Roots Analysis

FEBRUARY 27, 2024

Ambrx and NovoCodex Biopharmaceuticals announced that they have formed a second collaboration to develop and commercialize Ambrx’s internally developed site-specific antibody drug conjugates. The antibody drug conjugates market is expected to grow at a CAGR of ~10% during the forecast period.

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Pharmaceutical Technology

JANUARY 30, 2023

This is mixed news for contract manufacturing organisations (CMOs), as large CMOs such as Thermo Fisher Scientific (Waltham, MA, US) and Catalent Inc (Somerset, NJ, US) are typically involved in the manufacture of the most innovative products. However, non-NME and biosimilar approvals increased in 2022.

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BioPharma Reporter

SEPTEMBER 19, 2023

The big pharma company Bristol Myers Squibb (BMS) has recruited contract manufacturing and development organization (CDMO) Samsung Biologics to manufacture a commercial antibody cancer treatment until 2030.

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Manufacturing Contract Manufacturing Pharma Companies Antibody 59

BioPharma Reporter

FEBRUARY 9, 2023

The South Korean player plans to expand its recently acquired US facility, provide contract manufacturing services for Antibody Drug Conjugates (ADC), and to add drug product fill & finish facilities to establish a foothold in the North American CDMO market.

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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. The EMA had provided a positive opinion for this marketing authorization back in July. Source: GlobalData Pharmaceutical Intelligence Center.

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pharmaphorum

SEPTEMBER 15, 2020

Humanigen is hoping for emergency use authorisation in the US for an antibody to treat severe COVID-19 before the end of 2020, and has teamed up with Swiss contract manufacturer Lonza to make sure it can meet demand. Lilly also has studies on the go for LY3127804, an investigational antibody targeting angiopoietin 2 (Ang2).

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Pharmaceutical Technology

JULY 29, 2022

Despite the advanced stage of Covid-19 vaccination programmes in richer countries, which would suggest an approaching drop-off in contract manufacturing demand, there is still a considerable need for variant-specific boosters. Commercial dose manufacturing.

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The Pharma Data

SEPTEMBER 11, 2021

Boehringer Ingelheim believes Twist’s ability to generate potent, diverse therapeutic antibodies by mining its comprehensive libraries, combined with our extensive capabilities and experience in drug discovery and development, will enable us to deliver breakthrough opportunities to patients,” said Clive R. About Twist Bioscience Corporation.

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Roots Analysis

MARCH 9, 2022

In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines, and gene therapies), by the US FDA, have steadily risen. Biopharmaceutical Excipient Manufacturing Market. Biopharmaceutical Excipient Manufacturing Market.

Manufacturing 52

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The Pharma Data

JUNE 2, 2022

Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR.

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pharmaphorum

JULY 7, 2021

The complete response letter (CRL) for teplizumab as a treatment to delay clinical type 1 diabetes in at-risk individuals reiterates the FDA’s concerns around the pharmacokinetics (PK) data for the antibody.

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pharmaphorum

DECEMBER 18, 2020

GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the first and only FDA-approved treatment for lupus nephritis.

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Roots Analysis

FEBRUARY 27, 2024

What are Affimers : Affimers are small proteins that target and bind molecules on cellular surfaces in a manner analogous to monoclonal antibodies. Antibody drug conjugates (ADCs) are a class of cancer drugs that combine the targeting specificity of monoclonal antibodies with the cytotoxic potency of small-molecule drugs.

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Roots Analysis

FEBRUARY 15, 2022

ADCs are engineered therapeutics comprised of monoclonal antibodies attached to potent cytotoxic payloads through chemical linkers. Given the fact that ADCs are highly potent cytotoxic molecules, the manufacturing of ADCs requires elaborate technical capabilities and highly potent chemical substances.

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Roots Analysis

FEBRUARY 26, 2024

In fact, the share of biologics in the overall pharmaceutical contract manufacturing market has increased from 16% in 2006 to over 25% in 2017. Having reported over 70% increase in revenues over the past 5-6 years, the market for biologically derived products is currently estimated to be worth more than USD 200 billion.

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The Pharma Data

OCTOBER 6, 2021

Hightech production facility In the LSCC, Boehringer Ingelheim will produce biopharmaceuticals for its own product portfolio as well as for third-party contract manufacturing. Biopharmaceutical Contract Manufacturing Boehringer Ingelheim is one of the leading manufacturers of biopharmaceuticals.

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The Pharma Data

AUGUST 3, 2021

In July, Boehringer Ingelheim reported a breakthrough in the treatment of heart failure with empagliflozin (marketed as JARDIANCE ® ). In June, the European Commission granted marketing authorization for JARDIANCE ® as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). billion EUR.

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pharmaphorum

MARCH 21, 2022

Shares in Provention Bio cratered last July when the FDA turned down its marketing application for type 1 diabetes therapy teplizumab. But armed with new data it has tried again, with the FDA due to make a decision on the new filing by 17 August.

