Drug Discovery World

JANUARY 11, 2024

Argininosuccinic aciduria is an inherited metabolic disorder that affects how the body breaks down protein – potentially leading to high levels of ammonia in the blood. Patients affected by the disease are found to also experience an imbalance of glutathione regulation, which is important for liver detoxification.

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XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Regulators may ask at some point to provide that documentation, so it’s important to track that across the study.

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The Pharma Data

JANUARY 17, 2021

The treatment is based on the Grifols immunoglobulin Gamunex®-C, and contains anti-SARS-COV-2 polyclonal antibodies from plasma donors who have recovered from COVID-19. It could also help contain outbreaks in places where the vaccination hasn’t begun or is still underway. BARCELONA, Spain , Jan. and on the U.S.

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The Pharma Data

NOVEMBER 22, 2020

As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. Trials are also being run in the U.S.,

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Drug Discovery World

AUGUST 21, 2023

Medications containing semaglutide such as Ozempic, licensed for diabetes, and Wegovy, for weight loss, are being studied to see if they can treat a range of different conditions, including addiction and dementia. It’s an exciting area,” he told The Guardian.

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Pharma in Brief

DECEMBER 17, 2023

According to the Minister, JAMP’s new drug submission for SIMLANDI did not engage the Patented Medicines (Notice of Compliance) Regulations ( Regulations ). As a consequence, the Court’s recent decision of December 4, 2023 does not concern the Regulations , but rather parallel actions brought under the Patent Act. A-203-22).

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Antibody Production Regulation Marketing 52

pharmaphorum

SEPTEMBER 25, 2020

Leap Therapeutics will get a swift FDA review for its lead drug DKN-01 for a form of gastric and gastroesophageal junction (G/GEJ) cancer after being awarded fast-track status by the regulator.

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XTalks

AUGUST 6, 2020

Epidiolex is the only FDA-approved formulation that contains CBD derived from the cannabis plant. CBD is the most abundant non-psychoactive cannabinoid compound found in the cannabis plant, making up about 40 percent of the plant’s extract, which contains over 100 different cannabinoid compounds.

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The Pharma Data

JANUARY 10, 2021

PLANEGG / MUNICH, GERMANY / ACCESSWIRE / January 11, 2021 / MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR), a commercial-stage biopharmaceutical company and a leader in antibody, protein and peptide technologies, announced today that Jean-Paul Kress, M.D.,

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Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug. For biosimilars, however, this process is slightly more complex.

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XTalks

MARCH 10, 2023

It is caused by a mutation in the FXN gene , which is responsible for the production of the protein frataxin. Omaveloxolone Clinical Trials Skyclarys is an oral medication that contains omaveloxolone, an activator of the nuclear factor-erythroid 2 related factor 2 (Nrf2) pathway.

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XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease. Malaria Vaccine Phase II Trial.

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The Pharma Data

JANUARY 29, 2021

Following review of the application, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from a rolling review of trial data from the primary analysis of the Phase III programme led by the University of Oxford.

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The Pharma Data

JANUARY 29, 2021

Following review of the application, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from a rolling review of trial data from the primary analysis of the Phase III programme led by the University of Oxford.

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XTalks

JANUARY 28, 2022

Immunocore received Breakthrough Device Designation for Kimmtrak from the FDA in February 2021 followed by acceptance of its Biologics License Application (BLA) several months later by both US and European regulators. Kimmtrak is a bispecific protein that contains a soluble T cell receptor fused to an anti-CD3 immune-effector function.

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XTalks

NOVEMBER 10, 2023

The US Food and Drug Administration (FDA) has approved Takeda Pharmaceuticals’ Adzynma, the first recombinant protein product for prophylactic (preventive) or on‑demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare blood clotting disorder.

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FDA Approval Gene Therapy Gene Clinical Trials 59

The Pharma Data

DECEMBER 13, 2020

RLY-1971 is a potent small molecule inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2). SHP2 is a critical signaling node and regulator that promotes cancer cell survival and growth through the RAS pathway, playing a key role in the way cancer cells develop resistance to targeted therapies. About RLY-1971.

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The Pharma Data

DECEMBER 30, 2020

AstraZeneca’s COVID-19 vaccine candidate AZD1222 is a viral vector-based, weakened version of adenovirus containing the genetic material of SARS-CoV-2 spike protein. During Phase III trials, one of the cohorts was administered one and a half doses, as opposed to two full doses. AstraZeneca’s efficacy is at 70.4%.

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The Pharma Data

MARCH 14, 2021

Furthermore, in clinical trials, even though the number of thrombotic events was small, these were lower in the vaccinated group. All tests need to meet stringent criteria for quality control and this data is submitted to regulators within each country or region for independent review before any batch can be released to countries.

