FDA Law Blog: Biosimilars

SEPTEMBER 16, 2024

This FR Notice and draft strategy document are part of FDA’s commitment under the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2023-2027 (PDUFA VII), wherein FDA committed to advance the use and implementation of innovative manufacturing.

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Pharmaceutical Technology

MAY 4, 2023

Some of those insights will also be provided to the wider scientific community and regulatory agencies. IHB aims to add 250 scientists and bioengineers by 2027. The knowledge that is gained will boost Roche’s drug discovery and development projects and enable medicines to reach patients faster.

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Viseven

JUNE 12, 2023

from 2022 to 2027. Though South Korea is the third largest biopharma innovation hub, Suyoung admits that local pharma companies have low HCP engagement rates because marketers still use traditional methods of communication such as email, phone calls, and face-to-face visits. And it makes sense.

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Pharmaceutical Technology

NOVEMBER 30, 2022

Results from this trial are scheduled to be released in October 2027, and may allow non-diabetic obese patients to have access to Mounjaro. This study aims to recruit 15,000 participants to investigate the drug’s effect on the reduction of morbidity and mortality in adults with obesity, with or without complications.

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Pharmaceutical Technology

NOVEMBER 30, 2022

Results from this trial are scheduled to be released in October 2027, and may allow non-diabetic obese patients to have access to Mounjaro. This study aims to recruit 15,000 participants to investigate the drug’s effect on the reduction of morbidity and mortality in adults with obesity, with or without complications.

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PharmaShots

FEBRUARY 22, 2023

In the US, Trulicity is protected by a compound patent (2027) and by biologics data protection (2026).

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FDA Law Blog: Biosimilars

JUNE 7, 2023

Recall that CMS will require manufacturers of selected drugs to negotiate a maximum fair price (“MFP”) with the agency according to the following timeline (the dates apply from applicable year 2027 onwards). Second, Merck argues that the parody of a negotiation and a fair price compels speech in violation of the First Amendment.

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Pharmaceutical Technology

FEBRUARY 6, 2023

A Pliant spokesperson said, “This successful transaction, along with existing cash, cash equivalents, loan agreement and short-term investments, provides for operations to be funded to mid-2027, a year past the expected IPF Phase 2b clinical trial readout.” The company said a Phase IIb trial initiation should be expected in mid-2023.

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Pharmaceutical Technology

JUNE 21, 2023

Analysts forecast the biologics market to be worth $120 billion more than small molecules by 2027. At the helm is Johnson and Johnson alum, former head of immunology discovery within Janssen Pharmaceuticals. Murray KcKinnon, PhD He joined Empress as chief scientific officer. Free Report How is the Biopharmaceutical industry evolving?

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Pharmaceutical Technology

APRIL 24, 2023

GlobalData predicts that Comirnaty’s sales will increase by more than 20% between 2024 and 2027. These vaccines have proven to be blockbusters, with Moderna earning $18.4 billion in Spikevax sales in 2022, and Comirnaty generating $37 million for Pfizer in 2022. GlobalData is the parent company of Pharmaceutical Technology.

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Putting Patients First Blog

JANUARY 10, 2024

Failure to Reconcile (FTR) Process: The NHC views the proposed changes to the FTR process positively as safeguarding consumers’ health coverage access, particularly for those with chronic conditions, by enhancing education, aligning with consumer protection principles, and ensuring clarity and accessibility in communication strategies.

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Putting Patients First Blog

APRIL 14, 2023

The NHC requests insight on what opportunities CMS plans to put forward for stakeholders to provide formal input into adjusting future program guidance and whether there will be a comment opportunity to inform negotiation for IPAY 2027 and beyond. The negotiation program is a new policy that is being implemented in a non-traditional manner.

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Putting Patients First Blog

SEPTEMBER 20, 2024

Earlier this year CMS released draft guidance for Initial Payment Applicability Year (IPAY) 2027. This guidance will apply to the negotiation process for 15 drugs, which will occur next year, and the resulting prices will take effect in 2027. Conclusion To read the NHC’s full comments, click here and here.

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FDA Law Blog: Biosimilars

JUNE 14, 2023

In FY 2026 – FY 2027, continue to support products enrolled in previous fiscal years and expand to enroll up to 100 additional products each fiscal year within existing OHTs or expand to additional OHTs, depending on lessons learned from FY 2023 – FY 2025 experience (i.e., up to 125 total products enrolled through FY 2025).

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Pharmaceutical Technology

APRIL 24, 2023

Biologics Versus Small Molecules By 2027 Forecast Sales Credit: GlobalData “CRDMOs have a deep understanding of protein chemistry, cell culture, and the impact of process conditions on yield and protein structure down to the smallest detail, including changes from lab to GMP scale. Please check your email to download the Whitepaper.

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Putting Patients First Blog

FEBRUARY 27, 2025

The NHC Sets out a New Roadmap for 20252027 February 27, 2025 By Leah Poffenberger, Senior Manager, Communications Every three years, the National Health Council (NHC) launches a new strategic plan to guide the organization as it tackles evolving challenges in health care and continue the mission of putting patients first.

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Drug Patent Watch

JANUARY 6, 2025

billion by 2027. This involves defining clear goals, outlining project deliverables, and establishing effective communication channels. Establish Effective Communication Clear and effective communication is vital for a successful partnership. 10 ways to optimize your CDMO communications. 2022, November 7).

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