Pharmaceutical Technology

MAY 1, 2023

The NDA is supported by the data package licensed to Ocumension by Nicox as well as the Phase III clinical trial in China. Nicox granted exclusive license to Ocumension to develop and commercialise Zerviate in China and most of the Southeast Asian markets.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 23, 2023

With the chemists and druggists across the country opposing the sale of drugs through online, the Central government is taking a stand that the sale of medicines should be strictly under the provisions of the existing regulations and the State Licensing Authorities (SLAs) are legally empowered to act against violation of the legal provisions.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 11, 2023

The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June. […]

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 16, 2023

At least seven more pharma companies and a federation of pharma manufacturers have approached the Delhi High Court against the Central Government’s order in the beginning of June prohibiting manufacturing, distribution and sale of 14 fixed dose combinations (FDCs) licensed prior to the year 1988.

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pharmaphorum

NOVEMBER 15, 2022

Lantheus’ pipeline-building drive in radiopharma has continued with a $260 million upfront deal to license rights to two oncology candidates from POINT Biopharma. billion in milestone payments to POINT if the two radiotherapeutics get FDA approval and meet commercial objectives, plus royalties on net sales.

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Pharmaceutical Technology

MARCH 30, 2023

Laboratoires Théa’s sister company, Théa Open Innovation (TOI), has signed a licensing agreement with Galimedix Therapeutics for GAL-101. It is currently ready to enter Phase II/III clinical trials. GAL-101 binds to a specific motif from Aβ that is exposed only in the misfolded Aβ monomer form and can be targeted.

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Pharmaceutical Technology

NOVEMBER 10, 2022

Additionally, Royalty Pharma is entitled to receive further payments of up to $160m subject to meeting some clinical, regulatory and sales milestones. The rights to development, regulatory and sales milestone payments of $400m due from Amgen will be retained by Arrowhead. In 2016, it was licensed by the company to Amgen.

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Pharmaceutical Technology

MAY 19, 2023

Alimera Sciences has exclusive global rights to Yutiq excluding Southeast Asia, Hong Kong, Macau, China and South Korea, where the therapy was previously licensed to Ocumension Therapeutics. EyePoint Pharmaceuticals will also receive potential royalties on the combined net sales of Iluvien and Yutiq in the US from 2025 to 2028.

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Pharmaceutical Technology

MARCH 31, 2023

Ibrexafungerp is currently being evaluated in Phase III clinical trials to treat invasive candidiasis (IC), a life-threatening fungal infection. in sales-related milestone payments, along with tiered royalties on sales across all indications. Additionally, GSK will pay up to $242.5m

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Pharmaceutical Technology

DECEMBER 19, 2022

Innate is also eligible to receive a total of up to $1.43bn (€1.35bn) in preclinical, clinical, regulatory and commercial milestone payments and royalty payments on net sales in the future. As per the deal, Sanofi will hold an option to include up to two further ANKET targets.

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pharmaphorum

JUNE 23, 2021

GlaxoSmithKline’s pitch to shareholders kicked off this afternoon with an optimistic view of its late-stage pipeline – including some big sales predictions for products like its respiratory syncytial virus (RSV) vaccine and new blood cancer drug Blenrep. billion takeover of Tesaro in 2019. £1 mRNA ambitions.

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Pharmaceutical Technology

AUGUST 16, 2022

According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Under the agreement, Horizon will hold an option for the acquisition of the ADX-914 programme, which is exercisable through a period after concluding the Phase II trials.

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Pharmaceutical Technology

MAY 31, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company’s pipeline products include Busulipo which is under Phase II clinical trials and Nefecon for IgA Nephritis which is under Phase II clinical trials.

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Pharmaceutical Technology

MARCH 29, 2023

In September 2021, Bristol Myers Squibb in-licensed the first programme, EVT8683, after the successful filing of an investigative new drug (IND) application with the Food and Drug Administration (FDA). This programme has now proceeded into a Phase I clinical trial.

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pharmaphorum

AUGUST 18, 2021

Akili already has the first and only FDA cleared video game-based digital therapeutic (DTx) for children with attention-deficit hyperactivity disorder (ADHD), but is looking to add to its range via a licensing deal with Australia’s TALi Digital. . TALi is also in line for royalties on sales.

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Pharmaceutical Technology

FEBRUARY 14, 2023

Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). upfront payment and eligible for royalties on net sales. According to the agreement, CSPC will receive a $7.5m

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Pharmaceutical Technology

MARCH 23, 2023

The drug is currently licensed in combination with chemotherapy for patients with classical Hodgkin lymphoma, both as frontline therapy and for those at risk of progressing or having progressed following stem cell transplantation. The company also has several promising agents in early clinical development.

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pharmaphorum

AUGUST 10, 2021

Disitamab vedotin already has a conditional approval in China for HER2-positive gastric cancer, and has been filed for HER2-positive bladder cancer on the strength of a pair of phase 2 trials. While the licensing deal with Seagen tops up its finances, the scale well below the $6.9 Sales last year grew by a third to $1.7

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The Pharma Data

AUGUST 5, 2020

AstraZeneca has signed a licensing deal with UK-based biotech company Redx Pharma for its fibrotic disease candidate RXC006. Redx is also eligible to receive up to $360m in additional payments, dependent on development, regulatory and commercial milestones, as well as tiered royalties on any future sales.

