A Dose of Drug Development

SEPTEMBER 17, 2018

By: Kevin Cho Despite market volatility, 2018 has been on an astounding year for the biotech companies. How Integrium as a company plays a role in advanced technology such as these is that Integrium has the advantage of having 20 years of experience with variety of therapies within its portfolio. BIL and the year is yet to be over.

Marketing 40

Marketing Therapies 40

Drug Target Review

NOVEMBER 7, 2023

To test which patients are more likely to respond to LYTAC therapy, the level of neddylated CUL3 could be measured. Enzyme replacement therapy is a frequent treatment for these disorders. 2018 December [2023 November 1]; 6(24):476. The team also found proteins that block LYTACs from functioning normally. References 1 Sun A.

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Therapies Science Disease Treatment 59

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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FDA Disease Clinical Pharmacology Science 105

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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Therapies Production Disease Treatment 52

The Pharma Data

DECEMBER 22, 2020

Tagrisso Approved as Adjuvant Therapy for NSCLC With EGFR Mutations. Tagrisso was approved in 2018 for first-line treatment of patients with metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R mutations. Professional. TUESDAY, Dec. Food and Drug Administration announced Friday.

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Therapies Treatment FDA Disease 52

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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FDA Approval Therapies FDA Disease 52

Eye on FDA

AUGUST 4, 2021

Below is a chart that looks at 3 numbers – the number of AdComms; the number of new molecular entities approved each year, and the number of drugs that had breakthrough therapy designation. Fewer meetings – more approvals.

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FDA Clinical Pharmacology FDA Approval Therapies 122

Drug Target Review

DECEMBER 28, 2023

In most cancers, the tumour evolves by acquiring mutations that confer growth advantages or resistance to therapies. However, if the therapy targets only the subclonal (branch) mutations, this will result in the mere ‘pruning’ of specific branches rather than elimination of the whole cancer.

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Bioinformatics Immune Response DNA Vaccine 105

Drug Target Review

NOVEMBER 6, 2023

2 It is this complexity that necessitates powerful, targeted combination therapies. 4, 5 More recently, new combination regimens have emerged that incorporate targeted therapies to treat a variety of blood cancers, including multiple myeloma (MM), chronic lymphocytic leukaemia (CLL) and acute myelogenous leukaemia (AML).

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Small Molecule Therapies Treatment Disease 111

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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Drugs Therapies Regulations RNA 128

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

JANUARY 25, 2024

The peptide in development is based on a 2018 Cleveland Clinic discovery and serves as a proof-of-concept for this type of drug for triple-negative breast cancer. 2 The cells of this cancer lack certain receptors so drugs designed to treat other subtypes of breast cancer will not work.

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Treatment Clinical Trials Science Research 105

Drug Target Review

OCTOBER 11, 2023

1,2 Many, however, do have dysfunctional proteins at their core, and for these diseases, a new option is being explored: autophagy-boosting therapies. Gene therapy, of course, also holds great promise. 2018 [cited 2023 Sep 5]. Most of these conditions are genetic in origin and the majority have no effective treatment.

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Disease Treatment Small Molecule Therapies 113

Drug Target Review

JULY 7, 2023

This gives epigenetic editing the unique ability to treat complex multigenic diseases and opens the door to enhancing cell and regenerative therapies, which require the manipulation of multiple genes for optimal results. She is currently focused on using genetic tuning to enhance and develop cell and gene therapy products for clinical impact.

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DNA Engineering Therapies Regulations 105

Drug Target Review

OCTOBER 4, 2023

Dual payload ADCs As effective as therapies have been in treating solid and haematological cancers, tumour heterogeneity and resistance remain major clinical challenges. To overcome these obstacles, combination therapy, which delivers multiple small molecules, has emerged as a potential solution. 1 , 33–43 (2018). Cancer Res.

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Small Molecule Drugs Immune Response Targeted Protein Degradation 126

Drug Target Review

JANUARY 17, 2024

This insight could lead to potential therapies to prevent treatment resistance. The dataset became the largest of its kind, which featured matched tumour samples from 123 glioblastoma patients at diagnosis and then recurrence after initial therapy. World Neurosurgery 2018 August [2024 January 12]; 116:505-17.

Treatment 59

Treatment Therapies Disease Drugs 59

NIH Director's Blog: Drug Development

NOVEMBER 15, 2018

Wimley is working hard to change that, since peptides have shown promise as therapies against some microbes, dubbed “superbugs,” that have developed resistance to multiple drugs and present a serious health threat, especially to people with weakened immune systems. 2018 Jul 2;9(1):2568. [2] Kauffman WB, Guha S, Wimley WC. Nat Commun.

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Science Drugs Disease Therapies 52

Drug Target Review

AUGUST 24, 2023

Neutralising GDF-15 with CatalYm’s anti-GDF-15 antibody visugromab was shown to reverse its inhibitory effects and to re-sensitise tumours to anti-PD-1 treatment, achieving commensurate survival benefit of anti-GDF-15-anti-PD-1 combination therapy in vivo.

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Treatment Therapies Clinical Development Cell Biology 98

Drug Target Review

SEPTEMBER 26, 2023

Early detection of neurotoxicity induced by potential new therapies is a major challenge, and hiPSC-neuronal cells may provide a solution. 2018 Mar;17(3):167–81. 2018 Dec 11;94(10):390–411. 2018;(136):56573. Morgan P, Brown DG, Lennard S, Anderton MJ, Barrett JC, Eriksson U, et al. Nat Rev Drug Discov. 2016;81:37–46.

