The Pharma Data

MARCH 11, 2021

MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio. In 2018, Translate Bio entered into a collaboration and exclusive license agreement with Sanofi Pasteur Inc., Efforts are also underway to enable the product to be stable at routine refrigerator temperature (2-8°C).

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The Pharma Data

JANUARY 18, 2021

In total, there were 31 mostly virtual expert panel meetings in 2020, but more than a dozen of those did not involve votes on New Drug Applications (NDAs), Biologics License Applications (BLAs) or new indications, but instead focused on devices, tobacco or other topics.

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The Pharma Data

AUGUST 21, 2020

Tyvyt first earned its China nod in third-line classical Hodgkin lymphoma in late 2018, and the med’s looking at a potential new indication in previously untreated nonsquamous non-small cell lung cancer down the line. Lilly first licensed Tyvyt from Innovent in 2015. months experienced by the chemo group. Source link.

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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. Read on for this week’s. MacroGenics’ Margetuximab for Metastatic HER2+ Breast Cancer.

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Agency IQ

APRIL 26, 2024

In 2018, the FDA published a detailed guidance on labeling requirements for biosimilar products. However, the 2018 guidance it did not offer advice for interchangeable product labeling. regarding its administration, preparation, storage, or safety). However, the guidance didn’t offer recommendations on promotional materials.

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The Pharma Data

DECEMBER 9, 2020

Under its ongoing collaboration and license agreement, Crescendo’s proprietary transgenic platform and engineering expertise is being used to build Humabody ® -based therapeutics against certain targets selected by Takeda. This is the sixth technical milestone achieved by Crescendo in its collaboration with Takeda.

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The Pharma Data

DECEMBER 2, 2020

Previously, the company announced positive results of the previous Phase IIa induction study in UC in September 2018. Vivlion holds an exclusive license to Goethe University of Frankfurt’s proprietary 3Cs technology for the production of next generation 3Cs CRISPR/Cas gRNA libraries. Horizon Discovery Group – U.K.-based

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The Pharma Data

JUNE 26, 2021

About the Sanofi Pasteur and Translate Bio collaboratio n In June 2018, Translate Bio entered into a collaboration and exclusive license agreement with Sanofi Pasteur, the vaccines global business unit of Sanofi, to develop mRNA vaccines for up to five infectious disease pathogens.

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The Pharma Data

JANUARY 25, 2021

26, 2021 /PRNewswire/ — Asieris Pharmaceuticals announced today that the company has entered into a license agreement with Photocure ASA (Photocure, PHO: OSE) to exclusively register and commercialize Hexvix® in Mainland China and Taiwan. SHANGHAI , Jan. For more information, please visit us at www.asieris.com.

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

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New Drug Approvals

SEPTEMBER 8, 2024

2] Palopegteriparatide was granted an orphan drug designation by the US Food and Drug Administration (FDA) in 2018, [7] and by the EMA in 2020. [8] Palopegteriparatide is a pegylated synthetic peptide (molecular weight: ca. 48,000) consisting of 34 amino acid residues. 1] [2] It is a transiently pegylated parathyroid hormone. [4]

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The Pharma Data

MARCH 15, 2022

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc.,

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The Pharma Data

AUGUST 3, 2021

Accelerates development of current Sanofi licensed programs in vaccines and potential to explore other therapeutic areas Fast tracks establishment of Sanofi’s recently announced mRNA Center of Excellence Full integration upgrades drug formulation capabilities and enhances US talent in a promising new technology.

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The Pharma Data

JANUARY 12, 2021

On 14 May 2018, the Company announced a collaboration with GlobalCo to work on its CDX antibody. In either scenario, the Directors are confident that a successful outcome will be achieved to take the development of the CDX antibody forward toward clinical trials.

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The Pharma Data

MARCH 1, 2022

The lead molecule, SDI-118, was discovered by UCB before being out-licensed to Syndesi as of 2018. Syndesi’s Series A financing was co-led by Novo Holdings together with Fountain Healthcare Partners, with participation from Johnson & Johnson Innovation – JJDC, Inc., Source link: [link].

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The Pharma Data

DECEMBER 1, 2020

Innate Pharma’s commercial-stage product, Lumoxiti, in-licensed from AstraZeneca in the US, EU and Switzerland, was approved by the FDA in September 2018. About Innate Pharma: Innate Pharma S.A. Lumoxiti is a first-in class specialty oncology product for hairy cell leukemia.

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Agency IQ

AUGUST 25, 2023

Read AgencyIQ’s full analysis of the BsUFA Commitment Letter here.] Regulatory Context: Labeling for Biosimilar Products In 2018, the FDA released a guidance document entitled Labeling for Biosimilar Products. However, it also notes that it may be necessary to mention uses for non-approved conditions in order to ensure safe use.

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New Drug Approvals

SEPTEMBER 6, 2024

Retrieved 21 August 2024. ^ World Health Organization (2018). . ^ “Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) approved in the U.S. as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer” Johnson & Johnson (Press release). 20 August 2024. hdl : 10665/330941.

