LifeSciVC

JULY 17, 2024

It’s important to recognize that for many large pharmaceutical and biotechnology companies, compounds that have the potential to treat a rare disease of significant unmet need might become lower strategic priority than those that have mass market potential.

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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. Source link.

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The Pharma Data

JANUARY 10, 2021

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development.

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The Pharma Data

NOVEMBER 23, 2020

At Ultimovacs, he will lead all business and corporate development efforts and continue to maintain and foster connections with leading biotechnology and pharmaceutical companies. “In Mr. Berkien is currently a board member of the Nordic Pharma Licensing Group.

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The Pharma Data

APRIL 27, 2022

We plan to discuss these data with health authorities, and we will continue to expand our tislelizumab clinical development program in pursuit of novel, synergistic combinations with the ultimate goal of extending survival for more patients.”. About Novartis Novartis is reimagining medicine to improve and extend people’s lives.

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The Pharma Data

JUNE 28, 2021

The companies acquired by Bayer, Noria and PSMA Therapeutics, have exclusive world-wide rights to technology licensed from Weill Cornell Medicine (New York, NY, USA) and Johns Hopkins University (Baltimore, MD, USA). Xofigo is currently under further evaluation in a broad clinical development program in prostate cancer and beyond.

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The Pharma Data

NOVEMBER 23, 2020

Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to regain compliance with the continued listing standards by the end of the extension period, the ability to engage in a potential acquisition, merger, reverse merger, other business combination, sales of assets, (..)

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The Pharma Data

DECEMBER 2, 2020

ERS Genomics – Ireland’s ERS Genomics Limited, and Germany’s Vivlion GmbH, announced a non-exclusive license agreement granting Vivlion access to ERS Genomics’ CRISPR/Cas9 patent portfolio, to enhance Vivlion’s gene editing reagents and screening services. for its cGMP-compliant CHOSOURCE platform. in Mainland China.

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The Pharma Data

JANUARY 27, 2021

ET ) to discuss the results and next steps in clinical development of BI-1206. technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering.

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The Pharma Data

OCTOBER 26, 2020

AR-301 is a fully human IgG1 mAb currently in Phase 3 clinical development targeting gram-positive Staphylococcus aureus ( S. AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa ( P. AR-301 (VAP). aureus) alpha-toxin in VAP patients. AR-101 (HAP).

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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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PPD

MAY 7, 2024

Further, uncertainties arise regarding the applicability of centralized advice at the national level and the potential for longer timeframes to access certain markets. Additionally, there is a lack of consensus on appropriate methodologies, with existing guidelines often deemed insufficiently flexible for novel or pragmatic approaches.

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The Pharma Data

DECEMBER 23, 2020

The Company has Now Resumed the Clinical Development of its Proposed Anti-Nausea Pharmaceutical Grade Version of Tauri-Gum. With this funding now complete, the Company is excited about its prospects for 2021 – as it pertains to its pharmaceutical development efforts. . NEW YORK, NY, Dec.

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The Pharma Data

NOVEMBER 22, 2020

The company has an exclusive collaboration and license deal with CStone Pharmaceuticals for development and commercialization of pralsetinib and specific other drug candidates in Mainland China, Hong Kong, Macau and Taiwan. It holds the rights for the drug in the rest of the world. It is deficient in PAH patients.

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The Pharma Data

JANUARY 3, 2021

“We are delighted to support our partnership with EyePoint through this investment, as we prepare for the development and commercialization of YUTIQ and DEXYCU, under Ocumension branded labels, across Asian markets,” said Ye Liu, Chief Executive Officer of Ocumension. “We

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The Pharma Data

NOVEMBER 11, 2020

These data provide further evidence of efficacy and high potency of SLV213 against SARS-CoV-2 and support the clinical development of SLV213 as a potential oral treatment for COVID-19,” said Ted Daley, President and CEO, Selva Therapeutics. “As About Selva Therapeutics.

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The Pharma Data

JANUARY 19, 2021

(NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company’s business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

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The Pharma Data

OCTOBER 14, 2020

ELX-02 is in the early stages of clinical development focusing on cystic fibrosis. Eloxx’s lead investigational product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins. ELX-02 is an investigational drug that has not been approved by any global regulatory body.

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The Pharma Data

JANUARY 4, 2021

The program was licensed to Allergan in April 2016 , and Allergan was acquired by AbbVie in May 2020. Sosei Heptares will now conduct a full internal review to determine a strategy for the further development and re-partnering of the program. . ” About the License Agreement. TOKYO and CAMBRIDGE, England , Jan.

