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.

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pharmaphorum

MARCH 23, 2021

Roche has stopped dosing in a phase 3 trial of tominersen, a potential Huntington’s disease (HD) drug developed with Ionis, after a pre-planned review by independent experts. . The companies had been working on tominersen since December 2017, when Roche licensed it in from Ionis.

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Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

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Pharmaceutical Technology

MARCH 23, 2023

Seagen will maintain its operations in the Seattle area and will leverage Pfizer’s protein-engineering capabilities to develop next-generation biologics. 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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Pharmaceutical Technology

SEPTEMBER 22, 2022

AVR-RD-04 works by genetically modify a patient's hematopoietic stem cells (HSCs) to express the gene that encodes the cystinosin protein. Cystinosis patients have a high deficiency of this protein. A rare and fatal ailment, cystinosis is characterised by cystine buildup in cellular organelles called lysosomes.

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Pharmaceutical Technology

AUGUST 14, 2022

KMFDS granted the approval based on findings from a paediatric expansion of Phase III PREVENT-19 clinical trial underway to analyse the safety, immunogenicity and efficacy of the vaccine. . Tenderness/pain at the site of injection, headache, fatigue, myalgia and malaise was seen to be the most common adverse reactions in the trial. .

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The Pharma Data

MARCH 30, 2021

Basel, March 30, 2021 — Novartis has obtained exclusive worldwide rights to develop and commercialize therapeutic applications for a library of Fibroblast Activation Protein (FAP) targeting agents including FAPI-46 and FAPI-74, through an assignment agreement with iTheranostics, Inc., an affiliate of SOFIE Biosciences, Inc.

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pharmaphorum

NOVEMBER 15, 2022

Lantheus’ pipeline-building drive in radiopharma has continued with a $260 million upfront deal to license rights to two oncology candidates from POINT Biopharma. The post Lantheus on POINT in radio-oncology with $2bn licensing deal appeared first on. Lantheus is promising up to $1.8 billion in milestone payments.

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XTalks

OCTOBER 22, 2024

transmembrane tight junction protein, which is commonly found in some gastric and GEJ cancers. gene, and an estimated 60 percent of all gastric cancers harbor the protein. The FDA had rejected Vyloy in January due to “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility” for the drug.

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Pharmaceutical Technology

MARCH 1, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company offers advanced small protein therapies such as abicipar, a designed ankyrin repeat protein-based anti-angiogenic drug developed for diabetic macular edema and wet age- macular degeneration.

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Pharmaceutical Technology

MARCH 1, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company offers advanced small protein therapies such as abicipar, a designed ankyrin repeat protein-based anti-angiogenic drug developed for diabetic macular edema and wet age- macular degeneration.

Protein 100

Protein Clinical Trials Clinical Trials Development 100

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. C5 is a protein that is involved in the activation of the complement system.

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Pharmaceutical Technology

AUGUST 23, 2022

It comprises messenger ribonucleic acid (mRNA) that encodes for the initial spike protein of SARS-CoV-2 along with mRNA that encodes for Omicron BA.4/BA.5 5 variant spike protein. According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1,

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Pharmaceutical Technology

FEBRUARY 7, 2023

The US Food and Drug Administration (FDA) has accepted Sandoz’s biologics license application (BLA) for its proposed biosimilar denosumab. The human monoclonal antibody denosumab has been designed to bind to osteoclasts activator, RANKL protein.

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Packaging Packaging Medicine Licensing 130

pharmaphorum

JANUARY 7, 2022

AstraZeneca has clearly made the rare disease transthyretin amyloidosis (ATTR) a key component of its rare disease pipeline, licensing a second drug candidate in the space of a couple of months. Tafamidis is thought to work by stabilising the misfolded proteins. The new agreement comes just days after AZ closed a $3.1

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pharmaphorum

JULY 8, 2022

Swedish rare disease specialist Sobi is paying $55 million upfront to license rights to ADC Therapeutics’ lymphoma therapy Zynlonta – approved in the US last year – in Europe and other international markets. The post Sobi bolsters blood division via $435m ADC licensing deal appeared first on.

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XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. What Is a Surrogate Endpoint?

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The Pharma Data

JANUARY 6, 2021

CAMBRIDGE, England & WETHERBY, England–( BUSINESS WIRE )– Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer ® and pre|CISION platforms, is pleased to announce that it has entered into a license agreement with POINT Biopharma Inc.

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pharmaphorum

JUNE 21, 2022

Armed with new phase 3 data, AstraZeneca is preparing to file for regulatory approval of eplontersen, an antisense drug for one of the complications of the disease transthyretin amyloidosis (ATTR) it licensed from Ionis in a $3.6 billion deal last year. In its favour is the potential for less frequent dosing, at least in ATTR polyneuropathy.

