Pharmaceutical Technology

OCTOBER 7, 2022

The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk. A decision on the approval of the Biologics License Application (BLA) is anticipated on 17 November. An anti-CD3 monoclonal antibody, teplizumab is in the developmental stage to delay T1D.

FDA Approval 299

FDA Approval Antibody Drugs Medicine 299

XTalks

JULY 14, 2022

Over time, even the use of Krystexxa can lead to the development of antibodies against it, reducing its effectiveness. Early data also showed that methotrexate could prevent the formation of anti-drug antibodies. Related: Vtama (tapinarof) Cream Gains FDA Approval for the Treatment of Plaque Psoriasis in Adults.

FDA Approval 105

FDA Approval Antibody Drugs Trials 105

Pharmaceutical Technology

JUNE 9, 2023

Although AdCom verdicts are considered by the FDA when it comes to approvals, they are not binding. The FDA accepted nirsevimab’s biologics license application (BLA) in January, with a PDUFA date penned for Q3 2023. On 31 May, the FDA also approved Pfizer’s vaccine Abrysvo in the same patient population.

FDA Approval 147

FDA Approval Antibody Drugs Vaccination 147

pharmaphorum

SEPTEMBER 27, 2022

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The biotech said earlier it planned to seek FDA approval to start clinical trials towards the end of 2022.

Licensing 111

Licensing Licensing FDA Approval Clinical Trials 111

Drug Discovery World

NOVEMBER 21, 2022

The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for anti-CD3-directed antibody TZIELD (teplizumab-mzwv), the first immunomodulatory treatment for type 1 diabetes (T1D). .

FDA Approval 52

FDA Approval Antibody Drugs Medicine 52

XTalks

AUGUST 10, 2022

In this episode, Ayesha discussed a new COVID-19 test technology that Innova Medical Group, world leader in at-home COVID-19 tests, has reached a licensing deal for with the University of Birmingham where the technology was developed. The approval makes Enhertu the first approved drug for this indication.

FDA Approval 52

FDA Approval Life Science Drugs Antibody 52

Pharmaceutical Technology

FEBRUARY 21, 2023

The US Food and Drug Administration (FDA) has accepted a priority review of the biologics license application (BLA) for Regeneron Pharmaceuticals ’ pozelimab to treat children and adults with ultra-rare CHAPLE disease. The antibody is developed using the company’s VelocImmune technology.

FDA Approval 130

FDA Approval Antibody Drugs Protein 130

XTalks

APRIL 23, 2021

The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. The immunotherapy received approval as a monotherapy based on GSK’s Biologics License Application (BLA).

FDA Approval 105

FDA Approval Trials Antibody Drugs 105

pharmaphorum

DECEMBER 4, 2020

Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC). The post J&J files lung cancer bispecific amivantamab for FDA approval appeared first on.

FDA Approval 93

FDA Approval Antibody Drugs Licensing 93

Pharmaceutical Technology

MARCH 6, 2023

New data for TopAlliance Biosciences/ Coherus Biosciences’ anti-PD-1 monoclonal antibody Tuoyi (toripalimab) in combination with chemotherapy suggest that it can become the next standard of care in the frontline setting. Tuoyi also enjoys an FDA breakthrough therapy designation.

FDA Approval 130

FDA Approval Antibody Trials HR 130

Delveinsight

AUGUST 17, 2021

FDA’s Green Flag to Keytruda and Lenvima combination by Merck and Eisai for Advanced renal cell carcinoma (RCC). The FDA approved the combination of Keytruda and Lenvima produced by Merck and Eisai, as a first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Global President, Vaccines, Pfizer.

FDA Approval 98

FDA Approval Medicine Vaccination Vaccine 98

Pharmaceutical Technology

AUGUST 16, 2022

antibody, ADX-914 re-regulates adaptive immune function by hindering IL-7 and TSLP-facilitated signalling. In July, the US Food and Drug Administration (FDA) approved Horizon’s supplemental Biologics License Application for Krystexxa (pegloticase) plus methotrexate, to aid uncontrolled gout patients attain a complete response to treatment.

