XTalks

JANUARY 31, 2023

The US Department of Agriculture (USDA) recently updated its organic food regulations to tighten guidelines around organic products. However, products labeled “organic” may contain five percent non-certified organic materials. When is Food Considered Organic? The USDA has stringent rules for what is considered organic.

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XTalks

MAY 17, 2024

Given concerns about safety, the company said no unsafe products should be on the market, especially given that neither the FDA nor any global regulatory agency has reviewed the compounded products for safety, quality or efficacy. If you want your company to be featured on Xtalks.com, please email ayeshar@xtalks.com.

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Pharma Packaging Solutions

JULY 17, 2023

The biopharmaceutical market is ever growing, thanks to constant scientific advancements in the field. Due to the sensitive nature of many biological products, there are strict federal regulations in place to ensure safe packaging and distribution. General Regulations (From Section 112.1)

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Pharma in Brief

MAY 29, 2023

The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations ( CSP Regulations ) and to reflect changes to Health Canada’s administrative practices. Certificate of Supplementary Protection Regulations , SOR/2017-165

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Pharmaceutical Technology

MARCH 10, 2023

The pharmaceutical freeze-drying systems market is expected to be driven by the integration of smarter technologies in lyophilisation methods such as electron microscopy, biochemistry, and advancement in surgeries.

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FDA Law Blog

AUGUST 21, 2023

as non-prescription drugs) directly to walk-in customers or in face-to-face transactions by direct sales must self-certify with DEA that their employees have been trained on SCLP sales requirements. Regulated sellers must renew their self-certification annually for each place of business where they sell SCLPs. 21 U.S.C. §

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Delveinsight

OCTOBER 1, 2021

There are several therapies in the market to address the Myasthenia Gravis burden, and many companies are still working on their drug candidates to cope with Myasthenia Gravis. The current Myasthenia Gravis therapeutics market has many FDA-approved drugs for the treatment of Myasthenia Gravis. Myasthenia Gravis Approved Therapies.

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XTalks

MARCH 1, 2021

Anti-inflammatory drugs like Restasis and Xiidra are popular treatment options for the condition, but will the emergence of mask-associated dry eye bolster their sales? But if you thought the growing number of patients presenting with mask-associated dry eye would mean higher sales for Restasis, think again.

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FDA Law Blog

OCTOBER 5, 2023

Earlier this year, DOJ’s CPB issued its own voluntary disclosure policy , which applies more broadly to potential criminal violations “involving the manufacture, distribution, sale, or marketing of products,” as well as “misconduct involving failures to report to, or misrepresentations to” regulators.

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FDA Law Blog

JANUARY 15, 2024

Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. FDA also directed manufacturers to produce detailed marketing plans. Yet… Petitioners filed PMTAs for their flavored nicotine liquids, which included marketing and sales access restriction plans, with FDA before the deadline.

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FDA Law Blog

JULY 17, 2022

Kirschenbaum — Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package. million).

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Pharmaceutical Technology

JULY 4, 2022

Russia is an already insular country and its worldview has tended to be self-contained, but this has hardened in the face of recent sanctions and counter-sanctions imposed during the war with Ukraine. Thermo Fisher states on its website that “Given the ongoing conflict, we have paused sales and manufacturing operations in Russia and Belarus.

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Pharma in Brief

APRIL 13, 2021

The Food and Drug Regulations ( FDR ) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance ( NOC ) under the FDR. Health Canada has also published a guidance document that contains additional information for drug sponsors.

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The Pharma Data

DECEMBER 10, 2020

The ADSs have been approved for listing on the Nasdaq Global Select Market and are expected to begin trading on December 11, 2020 under the ticker symbol “NBTX.” The Company’s ordinary shares are listed on the regulated market of Euronext Paris under the ticker symbol “NANO.”.

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XTalks

NOVEMBER 9, 2022

Glucagon-like peptide-1 (GLP-1) receptor agonists are a newer class of diabetes drugs that have the potential to double as weight loss drugs, widening their lucrative market potentials. Novo’s obesity version of semaglutide (at a higher dose) is marketed as Wegovy and was approved in 2021. And the demand won’t be easing anytime soon.

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FDA Law Blog

DECEMBER 14, 2023

Conceding that they may disagree whether legalization of recreational cannabis or cannabis use is a “net positive,” the governors agreed that the cannabis industry is permanent, that states have implemented “strong regulations,” and supporting the state regulated cannabis marketplace “is essential for the safety of the American people.”

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The Pharma Data

JANUARY 24, 2021

million through the issuance of an aggregate 15,455,960 shares of its common stock and warrants to purchase up to an aggregate of 7,727,980 shares of common stock, at a purchase price of $1.294 per share of common stock and associated warrant in a private placement priced at-the-market under Nasdaq rules. H.C. .

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XTalks

MARCH 30, 2023

If passed, the bill would make California the first state to ban the sale and manufacture of foods containing titanium dioxide, among other chemicals and dyes. A handful of US food chains, including Panera Bread , have already outpaced regulators, announcing they will no longer sell products that contain the ingredient.

