Drug Channels

MARCH 15, 2022

Twice a year, I research and write two comprehensive, fact-based, and nonpartisan reports on drug channel economics. In some small way, I try to make the world a better and smarter place.

Pharmacy 84

Pharmacy Drugs Marketing Licensing 84

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 55

Camargo

MAY 10, 2021

Possibly in response, the Agency has issued the guidance Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. The title of the guidance is worth noting—“Remote Interactive Evaluations ,” not “Inspections.”

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Development Clinical Trials Clinical Trials Trials 185

Pharmacy Checkers

DECEMBER 5, 2019

The DAL now allows online sales by “third-party platforms” of medicines approved in China, but they must register with the drug regulatory department. Such platforms could register properly licensed pharmacies that could sell their medicines by mail order, pursuant to other applicable pharmacy laws in China, such as prescription requirements.

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Sales Medicine Pharmacy Drugs 64

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. TLC is consistently ranked top 5% among all listed companies in Taiwan’s Corporate Governance Evaluations.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Containment 40

World of DTC Marketing

JANUARY 28, 2022

The Department of Health and Human Services is currently considering whether to allow the generic manufacturing of Xtandi, which could drop the price of a pill from $400 to $3 overnight. When drug makers like Xtandi’s manufacturer, Astellas Pharma, price gouge sick Americans, the U.S. billion on Xtandi.

Drugs 284

Drugs Manufacturing Generic Drugs Licensing 284

Pharmaceutical Technology

AUGUST 12, 2022

Mark Samuels, chief executive of the British Generic Manufacturers Association (BGMA) remarked that these duplicative processes would add time and cost. “We It is part of the good manufacturing practice (GMP) quality assurance system, and is undertaken by laboratories, usually at contract research organisations (CROs).

Medicine 290

Medicine Production Generic Drugs Regulation 290

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. billion the drug generated in 2021. every eight weeks for the 90 mg dose, according to the manufacturer. First FDA-approved in March 2017, the list price of Ocrevus was about $75,102 annually, as reported by the manufacturer.

Sales 86

Sales Manufacturing FDA Approval Life Science 86

Druggist

MARCH 25, 2021

In terms of prescribing, both contraceptives are regarded as the same drug. . Although the active ingredient is the same, there are differences in non-active components (the core of the tablet and coating), which reflect both pills’ manufacturing process. The manufacturing process is of equal standards. . Cerazette**.

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Branding Bioequivalency Pharmacy Generic Drugs 98

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.

Drugs 71

Drugs Manufacturing Medicine Regulation 71

Druggist

OCTOBER 13, 2020

Truvada (emtricitabine/tenofovir disoproxil) is an antiviral drug used in the treatment of HIV, alone or as part of antiviral combination therapy. Truvada is also licensed as pre-exposure prophylaxis (PrEP) medication. One important message to take away is that Truvada and equivalent generic drugs are not 100% effective.

Generic Drugs 98

Generic Drugs Pharmacy Branding Doctor 98

The Pharma Data

MAY 4, 2021

Following the completion of the spin-off of the Upjohn Business (4) in the fourth quarter of 2020, Pfizer now operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sales and distribution of biopharmaceutical products worldwide. down 7%, which reflects relatively stable U.S.

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Gilenya legal drama.

Doctors 242

Doctors Doctor Drugs Sales 242

Pharmacy Checkers

OCTOBER 11, 2019

It’s not entirely clear to me what drugs are permissible under Pathway II and it won’t be until the draft guidance is made public. The discussion below applies to brand-name (not generic) drugs. Drug companies make their products in many countries and ship those same drugs around the world to different markets.

FDA Approval 55

FDA Approval Drugs Manufacturing Pharmacy 55

Pharmacy Checkers

DECEMBER 26, 2019

Our niche is comparative pricing and the proper credentialing of international online pharmacies, which process prescription drug orders filled by licensed pharmacies in several countries, require valid prescriptions, and do not ship controlled drugs into the U.S. but are also manufactured outside the U.S. Methodology.

Pharmacy 73

Pharmacy Drugs Branding Medicine 73

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.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41