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The Pharma Data

DECEMBER 14, 2020

The Company anticipates using net proceeds from the offering to fund the continued development of ublituximab and umbralisib, the potential in-license, acquisition, development and commercialization of other pharmaceutical products, and for general corporate purposes. Attention: Capital Markets, 499 Park Ave.,

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The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. You should not place undue reliance on any forward-looking statements.

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The Pharma Data

JANUARY 27, 2021

The Company is in late-stage clinical development and has been working toward establishing commercial readiness. The meeting will consist of presentations from the Company’s management team, with additional commentary from board members and collaborators, and will include a question and answer session for analysts and attendees.

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The Pharma Data

JANUARY 13, 2021

Our 5,000+ employees in China, the United States, Australia, Europe, and elsewhere are committed to expediting the development of a diverse pipeline of novel therapeutics. We also market or plan to market in China additional oncology products licensed from Amgen Inc.,

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The Pharma Data

NOVEMBER 3, 2020

According to the FDA, the purpose of Fast Track designation is to get important new drugs to patients earlier by facilitating the development, and expediting the review, of drugs to treat serious conditions and fill an unmet medical need. It may also allow for priority or rolling review of a company’s Biologics License Application (BLA).

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The Pharma Data

DECEMBER 8, 2020

The fully integrated pharmaceutical company creates value through China’s specialty pharmaceutical markets with focus on iron deficiency, pain management and respiratory. RayzeBio is also funneling cash into expanding its HQ in San Diego with plans to further develop internal R&D. . SciNeuro Pharmaceuticals .

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The Pharma Data

NOVEMBER 8, 2020

The active ingredient is violaxazine hydrochloride, which has an extensive safety record in Europe, where it was previously marketed as an antidepressant. SPN-812 is a serotonin norepinephrine modulating agent (SNMA). Bristol Myers Squibb’s Lisocabtagene Maraleucel (CAR-T) for R/R Large B-Cell Lymphoma.

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Drug Target Review

JUNE 3, 2024

How does COUR Pharmaceuticals plan to mitigate potential risks associated with reprogramming the immune system using its nanoparticle platform, and what are the anticipated challenges in bringing these therapies to market? This allows us to compress preclinical development and go directly into proof-of-concept Phase 2 studies.

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The Pharma Data

JANUARY 10, 2021

“We expect 2021 will mark a number of key clinical and commercial milestones. By the end of the year, we expect to have five independent TransCon product candidates in clinical development leveraging TransCon technologies through our algorithm for product innovation. Pipeline Updates. •. ?.

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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 (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S.

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The Pharma Data

JANUARY 13, 2021

.” MindMed Chief Development Officer Rob Barrow said, “Psychedelic therapies offer a once in a lifetime opportunity to revolutionize the delivery of mental healthcare.

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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.

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Drug Target Review

SEPTEMBER 19, 2024

IRL1117 is expected to be ready to move into clinical development at the end of 2024/first half 2025. Furthermore, the goal is to develop IRL1117 as a “once daily” medication in contrast to levodopa which often must be taken many times per day with fluctuations in efficacy as a result.

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The Pharma Data

MARCH 5, 2021

Amgen plans to leverage its presence in Japan and other Asia-Pacific markets to maximize bemarituzumab’s potential. This vision is what defines us and guides our research, clinical development and partnerships. About Amgen Oncology.

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Molecule Blog

MARCH 17, 2023

Moving research from concept to market is like conducting a symphony — there are numerous players and stakeholders, each bringing their unique expertise to work in harmony and advance a project. If approved, the company can then market and distribute the therapeutic.

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The Premier Consulting Blog

OCTOBER 21, 2024

However, the challenges surrounding confirmatory trials often revolve around delays and the complexities of conducting them once a drug has already hit the market. This decision, communicated in November 2022, delayed the BLA submission as the confirmatory trial needs to reach full enrollment before submission of the marketing application.

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The Pharma Data

DECEMBER 29, 2020

“We anticipate that the BRIDGE study results will be used to support the filing of a Marketing Authorization Application (MAA) with the European Medicines Agency, and having completed the analysis, we have taken an important step in the preparations for the application.” Protalix has licensed to Pfizer Inc.

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The Pharma Data

SEPTEMBER 16, 2020

Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C ?inhibitor Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected.

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