Pharmaceutical Technology

JANUARY 19, 2023

Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain. Nuvaxovid demonstrated a significant antibody response when given as a booster dose after primary vaccination with other authorised Covid-19 doses in the COV-BOOST trial.

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Pharmaceutical Technology

FEBRUARY 1, 2023

AstraZeneca’s Synagis (palivizumab), which was approved in 1998, was the only monoclonal antibody (mAb) available for use to prevent RSV in high-risk infants for the past two decades. However, specific antibody-resistant mutations have already been documented within the RSV- F protein after prophylactic administration of nirsevimab.

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Pharmaceutical Technology

JUNE 24, 2022

1 variant, on 22 June, Moderna said its booster also showed a “potent” antibody response against Omicron subvariants BA.4 As per Rohde, the spike protein in the Omicron variant has “wicked alterations” in its antigenicity, shows a very high transmission ability and immune escape from those early vaccine induced immune individuals.

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pharmaphorum

JANUARY 5, 2022

The new vaccine differs from the currently approved shots because it delivers antigens for both the spike protein and other proteins found in SARS-CoV-2. That could mean it is less susceptible to the loss of efficacy to vaccines that can occur when there are changes in the spoke protein – as witnessed with the new Omicron variant.

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Protein Vaccination Vaccine Immune Response 126

Roots Analysis

MAY 21, 2024

Proteins are the chains of amino acids linked together in different combinations and perform a wide variety of functions. These are the vital structural component of cells, which help in cell functioning and regulation of building body tissues.

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BioPharma Reporter

MARCH 27, 2023

The biotech is launched with an antibody-based protein degradation platform, with technology licensed from UCSF.

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Protein Licensing Licensing Antibody 52

BioPharma Reporter

MARCH 27, 2023

The biotech is launched with an antibody-based protein degradation platform, with technology licensed from UCSF.

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Protein Licensing Licensing Antibody 52

pharmaphorum

DECEMBER 8, 2020

AbCellera Biologics has been in the spotlight since coming up with Eli Lilly’s COVID-19 antibody drug bamlanivimab, and looks set to capitalise on that exposure with a sizeable initial public offering. Bamlanivimab is directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.

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Pharmaceutical Technology

MARCH 10, 2023

Pharmaceutical and biotechnology industries widely use freeze-drying systems to protect vaccines, antibodies, antibiotics such as penicillin, blood plasma, proteins, enzymes, hormones, viruses, and bacteria from heat and minimise their biological activity.

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pharmaphorum

NOVEMBER 23, 2020

AstraZeneca is preparing to file its COVID-19 vaccine with regulators after phase 3 trial results showed it is up to 90% effective. AZ made the announcemen t as the UK regulator reportedly gears up to make a decision on the rival vaccine from Pfizer and BioNTech, ahead of counterparts in the US and Europe.

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pharmaphorum

MAY 10, 2021

The EMA has begun a rolling review of a COVID-19 antibody developed by GlaxoSmithKline and Vir BioTech which could become the fourth drug of its type cleared for early use in the EU. . At the moment the regulator is looking at the first batch of data from lab and animal studies as well as quality studies. Intramuscular injection.

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pharmaphorum

NOVEMBER 26, 2020

Danyelza (naxitamab) is an antibody that targets GD2, a protein found on the surface of some tumour cells, and it has been cleared by the US regulator for use alongside GM-CSF – a cytokine drug – as a second-line neuroblastoma treatment after a priority review.

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Drugs Antibody Clinical Trials Clinical Trials 105

pharmaphorum

AUGUST 19, 2020

But like the rest of this first generation of antibody-based drugs, Remicade has been hit by cheaper competition from biosimilars and the hunt is on for newer drugs that outperform standard therapy in terms of safety and efficacy. per share is expected to close in the second half of 2020, subject to clearance by US antitrust regulators.

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The Pharma Data

NOVEMBER 2, 2020

2, 2020 — An experimental antibody drug that targets one of the body’s key metabolism regulators may help obese people lose weight — at least briefly. It would take much more research to prove the antibody is safe and effective, Ryan said. Adiponectin helps regulate blood sugar and fatty acid breakdown.

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The Pharma Data

SEPTEMBER 30, 2021

Scientists from the German Cancer research facility (DKFZ) and therefore the Medical Faculty Mannheim, Heidelberg University, have now identified a replacement protein produced by blood vessels that permits tumor cells to metastatically colonize organs.

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pharmaphorum

JULY 9, 2021

With the COVID-19 delta variant has become the dominant strain circulating in the US, Pfizer and BioNTech have said they will ask the FDA and other regulators to approve a third dose of their Comirnaty vaccine to guard against a winter surge in cases. .

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pharmaphorum

SEPTEMBER 7, 2020

Preliminary results published in The Lancet are from a non-randomised phase 1/2 trial of 76 people aged 18-60, which found an antibody response within 21 days and no serious adverse events after 42 days. All participants in the phase 2 trials (40 participants) produced antibodies against the SARS-CoV-2 spike protein.

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pharmaphorum

AUGUST 10, 2020

The FDA has set a decision date for March 27 next year, and Biogen said that the regulator could make a ruling before then. The other main method of action being investigated is targeting the tau protein tangles that are seen in brain cells of people with Alzheimer’s.

