Drug Target Review

NOVEMBER 6, 2023

Advances in research and development and the utilisation of combination treatment strategies are revolutionising the haematology care landscape, but more must be done to address patients’ individual needs. 2 It is this complexity that necessitates powerful, targeted combination therapies.

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Eye on FDA

AUGUST 4, 2021

Each committee is comprised of a number of experts, diverse for their expertise, geography and specialty – with some focused on statistics while others may be focused on areas of concentration within the category, such as the treatment of pediatric patients. Fewer meetings – more approvals.

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Drug Target Review

NOVEMBER 7, 2023

Chemists at Stanford University discovered how one of the pathways leading to this protein “woodchipper” works furthering the understanding of new therapeutics for autoimmune diseases, age-related disorders, and treatment-resistant cancers. Enzyme replacement therapy is a frequent treatment for these disorders.

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FDA Law Blog: Drug Discovery

JULY 17, 2024

An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.

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The Pharma Data

DECEMBER 17, 2020

18, 2020 /PRNewswire/ — Camurus AB (NASDAQ STO: CAMX) announced today that the Swiss agency for therapeutic products, Swissmedic, has approved weekly and monthly Buvidal ® prolonged release buprenorphine for the treatment of opioid dependence in adults and adolescents from 16 years of age. LUND, Sweden , Dec. About Buvidal.

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The Pharma Data

NOVEMBER 9, 2020

Talaris Chief Executive Officer Scott Requadt sees FCR001, the company’s investigational cell therapy, as a potential pipeline in a product (an experimental treatment that could have multiple uses across a number of indications). When that unit dissolved, rights to FCR001 reverted to Regenerex.

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The Pharma Data

DECEMBER 22, 2020

Tagrisso Approved as Adjuvant Therapy for NSCLC With EGFR Mutations. 22, 2020 — Tagrisso ( osimertinib ) received approval as an adjuvant treatment for patients with non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, the U.S. Professional. TUESDAY, Dec.

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Drug Target Review

OCTOBER 4, 2023

Antibody-drug conjugates (ADCs) have been a groundbreaking approach to cancer treatment with their ability to deliver cytotoxic drugs directly to diseased cells while sparing healthy tissues. To overcome these obstacles, combination therapy, which delivers multiple small molecules, has emerged as a potential solution.

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The Pharma Data

FEBRUARY 8, 2021

Janssen Announces Treatment with ERLEADA ® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer. In addition, health-related quality of life (HRQoL), per total Functional Assessment of Cancer Therapy–Prostate (FACT-P), continued to be maintained with ERLEADA ®.

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Broad Institute

JANUARY 22, 2024

Since 2018, the Cancer Dependency Map (DepMap) Consortium , an academic-industrial partnership launched by the Broad, has uncovered several potential drug targets by systematically screening cancer models in search of genetic dependencies. By Allessandra DiCorato January 22, 2024 Bill Sellers is the head of Broad's Cancer Program.

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Drug Target Review

SEPTEMBER 4, 2023

7,9 Dihydrofolate reductase-thymidylate synthase (DHFR) have been successfully exploited for the therapy of bacterial infections and other parasitic diseases such as malaria. 2018): Ubiquitin Proteasome pathway proteins as potential drug targets in parasite Trypanosoma cruzi, Scientific Reports. (8):8399. link] Ojewale Kayode (2018).

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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

JANUARY 11, 2021

-based subsidiary of Terumo and a global neurovascular company, announced today the FDA Approval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. The WEB System received its first PMA approval in late 2018.

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The Pharma Data

APRIL 17, 2021

TECFIDERA was approved under the National Medical Products Administration priority review process evaluating therapies with urgent clinical needs. Biogen’s expansion in China now includes treatment options approved for relapsing MS and spinal muscular atrophy. We thank the NMPA for undertaking priority review to approve TECFIDERA. “We

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PLOS: DNA Science

JUNE 1, 2023

The newest FDA-approved gene therapy treats the severe, skin-peeling condition dystrophic epidermolysis bullosa (DEB). The gene treatment has been a long time coming, but it differs from the handful of other approved gene therapies: it isn’t a one-and-done. DEB has been a candidate for a gene therapy since 2002.

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The Pharma Data

OCTOBER 26, 2020

Food and Drug Administration (FDA) has approved EYSUVIS for the short-term treatment of dry eye disease. . EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. Over-the-counter treatments fail due to the body’s natural protective system. 25% for dry eye disease treatment.

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The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of the novel combination of the cancer treatments copanlisib and rituximab. submission is for the treatment of patients with relapsed indolent B-cell non-Hodgkin’s lymphoma (B-iNHL). Fields, M.D.,

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Drug Target Review

JANUARY 17, 2024

This insight could lead to potential therapies to prevent treatment resistance. Furthermore, the stem cell-like characteristics promote resistance to treatment through upregulation of efflux transporters, promotion of glioblastoma stem cell proliferation in neurogenic zones, and immune suppression.

