Drug Discovery World

MARCH 26, 2024

For example, progress made in developing gene mutant-specific inhibitors, antibody-drug conjugates (ADC), or cellular therapies. In addition to STC-15 and our METTL1, our pipeline contains a number of preclinical programs that are advancing rapidly for the treatment of viruses, neurodegeneration, cancer, and immuno-inflammatory conditions.

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Camargo

DECEMBER 13, 2021

The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. An application submitted under 351(a), also known as a “stand-alone” application, must contain all safety and effectiveness information for a biological product and cannot depend on any other biological product.

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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 The mRNA-1273.214 booster contains the original Spikevax vaccine and a candidate targeting Omicron BA.1 In addition to providing protection against the Omicron BA.1 1 variant of concern.

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The Pharma Data

JANUARY 29, 2021

(MedMira) (TSXV: MIR) announces the development of a rapid antibody test prototype that detects the presence of the neutralizing antibodies against the SARS-CoV-2 virus. This news release contains forward ? Regulatory update as well as the latest product development strategy will be publicly announced soon.

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Delveinsight

OCTOBER 1, 2021

This disease is associated with antibodies directed against the acetylcholine receptor, muscle-specific kinase (MUSK), lipoprotein-related protein 4 (LRP4), or agrin in the postsynaptic membrane at the neuromuscular junction. Prograf is available for oral administration in the form of capsules (tacrolimus capsules USP) containing 0.5

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Roots Analysis

OCTOBER 24, 2023

As the global market for pharmaceutical solutions is increasing, pressure to bring biological APIs in different biological forms is rising and with the rising demand of targeted therapies, antibody-drug conjugates (ADCs) and cytotoxic drugs have gained wide attention in the field of HPAPIs.

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XTalks

JANUARY 9, 2024

The thyroid plays a critical role in the body by producing hormones that regulate metabolism, heart rate and body temperature among others. These include: Desiccated thyroid extract (DTE) : DTE is a natural form of thyroid hormone that contains both T4 and T3 (triiodothyronine). The thyroid disease market is huge, and lucrative.

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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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The Pharma Data

JANUARY 12, 2021

where he managed and oversaw a large portion of the Regeneron pipeline portfolio including leading the immunology and inflammation antibody products across all stages of development from preclinical to post-launch. Dr. Graham stated: “I am excited to join Tiziana to help develop its unique monoclonal antibody platform for autoimmune diseases.

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The Pharma Data

JANUARY 10, 2021

PLANEGG / MUNICH, GERMANY / ACCESSWIRE / January 11, 2021 / MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR), a commercial-stage biopharmaceutical company and a leader in antibody, protein and peptide technologies, announced today that Jean-Paul Kress, M.D., In July 2020, the U.S. Source link.

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The Pharma Data

JANUARY 17, 2021

The treatment is based on the Grifols immunoglobulin Gamunex®-C, and contains anti-SARS-COV-2 polyclonal antibodies from plasma donors who have recovered from COVID-19. It could also help contain outbreaks in places where the vaccination hasn’t begun or is still underway. BARCELONA, Spain , Jan.

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XTalks

JUNE 28, 2023

It is injected into a patient’s muscle tissue. The FDA approval came after several delays and a narrow advisory committee vote of eight to six in favor of the gene therapy’s risk-benefit profile. It has taken Sarepta six years to develop Elevidys with several roadblocks in its journey, including two clinical holds due to safety concerns.

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The Pharma Data

OCTOBER 26, 2020

On 14 May 2018, the Company announced a collaboration with GlobalCo to work on its CDX antibody. This additional extension of the collaboration will allow us to choose the best CDX antibody for pre-clinical and clinical development.” ” Market Abuse Regulation (MAR) Disclosure. [link].

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FDA Law Blog

DECEMBER 13, 2022

Gibbs — It is widely expected that the fate of the VALID Act – and therefore the world of diagnostic regulation – will be determined in the next two weeks (see our previous post here ). Javitt & Jeffrey N. is exempt from premarket review and its use is consistent with applicable limitations on the exemption.

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pharmaphorum

SEPTEMBER 25, 2020

Leap Therapeutics will get a swift FDA review for its lead drug DKN-01 for a form of gastric and gastroesophageal junction (G/GEJ) cancer after being awarded fast-track status by the regulator.

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The Pharma Data

OCTOBER 25, 2020

Company Confirms COVID-19 Antibody Home Test and Two Severity Triage Tests can be Submitted to U.S. SQI is accelerating the clinical development of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test.

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The Pharma Data

JULY 27, 2021

Acquisition Complements Amgen’s Antibody Research Capabilities Across Therapeutic Areas Acquisition Includes a Portfolio of Early-Stage Oncology Assets, Including a Phase 1 Bispecific Antibody for Patients With Advanced Prostate Cancer. billion in cash. Reese, M.D., executive vice president of Research and Development at Amgen.

