The Pharma Data

DECEMBER 14, 2020

15, 2020 /PRNewswire/ — Gmax Biopharm today holds ground-breaking ceremony for its Zhengzhou, China manufacturing site which is the production base for its GMA102 (T2D), GMA105 (obesity), and GMA301A/B (PAH for adult and children) drugs to be launched between 2023-2025, upon approval of respective clinical trials.

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Perficient: Drug Development

OCTOBER 30, 2024

Drupal Rector automates most custom code changes. For Users of Drupal 7 Drupal 7 will no longer be supported after January 5, 2025. Use the Upgrade Status Module to analyse your site.

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PPD

NOVEMBER 30, 2023

As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drug development shaped the pharma and biotech industries. Five Predictions for the Drug Development Industry in 2024 1. Stakeholders across the drug development sphere will unlock the transformative potential of AI.

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Perficient: Drug Development

FEBRUARY 2, 2024

Moving forward, these institutions will need to submit their resolution plans by March 31, 2025. In discussions with financial services executives, Perficient consultants consistently explore the extension of the submission deadline for resolution plans among certain large financial institutions with assets exceeding $250 billion.

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PPD

JULY 20, 2023

1, 2025, all plastic packaging and manufacturing materials for pharmaceutical use must meet the updated USP <661.2> It also enables drug developers to establish a robust testing history, or source and qualify alternative options should their current packaging systems fail to meet the requirements prescribed in the new chapters.

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Perficient: Drug Development

OCTOBER 25, 2023

Enforcement is coming soon from governments around the world by 2025 that global organizations must comply with or pay heavy fines, so it is strongly advised that organizations find experienced partners to improve accessibility as soon as possible.

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Perficient: Drug Development

OCTOBER 1, 2024

However, rather than the same sign to be put online, the December 2023 rule established a new black and navy blue official digital sign shown below: Beginning on New Year’s Day 2025, banks will be required to display the FDIC official digital sign near the name of the bank on all bank websites and mobile applications.

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Regulations Government Production Compliance 59

Codon

SEPTEMBER 29, 2024

2025 While the broader life sciences community had pivoted towards working on traditional mechanistic interpretations of biology, one graduate student still believed there was something to be learned using the models of life so celebrated previously. The 2025 genetic network paper fit that bill exactly.

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Agency IQ

JULY 7, 2023

This study was developed to help establish a workable framework for using real-world evidence (RWE) for regulatory cases within the E.U., building off the EMA’s Strategy through 2025. Regulators at EMA have outlined their intent to “enable” RWE and “establish its value for regulatory decision-making” by 2025.

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Regulations Research Production Government 40

Conversations in Drug Development Trends

MAY 23, 2024

The Critical EU-CTR Transition Deadline The three-year transition period for clinical trials authorized under the CTD that are expected to continue beyond the critical deadline of 30 January 2025 are required to transition to the new EU-CTR via a transition application through the CTIS.

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Perficient: Drug Development

OCTOBER 15, 2024

According to S&P Global, nearly 60% of global banks will be embedding climate risk into their core business models by 2025[4]. As banks face pressure to account for environmental factors in their risk assessments, data governance plays a critical role in ensuring the accuracy and transparency of these models.

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Government Compliance Regulations Production 52

Perficient: Drug Development

MARCH 15, 2024

EV Status: More models, more choices, more sales, 37 new models in 2024, 34 new models in 2025 EV Inventory: The day’s supply is well above the industry average. It was chips in 2022-2023 that caused a slowdown, but in 2024-2025, it could be graphite. Washington 15.4%

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Marketing Production Government 52

Perficient: Drug Development

MARCH 19, 2024

I got an email from Google Cloud Platform today entitled: [Action Required] Upgrade to Artifact Registry before March 18, 2025 This is not the first time Google has discontinued a product I use. They gave full year of lead time but I knew I would forget about it before then.

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Packaging Production 52

Conversations in Drug Development Trends

NOVEMBER 13, 2024

I will also run the Disney marathon in January 2025. I completed my second, the Chicago marathon, in 2022, my third in Philly in 2023 where I achieved a qualifying time for the Boston Marathon, and fourth, Atlantic City in October 2024.

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Hospitals Clinical Trials Doctors Nurses 52

Perficient: Drug Development

FEBRUARY 12, 2024

Veozah’s Super Bowl Ad Highlights an Invisible Issue By 2025, over 1 billion women will be in menopause. While it wasn’t the flashiest spot of the night, no pun intended, it did shine light on an issue, and an audience, that you don’t see many ads targeting. So what made this spot so exciting?

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Science Doctors Marketing 59

Drug Target Review

NOVEMBER 29, 2023

Given the fact that the typical company can spend 10 or more years to progress from identifying a new target to generating human data on a lead therapy, this pace change could transform the future of drug development as we know it. What sort of techniques do you use to analyse genomic data and identify novel drug targets?

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The Pharma Data

MARCH 28, 2022

By 2025, Dupixent is expected to generate an additional 11 new regulatory submissions across indications and age groups. These drug development programs include our acceleration of priority asset amlitelimab, an anti-OX40L antibody that aims to restore immune homeostasis between pro-inflammatory and anti-inflammatory T cells.