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Roots Analysis

MARCH 13, 2022

In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines and gene therapies), by the US FDA, have steadily risen. The Evolving Landscape of Biopharmaceutical Excipient Manufacturing Domain.

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Roots Analysis

APRIL 15, 2024

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

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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].

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pharmaphorum

NOVEMBER 18, 2022

The US regulator has approved the anti-CD3 antibody as Tzield to delay the onset of stage 3 T1D in people eight years and older who currently have stage 2 disease, which according to the FDA “may provide patients with months to years without the burdens of disease.”

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Drugs FDA Approval Insulin Clinical Trials 52

Roots Analysis

FEBRUARY 14, 2023

Players Offering Liposome Development and Manufacturing Services Presently, over 70 companies are actively engaged in offering services related to liposomes development and manufacturing, worldwide. Further, most of the liposome development and manufacturing service providers (68%) offer services for discovery / research purposes.

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The Pharma Data

MARCH 24, 2021

Other COVID-19 initiatives include the research and development of SARS-CoV-2 antibodies that can be combined with BI 767551, small molecules to inhibit its replication, and therapy development to prevent micro coagulation (blood clots). Animal Health – Strong performance in a highly competitive market . billion EUR. billion EUR.

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Roots Analysis

AUGUST 8, 2023

Disposable bioreactors have transformed the process of conventional biomanufacturing, and their adoption is increasing rapidly for production of various biologics, such as antibody, recombinant proteins, cell and gene therapy. It is worth mentioning that the single use bioreactors market is also witnessing the adoption of bioprocessing 4.0

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XTalks

APRIL 11, 2024

On the other hand, Abecma is now approved as a third-line treatment for patients with triple-class-exposed disease, which means previous treatment with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody. Plasma cells help fight infections by producing antibodies.

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Roots Analysis

OCTOBER 24, 2023

As the global market for pharmaceutical solutions is increasing, pressure to bring biological APIs in different biological forms is rising and with the rising demand of targeted therapies, antibody-drug conjugates (ADCs) and cytotoxic drugs have gained wide attention in the field of HPAPIs.

Manufacturing 40

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Roots Analysis

OCTOBER 3, 2023

Key Trends that are Shaping up the Global Bioreactors and Fermenters Market As per a recent market report by Roots Analysis, more than 255+ companies are currently involved in manufacturing bioreactors and fermenters, across the globe for the production of biopharmaceuticals, such as antibodies, vaccines, cell and gene therapies.

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The Pharma Data

MARCH 28, 2022

The European Medicines Agency validated the marketing authorization application for spesolimab in GPP in October 2021 and the submission is currently under evaluation. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. .

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The Pharma Data

JULY 29, 2021

Following the completion of the spin-off of the Upjohn Business(6) in the fourth quarter of 2020, Pfizer operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sale and distribution of biopharmaceutical products worldwide.

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The Pharma Data

NOVEMBER 5, 2020

Lastly, we are proud that our novel antibody cocktail REGN-EB3 recently became the first FDA-approved treatment for Ebola, underscoring the potential of antibody therapies to address deadly infectious diseases.” REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus. Evinacumab , an antibody to ANGPTL3.

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The Pharma Data

DECEMBER 23, 2020

Stanley Plotkin , Professor Emeritus at The Wistar Institute, said, “INOVIO’s DNA vaccine appeared to be quite safe with few significant reactions but yet induced both antibody and T cell responses to SARS-CoV-2.” mg dose group and 84% demonstrating neutralizing antibodies in the 2.0 . mg and 2.0

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The Pharma Data

JULY 21, 2021

Government at a not-for-profit price, that the government will, in turn, donate to the African Union and the COVAX 92 Advanced Market Commitment (AMC) countries, as well as a direct supply agreement with the COVAX facility for 40 million doses. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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Vaccination Vaccine Manufacturing Clinical Trials 52

The Pharma Data

MAY 4, 2021

Following the completion of the spin-off of the Upjohn Business (4) in the fourth quarter of 2020, Pfizer now operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sales and distribution of biopharmaceutical products worldwide. in December 2019; and.

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Roots Analysis

JANUARY 24, 2024

Presently, close to 60 manufacturers have adopted end to end continuous manufacturing and semi-continuous manufacturing process for various types of biologics, including antibodies, enzymes, proteins / peptides, vaccines and viral vectors. Such developments will support the continuous manufacturing market growth.

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Pharmaceutical Technology

APRIL 24, 2023

These attributes make some biologic drugs, especially monoclonal antibodies more specific and targeted in their treatment. With new drugs on the market, companies are now looking for ways to manufacture recently approved biologics, and countries are racing to claim their corner – or maintain their decades-old market share.

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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). Please check your email to download the Report.

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