The Pharma Data

JANUARY 24, 2021

1 Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials. PharmaDrug Inc.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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The Pharma Data

NOVEMBER 5, 2020

resolving patent litigation brought in response to Teva’s Abbreviated New Drug Application, seeking approval to market a generic version of Xtampza ER prior to the expiration of Collegium’s applicable patents. FDA approval, and customary exceptions). Reached a settlement with Teva Pharmaceutical USA, Inc.

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Codon

JULY 14, 2024

In 1940, Charles Drew—the first African-American researcher to earn a doctor of medical science degree at Columbia University—developed an ingenious method for separating and storing plasma , the liquid part of blood that contains essential proteins that promote clotting and regulate blood pressure.

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The Pharma Data

JANUARY 21, 2021

Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. These events may have been associated with inadvertent (partial) intravenous administration and began to resolve within a few minutes after the injection. Hepatotoxicity: Hepatic adverse events were reported.

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The Pharma Data

JANUARY 9, 2021

. A follow-on procurement contract with HHS is expected for the delivery of raxibacumab, the Company’s Food and Drug Administration-approved anthrax monoclonal antibody therapeutic, to the Strategic National Stockpile (SNS). FOOTNOTES. (1) We cannot guarantee that any forward-looking statement will be accurate.

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The Pharma Data

NOVEMBER 4, 2020

REDUCE-IT ® PCI results presented in October 2020 showed through post hoc subgroup analyses that patients in the REDUCE-IT study who had stenting, bypass or other forms of percutaneous cardiovascular intervention (PCI) experienced significantly reduced rates of ischemic events when treated with VASCEPA. commercial team. million and $8.9

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The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Bemarituzumab. Tarlatamab (AMG 757). Tezepelumab.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The remaining 19% would be furloughed.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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New Drug Approvals

DECEMBER 16, 2023

1 Factor B is a positive regulator of the alternative complement pathway, where it activates C3 convertase and subsequently C5 convertase. 5] [6] Iptacopan is also investigated as a drug in other complement-mediated diseases, like age-related macular degeneration and some types of glomerulopathies. [7] 5 December 2023. . 5 December 2023.

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The Pharma Data

JANUARY 5, 2021

based contract manufacturing business, Benuvia Manufacturing, which has significant chemistry and formulation capabilities, including manufacturing our FDA-approved cannabinoid drug, SYNDROS ® ,” said Todd C. Within PWS, cannabidiol targets signaling pathways and receptors that regulate the physical symptoms of hyperphagia and anxiety.

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The Pharma Data

JANUARY 13, 2021

Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infection. Source link.

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Codon

APRIL 2, 2023

Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals. Comparing the economic terms of biotechnology licenses from academic institutions with those between commercial firms. Comparing the economic terms of biotechnology licenses from academic institutions with those between commercial firms.

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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. What happens when a drug is not stored in its original container or within a licensed facility?

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The Pharma Data

AUGUST 6, 2020

FDA) approval of Opdivo (nivolumab) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. This approval was based on the Phase 3 CheckMate -9LA study. Oncology and Hematology. Regulatory.

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Agency IQ

JUNE 2, 2023

They might be required as part of a product’s Risk Evaluation and mitigation Strategy (REMS) or if they are deemed necessary to prevent serious adverse events, inform patients on the potential for serious side effects, and/or inform a patient on the importance of medication adherence to ensure a medication’s effectiveness.

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The Pharma Data

OCTOBER 29, 2020

ULTOMIRIS – Atypical Hemolytic Uremic Syndrome (aHUS): In September 2020 , Japan’s MHLW approved ULTOMIRIS for adults and children with aHUS. FDA approved the ULTOMIRIS 100 mg/mL formulation for PNH and aHUS. The 2020 GAAP and non-GAAP tax rates do not benefit from one-time events that benefited the tax rates in 2019.

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The Pharma Data

FEBRUARY 4, 2021

Recent Events. AbbVie announced that the European Commission (EC) has approved Rinvoq (upadacitinib, 15 mg, once daily) for the treatment of adults with active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS). and by AbbVie outside of the U.S. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc.

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The Pharma Data

APRIL 26, 2021

billion declined, mainly due to the USD 650 million upfront payment to in-license tislelizumab from BeiGene. Key innovation milestones: Entresto granted an expanded indication by the FDA in chronic heart failure patients (to include HFpEF). New approvals. Barring unforeseen events. Free cash flow¹ of USD 1.6 Entresto. .

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Drug Discovery World

FEBRUARY 22, 2024

The FDA has approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI (lecanemab-irmb) injection, for reducing the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease (AD).

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The Pharma Data

DECEMBER 29, 2020

PRX-102 was well-tolerated in the study, with all adverse events being transient in nature without sequelae. The most common moderate treatment emergent adverse events were nasopharyngitis, headache and dyspnea. Protalix has licensed to Pfizer Inc. mL/min/ 1.73m 2 in males, and 86.14 nM and 13.81 About Fabry Disease.

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The Pharma Data

MAY 4, 2021

Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). If approved, TicoVac would be the first vaccine in the U.S.

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FDA Law Blog: Biosimilars

JANUARY 9, 2024

However, before the state can start importing drugs, it must first submit for FDA approval a pre-import request for each eligible prescription drug it plans to import into the United States. This must be a Health Canada-licensed wholesaler that is registered with FDA as a foreign seller. See 21 C.F.R. 251.5; § 251.6(c).

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Drug & Device Law

DECEMBER 29, 2023

The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law. Express and implied preemption operate independently ( see Buckman ), thus the express Prop 65 saving clause was irrelevant.

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Drug & Device Law

JANUARY 4, 2024

That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original). & Com.

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Drug & Device Law

SEPTEMBER 7, 2023

For instance, Sorsaia primarily involves a challenge to a state trying to prevent in-state use of an FDA-approved drug for its FDA-approved use. The FDCA “does [not] mention any other specific procedure, device, cosmetic, or medication it instructs the FDA to regulate.” emphasis in original).

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Drug & Device Law

SEPTEMBER 29, 2022

Before a biologic may be marketed, the manufacturer must obtain a license from the FDA. Approval of an application “constitute[s] a determination” by the FDA “that … the product meet[s] applicable requirements to ensure the continued safety … of such products.” See 42 U.S.C. § See 21 C.F.R.

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