Bio Pharma Dive

FEBRUARY 7, 2023

The company said the experimental injection matched Soliris in a Phase 3 study and would soon be submitted to regulators around the world.

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Regulation 263

Bio Pharma Dive

JULY 29, 2022

After discussions with the FDA, the biotech aims to submit an application this fall — sooner than expected and ahead of a Phase 3 study that’s now ongoing.

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Gene Therapy Gene 273

The Pharma Data

DECEMBER 27, 2020

28, 2020 /PRNewswire/ — Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced that it has submitted a CTA (Clinical Trial Authorization) application to the relevant regulatory authorities to start a Phase II efficacy study of its wholly-owned CD40 targeting antibody mitazalimab. LUND, Sweden , Dec.

Antibody 52

Antibody Clinical Trials Clinical Trials Development 52

BioTech 365

SEPTEMBER 8, 2021

AIM ImmunoTech Submits Pre-IND Application to the FDA for Phase 2 Clinical Study of Ampligen as a Potential Infusion Therapy for Post-COVID-19 Cognitive Dysfunction AIM ImmunoTech Submits Pre-IND Application to the FDA for Phase 2 Clinical Study of Ampligen as … Continue reading →

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Bio Pharma Dive

DECEMBER 16, 2021

In granting approval, the FDA gave Biogen roughly nine years to run and submit results from an additional study of Aduhelm. Now, the company says it will do so in about half the time.

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Trials Drugs 213

Pharmaceutical Technology

MAY 17, 2023

There is no fee to submit information but to maximize your exposure we have a range of packages to promote your success to our 10+ ml audience. Please discuss promo packages with your awards adviser: tina.ross@globaldata.com or olga.kovalova@globaldata.com What sort of projects can I submit as case studies?

Packaging 130

Packaging Packaging Branding Research 130

BioSpace

SEPTEMBER 25, 2023

The company’s olezarsen cleared a late-stage study, eliciting a sharp reduction in triglyceride levels in patients with familial chylomicronemia syndrome. Ionis plans to submit a New Drug Application to the FDA.

Genetic Disease 119

Genetic Disease Genetics Drugs 119

BioSpace

OCTOBER 11, 2023

The subcutaneous version of its blockbuster multiple sclerosis drug notched a victory in a key late-stage study. Roche will submit the OCARINA II data to global health authorities in the coming months.

Trials 106

Trials Drugs 106

Drug Patent Watch

OCTOBER 2, 2023

The FDA conducted a study to identify factors that may predict the likelihood of generic drug marketing applications.

Generic Drugs 111

Generic Drugs Marketing Drugs 111

Pharmaceutical Technology

MAY 17, 2023

The BLA submitted to the FDA is supported by data obtained from the first Phase III randomised, controlled trial in cTTP patients, as well as the long-term data from a continuation study. According to the interim results, TAK-755 reduced 60% incidence of thrombocytopenia events over plasma-based therapy.

Genetics 242

Genetics Clinical Development Trials Drugs 242

Fierce Pharma

AUGUST 4, 2023

Based on the results of a phase 3 study, Galapagos has decided not to submit a Marketing Authorization Application in Europe for Jyseleca (filgotinib) in Crohn’s disease. And the hits just keep on coming for Galapagos. The company also will not proceed with its application for filgotinib in ulcerative colitis in Switzerland.

Sales 98

Sales Marketing 98

Pharmaceutical Technology

MAY 30, 2023

It was granted based on data from the Phase III study, which demonstrated that the vaccine induced neutralising antibodies against the SARS-CoV-2 original strain. SKYCovion is intended for the prevention of Covid-19 resulting from SARS-CoV-2 infection in individuals aged 18 years and above.

Vaccination 298

Vaccination Vaccine Protein Medicine 298

Pharmaceutical Technology

NOVEMBER 2, 2022

Ascletis Pharma has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for its drug candidate for Covid-19. All IND facilitating studies for the drug candidate including Good Laboratory Practice (GLP) toxicology studies in dogs and rats were completed by the company.

