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.

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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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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).

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XTalks

APRIL 25, 2024

Now we recognize that over the last ten years or so there have been major developments in pharmacotherapy for the management of different etiologies of heart failure,” says Dr. Nicholas Alp, MD, PhD, FACC, FRCP, Vice President of the Medical Department at Medpace.

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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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Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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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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Drug Discovery World

AUGUST 14, 2023

Over the past few decades, the incredible progress in personalised medicine has led to the development of life-saving cell and gene therapies (CGT). Driven by the rapid pace of innovation, the market for CGTs is expected to grow from $4.4 billion in 2020 to $15.5 billion in 2025 at a rate of 28.7%

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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.

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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.

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Drug Discovery World

NOVEMBER 14, 2022

A collaboration between PerkinElmer’s SIRION Biotech business and the Centre for Genomic Regulation (CRG) agreed to jointly develop new generation adeno-associated virus (AAV) vectors for type 1 and type 2 diabetes gene therapy in the pancreas. . Find out more: Collaboration to develop AAV vectors for diabetes gene therapy .

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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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The Pharma Data

MAY 15, 2023

Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced a multi-year partnership with Just – Evotec Biologics, the Seattle-based subsidiary of Evotec SE.

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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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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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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. The magic lies in its patented De-Sugaring technology developed by NTFC. The global sugar free beverage market reached $7.9 So, how did NTFC achieve this?

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Pfizer

JANUARY 27, 2023

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). The dose for patients with moderate renal impairment (eGFR ≥30 to For more information, please visit www.PAXLOVID.com.

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pharmaphorum

JANUARY 14, 2022

The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research.

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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

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. nAMD accounts for 10% of all age-related macular degeneration cases, but is responsible for 90% of AMD-related blindness 2 ,” said Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz.

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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.

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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).

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The Pharma Data

DECEMBER 12, 2020

Chief Executive Officer, Alexion , said: “For nearly 30 years Alexion has worked to develop and deliver transformative medicines to patients around the world with rare and devastating diseases. More recently, AstraZeneca has increased its efforts in immunology research and the development of medicines for immune-mediated diseases.

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The Pharma Data

NOVEMBER 2, 2020

The biotechnology production development program commenced in October 2020 with completion expected in September 2021. “Our goal is the development of precise and predictable psychedelic drug formulations for clinical study and therapeutic use.” from 2017 to 2023 according to Allied Market Research.

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The Pharma Data

OCTOBER 26, 2020

Under the terms of the agreement, Novasep will be in charge of developing and manufacturing (cell culture, AAV expression, purification, aseptic distribution and quality control) the two AAV vectors designed for the Sensorion OTOF-GT project and will supply Drug Product batches to support preclinical and clinical studies. About Sensorion.

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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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FDA Law Blog

MAY 25, 2022

Shuren identified in the Agency’s November 2015 “Public Health Evidence for FDA Oversight of Laboratory Developed Tests” ( here ). Our readers will recall that this report was issued shortly after FDA’s release of its draft guidance documents seeking to regulate laboratory developed tests.

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The Pharma Data

OCTOBER 26, 2020

This work complements the Company’s own development work currently being undertaken. This additional extension of the collaboration will allow us to choose the best CDX antibody for pre-clinical and clinical development.” ” Market Abuse Regulation (MAR) Disclosure. [link].

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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. extractables and leachables).

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The Pharma Data

OCTOBER 27, 2020

FDA Investigational New Drug application to test Ortho-R, our lead Chitosan-PRP hybrid drug/biologic implant combination product, for rotator cuff tear repair in patients” The OTCQB Venture Market is the premiere marketplace for early stage and developing U.S. institutional and retail investors. and international companies.

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Camargo

MAY 19, 2021

The HUD designation provides an incentive for sponsors developing medical devices to be used in the treatment or diagnosis of diseases affecting small populations. After obtaining HUD designation for a medical device, a sponsor can apply for a Humanitarian Device Exemption (HDE), a type of marketing application. The United States Code.

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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. Smoking Cessation: What are the drugs available in the market? The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products.

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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. CRANFORD, N.J. ,

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Pfizer

AUGUST 11, 2022

Pfizer sold Zantac only between 1998 and 2006, and the withdrawal of Zantac products from the market in 2019 and 2020 did not involve any Pfizer products. The information contained in this statement is as of August 11, 2022. Pfizer to Discontinue Development Program for PF-07265803 for LMNA-Related Dilated Cardiomyopathy.

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The Pharma Data

NOVEMBER 23, 2020

EVOTEC TO SUPPORT RAPPTA IN DEVELOPING SMALL MOLECULES THAT REACTIVATE PP2A, A KEY TUMOR SUPPRESSOR. THE COLLABORATION LEVERAGES EVOTEC’S ONCOLOGY EXPERTISE AND INTEGRATED DRUG DISCOVERY AND DEVELOPMENT PLATFORM. This is the perfect combination of expertise to translate these discoveries to the clinic.”

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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. In order to achieve this, a paradigm shift is being observed from the use serum-containing media to serum-free and xeno-free media.

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The Pharma Data

MAY 2, 2021

With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept.

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