Pharmaceutical Technology

SEPTEMBER 20, 2022

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Finding the best clinical trial packaging services providers.

Packaging 100

Packaging Packaging Marketing Clinical Trials 100

Pharmaceutical Technology

FEBRUARY 24, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Its investigational medicinal products comprise R-107, R-131 and R-147. The company also offers contract manufacturing and laboratory services.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

Pharmaceutical Technology

FEBRUARY 24, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Its investigational medicinal products comprise R-107, R-131 and R-147. The company also offers contract manufacturing and laboratory services.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

Drug Discovery World

MARCH 8, 2024

She also led the research collaboration with Editas Medicine. Kathryn Golden, bit.bio Kathryn Golden is SVP Technical Operations and Manufacturing at bit.bio. Kathryn Golden, bit.bio Kathryn Golden is SVP Technical Operations and Manufacturing at bit.bio. Read the interview. Read the interview. Read the interview.

Drugs 69

Drugs Gene Editing Contract Manufacturing Antibody 69

Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Regulatory decisions and clinical trial news.

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Manufacturing Drugs Packaging Packaging 147

The Pharma Data

OCTOBER 29, 2021

Boehringer Ingelheim announced today that the company’s marketing authorization application (MAA) for the treatment of flares in generalized pustular psoriasis (GPP), has been validated and is now under evaluation with the European Medicines Agency (EMA). Source link: [link].

Medicine 40

Medicine Marketing Contract Manufacturing Trials 40

pharmaphorum

NOVEMBER 5, 2021

The phase 3 trial found that Paxlovid – which combines new protease inhibitor PF-07321332 with already-approved HIV drug ritonavir – reduced the risk of hospitalisation or death by 89% when given to newly-diagnosed adults who were at risk of developing severe COVID-19 in the EPIC-HR trial.

Contract Manufacturing 113

Contract Manufacturing DNA HR Manufacturing 113

Drug Discovery World

MAY 21, 2024

In contrast, machine learning can facilitate epitope-specific design: directing the algorithm towards favourable epitopes that elicit favourable biological responses, which may improve the prospects for the antibody in drug trials. These targets, along with many others, are universally deemed as ‘difficult-to-drug’ targets.

Antibody 59

Antibody Development FDA Approval Contract Manufacturing 59

The Pharma Data

AUGUST 3, 2021

In the first half of 2021, Boehringer Ingelheim has supplied more humans and animals worldwide with innovative medicines than ever before. This pipeline has the potential to deliver up to 15 medicines for approval by 2025. These medical successes have the potential to improve the lives of millions of patients worldwide.”. billion EUR.

Development 52

Development Research Contract Manufacturing Sales 52

pharmaphorum

JANUARY 3, 2023

Polarean refiled in March 2022, and six months later the FDA requested additional information from the contract manufacturing organisation (CMO) responsible for manufacturing the xenon 129 gas blend used in Xenoview. The post FDA clears Polarean’s lung disease diagnostic Xenoview appeared first on.

Contract Manufacturing 62

Contract Manufacturing Manufacturing FDA Approval Pharma Companies 62

pharmaphorum

DECEMBER 18, 2020

The US regulator has cleared both intravenous and subcutaneous formulations of Benlysta (belimumab) for the new indication, extending the use of the drug beyond its earlier label covering the treatment of active systemic lupus erythematosus (SLE) in combination with other medicines.

FDA Approval 87

FDA Approval Contract Manufacturing Sales Trials 87

Pharmaceutical Technology

AUGUST 30, 2022

Oswaldo Cruz Foundation will package the drug in its facility in Rio de Janeiro before supplying it to the Brazilian public health system; the company is also involved in clinical trials for the drug’s possible use as Covid-19 prophylaxis. French and Italian manufacturers have two companies in Brazil.

Manufacturing 195

Manufacturing Marketing Pharma Companies Vaccination 195

The Pharma Data

FEBRUARY 24, 2022

senior vice president, Medicine and Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “BI We have built on our heritage in pulmonary fibrosis and are acting on the breakthrough designation and clinical data with the goal that this potential novel medicine can reach patients as soon as possible.”. Source link: [link].

Contract Manufacturing 52

Contract Manufacturing Medicine Clinical Trials Clinical Trials 52

pharmaphorum

FEBRUARY 8, 2022

Nevertheless, the decision by NICE to back routine NHS use of Wegovy is a win for Novo Nordisk, which has been hit by supply constraints linked to a contract manufacturer for the drug that have affect its rollout in the US, where it was approved last June. billion to the NHS and £27 billion to wider society.

