Pharmaceutical Technology

JUNE 29, 2022

Almost 40 years since it was instituted, some have described the FDA’s orphan drug program, which is meant to foster innovation, as “ one of the most successful US legislative actions in recent history ”. During 2001–10, the number of granted designations almost tripled, with 1,527 drugs receiving their first orphan drug designation.

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European Pharmaceutical Review

DECEMBER 14, 2023

Between 1999 and 2001, it supported 17 percent of withdrawals, between 2002 and 2011, it supported 26 percent of withdrawals and by 2012 to 2016, 80 percent of withdrawals were supported by observational studies (cohort, case-control, or other epidemiologic design). Meta-analyses contributed least frequently (31.4

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Medical Records Vaccines Hospitals Drug Development 116

PharmaShots

FEBRUARY 20, 2023

According to a survey, a majority from a cohort of pharmaceutical leaders expressed that the drug development plans, which ideally takes years of research, when asked to prepare in haste, may cause serious implications on the health of the population.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Drug Development 40

Pharmaceutical Technology

FEBRUARY 13, 2023

The first concept for a PROTAC was published in 2001, and recently these protein degraders have gained rapid momentum as a promising novel modality. By this same virtue, PROTACs are able to degrade previously undruggable targets, which provides a major competitive advantage for this modality if shown to be true.

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Express Pharma

SEPTEMBER 17, 2024

With an aim to become more value-driven, India’s pharma industry is looking beyond generics, targeting innovations in drug development. A Dr Reddy’s spokesperson informs, “Since 2001, through SMT, we have trained over 4,500+ youth (10+2 candidates) from economically weaker sections to help them join mainstream professional life.

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Communication Drug Development 102

pharmaphorum

JUNE 8, 2021

All these factors will support the growth of in-house R&D-driven pharmaceutical companies and bring more innovative drugs to Asian markets.”. Dr Jay Mei has nearly 30 years of experience in clinical research and development of oncology therapeutics globally. From 2006, Dr Mei worked as a senior director at Novartis Oncology.

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pharmaphorum

JANUARY 29, 2021

They wanted someone who had lots of experience in drug development, was a molecular biologist, and was stubborn enough to take on CRISPR!” From 2001 to 2012, Dr Macrae held roles of increasing responsibility at GlaxoSmithKline, including senior vice president, Emerging Markets Research and Development (R&D).

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Documentation Drug Development 145

FDA Law Blog: Biosimilars

APRIL 23, 2023

Outstanding Questions This Draft Guidance expands on the 2001 ICH E10 guidance (Choice of Control Group and Related Issues in Clinical Trials) and does a fairly thorough job describing the limitations and challenges facing sponsors seeking to use an externally controlled trial, particularly using RWD.

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pharmaphorum

SEPTEMBER 18, 2020

However, it withdrew its neuropharmacological drug, Zelmid, which was an SSRI, due to concerns over side effects only a year after it was introduced in 1982. In 1990, the US Food and Drug Administration (FDA) requested Astra to change Losec’s brand name to Prilosec, to avoid confusion with Sanofi-Aventis’ diuretic, Lasix (furosemide).

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Drug Development 116

PharmaShots

FEBRUARY 21, 2023

Market Cap: $29.30M Founded Year: 2001 Total Employees: ~20 Headquarters: Tokyo, Japan Stock Exchange: TYO Perseus Proteomics is a Japanese biotech company focused on developing antibodies by utilizing antibody technology to provide treatment options to patients worldwide.

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Pharmaceutical Technology

FEBRUARY 23, 2023

As formulators, we are often able to directly impact the amount of drug absorbed through formulation optimization and improve exposure. However, the chances of improving the exposure profile of a drug that is highly cleared by formulation modification are limited. S54 – S61 (2001).

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Pharmaceutical Technology

MAY 3, 2023

from 2001 to 2022.” In 2017, FDA announced the Drug Competition Action Plan (DCAP) to allow consumers to get access to medicines. She says in those cases the FDA applies a multiple first-applicant approach to eligibility for 180-day exclusivity. However, that percentage of multiple first generics is not very high—approximately 10.6%

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Generic Medicine Drug Development Communication Diabetes 98

Pharmaceutical Technology

FEBRUARY 28, 2023

Orphan drug development is expanding Change is happening. 1983 was a pivotal year for the rare disease community, with the US Food and Drug Administration’s introduction of the Orphan Drug Act. With similar incentives offered by EU/EEA and UK law, orphan drug development has taken off.

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Pharmaceutical Companies Pharmaceutical Companies Drug Development Communication 52

Pharmaceutical Technology

FEBRUARY 20, 2023

On the other hand, a lack of diversity in clinical trial populations, particularly when the disease population is significantly underrepresented, greatly diminishes the quality of data obtained for drug safety and efficacy profiles. This may sound obvious, but it is still a major hurdle in drug development.

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