Pharma Times

OCTOBER 7, 2021

AstraZeneca has submitted an emergency approval to the US drug regulators for its COVID-19 antibody cocktail, which would be the first non-vaccine protection from the virus to be granted approval.

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Drug Discovery World

SEPTEMBER 1, 2022

Bio-Rad Laboratories has introduced a range of type 1 antibodies that inhibit the binding of evolocumab (Repatha) to its target, human proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that has been shown to play a key role in the regulation of cholesterol levels. .

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STAT News

JANUARY 10, 2023

SAN FRANCISCO — For months, drugmakers have been pleading with regulators to lower the bar for authorizing antibody drugs for Covid. The virus, they noted, had evolved fast enough to render every previous antibody obsolete.

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BioSpace

OCTOBER 23, 2023

The regulator has approved the first-ever subcutaneous version of infliximab, an IgG1 monoclonal antibody, commonly sold by Johnson & Johnson under the brand name Remicade.

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Drug Discovery World

SEPTEMBER 8, 2023

The new version of Comirnaty was found to meet the UK regulator’s standards of safety, quality and effectiveness and has been approved for use in individuals from six months of age. The European Commission’s Committee for Medicinal Products for Human Use (CHMP) recommended the drug for approval in the EU in August. 1.16, and XBB.2.3,

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Drug Discovery World

JULY 6, 2023

The first patient has been dosed in the clinical Phase I evaluation of the Sema3A monoclonal antibody, part of the Evotec-Bayer multi-target research collaboration in kidney diseases. Semaphorin-3A is an extracellular guidance protein and a well-known regulator of the actin cytoskeleton.

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Drug Discovery World

JUNE 30, 2023

Whether it be a monoclonal antibody to treat peanut allergy, or using artificial intelligence (AI) to identify influenza drug targets, each discovery reflects the level of scientific innovation and diversity of approaches being employed in drug development today. The top stories: Could a monoclonal antibody treat peanut allergy?

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pharmaphorum

MARCH 30, 2021

Two antibodies targeting different parts of the COVID-19 virus spike protein, from Eli Lilly and GlaxoSmithKline/Vir Biotech, can cut viral load dramatically within a week. . GSK and Vir say they are discussing emergency use authorisation of VIR-7831 with the EMA and other regulators, including possible co-administration with bamlanivimab.

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Drug Discovery World

FEBRUARY 19, 2024

Dr Julie Warner is Vice President of Regulatory Affairs at drug development consultancy, Boyds. In this article, she provides her expert insights into the key trends and developments expected to shape the global drug development industry this year. antibody-drug conjugate [ADC] pipelines in some oncology settings).

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Drug Discovery World

FEBRUARY 16, 2024

The top stories: Dual-action treatment for fibrotic disease secures orphan drug status AM1476, a first-in-class, peripheral-acting serotonin receptor antagonist, has been granted US and EU Orphan Drug Designation as an anti-fibrotic treatment for systemic sclerosis.

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pharmaphorum

JANUARY 29, 2024

The US regulator has started a priority review of the HER2-targeting antibody-drug conjugate (ADC) for the treatment of adults with unresectable or metastatic HER2-positive solid tumours who have been treated previously or have limited treatment options.

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XTalks

OCTOBER 27, 2022

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the US Food and Drug Administration (FDA) approved Tecvayli (teclistamab-cqyv) for the treatment of relapsed or refractory multiple myeloma. Tecvayli is a first-in-class, bispecific T-cell engager antibody administered as a subcutaneous treatment.

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pharmaphorum

OCTOBER 2, 2020

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. The post European regulators begin rolling review of AZ’s COVID-19 vaccine appeared first on.

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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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pharmaphorum

JANUARY 15, 2021

South Korea’s Celltrion has announced encouraging top-line results for its potential antibody therapy for COVID-19, with the first part of a phase 2/3 trial showing it could cut recovery times and chances of progression from moderate to more severe disease. reported with placebo. Feature image courtesy of Rocky Mountain Laboratories/NIH.

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BioPharma Reporter

DECEMBER 16, 2020

Sterling Pharma Solutions, a global contract development and manufacturing organization (CDMO), has announced a new strategic partnership with ADC Biotechnology, a UK based company specializing in antibody-drug conjugates (ADCs).

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BioSpace

JUNE 28, 2023

Phase I/II data on AbbVie and Genmab’s recently approved bi-specific antibody in a second cancer indication positions them to talk to regulators about filings to challenge Roche’s Lunsumio.

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Drug Discovery World

MARCH 31, 2023

As March draws to a close, this week’s key announcements have demonstrated the breadth of international approaches to tackling cancer, with vaccines, proenzymes, immunotherapies and antibody-based treatments all currently under investigation around the world.

