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?

Treatment 75

Treatment FDA Clinical Trials Therapies 75

The Pharma Data

AUGUST 28, 2020

The UK remains under the jurisdiction of the European Medicines Agency and its licensing scheme until the end of the Brexit transition period on 31 December 2020. Oxford coronavirus vaccine triggers immune response. UK signs deals for 90 million virus vaccine doses.

Vaccine 52

Vaccine Immune Response Nurses Government 52

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 Moreover, Lilly should explain how a PTE application for a withdrawn “revoked” biologics license application is in compliance with requirements of 37 C.F.R.

FDA 59

FDA Production FDA Approval Compliance 59

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.”.

Pharmacy 40

Pharmacy Licensing Licensing Drugs 40

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

Packaging 40

Packaging Licensing Licensing Regulations 40

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.

FDA 59

FDA Production Marketing Pharmacy 59

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.

Therapies 98

Therapies FDA Trials Clinical Trials 98

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.

Treatment 52

Treatment Pharmacokinetics Licensing Licensing 52

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

Licensing 40

Licensing Licensing International Treatment 40

Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Last edit: 13 September 2023 Progress in biology is arguably moving faster today than at any point in the course of human history. PNAS (2012). Nature (2012). Nature (2012). & Charpentier E. Philosophical Transactions of the Royal Society B (2016).

DNA 52

DNA Cell Biology Engineering Molecular Biology 52

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.

FDA 52

FDA Clinical Trials Pharmaceuticals Treatment 52

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.

Drugs 189

Drugs Science Therapies Targeted Protein Degradation 189

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.”

Biosimilars 40

Biosimilars FDA Production Licensing 40

Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Progress in biology is arguably moving faster today than at any point in the course of human history. PNAS (2012). Engineered biology has profound potential to change how we live, but the field has become broad, bloated, nebulous. & Charpentier E. Science (2018).

DNA 98

DNA Cell Biology Molecular Biology Engineering 98

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.

Disease 52

Disease Treatment Clinical Trials FDA 52

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.

FDA 52

FDA Clinical Trials Trials Treatment 52

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.

Clinical Trials 40

Clinical Trials Trials Production International 40

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.

Treatment 52

Treatment FDA Clinical Trials Trials 52

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.,

International 40

International Regulations Production Marketing 40

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.,

Clinical Trials 40

Clinical Trials Drugs Disease Licensing 40

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.

Trials 52

Trials Clinical Trials International Production 52

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.

Regulations 40

Regulations FDA Science Production 40

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]

Drugs 52

Drugs Disease Drug Development Clinical Trials 52

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.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

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]

FDA 52

FDA Trials Drugs Clinical Trials 52

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.

FDA Approval 52

FDA Approval FDA Treatment Pharmaceutical Companies 52

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.

FDA 52

FDA Trials Therapies Treatment 52

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.

Treatment 52

Treatment RNA Disease Therapies 52

Agency IQ

JULY 28, 2023

September 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.

FDA 40

FDA Science Biosimilars Regulations 40

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).

FDA 40

FDA Science Regulations Production 40

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.

Vaccine 52

Vaccine FDA Approval FDA Disease 52

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.

FDA 40

FDA Science Regulations Production 40

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.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 29, 2023

The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

MAY 16, 2021

1: Increase in penis size data, and duration to achieve such growth has been collected from user feedback from 2009-2012. Don’t forget, I’m taking all the risk… If after trying my penis growth methods, you don’t get the same earth shattering results that I did, I’ll refund every penny. What have you got to lose?

Testimonials 52

Testimonials Production Licensing Licensing 52

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.

Production 52

Production Therapies Treatment Drugs 52

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.

Trials 52

Trials Production Clinical Trials Government 52