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XTalks

SEPTEMBER 2, 2021

The AlzoSure Predict prognostic biomarker Alzheimer’s blood test detects levels of an unfolded conformational variant of the p53 protein in the blood using a proprietary antibody called U-p53AZ. The Diadem AlzoSure Predict assay uses a proprietary antibody, U-p53AZ, to measure blood levels of the unfolded conformational p53 variant.

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pharmaphorum

JUNE 24, 2021

Just a few days after Biogen abandoned its tau-targeting Alzheimer’s disease candidate gosuranemab, Bristol-Myers Squibb has opted into a rival drug, paying $80 million for rights to Prothena’s PRX005 antibody in phase 1 testing. . The deal – which could be worth up to $2.2

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XTalks

NOVEMBER 26, 2020

In addition to innovative new antibody drugs and mRNA vaccines, researchers have found that the sleep-regulating hormone melatonin may also offer protection against COVID-19. Melatonin, which regulates the body’s circadian rhythm and sleep-wake cycle, is also available in pill form for use as a sleep aid.

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Pharmaceutical Technology

JULY 29, 2022

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. The booster dose elicited a significantly higher neutralising antibody response against Omicron subvariants BA.4 Regulators are well-disposed to these boosters.

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pharmaphorum

AUGUST 26, 2022

The US biotech claimed conditional marketing approval from the European Commission for Roctavian (valoctocogene roxaparvovec) as a treatment for adults with severe haemophilia A, who don’t have a history of developing the antibodies that inhibit the activity of blood-clotting protein Factor VIII.

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XTalks

JULY 10, 2023

Rystiggo received FDA approval under the Priority Review designation, specifically for the treatment of gMG in adult patients who have tested positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies. The active ingredient in Rystiggo is rozanolixizumab, a humanized IgG4 monoclonal antibody.

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Pharma in Brief

DECEMBER 17, 2023

On December 4, 2023, the Federal Court held that a patent claiming a formulation of adalimumab, a monoclonal antibody used to treat autoimmune diseases, is valid and is being infringed by a biosimilar product. The Court found that this publication disclosed adalimumab and self-buffering protein formulations. A-203-22).

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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. The half life of the new drug – one of the main draws for Sanofi’s $11.6

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XTalks

JULY 2, 2021

This is because the processes that maintain the uterine lining, including the placenta, during pregnancy are different than those that regulate the normal menstrual cycle. However, the similarity between the two proteins is not great enough for anti-spike antibodies to cross-react with placental syncytin-1.

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Pharmaceutical Technology

DECEMBER 9, 2022

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. Solvias is well equipped to provide stability testing for all stages of drug development. Quality control release testing.

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XTalks

JUNE 28, 2023

DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells. Elevidys’ approval was based on data from a randomized trial that showed the therapy increased expression of the Elevidys micro-dystrophin protein, which was used as a surrogate endpoint, in DMD patients aged four to five years of age.

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Gene Therapy Gene Protein FDA Approval 98

pharmaphorum

FEBRUARY 5, 2021

A spokesperson for the MHRA, which has proved to be faster in its decision making than the European system, said the regulator is working with Janssen to complete a rolling review process. “We J&J’s vaccine works by using an adenovirus as vector to deliver the genetic code of the Spike protein found on the coronavirus to the body.

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pharmaphorum

JUNE 9, 2022

mRNA-1273.214 stimulated almost twice the neutralising antibody levels against the Omicron strain than Spikevax , with a significantly higher response also seen against other variants of concern, one month after administration, according to the company. It has predicted sales of COVID-19 vaccines will be around $21 billion this year.

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The Pharma Data

MARCH 22, 2021

Investigational antibody cocktail of casirivimab and imdevimab also significantly shortened the duration of symptoms by four days. The combination of casirivimab and imdevimab is the only monoclonal antibody treatment to retain potency against key emerging variants, based on the recently updated EUA guidance from the U.S.

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Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. One strategy proposed the use of synthetic mRNA or modified mRNA analogs, which can enhance the stability and protein expression of mRNA.

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Pharmaceutical Technology

JUNE 4, 2023

Adeno-associated virus vectors, alcohol dehydrogenase compositions, and antibody serum stabilisers are some of the accelerating innovation areas, where adoption has been steadily increasing. Among maturing innovation areas are anti-influenza antibody compositions and anti-interleukin-1, which are now well established in the industry.

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pharmaphorum

DECEMBER 1, 2020

Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the year. They work by using a short length of genetic code that makes the body produce the “Spike” protein seen on the surface of the SARS-CoV-2 coronavirus.

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Vaccination Vaccine RNA Clinical Trials 88

pharmaphorum

NOVEMBER 17, 2020

Pfizer is poised to file the vaccine with the FDA in the coming days, seeking an Emergency Use Authorization (EUA) after gathering enough safety data required by the regulator. The four states will not receive the vaccine earlier because of the pilot, according to Pfizer. Pfizer and BioNTech have a $1.95

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The Pharma Data

AUGUST 18, 2020

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. following the initial European Medicines Agency (EMA) approval, and conducting any additional studies specifically required for approval by regulators outside the U.S. and around the world.

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