The Premier Consulting Blog

MAY 4, 2023

billion in 2022 and is expected to grow approximately eight percent from 2023 to 2030 [1]. The FDA has determined that ophthalmic dispensers are now regulated as devices, and the drug and device together are regulated as a combination product. The global ophthalmic drugs market size was valued at $33.81

FDA 52

FDA Packaging Compliance Regulations 52

Agency IQ

MAY 10, 2024

BY RAYAN BHARGAVA, MSC | MAY 9, 2024 11:03 PM CDT Regulatory background Until recently, the EU had plans to halve pesticide reduction by 2030. The proposal for a regulation on the sustainable use of pesticides (SUR), however, died in European Parliament in November 2023. Much financial weight is thrown behind Ecophyto 2030.

Government 40

Government Regulations Production Marketing 40

The Pharma Data

DECEMBER 15, 2020

The 2030 Consulting team provides high-caliber tactical contracting and strategic consulting for all aspects of business-to-business software solutions, from software sales and vendor selection to application development, implementation and managed services. Download the whitepaper at: [link]. Source link.

Science 52

Science Compliance Regulations FDA 52

Drug Patent Watch

DECEMBER 10, 2024

from 2023 to 2030. ” – Patheon “By possessing a deeper understanding of the regulations that apply to each step of the development and manufacturing journey, embedded CDMOs can often anticipate questions and issues that might arise and help avoid costly delays.”

Drug Development 59

Drug Development Compliance Pharmaceutical Companies Drugs 59

The Pharma Data

NOVEMBER 5, 2020

Since May, Member States have adopted a number of decisions – the Immunization Agenda 2030, the Decade of Healthy Ageing 2020-2030, as well as initiatives to tackle cervical cancer, tuberculosis, eye care, food safety, intellectual property and influenza preparedness. The WHA will consider a draft resolution ( EB146.R10

International 52

International Compliance Virus Vaccine 52

The Pharma Data

NOVEMBER 18, 2020

With only 10 years left until 2030, the rate at which access to sanitation is increasing will need to quadruple if the world is to achieve the Sustainable Development Goal (SDG) sanitation target. The consequences of poor sanitation are devastating to public health and social and economic development. What does this look like in practice?

Government 52

Government Regulations Production Treatment 52

The Pharma Data

MARCH 11, 2021

WHO prequalification helps regulators and procurers in low and middle-income countries to identify products that meet high quality standards and are safe and suitable for their intended use. Roche’s Global Access Program provides innovative diagnostic solutions improving disease and patient ma. management for those most in need.

Disease 52

Disease Treatment Laboratories Virus 52

DrugBank

MARCH 7, 2024

adults using obesity medications by 2030, further underlining the growing significance of this sector. Combination Therapies : Recognizing the complex nature of obesity, pharmaceutical companies are investigating combination therapies that target multiple pathways involved in appetite regulation, energy expenditure, and metabolic homeostasis.

Pharmaceutical Companies 81

Pharmaceutical Companies Clinical Trials Pharmaceuticals Therapies 81

DrugBank

MARCH 15, 2024

billion in 2022 and is projected to grow at a compound annual growth rate of 9.94% from 2023 to 2030. Mounjaro distinguishes itself from other treatments on the market by being the first to simultaneously activate GIP and GLP-1 pathways, offering a novel approach to regulating blood sugars for people with Type 2 Diabetes.

Pharmaceutical Companies 68

Pharmaceutical Companies Pharmaceuticals Treatment Clinical Trials 68

FDA Law Blog: Biosimilars

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

Clinical Trials 59

Clinical Trials Trials Regulations Treatment 59

PPD

OCTOBER 18, 2023

Continued expansion of the biotech industry is occurring in parallel, with an estimated compound annual growth rate of 13.96% from 2023-2030. There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care.

