The FDA Law Blog

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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FDA Documentation Adverse Reactions Communication 105

STAT

OCTOBER 10, 2024

The kickback case began four years ago when the Department of Justice accused Teva of using the foundations to ensure that, from 2006 through 2017, Medicare patients did not have to make a copayment or deductible for the Copaxone multiple sclerosis drug. At the same time, Teva steadily raised the price of its drug by thousands of dollars.

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Pharmaceutical Companies Pharmaceutical Companies 128

Drug Topics

AUGUST 22, 2023

E-cigarettes have garnered popularity since entering the market in 2006 as a potential aid for smoking cessation, but their use has been associated with increased adverse cardiovascular events.

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STAT

OCTOBER 2, 2023

The Pandemic All-Hazards Preparedness Act was a Bush administration priority that Congress passed in 2006 to help the government respond to nuclear and biological attacks and naturally occurring threats, such as pandemics. That temporary funding measure also extended a few programs that are part of the Pandemic All-Hazards Preparedness Act.

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STAT

FEBRUARY 1, 2023

billion fundraising in 2006, according to data from PitchBook. The firm, Patient Square Capital, closed on $3.9 billion for its fund Wednesday. That makes it the largest inaugural fund for a new U.S.-based based private equity firm. The previous record was set by Centerbridge Partners’ $3.2

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STAT

NOVEMBER 23, 2022

Since 2006, physician and researcher Emily Wang has been working to integrate the two. has two separate health care systems: one for people who aren’t incarcerated, and one for people behind bars. “There’s really no glue, no connection between these health care systems,” Wang said.

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STAT

NOVEMBER 27, 2023

The problem has persisted, even after the European Union in 2006 banned the use of antibiotics for promoting growth, since bulking up the animals makes them better suited for increased production.

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STAT

NOVEMBER 18, 2022

The problem has persisted, even after the European Union in 2006 banned the use of antibiotics for promoting growth, since bulking up the animals makes them better suited for increased production. Continue to STAT+ to read the full story…

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Pharmacy Times

APRIL 11, 2023

State-level respiratory syncytial virus hospitalization rates for 2022 could be the highest seen since 2006, analysis published in Frontiers in Pediatrics indicate.

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Hospitals 73

Fierce Healthcare

SEPTEMBER 1, 2023

Much of the growth experienced by Medicare Advantage over the last two decades can be attri | Beneficiaries switching from fee-for-service Medicare to Medicare Advantage more than tri-pled between 2006 and 2022. Conversely, switching from MA to traditional Medicare decreased.

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STAT

JULY 7, 2023

The Pandemic All-Hazards Preparedness Act was enacted in 2006 to help the government respond to nuclear and biological weapons, naturally occurring threats like avian influenza, and natural disasters.

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Packaging 98

IDStewardship

JUNE 18, 2023

It was the dawn of the online streaming era, and platforms such as YouTube, acquired by Google only a year earlier (2006), were brand new. When people thought about online web streaming in those days, they tended to think about cute cat videos and biting toddlers.

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Hospitals 217

European Pharmaceutical Review

JUNE 24, 2022

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance). Amsterdam: Gupta Strategists; 2019.

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Compounding Packaging Dosage Communication 105

STAT

SEPTEMBER 22, 2023

Krystal, who worked for both Yale and the VA at the time, and his co-inventors applied for patents with VA funding starting in 2006 for a ketamine nasal spray to treat depression and suicidal ideation. Yale and the VA agreed in 2003 to share royalties on patents with inventors from both institutions.

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Department of Veterans Affairs Compounding Pharmacies Compounding Chemotherapy 109

STAT

JULY 11, 2023

In 2006, when many Americans had barely heard the word “coronavirus,” Congress passed the Pandemic and All Hazards Preparedness Act (PAHPA), a landmark, bipartisan legislative framework that has successfully steered our nation’s biosecurity policy ever since.

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Vaccines 74

Pharmaceutical Technology

JUNE 7, 2023

Since 2006, IFC has repeatedly provided support to Fosun Pharma, which is committed to ensuring the continuous accessibility and affordability of pharmaceutical products and improving the resilience of healthcare supply chains in the region.”

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European Pharmaceutical Review

AUGUST 16, 2023

Sandoz launched its first biosimilar – somatropin (Omnitrope) – in Europe in 2006. The company, a division of Novartis, currently has a portfolio of eight marketed biosimilars, with a further 24 in various development stages.

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PioneerRx

AUGUST 11, 2022

Pleio began in 2006 when a group of partners sat around a kitchen table and shared their concerns for their friends and… Change always begins with a conversation.

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PioneerRx

AUGUST 11, 2022

Pleio began in 2006 when a group of partners sat around a kitchen table and shared their concerns for their friends and… Change always begins with a conversation.

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Pharmaceutical Technology

MAY 10, 2023

The CDC had applied for patents back in 2006, and was later granted four in 2015. The government had called for Gilead to “respect the US patent system” and the taxpayer-funded research undertaken by the CDC, per the statement. The November 2019 lawsuit marked a further escalation in an existing dispute.

