Pharmaceutical Technology

NOVEMBER 21, 2022

Meanwhile, another recently released MHLW report confirmed that 696 essential drugs from 94 companies were identified as unprofitable due to increasing costs of manufacturing and packaging and the depreciation of the Japanese yen.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

Avéma, for example, specialises in small molecule, oral solid, and liquid dose drugs. generic drugs at both small development companies and multinational pharmaceutical companies. Avéma has also expanded its liquid manufacturing capabilities and added full on-site serialisation capabilities to its packaging lines.

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FDA Law Blog

MARCH 5, 2023

Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. Indeed, PSGs help facilitate generic competition, and to date, OGD has published more than 2,000 PSGs.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Meanwhile, another recently released MHLW report confirmed that 696 essential drugs from 94 companies were identified as unprofitable due to increasing costs of manufacturing and packaging and the depreciation of the Japanese yen.

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Pharmacy Checkers

MAY 22, 2020

The Januvia package reads “Formulated in UK.” The Januvia package also states “Sitagliptin (active ingred.) the drug company that makes Janumet and Januvia) gets its sitagliptin from Italy to make Januvia, and it probably uses that same API to make Janumet. But Metformin is an off patent, widely-manufactured generic drug.

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Camargo

DECEMBER 9, 2020

The pharma industry has had meetings with the FDA for new drugs, biologics, and devices for decades. In stark contrast, meetings for ANDAs with the Generic Drug Division have been few and far between, inconsistently granted, and, if held, poorly documented. GDUFA has changed this picture, at least for complex drug products.

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FDA Law Blog

AUGUST 17, 2023

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § 355(j)(2)(A)(v).

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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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Pharmacy Checkers

FEBRUARY 14, 2020

Retail Price from GoodRX | *As the Canadian-based pharmacies only offer quantities in 90 or 180 tablet packages, this price was calculated based on the 90-day supply price. Prices collected February 2020 for quantity of 30 tablets | Average U.S. Below are U.S. pharmacy labels of Wellbutrin XL 150mg and 300mg.

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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.

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Pharmaceutical Technology

JULY 15, 2022

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. Most of the US insulin market is controlled by three pharma companies: Sanofi, Eli Lilly, and Novo Nordisk.

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XTalks

AUGUST 2, 2023

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. 2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. a month for either 150 mg or 300 mg dose strength packages, and $3,462.13 billion in 2022.

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Pharma in Brief

AUGUST 9, 2021

Rolling submissions, which are currently in use for COVID-19 drugs, would be extended to other drugs, such as those which address significant new and emerging infectious diseases in Canada, or which treat, prevent, or diagnose serious or severely debilitating diseases or conditions. Biologic Drugs. On-site Evaluations.

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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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Drug Patent Watch

JANUARY 7, 2025

Generic drugs play a crucial role in providing affordable medication options to patients. However, many individuals still harbor misconceptions and doubts about the efficacy and safety of generic alternatives. What Are Generic Drugs?

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Drug Patent Watch

MARCH 25, 2025

Breaking into the Generic Drug Market: Strategies for Success As a pharmaceutical professional, you know that the generic drug market is a highly competitive space. With new generic drugs entering the market every year, it can be challenging to stand out from the crowd and achieve success.

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Drug Patent Watch

FEBRUARY 17, 2025

Unlocking the Path to Affordable Medications: A Step-by-Step Guide to Generic Drug Approval As a healthcare professional or a patient advocate, you're likely no stranger to the importance of affordable medications. But have you ever wondered what it takes for a generic drug to hit the market?

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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.

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XTalks

JANUARY 23, 2025

In its second interim staff report released January 14, 2025, the Federal Trade Commission (FTC) revealed that the top three pharma benefit managers (PBM) in the US inflated prices of specialty generic drugs over the past several years, resulting in them raking in billions of dollars in profits. billion in 2021.

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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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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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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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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.

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FDA Law Blog

DECEMBER 11, 2024

Karst We learned earlier this week that an allision (a runner-up to Merriam-Websters 2024 Word of the Year, polarization) may be poised to occurperhaps within a fortnight (another runner-up to Merriam-Websters 2024 Word of the Year thanks to Taylor Swift)as Congress considers various pieces of healthcare legislation as part of its year-end package.

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Pharmacy Checkers

MARCH 11, 2020

Postal Service for packages coming through IMFs. [16]. That AED lets the USPS know the source of a package. Thus, for example, the path of a drug from a licensed pharmacy in Canada to a patient in the U.S. Personal Drug Importation Related to the Internet. could be guaranteed using AED.

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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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XTalks

SEPTEMBER 14, 2020

trillion) agreement reached in late July between leaders of the 27 countries in the European Union, a truly historic stimulus package designed to rescue flailing economies from COVID-19. The package is made up of a €390 billion fund in grants and a €360 billion in low interest loans. And stimulus packages continue.

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