Roots Analysis

MARCH 26, 2024

However, the road for transition from the conventional batch to continuous manufacturing requires a shift in variety of parameters and is still quite unclear to many of the pharmaceutical companies. As a result, many success stories have come into the light which involves continuous manufacturing of a drug.

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The Checkup by Singlecare

JULY 31, 2024

Entresto is made by the pharmaceutical company Novartis and was approved by the Food and Drug Administration (FDA) in 2015. Entresto (sacubitril/valsartan) is a medicine that is classified as an angiotensin receptor neprilysin inhibitor (ARNI).

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PharmaShots

MARCH 29, 2023

Shots: Drug patent expiry is when a patent granted to a pharmaceutical company for a particular drug expires, allowing other companies to produce and sell generic versions Like every other utility patent, pharmaceuticals also get market exclusivity of 20 years. The exact mechanism of action is uncertain.

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pharmaphorum

JUNE 1, 2021

Pharmaceutical companies are accountable for ensuring that their medicine is safe when it comes into the hands of patients. It is estimated that the incidence of counterfeiting, illegal diversion and theft in the US increased by almost 70% between 2015 and 2019 driven mainly by a rise in internet sales.

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ISPE

JULY 7, 2023

7 The workshop was attended by participants from industry, academia, the US FDA, and others. The organizing committee for the workshop included: Rich Chen, Executive Director, Purification & Viral Safety, Eli Lilly and Company Chris Hwang, Chief Technology Officer, Transcenta Therapeutics Inc.

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ISPE

JULY 6, 2023

Since then, agencies have begun officially adopting the guidance, with the FDA doing so in March 2023. Conclusion Over the course of the last decade, and even more so since the approval of the first product made by CM in 2015, there has been a significant amount of talk within the industry about the transition to the new technology.

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Pharma Marketing Network

JUNE 11, 2020

And when you look through who those Twitter followers are, it’s very heavily skewed towards industry, as is the website, we’ve also put some tools on our website to be able to look at who the visitors are, by company. Don Langsdorf (EHS): 141 different pharma companies from around the world. John Mack (PG): Yep.

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pharmaphorum

APRIL 16, 2021

Approval by regulators such as the FDA or EMA, as reported by the regulators themselves. Both the FDA and the EMA rose to the pandemic regulatory challenge very well – addressing the specific COVID treatment and vaccination needs, as well as keeping standard medicines approvals going.

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pharmaphorum

SEPTEMBER 18, 2020

But although it was dubbed a “dangerous game”, some companies came out on top… On 6th April 1999, two companies with similar science-based cultures and a shared vision of the pharmaceutical industry came together to form what’s now considered as one of the top ten pharma companies in the world: AstraZeneca.

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pharmaphorum

JANUARY 5, 2021

For pharmaceutical companies there are a number of implications. For pharmaceutical companies, this may mean a change in patient journeys to pharmacotherapy becoming longer and more complex, but also occurring in different settings. It will take a decade to fully evaluate the true impact.

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European Pharmaceutical Review

SEPTEMBER 25, 2023

Gregory’s industrial career spans an employment history with several major pharmaceutical companies. IPQ International Pharmaceutical Quality. 2015; 35(3): 77-79. Cited 2023Feb]. Available from: [link] Egelhofer V, Gobom J, Seitz H, et al. Agilent Technologies. Cited 2023Feb]. Available from: [link] Bakeev K.A.

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PharmaShots

APRIL 13, 2023

model is a holistic approach to incorporate the same strategy to life science and pharmaceutical companies. A globally fast-growing, and largest pharmaceutical company in the world was created through a merger between Pfizer and Pharmacia. Its top 8 products contributed more than $1B to the company’s net revenue.

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European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The FDA is doing this through the publications of Guidance for Industry. For example, in September 2022, the company Rebiotix, Inc.

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PharmaShots

MAY 23, 2023

The company first received the US FDA approval for its gene therapy Zynteglo in Aug 2022 for treating adult and pediatric patients with ß-thalassemia. In November 2021, bluebird bio spun off its Oncology business into a separate company named 2seventy Bio. MACI is the company’s only approved product to date.

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ISPE

JULY 5, 2023

For example, one pharmaceutical company that switched to CM reported a 50% reduction in operating costs, a 33% reduction in waste, an 80% reduction in manufacturing and testing cycle time, and a 66% reduction in time from testing to release. 5 In addition, there are human elements to consider.

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PharmaShots

FEBRUARY 21, 2023

Market Cap: $8.46M Founded Year: 2004 Total Employees: ~4 Headquarters: Texas, United States Stock Exchange: OTCMKTS QSam Biosciences is a clinical-stage biotech company focused on developing and commercializing targeted therapeutic radiopharmaceutical products for treating cancer and related diseases.

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ISPE

JULY 6, 2023

1 , 4 A Retrospective Journey In 2015, Vertex’s Orkambi was the first approved drug produced under a CM process for the treatment of cystic fibrosis. An average of two approved drugs via CM per year since 2015 shows that progress has been slow but steady and that interest in CM and its potential has been sustained.

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