Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. Expanded access to experimental biologics. BLA process (CBER).

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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. Phase1b/2 clinical study to be conducted in the United States and several European countries. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. Shailubhai, K.,

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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.

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XTalks

JUNE 28, 2023

It has taken Sarepta six years to develop Elevidys with several roadblocks in its journey, including two clinical holds due to safety concerns. 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.

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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. Clinical Trials for Thyroid Conditions New treatments are being evaluated in clinical studies for various thyroid conditions, including thyroid cancer. percent from 2023 to 2030.

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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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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

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

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

SEPTEMBER 9, 2020

“We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”. “As The information contained in this release is as of September 7, 2020.

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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?) Patients in the CANTOS trial were also at high risk for inflammatory cancers, like lung cancer, due to advanced age, smoking history and other clinical risk factors 8,9. About canakinumab (ACZ885).

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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

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Sanofi, 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. Malaria Vaccine Phase II Trial. Oxford researchers developed the R21/MM malaria vaccine in collaboration with the Serum Institute of India and biotech company Novavax.

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Empowering Life. www.sanofi.com.

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The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. CEO and Co-founder of BioNTech. “We

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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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pharmaphorum

JANUARY 5, 2022

The year 2020 ended on a note of hope, with the 8th December vaccination of 91-year-old Margaret Keenan, the world’s first person to receive a COVID-19 vaccine outside clinical trials. Despite an estimated 9.25 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

OCTOBER 19, 2020

Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine. About Pneumococcal Disease. Select Safety Information for PNEUMOVAX 23.

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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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FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. As part of the Accelerated Approval, Oncopeptides was required to conduct “further adequate and well-controlled clinical trials to verify and describe clinical benefit.” That did not happen.

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The Pharma Data

APRIL 28, 2021

This approval is based on data from the Phase 3 IKEMA study, a randomized, multi-center, open label clinical trial that enrolled 302 patients with relapsed MM across 69 centers spanning 16 countries. Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells. In the U.S., About Sanofi.

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The Pharma Data

JANUARY 6, 2021

Based on its proprietary technology, the company has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac had its initial public offering on the New York Nasdaq in August 2020. ak (2021-0003E).

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The Pharma Data

JANUARY 12, 2021

Dosing is underway in Phase 3 trials of ULTOMIRIS in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), ALXN2060 (AG10) in ATTR cardiomyopathy in Japan , CAEL -101 in AL amyloidosis and ALXN2040 in paroxysmal nocturnal hemoglobinuria (PNH) patients with extravascular hemolysis (EVH).

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The Pharma Data

AUGUST 5, 2020

About ofatumumab Ofatumumab (OMB157) is a fully human anti-CD20 monoclonal antibody (mAb) in development for RMS that is self-administered by a once-monthly injection, delivered subcutaneously 1,3. Ofatumumab is a fully human anti-CD20 antibody achieving potent B-cell depletion through binding a distinct epitope. 10% of patients 1.

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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. The trial compared tirzepatide to insulin glargine in adults with type 2 diabetes and increased cardiovascular risk. The company recognized worldwide revenue of $148.9

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pharmaphorum

JUNE 9, 2022

Moderna’s new version of its COVID-19 vaccine, which targets two virus variants including Omicron, has outperformed the company’s original Spikevax shot in a head-to-head clinical trial. It has predicted sales of COVID-19 vaccines will be around $21 billion this year.

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The Pharma Data

DECEMBER 3, 2020

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. 4, 2020 11:00 UTC. Forward-Looking Statements.

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The Pharma Data

JANUARY 15, 2021

Darzalex Faspro® is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials. About Darzalex Faspro® In August 2012, Janssen Biotech, Inc. Janssen Biotech, Inc.

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The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.

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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. Lilly is in discussions with global regulators to make bamlanivimab available around the world. INDIANAPOLIS, Nov.

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The Pharma Data

AUGUST 13, 2020

person” (as defined in Rule 902 of Regulation S under the Securities Act), outside the United States not purchasing for the account or benefit of a U.S. person, (B) acquiring the New Notes in an offshore transaction in accordance with Regulation S under the Securities Act and (C) otherwise a Non- U.S. Forward-Looking Statements.

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Drug Discovery World

AUGUST 10, 2022

Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2. Later, scientists took advantage of antibodies’ natural tendency to seek out specific antigens and created antibody therapies that guide T cells towards the cells they are supposed to destroy.

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The Pharma Data

MAY 7, 2021

GSK and Vir continue discussions with global regulators to make sotrovimab available to patients with COVID-19. The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. About the Sotrovimab Clinical Development Program. GlaxoSmithKline plc and Vir Biotechnology, Inc.

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The Pharma Data

AUGUST 13, 2020

person” (as defined in Rule 902 of Regulation S under the Securities Act), outside the United States not purchasing for the account or benefit of a U.S. person, (B) acquiring the New Notes in an offshore transaction in accordance with Regulation S under the Securities Act and (C) otherwise a Non- U.S. Forward-Looking Statements.

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XTalks

AUGUST 2, 2023

It contains the antiviral medications nirmatrelvir and ritonavir. 2) Darzalex (daratumumab) Darzalex is a targeted monoclonal antibody that slows or stops the progression of multiple myeloma (a blood cancer) by binding to the CD38 protein on multiple myeloma cells. Pfizer’s total global revenue from Paxlovid was $18.93 billion in 2022.

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The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — VBL Therapeutics (Nasdaq: VBLT), today announced that the European Patent Office (EPO) has granted Patent # 3328401 , which covers VBL’s proprietary investigational anti-MOSPD2 monoclonal antibodies to treat oncology conditions. TEL AVIV, Israel, Oct. About VBL Vascular Biogenics Ltd.,

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