Conversations in Drug Development Trends

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. The CRISPR technique was first published in 2012, outlining a method to harness the previously underappreciated bacterial immune system. In June 2023, the U.S. What Does This Approval Mean for the Future of Gene Editing?

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Drug Discovery World

MAY 6, 2024

The transfer of technologies from the lab to the market, is no longer purely via IP out licensing, but rather via start-up M&A deals – start-ups being the de-risking vehicle for large corporates. This enabled the Basel start-up ecosystem to grow considerably and consistently, with a strong acceleration in the last five to 10 years.

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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 Moreover, Lilly should explain how a PTE application for a withdrawn “revoked” biologics license application is in compliance with requirements of 37 C.F.R.

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FDA Law Blog: Drug Discovery

MARCH 13, 2023

The FDA took an early lead in the evolution of this movement when they launched the Patient Focused Drug Development (PFDD) initiative in 2012. Rather than speaking with one or two people with a condition of interest as had been previously done, they sought to find a more systematic way of getting broad patient and caregiver feedback.

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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. API and its source and any alternative sources; associated medical devices), and expected duration of the interruption.

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New Drug Approvals

AUGUST 21, 2023

4] [5] History Palovarotene is a retinoic acid receptor gamma (RARγ) agonist licensed to Clementia Pharmaceuticals from Roche Pharmaceuticals. August 2012). 4] [5] It is a highly selective retinoic acid receptor gamma (RARγ) agonist. [6] 22] Ipsen acquired Clementia in 2019. [23] 23] SYN Desjardins, C., Grogan, D. . 10 (11): 1243–50.

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Drug Discovery World

OCTOBER 16, 2023

Dr Tralau-Stewart says: “Indeed, many academic institutions have established new ways of supporting the discovery pipeline, providing tech transfer offices to support licensing, and entrepreneurship and start-up support through fundraising, accelerators, and incubators.

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Agency IQ

AUGUST 25, 2023

BsUFA was first authorized in 2012, and BsUFA I ran from FY2013-2017. The FDA states that “certain text in the reference product labeling related to condition(s) of use for the reference product that are not licensed for the biosimilar product would generally not be included in the biosimilar product labeling.”

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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. This marks another important milestone, after Toripalimab was granted the ODD and the BTD by the FDA.

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The Pharma Data

DECEMBER 9, 2020

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. million people live with dementia and about 4 million people live with Mild Cognitive Impairment (MCI) in Japan (2012). Since October 2017 Biogen and Eisai Co.,

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Scott and colleagues focused on six genes that encode potential drug targets licensed or in development by GlaxoSmithKline for the treatment of obesity or diabetes. 2012 Jul 6;337(6090):100-104. [4] 4] Victoza® significantly reduced the risk of major adverse cardiovascular events in the LEADER Trial. Novo Nordisk. 2016 March 4. [5]

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The Pharma Data

JANUARY 15, 2021

About Darzalex Faspro® In August 2012, Janssen Biotech, Inc. and Genmab A/S entered into a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab.

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The Pharma Data

AUGUST 29, 2020

Novartis has obtained global rights to develop, manufacture and commercialize inclisiran under a license and collaboration agreement with Alnylam Pharmaceuticals. Heart disease and stroke Statistics-2012 update. WHO Cardiovascular diseases (CVDs) ([link] ; accessed June 30, 2020). Circulation. 2012;125(1):e2–e220.

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Agency IQ

AUGUST 4, 2023

Last week, the MHRA provided a roadmap for upcoming labeling requirements, based on license type The Windsor Framework allows the MHRA to approve medicines for U.K. However, labeling requirements depend on the type of license of the medicine. wide license: The requirements of the E.U. only licenses will be converted to U.K.-wide

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The Pharma Data

MARCH 31, 2023

This is enabled by the signing of a voluntary licensing agreement for patents relating to cabotegravir LA for PrEP with MPP in July 2022. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. Shionogi became a ViiV shareholder in October 2012. According to UNAIDS’ latest estimates, approximately 1.5

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The Pharma Data

AUGUST 3, 2021

In July, the FDA accepted the Biologics License Application and granted Priority Review for tezepelumab for the treatment of asthma. Tax Court to contest notices of deficiencies received from the IRS during the quarter for 2010, 2011 and 2012. Tezepelumab. Regulatory reviews are also underway in the EU and Japan. Tax Petition.

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The Pharma Data

NOVEMBER 15, 2020

Most recently, she was a senior executive at Celgene Corporation, where she led corporate strategy from 2012 to 2017. drug development initiative from 2012 to February 2019. She earned a BA from Durham University, U.K., and an MBA from Harvard Business School. Before that, Ms.

