The Pharma Data

JANUARY 3, 2021

The FDA accepted the Biologics License Application for ide-cel, an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, under priority review in September. The CVR hinged on U.S. regulatory approval of three drugs, Zeposia, ide-cel and liso-cel. 16 PDUFA date.

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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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Drug Discovery World

MARCH 29, 2023

What is likely to be the cumulative effect on innovation of the different losses in exclusivity, also given the forthcoming Patent Package which could link the review’s rules on product shortages to EU-wide compulsory licensing?

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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

JANUARY 17, 2021

Shortly after its 2019 launch, the company licensed technology from Harvard University that could potentially improve the success of cell therapy treatments. When the company launched an IPO in late 2018, its valuation was $7 billion, which at the time was a record biotech IPO. Harr was also a director for Loxo Oncology.

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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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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. 17 September 2018. 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. .

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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 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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Policy Prescription

MARCH 11, 2022

The crux of the Manitoba court’s decision is that CanadaDrugs’ founder and CEO, Kris Thorkelson , gets his pharmacist license back after it was revoked in 2019. The Winnipeg Free Press has an excellent story on that. Kris Thorkelson never pled guilty to selling counterfeit drugs. clinics in 2011.

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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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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 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

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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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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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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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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Agency IQ

JANUARY 12, 2024

These windows depend on whether the new drug application (NDA) or biologics license application (BLA) is a new molecular entity, and if the application has received standard review (10 months, plus 2 months of administrative time) or priority review (6 months, plus 2 months of administrative time).

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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

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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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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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

JANUARY 25, 2021

. “ This marks our second strategic agreement with Asieris, a well-run and well-capitalized company that is executing ahead of plan on the clinical development of Cevira ®, which we licensed to them in July 2019. 75% of all bladder cancer cases occur in men.

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The Pharma Data

JANUARY 24, 2021

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. The FTD will significantly accelerate the research, development, and marketing of Toripalimab in the United States.

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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

JANUARY 24, 2021

1 Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials. PharmaDrug Inc.

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The Pharma Data

NOVEMBER 10, 2020

AlzeCure aims to pursue its own projects through preclinical research and development to an early clinical phase and is continuously working with business development to find suitable out-licensing solutions with other pharmaceutical companies. For more information, please visit www.alzecurepharma.se.

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The Pharma Data

JANUARY 13, 2021

Structure 3:1031-1039 (1995) 3 Waters J, Biocentury ; October 26, (2018) 4 NCT02273960; ClinicalTrials.gov ; “Study to Evaluate Safety and Efficacy in Adult Subjects With ITP (ITP)”; results posted April 1, 2019, updated July 29, 2019 and accessed Jan 11, 2021 5 Ferrant JL et al., 1 Lederman, S. International Immunol. (11):1583

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Agency IQ

JANUARY 19, 2024

However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. Reviews of orphan medicines and biosimilars have remained stable over the past three years. for the years 2020 to 2022. Based on the E.U.

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Codon

JANUARY 21, 2024

We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. And so, there was a lot of debate about that back in 2017 and 2018 , when they were considering these trials in the first place. That's the primary way that Zika is spread.

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The Pharma Data

AUGUST 19, 2021

In 2018, Janssen Biotech, Inc. entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib. 8] , [9] , [10] , [11] , [12]. **In About the CHRYSALIS Study.

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Broad Institute

MAY 14, 2024

Studier continued studying the T7 polymerase and promoter, fine-tuning the system for years, and publishing new improved versions as recently as 2018. Making medicine The T7 technology has also had immediate impacts in industry, with more than 900 biotech and pharmaceutical companies licensing it to produce therapeutics and vaccines.

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The Pharma Data

AUGUST 5, 2020

In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults. Adv Studies Pharm.

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The Pharma Data

NOVEMBER 2, 2020

Although the FDA did not identify any filing issues with the NDA, the Agency reiterated a position raised during the Pediatric Advisory Committee (PAC) and Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) held on May 11, 2018 recommending two-year controlled trials in different age groups. In the U.S., About BioMarin.

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Drug Target Review

FEBRUARY 28, 2024

Trends Immunol 39(6):446-459 (2018). Nat Commun 9(1):1760 (2018). Normality sensing licenses local T cells for innate-like tissue surveillance. J Front Immunol 9:1409 (2018). Davey M, Willcox C, Baker A, et al. Recasting human Vδ1 lymphocytes in an adaptive role. Davey M, Willcox C, Hunter S, et al. Fisher J, Anderson.

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