Pharmaceutical Technology

JANUARY 8, 2023

In 2023, the pharmaceutical industry will mark 20 years since Xolair, an anti-IgE antibody, became the first biologic approved to treat asthma. Since then, the US FDA, EMA, and other agencies have approved several biologic antibodies targeting the inflammatory cytokines IL-4, IL-13, IL-5, and others for asthma. Ongoing efforts.

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The Pharma Data

OCTOBER 27, 2020

Trial of Antibody Drug for COVID-19 Stopped for Lack of Effectiveness. 27, 2020 — Testing of the Eli Lilly antibody drug for hospitalized COVID-19 patients has been halted because the treatment does not help them recover from their infection. Food and Drug Administration while late-stage studies continue.

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Pharmaceutical Technology

JUNE 9, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of AstraZeneca’s and Sanofi’s respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) prophylactic nirsevimab for use in newborns and infants entering their first RSV season.

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pharmaphorum

AUGUST 3, 2020

While the world waits an effective coronavirus vaccine, Eli Lilly has started late-stage human testing an antibody drug as an alternative way to prevent viral transmission in high-risk locations. Lilly and AbCellera intend to test the drug both for prophylaxis against the coronavirus and as a treatment for confirmed infections.

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Scienmag

AUGUST 17, 2020

. — University of Wisconsin-Madison scientists have discovered that a majority of back-pain patients they tested who were taking opioid painkillers produced anti-opioid antibodies. These antibodies may contribute to some of the negative side effects of long-term opioid use.

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Delveinsight

AUGUST 6, 2020

TSHA-101, a potential treatment for GM2 gangliosidosis, is set to be the first drug to enter the clinic. Scientists have already isolated many highly potent neutralizing antibodies from patients who recovered from COVID-19. These antibodies defend a cell from infection by squarely preventing the pathogen’s biological activities.

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pharmaphorum

FEBRUARY 18, 2022

In CUPID STUDY B, IL-4 and IL-13 inhibitor Dupixent (dupilumab) wasn’t able to achieve a significant improvement in symptoms in Xolair-refractory CSU patients, and will be stopped for futility, although the antibody did show “numeric improvements” on itching and hive symptoms, according to its developers.

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XTalks

AUGUST 16, 2021

The US Food and Drug Administration (FDA) has amended its emergency use authorizations (EUA) for both the Pfizer and Moderna COVID-19 vaccines to incorporate a third dose for immunocompromised individuals. The majority of patients — 24 patients (80 percent) — had no antibodies against SARS-CoV-2, while six had low levels.

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Scienmag

AUGUST 11, 2020

Antibody that blocks TREM2 protein frees immune cells to reject cancer Credit: William Vermi/Martina Molgora Immunotherapy has revolutionized cancer treatment by stimulating the patient’s own immune system to attack cancer cells, yielding remarkably quick and complete remission in some cases.

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pharmaphorum

SEPTEMBER 29, 2022

Sanofi and Regeneron have claimed the first approval in the US for a drug for prurigo nodularis, after the FDA gave a green light to Dupixent as a treatment for adults with the rare skin disease following a priority review. Development in peanut allergy has also been discontinued, said Sanofi in its second-quarter update.

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pharmaphorum

JULY 8, 2021

The FDA has started a priority review of AstraZeneca and Amgen’s severe asthma antibody tezepelumab, setting a date for a decision in the first quarter of 2022. Overall, the antibody cut the annual asthma exacerbation rate (AAER) by 56% over 52 weeks, which was consistent with the benefit seen in the phase 2 PATHWAY trial.

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pharmaphorum

NOVEMBER 3, 2022

The hope that nerve growth factor (NGF) inhibitors could be an alternative to opioid for pain relief has finally been extinguished with the news that Regeneron had abandoned the last drug in the class. The post And then there were none: Regeneron cans last late-stage NGF drug appeared first on.

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The Pharma Data

JULY 11, 2021

3 These data are being presented at the 2021 European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress in Krakow, Poland and Madrid, Spain. TAKHZYRO is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity. No dedicated drug-drug interaction studies have been conducted.

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pharmaphorum

DECEMBER 29, 2021

Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. That was enough to secure approval although it remains to be seen how well it will fare commercially against Sanofi and Regeneron’s drug.

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pharmaphorum

APRIL 28, 2021

Sanofi’s much anticipated drug for both haemophilia A and B – fitusiran – could be filed in 2022 despite a problem with blood clots in some patients in late-stage testing. . The RNA interference (RNAi) drug is designed to treat haemophilia A and B patients by suppressing antithrombin (AT), a protein that inhibits blood clotting.

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The Pharma Data

APRIL 11, 2021

Basel, 12 April 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive results from the phase III REGN-COV 2069 trial assessing the ability of the investigational antibody cocktail casirivimab and imdevimab to reduce the risk and burden of COVID-19 infection among household contacts of SARS-CoV-2 infected individuals.

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The Pharma Data

APRIL 18, 2022

Food and Drug Administration issued a draft guidance that, when finalized, will outline the agency’s approach to evaluating the public health importance of food allergens that are not one of the major nine food allergens identified by law in the U.S (non-listed Today, the U.S. non-listed food allergens). effective Jan. effective Jan.

