Pharma Mirror

OCTOBER 4, 2021

Despite untold investment by numerous pharmaceutical companies, FDA-approved drugs that target critical brain functions and conditions like anxiety, depression, and sedation continue to present severe and unpredictable side effects, including suicidal ideation. In 2003 the Human Genome Project provided the first atlas.

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Pharmaceutical Companies Pharmaceutical Companies FDA 119

The FDA Law Blog

OCTOBER 27, 2022

Lewis, Senior Regulatory Device & Biologics Expert — FDA recently published the final guidance document “ Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.” FDA also provided additional examples as to what changes would be considered “annual reportable.”

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FDA Documentation 105

The Checkup by Singlecare

FEBRUARY 22, 2024

Food and Drug Administration (FDA) extended its prior approval of Xolair (omalizumab) to treat accidental exposure to food allergens. Xolair is not a new drug; it was originally approved in 2003 for the treatment of moderate to severe persistent allergic asthma in some patients. 16, the U.S. What is Xolair? RN, the CEO of FARE.

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FDA Immunization 103

STAT

JANUARY 30, 2023

Since it was signed into law in 1983, the FDA has approved more than 1,100 treatments for rare diseases. The human genome was sequenced in 2003. This month marks the 40th anniversary of the Orphan Drug Act. That said, a lot has changed in science and drug development since 1983.

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FDA 103

pharmaphorum

JUNE 7, 2021

Biogen and Eisai have defied the naysayers and secured an historic FDA approval for their amyloid-targeting antibody aducanumab as the first-ever disease-modifying treatment for Alzheimer’s disease. The approval of aducanumab, now given the name Aduhelm, comes after a three-month extension to the FDA’s review period.

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FDA 89

pharmaphorum

JUNE 8, 2021

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. The post FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag appeared first on.

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FDA Labelling 98

The FDA Law Blog

MARCH 18, 2025

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. FDA has already been there , of course, with respect to 180-day exclusivity.)

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Pharmaceutical Companies Pharmaceutical Companies FDA 59

The FDA Law Blog

SEPTEMBER 19, 2023

Industry has long requested input from FDA about the types of patents that can be listed in the Orange Book, and, in response, FDA asked for comments on the types of patents that should be listed. But FDA has never made an affirmative statement as to the types of patents that can be listed in the Orange Book.

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FDA Communication Dosage 105

Pharma Marketing Network

JUNE 15, 2025

Why the Network Matters in Today’s Pharma Landscape Conclusion and FAQs The Mission and History of Pharma Marketing Network Founded in 2003, the Pharma Marketing Network (PMN) was established to meet a growing need for collaboration and knowledge sharing in the evolving world of pharmaceutical communications. Are PMN resources free to access?

Communication 52

Communication FDA 52

pharmaphorum

NOVEMBER 20, 2022

The FDA subsequently raised serious concerns about the accuracy of testing that Theranos did conduct with its machines, and the company eventually retracted two years of blood tests before folding in 2018. “She knew that it could not successfully compete with the established conventional machines.”

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FDA 122

pharmaphorum

DECEMBER 16, 2020

The license agreement will help advance the development of ABBV-47D11, which in pre-clinical research demonstrated potential against SARS-CoV-2, as well as the related SARS-CoV-1 virus that caused an outbreak in Asia in 2003. Regeneron and Eli Lilly have been leading the charge to develop antibody-based therapies against the coronavirus.

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Hospitals FDA 98

pharmaphorum

JANUARY 27, 2022

Biogen and Eisai have increased the earning potential of their Alzheimer’s drug Aduhelm by expanding the post-marketing trial of the drug required by the FDA – which could be the primary source of income for the drug.

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FDA Labelling Insurance 81

pharmaphorum

NOVEMBER 4, 2020

As an influential panel of FDA-appointed experts prepares its verdict on Biogen’s Alzheimer’s drug, a little known China-based pharma is hoping to succeed where big name rivals have failed and develop a drug that is effective against the disease.

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FDA 74

The Checkup by Singlecare

APRIL 17, 2024

Food and Drug Administration (FDA) approved Wegovy for adults and children 12 years and older who have a body mass index (BMI) of 30 or higher or who have a BMI of 27 or higher with a related medical condition, such as high blood pressure, Type 2 diabetes, or high cholesterol.

