Camargo

OCTOBER 14, 2021

The Center for Drug Evaluation and Research (CDER) has announced the rollout of the Novel Excipient Review Pilot Program in Federal Register Vol. The pilot program is the first step in allowing manufacturers to receive a preliminary review of a novel excipient, prior to drug product formulation. Co-Authors: Bill Stoltman, JD.

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XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

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The Pharma Data

JULY 29, 2021

The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution” – much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilars marketed in the U.S.

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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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Pharmaceutical Technology

DECEMBER 4, 2022

While small molecule drugs can be remade into identical generics, biologics are more complex. There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Biosimilars have slightly different structures than the originator biologics but have the same effect in treating a disease.

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XTalks

JANUARY 20, 2025

Blockbuster products like Botox (botulinum toxin) and Restasis (cyclosporine) provided Actavis with high-margin, branded revenue streams that complemented its existing generic drug business. Key drivers of the acquisition included Allergans robust product portfolio, particularly in ophthalmology, neuroscience and aesthetics.

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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. That word “same” is hard to answer when it comes to prescription drugs.

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XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

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FDA Approval Drugs Sales Development 52

pharmaphorum

OCTOBER 3, 2022

Amylyx Pharmaceuticals’ Relyvrio – a new treatment for amyotrophic lateral sclerosis (ALS) approved by the FDA on Thursday, after review of the data from its phase 2 trial – was the next day set at a list price of $158,000 per year in the US, sparking outcry. ALS affects over 30,000 people in the US.

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Pharmacy Checkers

NOVEMBER 21, 2019

The FDA’s capacity to evaluate new and generic drug applications and its oversight over drug manufacturing are why we have this degree of assurance. billion, about 50% was dedicated to regulating medical products, including prescription drugs. The medications that we obtain in the U.S.,

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Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The agency also aims to prevent misinformation and disinformation with this clearer form of patient communication.

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FDA Law Blog

APRIL 30, 2021

1462 , the “ Simplifying the Generic Drug Application Process Act ,” and S.1463 1462, the “Simplifying the Generic Drug Application Process Act.”. Simplifying the Generic Drug Application Process Act (S. e), the Agency will approve or deny the petition no later than 90 days after the petition is submitted.”

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FDA Law Blog

APRIL 30, 2021

1462 , the “ Simplifying the Generic Drug Application Process Act ,” and S.1463 1462, the “Simplifying the Generic Drug Application Process Act.”. Simplifying the Generic Drug Application Process Act (S. e), the Agency will approve or deny the petition no later than 90 days after the petition is submitted.”

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XTalks

AUGUST 2, 2023

We delve into the driving forces behind their successes and shed light on the groundbreaking research that has earned them a place among the elite in the pharmaceutical arena. Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023.

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Delveinsight

FEBRUARY 5, 2021

Fortunately, there exists FDA-approved therapies and drugs that double the success rates of quitting. Smoking Cessation: What are the drugs available in the market? The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products.

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The Pharma Data

MARCH 7, 2022

“The launch of our first generic version of Revlimid® in the U.S. This product adds to our broad generic portfolio of oncology treatments, which accounts for 73% of the essential medicines in this category, as defined by the World Health Organization.”. Currently, 1 in 12 generic prescriptions dispensed in the U.S.

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The Pharma Data

DECEMBER 4, 2021

“The launch of our first-to-market authorized generic version of Epiduo® Forte Gel in the U.S. provides patients with another important treatment option,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. Source link: [link].

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Pharmacy Checkers

DECEMBER 12, 2019

Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. Food and Drug Administration exemplifies the “gold standard” in drug safety. For an excellent overview of the EU’s regulatory system, see: Excellent overview of the European Union’s drug regulatory system. For a longer report about the U.S

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Pharma Marketing Network

FEBRUARY 27, 2025

Want to target oncologists researching the latest checkpoint inhibitors ? For instance, a physician researching a new oncology treatment might leave your website without registering for an event. Provide relevant, engaging content (not just a generic drug page). Or patients looking for psoriasis treatment options ?

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The Pharma Data

MAY 4, 2021

The findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research. Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

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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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Pharma Marketing Network

MARCH 12, 2025

This makes broad PPC strategies less effective compared to highly targeted keyword research. Competition for High-Value Keywords Branded drug names and general medical terms attract intense competition. Generic drug manufacturers, healthcare providers, and wellness brands often bid on similar terms.

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Pharmacy Checkers

MARCH 11, 2020

While the NPRM recognizes the importance to Americans of buying more affordable drugs outside the U.S., the FDA seems to defer actions that are not only permissible but encouraged under Section 804(J) to expand access to personally imported FDA-approved and foreign versions of FDA-approved drugs.

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