Pharmaceutical Technology

MAY 25, 2023

Yuflyma is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody. The regulatory approval was based on a comprehensive data package of preclinical, analytical and clinical trials. It will be offered to patients in prefilled syringe and autoinjector administration options.

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The Pharma Data

MARCH 25, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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Pharmaceutical Technology

FEBRUARY 7, 2023

The human monoclonal antibody denosumab has been designed to bind to osteoclasts activator, RANKL protein. The BLA submission is supported by a comprehensive analytical and clinical data package, including the Phase I/III ROSALIA trial data.

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The Pharma Data

JANUARY 12, 2021

million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential U.S. Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021 , up to 1.25 TARRYTOWN, N.Y. , 12, 2021 /PRNewswire/ — . million doses.

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Pharmaceutical Technology

MARCH 21, 2023

Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

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The Pharma Data

NOVEMBER 4, 2020

Strong benchmark to competitor CD40 antibodies. . 5, 2020 /PRNewswire/ — Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced that its CD40 targeting antibody mitazalimab will be presented at the World Immunotherapy Congress, November 2-6, 2020. LUND, Sweden , Nov. CET on November 5, 2020.

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The Pharma Data

MARCH 29, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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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. The process eliminates the disadvantages of conventional drying methods or freezing.

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Pharmaceutical Technology

JUNE 9, 2023

Also known as palivizumab, Sobi ‘s Synagis was the first FDA-approved monoclonal antibody used in children at high risk of RSV disease. Marketed under the name Beyfortus in the EU, nirsevimab is a long-acting human recombinant monoclonal antibody. The single seasonal dosing of the drug is a large advance, he noted.

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Pharmaceutical Technology

FEBRUARY 27, 2023

Contract manufacturing organizations (CMOs) not only produce the active pharmaceutical ingredient (API) at the heart of a therapy, but are also responsible for the sterile manufacturing and packaging of liquid and inhalational drug constituents and packaging, depending on the needs of the particular therapy.

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The Pharma Data

DECEMBER 29, 2020

First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. futility analysis).

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Pharmaceutical Technology

SEPTEMBER 8, 2022

The list includes providers of development services, biologics management supply chain solutions, clinical trial services, commercial and logistics services, as well as packaging, labelling and distributing services for biologics.

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Pharmaceutical Technology

JULY 29, 2022

The booster dose elicited a significantly higher neutralising antibody response against Omicron subvariants BA.4 On 11 July, Moderna announced Phase II/III clinical data for its bivalent Omicron booster candidate, mRNA 1273.214, which is an adapted version of Moderna’s approved Spikevax vaccine.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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Pharmaceutical Technology

FEBRUARY 3, 2023

Moving the viral vector field closer to the monoclonal antibody field is really what we see as the way forward.” In the monoclonal antibody world, there’s been really large orders of magnitude in improvements of titer over the last twenty years or so, and all of that required having a stable cell line in place.” 1] BioNews.

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pharmaphorum

JULY 18, 2022

You have a response with immunoglobulins type G (antibodies) and robust cellular response with both CD4 and CD8 T-cells being activated,” Morgon states. CD4s are present to stimulate B cells, so they keep producing antibodies, whereas CD8 or inner cells go after infected cells, killing them before the virus spreads.

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Pharmaceutical Technology

MARCH 30, 2023

On the same day, researchers presented new interim data from the Phase III RUBY trial of GSK’s PD-1 antibody Jemperli (dostarlimab) in patients with primary advanced or recurrent endometrial cancer. Broadening uses and secured full approvals Since its first approval in September 2014, Keytruda has achieved blockbuster status on the market.

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Pharmaceutical Technology

NOVEMBER 22, 2022

It is therefore to be expected that there are a far greater number of Chinese sites for API manufacturing for FDA and EMA innovator and biosimilar drugs than for dose manufacturing and packaging. The majority of FDA and EMA innovator and biosimilar marketed drugs produced by Chinese sites are small molecules.

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The Pharma Data

OCTOBER 28, 2020

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron.

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pharmaphorum

JULY 22, 2021

Celltrion’s COVID-19 therapeutic, CT-P59, is a monoclonal antibody (mAb) with activity against COVID-19. It was identified as a potential treatment through the screening of antibody candidates from recovered patients and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus. Overcoming obstacles.