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Clinical Trials Clinical Trials Drugs Clinical Development 130

Pharmaceutical Technology

FEBRUARY 16, 2023

Accord BioPharma (Accord US), the business partner of Shanghai Henlius Biotech, has submitted the BLA. The BLA submission to the FDA is supported by the data obtained from studies conducted between HLX02 and the reference trastuzumab.

Medicine 130

Medicine Development Production Trials 130

Pharmaceutical Technology

APRIL 6, 2023

Mirum Pharmaceuticals has submitted a marketing authorisation variation application to the European Medicines Agency (EMA) for expanding the use of LIVMARLI (maralixibat) to treat progressive familial intrahepatic cholestasis (PFIC) patients aged two months and above.

Genetics 130

Genetics Trials Medicine Marketing 130

BioSpace

OCTOBER 12, 2022

Tiziana Life Sciences plans to submit an Investigational New Drug Application for a Phase I trial studying intranasal formulab, a breakthrough treatment option for Alzheimer’s Disease.

Life Science 79

Life Science Trials Drugs 79

Pharmaceutical Technology

MAY 2, 2023

The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application submitted by Bristol Myers Squibb for Reblozyl (luspatercept-aamt) as a first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS).

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Trials Clinical Trials Clinical Trials Medicine 246

Pharmaceutical Technology

MAY 22, 2023

Biogen and Eisai have submitted a marketing authorisation application (MAA) to the UK’s medicines and healthcare products regulatory agency (MHRA) for lecanemab to treat early Alzheimer’s disease (AD). The submission of MAA is based on the findings from the Phase III Clarity AD trial and Phase IIb clinical study (Study 201).

Marketing 130

Marketing Antibody Licensing Licensing 130

BioSpace

SEPTEMBER 26, 2021

With Pfizer expected to submit its COVID-19 vaccine data for children five to 11 years to regulators, a study showed just how damaging the pandemic has been to life expectancy. Here’s a look.

Regulation 101

Regulation Vaccination Vaccine 101

Rethinking Clinical Trials

FEBRUARY 7, 2023

An externally controlled trial uses patient-level data from a source outside the clinical trial—such as a registry, electronic health records, or administrative claims data—to provide a historical or concurrent control group for the study. Reviewers are asked to submit written comments on the draft guidance by May 2, 2023.

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Trials Clinical Trials Clinical Trials Drugs 100

BioSpace

MARCH 7, 2021

As of yet, the findings from the late-stage trial have not been published, but CytoDyn said it is preparing a manuscript of the study data to submit to one or more major journals.

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Trials 109

Camargo

JANUARY 17, 2020

If you are planning to submit a New Drug Application (NDA) for an oncology drug. The post Changes to Pediatric Study Plan Requirements for Oncology Drug Products: Are You Prepared? appeared first on Camargo.

Production 100

Production Drugs 100

World of DTC Marketing

APRIL 25, 2022

“The technology has outpaced us,” said Rod Passman, a cardiologist at Northwestern University who’s assisting with a study examining the Apple Watch’s ability to screen for the heart rhythm condition. Studies about the prevalence of anxiety that results from atrial fibrillation pings are hard to come by.

Doctors 231

Doctors Doctor Development Research 231

BioSpace

JULY 28, 2021

Biogen reportedly withdrew a paper it had submitted to the medical journal JAMA after the publication requested edits before publication. It’s standard for a technical journal to request edits, but it is the nature of the edits—and in this case, the nature of the study— that raises questions.

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Pharmaceutical Technology

JUNE 22, 2023

Calliditas Therapeutics has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for complete approval of TARPEYO (budesonide).

