Merck Discontinues Development of SARS-CoV-2/COVID-19 Vaccine Candidates; Continues Development of Two Investigational Therapeutic Candidates

Merck Discontinues Development of SARS-CoV-2/COVID-19 Vaccine Candidates; Continues Development of Two Investigational Therapeutic Candidates

Jan 25th: Merck, known as MSD outside the United States and Canada, announced that the company is discontinuing development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, and plans to focus its SARS-CoV-2/COVID-19 research strategy and production capabilities on advancing two therapeutic candidates, MK-4482 and MK-7110. This decision follows Merck’s review of findings from Phase 1 clinical studies for the vaccines. In these studies, both V590 and V591 were generally well tolerated, but the immune responses were inferior to those seen following natural infection and those reported for other SARS-CoV-2/COVID-19 vaccines. Merck continues to advance clinical programs and to scale-up ...
Read More
AAV Joins the Rank of Genotoxic Vectors

AAV Joins the Rank of Genotoxic Vectors

Cancer is one of the most feared diagnoses, and any treatment that increases the chance of a secondary malignancy requires careful consideration before offering it to patients. Integrating vectors based on retroviruses and lentiviruses carry the risk of malignancy related to insertional mutagenesis (IM), a process where vector insertion alters expression of critical genes involved with cell growth and differentiation. Adeno-associated viral (AAV) vectors have been touted as safer, given that these vectors generally persist episomally with infrequent integration. Unfortunately, mounting evidence supports the notion that AAV vectors can be genotoxic. The comment appeared In January 19th online issue of ...
Read More
Servier and MiNA Partner to Create Entirely New Class of Drugs

Servier and MiNA Partner to Create Entirely New Class of Drugs

France-based Servier and U.K.-based MiNA Therapeutics are partnering on small activating RNA (saRNA) therapies to treat neurological diseases. saRNA is an entirely new class of drugs. They are small oligonucleotides, similar to siRNAs. This technology is MiNA’s focus, based on inventions from the company’s founder Pål Saetrom, which were assigned to MiNA by the Norwegian University of Science and Technology. The company has also in-licensed fundamental patents from UT Southwestern Medical Center that covers RNA activation therapeutics. MiNA will leverage its saRNA platform to identify possible treatments to restore normal cell function in neurological diseases. Servier will handle preclinical and clinical development of potential candidates. Servier ...
Read More
Thermo Fisher Scientific Acquires Viral Vector Manufacturing Business from Novasep

Thermo Fisher Scientific Acquires Viral Vector Manufacturing Business from Novasep

Thermo Fisher Scientific Inc., announced on January 15th that Thermo Fisher has completed the acquisition of Henogen S.A., Novasep's viral vector manufacturing business in Belgium for approximately €725 million in cash. Novasep's viral vector manufacturing business provides contract manufacturing services for vaccines and therapies to biotechnology companies and large biopharma customers. With two locations in Seneffe and Gosselies, Belgium, Novasep's viral vector business offers more than 7,000 square meters of state-of-the-art clinical and commercial manufacturing capacity. Founded more than 20 years ago, the business has approximately 400 employees with substantial operational and technical expertise in a broad range of viral vector classes and estimated 2020 ...
Read More
SK Holdings set to jump into cell and gene CDMO space with Yposkesi buy

SK Holdings set to jump into cell and gene CDMO space with Yposkesi buy

Korean investment firm SK Holdings is looking to buy Yposkesi to add a cell and gene therapy business to its growing CDMO portfolio. While the deal is not done and financials have not been revealed, SK Holdings is looking to become the majority shareholder in the majority shareholder of Yposkesi, a France-based contract development and manufacturing organization (CDMO) specializing in advanced therapies. If it goes through, Yposkesi will fall under SK’s CDMO holding company, California-headquartered SK Pharmteco, formed last year to oversee the growing portfolio of pharma manufacturing facilities and businesses. Having first played in the pharma intermediate space, SK ...
Read More
Gene Therapy: The Rocky Road to Success

Gene Therapy: The Rocky Road to Success

The manipulation of genes to treat disease once seemed only to be the basis for an average science fiction novel. And if your story restored an individual’s vision by using a virus to replace a mutant version of a gene with a healthy one, you might have a best seller on your hands. But we all now know that this is not fiction; it is a description of Luxturna, the first FDA-approved gene therapy for an inherited retinal disease caused by mutations in both copies of the RPE65 gene. The concept of gene therapy was officially established back in 1972. And although gene ...
Read More
FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine

FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine

Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases. These advances have contributed to an increase in development and approval of drugs for the treatment of rare diseases in recent years. In fact, in the past eight years, the U.S. Food and Drug Administration has approved more than twice as many drugs for rare diseases, often referred to as orphan drugs, as in the previous eight years. For genetic diseases, recent approaches to testing and molecular diagnosis have allowed us ...
Read More