Clinical Trials 130

Clinical Trials Clinical Trials FDA Approval Development 130

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. TARRYTOWN, N.Y., NASDAQ: REGN) announced today that the U.S.

FDA Approval 52

FDA Approval Antibody Medicine Drugs 52

XTalks

APRIL 17, 2023

Monoclonal antibodies are gaining attention as alternative or additive treatments for atopic dermatitis. Lebrikizumab is a new and investigational monoclonal antibody designed to selectively inhibit IL-13. “In Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab outside of Europe.

Dermatology 97

Dermatology Antibody Clinical Trials Clinical Trials 97

The Pharma Data

JANUARY 17, 2021

. “Rolontis,” a treatment for neutropenia that had its technology licensed out to Spectrum Pharmaceuticals, Inc. and “Oraxol,” which was licensed out to Athenex, Inc. FDA approval this year. Belvarafenib (HM95573, solid tumor) , which was licensed to Genentech, Inc., .

FDA Approval 52

FDA Approval Drugs Clinical Trials Clinical Trials 52

pharmaphorum

FEBRUARY 8, 2022

In briefing documents released by the FDA reviewer, the agency has made it clear that the Chinese clinical results filed in support of the PD-1 inhibitor do not meet the criteria for foreign data fled in support of a marketing application in the US.

Antibody 52

Antibody FDA Approval Drugs Licensing 52

Pharmaceutical Technology

AUGUST 23, 2022

According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1, In July, the US FDA approved the companies’ supplemental Biologics License Application (sBLA) for their Covid-19 vaccine, Comirnaty, for use in adolescents aged 12 to 15 years.

Vaccination 130

Vaccination Vaccine Gene Therapy FDA Approval 130

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S. in 1-15 year olds and 98.7-100%

FDA Approval 52

FDA Approval Vaccination Vaccine Clinical Trials 52

pharmaphorum

APRIL 23, 2021

Dostarlimab was discovered by AnaptysBio and licensed to Tesaro before its merger with GSK and has led to two other antibodies entering the clinic: the TIM-3 antagonist cobolimab (GSK4069889) and a LAG-3 antagonist codenamed GSK4074386. GSK is responsible for ongoing R&D, marketing and manufacture of each of these drugs.

FDA Approval 52

FDA Approval Drugs Antibody Trials 52

Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. 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. NEW YORK, Nov.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Antibody 52

The Pharma Data

MAY 6, 2022

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the approval of COMIRNATY® (COVID-19 Vaccine, mRNA) to include individuals ages 12 through 15 years. Pfizer Inc.

FDA Approval 52

FDA Approval Licensing Licensing Vaccination 52

pharmaphorum

FEBRUARY 11, 2021

ACI-35.030, partnered with Johnson & Johnson, is designed to stimulate the body to generate antibodies against tau protein, one of the factors though to play a role in the development of AD dementia. It remains to be seen of course if that antibody response translates into an effect on symptom progression.

Antibody 128

Antibody Protein FDA Approval Vaccination 128

pharmaphorum

OCTOBER 31, 2022

The New York biotech said today that the SIERRA trial of Iomab-B – an antibody armed with a radioisotope designed to deliver targeted treatment to tumours and spare healthy tissues – met its primary objective.

Trials 124

Trials Gene Therapy Drugs FDA Approval 124

pharmaphorum

JANUARY 4, 2023

Talquetamab is an investigational, off-the-shelf (or ready-to-use) bispecific T-cell engager antibody that targets both GPRC5D – a novel drug target that is on some normal cells, but overexpressed on myeloma cells – and CD3 on T-cells. That included a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

Antibody 98

Antibody FDA Approval Marketing Medicine 98

Pharmaceutical Technology

JANUARY 19, 2023

However, it is possible to target CD33 in the clinic, as evidenced by the FDA approval of Pfizer’s anti-CD33 antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) in 2000. NiCord’s biologics license application is currently being investigated by the FDA with a review date set by May 2023.

