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. iii Current treatment options have limited efficacy in terms of weight loss or are often associated with adverse events. “We

Treatment 52

Treatment Bioinformatics Clinical Development Therapies 52

The Pharma Data

DECEMBER 20, 2020

Interventional treatment for mitral regurgitation is considered to be one of the most challenging areas in the field of structural heart disease, yet also represents huge market potential. The terms also allow cross-licensing on future improvements of the products, encouraging both companies to focus on innovations. About HighLife.

Licensing 40

Licensing Licensing Production Treatment 40

New Drug Approvals

OCTOBER 12, 2024

Alzheon licensed ALZ-801 from NeuroChem and is developing it for Alzheimer’s disease. ALZ-801 is an advanced and markedly improved candidate for the treatment of alzheimer’s disease. Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease.

Pharmacokinetics 62

Pharmacokinetics Small Molecule Disease Licensing 62

The Pharma Data

DECEMBER 30, 2020

(NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive results from the long-term, open-label Phase 3 MOVEMENT trial of AXS-07, Axsome’s novel, oral, multi-mechanistic investigational medicine in the acute treatment of migraine.

Trials 52

Trials Treatment Clinical Trials Therapies 52

The Pharma Data

JANUARY 3, 2021

Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. Inozyme Pharma was founded in 2017 by Joseph Schlessinger, Ph.D., BOSTON, Jan.

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

The Pharma Data

MARCH 5, 2021

Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease. If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimer’s. About Aducanumab.

Licensing 52

Licensing Licensing Biosimilars Disease 52

The Pharma Data

DECEMBER 17, 2020

San Diego-based Janux Therapeutics forged a strategic collaboration with pharma giant Merck potentially worth more than $1 billion to develop next-generation T cell engager immunotherapies for the treatment of cancer. Janux, which was founded in 2017, is still largely a preclinical company. Janux, in exchange, will receive up to $500.5

Immune Response 52

Immune Response Pharmacokinetics Engineering Licensing 52

Drug Target Review

FEBRUARY 28, 2024

Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. Prior to the founding of IN8bio, from 2014 to 2017, Mr Ho was the Founder and Managing Partner at AlephPoint Capital, a private healthcare investment fund. Normality sensing licenses local T cells for innate-like tissue surveillance.

Therapies 105

Therapies Engineering Molecular Biology Science 105

The Pharma Data

JANUARY 4, 2021

05, 2021 (GLOBE NEWSWIRE) — ViGeneron GmbH , a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc. The first, vgAAV gene therapy vector platform, allows superior transduction efficiency and intravitreal, a less invasive treatment administration. MUNICH, Germany, Jan.

Therapies 52

Therapies Virus Disease Licensing 52

The Pharma Data

MARCH 22, 2021

The HD community currently has no treatments to stop or slow the progression of this rare neurodegenerative disease that impacts families across generations.” In December 2017, Roche licensed the investigational molecule from Ionis Pharmaceuticals. said Levi Garraway, M.D., About Roche in Neuroscience.

Disease 52

Disease Clinical Trials Pharmacokinetics Treatment 52

New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] Peyrin-Biroulet L, Christopher R, Behan D, Lassen C (May 2017). 2017.03.007.

FDA 57

FDA FDA Approval International Pharmacokinetics 57

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

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%

Licensing 40

Licensing Licensing Production Treatment 40

The Pharma Data

DECEMBER 15, 2020

Treatment induced sustainable clinical responses and reduced systemic inflammation. Daratumumab already is approved for the treatment of multiple myeloma. The company is developing its platform for the treatment of chronic, inflammation-mediated autoimmune diseases, and is initially focused on the treatment of RA.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

NOVEMBER 8, 2020

In 2017 we bet on refocusing our strategy on medical dermatology to best address patients’ unmet needs. All Almirall’s production sites continue to operate at full capacity in order to be able to ensure the supply of medicines to all patients requiring treatment. In key markets such as Germany , Ilumetri ® gained c.

Licensing 52

Licensing Licensing Marketing Production 52

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

NOVEMBER 22, 2020

This patent completes the Ezeprogind related patents granted in the USA for composition of matter (US 9,562,018) and therapeutic uses in the treatment of Alzheimer’s and Parkinson’s diseases (US 10,537,569). The average life expectancy of PSP patients ranges from 5 to 7 years. View source version on businesswire.com: [link].

Drugs 40

Drugs Disease Clinical Trials Licensing 40

The Pharma Data

JANUARY 5, 2021

“Benuvia is excited to partner with the leadership of Radius Health to progress the late-stage development and commercialization of our synthetic cannabidiol oral solution for the treatment of rare and underserved diseases. We look forward to supporting Radius through our U.S. Source link.

Disease 52

Disease FDA Approval Clinical Trials Trials 52

The Pharma Data

JANUARY 10, 2021

In 2017, Tremfya (R) , developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys’ antibody technology to receive regulatory approval.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Supply Trials 52

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

DECEMBER 8, 2020

CEO and founder Min Li knows a thing or two from his time running GSK’s neuro R&D group before the company shuttered the program in 2017. With an intent to develop treatment for rare neurological disease where existing therapies have not shown much success, the company has licensed four clinical stage assets from Roche.

RNA 52

RNA Therapies Disease Protein Expression 52

The Pharma Data

NOVEMBER 30, 2020

I n-licensing of four clinical-stage product candidates to treat orphan neurological disorders. From the outset, Noema has been leveraging the latest scientific discoveries in neuroscience to identify and pursue promising new indications, and to elaborate a strategy around the four product candidates it licensed from Roche.

