Express Pharma

JUNE 5, 2023

Jakafi’s landmark approval in 2011 galvanised intensive drug development efforts by providing a strong positive investment signal for this market, as Jakafi is a blockbuster agent. Sam Warburton, Oncology Analyst at GlobalData, comments, “Despite MF being a rare disease, it is a blockbuster market with significant commercial potential.

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FDA Law Blog: Biosimilars

AUGUST 12, 2024

Patent and Trademark Office consulted with FDA on the appropriate timelines, FDA claimed that the INAD, and thereby the testing phase, was not effective until August 4, 2011 because no NCIE was submitted until then. Thus, the Agency concluded, the June 2011 date should stand. On August 8, 2024, the Court granted Nissan et al.’s

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Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. For example: Reduced stay. Revised section 8 damages.

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pharmaphorum

MAY 17, 2021

Arecor is also working on a portfolio of various hospital specialty drugs and future applications are likely to be to create novel biologicals, biosimilars, therapeutic vaccines and therapeutic peptides. It will also allow the company to incentivise employees through share incentive plans, potentially giving it an edge when hiring new staff.

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pharmaphorum

SEPTEMBER 30, 2022

Although the sticker shock that was at first associated with Yervoy (ipilimumab) in 2011 – in the early days of immuno-oncology monoclonal antibodies – has fallen by the wayside, especially in light of CAR-Ts and other “one and done” cell and gene therapies, the field of non-orphan oncology remains a target for cost savings by payers.

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FDA Law Blog: Biosimilars

MAY 27, 2024

Jennifer was with the firm from 2011-2017, before leaving for in-house roles at Apple, Abbott Laboratories, and Cognito Therapeutics. “Jennifer’s return adds depth and breadth to our device practice and her strong relationships from her earlier time at the firm has made for a seamless reentry,” said J.P. Ellison, Managing Director at HPM.

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European Pharmaceutical Review

JULY 4, 2024

4,6 Five patent issues that European biosimilar developers should consider before entering the US market Quality control of the botanical drug substances was one of the critical factors that led to barricades during the development of Veregen and Mytesi. 13 Currently, over 350 herbal remedies have been granted a THR licence. 2012/1916).

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pharmaphorum

MARCH 21, 2022

The results nevertheless make Opdualag an alternative to Opdivo plus Yervoy (ipilimumab) – BMS’ notoriously hard to tolerate CTLA4 checkpoint inhibitor – which has been approved as a monotherapy for melanoma since 2011 and as a dual therapy with Opdivo since 2015.

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FDA Law Blog: Biosimilars

SEPTEMBER 11, 2023

In 2011, the Institute of Medicine released a report recommending elimination of the 510(k) process altogether ( link ), noting an inherent conflict between the legislative framework and FDA’s stated goals to protect patients and promote innovation in support of public health.

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Documentation 64

FDA Law Blog: Biosimilars

FEBRUARY 28, 2024

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. In contrast , the two previous withdrawals, Makena in 2023 and Avastin in 2011, took 30 months and 11 months, respectively. All in all, the new expedited procedures took about 7 months from proposal to withdrawal.

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Documentation Labelling Drug Development 59

FDA Law Blog: Biosimilars

NOVEMBER 9, 2023

The FDA Food Safety Modernization Act (FSMA) enacted in 2011, aims to ensure the U.S. Customs and Border Protection (CBP), target import inspections more effectively and help protect the nation’s food supply against terrorist acts and other public health emergencies.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Kirschenbaum — The Inflation Reduction Act (IRA) significantly changed the Part D benefit.

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Labelling Drug Pricing Compounding Payment Processing 105

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

FDA Law Blog: Biosimilars

MAY 23, 2023

Since then, the science and legal and regulatory framework for food allergens have evolved considerably: Congress enacted the Food Allergen Labeling and Consumer Protection Act (2004) and the Food Safety Modernization Act (2011), and FDA implemented the regulatory requirements set forth in 21 C.F.R.

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Labelling 45

PharmaState Academy

MAY 1, 2023

In the coming age of biopharmaceuticals and biosimilars, every patient will have different needs, especially young patients with life-style disease problems. a pharmaco strong in biopharmaceuticals or biosimilars can work closely with banks. Some may need more education on self-care and home-care.

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Department of Veterans Affairs Communication Hospitals Biosimilars 52

FDA Law Blog: Biosimilars

JULY 24, 2023

Jazz, however, cites to the preamble to the 2011 revised implementing regulations for the Orphan Drug Act, which states that MC-to-PC is a narrow category that is applicable and “meaningful only when the subsequent drug [product] provides safety or effectiveness comparable to the approved drug.”

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FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

If expanded choices are desirable, FDA recommends following the standards from the 2011 HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status and provides more detailed categories from that guidance.

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Medical Records Drug Development 59

Safe Biologics

APRIL 25, 2023

1] Of cancer medicines launched globally between 2011 and 2019, more than 96% are available to US patients while only 65% are available in other developed nations such as Australia, Japan and the UK. 2 Furthermore, cancer death rates per 100,000 are 1.6 times higher in Europe than those in the US. 5 * [link]

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Drug Pricing Biosimilars Vaccines 130

Safe Biologics

APRIL 25, 2023

1] Of cancer medicines launched globally between 2011 and 2019, more than 96% are available to US patients while only 65% are available in other developed nations such as Australia, Japan and the UK. 2 Furthermore, cancer death rates per 100,000 are 1.6 times higher in Europe than those in the US. 5 * [link]

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Drug Pricing Biosimilars Vaccines 130

Express Pharma

JANUARY 3, 2025

While India was able to leverage the 2008 patent cliff of small molecules, the same playbook will not work for biologics and biosimilars. Many biopharma companies in India have already leveraged the biosimilar patent cliff. Biocon became the first company from India to launch its biosimilar Hulio in the US in July 2023.

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Biosimilars Vaccines Diabetes 105

FDA Law Blog: Biosimilars

NOVEMBER 4, 2024

As background, the Center for Veterinary Medicine (CVM) had approved a regulatory method for carbadox in 1998 but changed its position in 2011. Ultimately, Phibro filed this lawsuit alleging that FDA’s withdrawal of the carbadox NADA approvals violated the Administrative Procedure Act (APA).

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European Pharmaceutical Review

DECEMBER 23, 2024

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA. EMA/CHMP/ICH/425213/2011. 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

pharmaphorum

FEBRUARY 5, 2021

The FDA has developed in line with the life sciences industry during Woodcock’s time and has kept pace with development of innovations such as cancer cell therapies, biosimilars and digital therapeutics. But with the interim post seen as an audition for the permanent role, things have not got off to a good start for Woodcock.

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Vaccines Biosimilars Labelling 119

FDA Law Blog: Biosimilars

FEBRUARY 12, 2025

As an aside, TPSAC and its 2011 report were not without controversy; although later overturned by the D.C. 44,484 (July 24, 2013).

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