The Pharma Data

DECEMBER 20, 2020

Allecra, subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, is to receive an upfront cash payment and is eligible to receive additional development and commercial milestone payments with an overall deal value of $78 million, in addition to royalties.

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New Drug Approvals

APRIL 2, 2025

1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] The application received Breakthrough Therapy , Fast Track and Priority Review designations by the FDA. The FDA granted approval of Journavx to Vertex Pharmaceuticals Incorporated. under nitrogen.

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc. Source link: [link].

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Drug Target Review

MARCH 17, 2025

However, a deeper understanding of brain function particularly the role of synaptic plasticity is now opening the door to innovative therapies. Advancing drug candidates across key therapeutic areas Dr John Donello brings over 25 years of experience in pharmaceutical drug discovery, development and collaborations.

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The Pharma Data

JANUARY 21, 2021

–( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial. 22, 2021 12:00 UTC.

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Drug Target Review

DECEMBER 11, 2024

This approach not only boosts our clients’ ability to achieve high accuracy and meet regulatory requirements but also supports the seamless transition of innovative therapies from the lab to the clinic with confidence.

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The Pharma Data

NOVEMBER 1, 2020

Corlieve’s lead program employs a novel AAV gene therapy approach for the treatment of refractory temporal lobe epilepsy (TLE), the most commonly diagnosed focal epilepsy in humans. Maryland , US), a leading gene therapy company. Maryland , US), a leading gene therapy company. PARIS , Nov.

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

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The Pharma Data

AUGUST 17, 2020

DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. DF6002, Dragonfly’s extended half-life IL12 cytokine, is an investigational immunotherapy being evaluated in adult patients for the treatment of advanced solid tumors. About Dragonfly.

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New Drug Approvals

APRIL 25, 2025

3] Primary endocrine resistance was defined as relapse while on the first two years of adjuvant endocrine therapy (ET) and secondary endocrine resistance was defined as relapse while on adjuvant ET after at least two years or relapse within twelve months of completing adjuvant ET. [3] New Drug Therapy Approvals 2024 (PDF). PMC 8706051.

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The Pharma Data

JUNE 14, 2023

Global Head of Research and Early Development for Oncology, Pharmaceuticals Division, Bayer AG. With our oncology strategy, we are dedicated to accelerating the research and development of novel cancer therapies that have the potential to make a meaningful difference in the lives of patients.”

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The Pharma Data

DECEMBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China.

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The Pharma Data

JANUARY 27, 2021

28, 2021 /PRNewswire/ — CASI Pharmaceuticals (Formerly Known As EntreMed, Inc.). 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.

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The Pharma Data

JANUARY 3, 2021

03, 2021 (GLOBE NEWSWIRE) — EyePoint Pharmaceuticals, Inc. NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, today announced that Ocumension Therapeutics, a China-based ophthalmic pharmaceutical company traded on the Stock Exchange of Hong Kong (1477.HK),

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The Pharma Data

MARCH 30, 2021

Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that has shown superior efficacy with a similar safety profile compared with teriflunomide, a first-line treatment in MS 2. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. About Kesimpta ® (ofatumumab).

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The Pharma Data

OCTOBER 26, 2020

27, 2020 /PRNewswire/ — Aridis Pharmaceuticals, Inc. Dr. Hasan Jafri , Chief Medical Officer of Aridis Pharmaceuticals, will be a speaker on a panel entitled “Direct Antivirals and Other Agents Against SARS-CoV2 Virus.” About Aridis Pharmaceuticals, Inc. Aridis Pharmaceuticals, Inc. SAN JOSE, Calif. ,

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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). NURTEC is a trademark of Biohaven Pharmaceutical Ireland DAC. About CGRP.

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The Pharma Data

OCTOBER 15, 2020

Vertex Pharmaceuticals has decided to give up on its experimental VX-814, a small molecule drug for the rare genetic disease Alpha-1 antitrypsin deficiency (AATD), canning the drug’s development after seeing lackluster results from an early phase 2 trial. James Miessler.

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The Pharma Data

DECEMBER 16, 2020

17, 2020 /PRNewswire/ — CNS Pharmaceuticals, Inc. 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. About CNS Pharmaceuticals, Inc. SOURCE CNS Pharmaceuticals, Inc.

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The Pharma Data

NOVEMBER 25, 2020

25, 2020 /PRNewswire/ — Vivera Pharmaceuticals and Burkhan World today announce financial backing by JR Dallas Wealth Management in support of Vivera’s global growth strategies. “Our new partner, Vivera Pharmaceuticals, is the ideal strategic partner for our vision to make a difference in peoples’ lives.”

