pharmaphorum

OCTOBER 28, 2021

They acknowledge that it isn’t clear how the drug may be exerting its beneficial effects in these patients, but speculate it could stem from anti-inflammatory activity, or antiplatelet activity that could reduce blood clotting. Meanwhile, fluvoxamine is also known to raise melatonin, which may also play a role, they write.

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pharmaphorum

MARCH 16, 2022

Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca’s top-selling respiratory drug Symbicort, although launch plans remain uncertain for now. Generics of Symbicort are already available in some non-US markets, including in Europe. billion last year, with $1.1

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Drug Channels

MARCH 15, 2022

Click here to download a free report overview (including key industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study Examines Consolidation and Vertical Integration of U.S. drug pricing, reimbursement, and dispensing system. d/b/a Drug Channels Institute. The 2022 Economic Report on U.S.

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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. FDA’s Accelerated Approval Program Comes Under Fire. Indication. Triple-negative breast cancer.

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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 Law Blog

MARCH 13, 2024

Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). exclusively licensed U.S. exclusively licensed U.S.

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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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Druggist

SEPTEMBER 30, 2020

Buscopan and mebeverine are two common drugs used for symptomatic treatment of irritable bowel syndrome (IBS). Both drugs can be prescribed by a doctor or purchased over the counter from pharmacies and in case of Bucopa IBS relief from supermarkets. Buscopan vs Mebeverine lists similarities and differences between both drugs.

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FDA Law Blog

JULY 15, 2021

FDA’s 2018 CFL Guidance seemed to signal to industry that FDA would be more flexible on Rx drug benefit claims. Generally, FDA has stayed true to that approach – with a focus on promotion that has some element of risk minimization. It likewise does not support conclusions about any other FDA-licensed pegfilgrastim products.

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Druggist

MARCH 17, 2021

Lymecycline is a drug, which belongs to a group of tetracycline antibiotics. Lymecycline is usually prescribed as a generic drug – lymecycline 408mg capsules or occasionally as a branded medication called Tetralysal 300 mg capsules. Both drugs are the same medicines. Why is lymecycline used in the treatment of acne?

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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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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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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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FDA Law Blog

APRIL 26, 2021

To balance these concerns, Congress delegated to FTC the authority to review and sign off on all generic drug and biosimilar patent settlement agreements based on a “rule of reason” standard established in the 2013 case, FTC v. In February 2017, FTC had the opportunity to test out the Actavis framework.

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FDA Law Blog

APRIL 26, 2021

To balance these concerns, Congress delegated to FTC the authority to review and sign off on all generic drug and biosimilar patent settlement agreements based on a “rule of reason” standard established in the 2013 case, FTC v. In February 2017, FTC had the opportunity to test out the Actavis framework.

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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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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.

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Pharmaceutical Technology

AUGUST 12, 2022

And while the gloomiest predictions around medicine shortages do not appear to have come to pass, shortfalls in drugs like HRT products have been partially attributed to Brexit. 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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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. . As with other drugs, once a patent expires, other manufactures start to produce generic or new brands of the same pill (desogestrel). How can I get Cerazette pill?

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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.

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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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XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. billion the drug generated in 2021. billion in 2022.

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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.

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Pharmacy Checkers

OCTOBER 11, 2019

The FDA has finished draft guidance on one of two of the Trump administration’s drug importation policy ideas, referred to as Pathway II. The title of this post may seem like a joke for those of you who follow the issue of drug importation in America, but it is real. The discussion below applies to brand-name (not generic) drugs.

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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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The Pharma Data

MAY 4, 2021

Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Lorbrena (lorlatinib) — In March 2021, Pfizer announced that the U.S.

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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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Pharmacy Checkers

DECEMBER 26, 2019

Health System By Lowering Drug Prices, Reducing, Out-of-Pocket Costs and Improving the Medicare Benefit”. Health System By Lowering Drug Prices, Reducing, Out-of-Pocket Costs and Improving the Medicare Benefit”. Its mission is to end the crisis of high prescription drug prices in America, and to do so on a bipartisan basis.

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Pharmacy Checkers

MARCH 11, 2020

Below is a copy of Gabriel Levitt’s comments on the FDA Notice of Proposed Rulemaking titled “Importation of Prescription Drugs” that were submitted Monday, March 9th, 2020. Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. 70796 “ Docket No.

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