Licensing 40

Licensing Licensing Packaging Production 40

Agency IQ

AUGUST 16, 2024

Many commenters took issue with the guidance’s statement that, “The contribution of the psychotherapy component to any efficacy observed with psychedelic treatment has not been characterized. Throughout 2017, Lykos sought feedback on the protocol for its first Phase 3 study, MAPP1, via the Special Protocol Assessment (SPA) process.

FDA 40

FDA Trials Therapies Regulations 40

The Premier Consulting Blog

JANUARY 17, 2023

However, the FDA Reauthorization Act of 2017 (FDARA) amended PREA to require timely pediatric investigations of certain new active ingredients intended for the treatment of adult cancers, even if the indication does not occur in children and/or orphan designation has been granted.

Production 52

Production Clinical Trials FDA Disease 52

The Pharma Data

OCTOBER 14, 2020

iota is a start-up company founded in 2017 by Michel Maharbiz and Jose Carmena, each of whom has demonstrated outstanding achievement in the bioelectronics field. Established in 2017, iota is a start-up company focused on building a foundation for the future of bioelectronic medicine. About iota Biosciences.

Disease 40

Disease Production Pharmaceuticals Pharmaceutical Companies 40

The Pharma Data

OCTOBER 18, 2020

Crist will be responsible for building out AVEO’s sales force in anticipation of the potential approval and launch of tivozanib, the Company’s next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), as a treatment for relapsed or refractory renal cell carcinoma. “We said Mr. Crist. “I

Clinical Trials 40

Clinical Trials FDA Treatment Trials 40

The Pharma Data

NOVEMBER 11, 2020

Submitted CTA for INZ-701 for the treatment of ENPP1 deficiency to United Kingdom regulatory agency. Received Rare Pediatric Disease and Fast Track Designations for INZ-701 for the treatment of ENPP1 deficiency. BOSTON, Nov. 12, 2020 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. . BOSTON, Nov.

Clinical Trials 40

Clinical Trials Trials Disease FDA 40

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

FDA-2017-E-5106 ), and concerns FDA’s October 19, 2016 Accelerated Approval of BLA 761038 for LARTRUVO (olaratumab). 156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. 8,128,929 [] for [PTE] request under 35 U.S.C. §

FDA 59

FDA Production FDA Approval Licensing 59

The Pharma Data

NOVEMBER 9, 2020

NAVIGATOR is a Phase 3, randomized, double-blinded, placebo-controlled trial in adults (18–80 years old) and adolescents (12–17 years old) with severe, uncontrolled asthma, who were receiving treatment with medium- or high-dose ICS plus at least one additional controller medication with or without OCS. 2017; 377 (10): 936-946.

Trials 52

Trials Production Clinical Trials Government 52

The Pharma Data

DECEMBER 15, 2020

Patients received motixafortide monotherapy priming treatment for five days, followed by combination cycles of motixafortide, KEYTRUDA and chemotherapy (Onivyde ® /5-fluorouracil/leucovorin) until progression. Surgical resection does not offer adequate treatment since only 20% of patients have resectable tumors at the time of diagnosis.

Clinical Trials 40

Clinical Trials Trials Treatment Therapies 40

Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Biosimilars 40

The Pharma Data

DECEMBER 21, 2020

“The recent results from our NAVIGATOR trial were impressive, both in terms of the overall clinical data and the reduction in exacerbation rate with tezepelumab treatment, and we continue to work with AstraZeneca on planned regulatory filings in 2021. Detailed results from the SOURCE trial will be presented at a future medical meeting.

Trials 40

Trials Production Clinical Trials Therapies 40

The Pharma Data

OCTOBER 28, 2020

NASDAQ: RARE), companies partnered in the development of intrathecally administered GTX-102, an investigational treatment for Angelman syndrome, today announced positive interim data from the Phase 1/2 study of GTX-102. The UBE3A antisense transcript targeted by GTX-102 is a viable target for treatment,” stated Scott Stromatt, M.D.,

Protein Expression 40

Protein Expression Therapies Treatment Disease 40

The Pharma Data

NOVEMBER 15, 2020

Most recently, she was a senior executive at Celgene Corporation, where she led corporate strategy from 2012 to 2017. She earned a BA from Durham University, U.K., and an MBA from Harvard Business School. Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson.

Clinical Trials 40

Clinical Trials Trials Production Therapies 40

The Pharma Data

NOVEMBER 5, 2020

has been appointed to the additional role of president and will oversee the growth of the company’s technology portfolio for the treatment of ischemic and hemorrhagic stroke. Most recently, Holland served as Global Head of licensing at Lonza AG. Venugopal most recently served as executive director at Intercept Pharmaceuticals.

Analytical Chemistry 40

Analytical Chemistry Pharmaceuticals Small Molecule Therapies 40

The Pharma Data

OCTOBER 27, 2020

License-related fees (5). License-related fees (5). Medtronic), the premarket approval application (PMA) for the ISR was approved by the FDA in December 2017. Three Months Ended September 30, . 2020.

FDA 40

FDA Production Licensing Licensing 40

The Pharma Data

NOVEMBER 5, 2020

Background and reason Moberg Pharma is a Specialty Pharma company focused on developing and commercialising proprietary, acquired and licensed products globally, from clinical development of products based on proven substances to commercialisation.

Marketing 40

Marketing Production Regulations Pharma Companies 40