The Pharma Data

DECEMBER 21, 2020

The FDA granted cilta-cel Breakthrough Therapy and Orphan Drug designations in 2019, and the therapy received a PRIME Priority Medicines designation from the European Commission (EC) that same year and an Orphan Drug designation from the EC in February 2020. Source link.

Therapies 40

Therapies Licensing Licensing Clinical Development 40

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.

Therapies 52

Therapies Science Treatment Disease 52

The Pharma Data

MAY 6, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

FDA Approval 52

FDA Approval Licensing Licensing FDA 52

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.

Licensing 52

Licensing Licensing Production Clinical Trials 52

The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic.

Licensing 40

Licensing Licensing Therapies Laboratories 40

DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. However, such acquisitions also entail significant risks for biotech firms.

Pharmaceuticals 98

Pharmaceuticals Pharmaceutical Companies Therapies Marketing 98

The Pharma Data

JANUARY 24, 2021

Quercis’ lead drug candidate acts as an antithrombotic with significantly lower risk of adverse events than existing therapies. JCI Insight 2019. ZUG, Switzerland , Jan. Chief Medical Officer of Quercis Pharma. Chairman and Chief Executive Officer Quercis Pharma ilaeber@quercis.com. SOURCE Quercis Pharma AG.

Licensing 40

Licensing Licensing Clinical Trials Medical Schools 40

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. February 2019.

Licensing 52

Licensing Licensing Pharmaceutical Companies Treatment 52

The Pharma Data

DECEMBER 16, 2020

NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., The Otsuka group of companies employed 47,000 people worldwide and had consolidated sales of approximately USD 13 billion in 2019. VICTORIA, British Columbia & ROCKVILLE, Md.–(

Licensing 52

Licensing Licensing Pharmaceuticals Disease 52

The Pharma Data

JANUARY 17, 2021

Based in Seattle, Washington, Sana focuses on in vivo and ex vivo cell engineering platforms to develop therapies for cancer, diabetes, cardiovascular disease, CNS disorders, and genetic diseases. Launched in 2019, the company raised $700 million in June 2020 in its initial financing. Of course, this is how biotech investments work.

Marketing 52

Marketing Engineering Therapies Disease 52

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.

Small Molecule 40

Small Molecule Licensing Licensing Treatment 40

The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic.

Therapies 52

Therapies Hospitals Treatment FDA Approval 52

The Pharma Data

JANUARY 18, 2021

FDA advisory committees recommended just 50 percent of the 18 new therapies and indications they reviewed in 2020, the lowest rate since 2007, and the agency seems to be reserving the panels for more problematic applications, according to Prevision Policy, a Washington, D.C.-based based research firm. 9, 2020 ).

FDA 52

FDA FDA Approval Licensing Licensing 52

Codon

JULY 27, 2023

But what happens if you restore these cone cells, using gene therapy? approved a gene therapy for hemophilia A for the first time. It’s called Roctavian and it’s only available for people who don’t have antibodies against AAV5, which is the viral vector used to deliver the gene therapy. From Moazami et al.

Therapies 52

Therapies RNA DNA Engineering 52

Codon

JULY 27, 2023

But what happens if you restore these cone cells, using gene therapy? approved a gene therapy for hemophilia A for the first time. It’s called Roctavian and it’s only available for people who don’t have antibodies against AAV5, which is the viral vector used to deliver the gene therapy. From Moazami et al.

Therapies 52

Therapies RNA DNA Engineering 52

The Pharma Data

NOVEMBER 20, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S. TARRYTOWN, N.Y., November 21, 2020 – Regeneron Pharmaceuticals, Inc.

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

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. 2019, 62 , 445?447. SUZHOU, China and ROCKVILLE, Md. , 29, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), Aguilar, A.;

Licensing 40

Licensing Licensing Small Molecule Clinical Trials 40

PLOS: DNA Science

SEPTEMBER 7, 2023

Now, college tuition includes a fee to license an e-textbook for a limited time. ChatGPT accurately distinguishes gene therapy from gene editing. ChatGPT apparently didn’t read my article, Anatomy of an Impossible Burger , which I posted here at DNA Science in May 2019. The first E-books date from the 1990s.

DNA 98

DNA Science Therapies Licensing 98

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. SVP, Chief Medical Officer, Novartis Gene Therapies. “We 2 years and <5 years old with SMA Type 2.

Clinical Trials 52

Clinical Trials Trials Therapies Licensing 52

The Pharma Data

AUGUST 21, 2020

RELATED: Roche pens $2B biobucks pact with Innovent Biologics for bispecific and cell therapies. Lilly first licensed Tyvyt from Innovent in 2015. The original deal included rights outside of China, but in 2017, Lilly licensed back those rights while retaining downstream economics, Taylor said. Source link.

Licensing 52

Licensing Licensing FDA Therapies 52

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. That collaboration was to develop and commercialize four oncology antibody biosimilar therapies.