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The Pharma Data

APRIL 3, 2021

It was designed to test the safety, tolerability and efficacy of a combination treatment regimen for coronavirus disease 2019 (COVID-19) consisting of the antiviral remdesivir along with an anti-coronavirus hyperimmune intravenous immunoglobulin (H-Ig), which contains a highly concentrated solution of antibodies that neutralize SARS-CoV-2.

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The Pharma Data

NOVEMBER 4, 2020

CAEL-101 is a first-in-class monoclonal antibody (mAb) designed to improve organ function by reducing or eliminating amyloid deposits in the tissues and organs of patients with AL amyloidosis. The antibody is designed to bind to misfolded light chain protein and amyloid and shows binding to both kappa and lambda subtypes.

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The Pharma Data

DECEMBER 12, 2020

Alexion ‘s franchise includes Soliris (eculizumab), a first-in-class anti-complement component 5 (C5) monoclonal antibody. More recently, Alexion launched Ultomiris (ravulizumab), a second-generation C5 monoclonal antibody with a more convenient dosing regimen.

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The Pharma Data

AUGUST 18, 2020

Virus-neutralizing antibody discovery. Notice to Investors Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding development of potential preventive and treatment regimens for COVID-19.

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Delveinsight

JANUARY 22, 2021

There are newer agents coming to the market, for instance, Fc receptor via monoclonal IgG antibodies mechanism, BTK [Bruton tyrosine kinase] inhibition, and so on, however, the real challenge lies in the compliance in terms of patients perspectives such as cost and tolerance.

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The Pharma Data

NOVEMBER 27, 2020

the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. The FDA granted approval under the accelerated approval regulation. NEW YORK, Nov.

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The Pharma Data

OCTOBER 18, 2020

Developed and marketed by Janssen, Tremfya (R) is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. The focus is on cancer. In July 2020, the U.S. Monjuvi (R) and HuCAL (R) are registered trademarks of MorphoSys AG.

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The Pharma Data

OCTOBER 15, 2020

Y-mAbs is a development-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. NEW YORK, Oct. 16, 2020 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics Inc. About Y-mAbs.

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Drug Discovery World

OCTOBER 21, 2022

Their research revealed that, in HER2+ breast cancer, TGF-beta-activated fibroblasts block the effects of monoclonal antibody trastuzumab and protect the tumour. Read the full story: Breast cancer cells ‘regulate their own metastases’.

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The Pharma Data

MARCH 8, 2021

Canakinumab is a human monoclonal antibody that binds with high affinity and selectivity to human interleukin-1beta (IL-1?) This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. About canakinumab (ACZ885). 6 , 7 and neutralizes IL-1? Disclaimer.

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pharmaphorum

JANUARY 5, 2022

New oral therapies join the existing monoclonal antibody cocktails and include molnupiravir (Lagevrio, Merck) and a combination of the new antiviral nirmatrelvir with the HIV antiviral ritonavir (Paxlovid, Pfizer). New COVID-19 treatments will also be available in 2022, but they are not a panacea. CNS’s moment of truth.

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The Pharma Data

SEPTEMBER 8, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Sanofi, Empowering Life. For further information, please visit www.sanofi.com.

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The Pharma Data

NOVEMBER 10, 2020

First Ever Study with take-home capsules of Foralumab , a Fully Human Anti-CD3 Monoclonal Antibody. Oral administration of anti-CD3 monoclonal antibody is a novel approach to induce an anti-inflammatory immune response to suppress inflammation by inducing T regulatory (Tregs) cells in animal studies 3 ,4. Billion by 2025.

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The Pharma Data

SEPTEMBER 8, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. This press release contains “forward-looking statements” of. Empowering Life.

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XTalks

APRIL 26, 2021

The vaccine is protein-based and contains an adjuvant (MM), a component that helps generate a stronger immune response, that was developed by Novavax. R21/MM vaccinated participants had high titers of malaria-specific anti-NANP antibodies 28 days after the third vaccination, which were almost doubled with the higher adjuvant dose.

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The Pharma Data

SEPTEMBER 9, 2020

On July 27, Pfizer and BioNTech announced that following extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the FDA’s Center for Biologics Evaluation and Research (CBER) and other global regulators, the companies selected the BNT162b2 vaccine candidate to move forward into a Phase 2/3 study.

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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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The Pharma Data

AUGUST 3, 2021

Revenue growth was 12 percent when excluding effects of 2020 COVID-related stocking patterns, revenue from COVID-19 antibodies and recent business development. million in the second quarter of 2021 for its COVID-19 antibodies. million of revenue in the second quarter of 2021 from COVID-19 antibodies, $170.0 Excluding $148.9

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The Pharma Data

JANUARY 12, 2021

This communication contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S.

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FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. From there, the PTO notes that a PTE “determination is made based on the representations contained in the PTE application,” and that “35 U.S.C. § Karst — Earlier this week, we posted Part 1 of our three-part series on U.S. That did not happen.

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