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Pharmaceutical Technology

NOVEMBER 30, 2022

Crossing the approval hurdle for a new drug is a big milestone for pharmaceutical companies. However, efficiently manufacturing the drug represents another barrier to cross before realizing the full revenue potential then successfully. The EMA had provided a positive opinion for this marketing authorization back in July.

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The Pharma Data

JANUARY 27, 2021

COVID-19 Antibody Treatments Exceed Expectations in Early Trials. 27, 2021 — Promising new data on two antibody cocktails suggest these therapies can keep COVID-19 patients out of the hospital and even prevent illness altogether in some people. Professional. WEDNESDAY, Jan. At the same time, Regeneron Pharmaceuticals Inc.

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pharmaphorum

MARCH 29, 2021

The EU looks set to approve emergency use of a third antibody therapy for COVID-19 after its human medicines committee backed use of Celltrion’s regdanvimab at its March meeting. . The EU’s medicines regulator is also reviewing COVID-19 antibodies from AstraZeneca , GlaxoSmithKline/Vir Biotechnology, and Brii Biosciences.

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BioSpace

JUNE 14, 2023

Following cases of serious bleeding in patients, five of which were fatal, the regulator has put Mersana’s investigational antibody-drug conjugate UpRi on partial clinical hold in two ovarian cancer trials.

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Pharmaceutical Technology

MAY 22, 2023

Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody that will be used to treat mild cognitive impairment caused due to AD and mild AD dementia in people with the confirmed presence of amyloid pathology in the brain. The regulator has also designated the therapy for the innovative licensing and access pathway (ILAP).

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Pharmaceutical Technology

APRIL 5, 2023

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to InflaRx’s Gohibic (vilobelimab) to treat critically ill hospitalised Covid-19 adult patients. It is a first-in-class monoclonal anti-human complement factor C5a antibody.

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XTalks

MARCH 15, 2021

Eli Lilly (NASDAQ: LLY ) shared the latest results from a late-stage study which show its combination antibody COVID-19 treatment can reduce hospitalizations and deaths by an impressive 87 percent, compared with placebo. The study is part of Lilly’s ongoing Phase III BLAZE-1 trial evaluating the antibody duo.

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pharmaphorum

MAY 19, 2021

In a rare move, the FDA has publicly accused US biotech CytoDyn of misrepresenting clinical trial results for leronlimab, an antibody being developed for COVID-19. . Leronlimab was also no better than placebo when it came to secondary endpoints including survival, time to symptom resolution, and time to return to normal activity.

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Drug Discovery World

JULY 8, 2022

Biotechnology company Immutep has been a granted a patent for its immunosuppressive antibody by the Japanese Patent Office. . Immutep’s IMP761 is an immunosuppressive agonist antibody to LAG-3 – a cell surface molecule which plays a role in regulating T cell function, and which has been identified as a new immune-checkpoint. .

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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 Federal Court upheld the Minister’s decision; AbbVie’s appeal of the Federal Court’s decision is pending (Court File No.

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Pharmaceutical Technology

JANUARY 2, 2023

The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next. The drug candidate is administered orally.

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The Pharma Data

AUGUST 20, 2020

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. It is still not known whether having antibodies will protect people from a second infection. Coronavirus infection triggers the immune system to produce antibodies.

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BioPharma Reporter

NOVEMBER 10, 2020

Lilly's monoclonal antibody therapy, bamlanivimab (LY-CoV555), has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for the treatment of adults and children with recently diagnosed, mild to moderate COVID-19.

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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.

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Pharmaceutical Technology

APRIL 14, 2023

Alvotech has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its biologics licence application (BLA) for AVT02, a biosimilar to Humira (adalimumab). The regulator re-inspected the Reykjavik facility in March 2023 and again reported deficiencies.

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STAT News

NOVEMBER 28, 2022

… A 65-year-old woman who was receiving a promising experimental treatment to slow the cognitive decline caused by her early Alzheimer’s disease recently died from a massive brain hemorrhage that some researchers link to the drug , Science reports. STAT reported on another such case last month.

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The Pharma Data

AUGUST 17, 2020

The Chinese Centre for Drug Evaluation (CCDE) has said that coronavirus vaccines must show 50 percent efficacy to be approved. . The regulatory body also has stated that vaccines must be free of the risk of antibody dependent enhancement. Air Force photo by Senior Airman Cody R.

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pharmaphorum

DECEMBER 21, 2021

Novartis has joined the ranks of big pharma companies developing TIGIT-targeted drugs for cancer, and found its candidate in an existing partner, Chinese biotech BeiGene. billion in milestones – shortly after its own PD-1 drug candidate spartalizumab failed a phase 3 trial in melanoma.

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pharmaphorum

OCTOBER 24, 2022

Novartis has chalked up another clinical trial win for its targeted factor B inhibitor iptacopan as it strives to position the drug as a patient-friendly, oral alternative to big-selling injectable rivals. The post Novartis’ oral drug iptacopan tops injectables in head-to-head PNH trial appeared first on.

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