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. GPCR – G protein-coupled receptors.

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The Pharma Data

MAY 15, 2023

FDA accepts application for Roche’s Vabysmo for the treatment of retinal vein occlusion (RVO) Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Roche’s Chief Medical Officer and Head of Global Product Development. “If 1,2 Vabysmo’s safety profile was consistent with previous trials. mg) or aflibercept (2.0

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The Pharma Data

NOVEMBER 11, 2020

Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for SLV213 for the treatment of COVID-19 and has dosed the first subjects in a Phase 1 clinical study. SLV213 was developed based on research from UC San Diego and the university exclusively licensed it to Selva Therapeutics.

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The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].

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The Pharma Data

JANUARY 27, 2021

HK), announced today that China Center for Drug Evaluation (CDE) has granted Breakthrough Therapy designation to Batoclimab (HBM 9161), a fully human anti-FcRn monoclonal antibody (mAb), for the treatment of adult patients with Myasthenia Gravis (MG). Harbour BioMed also licenses the platforms to companies and academic institutions.

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The Pharma Data

AUGUST 15, 2021

Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. Vivet Therapeutics is a clinical-stage emerging biotechnology company developing novel gene therapy treatments for rare, inherited metabolic diseases. Vivet’s lead program, VTX-801, is currently under clinical development.

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The Pharma Data

JANUARY 27, 2021

– Second Product Candidate Expected to Enter Clinic in First Half of 2021. Preclinical Data Underscore Treatment Potential for PBFT02 in Frontotemporal Dementia with Granulin (GRN) Mutations, a Devastating, Progressive Disorder Impacting Adults with No Approved Disease-Modifying Therapy Options. PHILADELPHIA, Jan.

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The Pharma Data

MARCH 26, 2021

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation. About VIR-7831 / GSK4182136.

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The Pharma Data

NOVEMBER 3, 2020

Food and Drug Administration (FDA) has granted Fast Track designation to its clinical candidate, LB-001 for the treatment methylmalonic acidemia (MMA). Fast Track designation allows for early and frequent communication with the FDA throughout the entire drug development and review process. About LogicBio Therapeutics.

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The Pharma Data

JUNE 26, 2021

Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). Roche’s Chief Medical Officer and Head of Global Product Development. “If

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LifeSciVC

JULY 17, 2024

Reaching the end goal of delivering transformational new treatment options for patients can take a decade or more even when companies execute successfully and are well capitalized. Fortunately, AbbVie felt the same way, which is why we initiated discussions to in-license AbbVie’s most promising CF pipeline programs.

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The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Innovation Pharma (Formerly known as Cellceutix) (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to announce that the U.S. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. WAKEFIELD, Mass.,

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The Pharma Data

JANUARY 12, 2021

Boehringer Ingelheim has announced it has signed a collaboration and licensing deal with Enara Bio to advance novel targeted cancer immunotherapies. According to Enara, Dark Antigens can potentially be developed as targets for immunotherapy agents. Michael Vi/Shutterstock.

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The Pharma Data

OCTOBER 26, 2020

Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s experimental gene therapy program, PR001, for the treatment of neuronopathic Gaucher disease (nGD). In addition, the FDA has granted Fast Track designation for PR001 for the treatment of Parkinson’s disease with GBA1 mutations.

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Drug Target Review

FEBRUARY 1, 2024

What challenges has the industry faced in developing and commercialising treatments for neurological diseases, including rare diseases? But commitment to neuroscience drug development is critically important given the significant unmet medical needs and the ways in which patients, caregivers, and families suffer.

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Drug Target Review

SEPTEMBER 19, 2024

It has a well-defined and strategically focused R&D pipeline of innovative treatments targeting various stages of Parkinson’s as they worsen over time. The pipeline currently includes five drug candidates, all of which have the potential to revolutionise the treatment of PD.

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The Pharma Data

APRIL 14, 2021

Xolair for self-injection offers healthcare providers and appr opriate patients another administration option for more flexibility in managing their treatment. Roche’s Chief Medical Officer and Head of Global Product Development. today announced that the U.S. indications. indications. with Xolair since its initial approval in 2003.

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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. ” About Photocure ASA.

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The Pharma Data

JANUARY 3, 2021

Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. BOSTON, Jan. 04, 2021 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. About Inozyme Pharma.