Merck Discontinues Development of SARS-CoV-2/COVID-19 Vaccine Candidates; Continues Development of Two Investigational Therapeutic Candidates

Merck Discontinues Development of SARS-CoV-2/COVID-19 Vaccine Candidates; Continues Development of Two Investigational Therapeutic Candidates

Jan 25th: Merck, known as MSD outside the United States and Canada, announced that the company is discontinuing development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, and plans to focus its SARS-CoV-2/COVID-19 research strategy and production capabilities on advancing two therapeutic candidates, MK-4482 and MK-7110. This decision follows Merck’s review of findings from Phase 1 clinical studies for the vaccines. In these studies, both V590 and V591 were generally well tolerated, but the immune responses were inferior to those seen following natural infection and those reported for other SARS-CoV-2/COVID-19 vaccines. Merck continues to advance clinical programs and to scale-up ...
Read More
AAV Joins the Rank of Genotoxic Vectors

AAV Joins the Rank of Genotoxic Vectors

Cancer is one of the most feared diagnoses, and any treatment that increases the chance of a secondary malignancy requires careful consideration before offering it to patients. Integrating vectors based on retroviruses and lentiviruses carry the risk of malignancy related to insertional mutagenesis (IM), a process where vector insertion alters expression of critical genes involved with cell growth and differentiation. Adeno-associated viral (AAV) vectors have been touted as safer, given that these vectors generally persist episomally with infrequent integration. Unfortunately, mounting evidence supports the notion that AAV vectors can be genotoxic. The comment appeared In January 19th online issue of ...
Read More
Servier and MiNA Partner to Create Entirely New Class of Drugs

Servier and MiNA Partner to Create Entirely New Class of Drugs

France-based Servier and U.K.-based MiNA Therapeutics are partnering on small activating RNA (saRNA) therapies to treat neurological diseases. saRNA is an entirely new class of drugs. They are small oligonucleotides, similar to siRNAs. This technology is MiNA’s focus, based on inventions from the company’s founder Pål Saetrom, which were assigned to MiNA by the Norwegian University of Science and Technology. The company has also in-licensed fundamental patents from UT Southwestern Medical Center that covers RNA activation therapeutics. MiNA will leverage its saRNA platform to identify possible treatments to restore normal cell function in neurological diseases. Servier will handle preclinical and clinical development of potential candidates. Servier ...
Read More
Thermo Fisher Scientific Acquires Viral Vector Manufacturing Business from Novasep

Thermo Fisher Scientific Acquires Viral Vector Manufacturing Business from Novasep

Thermo Fisher Scientific Inc., announced on January 15th that Thermo Fisher has completed the acquisition of Henogen S.A., Novasep's viral vector manufacturing business in Belgium for approximately €725 million in cash. Novasep's viral vector manufacturing business provides contract manufacturing services for vaccines and therapies to biotechnology companies and large biopharma customers. With two locations in Seneffe and Gosselies, Belgium, Novasep's viral vector business offers more than 7,000 square meters of state-of-the-art clinical and commercial manufacturing capacity. Founded more than 20 years ago, the business has approximately 400 employees with substantial operational and technical expertise in a broad range of viral vector classes and estimated 2020 ...
Read More
SK Holdings set to jump into cell and gene CDMO space with Yposkesi buy

SK Holdings set to jump into cell and gene CDMO space with Yposkesi buy

Korean investment firm SK Holdings is looking to buy Yposkesi to add a cell and gene therapy business to its growing CDMO portfolio. While the deal is not done and financials have not been revealed, SK Holdings is looking to become the majority shareholder in the majority shareholder of Yposkesi, a France-based contract development and manufacturing organization (CDMO) specializing in advanced therapies. If it goes through, Yposkesi will fall under SK’s CDMO holding company, California-headquartered SK Pharmteco, formed last year to oversee the growing portfolio of pharma manufacturing facilities and businesses. Having first played in the pharma intermediate space, SK ...
Read More
Gene Therapy: The Rocky Road to Success

Gene Therapy: The Rocky Road to Success

The manipulation of genes to treat disease once seemed only to be the basis for an average science fiction novel. And if your story restored an individual’s vision by using a virus to replace a mutant version of a gene with a healthy one, you might have a best seller on your hands. But we all now know that this is not fiction; it is a description of Luxturna, the first FDA-approved gene therapy for an inherited retinal disease caused by mutations in both copies of the RPE65 gene. The concept of gene therapy was officially established back in 1972. And although gene ...
Read More
FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine

FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine

Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases. These advances have contributed to an increase in development and approval of drugs for the treatment of rare diseases in recent years. In fact, in the past eight years, the U.S. Food and Drug Administration has approved more than twice as many drugs for rare diseases, often referred to as orphan drugs, as in the previous eight years. For genetic diseases, recent approaches to testing and molecular diagnosis have allowed us ...
Read More
Merck Discontinues Development of SARS-CoV-2/COVID-19 Vaccine Candidates; Continues Development of Two Investigational Therapeutic Candidates

