The Pharma Data

MAY 2, 2023

including Executive Vice President and Chief Financial Officer from 2018 through the company’s sale to ICON plc, and previously as Senior Vice President, Accounting and Corporate Controller from 2008 to 2018. a clinical trial data collection company, from November 2021 to present.

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Clinical Trials Clinical Research Science Clinical Development 40

Drug Target Review

OCTOBER 11, 2023

1,2 Many, however, do have dysfunctional proteins at their core, and for these diseases, a new option is being explored: autophagy-boosting therapies. Gene therapy, of course, also holds great promise. 2018 [cited 2023 Sep 5]. Most of these conditions are genetic in origin and the majority have no effective treatment.

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Drug Target Review

AUGUST 24, 2023

Neutralising GDF-15 with CatalYm’s anti-GDF-15 antibody visugromab was shown to reverse its inhibitory effects and to re-sensitise tumours to anti-PD-1 treatment, achieving commensurate survival benefit of anti-GDF-15-anti-PD-1 combination therapy in vivo. in North America) in late 2017.

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Treatment Therapies Clinical Development Cell Biology 98

Drug Target Review

APRIL 3, 2024

I am currently working as Chief Scientific Officer at CatalYm, where we translate the latest scientific findings into clinical applications. Our company has identified a new role for Growth Differentiation Factor 15 (GDF-15) as a potent local immunosuppressor mediating cancer resistance to therapy. in North America) in late 2017.

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Science Clinical Development DNA Treatment 105

The Pharma Data

DECEMBER 9, 2020

This acquisition will significantly strengthen Boehringer Ingelheim’s focus on targeted cancer cell therapies, gaining the company access to NBE’s innovative immune-stimulatory iADC platform. . It has shown remarkably high safety and tolerability measure during non-clinical development. . billion US. .

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The Pharma Data

JUNE 28, 2021

Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA small molecule for the treatment of prostate cancer. About Targeted Alpha Therapies (TAT) at Bayer Targeted Alpha Therapies (TAT) are an emerging class of radionuclide therapy for various difficult to treat tumors.

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Drug Discovery World

MARCH 29, 2023

Peter O’Donnell, Applied Clinical Trials’ Brussels Correspondent, summarises this as the EMA being tasked with creating a European network of patient representatives, academics, drug developers, investigators, and centres with expertise in the performance of studies in the paediatric population.

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Drug Discovery World

SEPTEMBER 16, 2022

Here, DDW Editor Reece Armstrong explores the global hubs of innovation for cell and gene therapies. Since the approval of Kymirah in 2017, the cell and gene therapy sector has emerged as an exciting and innovative market, representing some of the most promising drugs the pharmaceutical industry has ever seen. .

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The Pharma Data

JANUARY 6, 2021

Currently, oral treatment options for plaque psoriasis are limited, and many patients with moderate-to-severe psoriasis are receiving systemic injectable therapies. We confidently believe in the benefits of oral orismilast, and the IND approval marks a significant milestone in our clinical development.” 2018.011.

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FDA Approval FDA Clinical Development Clinical Research 52

Drug Discovery World

OCTOBER 18, 2022

The robust SOTIO clinical pipeline includes a differentiated superagonist of the attractive immuno-oncology target IL-15, SOT101, an IL-15-based immunocytokine SOT201, a next generation Claudin18.2-targeted Engimmune develops highly potent and specific immunotherapies based on two distinct TCR cancer targeting approaches.

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International Engineering Science Pharmaceuticals 130

The Pharma Data

JULY 22, 2021

This should significantly enhance and accelerate the development and potential commercialization of ARV-471 while also advancing Arvinas’ strategy of building a global, integrated biopharmaceutical company,” said John Houston, Ph.D., Chief Scientific Officer for Oncology Research and Development at Pfizer.

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Targeted Protein Degradation Therapies Clinical Trials Treatment 52

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. Because of high tumor recurrence after TURBT, intravesical chemo- or immuno-therapies are required after the procedure.

