The FDA Law Blog

JULY 25, 2023

Recent industry comments submitted to FDA and new, international efforts against these nefarious, potentially carcinogenic organic compounds have the shifting state of regulation here back in the news. What is FDA doing about NDRSIs? Seek, and ye shall find, so FDA hopes. By John W.M. Claud & Sara W.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

The top 13 players reported more than 10% revenue growth, with BioNTech (3,834.4%), Moderna (2,199.1%), Pfizer (95.2%) and Regeneron Pharmaceuticals (89.1%) reporting a more than 80% year-on-year (YoY) revenue growth from 2020 to 2021, according to GlobalData’s Pharma Intelligence Centre Companies Database.

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European Pharmaceutical Review

FEBRUARY 28, 2023

The US Food and Drug Administration (FDA) subsequently developed a liquid chromatography – high resolution mass spectroscopy (LC-HRMS) method for the determination of NDMA in ranitidine. FDA assigned a provisional AI of 26.5 10 It is not clear whether FDA will adopt a similar t-AI. 2020 [cited 2023Jan]. 2020; 22(4): 89.

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European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

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Pharmaceutical Technology

FEBRUARY 6, 2023

In March 2020, the findings from the trial were published in the New England Journal of Medicine. The US Food and Drug Administration (FDA) has granted Fast Track Designation and Orphan Drug Designation to telacebec. In preclinical and clinical studies, the drug showed potent efficacy against drug-sensitive and drug-resistant TB.

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pharmaphorum

FEBRUARY 2, 2022

ViiV claimed the latter compound infringes its patents for dolutegravir and other compounds based on the drug’s chemical scaffold. Gilead acquired the drug as part of its $21 billion takeover of Immunomedics in 2020. Gilead now expects product sales in 2022 will be between $23.8 billion and $24.3

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Pharmafile

JANUARY 5, 2023

Summary: • TMP-301 (formerly HTL0014242) is a potent, selective, and orally available mGluR5 negative allosteric modulator (NAM) candidate discovered by Sosei Heptares and out-licensed to Tempero Bio • Phase 1 study in healthy volunteers expected to begin in Q1 2023 with support from a US$5.3M read more.

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European Pharmaceutical Review

JUNE 29, 2023

This challenge is further compounded by increasingly complex drug formulations and global ingredient supply chains that stretch manufacturers’ capabilities in testing and control of impurities. But with the spate of recalls, the FDA developed a Guidance for Industry on Control of Nitrosamine Impurities in Human Drugs. Internet] 2023.

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pharmaphorum

AUGUST 24, 2020

SMi Reports: SMi Group have made the decision due to travel restrictions to open the conference and workshops to all microbiologists by transforming it into a virtual-remote online access event only on October 28 and 29 2020. SMi’s 3rd Annual Pharmaceutical Microbiology East Coast 2020. Conference: October 28th-29th, 2020.

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Pharmaceutical Technology

JUNE 27, 2022

Adults with relapsed or refractory FL with positive tumours for an EZH2 mutation which are detected by an FDA-approved test as well as patients who have previously received at least two systemic therapies are also eligible for the treatment with Tazverik. The boards of directors of both the companies have approved the deal unanimously.

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The Checkup by Singlecare

NOVEMBER 21, 2023

Legumes are also great sources of fiber, which is beneficial for gut health, and according to a 2020 study , consuming legumes may help manage blood sugar in people with diabetes mellitus. Also, a diet rich in legumes reduces the risk of diabetes mellitus. This prompted health organizations, including the U.S. For example, 1.5

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European Pharmaceutical Review

SEPTEMBER 25, 2023

NMR relaxation methods distinguish between components (phases or compounds) that have different molecular mobilities For monoclonal antibodies, identification methodologies can employ chromatography, spectroscopy, isoelectric focusing, capillary electrophoresis and peptide mapping techniques. 2020; 10(1). Cited 2023Feb]. Prullière F.,

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The Checkup by Singlecare

JANUARY 10, 2024

Berberine is a yellow alkaloid compound extracted from several plants such as goldenseal, Oregon grape, and tree turmeric. Beyond that, berberine isn’t as effective for weight loss as methods approved by the Food & Drug Administration (FDA). Does berberine help with weight loss?

