Alta Sciences

JULY 3, 2025

It’s not just about staying ahead of the curve; it’s about helping our clients bring life-changing therapies to the people who need them, faster and more efficiently. ABOUT THE AUTHOR: LISA SANFORD Lisa Sanford joined Altasciences in 2020 and is currently the Vice President of Business Development. Ready to advance your next project?

Small Molecule 52

Small Molecule Drug Development Pharmaceuticals Science 52

SugarCone Biotech

MARCH 24, 2025

When we look at how TCEs interact with targeted cancer cells we can quickly see how cancers respond to T Cell-based therapies. The most common response is quite expected, which is that the cancer cells escape from TCE therapy by downregulating expression of the targeted cancer protein (Ref. Proc Natl Acad Sci U S A 115: E2068-E2076.

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Immune Response Therapies Treatment Disease 64

Drug Target Review

JUNE 5, 2025

Despite recent advances in gene therapy for sickle cell disease (SCD) , automated red blood cell exchange (aRBCX) remains a cornerstone therapy that plays a vital yet underutilised role in managing complications and enhancing quality of life for millions living with this devastating condition worldwide.

Disease 52

Disease Treatment Therapies Nurses 52

DrugBank

JUNE 18, 2025

Before a therapy can be approved for patient use, it must undergo extensive clinical testing and strictly adhere to regulatory guidelines. In 2020, the FDA halted Johnson & Johnson’s COVID-19 vaccine production at a contract manufacturing facility after discovering quality control issues.

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Drug Development Clinical Trials Compliance Drugs 52

New Drug Approvals

APRIL 25, 2025

3] Primary endocrine resistance was defined as relapse while on the first two years of adjuvant endocrine therapy (ET) and secondary endocrine resistance was defined as relapse while on adjuvant ET after at least two years or relapse within twelve months of completing adjuvant ET. [3] New Drug Therapy Approvals 2024 (PDF).

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FDA FDA Approval Therapies Trials 57

New Drug Approvals

MAY 9, 2025

Eligible participants had experienced disease progression on one or two prior lines of endocrine therapy , including one line with a CDK4/6 inhibitor , and could have received up to one prior line of chemotherapy in the advanced or metastatic setting. [2] 1] [4] It is taken by mouth. [1] 3] [7] PATENTS Cruskie MP, et al.

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FDA Pharmacokinetics Therapies Treatment 62

LifeSciVC

JULY 8, 2025

One team might be working on a cell therapy, another on RNA, another on small molecules. The exuberance of 2020–2021 has given way to a more constrained, unpredictable landscape. These organizations rarely follow a single asset path. They run portfolios across multiple programs, modalities, and often geographies.

Hospitals 54

Hospitals Small Molecule Science Nurses 54

Chemical Biology and Drug Design

DECEMBER 30, 2024

In 2020, two selective RET inhibitors, selpercatinib and pralsetinib were approved by the US FDA. G810C/S/R) become the new challenges for RET-based therapies. ABSTRACT RET (Rearranged during transfection) kinase is a validated target for non-small cell lung cancer (NSCLC).

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FDA Therapies Treatment Research 100

Codon

NOVEMBER 3, 2024

The experience showed me that new therapies are needed not only to meet the targets laid out by the End TB Strategy but also to prevent drug resistance from negating the effectiveness of current therapeutics. Cell (2020). coli plated onto media containing halicin or ciprofloxacin antibiotics, after 7 days of incubation.

Vaccine 113

Vaccine Trials Therapies Treatment 113

Codon

JUNE 5, 2025

The treatment, now known as Casgevy, became the first CRISPR-based therapy to gain FDA approval, in 2023. Such off-target cuts are obviously a big concern when developing human therapies, because they can cause mutations that lead to cancer or other diseases.

DNA 81

DNA RNA Clinical Trials Engineering 81

BioPharma Drive: Drug Pricing

JUNE 11, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. Among those who had gotten another such therapy, the rates were 52% and 62% in those trials.

