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. Regulatory Approvals for CTC-Based Assays in Oncology.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials FDA Approval Trials 52

XTalks

SEPTEMBER 28, 2023

a Texas-based pharmaceutical firm specializing in psychotropic drug development, revealed that its groundbreaking antidepressant, Exxua (gepirone extended release) for treating major depressive disorder (MDD), received US Food and Drug Administration (FDA) approval on September 22, 2023. Fabre Kramer Pharmaceuticals, Inc.,

FDA Approval 105

FDA Approval Clinical Trials Clinical Trials Trials 105

XTalks

APRIL 23, 2021

The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. The immunotherapy has also become the first targeted therapy for the dMMR positive subset of endometrial cancers.

FDA Approval 105

FDA Approval Trials Antibody DNA 105

XTalks

JUNE 6, 2023

Posluma is now the first and only radiohybrid PSMA-targeted PET imaging agent to receive FDA approval. Posluma contains a radioactive imaging agent, fluorine-18 ( 18 F), that is designed to specifically bind to the PSMA over-expressed on prostate cancer cells. Gauden, CEO of Blue Earth Diagnostics, in the company’s news release.

FDA Approval 96

FDA Approval Clinical Trials Clinical Trials Marketing 96

Bioengineer

JULY 20, 2021

FDA approval based on positive results of international, multi-center ProDERM study. The prospective, double-blind, placebo-controlled Phase III clinical trial enrolled 95 patients at 36 sites globally, including 17 sites in the U.S., Octagam® 10% does not contain sucrose. Credit: Octapharma. PARAMUS, N.J.

FDA Approval 40

FDA Approval Clinical Trials Clinical Trials Trials 40

XTalks

AUGUST 18, 2023

After Johnson & Johnson’s US Food and Drug Administration (FDA) approval last week for its second multiple myeloma bispecific, Talvey (talquetamab), Pfizer received an FDA nod for its B-cell maturation antigen (BCMA)-directed therapy Elrexfio (elranatamab) in the same indication.

FDA Approval 98

FDA Approval Drugs Antibody Trials 98

Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance.

Medicine 52

Medicine Scientist Production Regulation 52

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity. BOSTON, Nov. in the first quarter of 2021.

FDA Approval 52

FDA Approval Genetic Disease Genetics Clinical Trials 52

pharmaphorum

SEPTEMBER 21, 2020

Compass Pathways and its potential magic mushroom depression drug went public last week – and now psychedelic therapy firm Mind Medicine is aiming to follow suit by up-listing its shares on the Nasdaq. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

Medicine 134

Medicine FDA Approval Containment Clinical Trials 134

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. The increase in survival observed with Zokinvy was derived from two open-label clinical trials (N=62) conducted at Boston Children’s Hospital. PALO ALTO, Calif., Outside the U.S.,

FDA Approval 52

FDA Approval Genetics Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. The Verquvo label contains a boxed warning that indicates that Verquvo should not be administered to pregnant females because it may cause fetal harm. KENILWORTH, N.J.–(BUSINESS Verquvo (vericiguat) 2.5

FDA Approval 52

FDA Approval Production Trials Containment 52

The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. CEO and Co-founder of BioNTech. “We

Licensing 52

Licensing Licensing Vaccination Vaccine 52

The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]

FDA Approval 52

FDA Approval Production Research Doctors 52

XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

The Pharma Data

FEBRUARY 1, 2021

In clinical trials, the most common adverse events associated with Plegridy were injection site reactions and flu-like symptoms. A list of adverse events can be found in the full Plegridy product labeling for each country where it is approved. Related Articles: Plegridy (peginterferon beta-1a) FDA Approval History.

FDA Approval 40

FDA Approval Bioequivalency Clinical Trials Clinical Trials 40

XTalks

APRIL 25, 2024

The efficacy of the Revivent TC system is being evaluated through clinical trials, namely the LIVE trial and the ongoing ALIVE trial. The LIVE trial showcased the system’s potential to reduce ventricular volumes by approximately 25 percent and improve left ventricular ejection fraction by about 16 percent.

Development 111

Development Trials Clinical Trials Clinical Trials 111

XTalks

DECEMBER 5, 2022

The CBD prodrug will be going up against Jazz Pharma’s Epidiolex, the first FDA approved CBD drug formulation. Approved in 2018, Epidiolex is a CBD oral solution indicated for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, rare and severe forms of epilepsy, in patients two years of age and older.