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pharmaphorum

JANUARY 23, 2023

Morphic said it had received notice that Janssen had decided to pull out of the agreement, which initially focused on two targets but was revised at the end of 2020 to with the additional programme covering “antibody activators for an undisclosed integrin target.” In a filing with the Securities and Exchange Commission (SEC).

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The Checkup by Singlecare

OCTOBER 11, 2023

Phenylephrine In September 2023, the FDA announced that a common decongestant found on shelves, phenylephrine, is not actually effective to decrease congestion. Some studies suggest curcumin, the active compound in turmeric, may even have antiviral properties. Here’s what to skip. or make an anti-inflammatory chicken soup.

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European Pharmaceutical Review

AUGUST 22, 2022

The European Medicines Agency (EMA) advocates 18 ng/day 6 as the default AI, where the US Food and Drug Administration (FDA) supports a value of 26.5 8 As such, detection of an API nitrosamine with an MDI of 4000 mg/day may be feasible for FDA submissions, but probably not with the EMA. 25 June 2020. EMA/369136/2020.

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The Checkup by Singlecare

FEBRUARY 1, 2024

Foods high in estrogen Phytoestrogens are estrogen-like plant-based compounds and are the form of dietary estrogen obtained from foods we consume. Food and Drug Administration (FDA). Biologically active compounds in selected organic and conventionally produced dried fruits , Foods (2020).

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The Checkup by Singlecare

SEPTEMBER 28, 2023

Supplement with turmeric Curcumin is the main compound of the herb turmeric, and according to Dr. Garcia-Ibáñez, it works as a powerful antioxidant and anti-inflammatory. Garlic Garlic does contain anti-inflammatory compounds that, in theory, might reduce congestion. Eucalyptus is considered toxic to children under two.

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European Pharmaceutical Review

JUNE 24, 2022

The US Food and Drug Administration (FDA) requires that manufacturers establish whether nitrosamines, including NDSRIs, could be present in active pharmaceutical ingredients (APIs) and drug products, using the “three-step mitigation strategy described in the agency’s guidance”. 2020, 24 (12), 2915–292. 2020; 24(9): 1558–1585.

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The Checkup by Singlecare

JULY 10, 2024

This allows more of its beneficial compounds to reach the gut, where it can correct gut bacteria imbalances. The National Eczema Foundation points out that the polyphenols, or plant-based compounds in sea moss, may hold many of these benefits, as they’re frequently linked to reducing inflammation (a primary cause of eczema).

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The FDA Law Blog

AUGUST 21, 2023

Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act (“CSA”). We note that in December 2020, the same U.S. By Larry K.

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BuzzRx

SEPTEMBER 30, 2022

In 2020, Epidiolex was further approved to treat tuberous sclerosis complex (TSC), a rare genetic disorder causing benign brain tumors that can lead to seizures. The FDA approval of Epidiolex is the result of numerous studies in the U.S. This CBD oral solution can be used in adults and children as young as 1 year old.

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The Checkup by Singlecare

DECEMBER 1, 2023

For people with Type 2 diabetes, Ozempic is a game-changer: This FDA-approved drug not only lowers blood sugar but can also help people lose weight. American Diabetes Association (undated) Achieving Type 2 diabetes remission through weight loss , National Institute of Diabetes and Digestive and Kidney Diseases (2020) Carbohydrates.

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The Checkup by Singlecare

FEBRUARY 19, 2024

A 2020 review found that B12 supplementation may improve the effects of antidepressant medication , such as selective serotonin reuptake inhibitors ( SSRIs ). Turmeric Turmeric coupons “Turmeric contains an active compound called curcumin, which has potential benefits, including depression,” Dr. Mandel explains. mcg of B12 daily.

