New Drug Approvals

SEPTEMBER 20, 2023

1] Motixafortide was approved for medical use in the United States in September 2023. [2] 4 Similar in mechanism to the previously approved plerixafor , motixafortide is an inhibitor of C-X-C Motif Chemokine Receptor 4 (CXCR4), a protein that helps to anchor stem cells to bone marrow matrix. 4 September 2023.

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Drug Discovery World

JULY 2, 2024

A study conducted by IQVIA and published in the 2023 Swiss Biotech Report recently showed that 20% of European biotech companies are now headquartered in Switzerland 3. So what makes it so successful? In 2005, Glycart was acquired by the Roche Group and integrated in Roche Pharma Research and Early Development (pRED).

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New Drug Approvals

DECEMBER 24, 2023

2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] 7 March 2023. Archived from the original on 26 September 2023. Retrieved 21 December 2023 – via PR Newswire. February 2023). October 2023). 2023.18688. . ^ “Eplontersen: FDA-Approved Drugs” 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. The number of opinions issued by the EMA in 2023 fell in comparison to the previous two years.

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New Drug Approvals

DECEMBER 24, 2023

3] In November 2023, capivasertib was approved in the United States for people with hormone receptor-positive, human epidermal growth factor receptor 2 -negative breast cancer when used in combination with fulvestrant. [3] 16 November 2023. . 16 November 2023. Archived from the original on 20 November 2023.

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New Drug Approvals

SEPTEMBER 10, 2024

2] Vorasidenib was approved for medical use in the United States in August 2024. [2] 2] [3] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation. [2]

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New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] Food and Drug Administration (FDA). Retrieved 18 October 2023.

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Drug Discovery World

MARCH 7, 2023

She has over 15 years’ experience in corporate finance and restructurings, mergers and acquisitions, joint ventures and intellectual property licensing. In 2023, the company revealed data from a Phase III trial which showed that its vaccine candidate DCVax-L more than doubled overall survival in glioblastoma patients.

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FDA Law Blog: Biosimilars

MARCH 13, 2024

4,631,286, where the PTO considered “whether Hoechst-Roussel is eligible to file an application for [PTE] based on a regulatory review conducted by its competitor, the marketing applicant Warner-Lambert, wherein Hoechst-Roussel was not associated with the regulatory review that led to FDA approval for commercial marketing of the approved product.”

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The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. Pfizer Inc.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. Consider, for example, the following four PTO decisions we unearthed.

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Drug Discovery World

AUGUST 3, 2023

Even still, these approved drug products require a licensed healthcare provider’s prescription. With these exceptions, no other cannabis, cannabis-derived, or cannabidiol (CBD) products are FDA-approved and therefore on the market 1.

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Drug Discovery World

JUNE 14, 2023

In acknowledgement of Blood Donor Day 2023, DDW spoke with industry experts about the significance of blood donorship in drug discovery. One example we are following with anticipation are the two FDA approvals for the first gene therapies for sickle cell disease. Without it, this work stops.

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Drug Discovery World

MAY 24, 2024

Atara Biotherapeutics has submitted a Biologics License Application (BLA) for Tabelecleucel (Tab-cel), a for treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) with the US Food and Drug Administration (FDA). There are currently no FDA approved therapies in this treatment setting.

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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. billion during 2019-2023 (Technavio 2019).

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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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The Anticancer Fund

JUNE 23, 2023

23 June 2023 Language EN Drug repurposing is a strategy for identifying new uses for approved drugs, outside the scope of the original indication. They screened 20 FDA approved AEDs against a panel of six patient-derived IDHmut glioma stem-like cells. It is one of the focus areas of the Anticancer Fund.

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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. AgencyIQ October 1 Nitrosamine testing due to FDA.

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Agency IQ

NOVEMBER 3, 2023

BY CHELSEY MCINTYRE, PHARMD | OCT 30, 2023 10:57 PM CDT Background: What are microbiome-based therapies? Although this guidance document is mostly focused on chemistry, manufacturing and control (CMC) information, it clarifies that LBPs are considered biologics, and will thus need to utilize the Biologics License Application (BLA) pathway.

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New Drug Approvals

DECEMBER 16, 2023

2 On December 6th, 2023, Iptacopan under the brand name Fabhalta was approved by the FDA for the treatment of adults with PNH. This approval was based on favorable results obtained from the phase III APPL-PNH and APPOINT-PNH studies, where 82.3% 5 December 2023. . 5 December 2023. 6 December 2023.

