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API SUPPLIERS

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01

Shanghai Minbiotech

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

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Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Shanghai Minbiotech CB

02

Beijing Mesochem Technology

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMesochem is focused on incessant innovation along with the R&D of new APIs.

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Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Mesochem Company Banner
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Listed Suppliers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

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Digital Content Digital Content

Emicizumab

About the Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...

​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in Nantong, Jiangsu and Jinan, Shandong, with more than 13,000㎡ of production sites. While supplying products to customers, the company also provides services such as technology development, technology transfer and technology exchange, aiming to provide customers with comprehensive supply and solutions in the biomedical industry.
Shanghai Minbiotech CB

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMesochem is focused on incessant innovation along with the R&D of new APIs.

Flag China
Digital Content Digital Content

Emicizumab

About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...

Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine chemicals and fundamental chemical materials. It has an efficient research and development team. Beijing Mesochem provides its customers customized development, craft optimization, contract customization and outsourcing services. The company has a well-established industrial base in Weinan, Shanxi Province. The production base features a 20,000 ㎡ plant with a production capacity of over 8,000 MT per year.
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Drugs in Development

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Details:

Hemlibra (Emicizumab-kxwh) is a bispecific monoclonal antibody designed to bind factor IXa and factor X. In doing so, Hemlibra provides the cofactor function of factor VIII in people with hemophilia A, who either lack or have impaired coagulation function of factor VIII.


Lead Product(s): Emicizumab

Therapeutic Area: Genetic Disease Brand Name: Hemlibra

Study Phase: Approved FDFProduct Type: Antibody

Sponsor: Chugai Pharmaceutical

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 12, 2023

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01

Genentech

U.S.A
arrow
STLE Annual Meeting
Not Confirmed

Genentech

U.S.A
arrow
STLE Annual Meeting
Not Confirmed

Details : Hemlibra (Emicizumab-kxwh) is a bispecific monoclonal antibody designed to bind factor IXa and factor X. In doing so, Hemlibra provides the cofactor function of factor VIII in people with hemophilia A, who either lack or have impaired coagulation functio...

Product Name : Hemlibra

Product Type : Antibody

Upfront Cash : Inapplicable

September 12, 2023

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Details:

Hemlibra (emicizumab-kxwh) is a bispecific monoclonal antibody designed to bind factor IXa and factor X. In doing so, hemlibra provides the cofactor function of factor VIII in people with hemophilia A, who either lack or have impaired coagulation function of factor VIII.


Lead Product(s): Emicizumab

Therapeutic Area: Genetic Disease Brand Name: Hemlibra

Study Phase: Approved FDFProduct Type: Antibody

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 02, 2023

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02

STLE Annual Meeting
Not Confirmed
STLE Annual Meeting
Not Confirmed

Details : Hemlibra (emicizumab-kxwh) is a bispecific monoclonal antibody designed to bind factor IXa and factor X. In doing so, hemlibra provides the cofactor function of factor VIII in people with hemophilia A, who either lack or have impaired coagulation functio...

Product Name : Hemlibra

Product Type : Antibody

Upfront Cash : Inapplicable

January 02, 2023

blank

Details:

Hemlibra (Emicizumab-kxwh) is a bispecific monoclonal antibody designed to bind factor IXa and factor X. In doing so, Hemlibra provides the cofactor function of factor VIII in people with hemophilia A, who either lack or have impaired coagulation function of factor VIII.


Lead Product(s): Emicizumab

Therapeutic Area: Genetic Disease Brand Name: Hemlibra

Study Phase: Approved FDFProduct Type: Antibody

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 02, 2023

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03

F. Hoffmann-La Roche

Switzerland
arrow
STLE Annual Meeting
Not Confirmed

F. Hoffmann-La Roche

Switzerland
arrow
STLE Annual Meeting
Not Confirmed

Details : Hemlibra (Emicizumab-kxwh) is a bispecific monoclonal antibody designed to bind factor IXa and factor X. In doing so, Hemlibra provides the cofactor function of factor VIII in people with hemophilia A, who either lack or have impaired coagulation functio...