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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. Lisa Placanica, Senior Managing Director Center for Technology Licensing at Weill Cornell Medicine. Noria) and PSMA Therapeutics Inc.

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Conversations in Drug Development Trends

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. In recognition of the unmet need and medical urgency for innovative therapies in the sickle cell space, the FDA granted exa-cel Priority Review, with a formal decision expected by December 8, 2023.

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The Pharma Data

JANUARY 13, 2021

“Receiving Fast Track designation is an important acknowledgment of the results of our COVID-19 laboratory research,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. Alerts Sign-up for Innovation Pharmaceuticals email alerts is available at: [link]. Source link.

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Crown Bioscience

MAY 4, 2021

Crown Bioscience Director Mike Batey takes a closer look at pediatric cancer and how recent regulatory changes and additional research focus may deliver new therapies for kids. Unfortunately, children have limited access to novel therapies, and new drugs for adults are often only tested in children many years following approval.

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New Drug Approvals

SEPTEMBER 8, 2024

2222514-07-8 ] Palopegteriparatide , sold under the brand name Yorvipath , is a hormone replacement therapy used for the treatment of hypoparathyroidism. [1] 5] Study drug and conventional therapy were subsequently adjusted according to the albumin-corrected serum calcium levels. [5] 48,000) consisting of 34 amino acid residues.

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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 29, 2020

a biotechnology company developing cell therapies that enable organ regeneration, announced today that the U.S Under the IND, LyGenesis will be conducting a Phase 2a study on the safety, tolerability, and efficacy of its first-in-class novel cell therapy for patients with end stage liver disease (ESLD). and Longevity Vision Fund.

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The Pharma Data

NOVEMBER 4, 2020

–( BUSINESS WIRE )– Concert Pharmaceuticals, Inc. 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., 5, 2020 11:00 UTC. .

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Drug Target Review

JUNE 3, 2024

How does COUR Pharmaceuticals’ immune-modifying nanoparticle platform differ from traditional approaches to treating immune-mediated diseases? Could you explain the development of CNP-108 for T cell immunogenicity in gene therapy, and how it induces the immune system to build a tolerance to gene therapy treatments?

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The Pharma Data

NOVEMBER 25, 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.

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New Drug Approvals

DECEMBER 24, 2023

1] It was developed to treat hereditary transthyretin amyloidosis by Ionis Pharmaceuticals and AstraZeneca. [2] Ionis Pharmaceuticals. “Characteristics of Patients with Hereditary Transthyretin Amyloidosis-Polyneuropathy (ATTRv-PN) in NEURO-TTRansform, an Open-label Phase 3 Study of Eplontersen” Neurology and Therapy.

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The Pharma Data

NOVEMBER 29, 2020

Y-mAbs Therapeutics has a target action date of November 30 for its Biologics License Application (BLA) for Danyelza (naxitamab) for patients with relapsed/refractory high-risk neuroblastoma. The drug was developed by researchers at Memorial Sloan Kettering Cancer Center and exclusively licensed to Y-mAbs. It is approved in the U.S.

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The Pharma Data

MAY 4, 2021

Gilead sues Russia over a compulsory license issued to a company making remdesivir ( STAT ). Lilly accelerating baricitinib’s availability in India following receipt of permission for restricted emergency use as a COVID-19 therapy via donations and licensing agreements ( Press ).

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The Pharma Data

OCTOBER 20, 2020

21, 2020 (GLOBE NEWSWIRE) — TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage, specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, today announced the appointment of Thomas H. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Oct.

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The Pharma Data

SEPTEMBER 2, 2021

“Our presence at ERS this year reiterates our commitment to patients through the further development of first-in-class therapies like Enerzair Breezhaler, as well as by exploring the potential of digital health companions and the carbon footprint of our solutions,” said Dominic Brittain, Respiratory Global Program Head, Novartis Pharmaceuticals. “As

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The Pharma Data

SEPTEMBER 30, 2021

” To solve those problems, Varadarajan collaborated with Xinli Liu, professor of pharmaceutics at the UH College of Pharmacy, and an expert in nanoparticle delivery. a pioneering biotech company developing novel intranasal vaccines and therapies to assist patients defeat debilitating diseases, including COVID-19.

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The Premier Consulting Blog

NOVEMBER 20, 2024

Process validation is a critical regulatory requirement in pharmaceutical manufacturing. This process can be initiated during the review period of the biologics license application (BLA) or new drug application (NDA) prior to approval.

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