The Pharma Data

DECEMBER 13, 2020

About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics.

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FDA Law Blog: Biosimilars

APRIL 30, 2023

112-144 (2012). As background, FDC Act § 505(q) states that FDA shall not delay approval of a pending ANDA, 505(b)(2) application, or 351(k) biosimilar application as a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. 110-85 (2007), as amended by Section 301 of Pub.

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FDA Law Blog: Biosimilars

APRIL 16, 2024

It creates the prospect of larger inflation-based rebates, which make up an increasingly large portion of the total amount paid under the Medicaid Drug Rebate Program—more than half since 2012.”

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The Pharma Data

JANUARY 24, 2021

About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics.

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FDA Law Blog: Biosimilars

AUGUST 18, 2024

In 2012, the FDCA was modified to allow the submission of a De Novo request without the need for a prior 510(k), and set a target review time by FDA of 120 days. This amendment allowed sponsors with low or moderate risk devices to proactively employ the De Novo process.

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FDA Law Blog: Biosimilars

APRIL 3, 2023

This objection echoed a criticism that had been expressed by industry ever since CMS’s proposed rule in 2012. Finally, the court finally addressed Vanda’s claim that CMS’s definition of line extension was overly broad, exceeding Congress’ intent to capture only slight alterations to existing drugs.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

Our fourth example ties in our Part 1 post and the references to BELVIQ (lorcaserin HCl) Tablets (NDA 022529; approved on June 27, 2012) and the Improving Regulatory Transparency for New Medical Therapies Act (“IRTNMTA”), with the PTO’s December 21, 2023 ORDER TO SHOW CAUSE “based on the apparent ineligibility of U.S.

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The Pharma Data

JULY 8, 2021

Since the UK Biobank resource was opened for research use in April 2012, over 20,000 researchers from 90+ countries have been approved to use it and more than 2,000 peer-reviewed papers that used the resource have now been published.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

Since the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, manufacturers have been required to notify FDA of product changes affecting certain finished drugs and biological products.

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The Pharma Data

MAY 15, 2023

Since 2012, she serves as board member and currently as chair of the Audit Committee of Tecan Group, a Swiss listed company. Find out more at [link] About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our ambition is to be the world’s leading and most valued generics company.

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The Pharma Data

DECEMBER 9, 2020

million people live with dementia and about 4 million people live with Mild Cognitive Impairment (MCI) in Japan (2012). According to the Health, Labor and Welfare Ministry, it is estimated approximately 4.6 Alzheimer’s disease is suspected to represent around 60-70% of dementia cases.

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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., These inspections will be routine surveillance rather than inspections as part of an approval application.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

Our last two PTE-related posts concerned the issues of: (1) multiple PTEs—a topic we blogged on in 2020 , but that we have been following since the very early days of the FDA Law Blog in 2008 and 2009 (see our previous posts here , here , and here )—and (2) the Improving Regulatory Transparency for New Medical Therapies Act (“IRTNMTA”)—a topic we blogged (..)

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Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

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Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

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The Pharma Data

JUNE 2, 2022

BYOOVIZ™ is the first FDA approved ophthalmology biosimilar BYOOVIZ, priced 40% lower than LUCENTIS®, provides an equally effective and more affordable treatment option to patients suffering from retinal disorders BYOOVIZ will be commercially available through major distributors across the U.S. on July 1, 2022. Biogen Inc.

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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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The Pharma Data

NOVEMBER 9, 2020

” Amgen and AstraZeneca Collaboration Earlier in 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for tezepelumab. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid-single-digit royalty to Amgen.

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The Pharma Data

DECEMBER 21, 2020

Amgen and AstraZeneca Collaboration Earlier in 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for tezepelumab. In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype.

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Agency IQ

SEPTEMBER 1, 2023

The MHRA just opened a public comment period on its plan to end the ECDRP by the end of 2023 Regulation 58(4C) of the Human Medicines Regulation 2012 gives the MHRA the power to rely on EC decisions for approving medicines in the U.K. [See AgencyIQ’s analysis of the announcement.] according to the consultation document. reference product.

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FDA Law Blog: Biosimilars

APRIL 8, 2024

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

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FDA Law Blog: Drug Discovery

NOVEMBER 9, 2022

As we have done in the past for the initial and each quinquennial reauthorization of the drug and medical device user fee laws—in 1992 , 1997 , 2002 , 2007 , 2012 , and 2017 —Hyman, Phelps & McNamara, P.C. has prepared a detailed Summary and Analysis of FUFRA.