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Pharmaceutical Companies Pharmaceutical Companies FDA 105

Blog: Ask a Student Pharmacist

OCTOBER 4, 2023

Minneceutics Newsletter eomizowh Wed, 10/04/2023 - 12:47 Current Newsletter Expand all + Archive 1993 1994 1995 1999 2000 2001 2002 2003 2004 2006 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021

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European Pharmaceutical Review

NOVEMBER 16, 2023

To support biosimilar adoption and expand access for patients in Europe, measures must be taken to reduce the cost of developing biosimilars” Since their introduction in 2006, biosimilars have generated more than €30 billion in cumulative savings for European healthcare systems as of 2022, an IQVIA report from last year highlighted.

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pharmaphorum

DECEMBER 12, 2022

” Anderson joined Roche’s Genentech division in 2006 as head of its immunology and ophthalmology business unit, after nine years at Biogen that culminated in a two-year stint as head of neurology. “He has been instrumental in shaping Roche’s transformation and I wish him all the best for the future.”

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pharmaphorum

JUNE 16, 2022

It also probably marks the end of the road for crenezumab, which Roche’s Genentech subsidiary licensed from AC Immune in 2006 in a deal initially valued at $300 million.

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Immunization 111

Druggist

APRIL 16, 2021

Del Mar CB, Glasziou PP, Spinks AB (2006). Cochrane Database Syst Rev 2006; 18 4:CD000023. Additionally, both antiseptic agents showed to have local anaesthetic properties (NICE, 2009 ). When studied in the laboratory experiments, AMC/DCBA reduced the total number of viruses (viral load) caused by the common cold (Del Mar et al.,

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PQA

FEBRUARY 16, 2024

Kelman was a trusted advisor to PQA since its establishment in 2006. Kelman served on the PQA Board of Directors for 10 years and most recently served on the board as a CMS Special Advisor. He was kind, generous and thoughtful in his support of PQA and its mission.Kelman joined CMS in 2005 and helped implement the Part D program.

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pharmaphorum

JULY 29, 2021

The company took advantage of the lack of generic competitors on the market to charge the NHS “excessive and unfair prices” for liothyronine, which meant that NHS spending on the drug swelled from £600,000 in 2006 to more than £30 million by 2016.

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pharmaphorum

JANUARY 9, 2023

The transaction will be effected by means of a UK scheme of arrangement under Part 26 of the UK Companies Act 2006, subject to approval of Amryt shareholders, sanction by the High Court of Justice of England and Wales, and other customary closings, including regulatory/antitrust approvals.

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FDA 98

pharmaphorum

NOVEMBER 5, 2024

In today’s podcast, web editor Nicole Raleigh speaks with Dr Neal Kassell, chair and founder of the Focused Ultrasound Foundation and previously a neurosurgeon, who created the Foundation in 2006 to improve the lives of millions of people with serious medical disorders by accelerating the development and adoption of focused ultrasound.

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pharmaphorum

AUGUST 9, 2021

Myozyme was first to market in 2006 for infantile-onset Pompe, with Lumizyme reaching the market four years later to treat late-onset Pompe in children aged over eight. In 2010, Lumizyme’s label was expanded to the under-right group as well.

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pharmaphorum

OCTOBER 13, 2020

Past stars include Ocado, which first appeared in 2006 with sales of £143m, and is now valued at £19bn; Just Eat, which first appeared in 2011 with sales of £19m, and earlier this year completed a £6bn merger with Takeaway.com; and THG, which first appeared in 2007 with sales of £5.7m, and plans an IPO this month valued at £4.5bn.

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Vaccines FDA 82

pharmaphorum

JUNE 8, 2021

From 2006, Dr Mei worked as a senior director at Novartis Oncology. He has been a member of the American Society of Hematology since 2006 and was involved in the management of Antengene since April 2017.

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Chemotherapy Pharmaceutical Companies Pharmaceutical Companies Immunization 105

pharmaphorum

JUNE 24, 2021

Lucentis has been approved by the FDA since 2006 for wet AMD and is a big earner for both Roche and Novartis, who share rights to the product with Roche selling the drug in the US and Novartis selling it in Europe and other markets.

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FDA 95

The Checkup by Singlecare

APRIL 17, 2024

Obesity wasn’t considered a medical condition when the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 went into effect in 2006, thus establishing Medicare Part D. However, legislators are trying to change that with the Treat and Reduce Obesity Act of 2023.

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Insurance Insurance Coverage Pharmaceutical Companies Pharmaceutical Companies 98

pharmaphorum

MAY 27, 2022

First launched in 2006, Roblox is an online space where users can play games – more than 20 million of them at a recent count – created by developers and individuals. The platform is used mainly by children under 16, the group most likely to be affected by ADHD and a target demographic for Akili’s therapy.

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FDA 93

Pharmaceutical Technology

JULY 29, 2022

Janssen’s Risperdal (risperidone), a second-generation antipsychotic , got its first FDA approval for autism-related irritability for children over the age of five, in 2006.

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Communication Labelling Hospitals FDA 105

pharmaphorum

OCTOBER 24, 2021

Susvimo has the same active ingredient as Roche’s big-selling therapy Lucentis (ranibizumab), a VEGF inhibitor administered once a month that has been approved by the FDA since 2006 for wet AMD.

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FDA 98