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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Dosage Labelling Immunity Immunization 56

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.

Chemotherapy 105

Chemotherapy Pharmaceutical Companies Pharmaceutical Companies Immunity 105

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

European Pharmaceutical Review

SEPTEMBER 14, 2023

In 2001 and 2007, through 2009, the economy was hit hard. There was a significant slowdown in drug development, clinical trials, and new drugs coming to market. EMA prepares for winter antibiotic shortages That slowdown resulted in 211 drug shortages in 2010—the highest number recorded in a single year at the time.

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Drug Development Drug Pricing Communication 79

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 115

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.

Vaccines 40

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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Dosage Chemotherapy Compounding Immunity 59

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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Documentation Drug Development 49

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 Diabetes Communication 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.

Pharmaceutical Companies 52

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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Vaccines Communication Immunity Immunization 52