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Insurance Insurance Coverage Pharmaceutical Companies Pharmaceutical Companies 98

The FDA Law Blog

OCTOBER 18, 2022

On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here ). These are documents on the A-list, a list of prioritized documents that FDA intends to publish during FY2023. FDA published draft guidances for these topics in December 2021 ( here and here ).

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Documentation FDA Labelling 52

The Checkup by Singlecare

JANUARY 20, 2023

Food and Drug Administration (FDA), generic medications cost 80%-85% less than brand-name drugs. Chances are, you’ve taken a generic or authorized generic medication, and for good reason—according to the U.S. An estimated 90% of prescriptions filled in the United States are for commonly prescribed generic drugs.

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Prescription Filling Dosage FDA Labelling 98

The Checkup by Singlecare

DECEMBER 15, 2023

Food and Drug Administration (FDA) when proper dosage is followed. Food and Drug Administration (2003) The post Does Zyrtec make you drowsy? How to use Zyrtec safely Zyrtec is considered safe by the U.S. Always follow the instructions on the label for accurate dosing. appeared first on The Checkup.

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Pharmacy Program Director Dosage Labelling FDA 116

ISPE

SEPTEMBER 15, 2022

First published in 1989, there have been a total of 5 adaptations in 1996, 2003, 2005, 2007 and 2009, but no complete revision. Thomas Zimmer, PhD. 15 September 2022. Annex 1 of the EC GMP Guide " Manufacture of Sterile Medicinal Products " has a long history. 12 of February 2020 again received 2,000 comments from public consultation.

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Documentation FDA 97

The Checkup by Singlecare

NOVEMBER 14, 2024

For example, it’s FDA approved to treat soreness and joint pain from inflammatory conditions like rheumatoid arthritis and osteoarthritis, and research shows it’s effective in the short-term. Some older studies—like this one from 2003 —have concluded that ibuprofen can relieve exercise-induced soreness in the short term.

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FDA 97

Pharmaceutical Technology

SEPTEMBER 23, 2022

Dry eye syndrome (DES) is an indication whose mainstay treatment has been dominated by Allergan’s Restasis (cyclosporine ophthalmic emulsion 0.05%) ever since its launch in 2003 in the US. Novaliq/ Bausch + Lomb’s NOV-3 (perfluorohexyloctane) is also currently at pre-registration stage with the FDA. Novaliq’s CyclASol (0.1%

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FDA 59

The Checkup by Singlecare

MARCH 7, 2024

Yet the Food and Drug Administration (FDA) hasn’t approved this GLP-1 agonist injection for weight loss. Instead, it’s FDA approved to improve glycemic control in adults with Type 2 diabetes and to reduce the risk of adverse cardiovascular events in adults with Type 2 diabetes and known heart disease.

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Compounding Pharmacies Insurance Insurance Coverage Compounding 93

The Checkup by Singlecare

OCTOBER 20, 2023

In another small 2003 study where researchers placed participants into two groups—a placebo group and a shilajit receiving group—the researchers found a decrease in cholesterol and triglyceride levels in the shilajit group. Supplements are not regulated by the Food and Drug Administration (FDA), so contamination is possible.

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Immunization FDA 105

European Pharmaceutical Review

OCTOBER 19, 2023

we must prove the effectiveness of radiopharmaceuticals through clinical trials… This has been demonstrated recently with PLUVICTO… the first US Food and Drug Administration (FDA)-approved targeted radioligand therapy for eligible patients with prostate cancer” At this moment, there is no single treatment for cancer today.

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Chemotherapy Compounding Immunization FDA 105

The Checkup by Singlecare

APRIL 17, 2024

Legislation passed in 2003 prohibits Medicare from covering drugs prescribed specifically for weight loss, and while Medicaid has more flexibility here, not every state will cover them. I tried to prescribe Mounjaro, which helps with heart failure and diabetes, but I couldn’t get it covered.”

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Insurance Insurance Coverage Compounding Pharmacies Compounding 98

pharmaphorum

MARCH 2, 2022

A recent publication showcased that the number of active clinical trials running that are researching various psychedelic therapies has increased rapidly from 2003 to 2021. With promising pre-clinical and clinical stage results, there are more and more therapeutic candidates being developed in this space.