Merck Discontinues Development of SARS-CoV-2/COVID-19 Vaccine Candidates; Continues Development of Two Investigational Therapeutic Candidates

Jan 25th: Merck, known as MSD outside the United States and Canada, announced that the company is discontinuing development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, and plans to focus its SARS-CoV-2/COVID-19 research strategy and production capabilities on advancing two therapeutic candidates, MK-4482 and MK-7110. This decision follows Merck’s review of findings from Phase 1 clinical studies for the vaccines. In these studies, both V590 and V591 were generally well tolerated, but the immune responses were inferior to those seen following natural infection and those reported for other SARS-CoV-2/COVID-19 vaccines. Merck continues to advance clinical programs and to scale-up ...
Read More
AAV Joins the Rank of Genotoxic Vectors

AAV Joins the Rank of Genotoxic Vectors

Cancer is one of the most feared diagnoses, and any treatment that increases the chance of a secondary malignancy requires careful consideration before offering it to patients. Integrating vectors based on retroviruses and lentiviruses carry the risk of malignancy related to insertional mutagenesis (IM), a process where vector insertion alters expression of critical genes involved with cell growth and differentiation. Adeno-associated viral (AAV) vectors have been touted as safer, given that these vectors generally persist episomally with infrequent integration. Unfortunately, mounting evidence supports the notion that AAV vectors can be genotoxic. The comment appeared In January 19th online issue of ...
Read More
Servier and MiNA Partner to Create Entirely New Class of Drugs

Servier and MiNA Partner to Create Entirely New Class of Drugs

France-based Servier and U.K.-based MiNA Therapeutics are partnering on small activating RNA (saRNA) therapies to treat neurological diseases. saRNA is an entirely new class of drugs. They are small oligonucleotides, similar to siRNAs. This technology is MiNA’s focus, based on inventions from the company’s founder Pål Saetrom, which were assigned to MiNA by the Norwegian University of Science and Technology. The company has also in-licensed fundamental patents from UT Southwestern Medical Center that covers RNA activation therapeutics. MiNA will leverage its saRNA platform to identify possible treatments to restore normal cell function in neurological diseases. Servier will handle preclinical and clinical development of potential candidates. Servier ...
Read More
Thermo Fisher Scientific Acquires Viral Vector Manufacturing Business from Novasep

Thermo Fisher Scientific Acquires Viral Vector Manufacturing Business from Novasep

Thermo Fisher Scientific Inc., announced on January 15th that Thermo Fisher has completed the acquisition of Henogen S.A., Novasep's viral vector manufacturing business in Belgium for approximately €725 million in cash. Novasep's viral vector manufacturing business provides contract manufacturing services for vaccines and therapies to biotechnology companies and large biopharma customers. With two locations in Seneffe and Gosselies, Belgium, Novasep's viral vector business offers more than 7,000 square meters of state-of-the-art clinical and commercial manufacturing capacity. Founded more than 20 years ago, the business has approximately 400 employees with substantial operational and technical expertise in a broad range of viral vector classes and estimated 2020 ...
Read More
SK Holdings set to jump into cell and gene CDMO space with Yposkesi buy

SK Holdings set to jump into cell and gene CDMO space with Yposkesi buy

Korean investment firm SK Holdings is looking to buy Yposkesi to add a cell and gene therapy business to its growing CDMO portfolio. While the deal is not done and financials have not been revealed, SK Holdings is looking to become the majority shareholder in the majority shareholder of Yposkesi, a France-based contract development and manufacturing organization (CDMO) specializing in advanced therapies. If it goes through, Yposkesi will fall under SK’s CDMO holding company, California-headquartered SK Pharmteco, formed last year to oversee the growing portfolio of pharma manufacturing facilities and businesses. Having first played in the pharma intermediate space, SK ...
Read More
Gene Therapy: The Rocky Road to Success

Gene Therapy: The Rocky Road to Success

The manipulation of genes to treat disease once seemed only to be the basis for an average science fiction novel. And if your story restored an individual’s vision by using a virus to replace a mutant version of a gene with a healthy one, you might have a best seller on your hands. But we all now know that this is not fiction; it is a description of Luxturna, the first FDA-approved gene therapy for an inherited retinal disease caused by mutations in both copies of the RPE65 gene. The concept of gene therapy was officially established back in 1972. And although gene ...
Read More
FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine

FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine

Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases. These advances have contributed to an increase in development and approval of drugs for the treatment of rare diseases in recent years. In fact, in the past eight years, the U.S. Food and Drug Administration has approved more than twice as many drugs for rare diseases, often referred to as orphan drugs, as in the previous eight years. For genetic diseases, recent approaches to testing and molecular diagnosis have allowed us ...
Read More