Drugs 104

Drugs Contract Manufacturing Clinical Trials Clinical Trials 104

XTalks

APRIL 11, 2024

The results were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine. Concerns of Early Deaths The expanded approvals come after the FDA had flagged reports of early deaths in clinical trials evaluating the therapies in earlier treatment line settings.

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 52

The Pharma Data

MARCH 28, 2022

Boehringer Ingelheim announced today new data from the pivotal Effisayil™ 1 trial presented at the 2022 American Academy of Dermatology (AAD) Annual Meeting in Boston. of patients had no visible pustules after the 12-week trial duration and 81.3% of patients had no visible pustules after the 12-week trial duration and 81.3%

Dermatology 52

Dermatology Trials Contract Manufacturing Medicine 52

The Pharma Data

MARCH 29, 2022

With Veeva Development Cloud, Boehringer Ingelheim aims to establish a connected technology landscape for agile collaboration that can accelerate the development of novel medicines Transformation focuses on reducing complexity and developing an innovative, digital culture to better understand and address unmet medical needs.

Development 52

Development Contract Manufacturing Medicine Clinical Development 52

The Pharma Data

FEBRUARY 25, 2022

with heart failure with preserved ejection fraction, which has been classified as “the single largest unmet need in cardiovascular medicine” 1,2 Heart failure is a leading cause of hospitalization in the U.S. chairman, Department of Medicine, University of Mississippi. and Europe. Learn more at www.boehringer-ingelheim.com.

FDA Approval 52

FDA Approval Medicine Contract Manufacturing Clinical Trials 52

Pharmaceutical Technology

MARCH 21, 2023

In such turbulent times, ensuring the most efficient and cost-effective manufacturing frameworks becomes even more important. Most pharmaceutical and biotech companies outsource certain production tasks to contract manufacturing organizations (CMOs). BioCentriq is contracted to manufacture the biologic API.

Manufacturing 147

Manufacturing Drugs Packaging Packaging 147

Camargo

JANUARY 19, 2021

However – particularly in rare disease programs with only one Phase 3 trial, often of short duration – sponsors many times find themselves ready to file clinical data before completing the minimum 12 months of stability testing on the to-be-marketed finished product and API. Having a quality agreement in place is critical.

Production 135

Production Branding Contract Manufacturing Manufacturing 135

Drug Discovery World

DECEMBER 14, 2023

The new centre represents a flagship investment within the University’s Glasgow Riverside Innovation District (GRID) and will be home to commercial businesses as well as the University of Glasgow-led Living Laboratory for Precision Medicine. This is a core competency of BioAscent and we are enthusiastic in collaborating with the universities.”

Drugs 75

Drugs Life Science Research Scientist 75

The Pharma Data

JANUARY 27, 2021

MultiStem ® cell therapy is a patented regenerative medicine product candidate in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage. 28, 2021 11:00 UTC. About MultiStem ®.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

Drug Discovery World

FEBRUARY 22, 2023

In 2019 I forecast the arrival of AI in the drug discovery process, in 2023 we are seeing that this approach is now commonplace in molecule design, preclinical selection and the running of clinical trials. Once the drug reaches its end stages, plans to reduce manufacturing costs become a primary driver.

Development 52

Development Drugs Manufacturing Contract Manufacturing 52

The Pharma Data

DECEMBER 23, 2020

Joseph Kim , President and CEO of INOVIO, said, “We are very pleased to share peer-reviewed Phase 1 clinical data for INO-4800 published in The Lancet’s EClinicalMedicine , and are grateful for the support of all participants and investigator staff involved in the clinical trial.” . mg and 2.0 mg and 2.0

DNA 40

DNA Vaccination Vaccine Immune Response 40

The Pharma Data

MARCH 7, 2022

The blessing is grounded on results from the advance EMPEROR- Saved ® Phase III trial, which delved the effect of empagliflozin 10 mg compared with placebo formerly daily, both added to the standard of care, in grown-ups with heart failure with LVEF over40.6 In the trial, empagliflozin demonstrated a 21 relative threat reduction (3.3

Contract Manufacturing 52

Contract Manufacturing HR Trials Marketing 52

The Pharma Data

APRIL 17, 2021

The collaboration, launched in 2019, has successfully combined MD Anderson’s innovative clinical research infrastructure and the patient-driven drug development capabilities of the Therapeutics Discovery division with Boehringer Ingelheim’s pipeline of innovative cancer medicines and expertise in advancing breakthrough therapies.

