pharmaphorum

JULY 6, 2021

The resubmission to the FDA now lists one of its own sites in Austria as the manufacturing location for the final finished product, which it hopes will sidestep the issue and allow inclisiran to be approved in the US.

RNA 105

RNA Manufacturing Sales Drugs 105

Delveinsight

AUGUST 26, 2021

Shape’s RNA editing technologies can modify the RNA sequence, which makes the body’s protein building blocks. This system is designed to deliver RNA editing technology or other payloads directly to particular body areas, such as the nervous system or muscle. The study is set to conclude in the fall.

Vaccination 98

Vaccination Vaccine Gene Therapy RNA 98

pharmaphorum

DECEMBER 1, 2020

The FDA and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have already begun their reviews and similar rolling submissions have begun in countries including Australia, Canada and Japan. The EMA has also confirmed it has received a filing from Moderna, which is producing a rival vaccine based on similar RNA technology.

Vaccination 88

Vaccination Vaccine RNA Clinical Trials 88

pharmaphorum

DECEMBER 23, 2021

Novartis resubmitted its marketing application in the US earlier this year, after swapping fill-and-finish production to one of its own facilities in Schaftenau, Austria.

Drugs 105

Drugs Sales Antibody FDA Approval 105

Pharmaceutical Technology

APRIL 24, 2023

Since then, the field of nanomedicine has steadily progressed to reach high points such as the successful use of nanotechnology to deliver messenger RNA (mRNA)-based Covid-19 vaccines. Due to their size, cells can absorb them where they release products. This design protects antibodies from the innate immune system.

Drug Delivery 147

Drug Delivery Vaccination Vaccine Research 147

XTalks

FEBRUARY 3, 2022

billion into building new manufacturing plants in the US and Ireland to help boost production capacities. The state-of-the-art plant will be dedicated to the manufacture of parenteral (injectable) products and devices using cutting-edge technologies. Related: Eli Lilly Pursues RNA Editing in New Partnership with ProQR.

Manufacturing 52

Manufacturing RNA Life Science Antibody 52

The Pharma Data

DECEMBER 8, 2020

Since partnering with Eli Lilly to produce the first monoclonal antibody therapy approved for mild-to-moderate COVID-19 patients, antibody discovery company AbCellera is going big on the Nasdaq. Laying down a new track for RNA processing, Remix launched with $81 million in financing. Reduce cost. Nuance Pharma .

RNA 52

RNA Antibody Life Science Protein 52

pharmaphorum

MARCH 9, 2022

Sanofi and Sobi’s haemophilia partnership has been under competitive pressure from new therapies like Roche’s antibody Hemlibra, so the two companies are hoping a new long-acting drug candidate can revitalise the franchise.

Protein 98

Protein Gene Therapy Sales Regulation 98

pharmaphorum

OCTOBER 6, 2020

These studies suggest BNT162b2 triggers the production of neutralising antibodies and T-cells that target SARS-CoV-2, the coronavirus that causes COVID-19.

Vaccination 59

Vaccination Vaccine RNA Immune Response 59

The Pharma Data

AUGUST 16, 2021

Better activation of innate and adaptive immune responses was achieved with CV2CoV, resulting in faster response onset, higher titers of antibodies, and stronger memory B and T cell activation as compared to the first-generation candidate, CVnCoV. The full manuscript of the preclinical data is available on the pre-print server bioRxiv. “In

Immune Response 52

Immune Response Vaccination Vaccine Antibody 52

BioSpace

NOVEMBER 20, 2022

Former Theranos CEO Elizabeth Holmes will serve 11 years in prison on four counts of fraud, according to her sentencing by a federal judge in a California courtroom on Friday afternoon.

Antibody 51

Antibody Medicine Research Clinical Trials 51

The Pharma Data

JANUARY 31, 2021

Both vaccines induced high levels of neutralizing antibodies comparable to or exceeding levels in human convalescent sera as well as a strong Th1-biased cell-mediated immunity. Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

SEPTEMBER 9, 2020

Immunization of non-human primates (rhesus macaques) with BNT162b2, a nucleoside-modified messenger RNA (modRNA) candidate that expresses the SARS-CoV-2 spike glycoprotein, resulted in strong anti-viral effects against an infectious SARS-CoV-2 challenge. BNT162b2 vaccination elicited a high frequency of CD4+ T cells that produced IFN-?