Bioavailability 97

Bioavailability FDA Approval Trials Drugs 97

Pfizer

AUGUST 3, 2022

The Pfizer focus on rare disease builds on more than two decades of experience, a dedicated research unit focusing on rare disease, and a global portfolio of multiple medicines within a number of disease areas of focus, including rare hematologic, neurologic, cardiac, renal and inherited metabolic disorders. Disclosure Notice. 07.13.2022.

Development 101

Development Vaccination Vaccine Production 101

The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration and the European Medicines Agency. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicinehas published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. About the Phase 2/3 Study.

Vaccination 52

Vaccination Vaccine Trials Medicine 52

XTalks

DECEMBER 20, 2023

Novo Nordisk’s GLP-1 weight loss-specific drug Wegovy (semaglutide) has been facing similar shortages, as it contains the same active ingredient as Ozempic. The companies include a diverse range engaged in innovative approaches in areas like oncology, genetic medicines, inflammatory diseases, dermatology and cardiorenal therapy.

Life Science 59

Life Science Clinical Trials Clinical Trials FDA Approval 59

pharmaphorum

OCTOBER 2, 2020

UK-based Compass Pathways and its potential magic mushroom depression drug went public last month – and just a week later psychedelic therapy firm Mind Medicine announced it would be up-listing its shares on the Nasdaq. The past few weeks have seen a flurry of companies in this space announce that they intend to go public. .

Medicine 109

Medicine Life Science FDA Approval Development 109

Camargo

NOVEMBER 11, 2020

Approval of the Month: Companion Diagnostic for Bayer’s Vitrakvi Should Lead to Improved Patient Outcomes. In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics.

Development 242

Development Bioequivalency Generic Drugs Production 242

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.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

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.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Drug Discovery World

SEPTEMBER 28, 2023

In fact, the endometrial fluid contains peptides that may protect against a variety of fungi, bacteria, viruses, and other pathogens 4. Ongoing impactful trials are investigating the potential for microbiome-based diagnostic tests for endometriosis 5 and PCOS 6 using blood, faecal, vaginal, and/or endometrial samples.

Clinical Trials 64

Clinical Trials Clinical Trials Regulation Bacteria 64

The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. Casirivimab and imdevimab injection is not FDA approved for any use.

Antibody 52

Antibody Medicine Production Trials 52

XTalks

MARCH 3, 2021

Today’s action marks the first FDA approval for a therapy to treat this devastating disease,” said Hylton V. Joffe, MD, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research, in a press announcement from the FDA.

FDA Approval 64

FDA Approval Genotype Clinical Trials Clinical Trials 64

Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

pharmaphorum

AUGUST 31, 2021

Many of our innovative life sciences partners pre-socialise their ECA strategy in early discussions with the FDA before finalising the clinical trial to get feedback on the approach from the ultimate decision maker. Myth 3: RWD is too imperfect to be used to as a comparator arm to a clinical trial.

Clinical Trials 62

Clinical Trials Clinical Trials Life Science Trials 62

Drug Discovery World

AUGUST 14, 2023

Over the past few decades, the incredible progress in personalised medicine has led to the development of life-saving cell and gene therapies (CGT). Within the past year, the sector saw the EU’s landmark approval of the first allogeneic T cell therapy as well as the approval of several new gene therapies in the US.

Gene Therapy 52

Gene Therapy Marketing Gene DNA 52

XTalks

JANUARY 5, 2021

The pandemic itself will also continue to spur innovations and changes such as greater shifts towards decentralized clinical trials and patient-centric approaches. In addition to vaccines, there are handfuls of drugs currently being evaluated in clinical trials for the treatment of COVID-19.

Life Science 98

Life Science Clinical Trials Clinical Trials Trials 98

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Section 351(a) is the traditional pathway for approving biologics under the PHS Act.

Development 161

Development Production Immune Response Licensing 161

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. The approval in India is an important milestone as it will enable to supply India but also a large number of countries around the world.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 is immunocompromised or are on a medicine that affects the immune system. The information contained in this release is as of July 19, 2022.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

The Pharma Data

JANUARY 17, 2021

Guardant Health’s liquid biopsy tests have been extensively used in clinical trials with over 200 peer-reviewed publications demonstrating its benefits to patients. Guardant Health has achieved CE mark approval as well as U.S. Forward-Looking Statements.

Genome 40

Genome Genomics Clinical Trials Clinical Trials 40

pharmaphorum

APRIL 27, 2021

On Wednesday (28 April), the focus will shift to Keytruda and Tecentriq as first-line treatments for UC patients unable to be treated with cisplatin-containing chemotherapy – which got the go-ahead in 2017 and 2018, respectively.

Drugs 63

Drugs Trials FDA Approval Marketing 63