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FDA Drugs Therapies Science 273

The Pharma Data

JULY 3, 2025

NASDAQ: SBFM), a pharmaceutical company focused on developing and commercializing life-saving medicines across oncology, antiviral therapies, and other therapeutic areas, has announced the commercial launch of its first biosimilar drug, NIOPEG® , in Canada. The launch was executed through its wholly owned Canadian subsidiary, Nora Pharma Inc.,

Marketing 52

Marketing Biosimilars Pharmaceutical Companies Pharmaceuticals 52

LifeSciVC

JUNE 12, 2025

Building medicines by activating biological pathways As I joined the Company in Q4 2020 as its CEO, I had a vision of creating protein variants to activate biological pathways. Atlas Venture and NEA were early believers, incubating Korro Bio and providing the initial capital and strategic support needed to turn this vision into reality.

RNA 67

RNA Protein Expression DNA Science 67

New Drug Approvals

JUNE 29, 2025

2020/0062765) was dissolved in ethanol (604 mL) at 50℃. 3] The US Food and Drug Administration (FDA) granted the application for taletrectinib priority review , breakthrough therapy , and orphan drug designations. [3] Example 5: Preparation and Characterization of Crystalline Form A of Compound 1 Free Base [0212] Compound 1 HCl (75.5

International 62

International FDA Clinical Trials Treatment 62

Codon

NOVEMBER 1, 2024

A 200x drop in price over twenty-five years is impressive, but these costs have now flatlined — or have even risen — since 2020. Today, a single injection of an FDA-approved gene therapy, called Hemgenix , cures this disease. Today, the same feat can be done for about $0.10.

DNA 132

DNA RNA Molecular Biology Laboratories 132

BioPharma Drive: Drug Pricing

JULY 18, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. Food and Drug Administration headquarters in Silver Spring, Md.,

Therapies 162

Therapies FDA Clinical Trials Licensing 162

New Drug Approvals

APRIL 18, 2025

2] The US Food and Drug Administration (FDA) granted the application for crinecerfont fast track , breakthrough therapy , orphan drug , and priority review designations. [2] New Drug Therapy Approvals 2024 (PDF). 8 May 2020). 2] The primary measure of efficacy was the change from baseline in serum androstenedione at week four.

FDA 62

FDA FDA Approval Drugs Trials 62

New Drug Approvals

APRIL 19, 2025

4] Landiolol can be used as first-line treatment for acute ventricular rate control in patients with atrial fibrillation (Level I recommendation- 2020 Guidelines of the European Society of Cardiology [15] ). New Drug Therapy Approvals 2024 (PDF). Mode of action The drug acts as an ultra-short-acting 1-selective blocking agent.

FDA 62

FDA Clinical Trials Treatment Trials 62

New Drug Approvals

JULY 8, 2025

US FDA granted fast track designation for pritelivir in 2017 and breakthrough therapy designation 2020. NCT03073967 ^ 2020-004940-27 ^ Biswas, S.; It is currently in Phase III clinical development by the German biopharmaceutical company AiCuris Anti-infective Cures AG. 316 (23): 2495–2503. doi : 10.1001/jama.2016.18189.

Virus 62

Virus DNA Clinical Trials Treatment 62

Drug Patent Watch

JANUARY 13, 2025

from 2020 to 2025[1]. Oncology: Expanding Access to Life-Saving Treatments In the field of oncology, biosimilars have made significant inroads, particularly in supportive care and targeted therapies. ”[1] The global biosimilars market is experiencing exponential growth, with projections indicating it will reach $69.4

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Biosimilars Marketing Treatment Small Molecule 61

BioPharma Drive: Drug Pricing

JULY 9, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. billion purchase of Intra-Cellular Therapies , according to data tracked by BioPharma Dive. Alamy Merck & Co.

Clinical Trials 281

Clinical Trials Drugs Therapies Licensing 281

BioPharma Drive: Drug Pricing

JULY 14, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. In 2020, Partners Group flipped its ownership stake to Mubadala. You can unsubscribe at anytime. drug production.

Production 154

Production Drugs Therapies Clinical Trials 154

New Drug Approvals

JULY 18, 2025

2020, 63, 8554−8566. (7) China Patent CN 111892636, 2020. In August 2020, the Chang group found that the substance inhibits vif in vitro. [22] 14] Azvudine was found to inhibit some coronaviruses in vitro around 2020, leading to an interest in its use in COVID. Harrison C (April 2020). October 2020).

