Fierce Pharma

SEPTEMBER 17, 2024

Nearly a year after Coherus BioSciences’ on-body injector for Udenyca was rejected over external production issues, a third-party manufacturer has caused another spot of bother for the Ca | Thanks to “over-commitments and capacity constraints” facing the U.S.-based

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Pharma Packaging Solutions

NOVEMBER 10, 2022

The Role of Packaging in the Pharmaceutical Industry. Calling packaging a matter of life and death sounds dramatic in most cases, but if you’re speaking of pharmaceutical packaging, the phrase rings true. Packaging Protects Pharmaceuticals from Physical Damage. Packaging Protects Pharmaceuticals from Quality Degradation.

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Pharmaceutical Technology

NOVEMBER 22, 2022

These industries unexpectedly also included biotech, which was not a particularly strong area for Chinese manufacturing, which is more recognised for generics production. Guangdong is based in the south and has a comparatively strong number of manufacturing relationships producing innovative FDA and EMA drugs.

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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. Iomab-B met the durable complete remission endpoint.

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Pharmaceutical Technology

AUGUST 30, 2022

SUS provides full, free and universal access to healthcare for the country's entire population (215 million), which spends around 10% of its gross domestic product (GDP) on healthcare. Only a limited number of international pharma companies, however, operate manufacturing sites in the country.

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Pharmaceutical Technology

AUGUST 10, 2022

Working with a contract manufacturing organization (CMO) in the pursuit of bringing a new product to market can deliver a range of significant benefits. They are also likely to have already worked with a similar molecule and can even anticipate the hurdles a company may face in production. Packaging needs?.

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Pharmaceutical Technology

NOVEMBER 30, 2022

Each month, Pharmaceutical Technology takes a look at recent decisions taken by regulatory and reimbursement agencies and identifies the key manufacturing players that can be impacted by them. Regulatory decisions by the US FDA, EMA and Swissmedic for select therapies from late September to October and the CMOs contracted to manufacture them.

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Outsourcing Pharma

NOVEMBER 10, 2021

This capsule of industry news features Amcor, High Purity New England, MG America, and other firms offering packaging and labeling products and services.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

Streamlined development, flexibility in manufacturing, and improved product quality at reduced costs, while gaining access to capabilities and capacity are some of the factors fuelling the pharmaceutical solid dosage contract manufacturing market.

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Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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Pharmaceutical Technology

JULY 14, 2022

Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. In this ongoing series , we put a spotlight on contracts between pharma companies and contract manufacturing organizations (CMOs).

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Pharmaceutical Technology

MAY 26, 2023

The acquisition targets had a wide variety of manufacturing services, including API and dose manufacturing, packaging, and analytical services. Despite challenging business conditions in 2021 and 2022, large CMOs were still involved in acquisitions to enhance their capabilities or scale of production. Catalent Inc.

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Roots Analysis

APRIL 15, 2024

Further, the manufacturing of biologics fill finish is a highly complex and cost-intensive process. Notable examples of fill finish manufacturing companies equipped with SA25 aseptic filling workstation include ( in alphabetical order ) Emergent Bioservices, PCI Pharma Services, Singota Solutions and WuXi Biologics.

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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. Pediatric Plan.

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Outsourcing Pharma

DECEMBER 5, 2022

Experic raises $14m in series B led by Harro Hofilger Packaging Systems and East Seattle Partners as CDMO sees growth in DPI product and clinical trial supply needs.

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XTalks

FEBRUARY 11, 2021

Pfizer is planning to reduce that time to an average of 60 days, cutting production time by almost 50 percent. For Pfizer-BioNTech’s vaccine, a batch consists of between one and three million doses of vaccine per production run. This in light of Pfizer having upped its production goal to two billion COVID-19 vaccine doses this year.

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Pfizer

DECEMBER 13, 2021

After Pfizer and BioNtech signed a letter of intent in March 2020 to work together on a vaccine, two Pfizer facilities were swiftly selected for developing the processes and manufacturing the product at an industrial scale. Within those first 100 days, the first manufacturing run was a success. The work continues.

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Pharmaceutical Technology

JULY 4, 2022

US President Joe Biden has gained approval from Congress for a new package of aid worth $40bn, and the US government announced last month that it plans to provide an additional $1bn in security assistance to Ukraine. AbbVie (North Chicago, Illinois) and Novartis (Basel, Switzerland) have also withdrawn from their businesses in Russia.

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The Pharma Data

NOVEMBER 5, 2020

Key Pipeline Progress Regeneron has more than 20 product candidates in clinical development, including five marketed products for which it is investigating additional indications. In July 2020 , the Company announced an agreement whereby the Company was awarded a $450 million contract to manufacture and supply REGN-COV2 to the U.S.

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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). SK Biotek is contracted to manufacture the small molecule API.

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Pharmaceutical Technology

DECEMBER 15, 2022

The Agency for Science, Technology and Research (A*STAR), an organization within Singapore’s Ministry of Trade and Industry, has launched a consortium with support from the Singapore Economic Development Board (EDB), which aims to improve manufacturing productivity, efficiency and sustainability. Additionally, Merck & Co.

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Pharmaceutical Technology

JANUARY 12, 2023

– about the advantages and challenges of product lyophilization, developing lyophilization processes on site at their Bloomington, Indiana plant, and the importance of continuing research. That would not allow sufficient time to manufacture, package and distribute before half of the content was degraded.

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Pharmaceutical Technology

JANUARY 15, 2023

In order to get a therapy to the market, pharma companies often outsource the drug manufacturing to specialist contract manufacturing organizations (CMOs). While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API.

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Pharmaceutical Technology

FEBRUARY 27, 2023

Manufacturing a drug therapy usually involves several different stakeholders. Baxter Biopharma Solutions has been contracted for the ADC’s parenteral manufacture and packaging. Regulatory decisions by the EMA for select therapies from late December to late January, and the CMOs contracted to manufacture them.

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