Drug Discovery World

APRIL 13, 2023

This report will: Provide an overview of the monoclonal antibody (mAbs) industry: market value, key on the future of antibody-based drug players, opportunities and the future Explore what’s next for antibody-based drugs and where the opportunity is coming from Include an interview Bio-Rad’s John Cardone, who shares expertise on the future of (..)

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Biosimilars Drugs FDA Marketing 130

Perficient: Drug Development

DECEMBER 29, 2023

percent by the statutory deadline of September 30, 2028. percent by September 30, 2028. percent by the statutory deadline of September 30, 2028. This action became necessary due to extraordinary deposit growth during the first half of 2020, causing the DIF’s reserve ratio to dip below 1.35

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Drug Discovery World

DECEMBER 7, 2022

billion by 2028. If clinical research into collagen maintains this momentum, we can expect to see innovations in wound healing and bone care making their way to patients in the coming years.”. In 2021, the global collagen market was valued at $9.75 billion USD, and is expected to grow to $16.7

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Perficient: Drug Development

SEPTEMBER 25, 2023

According to Forrester, “Investment in hospital equipment will grow from $36 billion in 2018 to $262 billion in 2028. And that’s easy to understand due to the plethora of available options and new solutions entering the market each day. Yet, HCPs often purchase technology on a team-by-team basis.”

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The Pharma Data

APRIL 6, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Organon Finance 1 LLC plans to offer, subject to market conditions, euro-denominated senior secured notes due 2028, U.S. dollar-denominated senior secured notes due 2028 and U.S.

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Drug Discovery World

SEPTEMBER 26, 2022

According to MarketWatch, the drug repurposing sector was thought to be worth $25,280 in 2021 and is expected to grow to $30,620 million by 2028 with a CAGR of 2.8%. This level of growth is unsurprising for an industry which will always look to the latest opportunities to drive science. . Benefits and barriers .

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The Pharma Data

APRIL 8, 2021

dollar secured notes”) and $2,000,000,000 aggregate principal amount of 5.125% senior unsecured notes due 2031 (the “unsecured notes” and together with the euro secured notes and U.S. dollar secured notes, the “notes”), in connection with the previously announced spinoff of Organon & Co.

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Regulations Biosimilars Government Production 52

Drug Discovery World

MARCH 13, 2024

According to Statista, revenue in this sector is expected to grow at an annual rate of 6.77%, resulting in a market volume of US$2,208m by 2028 1. Thanks to significant investment by the government into research and development, Singapore has become a leading centre for biomedical sciences in Asia.

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Alta Sciences

APRIL 5, 2024

billion by 2028—a CAGR growth rate of 10.7% A McKinsey & Company report from 2022 also found that biotech companies often rely heavily on CROs to compensate for their relative lack of “infrastructure”. As of 2023, Contract Pharma reported that the CRO market was estimated to be worth USD 76.6 billion, with projections to reach USD 127.3

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Agency IQ

JUNE 7, 2024

Applicants have until June 19, 2028 , “individually or collectively,” to submit the application to the assigned RMS ( Article 8 ). Finally, companies will then have until June 19, 2028 , to submit applications for approval of the work program-listed substances to the assigned RMS.

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Perficient: Drug Development

SEPTEMBER 19, 2023

jobs by 2028. This solidifies that Salesforce is leading the charge in AI, and Perficient is leaning into the partnership to bring innovative solutions to our clients. We learned about new Salesforce capabilities and technologies, heard new product announcements, and connected with peers and clients from across industries.

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The Pharma Data

JUNE 2, 2023

Those taking up this offer will be required to hold the Shares or the corresponding FCPE units for a period of approximately five years, i.e. until 31 May 2028, except upon the occurrence of an early release event provided for under Article R. The voting rights attached to the subscribed Shares will be exercised directly by the employees.

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Drug Discovery World

SEPTEMBER 28, 2022

In fact, the market research firm, Bekryl, predicts that AI has the potential to offer over $70 billion in savings for the drug discovery process by 2028. . Lastly, it alleviates the need for repetitive tasks, such as the analysis of thousands of histology images, which saved hundreds of hours of laboratory work.

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The Pharma Data

JANUARY 19, 2021

It hopes to raise about $160 million in aggregate principal amount of 7.375% senior notes due 2025 and $270 million in aggregate principal amount of 7.250% senior notes due 2028. It is offering 70 million ordinary shares with a price between $20 and $23 per share. Ortho Clinical Diagnostics is a leader in in vitro diagnostics.

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The Premier Consulting Blog

NOVEMBER 20, 2023

Phase 5 (4 years after publication; no earlier than April 1, 2028) End of Enforcement Discretion for: Premarket review for moderate-risk and low-risk IVDs needing premarket review. Regulation Update: Class III LDTs will now fall under full Premarket Approval (PMA) requirements as per the FD&C Act.

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Laboratories FDA Clinical Development Regulations 52

Drug Discovery World

AUGUST 8, 2023

According to Talangana Today, the state initially set a target to double the life sciences value from $50 billion to $100 billion by 2030, but based on the momentum in the sector, the schedule is advanced to 2028 and IT and Industries Minister KT Rama Rao told Talangana Today that this target could be achieved even earlier than 2028 13.

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The Premier Consulting Blog

APRIL 27, 2023

offers significant advancements in the way that sponsors and regulatory bodies handle submissions, and adapting to these improvements will be mandatory across all major regulatory authorities by 2028 (earlier, in many regions). This blog post gives an overview of the changes that eCTD v4.0 As of April 2023, the FDA is overseeing its eCTD v4.0

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Packaging FDA International Pharmaceuticals 52

Agency IQ

JUNE 17, 2024

To support the extension, the request also noted the extended transitional periods for medical devices and diagnostics though December 31, 2028. In the new standardization request, this standard has a deadline of 2024 for IVDR (Annex II) but 2028 for MDR (Annex I). Another discrepancy is the symbols standard, ISO 15223-1.

