Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Evolution of the Regulations Coming into force (1993–1997).

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XTalks

JANUARY 31, 2023

The US Department of Agriculture (USDA) recently updated its organic food regulations to tighten guidelines around organic products. This update comes after a number of allegations claiming farmers have tried to sell non-organic or conventional food products with the lucrative white and green USDA “organic” label.

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WCG Clinical

DECEMBER 13, 2023

These supplements are not classified as drugs under the Dietary Supplement Health and Education Act of 1994 (DSHEA) and, as such, do not require pre-marketing approval from the U.S. In the alternative, the product may be classified only as a dietary supplement, and then the requirements under 21 CFR 312 would not be applicable.

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Camargo

MAY 19, 2021

The Camargo Blog has published a four-part blog series highlighting those designation programs available specifically for products with rare disease indications. The HUD designation program is designed for medical devices and is similar to the Orphan Drug Designation (ODD) program for drugs and biological products.

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Camargo

FEBRUARY 16, 2021

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Definition of a Rare Disease or Condition.

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pharmaphorum

OCTOBER 2, 2020

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. The post European regulators begin rolling review of AZ’s COVID-19 vaccine appeared first on.

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Pharmaceutical Technology

MARCH 10, 2023

Freeze drying is a crucial technique to prolong the shelf life of pharmaceutical products. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state.

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The Pharma Data

SEPTEMBER 24, 2020

Some supplements billed as ‘smart drugs’ may contain unapproved drugs in potentially dangerous combinations and doses, according to a new study. The team looked through the National Institute of Health’s Dietary Supplement Label Database and the Natural Medicines Database for products containing unapproved drugs. Conor Kavanagh.

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Camargo

MARCH 25, 2021

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications : Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation.

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The Pharma Data

MARCH 7, 2022

Food and Drug Administration announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns (low-risk determination). Today, the U.S. Solomon, D.V.M.,

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World of DTC Marketing

OCTOBER 4, 2021

SUMMARY: The Facebook whistleblower lawsuit can be summed up in one sentence: Facebook prioritizes engagement above all else because it leads to more profits even if that engagement containing inflammatory information. TV will still be the first choice for many DTC marketers, but digital is increasing even though 50% of that money is wasted.

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Pharma in Brief

AUGUST 5, 2020

s ( Gilead ) product DESCOVY as the Canadian Reference Product. DESCOVY contains a combination of tenofovir alafenamide ( TAF ) hemifumarate and emtricitabine. The Minister determined that TAF is a new chemical entity first approved in another Gilead drug product GENVOYA. Background. Minister of Health’s Decision.

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The Pharma Data

NOVEMBER 18, 2020

The topic of sanitation regulation is also covered in ‘ Catalysing Citywide Sanitation For All Through Regulating Service Providers ‘ by IWA’s Regulation for Citywide Inclusive Sanitation initiative’s advisory and taskforce members – Yvonne Magawa (ESAWAS), Diego Polania (CRA), and Gustavo Saltiel (World Bank).

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XTalks

OCTOBER 13, 2023

In the era of health-consciousness, sugar free cranberry juice is a product that consumers are eagerly looking for on the shelves. Based in Traverse City, Michigan, NTFC is the first company to acquire a patent and bring to market a revolutionary culturing method that extracts sugar from fruit juice. Sugar is ubiquitous.

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Pharmaceutical Technology

APRIL 24, 2023

While 80% of the world’s population practices some form of traditional medicine, according to the World Health Organization (WHO), the practice is regularly discredited due to a lack of scientific support and regulation as well as evidence of negative side effects with certain medicines.

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Pharma in Brief

SEPTEMBER 8, 2022

On August 17, 2022, the Federal Court dismissed applications for judicial review regarding the product-specificity requirements for addressing patents listed on the Patent Register under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). Background. mL strength pre-filled syringe).

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Pharma in Brief

JANUARY 26, 2022

The Federal Court has confirmed that issues of infringement, including by inducement, may be decided by summary trial in an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). the PMS Product ). Background. collectively, the Plaintiffs ). In that case, Manson J.

