Drug Target Review

SEPTEMBER 26, 2023

1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic. Another area in need of attention is central nervous system (CNS)-safety testing.

Drugs 111

Drugs FDA Disease Animal Testing 111

Advarra

JUNE 20, 2023

Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54 Typical clinical development timelines for anticancer drugs average an estimated 6.7

Trials 52

Trials Clinical Trials FDA Approval Therapies 52

Drug Target Review

OCTOBER 3, 2024

The creation of sophisticated human antibody libraries covering a vast immune repertoire through de novo synthesis, such as HuCAL (human combinatorial antibody library), 7 combined with phage display technology and optimised for in vitro expression, have revolutionised the development of recombinant monoclonal anti-idiotypic antibodies.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

Drug Target Review

SEPTEMBER 10, 2024

Drug developer companies across the pharma industry report notable reductions in drug development timelines where 10 to 12 months, from lead monoclonal antibody (mAb) identification to IND application, is the new norm and in which earlier Tox material generation has been a critical component for shortening IND timelines.

Drug Development 64

Drug Development Clinical Supply Production FDA 64

FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

The issues appropriate for an INTERACT meeting typically relate to IND requirements, such as questions about IND-enabling studies, complex manufacturing technologies or processes, development of innovative devices used with a drug or biologic, or the use of New Approach Methodologies (methods to be used in place of traditional animal testing).

FDA 64

FDA Packaging Animal Testing Production 64

Agency IQ

JUNE 9, 2023

The guidance looks very different from the draft that was published in February 2020, including changes in the scope of the guidance, its sponsorship, and the removal of all mentions of nonhuman primates for animal testing. Nonclinical studies encompass much more than just animal studies.

FDA 40

FDA Science Small Molecule Immune Response 40

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Instead, this guidance highlights questions about species, animal model, and product selection for nonclinical programs as well as several aimed at helping to understand the purpose and importance of POC, toxicity, and biodistribution studies.

Therapies 59

Therapies FDA Production Disease 59