FDA Law Blog: Biosimilars

FEBRUARY 4, 2025

The Tropical Disease PRV program was born the very next year as part of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and expanded in 2014 , which experts heralded as a game-changer for tropical disease therapies.

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pharmaphorum

MAY 17, 2021

C5 inhibitor Soliris – which has a list price in the US of more than $500,000 per year – has been a standard therapy for the rare disorder since 2007, and was joined on the market by longer-acting follow-up Ultomiris in 2018 which launched with a price tag of around $450,000 per year. billion and $1.1

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Labelling Vaccines 52

Fuld & Company Blog

MAY 15, 2023

In addition, in-person care would be available for follow-up care, vaccinations, or blood draws through a registered nurse who would be made available at a location of the patients’ choosing, at home or in the office. Soon after its soft launch, Amazon began testing the idea with potential corporate clients, but had little success.

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Health and Personal Care Stores Mail-Order Pharmacies Packaging Medication Delivery 59

PharmaShots

MARCH 14, 2023

The act includes drugs, vaccines, and therapeutics that are intended to treat a disease affecting <200,000 American citizens. In late 2007, both FDA and EMA came to a mutual understanding of using a common application process with a distinct approval process, making it easier for manufacturers to apply for orphan drug status.

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World Pharma News

SEPTEMBER 20, 2024

It was initially approved by the FDA in 2003 for use in individuals 5 through 49 years of age, and in 2007, the FDA approved the use of FluMist to include children 2 through 5 years of age. FluMist is sprayed into the nose and has been used safely and effectively for many years.

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Vaccines 125

Big Molecule Watch

MARCH 9, 2023

Her research established that cytolytic T cells had an ability to recognize multiple subtypes of viruses, laying the foundation for modern vaccine development. In 2007, she was awarded the Robert Koch Gold Medal, the leading international scientific prize in microbiology, and in 2012, an Honorary Doctorate by Cambridge University.

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Immunization Immunity Vaccines 52

pharmaphorum

OCTOBER 19, 2022

In 2018, CVS acquired the insurer, Aetna , and in 2007, the company acquired pharmacy services provider Caremark Rx. Automated messaging about prescriptions, appointments, and vaccinations improve the patient journey, while alleviating time-consuming tasks for providers.

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Communication Vaccines 52

PharmaShots

APRIL 13, 2023

Its flagship product Humira achieved a $2B global revenue Additionally, Abbott acquired Kos Pharmaceuticals and Guidant's vascular business and launched a new division, Abbott Nutrition International 2007 was a great year for Johnson & Johnson, its consumer health business showed a drastic growth of 48.3% over the previous year.

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Pharmaceutical Technology

SEPTEMBER 10, 2008

Secondly, we conduct pre-clinical research and development in the fields of oncology, cardiovascular disorders, anti-influenza vaccines and diabetology. NC: A few projects focusing on influenza, which Biotest was involved with, concluded in 2007. It will most probably lead to a new anti-flu vaccine.

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Vaccines Biosimilars 40

pharmaphorum

MAY 20, 2022

She began her career in clinical research as a clinical trial assistant for Novartis Vaccines and Diagnostics in 2007 and continued to pursue her interest is vaccine research in 2014 when she joined GSK (formerly Novartis Vaccines). Sheena has a wealth of experience of managing and delivering clinical trials.

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Hospitals Medical Records Vaccines Diabetes 59

pharmaphorum

MARCH 1, 2022

This was, and still is being, demonstrated through the UK’s COVID-19 vaccine research successes. She began her career in clinical research as a clinical trial assistant for Novartis Vaccines and Diagnostics in 2007 and continued to pursue her interest is vaccine research in 2014 when she joined GSK (formerly Novartis Vaccines).

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Vaccines Hospitals 96

PharmaShots

APRIL 25, 2023

Founded Year: 2007 Total Employees: ~100 Headquarters: Pennsylvania, United States Market Cap: $477.1M The company strives to discover and develop therapeutic products under its business segments, including General Medicines, Specialty Medicines, and Vaccines. R&D Expenditure: $84.4M R&D Expenditure: $6.6B

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HIV Treatment and Prevention Agents Diabetes Packaging Immunization 40

PharmaShots

JANUARY 31, 2023

Founded Year: 2007 No. Founded Year: 2007 No. Founded Year: 2007 No. The Company's premier line of smart safety syringes, Sharps Provensa, prevents accidental needlestick injuries, prevents needle reuse, and minimizes drug and vaccine waste—all while maintaining the intuitive simplicity of conventional syringes.

