The Pharma Data

MARCH 5, 2021

Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease. If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimer’s. About Aducanumab.

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The Pharma Data

OCTOBER 18, 2021

About Tofersen Tofersen is an antisense medicine being estimated for the implicit treatment of SOD1-ALS. under a cooperative development and license agreement. Tofersen binds to SOD1 mRNA, allowing for its declination by RNase-H in an trouble to reduce conflation of SOD1 protein product.

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The Pharma Data

MAY 2, 2022

Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of New Jersey will be ended, and Lupin will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances. Indications and Usage. IMPORTANT SAFETY INFORMATION.

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The Pharma Data

JANUARY 24, 2021

Food and Drug Administration (FDA) has granted toripalimab Fast Track designation for the first-line treatment of mucosal melanoma. On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (the “NMPA”) for the second-line treatment of unresectable or metastatic melanoma.

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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. 21 U.S.C. § 812(c)(c)(10). and lack accepted safety for use under medical supervision.

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Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources.

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FDA Law Blog: Biosimilars

AUGUST 9, 2023

DEA explained its chief reasons for amending its regulations to allow the transfer of EPCS for initial filling are to provide patients with the option of transferring to prevent treatment delays, reducing patient burden and stress, as well as minimizing opportunities for diversion. cannot be altered during the transmission.

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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. chief executive officer of Teneobio. ” In June 2021, AbbVie Inc.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

For purposes of these notification requirements, finished products are prescription drugs and biological products that are (1) life supporting, life sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, and (2) not radiopharmaceutical drug products or any other products specifically designated by FDA.

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Agency IQ

JULY 8, 2024

Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

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The Pharma Data

NOVEMBER 9, 2020

NAVIGATOR is a Phase 3, randomized, double-blinded, placebo-controlled trial in adults (18–80 years old) and adolescents (12–17 years old) with severe, uncontrolled asthma, who were receiving treatment with medium- or high-dose ICS plus at least one additional controller medication with or without OCS.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. Moreover, Lilly should explain how a PTE application for a withdrawn “revoked” biologics license application is in compliance with requirements of 37 C.F.R.

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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 BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it.

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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. ” Amgen Webcast Investor Call Amgen?will

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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 an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5 Recent Events.

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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. It also states that “[t]he pharmacist shall record any related information indicated by a licensed health care practitioner.” Id.

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The Pharma Data

APRIL 30, 2021

percent on an operational basis, due to biosimilar competition. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for Skyrizi (risankizumab, 150 mg) for the treatment of adults with active psoriatic arthritis (PsA). Humira net revenues were $3.907 billion , an increase of 6.9

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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. Detailed results from the SOURCE trial will be presented at a future medical meeting.

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Agency IQ

JUNE 29, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., The following PDUFA dates were obtained from publicly available sources. not discontinued) and are available for sale.

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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

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. “An

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Drug Target Review

JULY 6, 2023

3 Furthermore, the act “removes a requirement to use animal studies as part of the process to obtain a license for a biological product that is biosimilar or interchangeable with another biological product.”

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The Pharma Data

MAY 5, 2022

Nasdaq: BIIB) and MedRhythms have entered into a license agreement to develop and commercialize MR-004, an investigational prescription digital therapeutic for the potential treatment of gait deficits in multiple sclerosis (MS). Biogen Inc.

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The Pharma Data

DECEMBER 13, 2020

MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan. Read on for this week’s.

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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). AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.

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Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Reviews of orphan medicines and biosimilars have remained stable over the past three years. There were eight biosimilars reviewed in 2023, which is comparable to 2021 (seven) and 2022 (eight), but lower than 2020, which saw 12 biosimilars reviewed.

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The Pharma Data

NOVEMBER 6, 2020

The Advisory Committee also voted 0 yes, 7 no and 4 uncertain on the question, “Does Study 103 (PRIME) provide supportive evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?”, Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease.

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FDA Law Blog: Biosimilars

SEPTEMBER 5, 2023

Houck — Scheduling Criteria Under the Controlled Substances Act (“CSA”) Schedule I: • High potential for abuse; • No currently accepted medical use in treatment in the U.S.; Schedule III: • Potential for abuse less than drugs or substances in schedules I and II; • Currently accepted medical use in treatment in the U.S.; 21 U.S.C. §

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The Pharma Data

OCTOBER 29, 2020

(Tokyo, Japan) today announced that the European Medicines Agency (EMA) has confirmed it has accepted for review, following a standard timetable, the Marketing Authorization Application (MAA) for aducanumab, an investigational treatment for Alzheimer’s disease. Aducanumab is also under review with the U.S. About Aducanumab.

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The Pharma Data

AUGUST 3, 2021

The FDA has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir. The European Commission granted marketing authorization for Jardiance ® as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (systolic heart failure).

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

FDA found that marijuana continued to have a high potential for abuse, lacked accepted safety for use under medical supervision and had no currently accepted medical use in treatment in the United States. Schedule I drugs have a high potential for abuse and no currently accepted medical use in treatment in the U.S.

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Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

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The Pharma Data

OCTOBER 27, 2020

Novartis has been granted an option to in-license global rights of MP0420 and MP0423 – multi-targeted direct-acting antiviral therapeutic candidates demonstrating potential efficacy against COVID-19. During the clinical development stage, Molecular Partners will provide clinical supply.

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The Pharma Data

DECEMBER 9, 2020

If approved, aducanumab would become the first treatment to meaningfully change the course of Alzheimer’s disease. About Aducanumab Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease. CAMBRIDGE, Mass. and TOKYO, Dec.

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Agency IQ

OCTOBER 27, 2023

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in November and December FDA comment periods are typically open for 30-60 days, unless they are extended.

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FDA Law Blog: Biosimilars

MAY 5, 2024

Scheduling Under the CSA Substances in schedule I of the CSA have a high potential for abuse, no currently accepted medical use in treatment in the U.S., Those in schedule III have a potential for abuse less than schedule I or II substances, have a currently accepted use in treatment in the U.S., 21 U.S.C. § 21 U.S.C. §

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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. Priority B List.

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