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. With diabetes, the body doesn’t make enough insulin to keep sugar levels regulated in the normal range.

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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. He went to our site to discover that brand-name Livalo ( pitavastatin ). and arguably just as safe.

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pharmaphorum

JULY 20, 2021

The FDA has taken a longer than usual look at Ardelyx’ regulatory submission for tenapanor, a drug for high blood phosphate levels associated with chronic kidney disease (CKD), and found it wanting – sending the biotech’s shares into a tailspin. “Despite….advantageous “Despite….advantageous

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XTalks

SEPTEMBER 28, 2023

In most cases, commercials are regulated to ensure they provide accurate information, include the benefits and risks of the drugs and encourage viewers to talk to their healthcare providers about the medication. The US is among the few places in the world where DTC ads for health and medical products are legal; it is banned in most countries.

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Pharmacy Checkers

SEPTEMBER 10, 2020

While the FDA is known as a top drug regulator, for all intents and purposes, Valisure is saying that you can’t fully trust them. Furthermore, the agency’s position that FDA-approved generic drugs work just as well as the brand is often not true. I wrote “claims,” but I believe them!

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pharmaphorum

MARCH 21, 2022

Bristol-Myers Squibb has won FDA approval for the first LAG-3 inhibitor drug ahead of its rivals in cancer immunotherapy including Merck & Co. Like PD-1, LAG-3 is a negative regulator of T cells, suppressing their activity against cancer cells, so when that brake is released the immune system can attack and kill tumours.

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pharmaphorum

APRIL 29, 2022

Bristol-Myers Squibb’s has become the first company to bring a cardiac myosin inhibitor through to FDA approval, claiming a green light from the US regulator for mavacamten as a therapy for obstructive hypertrophic cardiomyopathy (HCM). The FDA approval was delayed b three months while the RENS was drawn up.

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pharmaphorum

DECEMBER 18, 2020

GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the first and only FDA-approved treatment for lupus nephritis. Benlysta binds and neutralises the B cell survival factor BAFF, while rituximab targets CD20, a protein found on the surface of B cells.

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FDA Law Blog

AUGUST 12, 2021

Koblitz — About two weeks ago, FDA made an exciting announcement (and it remains exciting even if we’re late posting about it): FDA approved the first interchangeable biosimilar. The expectation is that interchangeable biologics would make all the difference.

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pharmaphorum

JANUARY 12, 2021

Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of the drug in its first use beyond diabetes. Farxiga won FDA approval for adults with HFrEF in May 2020, which helped to drive its third-quarter sales up by a third to $525 million.

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pharmaphorum

AUGUST 20, 2021

The EU regulator has approved FibroGen and Astellas Evrenzo for adults with anaemia caused by chronic kidney disease (CKD), just days after the FDA turned down the drug in the US. In the US, roxadustat’s delay has provided an opportunity for GSK and Akebia to beat FibroGen and AZ to market.

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FDA Law Blog

MARCH 12, 2024

In fact, federal law and regulation appear to require AbbVie to list these patents.” No matter how Congress and FTC frame it, it is FDA that’s to blame for the listing confusion when it has had more than 20 years to respond to questions about whether these types of patents should have been listable in the first place.

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XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

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FDA Law Blog

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. That Policy Statement , issued on September 14, 2023, warns companies that improper listing of patents in the Orange Book could be “ an unfair method of competition in violation of the FTC Act ”.

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pharmaphorum

DECEMBER 14, 2020

Ruxolitinib is already FDA approved under the brand name Jakafi to treat the bone marrow diseases myelofibrosis, polycythemia vera and graft-versus-host disease. Trials of the drug in other indications are not affected by the outcome, Novartis said.

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pharmaphorum

JUNE 9, 2021

Pfizer has the FDA approval it was seeking for Prevnar 20, the latest update to its blockbuster pneumococcal vaccination franchise, keeping it one step ahead of a competing shot from Merck & Co. In two phase 3 trials in adults reported last year, V114 stimulated immune responses to all serotypes in the shot.

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pharmaphorum

APRIL 6, 2022

The EU regulator has started a review of Novartis’ PD-1 inhibitor tislelizumab – licensed from Chinese biotech BeiGene – for oesophageal and lung cancers, ahead of an FDA decision on the drug due in July. FDA clears Vijoice for rare overgrowths.

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Pharmaceutical Technology

NOVEMBER 29, 2022

In 1970, the FDA approved ketamine as an anesthetic. In March 2019, the American regulator approved esketamine , an enantiomer of ketamine, for use in treatment-resistant depression as a nasal spray. The drug is also known for its illegal recreational use. Depression research spurs efforts for other conditions.

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FDA Law Blog

MARCH 26, 2024

Late last week, the FTC submitted an Amicus Brief in recent Hatch-Waxman patent litigation in the District Court of New Jersey between Reference Listed Drug holder Teva Branded Pharmaceutical Products R&D Inc. Because a “drug product” is defined by regulation as a “Finished dosage form.

