FDA Law Blog: Biosimilars

MAY 23, 2023

Part 117, and the Food Allergy Safety, Treatment, Education and Research Act (2021). Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact.

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The Pharma Data

JANUARY 24, 2021

25, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that U.S. SHANGHAI, China, Jan. and a disease control rate (DCR) of 86.2%

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The Pharma Data

JANUARY 26, 2021

27, 2021 10:02 UTC. The full data analysis on 353 subjects would be available by the end of February 2021. Additional observational studies to evaluate efficacy of Avigan as part of early treatment in COVID 19 patients are also initiated. HYDERABAD, India–( BUSINESS WIRE )– Dr. Reddy’s Laboratories Ltd.

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FDA Law Blog: Biosimilars

JUNE 27, 2024

In addition, “incorrect drug dosage or duration of drug treatment” occurs when immediate-release opioids for treating acute pain are prescribed for chronic pain over extended periods of time. The regulation requires that pharmacists “ensure that a reasonable effort is made to obtain” this information. 72,694, 72,703 (Dec.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. You see, Oncopeptides has has pending at the PTO since March 2021 a PTE application for U.S. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S. 6,992,207 covering PEPAXTO (Docket No. FDA-2022-E-3124 ).

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The Pharma Data

FEBRUARY 8, 2021

IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia. About IBRANCE® (palbociclib) 125 mg tablets and capsules.

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The Pharma Data

JULY 27, 2021

” The acquisition will also add TNB-585, a Phase 1 bispecific T cell-engager for the treatment of metastatic castrate-resistant prostate cancer (mCRPC), and several preclinical oncology pipeline assets with the potential for near-term IND filings. ” In June 2021, AbbVie Inc. chief executive officer of Teneobio.

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FDA Law Blog: Biosimilars

JUNE 22, 2023

Mullen — FDA has been clearing over-the-counter (OTC) in vitro diagnostic (IVD) tests nearly since the beginning of its premarket regulation of devices. seeking treatment). This approach to regulation of collection devices is overly burdensome and it discourages innovation. Cato & Jeffrey N. Gibbs & Allyson B.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

But in addition to imposing civil penalties for alleged failure to comply with their obligations under the federal Controlled Substances Act and DEA regulations, the courts mandated how those registrants must handle controlled substances going forward. 6, 2023 ( DOJ Press Release ). 21 U.S.C. § 829; 21 C.F.R. Complaint ¶ 55. Complaint ¶ 58.

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. § 812(c)(c)(10).

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Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. BY KIRSTEN MESSMER, PHD, RAC JUN 5, 2023 10:14 PM CDT Regulatory Background: How things work now Regulation (EC) No 141/2000 (the Orphan Regulation) provides the legal framework for orphan drug designations and incentives.

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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.

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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

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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The Pharma Data

JULY 8, 2021

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. PFIZER DISCLOSURE NOTICE: The information contained in this release is as of July 8, 2021.

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Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area.

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The Pharma Data

MAY 4, 2021

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS. Tue, 05/04/2021 – 06:45. Tuesday, May 04, 2021 – 06:45am. <!–*/. First-Quarter 2021 Revenues of $14.6 First-Quarter 2021 Reported Diluted EPS (1) of $0.86, Adjusted Diluted EPS (2) of $0.93. Anonymous (not verified). –*/. <!–*/.q4default.bwalignc

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The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. Percent on a GAAP Basis – Provides 2021 GAAP Diluted EPS Guidance Range of $6.69 to $6.89; Provides 2021 Adjusted Diluted EPS Guidance Range of $12.32 Recent Events.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

FDA also approved two NDAs on the same first day for micafungin (MYCAMINE)—NDA 021506 for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation, and NDA 021754 for the treatment of esophageal candidiasis. These determinations were finalized in 2021. Patent Nos. FDA-2020-E-1840 (Mar.

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The Pharma Data

SEPTEMBER 20, 2020

No dose-limiting toxicities were observed and there were no fatal treatment-related adverse events (TRAEs). Eleven (18.6%) patients had grade 3 or higher TRAEs, one of whom had grade 3 TRAEs of ALT and AST increases that led to discontinuation of treatment. The Phase 2 CRC trial is expected to have a data readout in 2021.

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The Pharma Data

SEPTEMBER 16, 2020

Eligible patients were heavily pretreated with at least two or more prior lines of treatment, consistent with their tumor type and stage of disease. The Phase 2 CRC trial is expected to have a data readout in early 2021. Amgen is currently enrolling six Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101).

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The Pharma Data

DECEMBER 21, 2020

. “The recent results from our NAVIGATOR trial were impressive, both in terms of the overall clinical data and the reduction in exacerbation rate with tezepelumab treatment, and we continue to work with AstraZeneca on planned regulatory filings in 2021. 300 cells/µL) and 65% with low (<300 cells/µL) blood eosinophil counts.

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The Pharma Data

OCTOBER 29, 2020

Treatment compliance rates across all our medicines have remained strong and continue to be slightly above expectations. We have also seen the predicted slowing of new patient initiations and delays in treatment starts, and we are continuing to closely monitor this environment as the pandemic continues.

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The Pharma Data

MAY 14, 2021

Posted 14 May 2021 | By Michael Mezher . Biogen’s experimental eye treatment fails to meet study goal ( Reuters ) ( Endpoints ). Chugai Presses on with Japan Development of 3 COVID-19 Drugs, Aims for Antibody Cocktail Filing in 2021: President ( PharmaJapan ). In Focus: US. Medtech.

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Agency IQ

JULY 28, 2023

First, by March 2021, manufacturers were expected to conclude a risk assessment of their approved or marketed products to assess the risk of nitrosamines. October 1, 2023 [link] Regulations Expected to be Published in Q3These are taken from the most recent version of the White House’s Unified Agenda.

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FDA Law Blog: Biosimilars

JUNE 23, 2024

The CSA and regulations promulgated by DEA are intended to reduce the potential for diversion and abuse and ensure that controlled substances are dispensed and delivered to patients for a legitimate medical purpose. Then, President Biden revoked that Executive Order on his first day in office, January 20, 2021. the “ultimate user”).

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The Pharma Data

MAY 3, 2021

Posted 03 May 2021 | By Michael Mezher . Sarepta’s more potent Duchenne treatment shows promise, greater toxicity, in small study ( STAT ) ( Endpoints ). Novavax plans to ship COVID-19 vaccines to Europe from late 2021 ( Reuters ). © 2021 Regulatory Affairs Professionals Society. In Focus: US.

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The Pharma Data

MAY 17, 2021

Posted 17 May 2021 | By Michael Mezher . Incyte’s vitiligo treatment meets main goal in late-stage trial ( Reuters ). US Supreme Court denies Sandoz petition to review biosimilar Erelzi case ( Press ). Incyte’s vitiligo treatment meets main goal in late-stage trial ( Reuters ).

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