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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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Agency IQ

JANUARY 12, 2024

After lengthy review, FDA approves Florida’s drug importation plan After a years-long review process, the FDA today announced its approval of Florida’s proposal to import certain prescription drug products from Canada.

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

Rescheduling out of schedule I would allow for the medical use of FDA-approved prescription drugs dispensed by DEA-registered, state licensed pharmacies pursuant to prescriptions issued by similarly DEA-registered, state licensed practitioners. and lack accepted safety for use under medical supervision. 21 U.S.C. §

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By Larry K.

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Agency IQ

OCTOBER 6, 2023

FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms AgencyIQ analyzed CDER’s novel drug approvals in Fiscal Year 2023, identifying a recovery in approval numbers as the agency resumes a new normal following the pandemic. of all NME approvals this year.

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Agency IQ

APRIL 26, 2024

Recently, in September 2023, the FDA released an updated draft guidance on labeling for biosimilar and interchangeable products, suggesting a dramatic change in approach. Can information about a biosimilar product be included in promotional materials, even if it isn’t specifically included in the product’s actual FDA-approved labeling?

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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 latest update, announced this week, is known as the Spring 2023 Unified Agenda.

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The Pharma Data

JANUARY 5, 2021

On an operating basis, the Company believes the combination of a rationalized cost structure and expected ongoing growth in TYMLOS ® net revenue will fully fund the development of RAD011 through the top line readout in 2023 with minimal impact on near term cashflow generation. We look forward to supporting Radius through our U.S.

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Agency IQ

MAY 31, 2024

BY RACHEL COE, MSC | MAY 28, 2024 10:34 PM CDT Quick recap on platform technologies As part of the 2023 Consolidated Appropriations Act (Section 2503), Congress directed FDA to establish a new “Platform Technologies Designation” program. AgencyIQ breaks down what the designation means for sponsors and its limits for product sponsors.

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New Drug Approvals

JULY 10, 2023

g/mol BASE Vazegepant BMS-742413 BHV-3500 FDA APPR 3/9/2023 Zavzpret N -[(2 R )-3-(7-methyl-1 H -indazol-5-yl)-1-[4-(1-methylpiperidin-4-yl)piperazin-1-yl]-1-oxopropan-2-yl]-4-(2-oxo-1 H -quinolin-3-yl)piperidine-1-carboxamide ZAVZPRET is indicated for the acute treatment of migraine with or without aura in adults. 10 March 2023.

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Agency IQ

MARCH 25, 2024

FDA addressed the expanding practice of drug compounding in 1992 by issuing a compliance policy guide that clarified that pharmacies which compounded products at certain scales, for certain purposes, or without FDA approval were clearly operating “outside the bounds of traditional pharmacy practice.”

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Agency IQ

JUNE 2, 2023

BY ALEXANDER GAFFNEY, MS, RAC, LAURA DIANGELO, MPH MAY 30, 2023 9:39 PM CDT Regulatory background and context The FDA uses various controls, including labeling and warnings, to ensure that medical products are used appropriately and safely. OIRA eventually released the rule for release by the FDA (with changes) on May 10, 2023.

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Codon

MARCH 28, 2023

As of 2023, at least two programs, called “Bridging the Gap Plus” and “Next-Generation Nonsurgical Neurotechnology” are ongoing; the latter has a budget of at least $125 million and “ aims to develop high-performance, bi-directional brain-machine interfaces for able-bodied service members.”

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The Pharma Data

FEBRUARY 4, 2021

Food and Drug Administration (FDA) approved the update of the Imbruvica Prescribing Information to include efficacy and safety data for the combination of Imbruvica with rituximab for the treatment of Waldenström’s macroglobulinemia (WM). Humira (adalimumab) loss of exclusivity (LOE) in 2023. AbbVie announced that the U.S.

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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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FDA Law Blog: Biosimilars

MAY 21, 2024

29, 2023) (“Basis”); NPRM at 44,603. In 2023, HHS conducted a different approach, a two-part test, to determine whether marijuana has a CAMU. FDA analyzed anorexia related to a medical condition, anxiety, epilepsy, inflammatory bowel disease, chemotherapy-induced nausea and vomiting, pain, and post-traumatic stress disorder.

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FDA Law Blog: Biosimilars

SEPTEMBER 5, 2023

Cannabis in schedule III would require a prescription issued by a DEA-registered, state-licensed practitioner. FDA had not approved an NDA or ANDA for cannabis for any indication in 2016. FDA did approve Epidiolex , a cannabidiol oral solution derived from cannabis, in June 2018. Riley Griffin, et al.,

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