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Drug Discovery World

FEBRUARY 21, 2023

billion by 2028. Israel Stern, Oncology & Hematology Analyst at GlobalData, commented: “Patients with HR+/HER2- metastatic breast cancer who are treated with hormone therapy and chemotherapy often develop resistance to these treatments. Trodelvy has been marketed for triple-negative breast cancer since 2021.

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Drug Discovery World

AUGUST 10, 2022

As a result, the global CAR T cell market may reach $8 billion in size by 2028 23.With 23: Global CAR-T Cell Therapy Market to be Worth US$ 8 Billion by 2028.Coherent For example, the FDA supports the development of safe and effective T cell therapies through their guidances on cell therapy manufacturing 22. Gene Therapy.

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Agency IQ

JUNE 28, 2024

Manufacturers’ direct consultation of the expert panel is an extraordinary measure allowed only during the MDR transition period, ending in December 2028 at the latest. Where the clinical program is already underway, the manufacturer can consult the expert panel in exceptional cases.

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The Pharma Data

JANUARY 9, 2021

There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including the impact of global economic conditions and public health crises and epidemics, such as the global pandemic that arose from COVID-19, on the markets, our operations, and employees as well (..)

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Agency IQ

MAY 28, 2024

CE mark in addition to its own UKCA mark, with a plan to continue doing so through 2028 or 2030, depending on the legislation to which the CE mark applies. The current regulations include a sunset date that will fall in either 2028 or 2030, depending on the product type. and its national competent authorities, and the U.S. policy here.

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Agency IQ

MARCH 15, 2024

Improving recycling: SB 54 contains a set of recycling targets that increase between 2028 and 2032. By 2028, the state will require the recycling of 30% of single-use packaging and food service ware. Cutting waste: By 2032, SB 54 requires that the state cut the use of single-use packaging and food service ware by 25%.

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Agency IQ

MAY 17, 2024

The Creating Hope Reauthorization Act would extend the expiration date of the program for another four years , from September 30, 2024 to September 30, 2028. 3433, Give Kids a Chance Act This legislation has been under development for several years, and as of today has a whopping 230 co-sponsors in the House of Representatives.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028. Sunsetting of Coverage Gap Discount Program: The 70% coverage gap discount under the CGDP will continue until December 31, 2024. Final Guidance at 2.

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Compliance Pharmacy Drugs Licensing 105

FDA Law Blog: Biosimilars

OCTOBER 6, 2023

The Proposed Rule states that Stage 4 and Stage 5 would not begin before October 1, 2027, and April 1, 2028, respectively, in order to enable laboratories to participate in negotiations preceding user fee reauthorization in 2027 (taking effect in FY2028, which begins on October 1, 2027).

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Laboratories FDA Regulations Compliance 64

Agency IQ

MARCH 1, 2024

EPA also proposed an additional set of CO2 standards for HD vehicles that would begin to apply in MY 2028, with progressively more stringent standards each model year through 2032.

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The Pharma Data

NOVEMBER 8, 2020

It is estimated that there will potentially be 13 million moderate-to-severe acne patients treated with oral antibiotics in the urban Chinese population by 2028, which represents a significant opportunity to launch an innovative product whose clinical development is largely de-risked.

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Licensing Licensing Production Marketing 52

Agency IQ

JANUARY 26, 2024

That amendment allowed medical devices meeting certain conditions to extend the time for the transition to the MDR to 2027 or 2028, depending on the risk classification of the device. Read AgencyIQ’s analysis of that regulation and its impact here and here.]

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The Pharma Data

JANUARY 25, 2021

Prior to November 1, 2028, the notes will be convertible only upon satisfaction of certain conditions and during certain periods. The notes will bear interest at a rate of 2.25% per year, payable semi-annually in arrears on February 1 and August 1 of each year, beginning August 1, 2021.

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Agency IQ

OCTOBER 12, 2023

The Kigali Amendment created a timeline to reduce overall HFC use and consumption by 80-85% by the late 2040s, as well as HFC consumption level freezes in 2024 and 2028 for certain countries. President Biden ratified the Kigali Amendment on September 1, 2022.

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The Pharma Data

NOVEMBER 4, 2020

1 (908) 892-2028 PR@amarincorp.com (media inquiries). . Stern Solebury Trout In U.S.: +1 1 (646) 378-2992 lstern@soleburytrout.com. Media Inquiries: Alina Kolomeyer Communications Amarin Corporation plc In U.S.: +1 . . . .

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Agency IQ

MARCH 7, 2024

government recently extended that recognition through 2028 for medical devices and 2030 for IVDs. To keep critical devices and in vitro diagnostics (IVDs) available for patients in Great Britain (England, Scotland, and Wales), a much smaller market than the remaining 27 Member States of the E.U., There were myriad reasons for the extension.

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The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. Company has 89 pipeline projects spread across 6 targeted therapeutic areas with 4 programs in registration and 23 in Phase 3.

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Agency IQ

MARCH 29, 2024

EPA also proposed an additional set of CO2 standards for HD vehicles that would begin to apply in MY 2028, with progressively more stringent standards each model year through 2032.

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Regulations Compliance Production Government 40

Agency IQ

DECEMBER 15, 2023

EPA also proposed an additional set of CO2 standards for HD vehicles that would begin to apply in MY 2028, with progressively more stringent standards each model year through 2032. Monitoring preparations are anticipated in 2027, with sample collection between 2028-2030 and reporting concluding in 2031.

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