The Pharma Data

DECEMBER 13, 2020

As part of the collaboration, Hummingbird will be leveraging Tempus’ AI-enabled platform and proprietary data, as well as joining its TIME Trial® Network, for rapid identification, site activation and efficient enrollment of cancer patients who have NRG1 fusions and meet eligibility criteria for HMBD-001 clinical trials.

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The Pharma Data

JANUARY 14, 2021

(NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. Phase 2 FIGHT Trial: Summary of Efficacy*. Wainberg, M.D.,

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Drug Target Review

APRIL 3, 2024

This multi-layered mechanism contributes to the development of immunoresistance against current standard-of-care treatments such as checkpoint inhibitors, chemotherapy, or antibody-drug conjugates (ADCs). Visugromab is a monoclonal antibody – a treatment modality that has been extensively studied and de-risked.

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The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. One step closer to a novel treatment.

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Drug Target Review

AUGUST 24, 2023

We will explore how GDF-15 impacts the tumour microenvironment and hinders the infiltration of T cells into the tumour, as well as the implications of neutralising GDF-15 to reverse its inhibitory effects and sensitise tumours to anti-PD-1 treatment. T-cell infiltration is a prerequisite for responses to checkpoint inhibitors.

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The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].

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Drug Discovery World

JULY 11, 2022

These challenges exist across the translation cycle from early research to clinical trials, manufacturing, and ultimately reimbursement. The complexities of sample management can significantly extend the timelines for clinical trials. Methods& clinical development, 21,524–529. Molecular therapy.

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

Rare Disease Day on February 28th is a chance for rare disease communities to come together as one and join in conversation with stakeholders searching for treatments, raising money to support research, and changing the way healthcare and governments interact with patients. What will have the greatest impact on rare disease patients in 2023?

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The Pharma Data

DECEMBER 1, 2020

333-228656) previously filed with the Securities and Exchange Commission (the “SEC”) on December 3, 2018, and declared effective by the SEC on December 26, 2018. If adequate funds are not available on a timely basis, Allena may be required to delay, limit, reduce or terminate its clinical development of reloxaliase.

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The Pharma Data

JANUARY 13, 2021

This is our sixth global approval for an internally-developed product, and our first approval for tislelizumab in a lung cancer indication, an area where we believe tislelizumab can have a large impact for patients.”. This is the third approval in China for tislelizumab, and its first in a lung cancer indication.

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The Pharma Data

SEPTEMBER 9, 2021

PT027 significantly reduced the risk of severe exacerbations compared to albuterol in patients with moderate to severe asthma in MANDALA trial when used as a rescue medicine in response to symptoms. PT027 significantly improved lung function compared to individual components in mild to moderate asthma in DENALI trial .

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The Pharma Data

JULY 22, 2021

NYSE: PFE) today announced a global collaboration to develop and commercialize ARV-471, an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor protein degrader. We share Pfizer’s deep commitment to people with breast cancer and are thrilled to partner with them to develop this potentially best-in-class therapy.

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The Pharma Data

FEBRUARY 22, 2022

Then, she served on the Board of Directors of Capgemini for two years (2016-2018) before being appointed to her current position as Group CFO. He began his oncology development career at Rhône Poulenc Rorer Inc. In 1999, he joined the Aventis Group as Senior Director, Oncology Global Clinical Development.

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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). The company is also still conducting a Phase III trial in the adult ADHD patient population. The sNDA was built on data from the Phase III CANDOR trial.

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The Pharma Data

DECEMBER 13, 2020

We will continue to work closely with the Agency to potentially bring margetuximab as a treatment option to patients with HER2-positive metastatic breast cancer.”. Zai Labs obtained regional development and commercialization rights for the programs in mainland China, Hong Kong, Macau and Taiwan.

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The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. that are fast progressing clinical trials. SAN FRANCISCO and SUZHOU, China , Nov. TYVYT® is the only PD-1 inhibitor included in the NRDL.

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The Pharma Data

NOVEMBER 10, 2020

This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of Foralumab. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. NEW YORK and LONDON, Nov. NEW YORK and LONDON, Nov. and Europe. Dr. Howard L.

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The Pharma Data

MAY 31, 2022

The approval is based on interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting and standing with half walking after 12 months of treatment. All infants were alive at 12 months without permanent ventilation.

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The Pharma Data

NOVEMBER 10, 2020

The NCT03763149 study is a phase 1a clinical study evaluating the tolerability, safety, and PK/PD properties of IBI188 (letaplimab) as monotherapy for advanced malignancies that failed in standard treatments. . . SAN FRANCISCO , U.S. and SUZHOU, China , Nov. ” About Letaplimab.