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Drug Discovery World

DECEMBER 29, 2023

Dr Sofia Ferreira, Director of Applications at Refeyn, discusses how various technologies can address the main challenges in membrane protein characterization, describing how novel technologies, such as mass photometry, can streamline and support analytical processes. Scientists use a multitude of membrane mimetics to overcome this issue.

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The Pharma Data

JANUARY 6, 2021

The vaccine was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose. In addition to the University of Oxford-led trials, the Company is conducting a large trial in the US as part of a global programme.

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The Pharma Data

AUGUST 24, 2020

TGF-beta is a key cytokine that regulates various cell processes, including regulation of the immune system. In contrast, TGF-beta 2 is a positive regulator of hematopoiesis and normal cardiac function, and blockade of TGF-beta 2 is therefore undesirable. AVID200 neutralizes TGF-beta 1 and -beta 3 with picomolar potency.

Regulation 52

Regulation Engineer Development Protein 52

Delveinsight

OCTOBER 1, 2021

This disease is associated with antibodies directed against the acetylcholine receptor, muscle-specific kinase (MUSK), lipoprotein-related protein 4 (LRP4), or agrin in the postsynaptic membrane at the neuromuscular junction. Prograf is available for oral administration in the form of capsules (tacrolimus capsules USP) containing 0.5

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The Pharma Data

NOVEMBER 12, 2020

Keros is a leader in understanding the role of the transforming growth factor-Beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Cautionary Note Regarding Forward-Looking Statements.

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The Pharma Data

NOVEMBER 4, 2020

The antibody is designed to bind to misfolded light chain protein and amyloid and shows binding to both kappa and lambda subtypes. This press release may contain “forward-looking statements,” including as such term is defined within Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended.

Antibody 52

Antibody Containment Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 30, 2021

Overall, Leqvio was well-tolerated, with a safety profile similar to placebo and consistent with the overall pooled population from the combined trials 1 – 3. About the pooled post hoc analyses from Phase III ORION-9, -10 and -11 trials in patients with established cerebrovascular disease and patients with polyvascular disease.

RNA 52

RNA Trials Production Containment 52

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Sanofi, Empowering Life.

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Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Empowering Life. www.sanofi.com.

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Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

DECEMBER 18, 2020

The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. The vaccine was 94.1% SOURCE U.S. Food and Drug Administration.

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Vaccination Vaccine Production Manufacturing 52

The Pharma Data

NOVEMBER 16, 2020

We are pleased to submit these extended stability conditions for mRNA-1273 to regulators for approval. mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID’s Vaccine Research Center. About mRNA-1273.

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Vaccination Vaccine Containment Pharmacy 52

The Pharma Data

OCTOBER 18, 2020

Dyskeratosis congenita (DC) is a disease of pre-mature aging, which occurs due to a deficiency of telomere maintenance proteins. NR works by raising levels of NAD + , an important regulator that is known to naturally decline with age. These mice also had low NAD + levels. The scientists then supplemented the cells and mice with NR.

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DNA Scientist Genetic Disease Research 52

Roots Analysis

AUGUST 31, 2023

Further, the expression of any gene is dependent on the rate at which it is transcribed into mRNA and translated into proteins. There are various regulatory proteins or transcription factors that are responsible for affecting the transcription rate. These genetic switches assist transcription factors in binding to the promoter region.

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Gene Gene Therapy Gene Expression Regulation 40

Pfizer

JANUARY 27, 2023

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

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Marketing Production Drugs Licensing 75

Pfizer

AUGUST 15, 2022

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. 07.27.2022.

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The Pharma Data

JULY 27, 2021

Versatile antibody variable domains (UniDab®) derived from UniAb® can be assembled into multi-specific and multivalent therapeutic proteins, surpassing limitations of conventional antibody therapeutics. No forward-looking statement can be guaranteed and actual results may differ materially from those we project.

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Production Antibody Sales Manufacturing 52

The Pharma Data

OCTOBER 19, 2020

The V114 Phase 3 clinical development program is comprised of 16 trials investigating the safety, tolerability and immunogenicity of V114 in a variety of populations who are at increased risk for pneumococcal disease, including healthy older adults and children, as well as people who are immunocompromised or have certain chronic medical conditions.

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Vaccination Vaccine Immune Response Containment 52

The Pharma Data

JANUARY 24, 2021

We are grateful to our collaborators who worked with us on these vaccine candidates and to the volunteers in the trials,” said Dr. Dean Y. Molnupiravir is currently being evaluated in Phase 2/3 clinical trials in both the hospital and out-patient settings. Li, president, Merck Research Laboratories. “We About Merck.

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