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The Pharma Data

JUNE 7, 2023

Acuitas’ proprietary LNP technology is used in multiple vaccines and therapeutics in clinical development and was also used in some of the COVID-19 vaccines that were approved and administered to people in 180 countries. LNPs are spheric drug delivery bodies which can be equipped with therapeutic payloads for intracellular delivery.

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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. The pre-IND program focuses on the treatment of prostate cancer, the second most commonly diagnosed cancer in men. Noria) and PSMA Therapeutics Inc.

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The Pharma Data

DECEMBER 29, 2020

(NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases , a business unit of Chiesi Farmaceutici S.p.A.,

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The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. SHANGHAI , Jan. ” About SPR206.

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The Pharma Data

NOVEMBER 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. LUND, Sweden , Nov. About Cantargia.

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The Pharma Data

OCTOBER 27, 2020

(NASDAQ: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system disorders, today announced that the U.S. Passage Bio expects to initiate a Phase 1/2 trial for PBKR03 in the first half of 2021. president and chief executive officer of Passage Bio. “We About PBKR03.

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The Pharma Data

OCTOBER 18, 2020

DUBLIN–( BUSINESS WIRE )– Inflection Biosciences Ltd , a company developing innovative therapeutics for the treatment of cancer, today announced the appointment of industry veteran Gregory I. Dr. Berk most recently has served as a consultant to several companies developing oncology therapies. 19, 2020 08:02 UTC.

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The Premier Consulting Blog

OCTOBER 21, 2024

The 2022 FDORA Omnibus Act, enacted on December 29, 2022, further solidified this shift by making confirmatory trials a key component of the clinical development plan, contrasting with earlier practices where they were often a post-approval requirement.

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The Pharma Data

MARCH 16, 2021

Aligning with a circuitry-based approach to precision psychiatry, the collaboration will leverage Boehringer Ingelheim’s deep experience in central nervous system (CNS) drug discovery and development alongside Lieber’s expertise in centrally acting COMT inhibitors. Hugh Marston, Ph.D., Weinberger, M.D., LIBD CEO & Director. “We

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The Pharma Data

DECEMBER 14, 2020

Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. The product is designed for the prevention and treatment of COVID-19, along with related coronaviruses. Kate Krav-Rude/Shutterstock.

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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. Zai Lab is leading clinical development in its territory. “We Read on for this week’s.

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Metabolite Tales Blog

NOVEMBER 17, 2022

Roquinimex (Linomide), a drug developed by Pfizer for the treatment of multiple sclerosis, is structurally related to laquinimod. Figure 3: Roquinimex (linomide) Clinical development of both laquinimod and roquinimex was halted due to serious cardiovascular events. In a 2021 publication, Rothhammer et al.

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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. The new “pathoblocker” treatment aims to disarm pathogens and suppress the disease-causing properties of P.

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The Pharma Data

NOVEMBER 22, 2020

The FDA granted Breakthrough Therapy Designation to the drug for RET fusion-positive NSCLC that has progressed after platinum-based chemotherapy, and RET mutation-positive MTC that requires systemic treatment and for which there are no alternative treatments. It holds the rights for the drug in the rest of the world.

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The Pharma Data

JANUARY 27, 2021

. “The responses observed in six out of nine patients are very encouraging and clearly suggest that BI-1206 may restore the response to rituximab in patients who have few treatment alternatives. ET ) to discuss the results and next steps in clinical development of BI-1206. CEO of BioInvent.

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The Pharma Data

OCTOBER 26, 2020

AR-711 exhibits high affinity for SARS-CoV-2 spike protein, approximately 10-fold or higher than mAb candidates currently in late stage clinical testing. AR-711 was previously shown to be effective in prophylactic as well as therapeutic treatment modes in a SARS-CoV-2 viral challenge study. About Aridis Pharmaceuticals, Inc.

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The Pharma Data

DECEMBER 8, 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.

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The Pharma Data

JUNE 7, 2022

Eli Lilly and Company (NYSE: LLY) today announced topline results from one-year analyses of the efficacy and safety of lebrikizumab, the company’s investigational IL-13 inhibitor for the treatment of patients with moderate-to-severe atopic dermatitis (AD). Almirall S.A.’s ’s Chief Scientific Officer.

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