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Agency IQ

JULY 8, 2024

Negative *Biosimilar **Generic Notable public consultation periods and calls for evidence Below are various deadlines regarding European policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected to close into Q3 2024.

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Agency IQ

MAY 3, 2024

Positive *Biosimilar **Generic Notable public consultation periods and calls for evidence Below are various deadlines regarding European policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected to close into Q2 2024.

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Agency IQ

MAY 31, 2024

Anticipated EC Decision Drug Company CHMP Opinion June 2024 Agilus (dantrolene sodium, hemiheptahydrate) Norgine Positive June 2024 Altuvoct (efanesoctocog alfa) Swedish Orphan Biovitrum AB Positive June 2024 Fruzaqla (fruquintinib) Takeda Pharmaceuticals Positive June 2024 Jeraygo (aprocitentan) Idorsia Pharmaceuticals Positive June 2024 Obgemsa (vibegron) (..)

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Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials. For implementing acts, the Commission is required to consult with a committee before adoption.

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Agency IQ

MARCH 29, 2024

Title Type Deadline Guideline on clinical investigation of medicinal products in the treatment of depression [EMA] Scientific guideline 3/31/2024 Concept paper on the establishment of a Guideline on the development and manufacture of human medicinal products specifically designed for phage therapy [EMA] Concept paper 3/31/2024 Pharmeuropa 36.1

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Agency IQ

AUGUST 2, 2024

Positive September 2024 Fymskina (ustekinumab)* Formycon AG Positive September 2024 Ituxredi (rituximab)* Reddy Holding GmbH Positive September 2024 Otulfi (ustekinumab)* Fresenius Kabi Deutschland GmbH Positive September 2024 Ranibizumab Midas (ranibizumab)* Midas Pharma GmbH Positive September 2024 Tuznue (trastuzumab)* Prestige Biopharma Belgium (..)

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The Pharma Data

JULY 21, 2021

Pharmaceuticals Division sales decline 3%; sales grow 4% in the second quarter, following a first-quarter decrease of 9%; newly launched medicines (+30%) compensate for the continued impact from biosimilars. The ongoing impact from biosimilars, particularly in the US, resulted in a sales decrease of CHF 2.8 Outlook confirmed for 2021.

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Agency IQ

DECEMBER 1, 2023

Title Type Comments Close Optimizing the Use of Postapproval Pregnancy Safety Studies; Public Workshop RFI November 30 Medical Devices; Laboratory Developed Tests Rule December 4 Stimulant Use Disorders: Developing Drugs for Treatment Guidance December 4 Modernizing the Food and Drug Administration’s Premarket Notification Program Notice December (..)

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Agency IQ

DECEMBER 1, 2023

Positive *Biosimilar **Generic Notable comment periods closing in December Below are various deadlines regarding E.U. Q4 2023 Performance of pharmacovigilance activities for human medicines (update of Implementing Regulation (EU) 520/2012) [E.U.] The feedback period was set to open in Q4 2023; however, no action has yet been taken.

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Agency IQ

JULY 28, 2023

That would leave 19% of staff affected by furloughs.

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FDA Law Blog: Biosimilars

DECEMBER 1, 2024

Then along came the FDA Safety and Innovation Act (“FDASIA”) (our firm’s summary of the law, which was enacted in 2012, is here ). FDASIA authorized FDA, in Section 707(b), to issue a guidance about what constitutes refusing an authorized FDA inspection, which is a crime under Section 301(f) (21 U.S.C. 331(f)).

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FDA Law Blog: Biosimilars

FEBRUARY 4, 2025

This time, however, the program, which has helped incentivize the development of dozens of pediatric rare disease therapies since 2012, was not renewed. The Rare Pediatric Disease (RPD) Priority Review Voucher (PRV) was caught in the crosshair once again. As of the start of 2025, tropical PRVs represent less than 20% of all the PRVs granted.

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Drug Hunter

APRIL 24, 2023

A landmark part of the act is the requirement of Medicare to negotiate the prices for the 15 drugs with highest Medicare spend without generic and/or biosimilar substitutions across Part B (hospital drugs) and D (at-home drugs), with negotiated price implementation starting in 2026.

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FDA Law Blog: Biosimilars

JANUARY 9, 2025

Although FDA has long taken the position that it has broad authority in how it conducts its inspections, it was not until 2012 that Congress put some teeth behind FDAs policy position. Using publicly available examples, these lessons will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection.

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