The Pharma Data

SEPTEMBER 1, 2020

with whom Roche has a global distribution agreement and had also launched a Rapid Antibody Test in July. COVID-19 testing solutions that provide healthcare professionals and patients with a quick answer regarding their infection status are critical to contain the community-spread of the COVID-19 virus.

In-Vitro 52

In-Vitro Antibody Medicine Clinical Trials 52

The Pharma Data

OCTOBER 30, 2020

NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc. Cohort 3: patients on mechanical ventilation.

Production 52

Production Antibody Manufacturing Trials 52

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.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

The Pharma Data

APRIL 4, 2023

As part of the comprehensive submission package to the European Marketing Authorization, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing its approved adalimumab 50 mg/mL 2 with the 100 mg/mL (HCF). 1 In 2015, the EMA and US FDA approved Humira ® HCF, which contains adalimumab at a concentration of 100 mg/mL.

Medicine 40

Medicine Generic Pharmaceutical FDA Approval Marketing 40

The Pharma Data

JUNE 25, 2021

The CDC has defined Variant of Interest (VoI) as a variant with genetic markers that have been associated with changes to receptor binding, reduced neutralization by antibodies generated against previous infection or vaccination, or predicted increase in transmissibility or disease severity. efficacy against the B.1.351 and Australia.

Vaccination 40

Vaccination Vaccine Trials Immune Response 40

The Pharma Data

NOVEMBER 11, 2020

Details of the presentation are as follows: Event: Late Breaking Developments, Part II Title: One Year and Beyond: Long-term Multiple-dose Study of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate with Extended Durability, in wAMD, DME, and RVO Presenter: Arshad M Khanani, M.D., About KSI-301. Kodiak is based in Palo Alto, CA.

Development 40

Development Antibody Production Engineer 40

The Pharma Data

NOVEMBER 5, 2020

Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. (..)

Trials 52

Trials Production Clinical Trials Clinical Trials 52

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.

Antibody 52

Antibody Production Manufacturing Clinical Trials 52

The Pharma Data

NOVEMBER 20, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S. TARRYTOWN, N.Y., November 21, 2020 – Regeneron Pharmaceuticals, Inc.

Antibody 52

Antibody Production Clinical Trials Clinical Trials 52

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).

Antibody 52

Antibody Trials Production Clinical Trials 52

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.

Manufacturing 147

Manufacturing Production Containment Antibody 147

Pharmaceutical Technology

JANUARY 12, 2023

PM: Lyophilization is widely used in the pharmaceutical and biotech industry for small molecule drug products, vaccines, antibodies, and other biological material. That would not allow sufficient time to manufacture, package and distribute before half of the content was degraded. A great example is aspirin.

Production 130

Production Contamination Development Manufacturing 130

The Pharma Data

NOVEMBER 21, 2020

NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (also known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the U.S. government allocation program. Regeneron Pharmaceuticals, Inc.

Antibody 40

Antibody Production Clinical Trials Clinical Trials 40

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

Antibody 52

Antibody Sales Development Production 52

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. Trodelvy contains a monoclonal antibody linked to the anticancer cytotoxic drug SN-38.

HR 52

HR Hormones FDA Approval Antibody 52

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.

Development 130

Development Production Manufacturing Vaccination 130

The Pharma Data

AUGUST 6, 2020

See “Worldwide Pro Forma Revenue” in Quarterly Package of Financial Information for this quarter, which is available on bms.com/investors/financial-reporting/quarterly-results, for information on the revenue of the company and Celgene on a stand-alone basis for the prior-year period. Regulatory. Use of Non-GAAP Financial Information.

Production 52

Production Branding Marketing Containment 52

The Pharma Data

NOVEMBER 5, 2020

Lastly, we are proud that our novel antibody cocktail REGN-EB3 recently became the first FDA-approved treatment for Ebola, underscoring the potential of antibody therapies to address deadly infectious diseases.” REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus. Evinacumab , an antibody to ANGPTL3.

Sales 40

Sales Production Manufacturing Antibody 40

Pharmaceutical Technology

JULY 29, 2022

And we are very prepared and have data that will answer those questions, what would be the advantage of shifting to an Omicron-containing vaccine, whether it's monovalent or bivalent.” The booster dose elicited a significantly higher neutralising antibody response against Omicron subvariants BA.4

Manufacturing 130

Manufacturing Vaccination Vaccine Packaging 130

The Pharma Data

JANUARY 9, 2021

CDMO Services assumes continued growth in Development Services (DVS), Drug Substance (DS) manufacturing, and Drug Product (DP) manufacturing and Packaging for both clinical- and commercial-stage projects on behalf of a growing list of pharmaceutical and biotechnology innovators and government/NGO customers. FOOTNOTES. (1)

Production 40

Production Manufacturing Vaccination Vaccine 40

XTalks

AUGUST 2, 2023

2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. It contains the antiviral medications nirmatrelvir and ritonavir. The monoclonal antibody targets CD20, a protein found on the surface of B lymphocytes (B cells). The list price of Stelara was stated to be $25,497.12

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

OCTOBER 14, 2020

The treatment consists of three monoclonal antibodies of similar structure, atoltivimab, maftivimab and odesivimab, that bind to different, non-overlapping epitopes on Zaire ebolavirus glycoprotein. Inmazeb, previously called REGN-EB3, was created using Regeneron’s VelocImmune® platform and associated VelociSuite® technologies.

FDA Approval 52

FDA Approval Antibody Production Trials 52

The Pharma Data

JUNE 18, 2021

The BTK protein sends important signals that tell B cells to mature and produce antibodies. Concomitant use of preparations containing St. 8 VENCLEXTA (venetoclax) [Package Insert].?North?Chicago, BTK signaling is needed by specific cancer cells to multiply and spread. John’s wort as Venclyxto efficacy may be reduced.

Medicine 52

Medicine Production FDA Approval Development 52

XTalks

NOVEMBER 26, 2024

Darzalex Faspro: Subcutaneous solution containing 1,800 mg and 30,000 units per 15 mL, priced from $10,563.33 for a 120-count package of 140 mg capsules. Price of Darzalex and Darzalex Faspro: Darzalex: Intravenous solution at a concentration of 20 mg/mL, priced starting at $783.81 for a 5 mL vial. for a 15 mL vial.

Sales 105

Sales FDA Approval Drugs Marketing 105

The Pharma Data

JUNE 18, 2021

The BTK protein sends important signals that tell B cells to mature and produce antibodies. Concomitant use of preparations containing?St. 9 VENCLEXTA (venetoclax) [Package Insert].?North BTK signaling is needed by specific cancer cells to multiply and spread. John’s?wort wort as VENCLYXTO ® efficacy may be reduced. .

Medicine 40

Medicine Production FDA Approval Development 40

The Pharma Data

APRIL 27, 2021

For complete information on the safety of COMIRNATY® always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the European Union on the EMA website. The information contained in this release is as of April 19, 2021. Pfizer Disclosure Notice.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. For their part, Johnson & Johnson published findings at the end of July in which they reported a single dose of their vector-based vaccine induced robust neutralizing antibody responses in rhesus macaques. Johnson & Johnson’s COVID-19 Vaccine.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92