The Pharma Data

DECEMBER 17, 2020

With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec. About TLC.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Containment 40

pharmaphorum

OCTOBER 28, 2021

A generic pill has been shown to reduce hospitalisation rates in high-risk patients with early COVID-19, potentially offering a low-cost alternative to oral antivirals from Merck & Co and others, according to researchers in Brazil.

Generic Drugs 98

Generic Drugs Sales Drugs Licensing 98

Druggist

MARCH 25, 2021

This, however, does not come as a surprise since one of the requirements for licensing of generic medication is to provide the same products information leaflet as the branded drug’s leaflet. . New generic drugs are usually cheaper than original patent medicine, therefore switch in prescribing follows in the NHS.

Branding 98

Branding Bioequivalency Pharmacy Generic Drugs 98

FDA Law Blog

AUGUST 29, 2024

After all, as we have written before in other contexts ( i.e. , the BLOCKING Act), “[I]f you limit a generic drug manufacturer’s ability to settle cases, that manufacturer does not settle fewer cases, it submits fewer Paragraph IV ANDAs. And fewer ANDAs means less, not more, generic drug competition.”

Production 59

Production Licensing Licensing Generic Drugs 59

The Pharma Data

MAY 6, 2021

FDA extends research agreement with MIT-licensed organ-on-chip systems ( Endpoints ). Sherrill, Kinzinger Lead Bipartisan Letter to House Appropriations Committee Urging Them Not to Block E-Labeling of Prescription Drugs ( Press ). million to resolve claims it paid drug kickbacks through charity ( STAT ).

Sales 52

Sales Vaccination Vaccine Gene Therapy 52

World of DTC Marketing

JANUARY 28, 2022

.” Essentially, if certain circumstances are met, the government can act (“march-in”) and use its authority under the Bayh-Dole Act to grant a license to generic drug manufacturers to produce a drug in the United States—in this case,,, a generic version of Xtandi.

Drugs 284

Drugs Manufacturing Generic Drugs Licensing 284

XTalks

AUGUST 2, 2023

We delve into the driving forces behind their successes and shed light on the groundbreaking research that has earned them a place among the elite in the pharmaceutical arena. This acquisition also signifies the establishment of the company’s first research center outside the US. billion RMB ($34.47 billion USD) in 2022, a 7.49

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

MAY 4, 2021

The findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research. Clinical and Research Developments. Current 2021 financial guidance is presented below. . . and South African variants.

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharmacy Checkers

MARCH 11, 2020

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. counterparts. online mail order pharmacies. [9].

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41

FDA Law Blog

MARCH 31, 2025

1095 would authorize the Federal Trade Commission (FTC) to initiate a civil action against any person or entity that submits a baseless petition to FDA with the intent that the Agencys review of the petition would delay the approval of a generic drug, a biosimilar biological product, or certain other new drugs (see here ).

Production 64

Production Sales Licensing Licensing 64

FDA Law Blog

APRIL 2, 2025

1095 would authorize the Federal Trade Commission (FTC) to initiate a civil action against any person or entity that submits a baseless petition to FDA with the intent that the Agencys review of the petition would delay the approval of a generic drug, a biosimilar biological product, or certain other new drugs (see here ).

Production 59

Production Sales Licensing Licensing 59

FDA Law Blog

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. Given the explosion in diagnostic tests and genetic research, it is difficult to see how patenting sequences would stimulate innovation.

Gene 64

Gene DNA Genetics Gene Sequencing 64