RNA 62

RNA Clinical Trials Trials Virus 62

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Therapies FDA FDA Approval Treatment 119

Drug Target Review

FEBRUARY 28, 2024

Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers.

Therapies 105

Therapies Engineering Molecular Biology Science 105

Drug Target Review

OCTOBER 5, 2023

The research team identified 231 individuals diagnosed with relapsing-remitting MS, with 174 of them having undergone aHSCT treatment before the year 2020. While further research is needed, this study provides a significant step forward in the pursuit of improved therapies for individuals living with RRMS.

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Therapies Treatment Clinical Trials Disease 116

Drug Discovery Today

MAY 21, 2020

Translational Programme established for FIH late stage HER2 positive breast cancer in Q4 2020

Hospitals 100

Hospitals Production Therapies 100

The Pharma Data

JANUARY 12, 2021

Preliminary revenue for the fourth quarter of 2020 is expected to be approximately $40.6 Preliminary revenue for the fourth quarter of 2020 is expected to be approximately $40.6 Preliminary revenue for the full year 2020 is expected to be approximately $125.4 2020 was a transformational year for Vapotherm.

Therapies 52

Therapies Production Marketing Regulations 52

Drug Discovery Today

APRIL 22, 2020

Cambridge, UK, and Brisbane, CA, 21 April 2020 Mogrify Ltd (Mogrify®), a UK company aiming to transform the development of cell therapies by the systematic discovery of novel cell conversions, and Sangamo Therapeutics (Sangamo) (Nasdaq: SGMO), a genomic medicine company, today announced that they have executed a collaboration and exclusive license (..)

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Licensing Licensing Engineering Therapies 100

Drug Discovery Today

NOVEMBER 5, 2020

London, November 4th, 2020: NanoMab Technology Limited, a privately held biopharmaceutical company focussing on cancer precision therapies, today announced that it had received CTA Acceptance from the Medicines Healthcare products Regulatory Agency (MHRA) to carry out a Phase II clinical Study for its NM-01 product.

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Production Therapies 100

The Pharma Data

DECEMBER 21, 2020

FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer. 21, 2020 — Orgovyx (relugolix) is now approved to treat advanced prostate cancer and is the first oral hormone therapy approved for this indication, the U.S. © 2020 HealthDay. Posted: December 2020. MONDAY, Dec. More Information.

FDA Approval 52

FDA Approval Therapies FDA Science 52

Eye on FDA

AUGUST 18, 2020

But it is not likely to surprise anyone that the first half of 2020 has caused not only an increase in communication from FDA, but a focus as well. Approvals – There were 54 press statements regarding approvals so far in 2020, comparing to 42 approvals announced in 2019.

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FDA Production Drugs Therapies 61

Advarra

NOVEMBER 29, 2022

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

Therapies 52

Therapies Clinical Trials FDA Production 52

Drug Target Review

NOVEMBER 7, 2023

To reach the other 40 percent of those proteins, Stanford ChEM-H researchers pioneered lysosome targeting chimeras (LYTACs) in 2020. 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.

Therapies 59

Therapies Science Disease Treatment 59

The Pharma Data

DECEMBER 11, 2020

11, 2020 — Results from a long-term study of a gene therapy technique to prevent inherited mitochondrial disease show promise, researchers say. The therapy under investigation replaces disease-causing mutations in a mother’s egg with donor mitochondria. © 2020 HealthDay. Posted: December 2020.

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Therapies Clinical Trials Disease Trials 52

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. © 2020 HealthDay. Professional.

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Therapies Treatment FDA Disease 52

The Premier Consulting Blog

MARCH 7, 2024

The FDA’s January 2020 guidance, Chemistry, Manufacturing and Control (CMC) [1] Information for Human Gene Therapy Investigational New Drug Applications (INDs), outlines the analytical methods that define the quality, safety and efficacy of gene therapy therapeutics.

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Production Therapies DNA Virus 52