Product Name : Hemlibra

Product Type : Antibody

Upfront Cash : Inapplicable

January 02, 2023

blank

Details:

Hemlibra (emicizumab-kxwh), is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins involved in the natural coagulation cascade, and restore the blood clotting process for people with haemophilia A.


Lead Product(s): Emicizumab

Therapeutic Area: Genetic Disease Brand Name: Hemlibra

Study Phase: Approved FDFProduct Type: Antibody

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 16, 2022

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04

F. Hoffmann-La Roche

Switzerland
arrow
STLE Annual Meeting
Not Confirmed

F. Hoffmann-La Roche

Switzerland
arrow
STLE Annual Meeting
Not Confirmed

Details : Hemlibra (emicizumab-kxwh), is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins involved in the natural coagulation cascade, and restore the blood clotting process for people with...

Product Name : Hemlibra

Product Type : Antibody

Upfront Cash : Inapplicable

December 16, 2022

blank

Details:

Hemlibra (emicizumab-kxwh) is bispecific monoclonal antibody created with Chugai’s proprietary antibody engineering technologies. The drug is designed to bind factor IXa and factor X.


Lead Product(s): Emicizumab

Therapeutic Area: Genetic Disease Brand Name: Hemlibra

Study Phase: Approved FDFProduct Type: Antibody

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 07, 2022

blank

05

STLE Annual Meeting
Not Confirmed
STLE Annual Meeting
Not Confirmed

Details : Hemlibra (emicizumab-kxwh) is bispecific monoclonal antibody created with Chugai’s proprietary antibody engineering technologies. The drug is designed to bind factor IXa and factor X.

Product Name : Hemlibra

Product Type : Antibody

Upfront Cash : Inapplicable

December 07, 2022

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Details:

Data show that Hemlibra (emicizumab-kxwh) maintained low treated bleed rates across study period, with 66.7% of participants experiencing no bleeds that required treatment, 81.9% experiencing no spontaneous bleeds that required treatment.


Lead Product(s): Emicizumab

Therapeutic Area: Genetic Disease Brand Name: Hemlibra

Study Phase: Approved FDFProduct Type: Antibody

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 07, 2022

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06

F. Hoffmann-La Roche

Switzerland
arrow
STLE Annual Meeting
Not Confirmed

F. Hoffmann-La Roche

Switzerland
arrow
STLE Annual Meeting
Not Confirmed

Details : Data show that Hemlibra (emicizumab-kxwh) maintained low treated bleed rates across study period, with 66.7% of participants experiencing no bleeds that required treatment, 81.9% experiencing no spontaneous bleeds that required treatment.

Product Name : Hemlibra

Product Type : Antibody

Upfront Cash : Inapplicable

November 07, 2022

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Details:

Hemlibra (emicizumab-kxwh) continues to demonstrate clinically meaningful bleed control, with 66.7% of participants with moderate or mild haemophilia A experiencing zero treated bleeds at 55.6 weeks median follow-up.


Lead Product(s): Emicizumab

Therapeutic Area: Genetic Disease Brand Name: Hemlibra

Study Phase: Approved FDFProduct Type: Antibody

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 07, 2022

blank

07

F. Hoffmann-La Roche

Switzerland
arrow
STLE Annual Meeting
Not Confirmed

F. Hoffmann-La Roche

Switzerland
arrow
STLE Annual Meeting
Not Confirmed

Details : Hemlibra (emicizumab-kxwh) continues to demonstrate clinically meaningful bleed control, with 66.7% of participants with moderate or mild haemophilia A experiencing zero treated bleeds at 55.6 weeks median follow-up.

Product Name : Hemlibra

Product Type : Antibody

Upfront Cash : Inapplicable

November 07, 2022

blank

Details:

Hemlibra (Emicizumab-kxwh) is a bispecific monoclonal antibody created with Chugai’s proprietary antibody engineering technologies. The drug is designed to bind factor IXa and factor X. Hemlibra provides the cofactor function of factor VIII in people with hemophilia A.