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The Pharma Data

DECEMBER 3, 2020

The TAK-620-303 (SOLSTICE) trial (NCT02931539) is a multicenter, randomized, open-label, active-controlled trial comparing eight weeks of treatment with either maribavir or investigator assigned treatment (IAT) in transplant recipients with CMV infection refractory or resistant to existing antiviral treatments (i.e.,

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The Pharma Data

NOVEMBER 24, 2020

25, 2020 /CNW/ – On August 21, 2020 , Health Canada approved Lynparza® (olaparib), for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA or ATM- mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with a new hormonal agent (NHA).

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The Pharma Data

SEPTEMBER 18, 2020

Tecentriq in combination with Avastin was also recently included as a class I, A recommendation by the European Society for Medical Oncology (ESMO) for the treatment of unresectable HCC, as well as by many clinical practice guidelines globally. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

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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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The Pharma Data

MARCH 13, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for lanadelumab subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema (HAE).

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Drug Target Review

APRIL 3, 2024

Our company has identified a new role for Growth Differentiation Factor 15 (GDF-15) as a potent local immunosuppressor mediating cancer resistance to therapy. Visugromab is a monoclonal antibody – a treatment modality that has been extensively studied and de-risked.

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Drug Target Review

JULY 7, 2023

When targeted gene editing became a reality more than ten years ago, many people hoped for a revolutionary tsunami of new medical treatments. Epigenetic editing combines the power of multiplexing with the precise control of expression needed to expand the reach of gene therapies, enhance cell therapies, and enable genetic medicine.

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The Pharma Data

SEPTEMBER 9, 2020

CERENOVUS Launches New Suite of Technologies to Advance Stroke Treatment. CERENOVUS Launches New Suite of Technologies to Advance Stroke Treatment. The announcement was made during the virtual European Society of Minimally Invasive Neurological Therapy (ESMINT). Stroke Research and Treatment, Hindawi, 27 Nov.

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Drug Target Review

JUNE 21, 2023

Enabling the systematic discovery of these largely uncharted targets can be a valuable opportunity for development of novel therapies. Genetic-based therapeutics hold significant promise in the clinic Despite the growing number of genes linked to human disease, the proportion of genes targeted by approved therapies remains low.

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The Pharma Data

JUNE 30, 2021

The EC’s decision is based on results from the Phase 2 CheckMate -142 trial in which Opdivo plus Yervoy demonstrated a clinically meaningful improvement in objective response rate (ORR) in patients with MSI-H/dMMR mCRC who received prior treatment with fluoropyridine, oxaliplatin and irinotecan. achieving a complete response.

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The Pharma Data

JUNE 28, 2021

Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA small molecule for the treatment of prostate cancer. The pre-IND program focuses on the treatment of prostate cancer, the second most commonly diagnosed cancer in men. Noria) and PSMA Therapeutics Inc.

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The Pharma Data

JANUARY 14, 2021

The approval was based on data from Study ADVL0912, a multicenter, single-arm, open-label trial in 121 patients ranging in ages from one to 21, and included 26 patients with r/r/, systemic ALK-positive ALCL after at least one systemic treatment. For the full year of 2019, Xalkoria brought in $530 million, an increase of 1% from 2018. “We

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The Pharma Data

MARCH 16, 2021

Viela (Nasdaq: VIE), headquartered in Gaithersburg, Maryland, is a biotechnology company dedicated to the discovery, development and commercialisation of novel treatments for autoimmune and severe inflammatory diseases. AstraZeneca.

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Codon

JULY 14, 2024

The transfusion of platelets thus seems like an obvious treatment to stem bleeding. From Early Transfusion to Component Therapy The earliest documented attempts at blood transfusions involved the transfer of blood from animals to humans in the 17 th century. Component therapy offers several advantages over whole blood.

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The Pharma Data

OCTOBER 20, 2020

When thinking of cancer treatment centers, you likely think of the MD Anderson Cancer Center in Houston, TX. But they know they’re not the only ones out there with innovative ideas for cancer treatment. . After IND approval, MD Anderson will continue to support the chosen therapies by designing and hosting clinical studies.

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The Pharma Data

OCTOBER 29, 2020

29, 2020 — Long-term use of estrogen-only and combined estrogen and progestogen hormone replacement therapy (HRT) is associated with an increased risk for breast cancer, according to a study published online Oct. Study Updates Risks for Breast Cancer Associated With HRT. THURSDAY, Oct. 28 in The BMJ. Yana Vinogradova, Ph.D.,

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The Pharma Data

JANUARY 20, 2021

20, 2021 — In what may signal a seismic shift in the treatment of methamphetamine addiction, a pair of prescription drugs appears to help patients significantly reduce their stimulant use, or quit altogether. Standard behavioral treatment for meth addiction typically involves highly structured group therapy, Volkow explained.

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Eye on FDA

AUGUST 27, 2023

But in fact, as can be seen in previous years such as 2019, 2018 and 2015, the mid-year tally (in red) is not always predictive of what we may see by year’s end (in blue). AdComms and Approval Votes Are Up – In addition to NME approvals, there have been an increased number of FDA Advisory committees held to discuss new treatments.

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Codon

NOVEMBER 3, 2024

In the 1924 novel, The Magic Mountain , Thomas Mann describes a sanatorium patient named Anton Ferge as he undergoes a painful tuberculosis (TB) treatment. These challenges have led to strategies such as directly observed therapy (DOT), in which nurses or physicians monitor patients to ensure they take their medicine every day.

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