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Compounding FDA 105

The FDA Law Blog

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. This means that there multiple same-day FDA NDA approvals for the same drug. FDA-2020-E-1840 (Mar.

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FDA Controlled Substances Hospitals 59

ISPE

APRIL 13, 2023

1 More recently, regulators like the FDA have increasingly promoted the benefits of modeling (e.g., Topics in Chemical Engineering, 2003. Biopharma Adopts Mechanistic Modeling Mechanistic modeling has been widely used in the petrochemical industry for many decades, while biochemical producers have been slower to adopt. Melton, and E.

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Compounding FDA 98

The FDA Law Blog

MARCH 12, 2024

Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately. And FDA still hasn’t said a thing! In fact, federal law and regulation appear to require AbbVie to list these patents.”

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Dosage FDA 45

PharmaShots

APRIL 20, 2023

Food and Drug Administration (FDA) in June 2020 as a rapid-acting insulin to improve glycemic control in adults with type 1 and type 2 diabetes. On October 14, 2022, the FDA approved Lyumjev® (insulin lispro-aabc injection), a rapid-acting mealtime insulin, for the treatment of children with diabetes.

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FDA Insurance Labelling 40

The Checkup by Singlecare

FEBRUARY 1, 2024

Food and Drug Administration (FDA) to treat opioid use disorder and alcohol use disorder. Drug interactions | Food interactions | Other interactions | Avoiding interactions | When to see a doctor Naltrexone , also known by its brand-name counterpart Vivitrol, is approved by the U.S. It comes as an oral tablet and intramuscular (IM) injection.

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Communication Dosage FDA 92

pharmaphorum

JANUARY 4, 2022

Stanford University drop-out Holmes founded Theranos in 2003 when she was just 19, and at its height the company was worth $9 billion, with its founder feted as the next Steve Jobs. Theranos raised almost $1 billion from investors before the company and its claims were eventually exposed as a sham.

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Documentation Communication FDA 52

The Checkup by Singlecare

JUNE 11, 2024

Zepbound is an injectable medication that is FDA approved for weight management in adults with obesity. In fact, coverage of obesity medications was banned by the Medicare Modernization Act of 2003. It works by reducing cravings and overeating, contributing to weight loss.

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Insurance Insurance Coverage Mail-Order Pharmacies Dosage 59

Drug Topics

JUNE 8, 2025

J Am Pharm Assoc (2003). J Am Pharm Assoc (2003). BMC Health Serv Res. 2005;5(1):3. doi:10.1186/1472-6963-5-3 6. Manzur V, Mirzaian E, Huynh T, et al. Implementation and assessment of a pilot, community pharmacy-based, opioid pain medication management program. 2020;60(3):497-502. doi:10.1016/j.japh.2019.11.029 2019.11.029 7.

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Independent Pharmacies Community Pharmacies Compounding Vaccines 353

The FDA Law Blog

JUNE 7, 2023

With the IRA Negotiation Program, Congress jettisoned the voluntary agreement approach in all but name.

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Communication 45

The Checkup by Singlecare

MARCH 21, 2024

A 2003 law prohibits government-sponsored plans like Medicare from covering weight loss medication. Consider a compounded version For drugs on the Food and Drug Administration (FDA) shortage list, compounding pharmacies can create and sell copies, often at lower prices than the brand-name versions.

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Insurance Insurance Coverage Mail-Order Pharmacies Dosage 52

The Checkup by Singlecare

AUGUST 5, 2023

Cialis was initially approved in 2003 and has become a popular alternative to Viagra (sildenafil). Erectile Dysfunction Cialis is FDA-approved for ED and BPH. Benign Prostatic Hyperplasia Another FDA-approved use of Cialis is the treatment of BPH , which is characterized by an enlarged prostate.

Dosage 52

Dosage Insurance Mail-Order Pharmacies Insurance Coverage 52

The Checkup by Singlecare

DECEMBER 27, 2023

Although a doctor may prescribe Fioricet when appropriate, it is not approved by the Food and Drug Administration (FDA) for treating migraine headaches. Still, clinical experience shows that it may be effective for mild or acute migraines. appeared first on The Checkup.

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Mayo Clinic Dosage FDA 52