Development 52

Development Contract Manufacturing Research Medicine 52

The Pharma Data

NOVEMBER 19, 2021

Pfizer has also begun and will continue to invest up to roughly$ 1 billion of its own finances to support the manufacturing and distribution of this investigational treatment seeker, including exploring implicit contract manufacturing options.

HR 52

HR Contract Manufacturing Manufacturing Clinical Trials 52

Drug Discovery World

FEBRUARY 26, 2024

These therapies, which utilise human cells to replace diseased or damaged cells or use engineered cells to act as therapies for a specific disease, have become more common in recent years, with approvals and clinical trials increasing. Biography Kathryn Golden is SVP Technical Operations and Manufacturing at bit.bio.

Manufacturing 52

Manufacturing In-Vivo Development Production 52

Drug Discovery World

SEPTEMBER 6, 2022

This area of medicine, which turns our own bodies into agents of combat to fight disease, has quickly become one of the most promising fields in treating deadly diseases such as cancer, central nervous system disorders and even musculoskeletal conditions. . billion, compared to $19.9 million price point per dose. Cancer is king .

Gene Therapy 52

Gene Therapy Gene Manufacturing Medicine 52

The Pharma Data

NOVEMBER 15, 2020

NASDAQ: ATHX), a clinical-stage regenerative medicine company, is pleased to announce that it has appointed Ms. 16, 2020 11:00 UTC. CLEVELAND–( BUSINESS WIRE )– Athersys, Inc. Katherine Kalin, Ms. Jane Wasman and Mr. Baiju R. Shah to its board of directors. About MultiStem ®.

Clinical Trials 40

Clinical Trials Clinical Trials Production Trials 40

The Pharma Data

MARCH 8, 2022

We initiated clinical trials in all regions of the world to generate evidence across multiple geographies and diverse, at-risk populations and forged a strategic partnership with Aspen in Africa and others to manufacture our vaccine globally. Head of Global Public Health, Johnson & Johnson, Cilag GmbH International. “We

Manufacturing 40

Manufacturing Vaccination Vaccine Contract Manufacturing 40

Drug Discovery World

FEBRUARY 2, 2023

A late-stage clinical trial in head and neck cancer for the treatment of severe oral blistering or oral mucositis caused by radiation therapy is planned.

Manufacturing 52

Manufacturing Clinical Trials Clinical Trials Drugs 52

The Pharma Data

NOVEMBER 5, 2020

REGN-COV2 trial in the COVID-19 outpatient setting met primary and key secondary endpoints. In October 2020 , the Company and Sanofi announced that a Phase 3 trial met its primary and all key secondary endpoints in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. billion versus third quarter 2019.

Sales 52

Sales Production Manufacturing Antibody 52

The Pharma Data

JULY 21, 2021

Following administration of the Pfizer-BioNTech COVID-19 Vaccine, the following have been reported outside of clinical trials: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm). myocarditis and pericarditis.

Manufacturing 52

Manufacturing Vaccination Vaccine Clinical Trials 52

The Pharma Data

JULY 29, 2021

Billion Doses Expected to be Delivered in 2021 Under Signed Contracts as of Mid-July 2021 – Raises Guidance Ranges Excluding BNT162b2(1) for Revenue by $400 Million and Adjusted Diluted EPS(3) by $0.05 Second-Quarter 2021 Revenues of $19.0 Raises Full-Year 2021 Guidance(4) for Revenues to a Range of $78.0 Total Oper.

Manufacturing 52

Manufacturing Sales Contract Manufacturing Vaccination 52

The Pharma Data

JUNE 24, 2021

The production capacity has consistently grown due to continued enhancements to the vaccine’s supply chain, which include expanding existing facilities, adding more suppliers, and bringing on additional Pfizer/BioNTech sites and contract manufacturers around the world to produce the vaccine. Available data on Pfizer?

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

The Pharma Data

MAY 4, 2021

Internal Medicine. billion, primarily driven by Pfizer CentreOne, Pfizer’s contract manufacturing operation, reflecting sales of legacy Upjohn products to Viatris (4) and remdesivir to Gilead Sciences Inc., REVENUES. . . . . . ($ in millions). First-Quarter. . 1,611. . *. *. Inflammation & Immunology. Rare Disease.

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Vaccination Vaccine Production Sales 40