Pharmacy Checkers

DECEMBER 12, 2019

wholesale importation of lower-cost drugs. Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. Food and Drug Administration exemplifies the “gold standard” in drug safety. is not the gold standard in drug safety, it would fatally weaken anti-importation arguments. If the U.S.

Drugs 71

Drugs Manufacturing Medicine Compliance 71

Pharmacy Checkers

DECEMBER 5, 2019

A new Chinese law (in effect as of December 1, 2019) makes third-party online platform medicine sales legal, appropriately ends a draconian definition of counterfeit drugs, and effectively decriminalizes personal drug importation, but with a lot of gray! Decriminalizing Personal Drug Importation and Redefining “Counterfeit”.

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Sales Medicine Pharmacy Drugs 64

Camargo

MAY 10, 2021

The public’s faith in drugs approved under the FDA’s accelerated approval program is not blind — it relies heavily on the industry’s follow-through on confirmatory trials and the FDA’s subsequent review and final approval. Drug Product. It will be interesting to see if the FDA follows the ODAC recommendations. Indication. 7 Yes, 2 No.

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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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Pharmacy Checkers

JANUARY 10, 2020

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. John’s doctor was skeptical of drugs bought online from other countries. Is the drug safe? Let’s call him John.

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FDA Approval Branding Pharmacy Manufacturing 62

Drug Discovery World

MARCH 29, 2023

Politico published a summary of the key propositions outlined in the draft 2 , and DDW’s Multimedia Editor Megan Thomas investigates their intention, and observes how the industry has responded. Key proposals Approved drugs must launch in all EU countries within two years Politico described this as a measure to ensure a level playing field.

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Clinical Trials Clinical Trials Production Medicine 52

FDA Law Blog

APRIL 26, 2021

Koblitz — So-called “Pay-for-Delay” settlements, also called Reverse Payment, settlements—in which an innovator sponsor pays a generic sponsor to settle ongoing patent infringement litigation in exchange for a delay in generic market entry—have been fodder for antitrust concerns for decades (see, for example, our coverage from 2013 ).

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FDA Law Blog

APRIL 26, 2021

So-called “Pay-for-Delay” settlements, also called Reverse Payment, settlements—in which an innovator sponsor pays a generic sponsor to settle ongoing patent infringement litigation in exchange for a delay in generic market entry—have been fodder for antitrust concerns for decades (see, for example, our coverage from 2013 ).

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Marketing Production Generic Drugs Drugs 40

XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. 2022 Revenue: Pfizer reported an annual revenue of $100.33 Pfizer Inc.

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Sales Manufacturing FDA Approval Life Science 98

FDA Law Blog

NOVEMBER 16, 2021

5376 that has garnered the greatest amount of attention (at least in the food and drug law world) is TITLE XIII, Subtitle J (Drug Pricing), Part 1 (Lowering Prices Through Fair Drug Price Negotiation), Section 139001 (Providing for Lower Prices for Certain High-Priced Single Source Drugs). a) In General.—The

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Generic Drugs Manufacturing Drugs Licensing 52

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. The post Drug company profiteering.

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Drugs Manufacturing Generic Drugs Licensing 284

Druggist

MARCH 8, 2021

Modafinil (brand name Provigil) is one of the primary drugs used in the management of narcolepsy in the UK. The public’s interest in modafinil comes from the drug’s association with a class of medicines called ‘ smart drugs ‘, also called nootropics and cognitive enhancers. Is modafinil a smart drug?

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Drugs Licensing Licensing Doctors 90

Pharmaceutical Technology

AUGUST 12, 2022

Among the negative effects that have been reported are supply chain disruptions, skills shortages, issues around market authorisation, and added costs for pharma CMOs. Even following the Brexit vote, the EU remains the UK’s largest trading partner, and a high proportion of UK drugs originate from European countries.

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Medicine Production Generic Drugs Regulation 290

FDA Law Blog

JULY 13, 2022

Karst — The Build Back Better Act—the food and drug law implications of which we discussed last year —has popped up again in Congress, and it is just as dense as ever. With 190 pages dedicated to prescription drug pricing reform, the program is ambitious…and complicated. Koblitz & Kurt R.

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Druggist

MARCH 25, 2021

Do generic, and branded drugs produce exactly the same effect? . In terms of prescribing, both contraceptives are regarded as the same drug. . Before December 2015, Cerazette was protected by a patent, which gave producers of this pill exclusive rights of supply of desogestrel in the UK and other markets. Cerazette**.

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Branding Bioequivalency Pharmacy Generic Drugs 98

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. More details regarding the collaboration will be disclosed following the execution of a formal agreement.

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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. in December 2019; and. in December 2019; and.

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Vaccination Vaccine Production Sales 40

The Pharma Data

MAY 6, 2021

Taking double Covid-19 hits, Merck writes off $170M for scrapped drug, highlights $600M in missed sales ( Endpoints ). Biogen’s Alzheimer’s drug may only be cost effective at $2,500 a year ( STAT ). Biogen’s Alzheimer’s drug may only be cost effective at $2,500 a year ( STAT ). Reps.

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Sales Vaccination Vaccine Gene Therapy 52

Pharmaceutical Technology

JANUARY 6, 2023

In this most recent settlement, the drug company faced allegations of colluding with the generics company Par Pharmaceuticals to violate antitrust laws. Novartis has also been on the receiving end of litigation with the Greek health ministry, academic institutes, and more, engaging the drug company in other legal disputes.

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Doctors Doctor Drugs Sales 242