Pharmaceutical Technology

OCTOBER 25, 2022

Additionally, Astellas will obtain an exclusive option for licencing two clinical-stage programmes of Taysha, namely TSHA-102 and TSHA-120, for Rett syndrome and GAN, respectively. Astellas will also receive specific rights linked to any possible change of Taysha’s control.

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Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Pharmaceutical Technology

AUGUST 25, 2022

The approval is based on comprehensive data from the clinical development programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinical trial. The company plans to resubmit a Biologics License Application (BLA) for Roctavian by the end of next month.

Gene Therapy 264

Gene Therapy Gene Clinical Trials Clinical Trials 264

Pharmaceutical Technology

JUNE 10, 2023

PB-357 is under clinical development by Puma Biotechnology and currently in Phase I for Breast Cancer. According to GlobalData, Phase I drugs for Breast Cancer have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. The drug candidate is administered through oral route.

Clinical Trials 100

Clinical Trials Clinical Trials Licensing Licensing 100

Pharmaceutical Technology

JUNE 10, 2023

PB-357 is under clinical development by Puma Biotechnology and currently in Phase I for Breast Cancer. According to GlobalData, Phase I drugs for Breast Cancer have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. The drug candidate is administered through oral route.

Clinical Trials 100

Clinical Trials Clinical Trials Licensing Licensing 100

Roots Analysis

FEBRUARY 27, 2024

On November 1, 2019, Avacta Group and ADC Therapeutics have announced a collaboration agreement for the development of novel drug candidates. The firm also has the right to obtain exclusive licenses to the Affimer proteins for clinical development and commercialization.

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Antibody Licensing Licensing Contract Manufacturing 52

Drug Discovery World

JANUARY 15, 2024

Amgen and NVIDIA Amgen has announced plans to advance drug discovery using NVIDIA’s DGX SuperPOD-powered insights from human datasets. Chiesi and Oak Hill Bio Chiesi Group and Oak Hill Bio have entered a collaboration to develop OHB-607, a clinical-stage investigational drug candidate to treat complications of extremely premature birth.

Drugs 59

Drugs Licensing Licensing Protein 59

pharmaphorum

MAY 4, 2022

Testing drug compounds on a chip designed to mimic human organs sounds closer to science fiction than reality, yet the technology already exists and is already being put to use. The limits of animal models in drug discovery are well known. Beyond testing.

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Pharmaceutical Technology

MARCH 1, 2023

MP-0310 is under clinical development by Molecular Partners and currently in Phase I for Cervical Cancer. According to GlobalData, Phase I drugs for Cervical Cancer have an 81% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. The drug candidate is administered through intravenous route.

Protein 100

Protein Clinical Trials Clinical Trials Development 100

Pharmaceutical Technology

MARCH 1, 2023

MP-0310 is under clinical development by Molecular Partners and currently in Phase I for Colorectal Cancer. According to GlobalData, Phase I drugs for Colorectal Cancer have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. The drug candidate is administered through intravenous route.

Protein 100

Protein Clinical Trials Clinical Trials Development 100

Pharmaceutical Technology

MARCH 23, 2023

Seagen specialises in developing antibody-drug conjugates (ADCs) which will complement Pfizer’s oncology portfolio. Seagen will maintain its operations in the Seattle area and will leverage Pfizer’s protein-engineering capabilities to develop next-generation biologics.

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Drug Discovery World

FEBRUARY 28, 2024

Lu Rahman selects some of the year’s interesting and noteworthy advances in cancer research drug discovery and development. As always, a year within cancer drug discovery and development brings with it significant breakthroughs, and 2023 has been no exception. Research into new cancer drugs remain strong.

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Development Research Drugs Antibody 64

Pharmaceutical Technology

FEBRUARY 24, 2023

ACD-440 is under clinical development by AlzeCure Pharma and currently in Phase I for Neuropathic Pain (Neuralgia). According to GlobalData, Phase I drugs for Neuropathic Pain (Neuralgia) have a 77% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. Buy the report here.

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Drug Discovery World

MARCH 7, 2024

Following closing, the company will have an expanded pipeline that contains multiple assets spanning early and late development stages. The merged pipeline features an antibody-drug conjugate (ADC) toolkit with novel payload and linker technologies.

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Antibody Drugs Clinical Trials Clinical Trials 59

Pharmaceutical Technology

MARCH 1, 2023

Orvacabtagene autoleucel is under clinical development by Bristol-Myers Squibb and currently in Phase II for Relapsed Multiple Myeloma. According to GlobalData, Phase II drugs for Relapsed Multiple Myeloma have a 38% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. Buy the report here.

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pharmaphorum

DECEMBER 28, 2022

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. InnoCare says it will also introduce the restrictions on studies ongoing outside the US.

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Drugs Licensing Licensing Trials 68

Drug Discovery World

FEBRUARY 27, 2023

Under a new agreement, Destiny Pharma and Sebela Pharmaceuticals will co-develop NTCD-M3, Destiny’s lead asset for the prevention of Clostridioides difficile infection (CDI) recurrence. The post Companies agree up to $570m deal for C difficile drug appeared first on Drug Discovery World (DDW).

Drugs 52

Drugs Clinical Trials Clinical Trials Licensing 52

Pharmaceutical Technology

AUGUST 4, 2022

P-BCMA-ALLO1 is currently being analysed in a Phase I clinical trial while an investigational new drug (IND) application for P-CD19CD20-ALLO1 is anticipated next year. Furthermore, Roche will oversee the late-stage clinical development and worldwide marketing of all products under the alliance.

