BioPharma Reporter

DECEMBER 2, 2021

Several contract development and manufacturing organization (CDMO) supported biopharma projects have been flagged in the past month. We take a closer look.

Gene Therapy 97

Gene Therapy Antibody Gene Manufacturing 97

Advarra

JANUARY 11, 2024

While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. Personalized medicine using genetic resequencing techniques, such as cell and gene therapies, enables researchers to create more customized therapies for combatting cancer.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

Delveinsight

AUGUST 26, 2021

Shape Therapeutics inks gene therapy deal with Roche worth up to USD 3 Billion. Seattle biotech firm Shape Therapeutics has signed a deal potentially exceeding USD 3 billion with pharma giant Roche to bolster the development of gene therapies for Alzheimer’s and Parkinson’s disease.

Vaccination 98

Vaccination Vaccine Gene Therapy RNA 98

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

Delveinsight

JULY 28, 2020

AstraZeneca has inked an oncology deal with Daiichi Sankyo to jointly develop and commercialize an antibody-drug conjugate DS-1062 (trastuzumab deruxtecan), worldwide except in Japan. With an additional aid of USD 472 Million, Moderna begins Phase III study of its COVID-19 vaccine, mRNA-1273.

Gene Therapy 52

Gene Therapy Trials Gene Vaccination 52

Pharmaceutical Technology

AUGUST 30, 2022

Moderna has obtaine d temporary authorisation from Swissmedic for its Omicron-targeting bivalent booster vaccine for Covid-19, Spikevax Bivalent Original/Omicron (mRNA-1273.214), for individuals aged 18 years and above. . The vaccine is indicated for active immunisation for the prevention of Covid-19.

Vaccination 130

Vaccination Vaccine Gene Therapy Clinical Trials 130

Pharmaceutical Technology

MAY 24, 2023

Morphogenesis’s technologies include Immune Fx (IFx) personalised cancer vaccines and tumour microenvironment (TME) modulators. Morphogenesis’ lead personalised cancer vaccine, IFx-Hu2.0, Morphogenesis’ lead personalised cancer vaccine, IFx-Hu2.0, The company is also advancing its mRNA vaccine, IFx-Hu3.0,

Gene Therapy 130

Gene Therapy In-Vivo In-Vitro Immune Response 130

BioSpace

JUNE 29, 2021

The cash infusion will support the growth of its manufacturing capabilities in the US and the UK and the demands for gene therapies, antibodies, and vaccines such as COVID-19.

Manufacturing 55

Manufacturing Gene Therapy Antibody Gene 55

Pharmaceutical Technology

NOVEMBER 7, 2022

5 Omicron-targeting bivalent Covid-19 booster vaccine, mRNA-1273.222, for people aged 18 years and above. The 50µg vaccine is indicated for usage as a booster shot for active immunisation against Covid-19. Additionally, 28 days following inoculation, this vaccine showed enhanced neutralising antibody responses against Omicron BA.4/BA.5

Vaccination 130

Vaccination Vaccine Gene Therapy Trials 130

Pharmaceutical Technology

MARCH 27, 2023

National Resilience will use the funding to establish a significant domestic biomanufacturing capacity and capabilities for vaccines, nucleic acids including mRNA, and biologics including antibodies, proteins and multi-specifics. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Gene Therapy 130

Gene Therapy Manufacturing Vaccination Vaccine 130

Pharma Packaging Solutions

JUNE 30, 2023

Whole blood, organ and tissue transplants, breast milk, antibodies for passive immunity, fecal microbiota, human reproductive cells, and stem-cell therapy are all examples of this type of biologic.

Recombinant DNA Technology 52

Recombinant DNA Technology Packaging Packaging Gene Therapy 52

Delveinsight

AUGUST 6, 2020

Zydus starts phase 2 COVID-19 vaccine trial after clearing safety test. Zydus Cadila has finished a phase 1 clinical trial of its COVID-19 vaccine ZyCoV-D, setting it up to move straight into a 1,000-subject phase 2 study. Zydus has only said that the vaccine was well tolerated by people who received it in the first phase of the trial.

Allergies 53

Allergies Vaccination Vaccine Gene Therapy 53

Delveinsight

JANUARY 12, 2021

It is an IgM antibody targeting Death Receptor 5 (DR5), and IGM is hoping to test Birinapant with IGM-8444 for the treatment of solid cancers later this year. AvantGen Enters into a Licensing Agreement for its Anti-SARS-CoV-2 Antibodies with IGM Biosciences. million after Birinapant successfully becomes a part of the Phase I trials.