Vaccination 52

Vaccination Vaccine RNA Clinical Trials 52

Delveinsight

JULY 29, 2021

billion in biobucks on the table to buy Teneobio and its suite of bispecific and multispecific antibody technologies focused on cancer and other disease targets. An antisense treatment, BIIB080 potentially aims at microtubule-linked protein tau (MAPT) messenger RNA (mRNA) and impedes tau protein production.

Drugs 98

Drugs Protein Life Science Development 98

The Pharma Data

DECEMBER 3, 2020

S-Trimer adjuvanted with GSK’s pandemic adjuvant system induced neutralizing antibody titers (seroconversion) in 100% of participants at the selected 9 µg S-Trimer dose in both adult and elderly groups, with geometric mean titers (GMT) greater than 1:1,800. For more information, please visit our website: www.cloverbiopharma.com.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

Roots Analysis

OCTOBER 13, 2023

As a result, in late nineties, the conjugation of drug with biological entities such as antibodies emerged as a possible solution for targeting earlier undruggable entities. However, it was not until 2000 when the first drug conjugate in the form of antibody drug conjugate (ADC) was approved by the USFDA.

Drugs 40

Drugs Antibody RNA Genetics 40

The Pharma Data

JANUARY 12, 2021

About JTX-8064 JTX-8064 is a humanized IgG4 monoclonal antibody designed to specifically bind to Leukocyte Immunoglobulin Like Receptor B2 (LILRB2/ILT4) and block interactions with its ligands. About JTX-4014 JTX-4014 is a well-characterized fully human IgG4 monoclonal antibody designed to block binding to PD-L1 and PD-L2.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

pharmaphorum

JULY 21, 2021

It has since transferred production to its own plant. Leqvio – acquired via Novartis’ near $10 billion acquisition of the Medicine Company in 2019 – is already approved in Europe but getting it on the US market is central to Novartis’ hopes of blockbuster sales for the product.

Sales 52

Sales Gene Therapy RNA Production 52

The Pharma Data

SEPTEMBER 1, 2020

with whom Roche has a global distribution agreement and had also launched a Rapid Antibody Test in July. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a visually detectable signal on the test strip, typically with results ready in 15 minutes.

In-Vitro 52

In-Vitro Antibody Medicine Clinical Trials 52

The Pharma Data

NOVEMBER 29, 2020

Naxitamab is a monoclonal antibody that targets GD2, which is found on neuroblastoma and other related tumors. The antibody is designed to destroy GD2-expressing cancer cells by antibody-dependent cell-mediated cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC). Oxlumo decreases oxalate production.

Genetic Disease 52

Genetic Disease Antibody Licensing Licensing 52

The Pharma Data

JANUARY 22, 2021

As research developments into RNA vaccines help scientists accelerate drug candidates to arm the immune system against coronavirus, Pharma IQ ’s Keeping tabs on Covid-19 update returns with news from some of the biotechnology innovators leading the fight against the global pandemic.

Vaccination 52

Vaccination Vaccine Protein Immune Response 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. Efforts are also underway to enable the product to be stable at routine refrigerator temperature (2-8°C). Expected to enroll 415 participants; interim results expected in Q3 2021. Source link:[link].

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

MAY 7, 2021

The vaccine’s product information will now include advice that individuals who develop low blood platelets within 3 weeks of vaccination with the Janssen vaccine should be investigated for blood clots; likewise, patients who develop thromboembolism within the 3-week window should be assessed for thrombocytopenia.

Vaccination 40

Vaccination Vaccine Filler Antibody 40

The Pharma Data

JANUARY 31, 2021

In its Phase 1 clinical trial, Clover’s protein-based COVID-19 S-Trimer vaccine candidates in combination with adjuvants from either Dynavax or GlaxoSmithKline plc (GSK, London Stock Exchange: GSK) both performed well and induced high levels of neutralizing antibodies while demonstrating favorable safety and tolerability profiles.

