The Pharma Data

JANUARY 27, 2021

. A total of 15 patients have been recruited to date in the Phase I dose escalation part of the study, all of whom were late stage and have failed conventional treatments, including several lines of rituximab-containing therapies. View original content to download multimedia: [link].

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The Pharma Data

NOVEMBER 24, 2020

Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. This information was brought to you by Cision [link].

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The Pharma Data

JANUARY 13, 2021

At Usona, Mr. Barrow was responsible for launching the Phase 2 clinical program for psilocybin in the treatment of Major Depressive Disorder and for obtaining Breakthrough Therapy Designation for the program at FDA. View original content to download multimedia: [link]. MindMed Co-CEO J.R.

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The Pharma Data

JANUARY 19, 2021

BioInvent International AB (OMXS: BINV) is a clinical stage company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapies, with three ongoing programs in Phase l/ll clinical trials for the treatment of hematological cancer and solid tumors, respectively. About BioInvent. SOURCE BioInvent.

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The Pharma Data

NOVEMBER 25, 2020

is an innovative, science-driven pharmaceutical company focused on novel therapies for a variety of indications. View original content to download multimedia: [link]. . Vivera Pharmaceuticals, Inc., . SOURCE Vivera Pharmaceuticals, Inc. Source link.

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The Pharma Data

JANUARY 13, 2021

A preprint supporting Brilacidin’s COVID-19 treatment potential can be downloaded at the link below. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. Global COVID-19 Cases and Mortality An online tool tracking COVID-19 cases and mortality, both in the U.S.

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The Pharma Data

NOVEMBER 26, 2020

BioInvent International AB (OMXS: BINV) is a clinical stage company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapies, with two ongoing programs in Phase l/ll clinical trials for the treatment of hematological cancer and solid tumors, respectively. About BioInvent. SOURCE BioInvent.

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The Pharma Data

OCTOBER 26, 2020

Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, today announced the Company will present at the ROTH Capital Partners 2020 MedTech Innovation Forum on Wednesday, October 28, 2020. View original content to download multimedia: [link].

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The Pharma Data

NOVEMBER 26, 2020

Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company’s Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. Protalix has licensed to Pfizer Inc.

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The Pharma Data

JANUARY 10, 2021

Depending on the development of the escalating COVID-19 pandemic in the United States and on the resulting impact on enrollment, the Company expects to complete enrollment of this study in 2022 enabling a potential Biologics License Application (BLA) submission by 2023 under the accelerated approval pathway. SOURCE Hansa Biopharma AB.

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The Pharma Data

JANUARY 31, 2021

Importantly, the negative pressure component of each acoustic pulse is attenuated so therapy can be provided without creating cavitation or heating that could result in surrounding tissue damage. View original content to download multimedia: [link]. About Soliton, Inc. Soliton, Inc.

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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. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. .

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The Pharma Data

DECEMBER 30, 2020

31, 2020 /PRNewswire/ — ImmVira Group Company (“the Company”), a biotechnology platform dedicated to the development of oncolytic virus(“OV”) and vector type approaches to create more effective and safer therapies against cancer, announced today the signing of Series C financing. .

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The Pharma Data

NOVEMBER 10, 2020

AlzeCure ® is a Swedish pharmaceutical company that develops new innovative drug therapies for the treatment of severe diseases and conditions that affect the central nervous system, such as Alzheimer’s disease and pain – indications for which currently available treatment is extremely limited. [link].

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The Pharma Data

JANUARY 18, 2021

In-licensed from Merck KGaA, Darmstadt, Germany , atacicept has been studied previously in autoimmune diseases and shown to reduce autoantibodies in a dose-dependent fashion with once-weekly subcutaneous dosing and has a well-established and acceptable clinical safety profile. .” View original content to download multimedia: [link].

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The Pharma Data

SEPTEMBER 16, 2020

Additionally, data from Amgen ‘s bispecific T cell engager (BiTE ® ) platform will feature preliminary safety and efficacy findings from the ongoing Phase 1 study of AMG 160, an investigational half-life extended BiTE immuno-oncology therapy targeting prostate-specific membrane antigen (PSMA). 20 and AMG 160, Monday Sept. Reese , M.D.,

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The Pharma Data

NOVEMBER 2, 2020

If approved, 1st Therapy in U.S. Europe, Latin America, the Middle East, and most of Asia Pacific, there are currently no licensed medicines for achondroplasia. BioMarin is a global biotechnology company that develops and commercializes innovative therapies for serious and life-threatening rare and ultra-rare genetic diseases.

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The Pharma Data

SEPTEMBER 20, 2020

and 91.2%, respectively, in 34 heavily pretreated patients (median of two prior lines of therapy) with NSCLC, who were treated with the 960 mg daily dose (data cutoff of June 1 , 2020). Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. Reese , M.D.,

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The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in Sept. Amgen Inflammation Amgen brings therapies to millions of people with inflammatory diseases, with a focus on serving unmet patient needs. In doing so, we have introduced and evolved novel therapies that have changed the lives of patients.

