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. UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. SUZHOU, China and ROCKVILLE, Md. ,

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The Pharma Data

MARCH 30, 2021

Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. You should not place undue reliance on these statements. Source link:[link].

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The Pharma Data

AUGUST 17, 2020

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. About Bristol Myers Squibb. About Dragonfly. Dragonfly has a deep pipeline of wholly owned programs developed using its platform. Source link.

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Agency IQ

JUNE 21, 2024

CBER’s Peter Marks offers insights on a new Rare Disease Hub, upcoming accelerated approval guidance This week, PETER MARKS, director of FDA’s Center for Biologics Evaluation and Research (CBER), spoke at several sessions of the Drug Information Association (DIA) annual meeting.

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New Drug Approvals

SEPTEMBER 29, 2024

gingivalis has been called a risk factor for Alzheimer’s disease ( Kanagasingam et al., gingivalis is associated with cardiovascular disease. In aged dogs with periodontal disease, ninety days of COR388 reduced oral bacterial load and gum pathology ( Arastu-Kapur et al., Cortexyme’s approach is based on the theory that P.

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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.

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The Pharma Data

DECEMBER 29, 2020

(NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases , a business unit of Chiesi Farmaceutici S.p.A.,

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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. 1 Kratz et al.,

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The Pharma Data

JUNE 30, 2021

With a median follow-up of two years, the study met the primary endpoint of event-free survival (EFS; hazard ratio 0.398, p <0.0001). Event-free survival is defined as time from randomization to disease progression, commencement of new lymphoma therapy, or death from any cause. This press release features multimedia.

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The Pharma Data

NOVEMBER 6, 2020

The Advisory Committee also voted 0 yes, 7 no and 4 uncertain on the question, “Does Study 103 (PRIME) provide supportive evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?”, Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease.

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Drug Target Review

OCTOBER 10, 2024

What are the risks of over-reliance on healthy donor material in early-stage research, and how can decision-makers ensure a balanced integration of diseased material to avoid potential gaps when transitioning to clinical trials? Diseased cells are likely to be more fragile or less abundant, making it difficult to obtain enough for therapy.

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The Pharma Data

OCTOBER 27, 2020

Food and Drug Administration (FDA) has granted Orphan Drug and Rare Pediatric Disease (RPD) designations to PBKR03 for the treatment of Krabbe disease (Globoid Cell Leukodystrophy). About Krabbe Disease. Passage Bio expects to initiate a Phase 1/2 trial for PBKR03 in the first half of 2021.

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LifeSciVC

APRIL 24, 2024

Target validation : Do we believe the target(s) plays a central role in disease biology and that modulation will modify disease? There is nothing more exciting than digging into a new target and trying to develop a thesis on whether modulation may be impactful in disease. Is the functionality of mutations known?

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The Pharma Data

OCTOBER 29, 2020

If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and to meaningfully change the course of Alzheimer’s disease. If approved, aducanumab would become the first therapy to reduce the clinical decline in patients with Alzheimer’s disease. CAMBRIDGE, Mass.

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The Pharma Data

OCTOBER 26, 2020

(Nasdaq: PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that the U.S. In addition, the FDA has granted Fast Track designation for PR001 for the treatment of Parkinson’s disease with GBA1 mutations.

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The Pharma Data

NOVEMBER 29, 2020

Compared to conventional “occupancy-driven” pharmacological modality, the “event-driven” PROTAC technology has many advantages, such as high potency, high selectivity, with catalytic mode of action, and the ability to target undruggable proteins. SUZHOU, China and ROCKVILLE, Md. , About Ascentage Pharma.

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The Pharma Data

AUGUST 15, 2021

Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to discuss recommendations on the safe and appropriate use of TICOVAC. “We 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. adults and children against the TBE virus when visiting or living in TBE endemic areas.

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The Pharma Data

APRIL 26, 2022

Under the expanded indication, a three-day Veklury treatment regimen is recommended to help prevent hospitalization in non-hospitalized COVID-19 pediatric patients who are at high risk for COVID-19 disease progression. These data were presented at the 29th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2022).

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The Pharma Data

JANUARY 4, 2021

The program was licensed to Allergan in April 2016 , and Allergan was acquired by AbbVie in May 2020. The event reported today has no immediate impact on the consolidated financial results for the accounting period ending December 2021. ” About the License Agreement. TOKYO and CAMBRIDGE, England , Jan.

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LifeSciVC

JANUARY 16, 2024

recent announcements from Merck and Sanofi for obesity and broader metabolic disease). Rise of the best-in-class biologics plays: Are you looking to in-license or invest in “de-risked” biology that is already in the clinic? Join the club. A permanent gene edit to produce a difficult-to-titrate supply of GLP1 in the liver?

