Fierce BioTech

SEPTEMBER 30, 2024

Fierce Biotech Week Fierce Biotech Week features insights from C-suite and executive leadership at biotech, mid-sized and large pharma companies on emerging trends and market dynamics that will help effectively prioritize R&D spend, optimize drug development and clinical operations, and navigate capital raising and partnering deals.

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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. Subscribe to Asimov Press.

Engineering 133

Engineering Virus DNA Therapies 133

LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. Figure 2 shows pipelines across modalities for some of the competitive targets today.

Small Molecule 137

Small Molecule Trials Therapies Disease 137

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. In fact, according to the Harvard Business Review , only about 5% to 10% of marketing budgets are earmarked for women in the 50+ category. So What Can the Super Bowl Teach Us About Invisible Audience Marketing?

Science 59

Science Doctors Marketing 59

Perficient: Drug Development

MARCH 15, 2024

The US is taking some oil off the market by refilling our strategic petroleum reserves. of the market. 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. $2.68 million units. million units.

Marketing 52

Marketing Production Government 52

Perficient: Drug Development

NOVEMBER 22, 2024

In this blog, we’ll explore how Drupal Starshot is poised to transform enterprise-level content management, streamline development workflows, and enable marketing and IT teams to collaborate with unprecedented efficiency. This empowerment will accelerate time-to-market for campaigns and updates.

Packaging 52

Packaging Compliance Marketing Research 52

Drug Target Review

SEPTEMBER 19, 2024

Could you give us an overview of IRLAB’s current drug development pipeline? Top-line data from the Phase IIb study is expected at the beginning of 2025. The third project in clinical phase, IRL757, is in Phase I and is being developed for the treatment of apathy.

Disease 52

Disease Drugs Treatment Drug Development 52

Perficient: Drug Development

DECEMBER 24, 2024

Here are the key trends that will redefining the digital landscape in 2025: The AI Revolution: From Convenience to Necessity Artificial Intelligence will be the cornerstone of modern consumer interactions. Consumer behavior is not just shaping online business operationsit’s fundamentally changing the digital marketplace.

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Marketing Production 52

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.

Trials 52

Trials Clinical Trials Therapies Treatment 52

Perficient: Drug Development

DECEMBER 10, 2024

Were pleased to announce that Perficient has been named a Major Player in the IDC MarketScape: Worldwide Adobe Experience Cloud Professional Services 2024-2025 Vendor Assessment (Doc #US51741024, December 2024). It evaluates both quantitative and qualitative characteristics that contribute to success in this market.

Marketing 52

Marketing Research Science 52

The Pharma Data

MARCH 28, 2022

Dupixent is now a market leader and more than 400,000 patients with certain types of atopic dermatitis (AD), asthma and chronic rhinosinusitis with nasal polyposis have been treated globally. By 2025, Dupixent is expected to generate an additional 11 new regulatory submissions across indications and age groups.

Small Molecule 52

Small Molecule Clinical Development Disease Science 52

Perficient: Drug Development

NOVEMBER 14, 2023

That’s where you as a healthcare marketer come in. My son’s part of Generation Alpha, a cohort that includes children born between 2010 and 2025. Let’s talk about five aspects of Gen Alpha that you need to keep in mind and start planning for in your healthcare marketing. The oldest of the Gen Alpha kids are only 13.

Marketing 52

Marketing Regulations 52

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.

Production 40

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?

Clinical Trials 69

Clinical Trials Trials Disease Treatment 69

Vial

APRIL 18, 2024

Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding. Specifically, the global ophthalmic clinical trials market, valued at USD 1.5 Additionally, the ophthalmic drugs market, valued at USD 33.81

Clinical Trials 52

Clinical Trials Trials Treatment Clinical Research 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.

Production 40

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 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.

Clinical Trials 52

Clinical Trials Trials Science FDA 52

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.”

