Camargo

DECEMBER 9, 2020

Evergreening Orphan Drugs May Be Over. The Orphan Drug Act of 1983 provides market exclusivity for drugs intended to treat conditions affecting fewer than 200,000 patients in the US. This effectively “evergreens” the product, preventing generic competition. Unapproved Drug Initiative Ends.

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Development Production Drugs FDA Approval 140

The Pharma Data

MAY 17, 2021

The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. . Posted 17 May 2021 | By Jeff Craven .

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Drugs Research FDA Approval Manufacturing 52

Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. The following is a general summary of some of the highlights from the proposed amendments discussed in the Notice of Intent. Biologic Drugs.

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Regulation Drugs Manufacturing Production 98

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The FDA has finished draft guidance on one of two of the Trump administration’s drug importation policy ideas, referred to as Pathway II.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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FDA Approval Drugs Manufacturing Pharmacy 55

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

JUNE 21, 2019

With drug prices in the spotlight of our national healthcare debate, one could certainly view Amazon’s entry last year into the pharmacy space as a welcome development. to bring lower-cost generic drugs to market faster are a great step in. prescription drugs. prescription drugs. Recent bi-partisan efforts.

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Pharmacy Drugs Branding Medicine 61

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

Pharmaceutical Technology

SEPTEMBER 23, 2022

For pharma and biotech companies, there are many advantages to partnering with a Contract Development and Manufacturing Organisations (CDMO): they can access more specialized knowledge, state-of-the-art equipment, and qualified staff, as well as reduce their total cost of ownership, all while maintaining speed to market.

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Manufacturing Drugs Production Packaging 147

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

Pharmacy Checkers

FEBRUARY 14, 2020

Years ago, they took on the Food and Drug Administration in regards to Budeprion XL distributed by Teva Pharmaceuticals, the supposed generic equivalent to the popular antidepressant, Wellbutrin XL. Finally, I put it together that this was related to the drug because when I wouldn’t take it I would begin to feel better.

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Branding FDA Approval Pharmacy Bioequivalency 62

Pharma in Brief

JANUARY 9, 2022

In response to the COVID-19 pandemic, in 2020, the Minister of Health signed interim orders designed to streamline the process to authorize the importation or sale of drugs, vaccines, and medical devices used to diagnose, treat, mitigate, or prevent COVID-19. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.

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Regulation Manufacturing Medicine Drugs 52

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

XTalks

SEPTEMBER 14, 2020

All this cannot begin to explain the weird reality that the stock markets in the US (and elsewhere) are doing just fine. In fact, financial markets have almost regained most of the losses caused by COVID-19. The package is made up of a €390 billion fund in grants and a €360 billion in low interest loans. ECONOMIC IMPACT: Canada.

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Vaccination Vaccine Antibody Life Science 92

Pharmaceutical Technology

MARCH 22, 2023

During the pandemic, the shortage of basic drugs such as paracetamol in key EU countries led to growing calls to push local drug manufacturing to ensure a smooth supply and to minimise shortages. Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report.

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Production Manufacturing Generic Drugs Drugs 263

STAT News

MARCH 7, 2023

… The White House will propose raising taxes on Americans earning more than $400,000 and reducing what Medicare pays for prescription drugs in an attempt to ensure that the health-care program for seniors is funded for the next two decades , STAT writes.  The Continue to STAT+ to read the full story…

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Drugs Generic Drugs Marketing Packaging 98

FDA Law Blog

SEPTEMBER 13, 2021

Kirschenbaum — Despite vigorous criticism of high drug prices from the public and politicians in both parties, drug companies have largely dodged bullets on drug pricing and payment reform. The pieces of major drug pricing and payment reform are falling together. Koblitz & Alan M. Last Thursday, the U.S.

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