Laboratories 52

Laboratories Assay Development Small Molecule Drug Development 52

Translation

JULY 13, 2022

Last year, the companies partnered with Halo to seek solutions in carbon sequestration , plant growth regulators , and mycorrhizal fungi colonization. Soil organic carbon regulates the capacity of soil to provide regulatory ecosystem services. government targets to reduce greenhouse gas emissions by 50% below 2005 levels by 2030.

Regulations 52

Regulations Government Research International 52

Vial

MAY 20, 2024

billion by 2030 at a compound annual growth rate (CAGR) of 7.5% between 2024 and 2030. In this article, we will define preclinical and clinical CROs, as well as highlight the unique needs and challenges of these organizations in their respective stages of drug research. What is a Pre-Clinical CRO? over this period.

Clinical Research 52

Clinical Research Clinical Trials Research Trials 52

Agency IQ

FEBRUARY 23, 2024

NANCY SKINNER has updated a bill she introduced in early January 2024 to ban the sale of intentionally added PFAS in the state after 2030. In 2019, the state began to significantly ramp up its PFAS regulation and research. Spurred by NRDC report, California senator proposes state ban on PFAS California state Sen.

Packaging 40

Packaging Regulations Production Compliance 40

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

FDA 69

FDA Laboratories Regulations Production 69

Olympian Clinical Research

JULY 12, 2022

According to the World Health Organization, major depressive disorder is projected to rank first as the top burden of disease worldwide by 2030. Serotonin is a neurotransmitter that plays a role in mood regulation. Symptoms of Major Depressive Disorder. This type of depression is more than just a case of the blues.

Clinical Research 94

Clinical Research Doctors Treatment Research 94

Drug Patent Watch

DECEMBER 12, 2024

Streamlining FDA Approvals : The FDA should work with drug regulators in other countries to create a common portal for submitting generic drug applications. Generics 2030: Three strategies to curb the downward spiral. These settlements can delay generic drug market entry and cost consumers billions annually. References Schulman, K.

Marketing 52

Marketing Drugs FDA FDA Approval 52

Vial

FEBRUARY 15, 2024

over the forecast period (2022-2030). Expertise in regulatory compliance : With deep regulatory knowledge, CROs assist sponsors in obtaining regulatory approvals, ensuring compliance with local regulations, and managing interactions with regulatory authorities.

Pharma Companies 52

Pharma Companies Clinical Trials Compliance Trials 52

Vial

FEBRUARY 23, 2024

billion and is expected to climb at a compound annual growth rate (CAGR) of 19.44% between 2023 and 2030. These could include issues related to data security, patient privacy, and technological accessibility; furthermore, there may be additional digital regulations and policies that these platforms must follow.

Clinical Trials 52

Clinical Trials Clinical Research Trials Hospitals 52

The Pharma Data

SEPTEMBER 16, 2020

This move follows the recent launch of the new Novartis Code of Ethics, and the announcement of a new 2030 target for full carbon neutrality across the company’s entire supply chain. The distribution of this press release may be restricted by applicable laws and regulations.

Therapies 52

Therapies Regulations Government Disease 52

Agency IQ

NOVEMBER 20, 2023

Summary of Product Characteristics and Package Leaflet), recommending that sponsors and regulators “explore the use of electronic media” to provide product information “in the future”. If the ePI is approved by the regulator, then it will be made publicly available in the ePI database.

Production 40

Production Packaging Hospitals Regulations 40

The Pharma Data

JULY 27, 2021

Calico will be responsible for research and early development until 2025 and will advance collaboration projects into Phase 2a through 2030. .” Under the terms of the agreement, the collaboration between the two companies will extend in 2022 for an additional three years.

Disease 52

Disease Science Therapies Production 52

Agency IQ

JUNE 28, 2024

Generally, how have states attempted to regulate PFAS? States are attempting to regulate PFAS in a variety of ways, including via multiple in-state regulatory and legislative avenues. Used products and used product components are officially exempted from the regulations, as well as manufacturers that employ 25 or fewer people.