Vaccination 52

Vaccination Vaccine Trials Protein 52

pharmaphorum

AUGUST 11, 2020

This will lead to significant increases in productivity, employment, and quality of life in the North-West. The funding will be used to create a regional consortium and develop the full stage bid.

Medicine 52

Medicine Life Science Development RNA 52

The Pharma Data

JANUARY 17, 2021

The primary endpoint of this trial is to evaluate patients for complete histological clearance of the tumor cells within the treated BCC lesion with secondary endpoints, evaluating subjects for investigational product treatment related adverse events, as well as serious adverse events, and cutaneous skin reactions. Chief Medical Officer.

Gene Expression 52

Gene Expression Trials Development Production 52

The Pharma Data

JANUARY 12, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the COVID-19 Moderna Vaccine in Switzerland. .–(BUSINESS WIRE)–Jan. 12, 2021– Moderna, Inc. Authorized Use. About Moderna.

Vaccination 52

Vaccination Vaccine Manufacturing Medicine 52

Roots Analysis

DECEMBER 18, 2023

This novel modality emerged when pharmaceutical developers used non-antibody-based entities as targeting ligand to develop targeted therapeutics. Similar to the structure of the antibody drug conjugates, these next generation drug conjugates use a non-antibody-based targeting ligand, a cytotoxic payload and a linker.

Drugs 40

Drugs FDA Approval Development Antibody 40

The Pharma Data

NOVEMBER 16, 2020

It combines Moderna’s mRNA (messenger RNA) delivery platform with the stabilized SARS-CoV-2 spike immunogen (S-2P) developed by NIAID scientists. CoVPN will work to develop and conduct studies to ensure rapid and thorough evaluation of vaccines and antibodies for the prevention of COVID-19.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

DECEMBER 8, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 CAMBRIDGE, Mass.–(BUSINESS –(BUSINESS WIRE)–Dec. million to 7.5

Vaccination 40

Vaccination Vaccine Manufacturing Containment 40

The Pharma Data

JULY 6, 2021

Fitusiran is an investigational, subcutaneously administered small interference RNA therapy in development for the treatment of people with hemophilia A or B, with or without inhibitors and has the potential to transform treatment as it would be the only prophylactic therapy with as few as six injections per year. Oral presentation.

Protein 52

Protein RNA Development Marketing 52

The Pharma Data

JANUARY 6, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union. “I

Vaccination 52

Vaccination Vaccine Medicine Containment 52

The Pharma Data

DECEMBER 10, 2020

The goal of targeting both S and N was to both activate virus-specific T cells and generate anti-SARS-CoV-2-neutralizing antibodies. ImmunityBio’s hAd5 vaccine generated robust neutralizing antibody activity that was present 14 days post-final vaccination. This press release features multimedia. Graphic: Business Wire).

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

The Pharma Data

JUNE 26, 2021

Sanofi Pasteur, the vaccines global business unit of Sanofi and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, have initiated a Phase 1 clinical trial evaluating an mRNA-based investigational vaccine against seasonal influenza. JUNE 22 , 2021. Source link: [link].

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

DECEMBER 2, 2020

She is currently the CEO of Twentyeight-Seven, a biotech company focused on novel RNA biology that she co-founded alongside prominent Harvard investigators. The Company is building a pipeline of inhibitory monoclonal antibodies (mAbs) and fusion proteins targeting the pathway via multiple angles.

Development 52

Development RNA Research Drugs 52

The Pharma Data

JANUARY 13, 2021

” The Johnson & Johnson vaccine also would be hardier than either of the already approved vaccines because it relies on DNA technology rather than messenger RNA to prompt an immune system response. More than 90% of participants mounted an immune response within a month, and all had levels of neutralizing antibodies by day 57.

Vaccination 40

Vaccination Vaccine Trials Immune Response 40

pharmaphorum

APRIL 28, 2022

Because of the faster timelines and more agile marketing approach, and the need to launch a variety of products for separate but related diseases, the rare disease space moves at a different pace, Helfgott said. Whereas in the world of primary care with big numbers, it’s usually seven or eight.”.

Pharma Companies 59

Pharma Companies Branding Development Marketing 59