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.

Regulations 52

Regulations Biosimilars Government Production 52

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.

Regulations 52

Regulations Biosimilars Government Production 52

DrugBank

SEPTEMBER 26, 2024

billion by 2028. Biosimilar development's capital-intensive nature, regulatory hurdles, and potential patent litigation demand substantial investment and risk tolerance. However, the potential rewards are equally significant, with the global biosimilar market projected to reach $66.9

Biosimilars 98

Biosimilars Clinical Trials Production Marketing 98

Alta Sciences

AUGUST 29, 2024

billion USD by 2028. As the body’s processing center, the CNS is responsible for all functions of our bodies, including thoughts, emotions, memories, and behaviors. The global market for CNS therapeutics is a multi-billion-dollar industry, and is projected to grow from $102.4 billion USD in 2023 to $166.53

Drug Development 52

Drug Development Small Molecule Clinical Trials Drugs 52

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.

Licensing 59

Licensing Licensing Production Marketing 59

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.

Regulations 52

Regulations Marketing 52

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

Drug Development 52

Drug Development Pharma Companies Marketing Drugs 52

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.

Small Molecule 52

Small Molecule Trials Laboratories Immune Response 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.

Regulations 40

Regulations Production International Laboratories 40

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).

Laboratories 64

Laboratories FDA Regulations Production 64

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.

Regulations 40

Regulations Animal Testing Production Marketing 40

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%.

Regulations 40

Regulations Packaging Compliance Production 40

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.

Laboratories 52

Laboratories Clinical Development FDA Regulations 52

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.

International 40

International Regulations Licensing Licensing 40

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.

Licensing 52

Licensing Licensing Marketing Production 52

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.

Marketing 52

Marketing Disease Clinical Trials Clinical Development 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.]

Regulations 40

Regulations Compliance Laboratories Production 40

Agency IQ

AUGUST 16, 2024

The study is planned to begin in 2026 and conclude in 2028. Lykos also registered an additional open-label Phase 1 pharmacokinetics study of midomafetamine and metabolites in patients with moderate hepatic impairment to understand if a dose adjustment is necessary in that population.

FDA 40

FDA Trials Therapies Regulations 40

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.

Regulations 40

Regulations International Government Production 40

Agency IQ

FEBRUARY 2, 2024

However, the extension would also limit certain updates to these IVDs. To qualify, the devices must continue to comply with the IVDD, cannot undergo any significant design or use changes, and cannot present “an unacceptable risk to health or safety.”

FDA 40

FDA Laboratories Regulations Production 40

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.

Trials 40

Trials Marketing Clinical Trials Regulations 40

The Pharma Data

JUNE 25, 2025

In a landmark move, Bharat Biotech will progressively reduce the price of the RTS,S vaccine to below $5 per dose by 2028—a reduction of more than 50%. This announcement was made as part of their pledges to Gavi, the Vaccine Alliance, ahead of Gavi’s sixth replenishment cycle (Gavi 6.0) scheduled for 2026 to 2030.

Vaccine 52

Vaccine Production Hospitals Disease 52

The Pharma Data

JULY 2, 2025

GSK is also developing VH499, a capsid inhibitor, and is targeting the launch of its own twice-yearly HIV treatment and PrEP injectable between 2028 and 2030. The goal is clear: retain relevance in a market that Gilead continues to dominate. While Gilead currently holds a 51% share of the U.S.

Marketing 52

Marketing Treatment Therapies Compliance 52

DrugBank

AUGUST 9, 2024

trillion by 2028. billion by 2028, demonstrating the urgent need for effective treatments. This can significantly impact a company's ability to recoup its R&D investment. Pharmaceutical Market Analysis The global pharmaceutical market revenue in 2024 is projected to be 1.15 trillion dollars, and it is forecasted to exceed 1.4

Pharmaceuticals 98

Pharmaceuticals Research Pharmaceutical Companies Clinical Trials 98

BioPharma Drive: Drug Pricing

JUNE 26, 2025

But Jakafi’s main patents expire in 2028, a date that for years now has been on investors’ radar as they’ve pressed Incyte on what it expects will take the drug’s place. The company has had a good deal of success with Jakafi, a multipurpose drug approved to treat rare blood cancers and graft-versus-host disease. billion in sales.

Licensing 124

Licensing Licensing Therapies Vaccine 124

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.

Compliance 105

Compliance Drugs Pharmacy Licensing 105

The Pharma Data

JUNE 11, 2025

The expanded agreement, which now stretches the collaboration through at least 2028, marks a new chapter in the two organizations’ efforts to harness cutting-edge genomic research, high-throughput screening platforms, and translational science to deliver precision medicines that could alter the course of chronic cardiovascular diseases.

Drug Research 40

Drug Research Research Small Molecule Drugs 40

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.

FDA 40

FDA Disease FDA Approval Production 40

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.

Regulations 40

Regulations Production International Marketing 40

Codon

SEPTEMBER 29, 2024

2028 Over the next year, the scientific community ferociously interrogated the model. The trained model also went live on HuggingFace , open for both academic and commercial usage. The next model of life had officially been released. It was the last of its kind to be truly open source.

Engineering 144

Engineering Virus DNA Therapies 144

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 . . . .

Production 40

Production Trials FDA Disease 40

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 (..)

Government 40

Government Vaccine Production Licensing 40

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.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

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.

Regulations 40

Regulations Compliance Government Production 40

FDA Law Blog: Biosimilars

JANUARY 2, 2025

The compliance date is February 25, 2028. FDA believes that such a standardized graphic will further support FDAs goal of helping consumers identify food products that can be the basis of healthy eating patterns consistent with the DGs. The final rule is effective 60 days from December 27, 2024, i.e., February 25, 2025.

FDA 52

FDA Production Science Compliance 52

New Drug Approvals

APRIL 27, 2025

Flurpiridaz F 18 WeightAverage: 367.84 3] Flurpiridaz ( 18 F) It is given by intravenous injection. [3] 3] Flurpiridaz ( 18 F) was approved for medical use in the United States in September 2024. [3] 2008 ; Nagel 2014 ) Briefly, to a mixture of mucochloric acid ( 1 ) (1.18 mmol) and Na 2 CO 3 (0.33

FDA 57

FDA FDA Approval Clinical Trials Disease 57

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.

Regulations 40

Regulations Compliance Production Government 40