Licensing 52

Licensing Licensing Antibody Gene Therapy 52

Pharmaceutical Technology

JUNE 4, 2023

Within the emerging innovation stage, cell therapy for ocular disorders, coronavirus vaccine components, and DNA polymerase compositions are disruptive technologies that are in the early stages of application and should be tracked closely. The company has developed various assets based on lentivirus vectors.

Gene Therapy 246

Gene Therapy DNA Gene Genetics 246

pharmaphorum

JANUARY 13, 2022

Sanofi has joined a growing list of drugmakers going after alpha-synuclein targeting drugs for Parkinson’s disease, licensing a bispecific antibody from South Korea’s ABL Bio in a deal that could be worth more than $1 billion. An AbbVie antibody called ABBV-0805 successfully cleared a phase 1 trial but seems to have been shelved.

Antibody 98

Antibody Drugs Protein Licensing 98

The Pharma Data

AUGUST 28, 2020

The top 10 news stories this week are focused on coronavirus vaccines and treatments, as China is set to move ahead with human testing of a potential vaccine that has been created using insect cells, while AstraZeneca has started a clinical trial of its antibody treatment designed to prevent and also treat symptoms of coronavirus.

Gene Therapy 52

Gene Therapy Gene FDA Approval Clinical Trials 52

Pharmaceutical Technology

MAY 24, 2023

Within the emerging innovation stage, cell therapy for ocular disorders, coronavirus vaccine components, and DNA polymerase compositions are disruptive technologies that are in the early stages of application and should be tracked closely.

Medicine 130

Medicine Vaccination Vaccine Gene 130

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.

Manufacturing 130

Manufacturing Vaccination Vaccine Packaging 130

The Pharma Data

SEPTEMBER 18, 2020

This week Pharma IQ looks at how the pharma industry is expanding its vaccine manufacturing and testing protocols to ensure the deadly Covid-19 outbreak yields in its spread around the globe. . BioNTech acquires Novartis GMP manufacturing site to expand Covid-19 vaccine production.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Supply Chain 52

XTalks

NOVEMBER 30, 2023

More Investigational Therapies for HIV Are on the Way American Gene Technologies, a pioneering biotech company headquartered in Rockville, Maryland, has released promising results from its Phase I trial of AGT103-T, a gene therapy designed for individuals with chronic HIV disease. In November 2023, Hookipa Pharma Inc.,

FDA Approval 110

FDA Approval Gene Therapy Gene Clinical Trials 110

Pharmaceutical Technology

DECEMBER 9, 2022

The move is particularly timely given the significant growth expected in global sales of cell and gene therapies. Beyond our expertise in small molecules, we have built a solid reputation with biopharmaceutical companies for the characterisation and analysis of monoclonal antibodies, therapeutic proteins and biosimilars.

Development 130

Development Production Manufacturing Vaccination 130

XTalks

JANUARY 4, 2024

Pfizer has kickstarted the new year with its first-ever gene therapy approval, awarded by Health Canada to the company’s Beqvez (fidanacogene elaparvovec) for the treatment of hemophilia B. There is a significant focus on developing gene therapies as longer-term solutions for the disease.

Gene Therapy 109

Gene Therapy Gene Gene Editing Sales 109

pharmaphorum

AUGUST 8, 2022

As we reported this morning, the deal gives Pfizer already-approved SCD therapy Oxbryta (voxelator) – which industry watchers reckon could see a dramatic uptick in sales with Pfizer’s marketing muscle – plus a phase 3 antibody candidate, a phase 1 follow-up to Oxbryta that could offer improved dosing.

Marketing 111

Marketing Sales Gene Editing Antibody 111

XTalks

AUGUST 30, 2024

These breakthroughs, combined with the growing focus on gene therapy, oncology and immunology, have brought these companies to the forefront of global healthcare. The acquisition positioned Pfizer as a leading oncology company, enhancing its portfolio with Seagen’s four key antibody-drug conjugate (ADC) medicines.

Marketing 82

Marketing Production Sales Antibody 82

Pharmaceutical Technology

MAY 30, 2023

At the height of the pandemic, Catalent’s Bloomington site won contracts to produce Moderna’s (Cambridge, MA, US) and Johnson & Johnson’s (New Brunswick, NJ, US) Covid-19 vaccines, and Regeneron’s (Tarrytown, NY, US) Covid-19 monoclonal antibody Regen-Cov.