Lead Product(s): Emicizumab

Therapeutic Area: Genetic Disease Brand Name: Hemlibra

Study Phase: Approved FDFProduct Type: Antibody

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 20, 2022

blank

08

STLE Annual Meeting
Not Confirmed
STLE Annual Meeting
Not Confirmed

Details : Hemlibra (Emicizumab-kxwh) is a bispecific monoclonal antibody created with Chugai’s proprietary antibody engineering technologies. The drug is designed to bind factor IXa and factor X. Hemlibra provides the cofactor function of factor VIII in people w...

Product Name : Hemlibra

Product Type : Antibody

Upfront Cash : Inapplicable

June 20, 2022

blank

Details:

Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins involved in the natural coagulation cascade, and restore the blood clotting process for people with haemophilia A.


Lead Product(s): Emicizumab

Therapeutic Area: Genetic Disease Brand Name: Hemlibra

Study Phase: Approved FDFProduct Type: Antibody

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 13, 2021

blank

09

F. Hoffmann-La Roche

Switzerland
arrow
STLE Annual Meeting
Not Confirmed

F. Hoffmann-La Roche

Switzerland
arrow
STLE Annual Meeting
Not Confirmed

Details : Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins involved in the natural coagulation cascade, and restore the blood clotting process for people with haemophilia A.

Product Name : Hemlibra

Product Type : Antibody

Upfront Cash : Inapplicable

December 13, 2021

blank

Details:

The analysis did not show any new cases of thrombotic microangiopathy or serious thrombotic events (adverse events [AEs] that have been observed in people with bleeding disorders) related to Hemlibra.


Lead Product(s): Emicizumab

Therapeutic Area: Genetic Disease Brand Name: Hemlibra

Study Phase: Approved FDFProduct Type: Antibody

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 19, 2021

blank

10

F. Hoffmann-La Roche

Switzerland
arrow
STLE Annual Meeting
Not Confirmed

F. Hoffmann-La Roche

Switzerland
arrow
STLE Annual Meeting
Not Confirmed

Details : The analysis did not show any new cases of thrombotic microangiopathy or serious thrombotic events (adverse events [AEs] that have been observed in people with bleeding disorders) related to Hemlibra.

Product Name : Hemlibra

Product Type : Antibody

Upfront Cash : Inapplicable

July 19, 2021

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FDF Dossiers

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01

F. Hoffmann-La Roche

Switzerland
American Thoracic Society
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
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American Thoracic Society
Not Confirmed

Emicizumab

Brand Name : Hemlibra

Dosage Form : Inj Solution

Dosage Strength : 150mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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02

F. Hoffmann-La Roche

Switzerland
American Thoracic Society
Not Confirmed
arrow

F. Hoffmann-La Roche

Switzerland
arrow
American Thoracic Society
Not Confirmed

Emicizumab

Brand Name : Hemlibra

Dosage Form : Inj Solution

Dosage Strength : 30mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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03

F. Hoffmann-La Roche

Switzerland
American Thoracic Society
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
arrow
American Thoracic Society
Not Confirmed

Emicizumab

Brand Name : Hemlibra

Dosage Form : Inj Loose

Dosage Strength : 60mg/0.4ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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04

F. Hoffmann-La Roche

Switzerland
American Thoracic Society
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
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American Thoracic Society
Not Confirmed

EMICIZUMAB

Brand Name : HEMLIBRA

Dosage Form : SOLUTION

Dosage Strength : 30MG/1ML

Packaging : 1ML

Approval Date :

Application Number : 2479621

Regulatory Info : Prescription

Registration Country : Canada

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05

F. Hoffmann-La Roche

Switzerland
American Thoracic Society
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
arrow
American Thoracic Society
Not Confirmed

EMICIZUMAB

Brand Name : HEMLIBRA

Dosage Form : SOLUTION

Dosage Strength : 105MG/0.7ML

Packaging : 0.7ML

Approval Date :

