pharmaphorum

SEPTEMBER 28, 2020

Professor Mohamad Mohty, head of haematology and cellular therapy at Saint-Antoine Hospital, told the webinar audience: “It is really amazing to see the number of haematology indications, whether for new molecular entities or for biosimilars.”. for the period from 2007-2013.

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Biosimilars Hospitals 105

FDA Law Blog: Biosimilars

JULY 11, 2023

Approved in 2007 for the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy, with several indications added in the subsequent years, Somatuline Depot is a synthetic octapeptide available as ready-to-use prefilled syringes for deep subcutaneous injection.

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FDA Law Blog: Biosimilars

APRIL 30, 2023

Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub. 110-85 (2007), as amended by Section 301 of Pub. It does so by amending FDC Act § 505(q), the current statutory subsection regarding citizen petitions. 112-144 (2012).

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Immunization Immunity Biosimilars Labelling 59

FDA Law Blog: Biosimilars

AUGUST 12, 2024

FDA also consistently interpreted it that way between 1990 and 2007. FDA, since 1991, had publicly signaled that the opening of an INAD file starts the testing phase for a new animal drug. FDA explicitly said as much in the 1991 preamble accompanying proposed patent restoration regulations.

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Putting Patients First Blog

JANUARY 27, 2025

Formulary Inclusion and Placement of Generics and Biosimilars The NHC supports CMS proposals to improve formulary practices by prioritizing access to generics, biosimilars, and other cost-effective medications in the Medicare Part D program.

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Insurance Coverage and Processing Biosimilars Communication Department of Veterans Affairs 40

pharmaphorum

APRIL 13, 2022

The organisation noted that the average net cost of these insulin products is 20% lower than in 2007. Potential biosimilar impact. Outside of Congress, there is another element that could reduce the cost of insulin, in the form of biosimilars. Innovation to end debate?

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Drug Pricing Diabetes Biosimilars 130

PharmaShots

MARCH 29, 2023

Some companies accept the offered period and open doors to biological drugs or biosimilars. As of now, there are no the US FDA approved biosimilars available for Actemra. However, last August, Fresenius Kabi announced the US FDA's acceptance of its biosimilar BLA, bringing a potential candidate into the market before long.

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Biosimilars Diabetes Chemotherapy Immunity 49

FDA Law Blog: Biosimilars

MAY 11, 2023

No reasonable jury could have concluded that the carved-out labeling for petitioner’s generic carvedilol from 2007-2011 was itself evidence of intent to induce infringement.” Plainly, the Government brief states “The decision below is incorrect.

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Labelling Documentation Communication 72

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. “Companies used to be universally protected by patents but there is a pathway to approval opening up for biosimilar legislation. . And are we getting any closer to beating the Big C?

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Pharmaceutical Companies Pharmaceutical Companies Compounding Biosimilars 40

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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Biosimilars Vaccines Pharmaceutical Companies Pharmaceutical Companies 40

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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Vaccines 52

Pharmaceutical Technology

SEPTEMBER 10, 2008

NC: A few projects focusing on influenza, which Biotest was involved with, concluded in 2007. As far as human pharmaceuticals are concerned, both new chemical entities and so-called “biosimilars” are included, while in veterinary drugs most demand is for modified, as opposed to reference, drugs.

Vaccines 40

Vaccines Biosimilars 40

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.

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Labelling Vaccines Communication 40

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

European Pharmaceutical Review

DECEMBER 23, 2024

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA. EMA/CHMP/ICH/214732/2007. September 1999, CPMP/ICH/365/96. Eglovitch JS. EU Official Says ICH Q6B Is Outdated And Needs Revision. Internet] Regulatory Focus. cited 2024August]. Available from: [link] 4. Pharmaceutics. 2021; 13(1): 48. 22 June 2017.

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Biosimilars Vaccines 52