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Drug Discovery World

NOVEMBER 6, 2023

Under the partnership, KWF intends to provide funding to enable the development of select early phase clinical programmes through Cancer Research UK’s Centre for Drug Development (CDD). The CDD will sponsor and manage KWF-supported trials.

Research 52

Research Clinical Trials Clinical Trials Clinical Development 52

pharmaphorum

JANUARY 13, 2022

Sanofi has joined a growing list of drugmakers going after alpha-synuclein targeting drugs for Parkinson’s disease, licensing a bispecific antibody from South Korea’s ABL Bio in a deal that could be worth more than $1 billion. Despite the interest, there have already been some failures in the alpha-synuclein category.

Antibody 83

Antibody Drugs Protein Licensing 83

The Pharma Data

JANUARY 3, 2021

Food and Drug Administration cleared Investigational New Drug Application. United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. About the INZ701-101 Phase 1/2 Clinical Trial of INZ-701 in Adults with ENPP1 Deficiency. BOSTON, Jan.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Containment 52

pharmaphorum

AUGUST 11, 2020

Bayer is to buy UK-based KaNDy Therapeutics in a deal worth more than $800 million, adding the biotech’s menopause drug to its women’s health pipeline. At the beginning of this year, KaNDy completed a phase 2b trial of its first-in-class drug NT-814, showing activity against symptoms of the menopause such as hot flashes and night sweats.

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Drugs Hormones Marketing Trials 85

The Pharma Data

JANUARY 13, 2021

14, 2021 /PRNewswire/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company today announced the addition of Robert Barrow , an accomplished pharmaceutical executive, as Chief Development Officer. We are excited to attract such top tier talent from the psychedelic drug development community.

Clinical Trials 52

Clinical Trials Clinical Trials Development Trials 52

pharmaphorum

DECEMBER 21, 2021

Novartis has joined the ranks of big pharma companies developing TIGIT-targeted drugs for cancer, and found its candidate in an existing partner, Chinese biotech BeiGene. Novartis licensed rights to tislelizumab for $650 million upfront and up to $1.55 billion, providing a partner for its PD-1 agent Opdivo (nivolumab).

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Drugs Antibody Pharma Companies Development 86

XTalks

JULY 17, 2023

In a significant development, Astellas Pharma announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) had accepted their applications for Priority Review and Marketing Authorization respectively for zolbetuximab. In both trials, approximately 38 percent of the screened patients had CLDN18.2-positive

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Clinical Trials Clinical Trials Trials Antibody 95

Drug Discovery World

AUGUST 14, 2023

Research partners in the UK are progressing their orally available small molecule cancer immunotherapy drug into clinical development as a treatment for advanced solid tumours. In cancer, PGE2 acts in the tumour microenvironment to trigger cancer cells to evade the immune system.

Trials 52

Trials Clinical Trials Clinical Trials Licensing 52

Drug Discovery World

DECEMBER 20, 2022

The clinical development of etranacogene dezaparvovec was led by uniQure and sponsorship of the clinical trials transitioned to CSL after it licensed global rights to commercialise the treatment. . World’s most expensive drug. million, making it the world’s most expensive drug. .

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52

The Pharma Data

MAY 7, 2021

Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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Licensing Licensing Vaccination Vaccine 52

XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases. Reference: Chung DC, et al.

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Gene Therapy Gene Trials Clinical Trials 95

pharmaphorum

DECEMBER 4, 2020

Exelixis has taken a $20 million option to license in an antibody-drug conjugate cancer (ADC) drug from Iconic, with clinical trials expected to start next year. The California biotech had reached an agreement with Iconic and Zymeworks giving the option on the drug in May last year.

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Drug Discovery World

MARCH 13, 2024

Johnson & Johnson has announced the first data from FRONTIER 2, the long-term extension of the Phase IIb FRONTIER 1 clinical trial evaluating JNJ-2113, the first and only investigational targeted oral peptide designed to block the IL-23 receptor.

Trials 52

Trials Dermatology Clinical Trials Clinical Trials 52

XTalks

SEPTEMBER 5, 2023

Xtalks spoke with Maria Reyes Boceta-Muñoz, Clinical Operations Head of Development R&D at GlaxoSmithKline in Spain, Portugal & Israel, to understand the current vaccine development climate and where the sector is headed.

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Vaccination Vaccine Development Clinical Trials 96

XTalks

NOVEMBER 4, 2022

The second primary endpoint was not met because although a clinically meaningful efficacy of 57.1 However, the results for the first primary endpoint were strong enough that it prompted the study DMC to recommend that the company move ahead and file with the US Food and Drug Administration (FDA).

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Vaccination Vaccine Clinical Trials Clinical Trials 97

The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec. Vlad Coric , M.D., About Sosei Heptares.

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Delveinsight

AUGUST 13, 2020

Researchers call out Gilead over the diversity of remdesivir trials. Researchers have challenged the sponsors of COVID-19 clinical trials to run more diverse studies. The data hint approved COVID-19 drugs will be used extensively in Black, Latinx, and Native Americans. F2G raises USD 60.8 F2G has raised USD 60.8

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Trials Research Drugs Protein 52

The Pharma Data

DECEMBER 16, 2020

The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. “Since becoming a public company, our clear focus has been on advancing the clinical development of Berubicin.

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FDA Approval Drugs Clinical Trials Clinical Trials 52

pharmaphorum

JULY 5, 2021

Parexel’s chief executive Jamie Macdonald said that in the past 18 months, the company “has continued its strong growth trajectory” in a market for outsourced clinical services that at conservative estimates is expected to grow at a rate of 8% to 9% in the coming years.

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