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.

Manufacturing 59

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.

Contract Manufacturing 52

Contract Manufacturing Antibody Manufacturing Marketing 52

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).

Drugs 97

Drugs Antibody Contract Manufacturing Immune Response 97

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.

Antibody 52

Antibody DNA Containment Manufacturing 52

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.

Drugs 98

Drugs Insulin Contract Manufacturing Antibody 98

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.

Antibody 52

Antibody Licensing Licensing Contract Manufacturing 52

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.

Contract Manufacturing 52

Contract Manufacturing Manufacturing Marketing Containment 52

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.

Production 52

Production Contract Manufacturing Manufacturing Branding 52

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.

Manufacturing 130

Manufacturing Packaging Packaging Contract Manufacturing 130

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.

Drugs 52

Drugs Insulin Contract Manufacturing Clinical Trials 52

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.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

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.”

Drugs 52

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.

Development 52

Development Manufacturing Drug Delivery Systems Contract Manufacturing 52

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

Manufacturing 52

Manufacturing Production Marketing Gene Therapy 52

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

Manufacturing Hormones Contamination Containment 40

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. .

Dermatology 52

Dermatology Trials Contract Manufacturing Medicine 52

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

DNA 40

DNA Vaccination Vaccine Immune Response 40

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.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

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.

Contract Manufacturing 130

Contract Manufacturing Manufacturing Protein Sales 130

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.

Drugs 130

Drugs Manufacturing Contract Manufacturing FDA Approval 130

Pharmaceutical Technology

NOVEMBER 22, 2022

Despite China producing a significant proportion of the world’s API supply (mostly small molecule), it manufactures relatively few biosimilar and innovator drugs and no cell and gene therapies for the western markets of Europe and the US despite investments and an increasing number of startups to improve innovative manufacture.

Manufacturing 162

Manufacturing Gene Therapy Gene Contract Manufacturing 162

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.

Manufacturing 130

Manufacturing Packaging Packaging Drugs 130

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.

FDA Approval 99

FDA Approval Contract Manufacturing Sales Trials 99

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.

Antibody 52

Antibody Licensing Licensing Development 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). Please check your email to download the Report.

Manufacturing 147

Manufacturing Drugs Packaging Packaging 147

Pharmaceutical Technology

FEBRUARY 27, 2023

Manufacturing a drug therapy usually involves several different stakeholders. The monoclonal antibody targeting IL-4 and IL-13 is approved in several chronic inflammatory conditions. The parenteral manufacturing and packaging for Dupixent are outsourced to Catalent. GlobalData is the parent company of Pharmaceutical Technology.

Manufacturing 130

Manufacturing Drugs Packaging Packaging 130

Pharmaceutical Technology

JANUARY 12, 2023

PM: Lyophilization is widely used in the pharmaceutical and biotech industry for small molecule drug products, vaccines, antibodies, and other biological material. What are the key advantages of this stabilization method? United Kingdom. United States. Afghanistan. Åland Islands. Please check your email to download the eBook.

Production 130

Production Contamination Development Manufacturing 130

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

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.

Drug Delivery Systems 52

Drug Delivery Systems Drug Delivery Drugs Contract Manufacturing 52

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

Manufacturing Marketing Contract Manufacturing Protein 52

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.

Sales 40

Sales Production Manufacturing Antibody 40

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.

Manufacturing 52

Manufacturing Drug Delivery Marketing Drug Delivery Systems 52

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.

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 52

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.

Manufacturing 52

Manufacturing Sales Vaccination Vaccine 52

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.

Vaccination 40

Vaccination Vaccine Production Manufacturing 40

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.

Manufacturing 130

Manufacturing Vaccination Vaccine Packaging 130

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.

Manufacturing 40

Manufacturing Contract Manufacturing Production Marketing 40