2028 and Therapies - Drug Discovery Digest

How to Successfully Prepare for the HTAR Implementation in the EU

thought leadership

JUNE 4, 2024

The HTAR will take effect in January 2025 for oncology and/or advanced therapy medicinal product (ATMP) therapies, with other therapies following a staggered implementation process, including orphan drugs in 2028 and all drugs in 2030.

Therapies

Therapies Regulations Production Marketing

The Competitive Edge of Biosimilars

DrugBank

SEPTEMBER 26, 2024

This is because biosimilars are not new drugs but highly similar versions of already approved therapies with established safety and efficacy profiles. billion by 2028. One key challenge is the development of biosimilars for complex biologics, such as monoclonal antibodies used in cancer treatment and gene therapies.

Inside The Altascientist Issue 33: CNS Drug Development – Integrated Solutions Lessen Complexity

Alta Sciences

AUGUST 29, 2024

Listen or read Issue 33 of The Altascientist on altasciences.com , or wherever you listen to podcasts: GROWING NEEDS FOR CNS THERAPY SOLUTIONS The different parts of the nervous system, including the brain and spinal cord and the peripheral nervous system, are important drug targets for many serious diseases affecting human health.

Drug Development

Drug Development Clinical Trials Small Molecule Drugs

2021 Biotech IPOs Get Off to a Roaring Start

The Pharma Data

JANUARY 19, 2021

TCR 2 is developing novel T-cell therapies for solid tumors and hematological cancers. The company is using its pioneering FasTCAR and TruUCAR technology platforms to discover and develop breakthrough cell therapies. The company is based in Suzhou and Shanghai, China. Ortho Clinical Diagnostics is a leader in in vitro diagnostics.

Small Molecule

Small Molecule Trials Laboratories Immune Response

Article EMA Thank You New MDR/IVDR standardization request adds standards, moves deadlines

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.

Regulations

Regulations Production International Laboratories

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

AUGUST 16, 2024

However, the agency can describe a concomitant therapy in labeling for a product it has authority to regulate if it is essential for the therapeutic effect. While the ability to describe and specify aspects of the therapy is limited, the agency can specify the number and licensure of therapists who would participate in the MDMA treatment.

FDA

FDA Trials Therapies Regulations

Almirall demonstrates resilient performance year to date despite COVID-19 impacts

The Pharma Data

NOVEMBER 8, 2020

R&D pipeline continues to drive future value through innovation and differentiated therapies including expected upcoming approval of Tirbanibulin. Based on the solid year to date performance Almirall is reiterating its guidance for FY 2020. Financial highlights (€ million). .

Licensing

Licensing Licensing Marketing Production

Article EMA Thank You British regulators tease new device regulations in informative live session

Agency IQ

MARCH 7, 2024

government recently extended that recognition through 2028 for medical devices and 2030 for IVDs. Certain IVDs will be treated differently; companion diagnostics used with drug therapies would have to include the international non-proprietary name (INN) of the medicine the test is used with. There were myriad reasons for the extension.

Regulations

Regulations International Production Government

Investment Trends in Pharmaceutical Research

DrugBank

AUGUST 9, 2024

trillion by 2028. These new therapies have demonstrated significant LDL cholesterol reductions, but their high cost remains a barrier to widespread adoption. billion by 2028, demonstrating the urgent need for effective treatments. This can significantly impact a company's ability to recoup its R&D investment.

Pharmaceuticals

Pharmaceuticals Research Pharmaceutical Companies Clinical Trials

Article FDA Thank You House legislators set to markup legislation related to rare diseases, pediatric oncology and HCT/Ps

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. The Give Kids a Chance Act extends the RACE for Children Act’s requirements one major step farther , applying them to combination therapies in addition to single-drug therapies.

FDA

FDA Disease FDA Approval Production

Models of Life

Codon

SEPTEMBER 29, 2024

It suggested that, in the future, certain classes of drugs, specifically genetic therapies, could be screened entirely virtually via models of life. 2028 Over the next year, the scientific community ferociously interrogated the model. Of particular interest was how genetic therapies were delivered.

Engineering

Engineering Virus DNA Therapies

Amarin Reports Third Quarter 2020 Financial Results and Provides Business Update

The Pharma Data

NOVEMBER 4, 2020

“We are excited to be nearing the EMA’s regulatory decision on VASCEPA and are busy preparing for our anticipated commercial launch in Europe, where there is a large and growing opportunity for Amarin to bring this proven effective therapy to the millions of patients at high risk for cardiovascular events. 500 mg/dL) hypertriglyceridemia.

Production

Production Trials Disease FDA

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

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. Based on the acceptable safety profile and the favorable immune response data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation.

Vaccine

Vaccine Therapies Trials Clinical Trials

Flurpiridaz F 18

New Drug Approvals

APRIL 27, 2025

New Drug Therapy Approvals 2024 (PDF). 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

FDA Clinical Trials FDA Approval Disease

Drug Discovery Digest

How to Successfully Prepare for the HTAR Implementation in the EU

The Competitive Edge of Biosimilars

Trending Sources

Inside The Altascientist Issue 33: CNS Drug Development – Integrated Solutions Lessen Complexity

2021 Biotech IPOs Get Off to a Roaring Start

Article EMA Thank You New MDR/IVDR standardization request adds standards, moves deadlines

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Almirall demonstrates resilient performance year to date despite COVID-19 impacts

Article EMA Thank You British regulators tease new device regulations in informative live session

Investment Trends in Pharmaceutical Research

Article FDA Thank You House legislators set to markup legislation related to rare diseases, pediatric oncology and HCT/Ps

Models of Life

Amarin Reports Third Quarter 2020 Financial Results and Provides Business Update

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

Flurpiridaz F 18

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