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pharmaphorum

MAY 17, 2021

Apellis Pharma has secured FDA approval for its complement C3 inhibitor Empaveli as a treatment for paroxysmal nocturnal hemoglobinuria (PNH) – with a label that will allow it to challenge Alexion’s established therapies directly. . billion and $1.1

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Delveinsight

FEBRUARY 5, 2021

Fortunately, there exists FDA-approved therapies and drugs that double the success rates of quitting. The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. Some of these approved products contain nicotine as an active ingredient, while others do not.

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XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

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pharmaphorum

FEBRUARY 2, 2021

Orally-active S1P agonist Zeposia (ozanimod) has been submitted to the FDA as a treatment for adults with moderately to severely active ulcerative colitis (UC), with a decision from the US regulator due by 30 May after a priority review. The post BMS eyes May FDA verdict for MS drug Zeposia in ulcerative colitis appeared first on.

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pharmaphorum

FEBRUARY 23, 2022

One way in which the pharmaceutical industry and regulators have reacted is by developing or facilitating the development of biosimilars. This is where biosimilars can step in: a biosimilar is defined as a biologic medical product that is highly similar or is an almost identical copy of an original, branded, product.

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pharmaphorum

OCTOBER 28, 2020

Pfizer could be just a few months away from getting FDA approval for its JAK1 inhibitor abrocitinib in atopic dermatitis, a drug that CEO Albert Bourla believes hasn’t been given the credit it is due by Wall Street analysts.

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Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1.

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The Pharma Data

MAY 17, 2023

BTK, also known as tyrosine-protein kinase BTK, is an enzyme that regulates B-cell development and activation and is also involved in the activation of innate immune system myeloid lineage cells, such as macrophages and microglia. Until the FDA approval of OCREVUS, there had been no FDA-approved treatments for PPMS.

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Clinical Trial Podcast

FEBRUARY 23, 2021

Say you’re in the midst of securing FDA approval to start a new clinical trial. You find out that the FDA has follow-up questions. A field CRA needs to have thorough understanding of the study protocol, Good Clinical Practice (GCP) and regulations applicable to the conduct of clinical trials. Let me give you an example.

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Delveinsight

AUGUST 10, 2020

Ofev (Nintedanib) Approval History. In September 2019, Nintedanib was approved under the brand name Ofev by the United States Food and Drug Administration (FDA) for the treatment of Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD). In March 2020, The U.S. Esbriet (Pirfenidone) Facts.

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The Pharma Data

OCTOBER 15, 2020

For dry AMD, there’s nothing approved by the FDA. No one know why the retinal cells die off, so we manufacture brand new retinal cells (OpRegen) and implant them,” Culley said. As with dry AMD, there is no FDA-approved therapy. “We At Lineage, “we’re tackling problems that largely were intractable.

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Delveinsight

AUGUST 17, 2020

At present, Diet-regulation is one of the mainstays of gastroparesis treatment. In addition to nutritional assessment, the gastroparesis market provides few approved medications to treat the disease. However, the drug is not FDA-approved but is available in some European countries.

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FDA Law Blog

APRIL 30, 2023

1067, the “ Ensuring Timely Access to Generics Act of 2023 ,” and it would fundamentally transform the playing field for NDA, ANDA, BLA, and aBLA applicants seeking to preserve their rights in the wake of an adverse FDA approval decision. That bill is S.

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XTalks

OCTOBER 27, 2021

Ranibizumab was developed by Genentech and is sold under the brand name Lucentis. It received FDA approval in 2018. In September, the FDA approved Samsung and Biogen’s Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis for the treatment of nAMD and other eye diseases and conditions. Eylea registered $4.95

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Pharmacy Checkers

NOVEMBER 21, 2019

As my greater advocacy initiatives have worked to implore the FDA to bring more balance, commonsense and fairness to regulating and providing consumer education about personal imports of prescription drugs, I’ve realized that I should practice the same in how I talk about the FDA. The medications that we obtain in the U.S.,

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pharmaphorum

SEPTEMBER 2, 2022

German drugmaker Boehringer Ingelheim has its first regulatory approval for spesolimab, its antibody therapy for rare and life-threatening skin disorder generalised pustular psoriasis (GPP), in the US. It is also under review by regulators in Europe, with a decision expected before the end of the year.

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The Pharma Data

AUGUST 3, 2021

New-to-brand prescription (NBRx) volumes grew 10% year-over-year, even as patient visits to dermatologists remained 15% below pre-pandemic levels. LUMAKRAS received accelerated approval based on overall response rate and duration of response. In the U.S., Otezla continued to maintain first-line share leadership in psoriasis.

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Pharma Marketing Network

JUNE 11, 2020

So I would expect we’re going to find the same type of welcoming environment, maybe even more so with the pharma marketing network brand behind us. I think, you know, when we sat down, we had that lunch and I said, you know the opportunity here for us to take over the mantle and keep the pharma guy brand going.

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