Pharma in Brief

JANUARY 7, 2024

On January 5, 2024, the US Food and Drug Administration ( FDA ) approved Florida’s proposal to import prescription drugs from Canada. Whether Florida is able to import drugs from Canada, including in light of Canadian regulations controlling drug exports, remains to be seen.

Drugs 52

Drugs Regulation FDA Approval Manufacturing 52

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.

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

Regulation 52

Regulation Research Production Compliance 52

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.

Regulation 105

Regulation Vaccination Vaccine Protein 105

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

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).

Drugs 59

Drugs Licensing Licensing Production 59

Pharma in Brief

AUGUST 5, 2020

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. Because DESCOVY contains TAF, it benefits from the same data protection term granted to GENVOYA. Background.

Containment 52

Containment Drugs Regulation Medicine 52

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). mL pre-filled syringe.

Marketing 52

Marketing Drugs Regulation Compliance 52

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.

Marketing 65

Marketing Drugs Antibody Compliance 65

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. Continued authorization for COVID-19 drugs.

Regulation 52

Regulation Drugs Vaccination Vaccine 52

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

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. Criteria for Orphan Drug Designation.

Production 130

Production Drugs Marketing In-Vitro 130

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. The process eliminates the disadvantages of conventional drying methods or freezing.

Manufacturing 147

Manufacturing Production Containment Antibody 147

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. Health Canada has also updated its fee for CSP applications.

Regulation 59

Regulation Sales Clinical Trials Clinical Trials 59

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.

Manufacturing 130

Manufacturing Vaccination Vaccine Packaging 130

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

Gene Therapy 52

Gene Therapy Marketing Gene DNA 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. Venoglobulin IH.

Marketing 85

Marketing Antibody Drugs Sales 85

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.

Marketing 75

Marketing Production Drugs Licensing 75

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 ). Background. collectively, the Plaintiffs ). the PMS Product ). In that case, Manson J.

Regulation 52

Regulation Trials Production Compliance 52

Drug Discovery World

MARCH 7, 2023

DDW Editor Reece Armstrong takes a look at Qatar’s drug discovery and life sciences market, exploring how the country is utilising innovative technologies in its approach to healthcare. The Middle East represents one of the world’s most lucrative markets for pharmaceuticals.

Biobanking 52

Biobanking Drugs Genome Genomics 52

Camargo

JUNE 4, 2021

The labeling for Zenrelef is typical for a 505(b)(2) approval, relying to a large extent on approved product labeling for products containing bupivacaine and meloxicam. FDA-Issued Guidances Offer Clarification on PREA, QIDP Designation, Post-Marketing Requirements, and More. Contact us to find out how we can streamline your program.

Development 130

Development Production Drugs Marketing 130

FDA Law Blog

AUGUST 21, 2023

During a routine inspection in June 2022, Drug Enforcement Administration (“DEA”) diversion investigators determined that People’s Rx pharmacy violated recordkeeping requirements, improperly dispensed controlled substances to practitioners for office stock and issued prescriptions without authorization. 16, 2023 ( DOJ Press Release ).

Pharmacy 52

Pharmacy Regulation Sales Production 52

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

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.,

Genome 52

Genome Genomics Production Marketing 52

FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022.

Manufacturing 59

Manufacturing Production Drugs FDA Compliance 59

Drug Discovery World

NOVEMBER 14, 2022

Early-stage biopharma company Atrogi initiated a Phase I study for its drug candidate ATR-258 targeting type 2 diabetes in Germany, which is expected to announce results at the end of the year. . The post World Diabetes Day: Five important drug discovery developments appeared first on Drug Discovery World (DDW).

Development 52

Development Gene Therapy Drugs Gene 52

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.

Development 242

Development Bioequivalency Generic Drugs Production 242

FDA Law Blog

AUGUST 4, 2023

Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”). DASCA became law, amending the CSA, on December 18, 2014.

Hormones 52

Hormones Manufacturing Regulation Drugs 52

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.

Packaging 98

Packaging Packaging Containment Production 98

Drug Discovery World

SEPTEMBER 28, 2023

Earlier this year, we explored the microbiome and its role in drug development across various therapeutic areas. In fact, the endometrial fluid contains peptides that may protect against a variety of fungi, bacteria, viruses, and other pathogens 4. The influence of these microbiomes extends to children as well.

Clinical Trials 62

Clinical Trials Clinical Trials Regulation Bacteria 62

World of DTC Marketing

MAY 24, 2022

To make matters worse, a former executive at Cerebral, a well-funded online mental health startup, claims in a labor lawsuit that the company fired him after he complained that the company was too quick to prescribe powerful stimulant drugs. And the COVID-19 pandemic has likely given the market an added boost, Torous adds.

Licensing 252

Licensing Licensing Scientist Production 252

Camargo

MAY 19, 2021

The HUD designation program is designed for medical devices and is similar to the Orphan Drug Designation (ODD) program for drugs and biological products. After obtaining HUD designation for a medical device, a sponsor can apply for a Humanitarian Device Exemption (HDE), a type of marketing application.

Production 142

Production FDA Approval Marketing Drugs 142

FDA Law Blog

FEBRUARY 9, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.

Compliance 105

Compliance Manufacturing Containment Regulation 105

Delveinsight

FEBRUARY 5, 2021

According to the CDC, in 2018, tobacco companies spent over USD 9 Billion in just promoting and marketing their cigars and cigarettes in the US. Fortunately, there exists FDA-approved therapies and drugs that double the success rates of quitting. Smoking Cessation: What are the drugs available in the market?

Marketing 52

Marketing FDA Approval Branding Production 52

The Pharma Data

DECEMBER 29, 2020

The addressable market is estimated to be $80M CDN by 2022. If successful, it will provide Tetra with its first Drug Identification Number (DIN) for a THC-based prescription drug. The new drug name, REDUVO , is pending approval by Health Canada. The addressable market is estimated to be $80M CDN by 2022 1.

Drugs 52

Drugs Regulation Marketing Production 52

XTalks

FEBRUARY 8, 2024

Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. The top 15 diabetes drugs in 2023, according to 2022 sales data, reflect the current state of diabetes management and hint at the evolving needs and trends within this critical area of healthcare. Jardiance brought in $2.06

Sales 52

Sales Insulin FDA Approval Drugs 52

XTalks

OCTOBER 5, 2023

This is because the US has more lenient food ingredient regulations thanks to US Food and Drug Administration’s (FDA) “generally recognized as safe” (GRAS) designation. Whether it’s Whole Foods, Walmart or Aldi, Mooala has made its mark in the plant-based milk market.

Branding 52

Branding Hormones Regulation Containment 52