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

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. Read on for this week’s. MacroGenics’ Margetuximab for Metastatic HER2+ Breast Cancer.

FDA 52

FDA Biosimilars Clinical Trials 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. Previously, the company announced positive results of the previous Phase IIa induction study in UC in September 2018.

Licensing 52

Licensing Licensing DNA Vaccine 52

The Pharma Data

MARCH 11, 2021

MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio. In 2018, Translate Bio entered into a collaboration and exclusive license agreement with Sanofi Pasteur Inc., Efforts are also underway to enable the product to be stable at routine refrigerator temperature (2-8°C).

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

The Pharma Data

JANUARY 18, 2021

In total, there were 31 mostly virtual expert panel meetings in 2020, but more than a dozen of those did not involve votes on New Drug Applications (NDAs), Biologics License Applications (BLAs) or new indications, but instead focused on devices, tobacco or other topics.

FDA 52

FDA FDA Approval Licensing Licensing 52

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] 1] [5] Medical uses Palopegteriparatide is indicated for the treatment of adults with hypoparathyroidism. [1] 48,000) consisting of 34 amino acid residues. 14 August 2024.

FDA 62

FDA International Trials FDA Approval 62

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

The Pharma Data

AUGUST 21, 2020

Tyvyt first earned its China nod in third-line classical Hodgkin lymphoma in late 2018, and the med’s looking at a potential new indication in previously untreated nonsquamous non-small cell lung cancer down the line. Keytruda is currently the rightful king in front-line NSCLC treatment in the U.S. months, versus 4.9 Source link.

Licensing 52

Licensing Licensing FDA Therapies 52

The Pharma Data

JANUARY 17, 2021

Shortly after its 2019 launch, the company licensed technology from Harvard University that could potentially improve the success of cell therapy treatments. When the company launched an IPO in late 2018, its valuation was $7 billion, which at the time was a record biotech IPO. Harr was also a director for Loxo Oncology.

Marketing 52

Marketing Engineering Therapies Disease 52

The Pharma Data

JUNE 26, 2021

About the Sanofi Pasteur and Translate Bio collaboratio n In June 2018, Translate Bio entered into a collaboration and exclusive license agreement with Sanofi Pasteur, the vaccines global business unit of Sanofi, to develop mRNA vaccines for up to five infectious disease pathogens.

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

New Drug Approvals

SEPTEMBER 6, 2024

2 , 3 Lazertinib was first approved in South Korea on January 18, 2021, for the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) with EGFR mutations. 4 Lazertinib , sold under the brand name Lazcluze and Leclaza , is an anti-cancer medication used for the treatment of non-small cell lung cancer. [1]

FDA Approval 48

FDA Approval FDA International Treatment 48

Codon

JANUARY 21, 2024

yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. Scientists studied black men infected with syphilis for several decades while withholding known treatments. You can do a challenge trial with deadly diseases, but you need a “rescue therapy.”

Vaccine 124

Vaccine Trials Disease Treatment 124

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

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. Founder and CEO of Asieris. ” About Photocure ASA.

Licensing 40

Licensing Licensing Clinical Development Pharmaceutical Companies 40

New Drug Approvals

AUGUST 21, 2023

5] Medical uses Palovarotene is indicated for the treatment of heterotopic ossification and fibrodysplasia ossificans progressiva. [4] 4] [5] History Palovarotene is a retinoic acid receptor gamma (RARγ) agonist licensed to Clementia Pharmaceuticals from Roche Pharmaceuticals. 22] Ipsen acquired Clementia in 2019. [23] Grogan, D.

FDA 52

FDA Clinical Trials Treatment Pharmaceuticals 52

The Pharma Data

AUGUST 3, 2021

Accelerates development of current Sanofi licensed programs in vaccines and potential to explore other therapeutic areas Fast tracks establishment of Sanofi’s recently announced mRNA Center of Excellence Full integration upgrades drug formulation capabilities and enhances US talent in a promising new technology.

Vaccine 52

Vaccine Clinical Trials Disease Licensing 52

The Pharma Data

FEBRUARY 5, 2021

With the Elite applicator collection we are able to treat a wide range of body areas and personalize each patient’s treatment plan.” American Society for Dermatologic Surgery (ASDS) consumer survey on cosmetic dermatologic procedures 2018 available at [link]. COOLSCULPTING ® AND COOLSCULPTING ® ELITE IMPORTANT INFORMATION.

Treatment 52

Treatment FDA Licensing Licensing 52

The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

Pharmaceuticals 40

Pharmaceuticals Licensing Licensing Clinical Trials 40

The Pharma Data

MARCH 1, 2022

The mechanism is currently being evaluated for the potential treatment of cognitive impairment and other symptoms associated with a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer’s disease and major depressive disorder. senior vice president, R&D, chief scientific officer, AbbVie.

Small Molecule 52

Small Molecule Licensing Licensing Disease 52

Molecule Blog

JUNE 11, 2021

A system that could radically increase the diversity of treatments, and lower costs and time to market. Diseases have global networks of stakeholders: Imagine a new insulin treatment funded, governed, and owned by diabetics. We began exploring the combination of IP and NFTs with DeFi in 2018. Fortune favours the brave.

Drug Development 52

Drug Development Licensing Licensing Government 52

The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. Tezepelumab was granted an FDA Breakthrough Therapy Designation for patients with severe asthma without an eosinophilic phenotype in September 2018. About Severe Asthma.

