuld

FEBRUARY 20, 2024

BOSTON – February NN, 2024 – Fuld & Company, a fast-growing research, analytics, and advisory business, today announced the appointment of Jan Ellsberger to the role of Advisory Board Member. Jan, based in Munich, Germany, is a well-known leader and influencer in the automotive and ICT industries.

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STAT

JULY 25, 2023

Over decades, it feasted on upstarts with new datasets or novel technologies, growing into a juggernaut with no peer in the business of brokering Americans’ medical information. Now, government regulators say, IQVIA’s appetite for acquisition is getting out of control — and must be reined in.

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Hospitals 97

STAT

JUNE 20, 2023

The drugmaker accused the businesses of false advertising, unfair competition, and infringing on trademarks for three medicines: Wegovy, Ozempic, and Rybelsus. regulators to help people with overweight or obesity lose weight if they have a related condition such as high blood pressure.

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Compounding 98

pharmaphorum

OCTOBER 12, 2022

Non-compliance can be devastating for a business, not only does it cause major delays in a product’s release, but in some cases non-compliance can lead to a complete batch being destroyed. This need for data integrity facilitates and maintains trust between the regulators and the manufacturing organisations and, in turn, patients.

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Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 105

STAT

DECEMBER 12, 2022

But that business is now firmly in the past, and the company has switched to an even more regulated industry: health insurance. Curative rose to prominence during the throes of the pandemic, as people and governments across the country used its Covid-19 tests. Last year, Curative had a cloud hanging over its head.

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Health Insurance Companies Insurance FDA 107

STAT

FEBRUARY 28, 2024

And what better way to make the time fly than to keep busy. antitrust regulators into pharmaceutical industry middlemen has been stymied because the companies have failed to provide many of the documents that, in some cases, were requested as far back as June 2022 , STAT writes. So grab that cup of stimulation and get started.

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Pharmafile

JANUARY 24, 2023

The business holds strong market leadership across the United Kingdom and the portfolio includes trusted suction equipment, flowmeters, and medical regulators used in healthcare facilities across the region and internationally. Founded in 1983, Therapy Equipment Ltd. Founded in 1983, Therapy Equipment Ltd. read more

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STAT

SEPTEMBER 6, 2022

Telehealth prescription company Cerebral, which used pandemic-era regulatory flexibility to virtually treat mental health conditions like ADHD, has largely halted controlled substance prescriptions in light of scrutiny from federal and state regulators. Read the rest…

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Controlled Substances 101

pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. not a medical device, ii.

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pharmaphorum

JULY 21, 2022

The pharmaceutical industry has long been highly regulated to help ensure quality and safety across all aspects of its business. As a result, some businesses have been forced in the last 18 months to make risk-based decisions based on the resources available to them rather than the quality assurance of a product.

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European Pharmaceutical Review

NOVEMBER 14, 2023

Capitalising on the UK’s existing strengths by committing to a long-term manufacturing strategy, we will pave way for certainty, stability and sustained economic growth for businesses across our nation,” concluded Richard Torbett, ABPI’s Chief Executive.

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Pharma Marketing Network

OCTOBER 31, 2023

Overview of E-Commerce Strategies E-commerce strategies are used to help businesses maximize their online sales and reach new customers. Additionally, businesses must ensure that their website is secure and compliant with industry regulations.

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The Guardian - Pharmaceutical Industry

APRIL 21, 2023

Sciensus is paid millions of pounds each year by the NHS to transport vital drugs and medical items to the homes of about 200,000 people with conditions including cancer, heart disease, diabetes, dementia and HIV.

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The FDA Law Blog

SEPTEMBER 26, 2023

Grizzel will oversee the marketing organization, with responsibility for continuing and enhancing HP&M’s brand and expanding its business development activities. Jeff joins HP&M from Compliance Architects where he served as Vice President of Business Development.

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FDA 59

STAT

FEBRUARY 20, 2024

Whatever your timetable, we hope you are feeling invigorated and inspired, because another busy day is on the way. Good morning, everyone, and welcome to another working week, which is getting off to a late start on this side of the pond thanks to a holiday break. Our choice today is toasted coconut mocha.

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Pharmaceutical Companies Pharmaceutical Companies 107

The FDA Law Blog

JULY 21, 2023

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials AND a critical competency for legal and business professionals in the biopharmaceutical arena AT THE American Conference Institute’s (ACI’s) 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA ! This year’s co-chairs include Li Feng, Ph.D.

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FDA 52

STAT

NOVEMBER 16, 2023

Rise and shine, everyone, another busy day is on the way. regulators approved a CRISPR-based medicine to treat both sickle cell disease and beta thalassemia, making it the world’s first therapy built on the revolutionary gene-editing technology and ushering in a new era of genetic medicine , STAT reports. … U.K.

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FDA 92

STAT

JANUARY 31, 2024

And what better way to make the time fly than to keep busy.  Two therapies recently approved by health regulators cost $2.2 The middle of the week is upon us. Have heart, though. You made it this far, so why not hang on for another couple of days, yes? So grab that cup of stimulation and get started. million and $3.1

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The FDA Law Blog

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. Houck , and Kalie E.

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Controlled Substances Documentation Communication 45