Pharmaceutical Technology

DECEMBER 12, 2022

Pharmaceutical companies often outsource different parts of the manufacturing process, including the production of small molecule active pharmaceutical ingredients (APIs) and parenteral packaging, to contract manufacturing organizations (CMOs). Regulatory decisions and clinical trial news.

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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.

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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. The R&D pipeline in Human Pharma comprises more than 60 new substances and around 100 clinical and pre-clinical projects. In the first six months, the company generated net sales of 9.8

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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.”.

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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.

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The Pharma Data

DECEMBER 23, 2020

Additionally, Phase 1 clinical data found INO-4800 to have a favorable safety and tolerability profile with no serious adverse events reported; only six Grade 1 adverse events (AEs) were observed, primarily minor injection site reactions. . ” Findings from the Phase 1 Clinical Trial.

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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.”

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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.

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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.

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Pharmaceutical Technology

JULY 4, 2022

Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on the domestic market.

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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 .

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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

JULY 21, 2021

In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever 3 (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%).

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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.

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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.

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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.

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The Pharma Data

NOVEMBER 5, 2020

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. Cost of collaboration and contract manufacturing (COCM). $. An MAA for HoFH has also been submitted in the EU. 30%. *. *.

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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.

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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 ®.

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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.

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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% About the EffisayilTM 1 clinical trial. had clear/almost clear skin.

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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. She has a track record of shepherding complex drug candidates from discovery to pivotal trials.

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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

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Pharmaceutical Technology

APRIL 24, 2023

Mahesh Bhalgat, Syngene’s chief operating officer In the US, which has among the highest contract manufacturing rates globally, 140 contract manufacturing organizations have 207 facilities capable of producing active pharmaceutical ingredients (API) for protein and peptide-type biologics.

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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., Clinical and Research Developments. REVENUES. . . . . . ($ in millions). First-Quarter. . 1,611. . *. *.

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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?

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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.

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