FDA 52

FDA Trials Therapies Treatment 52

The Pharma Data

OCTOBER 28, 2020

We are pursuing an accelerated approval pathway for remestemcel-L in the treatment of children with SR-aGVHD, and a parallel approval pathway for COVID-19 ARDS if the randomized controlled Phase 3 trial is positive.”. agents and even among responders, up to 10% will lose their response to the drug every year.

Treatment 40

Treatment Trials Disease Production 40

The Pharma Data

JULY 22, 2021

ARV-471 is currently in a Phase 2 dose expansion clinical trial for the treatment of patients with estrogen receptor (ER) positive / human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic breast cancer. The estrogen receptor is a well-known disease driver in most breast cancers.

Targeted Protein Degradation 52

Targeted Protein Degradation Therapies Clinical Trials Treatment 52

The Pharma Data

JANUARY 14, 2021

We are strongly encouraged by these data and the potential for a frontline targeted treatment that can improve overall survival,” said Zev A. Five Prime granted an exclusive license to Zai Lab to develop and commercialize bemarituzumab in Greater China, and Zai Lab collaborated with Five Prime on the Phase 2 FIGHT trial in Greater China.

Trials 52

Trials Treatment Therapies Clinical Trials 52

The Pharma Data

NOVEMBER 8, 2020

Supernus Pharmaceuticals has a target action date of November 8, 2020 for SPN-812 for the treatment of attention deficit hyperactivity disorder (ADHD). Alkermes has a target action date of November 15 for ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and for the treatment of bipolar I disorder.

FDA 52

FDA Trials Therapies Pharmaceuticals 52

The Pharma Data

NOVEMBER 17, 2020

of the Net Proceeds is originally intended to be used for the Group’s research and development of ASC21, which is an IND-approved NS5B polymerase nocleot(s)ide inhibitor licensed from Medivir AB under the exclusive licensing agreement executed in June 2017. (b) The Prospectus stipulates that approximately 10.0% Source link.

Licensing 40

Licensing Licensing Production Treatment 40

New Drug Approvals

SEPTEMBER 10, 2024

2] Medical uses Vorasidenib is indicated for the treatment of people aged twelve years of age and older with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation, following surgery including biopsy , sub-total resection, or gross total resection. [2] April 2018).

FDA Approval 62

FDA Approval FDA Clinical Trials Trials 62

Policy Prescription

MARCH 11, 2022

The crux of the Manitoba court’s decision is that CanadaDrugs’ founder and CEO, Kris Thorkelson , gets his pharmacist license back after it was revoked in 2019. The agency, ironically, must have known that it was safe for Americans to get their prescription drugs that way and didn’t want them to be abruptly cut off from their treatments.

Online Pharmacies 52

Online Pharmacies Pharmacy FDA International 52

The Pharma Data

DECEMBER 1, 2020

is a commercial stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer. About Innate Pharma: Innate Pharma S.A. Lumoxiti is a first-in class specialty oncology product for hairy cell leukemia.

Cell Biology 52

Cell Biology Clinical Trials Production Licensing 52

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. ” . . About Inmazeb.

FDA Approval 52

FDA Approval FDA Production Treatment 52

The Pharma Data

JANUARY 13, 2021

We believe that it is an important immunotherapy and demonstrates our work at BeiGene to bring innovative, impactful, and quality treatments to patients in need.”. We are grateful to have a new treatment available in the front-line setting for patients with advanced squamous non-small cell lung cancer,” said Jie Wang, M.D.,

Production 52

Production Trials Clinical Trials Treatment 52

Codon

JULY 14, 2024

The transfusion of platelets thus seems like an obvious treatment to stem bleeding. It is licensed in Russia and South Africa and is included in a few compassionate use programs across the globe, meaning it can be used clinically in cases where patients have few remaining options. Science Robotics (2018). Cite: Keith Neeves.

Production 140

Production Clinical Trials Trials Therapies 140

The Pharma Data

AUGUST 5, 2020

Ofatumumab is a targeted B-cell therapy that delivers superior efficacy with a similar safety profile when compared with teriflunomide, a commonly prescribed oral treatment for multiple sclerosis 1 . 10% of patients 1,3. ” These data were published in the August 6, 2020 issue of The New England Journal of Medicine.

Trials 52

Trials Treatment Disease Therapies 52

The Pharma Data

AUGUST 22, 2021

Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein(7) and were optimised by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding. 2018; 37(9): 886-892. About AstraZeneca.

Trials 52

Trials Virus Vaccine Pharmacokinetics 52

The Pharma Data

JANUARY 24, 2021

Food and Drug Administration (FDA) has granted toripalimab Fast Track designation for the first-line treatment of mucosal melanoma. On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (the “NMPA”) for the second-line treatment of unresectable or metastatic melanoma.

FDA 40

FDA Clinical Trials Trials Treatment 40

The Pharma Data

FEBRUARY 25, 2021

Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac , its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older. 5 Currently there is no cure or treatment for TBE, only management of symptoms.

FDA 52

FDA Vaccine Virus Clinical Trials 52

The Pharma Data

NOVEMBER 10, 2020

. The poster presentation, given by Johan Sandin , CSO at AlzeCure, presents how the mechanisms in the research platform Alzstatin work and shows that the target mechanism within the platform is suitable as a new treatment for Alzheimer’s disease. About AlzeCure Pharma AB (publ).

Pharmaceutical Companies 40

Pharmaceutical Companies Disease Treatment Pharmaceuticals 40