The Pharma Data

MAY 17, 2021

These initiatives could support insurance coverage of previously off-label uses, prevent costly new drugs from inappropriately receiving preferential regulatory treatment that is intended for drugs with no FDA-approved alternatives, and better inform clinicians by providing evidence-based information about how drugs should be used,” they noted. .

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Drugs Research FDA Approval Manufacturing 52

Pharmacy Checkers

MAY 22, 2020

The Januvia package reads “Formulated in UK.” The Januvia package also states “Sitagliptin (active ingred.) Drug manufacturers are not forced to disclose where the APIs of their drugs are made. There are many thousands of drugs approved for the U.S. But Metformin is an off patent, widely-manufactured generic drug.

Manufacturing 98

Manufacturing Drugs Generic Drugs Branding 98

Pharmacy Checkers

FEBRUARY 14, 2020

Several years later, the FDA ordered bioequivalence tests and finally, through those results, which found, like ConsumerLab.com did, that the People’s Pharmacy was right, and forced the drug off the market. As of February 2020, the Graedons say there is no authorized generic version (i.e., Below are U.S.

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Branding FDA Approval Pharmacy Bioequivalency 62

Pharmacy Checkers

JANUARY 10, 2020

For example, when I’m asked if an FDA-approved generic is the exact same as the FDA-approved brand, my answer is often “no.” That response is related to well-made generic drugs – not those discovered as inferior due to fraud or poor manufacturing , which is a serious problem. So, are these the “same” drug?

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FDA Approval Branding Pharmacy Manufacturing 62

Pharmaceutical Technology

JULY 15, 2022

Nothing epitomises market failures more than the cost of insulin,” Newsom said in a video posted on Twitter. CivicaRx is a non-profit generic drug company producing affordable insulin biosimilars in collaboration with the Juvenile Diabetes Research Foundation (JDRF). In-house manufacturing the norm.

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Insulin Manufacturing Contract Manufacturing Production 328

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 93

Pharmacy Checkers

DECEMBER 12, 2019

The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the Generic Drug Boom.” counterpart, the Drug Supply Chain Security Act (DSCSA) doesn’t come into full force until 2023. What about other countries?

Drugs 71

Drugs Manufacturing Medicine Regulation 71

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. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs. On-site Evaluations.

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Regulation Drugs Manufacturing Production 98

Pharma in Brief

JANUARY 9, 2022

The intent of the draft guidance document is to describe Health Canada’s expectations for manufacturers who distribute prescription drug information through an electronic means, such as a website or mobile app, that is directly linked to a product’s packaging or label.

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Regulation Manufacturing Medicine Drugs 52

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 Drugs Generic Drugs 263

STAT News

MARCH 7, 2023

 The plan would give the administration authority to negotiate what price the federal government pays for more drugs than the limited number approved as part of Democrats’ legislative package last year, while also speeding up the process for negotiations. Continue to STAT+ to read the full story…

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Drugs Generic Drugs Marketing Packaging 98

Pharmacy Checkers

OCTOBER 11, 2019

It doesn’t relate – at least not directly – to personal drug importation, but it frees the hands of drug companies to sell their own foreign versions of FDA-approved drugs at lower prices in the U.S. Its indirect relation to personal drug importation is noted at the end of this post. It’s legal to import those drugs.

FDA Approval 55

FDA Approval Drugs Manufacturing Pharmacy 55

Pharmacy Checkers

JUNE 21, 2019

Amazon’s support for The Affordable and Safe Prescription Drug Importation Act , introduced by Senator Bernie Sanders (I-VT)—to allow for the importation of lower-cost prescription drugs—would be the game changer that would have American patients cheering and the pharmaceutical industry crying. prescription drugs.

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Pharmacy Drugs Branding Medicine 61

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 74

FDA Law Blog

SEPTEMBER 13, 2021

Readers following drug pricing activity will recognize several strategies already associated with Senate Democrats (e.g., Medicare negotiation authority; encourage biosimilars and generic drug utilization). The HHS plan’s proposals are defined in general terms, without estimates of taxpayer savings or timelines.

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Drugs Manufacturing Generic Drugs Branding 98