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Pharmaceutical Technology

JULY 23, 2008

Demand for treatment The American Cancer Society estimates that over 12 million new cancer cases were diagnosed worldwide in 2007. “You can get vaccines now to prevent cervical cancer. And are we getting any closer to beating the Big C? “For certain cancers, yes,” says Ando.

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

FDA did, however, try to identify safety issues through the medical literature and (after 2007 when mandatory safety reporting for OTC human drug products marketed without an approved application became effective) through the adverse event reporting system. billion in damages were brought between 1980 and 1986.

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Labelling Vaccines Communication 40

STAT

DECEMBER 3, 2024

  In April 2023, Kennedy announced his presidential run and left his post as chairman and chief legal counsel of the organization he founded in 2007. ” It is widely known for seeding vaccine skepticism, with Kennedy as its most visible advocate.  Kennedy Jr.   Continue to STAT+ to read the full story…

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Vaccines 364

pharmaphorum

DECEMBER 2, 2020

“Lipitor…became the biggest-selling prescription medicine ever, earning Pfizer $12 billion a year in 2007, one quarter of its total sales” The areas that Pfizer directed its research into expanded in these years as well.

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Compounding Vaccines Biosimilars Diabetes 128

pharmaphorum

JANUARY 16, 2023

Across swathes of primary care, pharmacological innovation has stalled; the last new antihypertensive class was introduced in 2007 and new antibiotics have trickled in at a dangerously slow pace. The fundamental engine of innovation for the global pharmaceutical industry continues.

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Quality Matters

OCTOBER 13, 2021

In 2007 and 2008, nearly 150 patients died and hundreds more suffered serious adverse reactions after they were treated with heparin, a commonly used blood-thinning drug. Heparin is made from pig intestines, which at that time in China were subject to sharp price increases due to widespread pig deaths from “blue ear disease.”

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epicur

NOVEMBER 9, 2023

I started in shelter medicine in 2007, and it’s remarkable to see how far we’ve progressed. We can set up free or low-cost vaccine clinics in “veterinary deserts.” So, many animals have never seen veterinary care in their life and are suddenly being put on a good vaccine prevention program. It’s high-quality care now.

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Compounding Vaccines 52

Pharmaceutical Technology

AUGUST 26, 2008

.” By the early 2000s AstraZeneca had already realised the critical importance of biotechnology, making a number of strategic investments in biotech companies, Abgenix in 2003, Cambridge Antibody Technology in 2006 and culminating in its acquisition of US biotech firm, Medimmune in April 2007 for £15bn.

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Putting Patients First Blog

SEPTEMBER 9, 2024

Preventive Services The expansion of preventive services, including hepatitis B vaccinations and colorectal cancer screenings, is a positive development for public health. 30 Hepatitis B vaccinations and colorectal cancer screenings are vital components of a comprehensive preventive care strategy. Preventive Medicine , 92, 31-36.

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Insurance Coverage and Processing Documentation Vaccines Communication 40

European Pharmaceutical Review

DECEMBER 23, 2024

EMA/CHMP/ICH/214732/2007. Internet] Vaccines Europe. ICH Q9(R1) Quality Risk Management – Scientific Guideline. 3 February 2023. EMA/CHMP/ICH/24235/2006. ICH Q10 Pharmaceutical Quality System – Scientific Guideline. September 2015. November 2012. EMA/CHMP/ICH/425213/2011. J Pharm Sci. 2024; 113: 837-855. 25 June 2024.

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Biosimilars Vaccines 52

STAT

OCTOBER 7, 2024

Its shares have been roughly cut in half from a record high notched in late 2021 after the company delivered the world’s first Covid-19 vaccine. D’Amelio was chief financial officer from 2007 to 2021. Bourla Pfizer had a market value of about $162 billion as of Friday.

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