Pharmaceutical Technology

SEPTEMBER 16, 2022

The US Food and Drug Administration (FDA) has granted fast track designation to Jasper Therapeutics’ antibody, JSP191, for the treatment of severe combined immunodeficiency (SCID) patients who undergo allogeneic hematopoietic stem cell transplant. . The antibody was also analysed in a total of more than 110 healthy subjects and patients. .

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Antibody Clinical Trials Clinical Trials Licensing 130

Pharmaceutical Technology

MARCH 28, 2023

On March 27, OncoVerity announced the acquisition of worldwide licensing rights of the anti-CD70 monoclonal antibody cusatuzumab from the biotech argenx. Alongside this, the company closed a $30 million Series A, which came from both argenx and the venture of UCHealth and the University License Equity Holdings.

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Licensing Licensing Development Antibody 130

Bio Pharma Dive

AUGUST 20, 2024

In addition to new stock offerings, this week saw Merck license an antibody drug conjugate and BARDA further work trying to innovate remote clinical trials.

Clinical Trials 144

Clinical Trials Clinical Trials Licensing Licensing 144

XTalks

JANUARY 22, 2025

IXCHIQ is the only licensed chikungunya vaccine in the US for adults aged 18 and older at increased risk of exposure to the virus. seroresponse rate indicating the proportion of participants achieving antibody levels above a predefined protective threshold sustained one year after vaccination. The findings reveal a remarkable 98.3%

Immune Response 59

Immune Response Vaccine Vaccination Trials 59

Pharmaceutical Technology

APRIL 6, 2023

The designation, under the regulator’s Innovative Licensing and Access Pathway (ILAP), will fast-track a potential route to market for AD04 by providing collaborative opportunities with UK institutes like the National Institute for Health and Care Excellence (NICE).

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FDA Approval Licensing Licensing Antibody 264

Pharmaceutical Technology

AUGUST 25, 2022

The treatment is indicated for patients with no history of Factor VIII inhibitors and any detectable antibodies to adeno-associated virus serotype 5 (AAV5). The approval is based on comprehensive data from the clinical development programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinical trial.

Gene Therapy 264

Gene Therapy Gene Clinical Trials Clinical Trials 264

pharmaphorum

AUGUST 25, 2020

The first patients have been dosed in a trial of two AstraZeneca antibodies, collectively known as AZD7442, that are being developed to both treat and prevent coronavirus infections. The phase 1 trial – funded by the US government – will take place in the UK and will test the safety of AZD7442 and its pharmacokinetic profile.

Antibody 84

Antibody Trials Trial Funding Licensing 84

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.

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Licensing Licensing FDA Approval Clinical Trials 111

pharmaphorum

JANUARY 27, 2021

AstraZeneca is playing catch up with Eli Lilly and Regeneron with its antibody therapy for COVID-19, but aims to narrow the gap with the help of decentralised clinical trial specialist Care Access Research. One of those trials – BLAZE-2 – was also run using Care Access’ mobile capabilities.

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Antibody Clinical Trials Clinical Trials Trials 94

XTalks

MAY 2, 2022

This year, the monoclonal antibody lecanemab is approaching final stages of investigation as a treatment for targeting the A? The Phase IIb clinical trial focused on the long-term clinical outcomes and safety for patients with MCI and amyloid pathology (early AD). The main pathological markers of AD are beta-amyloid (A?)

Clinical Trials 98

Clinical Trials Clinical Trials Antibody Trials 98

pharmaphorum

MARCH 8, 2021

The EMA’s human medicines committee has said two Eli Lilly antibodies are effective in people with COVID-19 who are at risk of developing severe disease, clearing the way for use in EU member states. The post EMA backs emergency use of Lilly’s COVID antibodies appeared first on.

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Antibody Licensing Licensing Protein 105

pharmaphorum

JUNE 24, 2021

Armed with a positive mid-stage trial readout in lung cancer, Arcus Biosciences will expand a phase 3 programme for domvanalimab, its anti-TIGIT antibody. Zimberelimab “showed activity similar to that of marketed anti-PD-1 antibodies studied in this setting,” said Arcus’ chief medical officer Bill Grossman.

Antibody 84

Antibody Trials Licensing Licensing 84

pharmaphorum

JANUARY 12, 2021

ImmunityBio has licensed technology underpinning a COVID-19 vaccine that could be administered orally rather than by injection from UK biotech iosBio. ImmunityBio’s vaccine design drives both antibody and T-cells to the spike (S) protein and nucleocapsid (N) protein.