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The Pharma Data

JULY 8, 2021

AstraZeneca’s Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from the US Food and Drug Administration (FDA). Amgen collaboration In 2020, Amgen and AstraZeneca updated a 2012 collaboration agreement for tezepelumab.

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The Pharma Data

MARCH 2, 2021

and Shionogi Limited as shareholders, today announced the presentation of 16 sponsored abstracts from its diverse portfolio of innovative pipeline and licensed HIV treatment and prevention options at the Conference on Retroviruses and Opportunistic Infections (CROI 2021), being held virtually 6-10 March. Shionogi joined in October 2012.

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Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

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The Pharma Data

NOVEMBER 26, 2020

Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company’s Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. Protalix has licensed to Pfizer Inc.

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The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. In 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for tezepelumab. Amgen (NASDAQ:AMGN) announced that the U.S. About the Amgen and AstraZeneca Collaboration.

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The Pharma Data

JUNE 18, 2021

Noninvasive Streptococcus pneumoniae Serotypes Recovered from Hospitalized Adult Patients in the United States in 2009 to 2012. Clin Infect Dis. 2016;62(9):1119-1125. 18 Mendes RE, Hollingsworth RC, Costello A, et al. Antimicrob Agents Chemother. 2015;59(9):5595-5601. 19 Olarte L, Barson WJ, Lin PL, et al.

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Agency IQ

SEPTEMBER 29, 2023

The following PDUFA dates were obtained from publicly available sources. The following commitments are due within the next two months, minus any commitments the FDA has already met (to our knowledge).

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Agency IQ

DECEMBER 1, 2023

The following PDUFA dates were obtained from publicly available sources. Date Company Drug November 30 Takeda/HUTCHMED Fruquintinib December 8 Vertex / CRISPR Therapeutics Exagamglogene autotemcel December 16 Arcutis Roflumilast December 16 Optinose XHANCE December 16 Merck KEYTRUDA Delayed (Orig.

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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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. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures.

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Agency IQ

SEPTEMBER 29, 2023

Open interoperability specifications and harmonized standard come from Regulation (EU) No 1025/2012 (on European standardization). Important definitions come both within the proposed law and from other Union legislation. These definitions come from the GDPR: Personal data, consent, data subject.

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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. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures.

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Agency IQ

JUNE 29, 2023

The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

MAY 4, 2021

Long-acting cabotegravir has not been approved or licensed anywhere in the world for use in HIV prevention. . Shionogi joined in October 2012. HIV continues to be a global public health crisis, with an estimated 38 million people living with HIV and 1.7 million new cases of HIV at the end of 2019. [3]

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Agency IQ

JUNE 16, 2023

The EPA is also proposing our response to a petition regarding the continued validity of EPA’s 2012 determination (and September 2017 affirmation) that participation in the Cross State Air Pollution Rule (CSAPR) meets the Regional Haze Rule’s criteria for an alternative to the application of source-specific BART.

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Agency IQ

SEPTEMBER 1, 2023

The MHRA notes that the new pathway will be parallel to its innovation pathway (the Innovative Licensing and Access Pathway , or ILAP), which integrates “early regulatory advice with health technology assessment advice.” In May 2023, the MHRA revealed which regulators will be included in the scheme: Australia, Canada, the E.U.,

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The Pharma Data

DECEMBER 29, 2020

” In May 2020 , Protalix and Chiesi Global Rare Diseases announced the submission of a Biologics License Application (BLA) to the U.S. Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the FDA in May 2012 and, subsequently, by the regulatory authorities of other countries.

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Policy Prescription

APRIL 1, 2022

from licensed pharmacies to American patients. Instead, it had everything to do with licensed U.S. As alleged by Gilead’s complaint , filed in the Eastern District of New York, licensed U.S. We purchased our products only from state-licensed suppliers who went through an extensive vendor vetting process.”.

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The Pharma Data

NOVEMBER 22, 2020

In 2012, Merck licensed islatravir (4’-ethynyl-2-fluoro-2’-deoxyadenosine or EFdA) from the Yamasa Corporation based in Choshi, Japan. Merck’s Commitment to HIV.

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The Pharma Data

DECEMBER 27, 2020

Since its first approval in 2012, approximately 150,000 patients worldwide have received KYPROLIS. We also market or plan to market in China additional oncology products licensed from Amgen Inc., 2012 Aug 2;120(5):947-59. i KYPROLIS has been shown to block proteasomes, leading to an excessive build-up of proteins within cells.

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