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Pharmaceutical Technology

JANUARY 16, 2023

While the impact of underlying inflation is gradually expected to become less severe over the year, there are signs indicating that inflation pressure will be more persistent in some markets than previously assumed. The magnitude of the hindrance to sales growth and profitability will impact companies from multiple different angles.

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FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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The Pharma Data

DECEMBER 20, 2020

The portfolio generated FY2019 net sales of approximately $109.5 million USD, driven by strong sales of cardiovascular products such as Ebrantil ®. This sale will further sharpen Takeda’s focus and resources in fast tracking innovation in China, and the Emerging Markets. billion ($2.3 billion USD).

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The Pharma Data

APRIL 28, 2021

This document contains statements that are, or may be deemed to be, “forward-looking statements”. Forward-looking statements give the Group’s current expectations or forecasts of future events.

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The Pharma Data

OCTOBER 19, 2020

(OTCQB: BRSF ), a neurology-focused medical device and software company, today announced the appointment of Stuart Bernstein as Vice President of Marketing. In this role, Bernstein will be responsible for Brain Scientific’s overall marketing strategy and efforts to strengthen the company’s market position.

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XTalks

JULY 27, 2022

Pink Sauce, a product created and marketed by a woman who goes by Chef Pii on TikTok, has gone viral for all the wrong reasons. Yet over the past few weeks, she’s faced numerous questions about Pink Sauce’s ingredients, packaging and marketing, prompting a social media-based food scandal.

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FDA Law Blog

MARCH 5, 2024

Last November, Florida went further by introducing a bill to prohibit the manufacture, sale, and distribution of cell-cultured meat entirely. Many states have proposed but failed to enact legislation regulating the labeling of APPs, in some cases due to concerns of potential legal challenges based on federal preemption claims.

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Pharmaceutical Technology

FEBRUARY 16, 2023

Stringent government regulations and the growing need for uncompromised quality have further encouraged demand. The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision. Please check your email to download the Buyer's Guide.

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Camargo

NOVEMBER 11, 2020

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

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XTalks

JULY 13, 2023

Prime Energy drink, a popular beverage created by prominent YouTubers KSI and Logan Paul, is facing scrutiny as US Senate Majority Leader Chuck Schumer calls for regulators to investigate its marketing tactics. The beverage, containing 200 mg of caffeine per 355 mL can, packs twice the amount found in its rival, Red Bull.

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pharmaphorum

MARCH 4, 2021

The pipeline for dry eye disease drugs is beginning to heat up, with two biotechs announcing key developments, aiming to disrupt a market led by Allergan and Novartis. billion for its FDA-approved dry eye drug Xiidra during the Japanese pharma’s merger with Shire in 2019, outlining the sales potential in this market niche.

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Pharmaceutical Technology

JANUARY 16, 2023

While the impact of underlying inflation is gradually expected to become less severe over the year, there are signs indicating that inflation pressure will be more persistent in some markets than previously assumed. The magnitude of the hindrance to sales growth and profitability will impact companies from multiple different angles.

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XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. It contains the antiviral medications nirmatrelvir and ritonavir.

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The Pharma Data

JANUARY 17, 2021

Genus’s worldwide sales are made in over 80 countries under the trademarks ‘ABS’ (dairy and beef cattle) and ‘PIC’ (pigs) and comprise semen, embryos and breeding animals with superior genetics to those animals currently in farms. This announcement is available on the Genus website www.genusplc.com.

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Drug Discovery World

FEBRUARY 1, 2023

It is estimated that there will be 340,000 medicinal cannabis users in Europe in 2022 alone, and the overall market is estiated to grow over 500% over the next three years – with the market value in Germany alone poised to hit over €7 billion by 2027 1. Only with more evidence-backed indications will the medicinal market boom.

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Pharma in Brief

JANUARY 9, 2022

These policy initiatives included reforms to the Patented Medicine Prices Review Board ( PMPRB ), the Patented Medicines (Notice of Compliance Regulations) ( PM(NOC) Regulations ), the Patent Rules , and other regulatory matters at Health Canada. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.

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XTalks

JANUARY 25, 2023

Related: Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner? Abbott denied its formula contained the bacteria following the results of routine testing it conducts before the formula is distributed, saying in a statement that its focus “has, is and always will be to ensure safe food for families.”

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FDA Law Blog

JULY 26, 2022

Like all Guidance documents, it starts out with background, explaining that the Orange Book is FDA’s list of drug products approved under the Federal Food, Drug, and Cosmetic Act and contains patent and exclusivity information related to such products.

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The Pharma Data

MAY 15, 2023

Sandoz is a pioneer and market leader in biosimilars and this partnership with Just – Evotec Biologics comes shortly after the company announced increased investments in its Holzkirchen site in Germany to create a core Biopharma Technical Development hub supporting future biosimilar growth. Source link: [link]

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