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The Pharma Data

SEPTEMBER 11, 2020

Now, a new form of nuclear medicine is on the scene and it looks nothing like the radiation therapy of the past. Targeted radioligand therapy harnesses the power of radioactive atoms and delivers it directly to cancer cells no matter where they are in the body. Targeted radioligand therapy expands on these capabilities.

Doctors 52

Doctors Therapies Treatment Clinical Trials 52

The Pharma Data

DECEMBER 13, 2020

About 15 to 20% of breast cancers cases are HER2+, and antibody-based therapies targeting HER2 have significantly improved outcomes of patients with HER2+ breast cancer. Zai Labs obtained regional development and commercialization rights for the programs in mainland China, Hong Kong, Macau and Taiwan.

FDA 52

FDA Biosimilars Clinical Trials Licensing 52

The Pharma Data

MARCH 1, 2022

“There is a major unmet need for new therapies that can help improve cognitive function in patients suffering from difficult-to-treat neurologic diseases,” said Tom Hudson, M.D., It has been a pleasure to partner with our investors to investigate the potential of SDI-118 in early clinical studies. Source link: [link].

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Small Molecule Licensing Licensing Disease 52

The Pharma Data

NOVEMBER 1, 2020

. Program-related investment estimated at up to US$65M (~AU$90M) for clinical costs associated with the development of the therapeutic products in the Territory, to align with Telix’s global clinical development programs. 6 Globocan 2018 [link] 7 Chang L, et al. . .

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The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group.

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Small Molecule Engineering Pharmaceuticals Clinical Development 52

The Pharma Data

JANUARY 20, 2021

Nasdaq:CTMX), a clinical-stage, oncology-focused biopharmaceutical company with a vision of transforming lives with safer, more effective therapies, today announced the pricing of an underwritten public offering of 14,285,714 shares of its common stock at a price to the public of $7.00 SOUTH SAN FRANCISCO, Calif.,

Clinical Development 40

Clinical Development Therapies Science Drugs 40

The Pharma Data

NOVEMBER 8, 2020

The submission includes data from the ENLIGHTEN clinical development program in schizophrenia, and pharmacokinetic (PK) bridging data comparing ALKS 3831 and Zyprexa (olanzapine), to support an indication for schizophrenia. Celgene acquired it in 2018 from bluebird bio, who originally developed the therapy.

FDA 52

FDA Trials Pharmacokinetics Pharmaceuticals 52

The Pharma Data

JANUARY 18, 2021

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers. ZTlido ® was approved by the FDA on February 28, 2018. for the treatment of post-herpetic neuralgia. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica.

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Small Molecule Clinical Trials Trials Therapies 40

The Pharma Data

JUNE 29, 2021

The Phase III SAkuraSky study evaluated the efficacy and safety of ENSPRYNG in combination with baseline immunosuppressive therapy in adults and adolescents with NMOSD. The Phase III clinical development programme for ENSPRYNG included two studies: SAkuraStar and SAkuraSky. Europe and Japan.

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Treatment Therapies Disease Clinical Development 52

The Pharma Data

DECEMBER 3, 2020

Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

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Vaccine Immune Response Virus RNA 52

The Pharma Data

SEPTEMBER 9, 2021

The trial included 1,001 patients with mild to moderate asthma previously treated either with a SABA as needed alone or in addition to low-dose maintenance ICS therapy. 12 Repeated courses of OCS therapy are associated with an increased risk of systemic side effects including pneumonia, osteoporosis and type 2 diabetes.

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Trials Treatment Disease Therapies 52

The Pharma Data

JANUARY 13, 2021

This press release contains “forward-looking statements,” including statements relating to planned regulatory filings and clinical development programs. 2018 Aug 2;132(5):501-509. The study was conducted at 28 U.S. study centers. Measuring Eosinophils to Make Treatment Decisions in Asthma. 2016 Sep;150(3):485-7.