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40

Agency IQ

JULY 8, 2024

The outgoing Belgian Presidency further complicated discussions in the “incentives cluster” by suggesting four options that aim to ensure market access. Some “add-on” regulatory data protection may also be converted to market exclusivity. However, this was the first public debate and Hungary will take over the Presidency next week.

Regulations 40

Regulations Pharmaceuticals Production Vaccine 40

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. the drug and device) of the combination product.

FDA 40

FDA Science Regulations Production 40

Perficient: Drug Development

AUGUST 29, 2023

Market Overall, the automotive industry is up 13%. Further, there are fresh signs of labor market strength that reinforce a picture of an economy with broad momentum despite high interest rates. Tighter than expected labor market. million 14% 2025 26 17.9 An Overview of the U.S.

Marketing 52

Marketing Production 52

FDA Law Blog: Drug Discovery

JULY 9, 2024

The status of the DAP submission and any interactions with FDA regarding the DAP should be included in the regulatory history for milestone meetings and marketing submissions. A sponsor could conduct a study that is not initially viewed as pivotal but which ends up being so for its marketing application.

FDA 59

FDA Clinical Trials Disease Trials 59

Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest. Priority A List.

FDA 40

FDA Science Biosimilars Clinical Trials 40

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

FDA Trials Therapies Regulations 40

Perficient: Drug Development

DECEMBER 19, 2024

In the spirit of Seinfeld s airing of grievances, here are 12 web trends that need to end in 2025! While many bad user experiences have faded away, some daily annoyances still need to go. NOTE: This list highlights issues with better alternatives, so theres no excuse not to fix them!

Marketing 105

Marketing Research 105

Agency IQ

FEBRUARY 2, 2024

This means that the medical device frameworks – including the pre-market pathways and evidentiary requirements, as well as post-market quality system frameworks and reporting requirements – are applied to the vast majority of all (CDRH-regulated) IVD products. IVDs used in blood donation screening/processing). In the E.U.,

FDA 40

FDA Laboratories Regulations Production 40

Agency IQ

FEBRUARY 2, 2024

Start Date End Date Event Event Type Center 01/10/2024 01/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Bringing Innovation to People Facing Cancer” Webcast Office of the Commissioner 01/26/2024 01/26/2024 Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) (..)

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

JULY 22, 2024

Facing headwinds, FDA moves ahead on diagnostics policy implementation but faces Congressional, legal, and judicial questions In April 2024, the FDA issued a final rule to update its regulatory approach to certain test products known as Laboratory Developed Tests (LDTs). AgencyIQ provides a status update for regulated industry.

FDA 40

FDA Laboratories Regulations Clinical Trials 40

Agency IQ

AUGUST 9, 2024

EMA’s psychedelic workshop leaves stakeholders with as many questions as answers Earlier this year, the EMA hosted a multi-stakeholder workshop to discuss regulatory issues surrounding drug development of psychedelic products. EMA has now published a report on the workshop; read on for AgencyIQ’s analysis. integration sessions).

Clinical Trials 40

Clinical Trials Regulations Trials FDA 40

Alta Sciences

JULY 31, 2024

Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. These are just some examples that highlight the critical importance of diversity in clinical trial data for the medicines reaching the market.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Pharmacokinetics 52

Drug Target Review

NOVEMBER 27, 2024

Introduction Biomarkers are becoming increasingly essential in drug development and clinical practice, driving the need for more precise validation methods. 2 The biomarker development pipeline involves multiple stages, including discovery, analytical validation, clinical validation and regulatory qualification. only about 0.1

Drug Development 52

Drug Development Regulations Laboratories FDA 52

Agency IQ

JUNE 28, 2024

In order to give the agency time to give feedback on the DAP, it goes on to recommend DAP submission “when the sponsor is seeking feedback regarding the applicable clinical study for the drug (typically at the End-Of-Phase 2 meeting).” For these products, DAPs must be submitted as part of the pre-market request (i.e.,

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FDA Science Clinical Trials Production 40