Pharmaceutical Technology

NOVEMBER 21, 2022

A lower number of clinical trials and regulatory filings were other important influences behind the decision. In terms of the influence caused by negative changes in international investment in Japan, the pharmaceutical companies that decided to lower their business priority in Japan reported lower pharmaceutical sales.

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Pharmaceutical Technology

JULY 10, 2008

The industry sits at a pivotal point in its evolution and analysts say it can no longer rest on its laurels happy to produce generic drugs while expending vast sums on marketing at the expense of R&D. The report says the infrastructure around regulators vendors and the support industry will have to significantly change.

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FDA Law Blog

JANUARY 22, 2024

Led by former federal prosecutor Jill Furman, OC is charged with shielding consumers “from poor quality, unsafe, and ineffective drugs through compliance strategies and risk-based enforcement actions.” This is another area in which FDA works with industry to try to ensure voluntary compliance from regulated entities. Clinical Trials.

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Compliance Clinical Trials Clinical Trials Regulation 59

XTalks

JUNE 16, 2023

XTALKS WEBINAR: Fostering Patient-Centricity: Clinical Supply Chain Strategies and Sourcing Solutions Live and On-Demand: Thursday, July 20, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn how to review clinical trial trends and supply strategies that impact the patient experience.

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Drugs Manufacturing Clinical Supply Chain Clinical Trials 98

pharmaphorum

JUNE 8, 2021

But we are glad to see the situation for innovative drugs in Asian markets improving, especially in mainland China and South Korea, where policies, societies and regulations are actively promoting innovation. “At In addition, the pharmaceutical industry in China is still heavily dependent on generic drugs.”.

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Marketing Drugs Development Regulation 105

Pharmacy Checkers

DECEMBER 12, 2019

The FDA’s continuing problems with inspections of drug manufacturing plants, as well as the relative comparative strength of other drug regulators, ought to inspire serious reflection, even introspection, among drug safety policy professionals about whether or not, and how, we have the gold standard.

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Drugs Manufacturing Medicine Regulation 71

FDA Law Blog

AUGUST 16, 2021

While generic drugs as we know them are a creation of the 1984 Hatch-Waxman Amendments, the Federal Register Notice explains that FDA first introduced the concept of an ANDA in 1968 to facilitate approval of Drug Efficacy Study Implementation (DESI) drugs.

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The Pharma Data

OCTOBER 14, 2020

Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt , visit www.mallinckrodt.com. and foreign tax laws or the impact of disputes with governmental tax authorities; and the impact of Irish laws.

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Production Branding Development Regulation 40

XTalks

FEBRUARY 8, 2021

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world.

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Production Insulin Branding Generic Drugs 78

Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.

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Bioequivalency Production Contamination Branding 130

XTalks

FEBRUARY 5, 2024

PD-1 checkpoint inhibitors like Opdivo and Keytruda have been transformative in oncology, with Keytruda having had the edge due to having approvals in several more indications than Opdivo and strong clinical trial results, including as a first-line treatment in combination with chemotherapy. Internationally, revenue reached $355.7

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FDA Approval Drugs Sales Development 101

XTalks

FEBRUARY 5, 2024

PD-1 checkpoint inhibitors like Opdivo and Keytruda have been transformative in oncology, with Keytruda having had the edge due to having approvals in several more indications than Opdivo and strong clinical trial results, including as a first-line treatment in combination with chemotherapy. Internationally, revenue reached $355.7

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FDA Approval Drugs Sales Development 52

XTalks

AUGUST 2, 2023

In September 2022, Roche acquired Good Therapeutics for an upfront payment of $250 million, and has access to their PD-1-regulated IL-2 program. The TPO receptor agonist regulates blood platelet production by binding to and activating TPO receptors on megakaryocyte cells and inducing signalling cascades that increase platelet production.

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Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

MAY 4, 2021

On December 21, 2020, which falls in Pfizer’s international first-quarter 2021, Pfizer and Viatris completed the termination of a pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in Japan (Mylan-Japan collaboration) and Pfizer transferred related operations that were part of the Mylan-Japan collaboration to Viatris.

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Vaccination Vaccine Production Sales 40

XTalks

SEPTEMBER 14, 2020

By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. Sinovac Biotech is already in Phase III clinical trials testing its CoronaVac vaccine which it plans to evaluate in approximately 11,000 volunteers. The price of that prize is incalculable.

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Vaccination Vaccine Antibody Life Science 92