Small Molecule 52

Small Molecule Clinical Development Disease Science 52

Perficient: Drug Development

OCTOBER 7, 2024

Introduction A quick summary of the new official digital sign requirement of the FDIC is that effective January 1, 2025, this logo: must be replaced by this logo: For readers who missed part 1 of this series or want to reread the original blog can find it here.

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Compliance Regulations Research 52

Perficient: Drug Development

SEPTEMBER 8, 2023

Healthcare Workers Plan To Leave Their Positions By 2025. What’s New in Artificial Intelligence from the 2022 Gartner Hype Cycle. link] Forbes. New Survey Shows That Up To 47% Of U.S. link] National Center for Health Statistics (NCHS). Births: Final Data for 2021.

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LifeSciVC

JANUARY 16, 2024

Whether trial design, execution, or otherwise, drug development even where there is precedent is a challenging road and should not be taken for granted. Cheers to all the innovative medicines we will collectively shepherd through discovery and development in 2024, and can’t wait to discuss at JPM in 2025!

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The Pharma Data

DECEMBER 2, 2020

million aggregate principal amount of 7.25% convertible senior notes due 2025 (the “notes”) in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). The notes will mature on December 1, 2025, unless earlier repurchased, redeemed or converted.

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Production Drug Development Therapies Research 40

LifeSciVC

AUGUST 21, 2024

At this point of the year, the JPMorgan conference seems like ancient history and you are looking into flights for JPM 2025. Drug development is a long process, and patients are waiting. For some, a Midsummer’s Madness can be a Midsummer’s Nightmare. These goals were believable and achievable. Was that only six months ago?

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Clinical Trials Trials Disease Treatment 62

Agency IQ

JULY 28, 2023

But according to AgencyIQ’s user fee program performance tracker linked above and the FDA’s PDUFA VII user fee commitments, CDER and CBER committed to perform an “assessment of hiring and retention” with experience in HR operations “to conduct a targeted assessment of the hiring and retention of staff for the human drug review program.”

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Vial

APRIL 18, 2024

The study, projected to conclude by July 2025, anticipates enrolling approximately 500 participants. Our [ophthalmology CRO]( [link] team has extensive therapeutic knowledge to support all stages of ophthalmology drug development and clinical research.

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Clinical Trials Trials Treatment Clinical Research 52

Agency IQ

JULY 22, 2024

Assuming that the comment period is not extended, and FDA meets its statutory timeline to finalize the guidance within nine months of the closing of the comment period, the guidance could theoretically be put into force by late 2025.

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Clinical Trials Trials Science FDA 52

Perficient: Drug Development

NOVEMBER 14, 2023

My son’s part of Generation Alpha, a cohort that includes children born between 2010 and 2025. And because of my job, part of that worry involves wondering about the state of the healthcare industry when it’s time for him to start accessing it beyond the familiar walls of his pediatrician’s office.

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Marketing Regulations 52

The Pharma Data

DECEMBER 2, 2020

The issuance and sale of the notes are scheduled to settle on December 7, 2020, subject to customary closing conditions.

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Production Drug Development Therapies Research 40

Agency IQ

JUNE 21, 2024

Modeled on the Operation Warp Speed vaccine development communications approach, the pilot aims to test out a rapid communications approach for accelerating rare disease drug development.

Disease 40

Disease Science FDA Production 40

Agency IQ

JULY 8, 2024

The information below includes the event type and whether the meeting can be attended by the public (Open) or not (Closed).

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New Drug Approvals

SEPTEMBER 13, 2024

2] [3] [4] A regulatory application for approval of the medication is expected to be submitted by 2025. [2] 4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] Drug Discovery. nM vs. 24.0 December 2018).

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Agency IQ

FEBRUARY 15, 2024

CDER, CBER Draft or Revised Draft No date given FDORA Legislation Advanced Manufacturing FDA must issue draft guidance for industry sponsors seeking new drug approval or licensure of antifungal therapies designed to treat coccidioidomycosis (Valley Fever).

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FDA Law Blog: Drug Discovery

JULY 9, 2024

Another question is the impact on rare disease drug development, where broader populations are small and there may be limited knowledge about differential impacts of disease. If FDA meets this timeline, the requirement to submit DAPs for relevant clinical studies would begin around the end of 2025.

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Perficient: Drug Development

AUGUST 29, 2023

million 14% 2025 26 17.9 44 days supply of hybrids industry wide with Toyota Prius and Rav4 Hybrids under 30 days In comparison Toyota only fully electric model BZ4X has 101 days’ supply EV prices expected to be at parity with gas vehicles around 2025. million 1.7 Hawaii – $4.66

Marketing 52

Marketing Production 52

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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FDA Science Regulations Production 40

FDA Law Blog: Drug Discovery

JANUARY 23, 2023

Finally, FDA must submit an annual report to Congress summarizing the Agency’s aggregated experience with sponsors’ diversity action plans beginning not later than early 2025. More about FDORA Please see out blog post here to obtain a copy of HPM’s detailed Summary and Analysis of all the provisions of FDORA.

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. This study is planned to start in late 2024 and conclude in late 2025.

FDA 40

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Agency IQ

FEBRUARY 2, 2024

There are also continued questions about regulatory capacity and what the field will look like going forward, with implications for drug developers who rely on diagnostic products. A sea change for lab tests, the implications for drug developers and outstanding questions about endpoints In the U.S.,

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