Pharmacy Checkers

JULY 11, 2019

I’m proud to share that PharmacyChecker has published a white paper that examines prices and availability of newly approved generic drugs. Out of 40 generic medications that were approved from 2017 to 2018, PharmacyChecker research found the following: 42.5% (17) are not available in the U.S. generic versions.

Generic Drugs 48

Generic Drugs FDA Approval Drugs Branding 48

Camargo

NOVEMBER 11, 2020

announced a collaboration to develop a companion diagnostic for Vitrakvi® (larotrectinib) NTRK (neurotrophic tropomyosin receptor kinase) inhibitor, approved in the U.S. In October, less than 18 months later, the FDA approved the companion test, which will allow physicians to better identify target eligible patients.

Development 242

Development Bioequivalency Generic Drugs Production 242

pharmaphorum

JUNE 3, 2021

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market. The post After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi appeared first on.

FDA Approval 52

FDA Approval Marketing Branding Generic Drugs 52

FDA Law Blog

SEPTEMBER 6, 2023

Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S. Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.

Generic Drugs 45

Generic Drugs Manufacturing Drugs Cosmetics 45

pharmaphorum

OCTOBER 12, 2021

The research by a team of National Institutes of Health (NIH) scientists found that people who took bumetanide, a generic drug usually used to treat heart failure and oedema, had a significantly lower prevalence of Alzheimer’s compared to those not taking the drug.

Gene Expression 111

Gene Expression Drugs FDA Approval Gene 111

Pharmaceutical Technology

DECEMBER 20, 2022

The growing competition from generic drugs presents challenges for the top 20 players placing pressure on drug prices. The company is expected to continue experiencing positive growth from its new immunology drugs, Skyrizi (risankizumab-rzaa) and Rinvoq (upadacitinib). trillion in Q2 2022 to $3.14

Marketing 130

Marketing Vaccination Vaccine Sales 130

Camargo

OCTOBER 14, 2021

The pilot program is the first step in allowing manufacturers to receive a preliminary review of a novel excipient, prior to drug product formulation. Eligibility for the pilot program has been limited to excipients that 1) have not been previously used in FDA-approved drug products, and 2) do not have an established use in food.

Development 189

Development Packaging Packaging Generic Drugs 189

Pharmacy Checkers

FEBRUARY 14, 2020

Of our most merciful health insurance companies, few are willing to cough up the cost of expensive brand meds when there’s an FDA-approved generic on the market. Despite the small but mighty uproar on lack of true generic equivalence, this is the case with Wellbutrin. Wellbutrin XL 300mg sold at U.S.

Branding 62

Branding FDA Approval Pharmacy Bioequivalency 62

Camargo

DECEMBER 9, 2020

If you are facing an FDA remote review, Camargo can help design a comprehensive approach in order to avoid such pitfalls. Approval of the Month: Alnylam to Use Value-Based Agreements for Ultra-rare Disease Treatment. Unapproved Drug Initiative Ends. In November, the FDA ended its Unapproved Drug Initiative.

Development 140

Development Production Drugs FDA Approval 140

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.

Insulin 52

Insulin Production FDA Approval Generic Drugs 52

Pharmaceutical Technology

NOVEMBER 29, 2022

In 1970, the FDA approved ketamine as an anesthetic. In the Phase I/II study, the drug’s effect on pain intensity at 15 minutes after treatment did not meet the required efficacy threshold for the trial’s success, but some efficacy was observed after 30 minutes.

Research 275

Research Trials Drugs Generic Drugs 275

pharmaphorum

JULY 29, 2021

Generic drugmaker Mylan has become the first company to secure FDA approval for a biosimilar product that is considered completely interchangeable with the reference product – namely Sanofi’s once-daily insulin Lantus.

Insulin 98

Insulin Drugs Production Generic Drugs 98

Pharmacy Checkers

SEPTEMBER 10, 2020

Because they don’t do adequate testing to prove safety and effectiveness of drugs. Furthermore, the agency’s position that FDA-approved generic drugs work just as well as the brand is often not true. Indeed, according to Valisure, not all FDA-approved generic versions of brand drugs are created equal.

Drugs 61

Drugs FDA Approval Generic Drugs Branding 61

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.

Marketing 262

Marketing Pharmacy Production Branding 262

Pharmaceutical Technology

JANUARY 6, 2023

In Par and Novartis’ agreement, Par gained exclusive rights to market its generic for six months after Novartis’ period of exclusivity finished, beginning September 30, 2014 and ending March 30, 2015. Gilenya legal drama. Gilenya is an oral medication for multiple sclerosis.

Doctors 242

Doctors Doctor Drugs Sales 242

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.

Marketing 104

Marketing Botox Life Science Pharma Companies 104

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.

FDA Approval 62

FDA Approval Branding Pharmacy Manufacturing 62

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.

