Common Sense for Drug Policy Blog

OCTOBER 29, 2024

Limited Evidence for Nalfmefene "In 2021, due to the widespread availability of high-potency synthetic opioids like fentanyl, the US FDA approved two high-dose naloxone products, an 8 mg IN spray (Kloxxado) and a 5 mg IM injectable (Zimhi). In 2023, the FDA approved a 2.7

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The Pharma Data

JANUARY 6, 2021

End-to-End Single-Site Solution from Drug Substances to Fill-Finish & Packaging. In addition to drug substance manufacture, the facility will also provide commercial scale, automated fill-finish and assembly, packaging and labeling services. Drug substance production line?. Packaging line?. TOKYO , Jan.

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Agency IQ

NOVEMBER 10, 2023

The delayed enforcement is part of FDA’s finalized guidance, “Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.” MoCRA amends the FD&C Act by expanding the FDA’s authority over cosmetics, adding new definitions and requirements for manufacturers and importers of cosmetics.

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The Premier Consulting Blog

SEPTEMBER 11, 2024

The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to. The overall development strategy for GT123 was to include a complete CMC package.

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The Pharma Data

MAY 15, 2021

Product Name: Dentitox Pro – Text Presentation. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked. Dentitox Pro is non-GMO and safe.

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The ChEMBL-og

JUNE 13, 2023

This fresh release comes with a few new data soures and also some new features: we added bioactivity data for understudied SLC targets from the RESOLUTE project and included a flag for Natural Products and for Chemical Probes. An an annotation for the ACTION_TYPE of a measurement was included for approx. 270 K bioactivities.

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The Pharma Data

DECEMBER 16, 2020

Food and Drug Administration (FDA) advisory panel in regard to the COVID-19 vaccine from Moderna. The Vaccines and Related Biological Products Advisory Committee will be determining whether the product should be authorized for emergency use, according to CNBC. A critical vote is set to take place today amongst those on a U.S.

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Drug Target Review

DECEMBER 5, 2024

1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2. 2 Since then, the FDA has approved four more AAV-based gene therapies—Zolgensma, Hemgenix, Elevidys and Rocktavian—for treating various diseases.

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Codon

MARCH 24, 2024

The market for semaglutide-based products is projected to swell to $71B in less than a decade. All of this future value, of course, relies upon these companies actually making enough of their product to meet the growing demand. In November, Novo Nordisk invested $6B in additional production capacity.

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The Pharma Data

MAY 16, 2021

Product Name: DermaPrime. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked. DermaPrime Plus capsules are non-GMO and safe.

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Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics).

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The Premier Consulting Blog

APRIL 15, 2024

Even for repurposed drugs being developed under the 505(b)(2) New Drug Application (NDA) pathway, it is critical to review the existing nonclinical and clinical data on the drug to determine what nonclinical studies may be beneficial to conduct prior to the PIND meeting and include this information in the package.

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Advarra

JULY 19, 2022

Do you search for similar products, and use existing IND criteria requirements against the latest manufacturing guidance docs? A: This is a complex topic and is best outlined in the FDA’s guidance document. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting?

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FDA Law Blog: Biosimilars

AUGUST 17, 2023

FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. §

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Alta Sciences

SEPTEMBER 20, 2023

NASDAQ:VRPX) (“Virpax”), a company specializing in developing non-addictive products for pain management, PTSD, central nervous system (CNS) disorders, and viral barrier indications, to conduct nonclinical studies in support of their development of quaternary ammonium palmitoyl glycol chitosan (GCPQ, under the trade name of AnQlar™). “We

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The Pharma Data

MAY 13, 2021

Product Name: Met Slim Pro. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked. ClickBank is the retailer of products on this site.

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Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products.

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The Pharma Data

DECEMBER 8, 2020

Now poised to advance a robust therapeutics pipeline to clinical development, Nuance will use the funds for ongoing R&D of existing products and business development of potential new assets. Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease. Sigilon Therapeutics .

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The Pharma Data

NOVEMBER 20, 2020

The science and technology investments Regeneron has made over three decades positioned us to move rapidly to invent, study and maximize production of our antibody cocktail. Production of monoclonal antibodies is a complex, time- and labor-intensive process that requires deep expertise. Schleifer, M.D.,

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The Pharma Data

MAY 13, 2021

Product Name: AlphaZym Plus. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked. AlphaZym Plus capsules are non-GMO and safe.

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NIH Director's Blog: Drug Discovery

MARCH 8, 2016

Instead of the black, printed stripes of the Universal Product Codes (UPCs) that we see on everything from package deliveries to clothing tags, they used short, unique snippets of DNA to label cells. A little more than a decade ago, researchers began adapting a familiar commercial concept to genomics: the barcode.

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The Pharma Data

OCTOBER 30, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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Agency IQ

JUNE 2, 2023

FDA unveils long-awaited Patient Medication Information proposed rule Since 2017, the FDA has been working on a proposal to create a new type of patient-focused labeling for certain outpatient drug products that would be specifically targeted for patient use. The FDA recently concluded its work on a proposed rule focused on PMI.

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FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. pricing, among other things.

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The Pharma Data

AUGUST 6, 2020

NEW YORK–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE:BMY) today reports results for the second quarter of 2020, which reflect strong product sales, continued advancement of the pipeline and robust operating performance. SECOND QUARTER PRODUCT REVENUE HIGHLIGHTS. FIRST HALF PRODUCT REVENUE HIGHLIGHTS.

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The Pharma Data

DECEMBER 17, 2020

Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 in patients 12 years of age and older and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

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The Pharma Data

JANUARY 12, 2021

Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

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The Pharma Data

JANUARY 6, 2021

” AstraZeneca has already submitted a substantial data package to support a conditional marketing authorisation for its COVID-19 vaccine to the European Medicines Agency (EMA), as part of an ongoing rolling review process and will continue to work closely with the EMA to seek approval in the coming weeks. Source: AstraZeneca.

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The Pharma Data

DECEMBER 29, 2020

Regeneron continues to increase in-house production of casirivimab and imdevimab, and the company has partnered with Roche to increase the global supply beginning in 2021. If the therapy proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S.

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Agency IQ

JANUARY 19, 2024

EMA’s 2023 new medicines report suggests return to pre-pandemic volume This week, the EMA released its 2023 New Medicines Highlights report, providing insights into the number of opinions provided and the types of products reviewed. Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars.

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Agency IQ

NOVEMBER 3, 2023

regulatory landscape for probiotics and other microbiome-based therapies Probiotics, a type of microbiome-based therapy containing live micro-organisms, are broadly available on drug store and grocery store shelves, but the regulatory classifications for products containing the same micro-organism can differ dramatically.

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Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Broadly, the rule sought to require the use of certain safeguards in the production, storage, and use of medical gases.

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The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). Product Sales Performance. driven by the write-off of $1.5

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The Pharma Data

DECEMBER 5, 2020

Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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The Pharma Data

NOVEMBER 21, 2020

“The science and technology investments Regeneron has made over three decades positioned us to move rapidly to invent, study and maximize production of REGEN-COV2. ” Production of monoclonal antibodies is a complex, time- and labor-intensive process that requires deep expertise. Schleifer , M.D.,

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The Pharma Data

OCTOBER 28, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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The Pharma Data

NOVEMBER 5, 2020

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). The Company commenced delivery of REGN-COV2 drug product under the agreement during the third quarter of 2020. Business Highlights.

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