Production 40

Production Regulations Compliance Packaging 40

Agency IQ

MAY 10, 2024

In general, the law also pushes out a prohibition on almost all products with intentionally added PFAS from January 2030 to January 2032 , except for some cooling, heating, and refrigerant products which will be allowed until 2040. If passed, the law would go into effect in January 2025.

Packaging 40

Packaging Regulations Production Compliance 40

Perficient: Drug Development

NOVEMBER 15, 2024

election results could significantly shift healthcare policy and impact healthcare access, affordability, regulation, and innovation. billion by 2030. Strict regulations around HIPAA, PHI, and PII create significant barriers, making it difficult to adopt off-the-shelf AI solutions from fields like commerce or digital experience.

Regulations 64

Regulations Compliance Production Nurses 64

Perficient: Drug Development

NOVEMBER 15, 2024

election results could significantly shift healthcare policy and impact healthcare access, affordability, regulation, and innovation. billion by 2030. Strict regulations around HIPAA, PHI, and PII create significant barriers, making it difficult to adopt off-the-shelf AI solutions from fields like commerce or digital experience.

Regulations 52

Regulations Compliance Production Nurses 52

Codon

MARCH 24, 2024

market with Wegovy will, by 2030, require about one million liters of production capacity. In response to this hysteria, regulation was aggressively tightened. The total global bioprocessing capacity was estimated at 17.4 million liters in 2021, according to an analysis by BioProcess International.

Engineering 84

Engineering Vaccine Production RNA 84

The Pharma Data

MARCH 13, 2021

” Discussions with regulators are ongoing and an update on the TRAILBLAZER clinical trial program will be provided on a webcast on Monday, March 15 at 10:30 AM EDT including an update on the ongoing TRAILBLAZER-ALZ 2 trial. In the US alone, there was an increase of 8 million new caregivers from 2015 to 2020 5. Source link:[link].

Disease 40

Disease Trials Treatment Medical Schools 40

Agency IQ

MARCH 7, 2024

British regulators tease new device regulations in informative live session This week, the British regulator MHRA offered a new peek into its planned medical device regulations. BY COREY JASEPH, MS, RAC | MAR 5, 2024 11:10 PM CST Quick background on medical device regulation in the U.K. post-market regulation here.]

Regulations 40

Regulations International Production Government 40

The Pharma Data

JANUARY 9, 2021

RECONCILIATION OF NON-GAAP MEASURES (unaudited) This press release contains two financial measures (Adjusted Net Income and Adjusted EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization)) that are considered “non-GAAP” financial measures under applicable Securities and Exchange Commission rules and regulations.

Government 40

Government Vaccine Production Licensing 40

Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

MAY 28, 2024

regulator lays out proposal for international device and diagnostics recognition The British medical device regulator just issued its promised framework on international recognition. law as the Medical Devices Regulation 2002 (UK MDR 2002). law as the Medical Devices Regulation 2002 (UK MDR 2002).

International 40

International Regulations Licensing Licensing 40

Agency IQ

DECEMBER 1, 2023

What we expect the EPA to do in December 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Production Compliance Science 40

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

Regulations 40

Regulations Compliance Production Science 40

The Pharma Data

DECEMBER 18, 2020

billion: Norway has signed a new commitment of NOK 1 billion to the International Finance Facility for Immunisation (IFFIm), to be paid from 2021 to 2030. It provides normative guidance on vaccine policy, regulation, safety, R&D, allocation, and country readiness and delivery. million in direct funding and $6.25

Vaccine 52

Vaccine Government International Virus 52

Codon

MARCH 3, 2024

Link A synthetic oscillatory network of transcriptional regulators. per kilo by 2030. Is it because we lack appropriate mathematical models, or because transgenes simply impose too much “burden” on the cells in which they are placed, or something else? Related: Construction of a genetic toggle switch in Escherichia coli.

DNA 81

DNA Engineering Vaccine Virus 81