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The Thyroid Pharmacist

OCTOBER 7, 2022

Stevia is a natural sweetener derived from the plant Stevia rebaudiana , or “honey leaf,” which contains the sweet-tasting compounds known as steviol glycosides. Steviol glycosides, which are refined extracts of stevia, are recognized as safe by the Food and Drug Administration (FDA). doi:10.15344/2456-8007/2020/142. 2020;5:142.

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pharmaphorum

AUGUST 25, 2021

It’s now globally accessible due to Gilead’s work with a network of generic manufacturers and their ability to sign licensing agreements just days after the US FDA registered its authorisation. When the news was getting out from China, our virologists in San Francisco were already scanning compounds, seeing which ones were the most effective.

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The Checkup by Singlecare

MARCH 23, 2023

Understanding the difference between CBD vs. marijuana Cannabinoids are compounds found in the cannabis plant, Cannabis sativa. A small study in 2020 compared the use of hemp CBD, cannabis CBD containing THC, or a placebo in patients with fibromyalgia. Marijuana , also called cannabis, contains more than 100 cannabinoids.

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The Thyroid Pharmacist

SEPTEMBER 20, 2024

According to a 2020 study, there seems to be a connection between hemorrhoids and Hashimoto’s. [23] Plecanatide : This is one of the newest medications for IBS-C that has been approved by the FDA. Tenapanor : Tenapanor was approved by the FDA in September of 2019 for IBS-C. 78] This makes the stool softer and easier to pass.

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The Thyroid Pharmacist

OCTOBER 21, 2022

In general, the anti-bacterial compounds derived from plant sources tend to spare the healthy gut bacteria more so than pharmacological antibiotics, which may decrease the risk of diarrhea and other digestive complications. Published 2020 Mar 20. BMC Musculoskelet Disord. 2020;21(1):181. doi:10.1186/s12891-020-03201-9. doi:10.5056/jnm.2011.17.2.185.

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pharmaphorum

DECEMBER 23, 2020

2020 also saw some of the first “tumour agnostic” cancer drugs get to market, with Bayer’s Vitravki (larotrectinib) getting funding in the UK for tumours with confirmed neurotrophic tyrosine receptor kinase (NTRK) gene fusions.”. Merck & Co is already a major player in immunotherapy with its Keytruda (pembrolizumab) and spent $2.75

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Pharmaceutical Technology

JANUARY 10, 2023

billion in 2029, with drug sales almost doubling at a compound annual growth rate (CAGR) of 11.5%. However, Invokana is likely to continue to lose market share (forecast 9MM CAGR decline of 14.6%), due to an FDA boxed warning regarding diabetic ketoacidosis and increased risk of lower limb amputations.

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The Checkup by Singlecare

NOVEMBER 30, 2023

Rosuvastatin , also known by the brand name Crestor, is a prescription drug approved by the Food and Drug Administration (FDA) to treat high cholesterol levels. Red yeast rice: Red yeast rice contains monacolin K, a compound similar to statins. It belongs to a class of drugs called HMG-CoA reductase inhibitors, or statins.

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ISPE

MARCH 29, 2023

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

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ISPE

MARCH 29, 2023

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

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PharmaShots

JUNE 28, 2023

In 2020 and 2021, this decrease was driven by lower net selling price, unit demand, and unfavorable changes in inventory, partially offset by favorable changes to estimated sales deductions and inventory.

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ISPE

MAY 9, 2023

Additionally, quality control testing of these compounds is conducted using standard testing following applicable pharmacopeia—such as United States Pharmacopeia (USP), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP)—that was current at the time of testing. Published 2020. EMA/206719/2020 Rev 1.

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European Pharmaceutical Review

OCTOBER 9, 2022

Research published in the journal Nature Chemistry , shows how researchers from Stanford University in the US uncovered a promising new method to synthetically manufacture the compound tigilanol tiglate, named EBC-46, which could offer targeted medicine for cancer and other diseases.

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