XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Abbott Spinal Cord Stimulation (SCS) Systems Manufacturer/developer : Abbott Medical Date of FDA approval : May 30, 2024 Approved for : Chronic, hard-to-manage pain in the torso, arms and legs.

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XTalks

SEPTEMBER 8, 2020

Albany Molecular Research Inc (AMRI), a global provider of advanced drug development and manufacturing solutions, announced that they have signed a supply agreement with AstraZeneca. The company has signed on to help manufacture AstraZeneca’s COVID-19 vaccine candidate, AZD1222, intended to protect against the SARS-CoV-2 novel coronavirus.

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Manufacturing Vaccination Vaccine Allergies 83

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Clinical Trials Clinical Trials Vaccination Vaccine 76

The Pharma Data

OCTOBER 19, 2020

manufacturer, Pharmaceutics International, Inc. (“Pii”), has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable. . .

Clinical Trials 52

Clinical Trials Clinical Trials Manufacturing Trials 52

Pharmaceutical Technology

SEPTEMBER 20, 2022

Unlike commercial pharmaceutical packaging, the primary consideration in clinical trial packaging is protecting the product quality and reliability for research. Finding the best clinical trial packaging services providers. Clinical trial packaging and labelling solutions.

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Packaging Packaging Marketing Clinical Trials 100

Pharmaceutical Technology

SEPTEMBER 15, 2022

The document contains detailed information on the suppliers and their products, alongside contact details to aid your purchasing or hiring decisions. The post Leading API chemical companies in contract marketing appeared first on Pharmaceutical Technology.

Marketing 100

Marketing Manufacturing Generic Drugs Containment 100

Pharmaceutical Technology

OCTOBER 26, 2022

Collaboration and integrated manufacturing. Streamlined clinical trial design with integrated manufacturing can ensure that gene and cell therapies are developed much faster. As the market grows, biopharmaceutical companies will need to be mindful of the scalability of their gene therapy manufacturing processes.

Gene Therapy 130

Gene Therapy Gene Marketing Manufacturing 130

Camargo

SEPTEMBER 14, 2021

An IND submission serves as a request to start clinical studies, containing a summary of information known about the drug, including nonclinical studies; chemistry, manufacturing and controls (CMC); and a proposed clinical plan. INDs must contain full study reports of nonclinical and clinical (if available) studies.

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Pharmaceutical Technology

SEPTEMBER 14, 2022

Pharmaceutical drug research and development (R&D) activities are capital-intensive, which makes the outsourcing of clinical dose manufacturing and marketing popular. The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing or hiring decision.

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Marketing Contract Manufacturing Sales Clinical Trials 100

Pharmaceutical Technology

SEPTEMBER 8, 2022

The list includes providers of development services, biologics management supply chain solutions, clinical trial services, commercial and logistics services, as well as packaging, labelling and distributing services for biologics. What is driving the biologics API manufacturing services industry.

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Gene Marketing Vaccination Vaccine 100

Worldwide Clinical Trials

JUNE 15, 2022

Consulting with regulatory experts and experts in toxicology, manufacturing, etc., Early engagement and discussions can help you prevent the risk of a clinical hold. To discuss your study and how to reduce the chances of receiving a clinical hold, talk with us. .

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Gene Therapy Gene Clinical Trials Clinical Trials 130

The Pharma Data

NOVEMBER 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. LUND, Sweden , Nov. About BioInvent. About Cantargia.

Antibody 52

Antibody Manufacturing Clinical Trials Clinical Trials 52

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. Th e first clinical trial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of inf lu enza vaccines. The two formulations differ in the lipid nanoparticle (LNP) that contains the mRNA.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

Pharmaceutical Technology

AUGUST 3, 2022

During this stage, a team of lab technicians must identify the best way to manufacture the active pharmaceutical ingredient (API) into a suitable dosage form for pilot production. If clinical trials prove successful, that same process should then be scaled to commercial manufacturing.

Development 130

Development Production Manufacturing Bioavailability 130

Roots Analysis

FEBRUARY 28, 2024

Cell Therapy pipeline update, Talaris Therapeutics , a late-clinical stage biotechnology company based in Boston, MA and Louisville, KY , announced the initiation of FREEDOM-1 ( NCT03995901 ), the company’s Phase 3 clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients.

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The Pharma Data

APRIL 3, 2021

The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.