Application Number : 2479656

Regulatory Info : Prescription

Registration Country : Canada

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06

F. Hoffmann-La Roche

Switzerland
American Thoracic Society
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
arrow
American Thoracic Society
Not Confirmed

Emicizumab

Brand Name : Hemlibra 105mg/0.7 ml

Dosage Form : INJ

Dosage Strength : 105mg

Packaging : 0.7X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

F. Hoffmann-La Roche

Switzerland
American Thoracic Society
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
arrow
American Thoracic Society
Not Confirmed

Emicizumab

Brand Name : Hemlibra 150mg/1 ml

Dosage Form : INJ

Dosage Strength : 150mg

Packaging : 1X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

F. Hoffmann-La Roche

Switzerland
American Thoracic Society
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
arrow
American Thoracic Society
Not Confirmed

Emicizumab

Brand Name : Hemlibra 30mg/1 ml

Dosage Form : INJ

Dosage Strength : 30mg

Packaging : 1X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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09

Genentech

U.S.A
American Thoracic Society
Not Confirmed
arrow

Genentech

U.S.A
arrow
American Thoracic Society
Not Confirmed

EMICIZUMAB

Brand Name : HEMLIBRA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 30MG/ML

Packaging :

Approval Date :

Application Number : 761083

Regulatory Info :

Registration Country : USA

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10

Genentech

U.S.A
American Thoracic Society
Not Confirmed
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Genentech

U.S.A
arrow
American Thoracic Society
Not Confirmed

EMICIZUMAB

Brand Name : HEMLIBRA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 60MG/0.4ML

Packaging :

Approval Date :

Application Number : 761083

Regulatory Info :

Registration Country : USA

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Europe

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01

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

Emicizumab

Brand Name : Hemlibra

Dosage Form : Inj L?s

Dosage Strength : 105mg/0.7ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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02

STLE Annual Meeting
Not Confirmed
arrow
arrow
STLE Annual Meeting
Not Confirmed

Emicizumab

Brand Name : Hemlibra

Dosage Form : Inj Solution

Dosage Strength : 150mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

03

STLE Annual Meeting
Not Confirmed
arrow
arrow
STLE Annual Meeting
Not Confirmed

Emicizumab

Brand Name : Hemlibra

Dosage Form : Inj Solution

Dosage Strength : 30mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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04

American Thoracic Society
Not Confirmed
arrow
arrow
American Thoracic Society
Not Confirmed

Emicizumab

Brand Name : Hemlibra

Dosage Form : Inj Loose

Dosage Strength : 60mg/0.4ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Canada

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01

American Thoracic Society
Not Confirmed
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American Thoracic Society
Not Confirmed

EMICIZUMAB

Brand Name : HEMLIBRA

Dosage Form : SOLUTION

Dosage Strength : 30MG/1ML

Packaging : 1ML

Approval Date :

Application Number : 2479621

Regulatory Info : Prescription

Registration Country : Canada

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02

American Thoracic Society
Not Confirmed
arrow
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American Thoracic Society
Not Confirmed

EMICIZUMAB

Brand Name : HEMLIBRA

Dosage Form : SOLUTION

Dosage Strength : 60MG/0.4ML

Packaging : 0.4ML

Approval Date :

Application Number : 2479648

Regulatory Info : Prescription

Registration Country : Canada

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03

American Thoracic Society
Not Confirmed
arrow
arrow
American Thoracic Society
Not Confirmed

EMICIZUMAB

Brand Name : HEMLIBRA

Dosage Form : SOLUTION

Dosage Strength : 105MG/0.7ML

Packaging : 0.7ML

Approval Date :

Application Number : 2479656

Regulatory Info : Prescription

Registration Country : Canada

blank

04

American Thoracic Society
Not Confirmed
arrow
arrow
American Thoracic Society
Not Confirmed

EMICIZUMAB

Brand Name : HEMLIBRA

Dosage Form : SOLUTION

Dosage Strength : 150MG/ML

Packaging :