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The Pharma Data

APRIL 27, 2023

1 If approved, GSK’s candidate has the potential to be the first vaccine available to help protect older adults from RSV disease. The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia, headache, and arthralgia. Efficacy was 94.6% (95% CI, 65.9–99.9,

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Olympian Clinical Research

JANUARY 5, 2022

When a loved one is diagnosed with Alzheimer’s disease , it can be challenging to know what to do or how to cope. You may first want to understand this degenerative disease so that you can best support your loved one after their Alzheimer’s diagnosis. What is Alzheimer’s Disease? . Learn More About Alzheimer’s Disease.

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The Pharma Data

JANUARY 14, 2021

“Buprenorphine is the most important medication in our arsenal for treating opioid use disorder, which is currently one of the most lethal diseases for Americans.” As a result, some clinicians are hesitant to pursue this DEA license or even engage in treatment of patients with OUD.

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The Pharma Data

AUGUST 31, 2021

Over three years ~300,000 patients at high risk of a second cardiovascular event are expected to be treated with inclisiran, a small interfering RNA therapy administered as a 6-monthly maintenance dose ‡ , in the community setting. High cholesterol is a major cause of cardiovascular disease – disease of the heart and blood vessels.

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The Pharma Data

OCTOBER 14, 2020

Live Webcast : accessible from the Company’s website at www.eloxxpharma.com under Events and Presentations or with this link: [link]. These premature stop codons have been identified in over 1,800 rare and ultra-rare diseases. WALTHAM, Mass., 15, 2020 (GLOBE NEWSWIRE) — Eloxx Pharmaceuticals, Inc.

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The Pharma Data

SEPTEMBER 25, 2020

According to Phase 2 and 3 data drawn from over 3,500 patients and submitted in support of the application, patients receiving Jyseleca once daily saw their symptoms and disease activity improve, while slowing the progression of structural joint damage.

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The Pharma Data

NOVEMBER 23, 2020

NYSE American: SYN) is a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need. . ROCKVILLE, Md. , 24, 2020 /PRNewswire/ — Synthetic Biologics, Inc. Synthetic Biologics, Inc. .

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The Pharma Data

AUGUST 30, 2021

Separate post hoc analyses of pooled Phase III ORION-9, -10 and -11 data show twice-yearly** Leqvio ® (inclisiran) consistently reduced low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD) with established cerebrovascular disease (CeVD) 1 and polyvascular disease (PVD) 2.

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Codon

JANUARY 21, 2024

Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. How are disease targets selected for challenge trials?

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The Pharma Data

JUNE 25, 2021

We await results from PROVENT, our pre-exposure prevention trial and TACKLE, our treatment trial in preventing more severe disease, to understand the potential role of AZD7442 in protecting against COVID-19.”. Preliminary analyses show similar adverse events in the placebo and treatment arms. AZD7442 was well tolerated in the trial.

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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”).

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The Pharma Data

MAY 31, 2022

if approved Acceptance marks another important step in advancing Dupixent for a broad range of diseases with underlying type 2 inflammation. Both trials met the primary and key secondary endpoints, showing Dupixent significantly improved disease signs and symptoms compared to placebo, including reduction in itch and skin lesions.

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The Pharma Data

OCTOBER 15, 2020

Flu-like symptoms and GI adverse events most commonly attributed to oral pirfenidone were seen in less than 10% of patients treated with AP01. Adverse events with a frequency of greater that 10% were rash 18%, upper respiratory tract infection 18%, cough 24%. 16, 2020 10:00 UTC. AP01 was safe and well tolerated at both doses.

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The Pharma Data

JANUARY 10, 2021

LA ROCHELLE, France–( BUSINESS WIRE )– Regulatory News: VALBIOTIS (FR0013254851 – ALVAL / eligible for the PEA/SME) (Paris:ALVAL), a French Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces its participation in the prestigious ‘J.P.

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The Pharma Data

APRIL 20, 2023

With continuous Kesimpta treatment, key indicators of disability progression and brain volume change showed that most patients remained free from disease progression up to five years,” said principal investigator Jeffrey A. The overall rates of adverse events (AEs) and serious AEs were consistent with the core Phase III trials 2 , 3.

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The Pharma Data

APRIL 6, 2021

Ongoing research for baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, in adult and pediatric AD, alopecia areata (AA), systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA), COVID-19 and for its approved indication for rheumatoid arthritis (RA) continues. WARNINGS AND PRECAUTIONS.

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The Pharma Data

MARCH 4, 2021

AA is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress. “This level of high-quality research is needed to advance our understanding and the treatment of this frequently devastating disease.” vice president of immunology development at Lilly.

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