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The Pharma Data

DECEMBER 21, 2020

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. Amgen Inflammation Amgen brings therapies to millions of people with inflammatory diseases, with a focus on serving unmet patient needs.

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The Pharma Data

NOVEMBER 4, 2020

Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., License and research and development revenue. .

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Codon

FEBRUARY 13, 2024

Tom Ireland writes about the companies and technologies that are reimagining phage therapy. Soon after its publication, scientists, journalists, and investors were revisiting ‘phage therapy’ as a promising alternative to our failing antibiotics. Read it on our website here. Illustration by David S. Fast forward to 2023.

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DECEMBER 22, 2020

Primary endpoints of this study include safety, tolerability, and tumor response of the ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy. Outside of Japan , Illuminox therapies have not yet been approved as safe or effective by any regulatory authority. SAN MATEO, Calif. , ” About Rakuten Medical, Inc.

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The Pharma Data

NOVEMBER 29, 2020

1 Meanwhile, these MDM2 inhibitors present some challenges, including dose-limiting hematological toxicities, thus the urgent need to develop new generation of MDM2-targeting therapies in the treatment of cancer. View original content to download multimedia: [link]. SUZHOU, China and ROCKVILLE, Md. , ” References: Zhao, Y.;

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The Pharma Data

JANUARY 21, 2021

Prior to initiating treatment with CABENUVA, oral cabotegravir (VOCABRIA) and oral rilpivirine (EDURANT ® ) should be administered for approximately one month to assess the tolerability of each therapy. Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. 50 c/mL, meeting noninferiority criteria.

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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. View original content to download multimedia: [link].

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The Pharma Data

OCTOBER 27, 2020

We are pleased to see more vision-saving therapies moving toward clinical trials and potentially out to the people who urgently need them,” says Brian Mansfield , PhD, executive vice president research, interim chief scientific officer of the Foundation Fighting Blindness. RIDGEWOOD, N.J. ,

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PerkinElmer

JUNE 7, 2021

Targeted cancer therapy has been a game changer in cancer treatment, significantly improving the survival and quality of life of many patients. Unlike chemotherapy, which acts on both cancer and normal cells, targeted therapy affects only the specific oncogenes, tumor suppressor genes, or pathways involved in tumor progression.

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The Pharma Data

MAY 15, 2021

“WARNING: Common Drugs And Therapies Used To Treat CFS & Its Symptoms Can Have Serious Side Effects” Conventional drugs can have a myriad of side effects and are not effective at treating CFS from its roots. Once you’ve downloaded your book, read the entire guide and start immediately! Alisha Smith.

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The Pharma Data

JANUARY 27, 2021

Finalized the technical development of modia , a digital therapy for opioid use disorder, for which Orexo owns the exclusive global rights. Entered an exclusive license and supply agreement with Accord Healthcare for ZUBSOLV® covering 29 European countries. Important events after the period.

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Drug Channels

OCTOBER 19, 2020

You can download the complete agenda here. Medical Plus – Tailored Track Options Based on Company Size : Emerging/Small Companies – Infrastructure Set-Up, License Procurement and 3PL Contracting Mid-Large Companies – How Do I Think About My Portfolio Differently Based on Product Type?

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The Pharma Data

JANUARY 7, 2021

RMI), a global biotechnology company developing precision-targeted cancer therapies based on its proprietary, anti-cancer treatment platform, Illuminox , will present at the 39th Annual J.P. Outside of Japan, Illuminox therapies have not yet been approved as safe or effective by any regulatory authority. SAN MATEO, Calif. ,

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The Pharma Data

JANUARY 25, 2021

26, 2021 /PRNewswire/ — Dynacure , a clinical-stage company focused on developing and commercializing novel therapies to transform the lives of patients with rare diseases who have limited or no treatment options, announced today that the U.S. View original content to download multimedia: [link]. Patent No. ” The U.S.

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The Pharma Data

OCTOBER 28, 2020

Wenger, a licensed counselor and senior training and consultation specialist at the Mental Health Technology Transfer Center at Rutgers University in Piscataway, N.J. Teens can also download apps for meditation or mindfulness, Gurwitch said. . “Teenage years are when kids don’t want their parents around. More information.

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The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. PLYMOUTH MEETING, Pa. and CHICAGO , Oct.

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The Pharma Data

DECEMBER 20, 2020

BioInvent International AB (OMXS: BINV) is a clinical stage company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapies, with four programs in clinical development. The following files are available for download: View original content: [link]. SOURCE BioInvent. Source link.

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Agency IQ

MAY 10, 2024

The agencies have also worked together on topics such standardization in digital imaging and medical displays and cell and gene therapy manufacturing. GAI systems may infringe on copyrighted or trademarked content, trade secrets, or other licensed content,” which are “often” part of the training data sets.

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