Approval Date :

Application Number : 2479664

Regulatory Info : Prescription

Registration Country : Canada

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Pipeline Prospector May 2024: J&J inks two deals for eczema drugs; Novo scores trial wins in hemophilia, kidney disease
Pharma indices have rebounded after ending March and April in the red. May saw the Nasdaq Biotechnology Index (NBI) spike 5.6 percent from 4,168.63 to 4,401.1 and the SPDR S&P Biotech ETF (XBI) index rise 5.1 percent from 84.82 to 89.13. The S&P Biotechnology Select Industry Index (SPSIBI) saw a 5.3 percent gain to 6,930.67 from 6,584.4 at the end of April.The month didn’t see very many approvals from the US Food and Drug Administration (FDA). But what May lacked in approvals, it made up in acquisitions, deals, and trial news. Among the noteworthy approvals were Amgen’s (stock up 9 percent) Imdelltra, which won FDA’s accelerated approval to treat adults in the advanced stages of small cell lung cancer (SCLC). The agency okayed Tris Pharma’s Onyda XR, a once-a-day treatment for attention deficit hyperactivity disorder (ADHD) for patients six years and older. This makes it the first liquid non-stimulant ADHD drug approved in the US.Bristol Myers Squibb’s Breyanzi saw two FDA approvals in May. The agency first expanded its use to treat adults with a type of blood cancer known as follicular lymphoma. FDA then okayed it to treat relapsed or refractory mantle cell lymphoma. With five approvals, Breyanzi is the only CAR T cell therapy approved in the US for four distinct subtypes of non-Hodgkin lymphoma, bringing this personalized therapy to the broadest array of patients with B-cell malignancies. And FDA approved Moderna’s (stock up 39 percent) mRESVIA, an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.Access the Pipeline Prospector Dashboard for May 2024 Newsmakers (Free Excel)J&J pays US$ 2.1 bn for eczema drug assets; Merck to buy EyeBio for up to US$ 3 bnSeeking to address the significant need in atopic dermatitis (eczema), J&J spent US$ 2.1 billion on bispecific antibody candidates. This included acquiring Proteologix for US$ 850 million and rights to Numab Therapeutics' NM26 for US$ 1.25 billion. NM26 is a promising phase 2-ready treatment. Bolstering its ophthalmology portfolio, Merck is acquiring EyeBio for up to US$ 3 billion. The deal includes an upfront payment of US$ 1.3 billion and grants Merck access to EyeBio's lead candidate, Restoret, for diabetic macular edema and neovascular age-related macular degeneration.In a US$ 1.8 billion deal (including US$ 1.15 billion upfront), Biogen acquired Human Immunology Biosciences (HI-Bio) to gain access to felzartamab, a potential cure for various immune-mediated diseases. Expanding its oncology portfolio, Novartis acquired Mariana Oncology for US$ 1 billion upfront and US $750 million in milestone payments. Mariana focuses on developing novel radioligand therapies to treat cancers with high unmet needs. Aiming to become a major player in the pharmaceutical industry, Japanese conglomerate Asahi Kasei offered US$ 1.1 billion to acquire Swedish drugmaker Calliditas Therapeutics.Access the Pipeline Prospector Dashboard for May 2024 Newsmakers (Free Excel) Sanofi bails out Novavax with US$ 1.2 bn deal; Takeda nabs option to license Alzheimer’s therapiesNovavax has received a timely shot in the arm, as Sanofi will pay the former up to US$ 1.2 billion in exchange for a license to commercialize its existing Covid vaccine and develop a combo jab to protect against Covid and influenza. The struggling Maryland biotech’s management, or lack thereof, had come under fire from investors. Sanofi also gets a minority 4.9 percent stake in Novavax. Following this, Novavax raised its 2024 revenue guidance from between US$ 800 million and US$ 1 billion to between US$ 970 million and US$ 1.17 billion. Novavax’s stock rocketed 200 percent in May.Japanese pharmaceutical giant Takeda made two significant moves. After an upfront payment of US$ 100 million, Takeda now