Manufacturing 130

Manufacturing Production Gene Therapy Sales 130

Cloudbyz

MARCH 6, 2024

This allows for the creation of highly specific and targeted therapies that can modulate biological pathways with remarkable precision. Some notable examples include: Monoclonal antibodies targeting cancer cells or tumor microenvironments, such as trastuzumab for breast cancer and pembrolizumab for melanoma.

Gene 99

Gene Immune Response Manufacturing Gene Therapy 99

XTalks

APRIL 24, 2024

ImmunityBio’s Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) along with the Bacillus Calmette-Guérin (BCG) vaccine has won US Food and Drug Administration (FDA) approval for the treatment of non-muscle invasive bladder cancer (NMIBC). Anktiva is mixed together with the BCG vaccine before administration.

FDA Approval 52

FDA Approval Vaccination Vaccine Sales 52

Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. Pharmaceutical companies are pushing to develop drugs and vaccines for RSV with these populations in mind.

Vaccination 162

Vaccination Vaccine Antibody FDA Approval 162

Delveinsight

JANUARY 19, 2021

Enhertu is an antibody-drug conjugate (ADC) that comprises a humanized anti-HER2 IgG1 monoclonal antibody. Fujifilm Increases Legroom In Cell And Gene Therapy, Plans For New Manufacturing Facility. Fujifilm is trying everything to build its position in the cell and gene therapy domain even stronger.

Manufacturing 40

Manufacturing Gene Therapy Life Science FDA Approval 40

pharmaphorum

JANUARY 13, 2023

Cell and gene therapies – big opportunities, big challenges. Everyone agrees that cell and gene therapies are poised for an explosion, with far more drugs in the pipeline than are currently approved, and the FDA predicts it will clear 10 to 20 per year by 2025. But enough vagaries. Let’s talk trends.

Clinical Trials 98

Clinical Trials Clinical Trials Gene Therapy Trials 98

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. Over the years, the rising popularity of biologics has led to a paradigm shift in the healthcare industry.

Manufacturing 52

Manufacturing Marketing Contract Manufacturing Protein 52

Delveinsight

SEPTEMBER 23, 2021

The biotech has evolved a T-cell receptor-like antibody to damage a selected immune checkpoint in oncology. That deal, signed in 2014, had aimed to convey most cancer mRNA vaccines to the marketplace. Novartis is expanding its optogenetics portfolio with the acquisition of gene therapy company Arctos Medical.

RNA 61

RNA Gene Therapy Gene Protein 61

Pharmaceutical Technology

APRIL 19, 2023

The US Food and Drug Administration (FDA) has made changes to the emergency use authorisations (EUAs) of the Pfizer -BioNTech and Moderna bivalent mRNA Covid-19 vaccines. The latest amendment aims to simplify the vaccination schedule for most people. The changes mean that the current bivalent vaccines for the original and Omicron BA.4/BA.5

Vaccination 334

Vaccination Vaccine Gene Therapy Gene 334

WCG Clinical

MAY 28, 2024

T cells and B cells — both specialized white blood cells called “lymphocytes”– represent the two arms of the adaptive immune system responsible for immune memory and recall responses to vaccines and infections. If circulating antibody levels become too low, they may be supplemented with immunoglobulin therapy.

In-Vivo 52

In-Vivo Clinical Trials Clinical Trials FDA Approval 52

The Pharma Data

JANUARY 10, 2021

Arcturus Therapeutics got the FDA go-ahead for its Phase II trial of its COVID-19 vaccine candidate ARCT-021. CERC-002 is a human anti-LIGHT monoclonal antibody. China’s Sinovac Biotech reported that its COVID-19 vaccine, CoronaVac, had a 78% efficacy rate in a Phase III clinical trial in Brazil. Here’s a look.

Gene Therapy 52

Gene Therapy Trials Gene Clinical Trials 52

Delveinsight

DECEMBER 3, 2020

Roche receives FDA authorization for the quantitative COVID-19 antibody test. Roche has got an authorization from the FDA for a more accurate COVID-19 blood test capable of measuring the levels of specific antibodies, which target the cell-unlocking spike protein of coronavirus. Janssen buys a gene therapy asset.

Gene Therapy 52

Gene Therapy Gene Antibody Research 52

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. Over the years, the rising popularity of biologics has led to a paradigm shift in the healthcare industry. Web: [link].

Manufacturing 52

Manufacturing Drug Delivery Marketing Drug Delivery Systems 52