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The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for Eli Lilly and Company’s (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. Bamlanivimab remains an investigational drug and has not been approved under a Biologics License Application (BLA).

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The Pharma Data

DECEMBER 30, 2020

billion acquisition of immuno-oncology company Forty Seven and its lead asset, magrolimab, a monoclonal antibody in the clinic for several cancers, including myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) and diffuse large B-cell lymphoma (DLBCL). It began in May with the $4.9 Magrolimab targets CD47.

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The Pharma Data

JANUARY 26, 2021

. “These exciting results, which replicate positive Phase 2 data in a much larger set of patients, add valuable clinical evidence about the role neutralizing antibodies can play in fighting this pandemic. Lilly’s chief scientific officer and president of Lilly Research Laboratories. have reached record highs.

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XTalks

NOVEMBER 30, 2023

In 2022, the US Food and Drug Administration (FDA) granted approval to the medication Sunlenca (lenacapavir) for adults living with multi-drug resistant HIV-1 infection. Developed by Gilead, Sunlenca is the first drug in a novel class known as capsid inhibitors to receive FDA approval for treating HIV-1.

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XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

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The Pharma Data

OCTOBER 28, 2020

government to supply 300,000 vials of bamlanivimab (LY-CoV555) 700 mg, an investigational neutralizing antibody, for $375 million. Food and Drug Administration (FDA). Read more about Lilly’s global pricing and access principles for its antibody therapies at lilly.com. INDIANAPOLIS, Oct.

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Scienmag

DECEMBER 11, 2020

Credit: Mikael Wallerstedt In a new study, researchers at Uppsala University have been able to show differences in how Rituximab, a monoclonal antibody drug, interacts with the blood of healthy individuals compared to patients with chronic lymphatic leukaemia.

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The Pharma Data

OCTOBER 26, 2020

Diagnostics Update : To-date the FDA has authorized 284 individual EUAs, which include 221 molecular tests, 56 antibody tests and 7 antigen tests. . Only a fraction of intravenous antibody treatments will make their way to the lungs of COVID-19 patients, which is where the infection is primarily located. Please read more here. .

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Delveinsight

AUGUST 27, 2020

The phase 1 study that is being run by the National Institute of Allergy and Infectious Diseases tests three dose levels of the vaccine, mRNA-1273, given in two injections a month apart in 120 adults. Targeted drug combo attacks breast cancer brain metastases in mice.

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XTalks

DECEMBER 7, 2020

This level of protection far exceeds expectations set by the Food and Drug Administration (FDA) in the US that indicated they would approve a vaccine if it were only 50 percent effective against the virus. Eli Lilly’s monoclonal antibody, bamlanivimab has been given emergency authorization by the FDA now too.

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The Pharma Data

JANUARY 12, 2021

Virology, Respiratory, Dermatology, Allergy, & Rheumatology) in early & late stage Clinical Development and in Medical Affairs, with a strong track record for Developing and Accelerating Phase I–IV programs. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world.

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Delveinsight

JANUARY 21, 2021

Drugs that target the cancer-promoting proteins MDM2 and BET have been attempted in acute myeloid leukaemia (AML) and have not been all that effective on their own. The new research provides a scientific rationale to advance clinical studies of the drug combination in patients with AML. billion in total for three drugs.

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The Pharma Data

JANUARY 6, 2021

Studies Show Cyto-111 Enables Delivery of Antibodies to Previously Inaccessible Intraneuronal Targets without the need for a Viral Vector or Transfection. The complete text of the article titled, “Neuronal Delivery of Antibodies has Therapeutic Effects in Animal Models of Botulism,” can be found h e re. NEW YORK, Jan.

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The Pharma Data

JANUARY 24, 2021

It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. The drug appears to inhibit IL-6, IL-1beta, TNF-alpha and other pro-inflammatory cytokines and chemokines. All participants randomized to receive either 4,200 mg of bamlanivimab, Lilly’s neutralizing antibody, or placebo.

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XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. billion the drug generated in 2021. billion in 2022. billion, a 26.55

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Pfizer

JANUARY 27, 2023

This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS).

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The Pharma Data

NOVEMBER 16, 2020

and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. About the COVID-19 Prevention Network: The COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the U.S.

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The Pharma Data

AUGUST 7, 2020

NIH tests antibodies in Covid-19 clinical trial alongside Eli Lilly and AbCellera . The LY-CoV555 antibodies are infection fighting that can bind to the surface of viruses and prevent the virus infecting cells.

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XTalks

OCTOBER 26, 2023

The US Food and Drug Administration (FDA) approved new updated COVID-19 vaccines from both Pfizer-BioNTech and Moderna that target the Omicron XBB.1.5 For measles, the correlate of protection is having a certain concentration of antibodies in your system that will generally provide protection from getting measles infection.

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The Pharma Data

APRIL 14, 2021

government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. Lilly’s bamlanivimab was the first neutralizing monoclonal antibody to receive emergency use authorization from the U.S. Food and Drug Administration. patients who recovered from COVID-19.

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