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XTalks

NOVEMBER 23, 2023

This persistent strain of Salmonella , also known as REPJFX01, not only led to significant illnesses but also prompted a massive recall and stricter regulations on poultry processing. The scandal led to stricter regulations on pesticide use and a push for organic farming methods.

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Drug Discovery World

AUGUST 14, 2023

While CGT is still an emerging market, its growth has accelerated over the last five years, resulting in a wave of products approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Driven by the rapid pace of innovation, the market for CGTs is expected to grow from $4.4

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Pharmaceutical Technology

JULY 29, 2022

Once new vaccines for the Omicron variant are approved, they will partly make up for the waning interest in older Covid boosters in developed markets. This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned.

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XTalks

MAY 17, 2024

The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products. The med spa has agreed to this requirement.

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FDA Law Blog

JANUARY 3, 2024

Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

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The Pharma Data

JANUARY 29, 2021

At this time, there is no guarantee that this product will meet all regulatory requirements and receive a subsequent regulatory approval. This is yet another milestone in the expansion of our COVID-19 product family, and we are excited about what is coming up next.”. This news release contains forward ?

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Pharma in Brief

JANUARY 7, 2024

Whether Florida is able to import drugs from Canada, including in light of Canadian regulations controlling drug exports, remains to be seen. Eligible drugs must: (i) be approved by Health Canada; and (ii) meet FDA-approval conditions for a drug currently marketed in the US (aside from US labeling). 01.014.8).

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Pfizer

JANUARY 27, 2023

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The dose for patients with moderate renal impairment (eGFR ≥30 to For more information, please visit www.PAXLOVID.com. AUTHORIZED USE The U.S.

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FDA Law Blog

MARCH 5, 2024

Gaulkin & Riëtte van Laack — As readers of this blog know, there is a lot of contention about the naming of alternative protein products (APPs), including both plant-based and cell-cultured alternatives for (traditional) animal products. We’ve previously blogged about this ongoing battle here , here , here , and here.

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Camargo

JUNE 4, 2021

Heron Therapeutic received FDA approval for its bupivacaine/meloxicam extended-release solution product to treat post-operative pain after total knee replacement, bunionectomy, and groin hernia repair. Because of the significant public health need, FDA granted this 505(b)(2) pathway product a fast track designation in late 2017.

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Delveinsight

JANUARY 22, 2021

The launch of a novel drug in the market is not less than a celebration in the pharmaceutical and healthcare market; however, it also brings the real challenge of sustenance in the market. Similar is the picture of the Thrombocytopenia Drugs Market. At present, there stands no treatment option that can cure the disease.

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FDA Law Blog

AUGUST 21, 2023

Investigators also found that the pharmacy sold pseudoephedrine (“PSE”) products but failed to self-certify in violation of the Combat Methamphetamine Act of 2005 (“CMEA”). Regulated sellers must renew their self-certification annually for each place of business where they sell SCLPs. We note that in December 2020, the same U.S.

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Pharma Marketing Network

JULY 13, 2023

. ● Security: Your website will likely contain sensitive information about your products and customers. Compliance: The pharmaceutical industry is heavily regulated. Make sure the company you choose is familiar with the applicable regulations and can help you ensure your website complies with them.

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The Pharma Data

NOVEMBER 2, 2020

Research agreement to investigate the feasibility of a proprietary biotechnology process for the industrial production of psilocybin API. XPhyto is currently focused on securing industrial scale production of psychedelic APIs and the standardization of drug formulations for the delivery of such APIs. ON BEHALF OF THE BOARD.

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XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy.

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Roots Analysis

AUGUST 29, 2023

Cell therapy is the therapeutic approach which involves the injection of healthy cells in the human body, in order to replace the diseased / non-functioning cells to regulate certain functions. Cell therapy consumables are materials which are used in the manufacturing of cell therapies, however, do not form a part of the final product.

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FDA Law Blog

JANUARY 1, 2024

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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FDA Law Blog

JUNE 21, 2022

By way of background, FDA’s longstanding regulations “fulfill[] the statutory requirements for patent listing,” 80 Fed. 6,802, 6,823, by compelling NDA holders to submit patent information for any supplement that seeks “[t]o change [a] drug product from prescription use to over-the-counter use.” Product Number: 001”).

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Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. 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. In October, the U.S.

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