The Pharma Data

MARCH 5, 2021

Securities and Exchange Commission (SEC) and its “ Document d’Enregistrement Universel ” containing its Annual Financial Report with the French market regulator Autorité des marchés financiers ( AMF ). Sanofi announces today the filing of its Form 20-F with the U.S. Source link:[link].

Containment 52

Containment Regulation Marketing 52

XTalks

JUNE 13, 2024

The market for hemp beverages has been growing rapidly in recent years. The passing of the 2018 Farm Bill, which legalized hemp production, boosted the market, allowing companies to explore hemp as a primary ingredient. This ruling, dated May 15, 2024, is only the 15th such declaration by the agency since 2010.

Marketing 52

Marketing Protein Regulation Production 52

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.

Regulation 52

Regulation Production Bacteria Packaging 52

XTalks

FEBRUARY 13, 2024

However, the line between enticing marketing and misleading information can sometimes blur, leading to controversies and legal actions. This dynamic has propelled misleading advertisement lawsuits into the spotlight, with several high-profile cases raising questions about the integrity of food marketing and its impact on consumer trust.

Marketing 59

Marketing Containment Production Packaging 59

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.

Containment 52

Containment Drugs Production Engineer 52

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. This is true regardless of whether the product is legally marketed as a food or a dietary supplement. Food and Drug Administration (FDA).

Regulation 52

Regulation Research Production Compliance 52

FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.

Regulation 44

Regulation Production Cosmetics Sales 44

BioPharma Reporter

NOVEMBER 24, 2020

Up to 10% of vaccines can be reportedly lost in transit due to breakage or fluctuations in sub-zero temperatures required for preservation, but a manufacturer of data-driven temperature-controlled smart containers says it can cut that rate to just 0.1%.

Containment 98

Containment Vaccination Vaccine Manufacturing 98

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).

Regulation 52

Regulation Compliance Contamination Marketing 52

XTalks

AUGUST 26, 2024

A recent study published in the journal Nutrients highlights significant concerns, revealing that many baby foods contain excessive amounts of sugar and salt, coupled with misleading marketing claims. The study examined 651 baby food products from ten major US supermarkets, focusing on foods marketed for children aged six to 36 months.

Containment 52

Containment Production Regulation Protein 52

XTalks

AUGUST 12, 2024

Despite the elimination of many lead-based products in the US, certain goods, especially those imported, may still contain lead. Given that no safe level of lead exposure has been established, the FDA takes a proactive role in monitoring and regulating lead levels in food to protect public health.

Contamination 91

Contamination Compliance Regulation Production 91

Pharma in Brief

JANUARY 18, 2021

The change was implemented by an amendment to the CSP Regulations that came into force on January 6, 2021. Impact on “timely submission requirement” CSP eligibility is tied to both a patent and a medicinal ingredient contained in an approved drug. There are also certain timing requirements.

Regulation 52

Regulation Containment Marketing Medicine 52

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.

Branding 224

Branding Marketing Pharmacy Pharma Companies 224

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)

Packaging 52

Packaging Packaging Containment Regulation 52

XTalks

JUNE 22, 2023

The Rethink Plastic alliance, in collaboration with a coalition of 81 organizations, is advocating for the integration of effective reuse systems into the European Union’s (EU’s) Packaging and Packaging Waste Regulation. The success of The Better Bagel reflects the growing market demand for low-carb and keto-friendly products.

Packaging 52

Packaging Packaging Containment Contamination 52

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.

Manufacturing 147

Manufacturing Production Containment Antibody 147

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.

Marketing 65

Marketing Drugs Antibody Compliance 65

The Pharma Data

JULY 15, 2021

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION. In addition, the new AstraZeneca American Depositary Shares (ADSs) will be admitted on the Nasdaq Stock Market.

Marketing 52

Marketing Containment Regulation Medicine 52

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.

Marketing 85

Marketing Antibody Drugs Sales 85

Pharmaceutical Technology

JANUARY 24, 2023

The investigational adeno-associated virus (AAV) gene therapy candidate NGN-401 is claimed to be the first to deliver the full-length human MECP2 gene using the company’s Expression Attenuation via Construct Tuning (EXACT) gene regulation technology.

Gene Therapy 208

Gene Therapy Gene Gene Expression Regulation 208

FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. Post-market requirements cover activities such as registration and listing (21 C.F.R. By Adrienne R.

Compliance 98

Compliance Marketing Regulation Development 98

FDA Law Blog

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.

Cosmetics 62

Cosmetics Production Compliance Regulation 62

XTalks

OCTOBER 13, 2023

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. This diagnosis sparked a realization for the team, inspiring them to create beverages that were healthier and contained reduced sugar. Sugar is ubiquitous.

Containment 105

Containment Production Marketing Branding 105

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. Disclosure Notice The information contained in this statement is as of January 27, 2023.

Marketing 75

Marketing Production Drugs Licensing 75

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.

Development 97

Development Regulation Compliance Containment 97

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

Regulation 59

Regulation Sales Clinical Trials Clinical Trials 59

Outsourcing Pharma

FEBRUARY 6, 2024

Phesiâs artificial intelligence (AI) driven platform, Trial Accelerator, has reached a milestone and now contains global data from more than 100 million patients.

Trials 98

Trials Containment Regulation Marketing 98

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.,

Genomics 52

Genomics Genome Production Marketing 52

FDA Law Blog

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price.

Drugs 57

Drugs Manufacturing Regulation Production 57

BioTech 365

MARCH 28, 2021

Results for the year ended 31 December 2020 Results for the year ended 31 December 2020 This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014. Acacia Pharma Group plc … Continue reading →

Containment 40

Containment Regulation Marketing 40

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.”.

Marketing 52

Marketing Regulation Sales Containment 52

FDA Law Blog

MARCH 16, 2023

Baumhardt, Senior Medical Device Regulation Expert — On March 8th FDA granted Quidel’s Sofia 2 SARS Antigen+ FIA and Sofia 2 SARS Antigen+ FIA Control Swab Set. This announcement is the first traditional marketing authorization for a non-PCR based test to detect SARS-CoV-2.

Marketing 40

Marketing In-Vitro Regulation Reagent 40

BioTech 365

OCTOBER 8, 2020

Acacia Pharma completes drawdown from €25 million loan facility from Cosmo Pharmaceuticals to support US launches of BARHEMSYS® and BYFAVO™ This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014. Cambridge, … Continue reading →

Containment 40

Containment Regulation Marketing 40

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).

Drugs 52

Drugs Containment Packaging Packaging 52

XTalks

JULY 11, 2024

The European Food Safety Authority (EFSA) found that smoky flavorings can contain harmful chemicals formed during the smoking process. The team wonders whether the US Food and Drug Administration (FDA) will take note of this ban and implement similar regulations in the US.

Regulation 52

Regulation Containment Branding Production 52

FDA Law Blog

AUGUST 21, 2023

830(e)(1)(B)(i). “Regulated sellers” (retail distributors including pharmacies, grocery stores, general merchandise stores and mobile vendors) selling “scheduled listed chemical products” (“SCLPs”) (products containing ephedrine, PSE and phenylpropanolamine that may be marketed in the U.S. 21 U.S.C. § 21 U.S.C. § 1314.102(a).

Pharmacy 52

Pharmacy Regulation Sales Production 52

Camargo

SEPTEMBER 14, 2021

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. In this second installment, we compare applications for conducting clinical studies, expedited programs, pediatric plans, and labeling in the US and EU markets.

Clinical Trials 144

Clinical Trials Clinical Trials Medicine Production 144