Gene Editing 130

Gene Editing FDA Approval Marketing Gene 130

XTalks

AUGUST 15, 2023

struck a worldwide collaboration (excluding Japan) and license agreement with niraparib developer Tesaro (acquired by GSK in 2019) for exclusive rights to the drug in prostate cancer. Lynparza received FDA approval in May 2020 for mCRPC in patients with homologous recombinational repair ( HRR ) gene mutations.

FDA Approval 52

FDA Approval Gene Drugs Hormones 52

Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

Development 161

Development Antibody Immune Response Bioequivalency 161

pharmaphorum

NOVEMBER 10, 2021

The agreement includes a sizeable $500 million upfront payment, reflecting that Nurtec ODT (rimegepant) is already FDA-approved for treating acute migraine with and without aura in adults, and for prevention of episodic migraine in patients who suffer less than 15 headache days per month.

Licensing 52

Licensing Licensing Drugs FDA Approval 52

pharmaphorum

DECEMBER 8, 2020

AbCellera Biologics has been in the spotlight since coming up with Eli Lilly’s COVID-19 antibody drug bamlanivimab, and looks set to capitalise on that exposure with a sizeable initial public offering. The drug is also being tested in other trials, including a phase 3 study looking at its role in prevention of SARS-CoV-2 infection.

Drugs 111

Drugs Antibody FDA Approval Pharma Companies 111

Pharmaceutical Technology

SEPTEMBER 13, 2022

Gilead’s Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2 directed antibody-drug conjugate (ADC), with a potent topoisomerase I inhibitor payload. Trop-2 is highly expressed across multiple cancer types, with expression detected in more than 90% of breast cancers.

Marketing 162

Marketing FDA Approval HR Hormones 162

Drug Discovery World

NOVEMBER 25, 2022

FDA approves first disease-modifying therapy for T1D . The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for anti-CD3-directed antibody TZIELD (teplizumab-mzwv), the first immunomodulatory treatment for type 1 diabetes (T1D). .

Gene Therapy 52

Gene Therapy Drugs FDA Approval Gene 52

Pharmaceutical Technology

NOVEMBER 9, 2022

An approval decision on the gene therapy, also known as EtranaDez, is expected by the end of this month. CSL Behring has a commercialisation and license agreement to develop EtranaDez. After its approval, bluebird had set Zynteglo’s price at roughly EUR1.6 million ($1.8 million at the time). million price tag.

Gene Therapy 278

Gene Therapy Gene FDA Approval Medicine 278

pharmaphorum

NOVEMBER 21, 2022

The US FDA approved the anti-CD3 antibody to delay the onset of stage 3 T1D in patients aged eight years and older who are currently diagnosed with stage 2 disease – a population estimated by Provention to be around 30,000 in the US. It also has an option on global marketing rights to the drug.

Drugs 116

Drugs FDA Approval Insulin Antibody 116

The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. Vivity received FDA approval in February 2020. A second liver biopsy will be performed after 18 months.

Licensing 52

Licensing Licensing Clinical Trials Clinical Trials 52

pharmaphorum

OCTOBER 27, 2022

The antibody – which targets granulocyte-macrophage colony-stimulating factor (GM-CSF) – did show efficacy in the ContRast-1 and ContRast-2 studies, working better than placebo at reducing symptoms of RA in patients who did not respond to conventional disease-modifying antirheumatic drugs (DMARDs), like methotrexate. Daprodustat backed.

Antibody 97

Antibody FDA Approval Drugs Trials 97

XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. Tegoprubart is an anti-CD40L antibody designed to inhibit the CD40 and CD11 costimulatory signaling pathways. The recommended dosage of Qalsody is 100 mg (15 mL) per administration.

Gene 89

Gene FDA Approval Clinical Trials Clinical Trials 89