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Clinical Trials Clinical Trials Medicine Trials 52

The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

Pharmaceutical Technology

FEBRUARY 27, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Antares Pharma overview Antares Pharma is a specialty pharmaceutical company engaged in the development, manufacturing, and commercialization of pharmaceutical products and technologies.

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Drug Delivery Drug Delivery Systems Production Drugs 100

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) has cleared Armata’s IND to initiate a clinical trial of its lead therapeutic candidate, AP-PA02, in Pseudomonas aeruginosa infections. . “Results from this study, which we are calling SWARM- P.a. The SWARM- P.a. About Armata Pharmaceuticals, Inc.

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Clinical Trials Clinical Trials Trials Drugs 52

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.

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Clinical Trials Clinical Trials FDA Approval Trials 52

The Pharma Data

SEPTEMBER 23, 2020

Johnson & Johnson has continued the scaling up of its manufacturing capacity and remains on track to meet its goal of providing one billion doses of a vaccine each year. We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.”. “We

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

Advarra

SEPTEMBER 23, 2022

Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . Whether the methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality, and purity.” .

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

Pharmaceutical Technology

FEBRUARY 7, 2023

One general trend throughout Europe is the use of cost-containment measures to control public spending. Don’t leave it too late Focusing on P&R earlier in development helps manufacturers avoid a rushed or ill-informed decision that could come back to bite them. “If

Marketing 130

Marketing Drugs Medicine Clinical Trials 130

XTalks

NOVEMBER 23, 2020

The global trials are assessing the safety and efficacy of the vaccine in individuals aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions. Oxford-AstraZeneca COVID-19 Vaccine Induces Immune Responses in Early Clinical Trials.

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Vaccination Vaccine Clinical Trials Clinical Trials 97

The Pharma Data

JANUARY 13, 2021

Barrow previously served as Director of Drug Development & Discovery at Usona Institute, where he oversaw preclinical, clinical and regulatory development efforts for all of Usona’s development programs.

Clinical Trials 52

Clinical Trials Clinical Trials Development Trials 52

The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. INDIANAPOLIS and THOUSAND OAKS, Calif.

Antibody 52

Antibody Manufacturing Production Sales 52

The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

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 89

Clinical Trials Clinical Trials Life Science Trials 89

pharmaphorum

JANUARY 19, 2021

As vaccine manufacturers face unprecedented demand for their newly approved products, the race is on to provide enough shots for billions of people across the world. Pfizer and BioNTech have responded to this by upgrading their manufacturing facility in Puurs, Belgium.

Vaccination 89

Vaccination Vaccine Manufacturing Contract Manufacturing 89

Pfizer

JULY 26, 2022

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. The information contained in this release is as of July 27, 2022. Pfizer Disclosure Notice.

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

Druggist

MAY 12, 2021

Celevac is a brand of tablets containing methylcellulose. Each Celevac tablet contained 500mg of methylcellulose. Celevac tablets were discontinued by the manufacturer, which means they cannot be purchased over the counter or supplied on prescription. In total, six clinical trials were included in this review.

Containment 97

Containment Production Pharmacy Licensing 97

Pfizer

SEPTEMBER 28, 2022

1-adapted bivalent vaccine, non clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus . 5-adapted bivalent vaccine. Pfizer Disclosure Notice.

Vaccination 101

Vaccination Vaccine Medicine Clinical Trials 101

FDA Law Blog

JANUARY 15, 2024

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). FDA also directed manufacturers to produce detailed marketing plans.

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Production Manufacturing Marketing Regulation 115

XTalks

MAY 30, 2023

The patch itself is made of biodegradable nanocellulose and contains no plastic additives. The healthcare industry has one of the heaviest environmental footprints, and manufacturers are increasingly faced with regulations to make more sustainable products,” said Mohammad H. Behfar, senior scientist at VTT, in the news release.

Drug Delivery 98

Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

Camargo

DECEMBER 10, 2021

Voxzogo’s approval was based on an intermediate clinical endpoint (though accelerated approvals can also come from surrogate endpoints ). This means that full approval can only come from a clinical trial that assesses adult height. Voxzogo also received a priority review voucher.

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Development Genetics Production Clinical Trials 176

The Pharma Data

MAY 15, 2023

Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced a multi-year partnership with Just – Evotec Biologics, the Seattle-based subsidiary of Evotec SE.

Manufacturing 40

Manufacturing Development Production Containment 40

Pfizer

JULY 8, 2022

Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial. Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age. The information contained in this release is as of July 8, 2022. Pfizer Disclosure Notice.

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FDA Approval Vaccination Vaccine Clinical Trials 102