FDA Approval 59

FDA Approval Generic Drugs Marketing Drug Delivery 59

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. For new or generic drugs to work in a patient, they must, of course, be made correctly by using Current Good Manufacturing Practices. drug supply.

Generic Drugs 68

Generic Drugs Manufacturing Drugs Regulation 68

FDA Law Blog

JULY 22, 2021

Drug product family” is defined as “a group of one or more prescription drugs that share a unique generic drug description and drug form.” Manufacturers of drugs that appear on either or both of the current Essential Drug List or WAC Increase List must submit reports to the state by April 1 of each year.

Drugs 52

Drugs Manufacturing Generic Drugs FDA Approval 52

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. .

Drugs 52

Drugs Research FDA Approval Manufacturing 52

XTalks

JUNE 8, 2022

Novartis’ biosimilars and generics drug division Sandoz has announced a new global campaign called ‘Act4Biosimilars’ to help raise awareness about biosimilars and increase their adoption by at least 30 percent in over 30 countries by the year 2030. Related: Cyltezo Becomes First FDA-Approved Interchangeable Humira Biosimilar.

Generic Pharmaceutical 69

Generic Pharmaceutical Production Medicine Branding 69

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.”

Generic Drugs 40

Generic Drugs Drugs Production Branding 40

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.”

Generic Drugs 40

Generic Drugs Drugs Production Branding 40

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).

Generic Drugs 40

Generic Drugs Production Drugs Manufacturing 40

FDA Law Blog

SEPTEMBER 19, 2023

The FTC expressed concern that patent listings that do not meet the statutory criteria undermine the competitive process, may disincentivize investment in developing generic and follow-on products, and reduce patient access to more affordable drugs thereby increasing costs to the healthcare system.

Drugs 105

Drugs Branding Drug Delivery Systems Generic Drugs 105

FDA Law Blog

OCTOBER 1, 2024

2) because the FDA employees who approved the application were not “Officers of the United States.” Murphy, Director of the Office of Generic Drugs’] ratification cured any Appointments Clause deficiency because it is unclear whether any statute properly authorized her appointment. II, § 2, cl.

Drugs 59

Drugs FDA Approval Generic Drugs Regulation 59

The Pharma Data

DECEMBER 28, 2020

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. ” According to IQVIA, the U.S.

Bioequivalency 52

Bioequivalency Production Sales Marketing 52

FDA Law Blog

MARCH 26, 2024

Very clearly, the brief states “In the FTC’s view, device patents that do not mention any drug in their claims do not meet the statutory criteria for Orange Book listing , and a device patent that is improperly listed in the Orange Book must be delisted” (emphasis added).

Drugs 59

Drugs Production Containment Generic Drugs 59

FDA Law Blog

FEBRUARY 26, 2024

Even more definitively, FDA wrote: Thus, when the BPCI Act was passed by Congress in 2009 and signed into law on March 23, 2010, the statutory term “strength” in section 505(j)(2)(A)(iii) of the FD&C Act had an existing, well-established administrative meaning that reflected both the total drug content (e.g.,

Production 59

Production Bioequivalency Drugs Containment 59

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.

Doctors 52

Doctors Doctor Medicine Production 52

FDA Law Blog

AUGUST 16, 2021

Nonetheless, FDA has been calling them ANDAs and listing them in the Orange Book as ANDAs for years, but recent changes to the Orange Book have spurred some confusion. Thus, FDA divided them into their own category and is now seeking Comments on whether the 505(b) or the 505(j) regulatory scheme should apply.

Production 52

Production Drugs Generic Drugs Cosmetics 52

Pharma Marketing Network

FEBRUARY 27, 2025

Provide relevant, engaging content (not just a generic drug page). By using FDA-approved messaging, targeting restrictions, and clear disclaimers , brands can run PPC campaigns without regulatory risks. Pharma brands should ensure landing pages: Have clear CTAs (Call-to-Actions) (e.g.,

Branding 52

Branding Marketing Compliance Engineer 52

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.” For an excellent overview of the EU’s regulatory system, see: Excellent overview of the European Union’s drug regulatory system.

Drugs 71

Drugs Manufacturing Medicine Regulation 71

FDA Law Blog

JULY 13, 2022

This is particularly true for so-called “complex generics,” which require a significant investment and that can languish for years in the FDA approval process. As we said back in November, the Build Back Better Act may have a serious effect on the generic drug and biosimilars markets.

Manufacturing 52

Manufacturing Production Marketing Drugs 52

XTalks

FEBRUARY 5, 2024

Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. Why it did so well: Darzalex was the first human anti-CD38 monoclonal antibody approved by the FDA for multiple myeloma. Price of Revlimid: A supply of 28 oral 2.5 mg capsules is $24,576.

FDA Approval 101

FDA Approval Drugs Sales Development 101

The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

FDA Approval 52

FDA Approval Generic Drugs Production Drugs 52