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pharmaphorum

APRIL 21, 2022

” Alpha-synuclein is a protein that gets misfolded and clumps together in the brains of patients with Parkinson’s and other diseases collectively known as synucleinopathies. AZ/Takeda are meanwhile running phase 2 trials of their MEDI 1342 antibody candidate. billion.

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The Pharma Data

NOVEMBER 3, 2020

The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to fund development of a potential COVID-19 vaccine from China’s Clover Biopharmaceuticals with a global phase 2/3 study and through licensing and distribution. million for an initial trial of SCB-2019 in Australia that enrolled 150 participants.

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Vaccine Vaccination Trials Licensing 52

The Pharma Data

JULY 22, 2021

(NYSE: PFE) today announced a global collaboration to develop and commercialize ARV-471, an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor protein degrader. The estrogen receptor is a well-known disease driver in most breast cancers. Chief Executive Officer at Arvinas. Terms of the Collaboration.

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pharmaphorum

MARCH 8, 2021

The combination of bamlanivimab and etesevimab was granted an emergency use authorization (EUA) by the FDA last month, and the CHMP decision means that EU states can now consider their own emergency licensing for the treatment.

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pharmaphorum

APRIL 8, 2022

billion licensing agreement with Werewolf Therapeutics that adds its first immuno-oncology candidate. As it is in the very early stages Jazz’s licensing deal is heavily back-weighted, but does include $1.26 Jazz Pharma has bolstered its pipeline of cancer drugs through a $1.3 Image by Lukas Bieri from Pixabay .

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XTalks

FEBRUARY 19, 2024

The team used the data and patient samples from a gB/MF59 Phase II trial in adolescent girls as a benchmark to assess the new mRNA-based vaccine. The comparison is particularly important as gB/MF59 demonstrated promise in Phase II clinical trials but did not advance to Phase III.

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The Pharma Data

OCTOBER 27, 2021

NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433. synuclein protein, mainly in oligodendroglial cells (glial cytoplasmic inclusions) and also in certain nerve cells.

Licensing 52

Licensing Licensing Drugs Development 52

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Clinical Trials Clinical Trials Vaccine Vaccination 76

pharmaphorum

AUGUST 16, 2020

ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing. Those deals cover 200 million doses of J&J’s Ad26.COV2.S

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pharmaphorum

JULY 18, 2022

Convidencia’s injectable version was granted World Health Organization (WHO) Emergency Use Listing (EUL), and its inhalant counterpart, currently in phase three clinical trials, has shown enormous promise. CanSinoBIO’s inhalant has finished phase three trials in China and is presently undergoing trials in several countries.

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pharmaphorum

MARCH 31, 2021

Novartis has added to its pipeline of radiopharmaceuticals pipeline once again, licensing a series of agents from iTheranostics that can be used to show where tumours are located in the body. . billion to buy targeted radioligand therapy Lu-PSMA-617 from Endocyte , shortly after encouraging results in a phase 2 prostate cancer trial.

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Licensing Licensing Gene Therapy Sales 98

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio.

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Clinical Trials Clinical Trials Vaccine Vaccination 52

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

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Clinical Trials Clinical Trials Vaccine Vaccination 52

pharmaphorum

DECEMBER 8, 2020

Its approach involves licensing rights to the antibodies to other pharma companies, rather than bringing its own candidates through development. Bamlanivimab is directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.

Drugs 111

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XTalks

APRIL 3, 2024

The RBCs in circulation are marked by proteins in the complement system for removal by the spleen and liver. Voydeya’s FDA approval was based on positive results from the pivotal ALPHA Phase III trial. In the trial, the most common adverse events were headache, nausea, arthralgia (joint stiffness) and diarrhea.

FDA Approval 102

FDA Approval Sales Trials Development 102

Delveinsight

AUGUST 13, 2020

Researchers call out Gilead over the diversity of remdesivir trials. Researchers have challenged the sponsors of COVID-19 clinical trials to run more diverse studies. Roche was preparing to commence another combination trial in lymphoma patients when it withdrew the study before enrolling in the first subject in 2018.

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pharmaphorum

OCTOBER 27, 2021

Eli Lilly has followed through on its plan to file for approval of its Alzheimer’s disease candidate donanemab, and is planning to take on Biogen and Eisai with a head-to-head trial against their recently-approved Aduhelm drug. Cortexyme trial disappoints. gingivalis detectable in their saliva at the start of the trial.

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The Pharma Data

AUGUST 17, 2020

. (“Dragonfly”), today announced that they have entered into a definitive agreement under which Bristol Myers Squibb will be granted the global exclusive license to Dragonfly’s interleukin-12 (IL-12) investigational immunotherapy program, including its extended half-life cytokine DF6002.

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