Small Molecule 52

Small Molecule Trials Clinical Trials Treatment 52

The Pharma Data

SEPTEMBER 9, 2020

The patients treated with ENSPRYNG were also less likely to require rescue therapy for a relapse compared with placebo (OR 0.46; 95% CI, 0.25–0.86, In addition, it was granted Breakthrough Therapy Designation for the treatment of NMOSD by the FDA in December 2018. 0.86, p=0.015). 2 points on the Expanded Disability Status Scale.

Treatment 52

Treatment Disease Therapies FDA 52

The Pharma Data

JANUARY 31, 2021

These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.” Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. For more information, please visit our website: www.cloverbiopharma.com. About Dynavax.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

JANUARY 21, 2021

Escolar was the principal medical consultant for Genzyme’s pivotal trial for Myozyme, an enzyme replacement therapy approved to treat adult-onset Pompe disease. since May 2018. Before Acceleron, Attie held clinical development and medical affairs leadership roles of increasing responsibility at Altus Pharmaceuticals, Insmed, Inc.

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Laboratories Pharmaceuticals Engineering Clinical Development 52

The Pharma Data

OCTOBER 26, 2020

On 14 May 2018, the Company announced a collaboration with GlobalCo to work on its CDX antibody. This additional extension of the collaboration will allow us to choose the best CDX antibody for pre-clinical and clinical development.” ” Market Abuse Regulation (MAR) Disclosure.

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Pharmaceuticals Engineering Regulations Pharmaceutical Companies 40

The Pharma Data

JANUARY 14, 2021

NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. .–( BUSINESS WIRE )– Five Prime Therapeutics, Inc.

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Trials Treatment Therapies Clinical Trials 52

The Pharma Data

MARCH 16, 2021

Mirikizumab also reduced symptoms among patients who had previously not responded to or stopped responding to biologic and/or Janus kinase (JAK) inhibitor therapies. About the LUCENT Clinical Trial Program. The LUCENT Phase 3 clinical development program for mirikizumab includes LUCENT-1, LUCENT-2 and LUCENT-3.

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Treatment Disease Clinical Trials Trials 40

The Pharma Data

AUGUST 16, 2020

First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology. Approval supported by one of the largest clinical trial programmes undertaken for this rare disease. “We In the SAkuraStar monotherapy study’s AQP4 antibody positive subgroup, 76.5%

FDA Approval 52

FDA Approval FDA Clinical Trials Treatment 52

The Pharma Data

DECEMBER 27, 2020

NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021. CARLSBAD, Calif.–( –( BUSINESS WIRE )– Lineage Cell Therapeutics, Inc.

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Therapies Clinical Trials Production Treatment 52

The Pharma Data

AUGUST 19, 2021

3] While MET inhibitors have recently received accelerated approval in this setting in some regions, the vast majority of patients eventually acquire resistance to these therapies, thus underscoring the need for new treatment options. [4] Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “We

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

JANUARY 13, 2021

v Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. Accessed December 2020. v Zhang, T., Tang, Z., … Li, K.

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Production Trials Clinical Trials Treatment 52

Drug Discovery World

JANUARY 17, 2024

With oncology accounting for a third of pharma’s product pipeline, significant challenges include fierce competition, high research and development costs over, 10-15 years for clinical development, and pressures to rapidly meet the demand for new treatments 2-4. 21 In a recent publication, Silvestri et al.,

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

I was fortunate to understand how the clinical development sausage is made and was frustrated by the fact that we could do a better job to incorporate the patient perspective into the studies we design and the therapies we commercialize. So, I decided to pivot.

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Disease Clinical Trials Trials Treatment 52

The Pharma Data

JANUARY 13, 2021

Dr. Lederman continued, “Despite the recognized promise of anti-CD40-ligand mAb therapy, first generation anti-CD40-ligand mAbs were limited because their crystallizable fragment (Fc) domain interacted with a cell surface receptor called Fc?RII, RII, which resulted in an increased risk of thrombosis. 1 Lederman, S. International Immunol. (11):1583

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