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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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Therapies Doctors Treatment Research 52

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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Disease Clinical Trials Therapies Science 111

New Drug Approvals

SEPTEMBER 23, 2024

There are no current small molecule therapies targeting the underlying cause of the disease, leaving a high unmet need for medications that can be used for treating or ameliorating HD. Consequently, there remains a need to identify and provide small molecule compounds for treating or ameliorating HD. SCHEME PATENT PTC Therapeutics Inc.,

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Small Molecule RNA DNA Disease 57

The Pharma Data

JANUARY 14, 2021

For the full year of 2019, Xalkoria brought in $530 million, an increase of 1% from 2018. “We We are proud to deliver the first biomarker-driven therapy for children and young adults with ALCL,” said Chris Boshoff, chief development officer, Oncology, Pfizer Global Product Development.

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FDA Approval FDA Therapies Treatment 52

Codon

JULY 14, 2024

While this departs from the reductionist, single-component therapies that have dominated transfusion medicine since World War II, emerging data underscores that whole blood transfusions—blood with all its parts—yield better outcomes following severe blood loss than transfusions involving discrete blood components. Always free.

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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. About Targeted Alpha Therapies (TAT) at Bayer Targeted Alpha Therapies (TAT) are an emerging class of radionuclide therapy for various difficult to treat tumors.

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The Pharma Data

MARCH 16, 2021

Viela was founded in 2018 as a spinout from AstraZeneca, with clinical and pre-clinical projects from AstraZeneca’s inflammation and autoimmunity pipeline. AstraZeneca. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Treatment 52

Treatment Science Disease Therapies 52

The Pharma Data

OCTOBER 23, 2020

breast cancer units between 2013 and 2018. The propensity-matched analysis included 426 surgery and 240 primary endocrine therapy (PET) patients matched for age, fitness, and frailty. Lynda Wyld, M.B.Ch.B., The researchers found that the median age varied by treatment allocation (surgery: 76 years; PET: 84 years). © 2020 HealthDay.

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Therapies Treatment Research 52

The Pharma Data

OCTOBER 20, 2020

In hopes to advance the best and brightest, MD Anderson, in partnership with The Focus Fund GP, has launched the Cancer Focus Fund to propel compelling investigational cancer therapies from preclinical development through Phase II clinical trials. But now they’ll be choosing the therapies themselves. . Cancer is still the No.

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Clinical Trials Therapies Pharma Companies Trials 52

DrugBank

OCTOBER 4, 2024

For example, Takeda Pharmaceutical's $62 billion acquisition of Shire plc in 2018 expanded its global footprint and tapped into Shire's strong presence in emerging markets. The Evolving Regulatory System Regulatory frameworks play a pivotal role in shaping the pharmaceutical M&A landscape.

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Pharmaceuticals Pharmaceutical Companies Therapies Marketing 81

The Pharma Data

DECEMBER 9, 2020

This acquisition will significantly strengthen Boehringer Ingelheim’s focus on targeted cancer cell therapies, gaining the company access to NBE’s innovative immune-stimulatory iADC platform. . The German company bought ViraTherapeutics in 2018 and cancer vaccine creator AMAL Therapeutics the next year. billion US. .

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FDA Approval Clinical Development Therapies Vaccine 52

PPD

SEPTEMBER 6, 2023

Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. In 2018, market utilization of FSO models was at 72%, with usage of FSP models lagging at 28%. Growth of the FSP market is steadily increasing.

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Drug Development Clinical Trials Drugs Clinical Research 98

Eye on FDA

DECEMBER 6, 2023

First, there was an increase in the number of meetings held to consider the status of new medicines, the most since 2018 and far more than were held in 2020, 2021 and 2022. The Antimicrobial and the Cellular, Tissue, and Gene Therapy each met three times. There are two things of note from this year.

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FDA FDA Approval Therapies Drugs 77

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. She joined the company in November 2018 with more than 10 years of experience in drug discovery and non-clinical development of immunomodulatory drugs in the immuno-oncology space.

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Science Clinical Development Treatment DNA 105

The Pharma Data

JANUARY 20, 2021

The combination therapy involves an injectable medication called extended-release naltrexone and a daily generic pill called bupropion. A separate NIDA study finds that methamphetamine overdose deaths in the United States surged from 2011 to 2018, increasing fivefold in just eight years. WEDNESDAY, Jan. That report was published Jan.

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Drugs Therapies Treatment Clinical Trials 52

FDA Law Blog: Drug Discovery

DECEMBER 13, 2023

An Opportunity to Convene this New Advisory Committee for All Rare Disease Therapies In 2018, HP&M attorneys Frank Sasinowski and James Valentine proposed a Rare Disease Center of Excellence (which we blogged about here ).

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Disease Production FDA Drug Development 59

The Pharma Data

APRIL 23, 2021

European Commission approves GSK’s JEMPERLI (dostarlimab), the first anti-PD-1 therapy approved for recurrent or advanced endometrial cancer. The approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe. Hormone replacement therapy for endocrinopathies should be instituted as warranted.

Therapies 40

Therapies Treatment Licensing Licensing 40

Eye on FDA

MARCH 5, 2023

Just to recap, for the entire year of 2022 there were only 14 meetings held to consider whether new medicines should be recommended for approval, a slight increase over the 10 the year before, but considerably lower fewer than 2018 and 2019 when there were 29 and 22 meetings held, respectively.

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FDA Vaccine Drugs Therapies 72