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

DECEMBER 2, 2020

Onivyde, in combination with fluorouracil and leucovorin, was previously approved for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Previously, the company announced positive results of the previous Phase IIa induction study in UC in September 2018.

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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. Transaction Terms.

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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. Founder and CEO of Asieris. ” About Photocure ASA. About Asieris.

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The Pharma Data

MARCH 1, 2022

The mechanism is currently being evaluated for the potential treatment of cognitive impairment and other symptoms associated with a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer’s disease and major depressive disorder. senior vice president, R&D, chief scientific officer, AbbVie.

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The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

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New Drug Approvals

SEPTEMBER 6, 2024

2 History Efficacy was evaluated in MARIPOSA (NCT04487080), a randomized, active-controlled, multicenter trial of 1074 participants with exon 19 deletion or exon 21 L858R substitution mutation-positive locally advanced or metastatic non-small cell lung cancer and no prior systemic therapy for advanced disease. [2] 20 August 2024.

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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

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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New Drug Approvals

SEPTEMBER 8, 2024

4] [6] The applicant for this medicinal product is Ascendis Pharma Bone Diseases A/S. [4] 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. 14 August 2024.

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Codon

JULY 14, 2024

In contrast, people with sickle cell disease commonly receive red blood cell transfusions to alleviate vaso-occlusive pain crises. 2 And while transfusions are among the safest procedures in medicine, there is still a very slight risk of transmission of infectious diseases and adverse immune reactions. Science Robotics (2018).

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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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Pharmaceuticals Pharmaceutical Companies Therapies Marketing 81

The Pharma Data

JUNE 18, 2021

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, 1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Following today’s FDA approval, the U.S. Jansen, Ph.D.,

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The Pharma Data

AUGUST 22, 2021

We are very encouraged by these efficacy and safety data in high-risk people, showing our long-acting antibody combination has the potential to protect from symptomatic and severe disease, alongside vaccines. Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales.

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Trials Vaccine Virus Pharmacokinetics 52

The Pharma Data

JULY 22, 2021

The estrogen receptor is a well-known disease driver in most breast cancers. Together with Pfizer, we will deploy our PROTAC technology in an effort to help people with this devastating disease.”. Despite advancements in oncology in recent years, considerable unmet need persists in the treatment of HR+ breast cancer.

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Targeted Protein Degradation Therapies Clinical Trials Treatment 52

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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NIH Director's Blog: Drug Development

FEBRUARY 27, 2018

Credit: National Institute of Allergy and Infectious Diseases, NIH A major part of NIH’s mission is to support basic research that generates fundamental knowledge about the nature and behavior of living systems. 2018 Feb 12. Such studies suggested that 10 percent or less of newly approved drugs were based on academic patents.

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Research Science FDA Drug Development 52

New Drug Approvals

SEPTEMBER 10, 2024

2] Participants were randomized 1:1 to receive vorasidenib 40 mg orally once daily or placebo orally once daily until disease progression or unacceptable toxicity. [2] 2] Participants randomized to placebo were allowed to cross over to vorasidenib after documented radiographic disease progression. [2] April 2018). Hz, 1H), 5.70-5.13

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The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval.

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The Pharma Data

NOVEMBER 10, 2020

The poster presentation, given by Johan Sandin , CSO at AlzeCure, presents how the mechanisms in the research platform Alzstatin work and shows that the target mechanism within the platform is suitable as a new treatment for Alzheimer’s disease. . STOCKHOLM , Nov. in the brain.

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Practical Cheminformatics

DECEMBER 7, 2023

In these cases, broadening your skillset into other areas like medicinal chemistry, pharmacology, biophysics, pharmacokinetics, and disease biology is important. Mark Murcko’s 2018 paper in J Med. It should be noted that not all biotechs skimp on software licenses. There are many ways to broaden your skills.

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Computational Chemistry Pharmacokinetics Drugs Pharmaceutical Companies 90

The Pharma Data

AUGUST 5, 2020

A separate post hoc analysis demonstrated that nearly 9 out of 10 patients experienced no evidence of disease activity in the second year of treatment 4. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. ” These data were published in the August 6, 2020 issue of The New England Journal of Medicine.

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Trials Treatment Disease Therapies 52

The Pharma Data

FEBRUARY 5, 2021

American Society for Dermatologic Surgery (ASDS) consumer survey on cosmetic dermatologic procedures 2018 available at [link]. Important Safety Information CoolSculpting ® and CoolSculpting ® Elite are contraindicated in patients with cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.

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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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FDA Trials Therapies Pharmacokinetics 52

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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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 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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Pharmaceuticals Small Molecule Vaccine Protein Expression 52

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. and a disease control rate (DCR) of 86.2% The results of the study were published in the Journal of Clinical Oncology in August 2019.

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The Pharma Data

AUGUST 19, 2021

1 Disease response was evaluated using overall response rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1* (RECIST v1.1) In 2018, Janssen Biotech, Inc. entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib. Interstitial Lung Disease/Pneumonitis 7.

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The Pharma Data

OCTOBER 14, 2020

2018) PLoS One. Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. TNX-102 SL is also in development for agitation in Alzheimer’s disease and alcohol use disorder (AUD).

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Vaccine Pharmaceuticals Small Molecule Virus 40

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). before any other country.

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The Pharma Data

OCTOBER 28, 2020

29, 2020 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the potential pathway to marketing approval for its lead product candidate remestemcel-L. NEW YORK, Oct.

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The Pharma Data

JANUARY 14, 2021

The FIGHT trial results demonstrate that treatment with bemarituzumab in combination with chemotherapy can deliver a significant reduction in the risk of disease progression and death in gastric cancer patients whose tumors overexpress FGFR2b.”. ORR (measurable disease at baseline). Wainberg, M.D.,

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Trials Treatment Therapies Clinical Trials 52

The Pharma Data

JANUARY 13, 2021

Lung cancer is the leading cause of cancer-related death in China, and with NSCLC comprising the most common form of the disease, there is significant patient need. We also market or plan to market in China additional oncology products licensed from Amgen Inc., Accessed December 2020. v Zhang, T., Tang, Z., … Li, K.

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Production Trials Clinical Trials Treatment 52

The Pharma Data

APRIL 23, 2021

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “Women with recurrent endometrial cancer, or advanced disease that has progressed on or after chemotherapy, currently have limited treatment options and a poor prognosis. and a disease control rate of 55.6% (95% CI; 45.7-65.1). Published 2018.

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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. About Achondroplasia. In the U.S.,

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