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Pharmaceutical Technology

AUGUST 4, 2022

P-BCMA-ALLO1 is currently being analysed in a Phase I clinical trial while an investigational new drug (IND) application for P-CD19CD20-ALLO1 is anticipated next year. The programmes include P-BCMA-ALLO1, an allogeneic CAR-T to treat multiple myeloma and P-CD19CD20-ALLO1, an allogeneic dual CAR-T to treat B-cell malignancies.

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pharmaphorum

NOVEMBER 10, 2021

The drug was the first in the oral CGRP inhibitor class to get an prevention indication approved by the FDA in May, and that has helped accelerate its rollout, bringing in $336 million in US sales for Biohaven so far this year. The post Pfizer strikes $1.2bn licensing deal for Biohaven migraine drug appeared first on.

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Pharmaceutical Technology

JANUARY 31, 2023

Daewoong Pharmaceutical has entered an exclusive licensing agreement with CS Pharmaceuticals (CSP) for Bersiporocin, a first-in-class PRS inhibitor, in the Greater China region for Idiopathic Pulmonary Fibrosis (IPF). The Korea Drug Development Fund is supporting the trial by providing funds.

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The Pharma Data

JANUARY 13, 2021

Barrow previously served as Director of Drug Development & Discovery at Usona Institute, where he oversaw preclinical, clinical and regulatory development efforts for all of Usona’s development programs.

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The Pharma Data

JANUARY 6, 2021

CAMBRIDGE, England & WETHERBY, England–( BUSINESS WIRE )– Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer ® and pre|CISION platforms, is pleased to announce that it has entered into a license agreement with POINT Biopharma Inc.

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The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. Novartis today announced that the U.S. SVP, Chief Medical Officer, Novartis Gene Therapies. “We

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pharmaphorum

OCTOBER 27, 2021

Merck & Co has signed a licensing deal with the UN-backed Medicines Patent Pool (MPP) that could pave the way for generic companies to manufacture its much-anticipated oral antiviral for COVID-19. ” Under the agreement, MPP will sublicense manufacturing rights to other drugmakers.

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Pharmaceutical Technology

JANUARY 19, 2023

While allogeneic hematopoietic stem cell transplants (HSCT) provide long-term benefit to a subset of AML patients, other cell therapy modalities such as natural killer (NK) cells or chimeric antigen receptor (CAR)-T cells have failed to show conclusive benefit in late-stage clinical trials.

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The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. Few details of the deal were disclosed in the announcement. A second liver biopsy will be performed after 18 months.

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pharmaphorum

NOVEMBER 17, 2022

AstraZeneca has extended a contract to use a digital health device developed by ImpediMed that is being deployed in a trial of two of its drugs in chronic kidney disease (CKD). million deal to use SOZO in a pair of heart failure and CKD trials in 2020, leasing 375 devices in 31 countries. ImpediMed reported sales of A$2.9

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The Pharma Data

OCTOBER 22, 2020

Dosing of the first patient in this trial has triggered a $50 million milestone payment from AstraZeneca to Innate. “W Additional details on the INTERLINK-1 clinical trial can be found here. . MARSEILLE, France, Oct. About Innate Pharma: Innate Pharma S.A.

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pharmaphorum

MARCH 19, 2021

DeepVerge has announced trial data showing its COVID-19 Microtox BT breath test can deliver accurate results in under 60 seconds, with a potential roll-out later this year if further tests support it. It has licensed in a patented breathalyser, the analysts noted. A large clinical trial is ongoing in Dubai.

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The Pharma Data

JANUARY 13, 2021

Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

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Pharmaceutical Technology

MARCH 1, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Pharmaceutical Technology

JANUARY 2, 2023

Danicamtiv is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway. It is developed based on MyoKardia's drug discovery platform. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects.

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Delveinsight

JANUARY 12, 2021

Medivir, IGM Biosciences enters into an exclusive licensing agreement for Birinapant. Medivir AB has entered into an exclusive licensing agreement with IGM Biosciences to receive global, exclusive development rights for Birinapant. million after Birinapant successfully becomes a part of the Phase I trials.

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The Pharma Data

DECEMBER 13, 2020

. Relay Therapeutics will receive $75 million upfront and is eligible to receive an additional $25 million in near-term payments and $695 million in additional potential milestones, plus royalties on global net product sales. sales and up to $410 million in additional ex-U.S. CAMBRIDGE, Mass.,

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pharmaphorum

SEPTEMBER 22, 2022

GSK is paying $66 million upfront to license rights to Spero Therapeutics novel antibiotic tebipenem Hbr, unswayed by the FDA’s decision earlier this year not to approve the drug for adults with complicated urinary tract infections (cUTI). ” The post Undeterred by FDA setback, GSK snaps up Spero antibiotic appeared first on.

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