Licensing 119

Licensing Licensing Vaccine Vaccination 119

XTalks

APRIL 1, 2025

The randomized, double-blind, placebo-controlled global trial assessed itolizumab in patients with newly diagnosed grade II-IV aGVHD. While the trial data showed that itolizumab did not improve complete or overall response rates at Day 29, statistically significant and clinically meaningful benefit in longer-term outcomes were achieved.

Immune Response 94

Immune Response Trials Licensing Licensing 94

Pharmaceutical Technology

DECEMBER 19, 2022

With the latest development, Sanofi will licence a NK cell engager programme that acts on B7H3 from the antibody-based NK cell engager therapeutics (ANKET) platform of Innate. Initially, the companies signed a research collaboration and licensing agreement in 2016 to develop and assess up to two bispecific NK cell engagers.

Development 264

Development Engineer Clinical Trials Clinical Trials 264

pharmaphorum

APRIL 9, 2021

The issues are holding up discussions between the agency and company about labeling and post-marketing requirements for teplizumab, and are concentrated around the pharmacokinetics data for the antibody, and whether it is comparable to the drug that its original developer Eli Lilly entered into clinical trials.

Antibody 98

Antibody Insulin Trials Production 98

Pharmaceutical Technology

OCTOBER 25, 2022

TSHA-102 is the first gene therapy in the clinical development stage for Rett syndrome currently while TSHA-120 is being analysed in a Phase I/II clinical trial for treating GAN. Astellas will also receive specific rights linked to any possible change of Taysha’s control.

Gene Therapy 264

Gene Therapy Gene Development Genetics 264

Pharmaceutical Technology

MAY 12, 2023

On 8 May 2023, China-based Bliss Biopharmaceutical (BlissBio) announced a clinical trial collaboration with Eisai to develop BB-1701, an antibody-drug conjugate (ADC) for multiple cancer types. Eisai signed a licensing agreement with BlissBio in 2018 for the Chinese companies’ exclusive right to use eribulin as their ADC payload.

Clinical Trials 162

Clinical Trials Clinical Trials Licensing Licensing 162

pharmaphorum

NOVEMBER 28, 2021

An investigator-led trial of Jazz Pharma’s cannabis extract-based drug Sativex in glioblastoma – an aggressive form of brain cancer – will get underway in the UK next year. The post Trial of Jazz’ cannabis drug in glioblastoma will start next year appeared first on.

Trials 136

Trials Drugs Clinical Trials Clinical Trials 136

pharmaphorum

OCTOBER 31, 2022

Actinium Pharma is on course to submit its targeted radiotherapy for acute myeloid leukaemia (AML) patients needing a bone marrow transplant in the US, buoyed by top-line data from a pivotal trial. The post Actinium eyes filing as conditioning drug for AML aces trial appeared first on.

Trials 124

Trials Gene Therapy Drugs Antibody 124

Pharmaceutical Technology

JANUARY 23, 2023

Furthermore, similar to GSK’s strategy with Benlysta, AstraZeneca initiated the Phase III TULIP subcutaneous (SC) trial in SLE using subcutaneous delivery of Saphnelo in June 2021. However, the 2021 approval of AstraZeneca’s Saphnelo in the US will mean increasing competition for Benlysta in the coming years.

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Marketing Production Drugs Trials 278

pharmaphorum

SEPTEMBER 2, 2020

The drug, JTX-1811, is a monoclonal antibody designed to selectively deplete immunosuppressive tumour-infiltrating T regulatory (TITR) cells. . When JTX-1811 binds to CCR8, it targets TITR cells for depletion by an enhanced antibody-dependent cellular cytotoxicity mechanism. . In 2016 Celgene signed a $2.6 In 2016 Celgene signed a $2.6

Licensing 71

Licensing Licensing Antibody Immune Response 71

Pharmaceutical Technology

JUNE 1, 2023

Sanofi has announced that its anti-CD40L antibody frexalimab demonstrated significantly reduced disease activity in a Phase II trial of patients with relapsing multiple sclerosis (RMS). Following these positive results, Sanofi plans to initiate further RMS trials next year.

Trials 162

Trials Antibody Marketing Development 162

Pharmaceutical Technology

JULY 7, 2022

The US Food and Drug Administration (FDA) has granted priority review to Roche’s Biologics License Application (BLA) of Lunsumio (mosunetuzumab) to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL). The submission is based on positive data from the pivotal Phase I/II GO29781 clinical trial of Lunsumio.