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The Pharma Data

DECEMBER 5, 2020

NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences.

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The Pharma Data

AUGUST 7, 2020

CluePoints provides clinical studies with risk management support package during Covid-19. Patrick Hughes, Co-Founder and Chief Commercial Officer of CluePoints, said: “The response to our complimentary risk assessment package has been fantastic. NIH tests antibodies in Covid-19 clinical trial alongside Eli Lilly and AbCellera .

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Pharmaceutical Technology

APRIL 14, 2023

Recombinant insulin is used as a supplement in the upstream manufacturing of a range of biologic drugs, including recombinant proteins, such as monoclonal antibodies, viral vectors, and viruses. In particular, a final concentration of 2 mg/L improved antibody production by 49%. For lentivirus, a four-plasmid packaging system was used.

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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.

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Roots Analysis

APRIL 15, 2024

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

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The Pharma Data

AUGUST 24, 2020

The Head of the National Health Commission’s Science and Technology Centre, Zheng Zhongwei, said: “We’ve drawn up a series of plan packages, including medical consent forms, side effect monitoring plans, rescuing plans, compensation plans, to make sure the emergency use is well regulated and monitored.”. Conor Kavanagh.

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XTalks

FEBRUARY 7, 2023

Trodelvy is a Targeted Therapy Trodelvy is a Trop -2 directed antibody-drug conjugate therapy. Trodelvy contains a monoclonal antibody linked to the anticancer cytotoxic drug SN-38. What to Know Before Considering Trodelvy Trodelvy is packaged in a single-use vial at a dosage of 180mg, to be delivered via an intravenous injection.

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Pharmaceutical Technology

JANUARY 15, 2023

While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API. Vetter Pharma-Fertigung GmbH & Co KG is conducting the parenteral manufacture and packaging for Trulicity.

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The Pharma Data

MAY 3, 2021

Pfizer also shared antibody responses from the younger age group. At one month after the second dose in the two-dose regimen, participants aged 12 to 15 years had neutralizing antibody geometric mean titers that were numerically higher and statistically non-inferior to those of 16-25 year-olds. .

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pharmaphorum

AUGUST 6, 2020

Blenrep, which is predicted by analysts to produce revenues of around $1.5bn in 2026, is an antibody-drug conjugate that works by targeting B-cell maturation antigen (BCMA), a protein commonly found on the surface of the malignant B-cells that cause the disease.

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The Pharma Data

JANUARY 6, 2021

1 and 20 will be automatically entered to win the “Big Game at Home” package for viewing at home, with a 65-inch television and a $500 gift card. People who have recovered from COVID-19 may have antibodies in their plasma that could give a patient’s immune system the boost it needs to beat the virus. © 2021 HealthDay.

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The Pharma Data

JUNE 7, 2023

Originally launched in 2019 for early-phase protein therapy development, OneBio Suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinical supply and commercial launch.

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Roots Analysis

DECEMBER 8, 2021

In order to devise a framework to determine / compare the prices of bio-preservation media, six relevant parameters were taken into consideration, namely, preservation condition, type of serum, type of biological sample, packaging volume, packaging format, and area of application.

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pharmaphorum

SEPTEMBER 21, 2021

AZ has also invested in its facilities in the UK, with a £380 million ($520 million) programme at its Macclesfield campus for breast cancer therapy Zoladex (goserelin acetate) as well as a new medicines packaging facility. “This significant investment will ensure the AstraZeneca supply network is fit for the future.”

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The Pharma Data

JUNE 17, 2022

As part of the comprehensive submission package to the EMA, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing Hyrimoz 50 mg/mL 2 and Hyrimoz HCF. About adalimumab Adalimumab is a human immunoglobulin G1 (IgG(1)) monoclonal antibody targeting tumor necrosis factor alpha (TNF-a).

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XTalks

OCTOBER 26, 2020

Provention is developing an investigational anti-CD3 monoclonal antibody called PRV-031 (teplizumab), which is designed to delay onset, or prevent T1D in at-risk individuals. Provention will conclude the filing upon submission of its manufacturing package this quarter.

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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. Already having been in clinical studies at Roche, all four candidates have strong clinical and preclinical safety packages.

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