Clinical Trials 130

Clinical Trials Clinical Trials Branding Protein 130

Outsourcing Pharma

JANUARY 16, 2023

A Florida doctor has been sent to prison after submitting a false affidavit claiming she had screened children in a clinical study looking at the effectiveness of drugs given to children with asthma when she had not.

Drug Trials 59

Drug Trials Doctors Doctor Drugs 59

FDA Law Blog

SEPTEMBER 10, 2023

The focus of both documents is on non-interventional studies using real-world data (“RWD”). Interventional studies are generally clinical investigations under the regulations and thus require an IND under 21 C.F.R. § Non-interventional studies thus do not require an IND.

Production 108

Production Drugs Containment Marketing 108

STAT News

AUGUST 8, 2022

With positive study results in hand, the Boston-based biotech intends to submit a marketing application with the Food and Drug Administration by the middle of next year. If approved, the Karuna drug would usher in the first new class of medicines for the treatment of schizophrenia in decades.

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Clinical Trials Clinical Trials Drugs Trials 98

STAT News

NOVEMBER 30, 2022

Musk said the company has been “working hard to be ready for our first human,” and has submitted most of the required paperwork to the Food and Drug Administration to launch a study in humans.

Drugs 119

Drugs 119

Drug Discovery World

JUNE 28, 2023

Verona Pharma has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for approval of ensifentrine for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

FDA Approval 52

FDA Approval Drugs Containment 52

Pharmaceutical Technology

MAY 16, 2023

The Foundation’s Accelerating Medicines Partnership (AMP) Bespoke Gene Therapy Consortium (BGTC) will study these eight conditions by focusing on gene therapies using adeno-associated vectors (AAV). Silverthorn said, “We hope to have those INDs submitted in the first half of next year, and hopefully, enrol patients in mid to late 2024”.

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Gene Therapy Gene Research Clinical Trials 227

Medical Xpress

MARCH 23, 2023

Physical exercise practiced by patients submitted to bariatric surgery acts on brain regions involved in food intake, reducing hunger or accelerating satiety, for example.

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Regulation Clinical Trials Clinical Trials Trials 75

Pharma in Brief

NOVEMBER 5, 2023

On October 19, 2023, the Ontario government proposed regulatory amendments that may eliminate the need to submit certain clinical studies and evidence when requesting that a “well-established drug” be (i) listed or (ii) designated as interchangeable on Ontario’s publicly-funded formulary.

Drugs 52

Drugs Regulation Production Generic Drugs 52

Pharmaceutical Technology

JUNE 12, 2023

Astellas Pharma has submitted a new drug application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for zolbetuximab as a treatment option for advanced gastric and gastroesophageal cancer. Zolbetuximab is an investigational Claudin 18.2 mFOLFOX6 includes a combination of leucovorin, oxaliplati and fluorouracil.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Antibody 130

Pharmaceutical Technology

MAY 29, 2023

The company submitted the BLA in March this year. The BLA submission for lifileucel was based on positive data from the C-144-01 clinical study, which included patients with advanced melanoma.

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Licensing Licensing Drugs Trials 130

Drug Discovery World

JULY 21, 2023

Madrigal Pharmaceuticals has submitted an application for resmetirom, a drug for nonalcoholic steatohepatitis (NASH) with liver fibrosis, to the US Food and Drug Administration (FDA) and has requested a priority review. The post First drug for NASH with liver fibrosis submitted to FDA appeared first on Drug Discovery World (DDW).

Drugs 52

Drugs Hormones Clinical Development Trials 52

CTTI (Clinical Trials Transformation Initiative)

JANUARY 10, 2024

Some of the strategies include: Use a centralized/dedicated approach to meeting ClinicalTrials.gov requirements Take a proactive, rather than reactive, approach to complying with ClinicalTrials.gov regulatory requirements Escalate to upper levels of leadership for PIs/study teams that are non-responsive to the administrative unit’s communication (..)

Clinical Trials 65

Clinical Trials Clinical Trials Trials Compliance 65