Clinical Trials 162

Clinical Trials Clinical Trials Trials Licensing 162

Pharmaceutical Technology

MAY 22, 2023

Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody that will be used to treat mild cognitive impairment caused due to AD and mild AD dementia in people with the confirmed presence of amyloid pathology in the brain. The regulator has also designated the therapy for the innovative licensing and access pathway (ILAP).

Marketing 130

Marketing Antibody Licensing Licensing 130

pharmaphorum

JANUARY 25, 2021

GlaxoSmithKline has suffered another research setback after it axed a phase 2 trial of an anti-LAG3 drug in patients with ulcerative colitis, following a major disappointment with a key lung cancer drug last week. Immutep said a collaboration with GSK remains in place and GSK2831781 continues to be under exclusive license with GSK.

Drug Trials 103

Drug Trials Trials Drugs Licensing 103

pharmaphorum

FEBRUARY 21, 2022

In contrast, up to 55% of all patients with breast cancer have tumours with a HER2-low score, as defined in the DESTINY-Breast04 trial, and approval in this group could unlock $3 billion in additional sales for Enhertu, according to analysts at Credit Suisse. billion upfront to license rights to Enhertu in a deal that could be worth up to $6.9

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Trials Sales Hormones Drugs 132

Pharmaceutical Technology

OCTOBER 31, 2022

Simultaneously, Genmab has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for the investigational subcutaneous IgG1-bispecific antibody to treat R/R large B-cell lymphoma (LBCL) patients.

Antibody 130

Antibody Licensing Licensing Trials 130

Pharmaceutical Technology

AUGUST 11, 2022

The proceeds from the business combination will be utilised to advance the pipeline of Disc to clinical trials and offer funding into 2025. They include various patient clinical trials for Disc’s programmes, bitopertin and DISC-0974, which are currently in the clinical development stage.

Medicine 147

Medicine Clinical Trials Clinical Trials Licensing 147

pharmaphorum

JUNE 16, 2022

The litany of failed trials of amyloid-targeting drugs for Alzheimer’s disease has added another verse, as Roche concedes that its crenezumab candidate was unable to slow cognitive decline in patients with an inherited form of the disease.

Trials 111

Trials Clinical Trials Clinical Trials Licensing 111

Pharmaceutical Technology

JANUARY 19, 2023

The expanded manufacturing and marketing approval was based on the data obtained from the Phase II trial, conducted in Australia and the US; a separate Phase II trial held in South Africa; and the UK-sponsored COV-BOOST trial. It has been developed using the company’s recombinant nanoparticle technology.

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Vaccine Vaccination Immune Response Protein 147

pharmaphorum

JUNE 16, 2022

MorphoSys seemingly inexorable shift into an oncology pure-play has continued with an out-licensing deal for two programmes in the kidney disease and immunology categories to China’s HIBio.

Licensing 104

Licensing Licensing Antibody Sales 104

pharmaphorum

APRIL 14, 2022

The drugmaker has reported top-line results from the phase 1/2 EPCORE trial of epcoritamab as a third-line therapy for relapsed/refractory LBCL, revealing an overall response rate of 63% and a median duration of response of 12 months. The post AbbVie preps filings for lymphoma bispecific licensed from Genmab appeared first on.

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Licensing Licensing Immune Response Antibody 64

Fierce Pharma

JANUARY 9, 2024

The FDA has sent a complete response letter to Astellas, rejecting zolbetuximab because of unresolved deficiencies identified in a pre-license inspection of a third-party manufacturing facility. But the Japanese company will have to clear up manufacturing issues first.

Manufacturing 88

Manufacturing Antibody Licensing Licensing 88

XTalks

FEBRUARY 12, 2025

LIB Therapeutics has announced that the FDA has accepted its Biologics License Application (BLA) for lerodalcibep, a novel investigational treatment aimed at reducing low-density lipoprotein cholesterol (LDL-C) in a broad patient population. Over 2,400 patients have continued in the 72-week open-label extension trial.

Cardiology 59

Cardiology Trials Clinical Trials Clinical Trials 59

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.

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Antibody FDA Approval Licensing Licensing 130

Pharmaceutical Technology

MARCH 23, 2023

Seagen specialises in developing antibody-drug conjugates (ADCs) which will complement Pfizer’s oncology portfolio. Adcetris is currently active in multiple clinical trials, including the ECHELON-3 Phase lll study for patients with relapsed or refractory diffuse large B-cell lymphoma.

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Licensing Licensing Sales Trials 147