FDA 52

FDA Biosimilars Clinical Trials Licensing 52

The Pharma Data

MARCH 16, 2021

While peripherally acting COMT inhibitors are currently used as an adjunctive therapy in the treatment of neurological conditions, including Parkinson’s disease, this new collaboration is investigating centrally acting COMT inhibitors in neuropsychiatric disorders. Our mission is to create breakthrough therapies that change lives.

Licensing 52

Licensing Licensing Research Laboratories Treatment 52

The Pharma Data

NOVEMBER 23, 2020

His most recent position was at Amgen as Director Global Business Development – Transactions, a position he assumed in August 2019 following the acquisition of Nuevolution, a Danish small molecule development company, at which he led the commercial and business activities as Chief Business Officer.

Clinical Trials 52

Clinical Trials Small Molecule Pharmaceutical Companies Licensing 52

The Pharma Data

NOVEMBER 8, 2020

The resubmission came after a meeting with the FDA in February 2020 and addresses issues raised by the agency’s Complete Response Letter (CRL) in November 2019. “We Celgene acquired it in 2018 from bluebird bio, who originally developed the therapy. The NDA was resubmitted on May 2020.

FDA 52

FDA Trials Therapies Pharmaceuticals 52

Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. Peter Marks, head of FDA’s CBER – the organization responsible for regulating gene therapies.

Drug Development 52

Drug Development Disease Therapies Engineering 52

The Pharma Data

OCTOBER 26, 2020

Testing Therapies, Antivirals and Vaccines. Moderna has fully enrolled its late-stage coronavirus disease 2019 (COVID-19) vaccine trial by hitting its target of 30,000 participants. Diagnostics Update : To-date the FDA has authorized 284 individual EUAs, which include 221 molecular tests, 56 antibody tests and 7 antigen tests. .

Vaccine 52

Vaccine FDA Approval Clinical Trials FDA 52

The Pharma Data

MARCH 2, 2021

Boehringer Ingelheim and Gubra today announced a new research and licensing agreement focused on the identification and validation of targets and innovative peptide compounds for the treatment of obesity. Our mission is to create breakthrough therapies that change lives. Financial terms of the new agreement are not disclosed.

Treatment 52

Treatment Bioinformatics Clinical Development Therapies 52

The Pharma Data

OCTOBER 20, 2020

We look forward to successful commercialization and licensing of TLC’s programs across the globe under Mr. Bliss’s leadership, as well as to creating benefit and bringing value for all of TLC’s stakeholders.”. Earlier in his career, he ran business-development functions at Amgen and Baxter. Securities and Exchange Commission.

Licensing 40

Licensing Licensing Pharmaceutical Companies Clinical Trials 40

The Pharma Data

DECEMBER 9, 2020

Under its ongoing collaboration and license agreement, Crescendo’s proprietary transgenic platform and engineering expertise is being used to build Humabody ® -based therapeutics against certain targets selected by Takeda. This is the sixth technical milestone achieved by Crescendo in its collaboration with Takeda. – Ends-.

Licensing 40

Licensing Licensing Pharmaceutical Companies Engineering 40

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. SUZHOU, China and ROCKVILLE, Md. ,

Clinical Development 40

Clinical Development Disease Treatment Licensing 40

The Pharma Data

JANUARY 12, 2021

Preclinical data presented at the 2020 Society for Immunotherapy of Cancer’s Annual Meeting and the 2019 American Association for Cancer Research Annual Meeting support the development of JTX-8064 as a novel immunotherapy to reprogram immune-suppressive macrophages and enhance anti-tumor immunity.

Clinical Trials 52

Clinical Trials Therapies Trials Science 52

The Pharma Data

AUGUST 10, 2021

KEYNOTE-158 ( ClinicalTrials.gov , NCT02628067 ) is an ongoing global, open-label, non-randomized, multi-cohort, multi-center, Phase 2 study evaluating KEYTRUDA in patients with multiple types of advanced solid tumors – including endometrial carcinoma – that have progressed on standard of care therapy.

FDA 52

FDA Therapies Treatment Clinical Research 52

The Pharma Data

MARCH 15, 2022

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc.,

Trials 52

Trials FDA Disease Licensing 52

DrugBank

DECEMBER 4, 2024

For instance,  in sub-Saharan Africa , where the burden of HIV/AIDS is disproportionately high, only 71% of people living with HIV have access to antiretroviral therapy, compared to over 90% in North America and Europe.    This disparity in access extends beyond infectious diseases.

Drugs 52

Drugs Licensing Licensing Pharmaceutical Companies 52

The Pharma Data

JUNE 24, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. AUTHORIZED USE IN THE U.S.:

Vaccine 52

Vaccine Immune Response FDA Licensing 52

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 Phase IIb induction study in patients with moderate-to-severe UC, enrolled the first patient in August 2019.

Licensing 52

Licensing Licensing DNA Vaccine 52

The Pharma Data

FEBRUARY 8, 2021

At the end of 2020, Dupixent ® was launched in 47 countries with approximately 230 000 patients on therapy. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. In 2020, Dupixent ® sales reached €3,534 million, up 73.9% In the U.S.,

Vaccine 52

Vaccine Production FDA Therapies 52