XTalks

DECEMBER 7, 2022

Rigel Pharmaceuticals’ isocitrate dehydrogenase-1 mutant (mIDH1) targeting small molecule inhibitor Rezlidhia (olutasidenib) has won US Food and Drug Administration (FDA) approval for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML). The median time to complete remission was 1.9 billion deal.

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Pharmaceutical Technology

NOVEMBER 9, 2022

CSL Behring has a commercialisation and license agreement to develop EtranaDez. On November 7, the company announced that the FDA has scheduled a pre-licensure inspection of BioMarin’s manufacturing facility, and required the company to submit three-year Phase III Roctavian data in the approval application. million ($1.8

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The Pharma Data

MAY 7, 2021

The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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pharmaphorum

APRIL 23, 2021

Dostarlimab was discovered by AnaptysBio and licensed to Tesaro before its merger with GSK and has led to two other antibodies entering the clinic: the TIM-3 antagonist cobolimab (GSK4069889) and a LAG-3 antagonist codenamed GSK4074386. GSK is responsible for ongoing R&D, marketing and manufacture of each of these drugs.

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XTalks

JUNE 5, 2023

Drug compounding involves combining, mixing or altering ingredients to create customized medications for individual patients; however, compounded drugs are not FDA-approved, and their safety and efficacy are not validated. The approved drugs contain the base form of semaglutide.

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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

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. About High-Risk Neuroblastoma.

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The Pharma Data

DECEMBER 13, 2020

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. Specifically, the FDA requested that Gamida Cell demonstrate analytical and clinical comparability from the company’s planned commercial manufacturing sites.

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Pharmacy Checkers

JANUARY 10, 2020

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. The exact same FDA-approved drugs are sold in America and other countries, but with different labels.

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Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Throughout 2022, Novartis was at the opposing ends of legal cases.

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XTalks

JULY 10, 2023

“Ignoring drug-approval requirements provides the defendant an unfair competitive advantage over pharmaceutical manufacturers like Novo Nordisk. Novo’s FDA-approved prescription semaglutide products include Wegovy for chronic weight management, and Ozempic and Rybelsus for type 2 diabetes.

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Triage Cancer

AUGUST 18, 2020

Steven Joffe from the University of Pennsylvania’s Perelman School of Medicine found that the FDA approved 99% of all expanded access requests for almost 9,000 investigational drugs. To apply for Expanded Access: The patient consults with their licensed physician to make sure they have exhausted all other treatment options.

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pharmaphorum

DECEMBER 23, 2021

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. Novartis added inclisiran to its pipeline after buying The Medicines Company – which had licensed the drug from Alnylam – for $9.7 It has a long way to go.

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The Pharma Data

AUGUST 21, 2020

The FDA has approved Genmab and Janssen’s Darzalex (daratumumab) as a treatment for relapsed and refractory multiple myeloma, when combined with carfilzomib and dexamethasone, in patients who have previously received between one and three lines of therapy. Multiple myeloma affects 26,000 new patients in America every year.

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FDA Law Blog

OCTOBER 12, 2022

As background, naloxone hydrochloride (“naloxone”) is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdoses and is available in three FDA-approved forms (injectable, auto-injector, and nasal spray). plies for administration (e.g.,

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pharmaphorum

AUGUST 12, 2020

UK biotech Celleron Therapeutics has bought a licence to develop, manufacture and market emactuzumab, an unwanted drug from Roche’s pipeline that could be used in a rare tendon sheath cancer already targeted by Daiichi Sankyo.

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Pfizer

JULY 26, 2022

a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine. a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.

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XTalks

JUNE 12, 2023

Medtronic, the leading global medical device manufacturer, reported a revenue growth of 5 percent in the last fiscal year, affirming its position as the top global medical technology company by revenue. The growth is attributed to regulatory approvals, strategic partnerships and the acquisitions of innovative medical technology companies.

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The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec.

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FDA Law Blog

JULY 13, 2022

If a drug that has been approved for 12 years—but less than 16 years—is selected for the Drug Price Negotiation Program, a biosimilar manufacturer can request a one-year moratorium on negotiations for that product so that the biosimilar manufacturer has time to secure licensure and begin marketing of the biosimilar version.

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XTalks

SEPTEMBER 13, 2024

McKesson’s Biologics division was selected as the exclusive provider of Zokinvy (lonafarnib) , the only US Food and Drug Administration (FDA)-approved treatment for Hutchinson-Gilford progeria syndrome, a rare and fatal condition. McKesson (MCK) Market Capitalization : $89.78

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Pharmacy Checkers

DECEMBER 12, 2019

Testimony this week by the Government Accountability Office before the House Energy and Commerce Subcommittee on Oversight and Investigations about the FDA’s potential failures to protect the public health may not take you into such a totally lopsided universe, but it shows that things may not be so golden. and the EU are very similar.

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Delveinsight

DECEMBER 10, 2020

Currently, many small- and mid-size companies are working to develop, manufacture and launch their software-based therapeutic interventions, while we are observing a significant growth of acquisitions, licensing deals, and collaborations among the big-pharma players, all vying to have a niche in this arena.

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Pfizer

JULY 19, 2022

a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine. a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.

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FDA Law Blog

JULY 5, 2023

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. See 21 U.S.C. 353b(a). Section II at 2. Draft Guidance III.B.2(e)

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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. We look forward to supporting Radius through our U.S. Davis, executive chairman of Benuvia.

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XTalks

NOVEMBER 28, 2023

Samsung Bioepis was the first company to receive FDA approval for both high-concentration and low-concentration formulations of adalimumab biosimilar. What is the significance of having both high-concentration and low-concentration formulations of adalimumab biosimilars approved?

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The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. Food and Drug Administration (FDA)-approved for this use and there is limited information known about the safety or effectiveness of using Actemra/RoActemra to treat people in the hospital with COVID-19.

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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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XTalks

MAY 28, 2024

In March 2024, the VRBPAC met once again and made their recommendations for the strains of A(H1N1) and A(H3N2) as well as the B virus to be included in the 2024/25 Northern Hemisphere trivalent formulation of influenza vaccines licensed for use in the US.

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Pfizer

JULY 8, 2022

a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine. a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.

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FDA Law Blog

AUGUST 8, 2024

Rescheduling or descheduling from the most stringent schedule under the CSA, should one of those actions occur, would loosen federal manufacturing, import/export, distribution, and security requirements.

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The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older. Manufacturing and Delivery Capabilities.

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Roots Analysis

FEBRUARY 22, 2022

The generic version of EpiPen received the FDA approval in 2018. We observed that many companies have entered this field by in-licensing technologies from other players to establish the necessary expertise required to develop / manufacture autoinjectors. Concluding Remarks. Our Social Media Platform. Web: [link].

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The Pharma Data

JANUARY 12, 2021

Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. Source: Moderna, Inc. . Posted: January 2021. Source link.

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The Pharma Data

FEBRUARY 24, 2022

The booster schedule is based on the labeling information of the vaccine used for the primary series COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

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The Pharma Data

DECEMBER 8, 2020

Swiss vaccine supply will be sourced from Moderna’s European production capacity with its strategic manufacturing partner Lonza of Switzerland, and ROVI of Spain for fill-finish services. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. against COVID-19 and 100% efficacy against severe disease. Source: Moderna, Inc. .

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