has the exclusive option to secure global rights to AC Immune's Alzheimer's vaccine and immunotherapies targeting amyloid beta for another US$ 2.1 billion. Additionally, Takeda partnered with Shanghai-based Degron Therapeutics in a deal valued at up to US$1.2 billion. This collaboration focuses on discovering and developing novel cancer, neurological, and inflammatory drugs using a promising new approach called "molecular glue degraders."Access the Pipeline Prospector Dashboard for May 2024 Newsmakers (Free Excel) Novo scores late-stage wins in hemophilia, kidney disease; Lilly’s weekly insulin proves to be as effective as daily dosesNovo Nordisk’s Mim8 has hit its primary endpoint in a late-stage trial to treat people with hemophilia A. This paves the way for filing for approval later this year and competing with Roche’s blockbuster Hemlibra. Meanwhile, Ozempic lowered the risk of death in type 2 diabetes patients with chronic kidney disease. A late-stage trial with 3,533 people showed weekly semaglutide injections reduced kidney failure and death due to kidney complications by 24 percent.However, Novo did suffer a setback this month. FDA’s advisory panel voted seven to four that the benefits of Novo’s once-weekly insulin, Awiqli, do not outweigh its risks. The Danish drugmaker is in a race with Lilly to bring to market weekly injections with long-acting insulins, which would lower the treatment burden for diabetes patients. An increased risk of low blood sugar was flagged by the advisors in patients with type 1 diabetes. Novo's sales increased 24 percent to DKK 65.3 billion (US$ 9.4 billion) in the first quarter of 2024.Eli Lilly’s once-weekly insulin jab, efsitora, showed blood sugar reduction consistent with the daily insulins widely used today by patients with type 2 diabetes. Efsitora met its primary endpoints in two phase 3 trials. The Indiana drugmaker said it is investing an additional US$ 5.3 billion at its Lebanon (Indiana, US) manufacturing site to boost the supply of Zepbound and Mounjaro.Access the Pipeline Prospector Dashboard for May 2024 Newsmakers (Free Excel) Novartis tees up two rare kidney disease therapy approvals; Bayer’s menopause drug reduces hot flashes Novartis touted two promising late-stage readouts for rare kidney disease treatments as it tees up two potential approvals in the renal therapy space. The Swiss drugmaker’s experimental drug, atrasentan, reduced proteinuria (elevated protein in the urine) by 36.1 percent in IgA nephropathy patients. Fabhalta achieved a 35.1 percent proteinuria reduction in patients with the ultra-rare kidney disease C3 glomerulopathy (C3G). C3G currently has no approved therapies.Bayer said its non-hormonal drug, elinzanetant, significantly reduced debilitating bursts of body heat (hot flashes) associated with menopause. This tees it up to become only the second non-hormonal drug to do so after Astellas’ Veozah.Access the Pipeline Prospector Dashboard for May 2024 Newsmakers (Free Excel) Our viewFor long, mental health researchers have been captivated by psychoactive ingredients found in cannabis and LSD. However, advocates suffered a setback in early June when an FDA advisory panel voted against the first MDMA treatment for post-traumatic stress disorder (PTSD). Still, June kicked off with the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, which saw tons of developments in treating cancers. It is shaping up to be an interesting month with over a dozen Prescription Drug User Fee Act (PDUFA) dates including for two drugs to treat chronic obstructive pulmonary disease (COPD) – Dupixent and ensifentrine.Access the Pipeline Prospector Dashboard for May 2024 Newsmakers (Free Excel)  

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https://www.pharmacompass.com/pipeline-prospector-blog/j-j-inks-two-deals-totaling-us-2-1-bn-for-eczema-drugs-novo-scores-late-stage-wins-in-hemophilia-kidney-disease

#PharmaFlow by PHARMACOMPASS
06 Jun 2024

NEWS #PharmaBuzz

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