The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDA approved. NEW YORK, Nov. 25, 2020 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics, Inc.

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XTalks

JANUARY 25, 2021

GlaxoSmithKline’s (GSK) ViiV Healthcare — which focuses on HIV treatments and prevention — has received approval from the US Food and Drug Administration (FDA) for its highly anticipated injectable HIV treatment. The long-acting injection can help relieve HIV patients from having to take a daily cocktail of pills.

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XTalks

AUGUST 18, 2020

Moreover, samples for the SalivaDirect test can be collected in any sterile container, and hence does not require any specific type of swab or collection vessel, making collection quick and easy. Last month, the FDA approved a pooled test for COVID-19 developed by Quest Diagnostics. And now it’s getting approval.

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The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

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FDA Law Blog

NOVEMBER 30, 2022

According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

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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. This is the first approval of a Section 804 Importation Program ( SIP ) by the FDA. Biologics, controlled substances, and certain other drugs are not eligible for importation.

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XTalks

JULY 27, 2022

He showed the bottle label that seemed to indicate that it contains 444 servings of the product, at 60 calories per serving of about a tablespoon — a near mathematical impossibility. FDA-Approved? Shaw was recently fielding questions live on TikTok when someone asked her whether Pink Sauce was FDA-approved.

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Camargo

NOVEMBER 15, 2021

In October, the FDA took a step towards clarifying these questions with a guidance called “ Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”. The guidance also contains some useful information, despite the limitations described above.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. The Verquvo label contains a boxed warning that indicates that Verquvo should not be administered to pregnant females because it may cause fetal harm. Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Janssen Biotech, Inc.

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Zokinvy for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company’s first FDA approval. PALO ALTO, Calif.,

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The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. CEO and Co-founder of BioNTech. “We

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XTalks

FEBRUARY 8, 2024

Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics.

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XTalks

NOVEMBER 9, 2023

Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDA approved Zepbound for chronic weight management in adults with obesity.

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The Pharma Data

DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Food and Drug Administration (FDA) has approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. Orgovyx (relugolix) FDA Approval History.

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Pharma Packaging Solutions

SEPTEMBER 22, 2023

Biologics are drug products that are manufactured using materials from living sources. A biosimilar is a biologic that is similar enough to an existing FDA-approved product that it performs in exactly the same way, but different enough to avoid legal battles with the producers of the original product. What are Biosimilars?

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The Pharma Data

JULY 8, 2021

With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. For more information about Eisai Co.,

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XTalks

JUNE 28, 2023

The FDA approval came after several delays and a narrow advisory committee vote of eight to six in favor of the gene therapy’s risk-benefit profile. It is injected into a patient’s muscle tissue.

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The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

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Camargo

OCTOBER 14, 2021

The pilot program is the first step in allowing manufacturers to receive a preliminary review of a novel excipient, prior to drug product formulation. Eligibility for the pilot program has been limited to excipients that 1) have not been previously used in FDA-approved drug products, and 2) do not have an established use in food.

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XTalks

AUGUST 6, 2020

The US Food and Drug Administration (FDA) has approved the use of an oral cannabidiol (CBD) solution called Epidiolex for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients aged one year and older. Epidiolex is the only FDA-approved formulation that contains CBD derived from the cannabis plant.

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Drug Discovery World

AUGUST 14, 2023

A Mutual Recognition Agreement (MRA) 2 for inspections of manufacturing sites for certain human medicines, signed and implemented by the United States and EU in July 2019, served as an important milestone in harmonising certain regulatory aspects in developing a global drug. Archiving samples from the early manufacturing stages is key.

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Pfizer

JUNE 30, 2022

To accelerate GHG emission reductions, Pfizer recognizes that bold partner action and innovation is necessary to develop alternate technologies to enable reliable generation of heat and steam production to meet the demand of Pfizer’s manufacturing, R&D and commercial operations without fossil fuels. Recent Announcements. 07.13.2022.

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XTalks

DECEMBER 5, 2022

The CBD prodrug will be going up against Jazz Pharma’s Epidiolex, the first FDA approved CBD drug formulation. Approved in 2018, Epidiolex is a CBD oral solution indicated for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, rare and severe forms of epilepsy, in patients two years of age and older.

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XTalks

APRIL 21, 2021

The product is food-grade, non-stick, chemical-free and made of a high-performance FDA-approved silicone material. She says, “You can prep, cook, eat, store, and reheat in the same container without having to transfer food over and over. Xtalks spoke with Seema Shenoy, the founder and CEO of Chef Avenue, about their product.

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pharmaphorum

SEPTEMBER 8, 2022

This year, Novartis’ deal-making in the area paid off when it received US FDA approval for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for previously-treated patients with PSMA-positive metastatic castration-resistant prostate cancer. The copper pairing provides significant supply and manufacturing advantages.

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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. COMIRNATY was previously FDA approved for individuals 16 years and older in August 2021. Fri, 07/08/2022 - 11:48.

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Pfizer

AUGUST 3, 2022

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. The information contained in this release is as of August 3, 2022. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age.

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Camargo

DECEMBER 9, 2020

The August edition of In the News discussed recent FDA guidance detailing the approach to inspections during the COVID-19 pandemic, including the proposed use of various “remote” inspection methods—such as document review—to allow inspections to progress without physical access to the facilities involved. Unapproved Drug Initiative Ends.

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Pharmaceutical Technology

NOVEMBER 22, 2022

326 days after SARS-CoV-2 was first sequenced, the FDA approved Pfizer and BioNTech’s Comirnaty® under Emergency Use Authorization (EUA). According to CEPI: “Achieving the 100 Days Mission would give the world a fighting chance of containing a future outbreak before it spreads to become a global pandemic.”.

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pharmaphorum

AUGUST 1, 2022

Monkeypox has claimed the first lives outside Africa – one in Brazil and another two in Spain – although the World Health organization (WHO) has said the outbreak remains “containable.” Meanwhile, there are unconfirmed reports of a possible death in india.

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FDA Law Blog

AUGUST 17, 2023

This statutory provision requires generic drugs to have the same labeling as that approved for the listed drug “except for changes required because of differences approved under a [suitability petition, allowing for certain differences] or because the new drug and the listed drug are produced or distributed by different manufacturers.”

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The Pharma Data

JUNE 17, 2022

With a strong portfolio of eight marketed biosimilars and a further 15+ in various stages of development, Sandoz has an unparalleled heritage and extensive expertise in the development, manufacturing and delivery of biosimilar medicines to patients and the healthcare community worldwide.

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XTalks

DECEMBER 20, 2023

Novo Nordisk’s GLP-1 weight loss-specific drug Wegovy (semaglutide) has been facing similar shortages, as it contains the same active ingredient as Ozempic. Novo and Lilly are hard at work to expand their manufacturing capacities to meet the skyrocketing demand for their GLP-1 blockbusters.

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Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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The Pharma Data

FEBRUARY 23, 2022

Food and Drug Administration (FDA) approved TicoVac™ for active immunization to prevent TBE in individuals 1 year of age and older. 1 TicoVac™ is the only FDA-approved vaccine to help protect U.S. On August 13, 2021, the U.S. adults and children against the TBEV when traveling or moving to TBE endemic areas.

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The Pharma Data

NOVEMBER 2, 2020

.- Based Testing at FDA & CLIA Certified Lab. OTC PINK:DECN) www.decisiondiagnostics.co , a leading manufacturer and worldwide distributor of diabetic test strips engineered to operate on legacy glucose meters through its subsidiary Pharma Tech Solutions, Inc., ABOUT DECISION DIAGNOSTICS CORP Decision Diagnostics Corp.

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