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The Pharma Data

NOVEMBER 17, 2020

of the Net Proceeds is originally intended to be used for the Group’s research and development of ASC21, which is an IND-approved NS5B polymerase nocleot(s)ide inhibitor licensed from Medivir AB under the exclusive licensing agreement executed in June 2017. (b) The Prospectus stipulates that approximately 10.0%

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Molecule Blog

AUGUST 19, 2021

In a best case scenario, that technology is out-licensed to a pharmaceutical company and the remainder of the development carries on there. Molecule has been exploring a use case for combining IP and NFTs with DeFi in 2018, and this week, that use case was fully realised. Transacts the real-world legal rights/licenses of the IP (req.

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DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. The Evolving Regulatory System Regulatory frameworks play a pivotal role in shaping the pharmaceutical M&A landscape.

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NIH Director's Blog: Drug Development

FEBRUARY 27, 2018

Most have focused on patents specifically licensed to pharmaceutical companies from academic institutions, where the vast majority of basic biological research takes place in America, most of it supported by NIH. 2018 Feb 12. Such studies suggested that 10 percent or less of newly approved drugs were based on academic patents.

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The Pharma Data

NOVEMBER 30, 2020

I n-licensing of four clinical-stage product candidates to treat orphan neurological disorders. From the outset, Noema has been leveraging the latest scientific discoveries in neuroscience to identify and pursue promising new indications, and to elaborate a strategy around the four product candidates it licensed from Roche.

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Practical Cheminformatics

DECEMBER 7, 2023

Mark Murcko’s 2018 paper in J Med. It should be noted that not all biotechs skimp on software licenses. In my experience, the most successful drug discovery project leaders are curious people with broad scientific knowledge. There are many ways to broaden your skills. Read papers from areas outside your discipline.

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The Pharma Data

FEBRUARY 25, 2021

Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac , its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older. Last updated: November 2018. Last updated: November 2018. References.

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LifeSciVC

JANUARY 25, 2024

Getting funding and publishing papers in these two controversial fields was difficult, but the research teams I led there persevered for 15 years and succeeded in discovering new drugs that were licensed to pharma and biotech companies. Importantly, we were also able to publish the underlying work in high-quality journals.

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The Pharma Data

FEBRUARY 5, 2021

American Society for Dermatologic Surgery (ASDS) consumer survey on cosmetic dermatologic procedures 2018 available at [link]. As with any medical procedure, a consultation should be done by a licensed healthcare professional to determine if the patient is a candidate for treatment. N= 3,525 total study population.

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The Pharma Data

NOVEMBER 8, 2020

Bristol Myers Squibb has a target action date of November 16 for the biologics license application (BLA) for lisocabtagene maraleucel (liso-cel), a CD19-directed CAR T cell therapy for adults with r/r large B-cell lymphoma after at least two previous therapies. Bristol Myers Squibb picked up liso-cel when it acquired Celgene.

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New Drug Approvals

SEPTEMBER 10, 2024

April 2018). LC-MS: m/z 415 (M+H) +.Compound Compound 6-(6-Chloropyridin-2-yl)-N 2 ,N 4 -bis(1,1,1-trifluoropropan-2-yl)-1,3,5-triazine-2,4-diamine 1 H NMR (400 MHz, CDCl 3 ) δ 8.29-8.16 8.16 (m, 1H), 7.72 (d, J=7.6 Hz, 1H), 7.41 (d, J=7.9 Hz, 1H), 5.70-5.13 5.13 (m, 2H), 5.09-4.71 4.71 (m, 2H), 1.34 (m, 6H). LC-MS: m/z 415 (M+H) +.

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National Drug & Alcohol Research Centre Blog

NOVEMBER 23, 2023

Despite this increasing evidence, a 2018 study of people who use drugs found Australia had one of the highest reported incidences of drug-dog encounters. These occurred most often at festivals, on public transport, and on licensed premises.

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The Pharma Data

AUGUST 22, 2021

Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein(7) and were optimised by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding. 2018; 37(9): 886-892. About AstraZeneca.

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FDA Law Blog: Biosimilars

DECEMBER 11, 2023

This is based on FDA’s reported 2018 review of the CLIA database. [2] This is 50% greater than the 2018 numbers relied upon by FDA in its estimates. [3] FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests.

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The Pharma Data

JULY 22, 2021

The two companies had previously announced in 2018 a separate research collaboration and license agreement for the discovery and development of drug candidates using Arvinas’ PROTAC technology. Terms of the Collaboration. The agreement is a worldwide co-development and co-commercialization collaboration.

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The Pharma Data

APRIL 1, 2021

In 2018, Sanofi made another historic investment at the Toronto Site, to establish one of the most advanced vaccine bulk manufacturing facilities in the world. License approval for the United States and Canada is expected in 2024 for the five-component-pertussis and in 2025 for diphtheria and tetanus.

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The Pharma Data

OCTOBER 22, 2020

Monalizumab may re-establish a broad anti-tumor response mediated by NK and T cells, and may enhance the cytotoxic potential of other therapeutic antibodies (André et al, Cell 2018). AstraZeneca obtained full oncology rights to monalizumab in October 2018 through a co-development and commercialization agreement initiated in 2015.

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Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA.

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The Pharma Data

JANUARY 18, 2021

ZTlido ® was approved by the FDA on February 28, 2018. RTX has completed a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. For more information visit www.sorrentotherapeutics.com.

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