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The Pharma Data

MARCH 16, 2021

“There is a continued need for additional treatments that can provide people living with ulcerative colitis relief from their most challenging symptoms,” said William J. ” In LUCENT-1, mirikizumab met the primary endpoint of clinical remission at Week 12 compared to placebo (p<0.0001). ” About Mirikizumab.

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The Pharma Data

JANUARY 18, 2021

for the treatment of post-herpetic neuralgia. RTX has completed a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica.

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Drug Discovery World

OCTOBER 18, 2022

SOTIO, for example – an international biotech originating from the Czech Republic – focuses on immuno-oncology and developing innovative methods for treating cancer. These soluble TCR products do not require costly personalised therapy in the way that TCR-T cell treatments do. . For example, it demonstrated a 9.3%

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The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. Approval supported by one of the largest clinical trial programmes undertaken for this rare disease. Basel, 17 August 2020.

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The Pharma Data

SEPTEMBER 11, 2020

Marie Curie discovered radium’s radioactive properties and championed its use in the treatment of cancer. The approach is a staple of cancer therapy today but is limited to spot treatment. In addition, future scans can help doctors determine if the medicine is working as treatment progresses. “We A foundational pillar.

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The Pharma Data

JANUARY 13, 2021

we determined the crystal structure of CD40-ligand 2 , developed a humanized version of our antibody (hu5c8, ruplizumab, or Antova®) and tested it in human trials for preventing organ transplant rejection and autoimmunity. Collaborating with a team at Biogen Inc., 1 Lederman, S. 1 Lederman, S. International Immunol. (11):1583

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Drug Discovery World

JANUARY 17, 2024

Brett Swansiger, Chief Commercial Officer at ANGLE discusses the importance of liquid biopsies in precision medicine trials for cancer. Furthermore, oncology clinical trials are frequently challenged by low enrolment rates, failure to achieve primary endpoints, study design complexity and limited funding 5.

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Drug Discovery World

AUGUST 10, 2023

Evident by the rapid enrollment in our clinical trial and survey findings of people who use e-cigarettes, many people want to quit and have difficulty in doing so successfully. JB: Nicotine, in all forms, is very addictive, and many people struggle to quit without the use of medical and/or behavioral intervention.

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Agency IQ

SEPTEMBER 15, 2023

developing or amending a monograph) or sponsor-initiated operations (e.g., Background on oral phenylephrine as a nonprescription nasal decongestant Phenylephrine is an alpha-1 adrenergic agonist that is approved as a nonprescription oral treatment for temporary relief of nasal congestion , sinus congestion and pressure.

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The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval.

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The Pharma Data

DECEMBER 27, 2020

This year has been difficult, but it has reinforced the importance of our mission: to treat and potentially even reverse the effects of serious diseases and conditions by advancing our novel cell therapy product candidates through clinical trials and into the hands of physicians.

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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. ,

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Drug Discovery World

SEPTEMBER 16, 2022

Globally, the pipeline for therapies in this sector has continued to grow over the years, and in 2021, there were just under 2,500 cell and gene therapies in some stage of clinical development. . The UK stands as one of the key markets for cell and gene therapies. billion in funding. . billion in funding. .

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The Pharma Data

APRIL 7, 2023

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today provided updates on two Phase 3 trials, LEAP-003 and LEAP-017 investigating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai.

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The Pharma Data

APRIL 8, 2021

today announced that new data for its approved and investigational medicines for the treatment of neurological disorders will be presented at the 73rd American Academy of Neurology (AAN) Annual Meeting being held virtually April 17-22, 2021. Spinal Muscular Atrophy (SMA). Multiple Sclerosis (MS).

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The Pharma Data

APRIL 29, 2022

The data showed an estimated 91% of infants (n=58) treated with Evrysdi were alive after three years of treatment. The Evrysdi-treated infants continued to improve or maintain motor functions, including the ability to swallow, sit without support, stand with support and walk while holding on, between two and three years of treatment.

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The Pharma Data

JUNE 30, 2021

Approval based on Phase 2 CheckMate -142 trial results showing nearly two-thirds of patients responded to the Opdivo plus Yervoy combination with durable responses observed. The combination of Opdivo plus Yervoy is the first approved dual immunotherapy treatment option for any GI tumor in the European Union (EU). months).

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Drug Target Review

SEPTEMBER 26, 2023

1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. 2018 Mar;17(3):167–81.

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