pharmaphorum

DECEMBER 16, 2020

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.

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pharmaphorum

SEPTEMBER 30, 2020

Regeneron’s antibody cocktail seems to reduce levels of coronavirus and improve symptoms in patients, according to early test results. This first data comes from a descriptive analysis from the seamless phase 1/2/3 trial that Regeneron hopes will hurry the medicine dubbed REGN-COV2 to market. There were no deaths in the trial.

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Pharmaceutical Technology

FEBRUARY 8, 2023

The top 20 companies in the global biopharma industry saw 5.4%* aggregate market capitalization from $3.43 Pfizer maintained its third-place position in the market in 2022, reporting a market capitalization of $287.6 witnessed the biggest market capitalization growth of 45.3% trillion to $3.61 billion on Dec 31, 2022.

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Pharmaceutical Technology

JANUARY 13, 2023

Being co-developed and co-marketed by Daiichi Sankyo along with AstraZeneca , Enhertu is a specifically engineered HER2-directed antibody-drug conjugate (ADC). Enhertu’s safety profile was consistent with the previous clinical trials.

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Worldwide Clinical Trials

OCTOBER 14, 2024

With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world. One of the biggest hurdles in developing new therapies is recruiting diverse patients for clinical trials.

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pharmaphorum

NOVEMBER 22, 2022

GSK confirmed this morning that the disappointing readout from the DREAMM-3 trial of multiple myeloma therapy Blenrep reported earlier this month means that it will take the drug off the US market. The post GSK will pull Blenrep from US market after failed trial appeared first on.

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World of DTC Marketing

MARCH 16, 2021

IN BRIEF: As a marketer, most of us, like a Jungian archetype, are true Communicators. As a pharma marketer who has worked in many other therapeutic categories and recently on a Covid launch, I have become acutely aware of the interaction between national poles and the on-the-ground sentiment I have observed.

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Worldwide Clinical Trials

OCTOBER 14, 2024

With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world. One of the biggest hurdles in developing new therapies is recruiting diverse patients for clinical trials.

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pharmaphorum

OCTOBER 25, 2021

Expectations for Novartis’ canakinumab as a therapy for cancer have taken another dive, after a second phase 3 trial in non-small cell lung cancer (NSCLC) failed to meet its primary objectives. The post Strike two for Novartis’ lung cancer antibody canakinumab appeared first on.

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Pharmaceutical Technology

NOVEMBER 14, 2022

The antibody-drug conjugate (ADC) treatment is indicated for such patients who have previously received one to three systemic therapy regimens, irrespective of the usage of Avastin priorly. Elahere obtained the approval based on the findings on objective response rate (ORR) and duration of response (DOR) reported in the SORAYA clinical trial.

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Bio Pharma Dive

FEBRUARY 14, 2023

The British drugmaker will retain an interest in COVID antibody drug sotrovimab, which was withdrawn from the U.S. market, and a second treatment still in early-stage trials.

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Pharmaceutical Technology

MARCH 16, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for argenx’s Vyvgart (efgartigimod alfa-fcab) to treat generalised myasthenia gravis (gMG). The regulatory approval was based on the data obtained from the international Phase III ADAPT trial.

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pharmaphorum

OCTOBER 8, 2024

The stock rocketed 362% after the announcement, taking Scholar Rock's market cap above $2.7 Shares in Scholar Rock have gone into overdrive after the biotech reported positive phase 3 results with apitegromab in patients with spinal muscular atrophy (SMA), setting up regulatory filings in early 2025.The

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pharmaphorum

NOVEMBER 8, 2021

A single dose of the COVID-19 monoclonal antibody therapy developing Regeneron reduced the risk of contracting the virus by around 82% for up to eight months, according to new trial data. The post One dose of Regeneron’s COVID antibody protects for eight months appeared first on. That was down from almost $2.6

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Pharmaceutical Technology

AUGUST 25, 2022

The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency).

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pharmaphorum

OCTOBER 5, 2021

AstraZeneca has sought emergency use authorisation for its antibody combination AZD7442, following trial results indicating it can prevent symptomatic COVID-19 infection when given to healthy patients. The post AZ files for emergency use of COVID-19 antibody combo in US appeared first on.

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Pharmaceutical Technology

JULY 29, 2022

The company submitted the BLA based on positive data from various studies of the investigational therapy, including the Phase II/III QUILT 3.032 clinical trial underway. The open-label, three-cohort, multicentre trial analysed intravesical BCG, N-803 combination in BCG-unresponsive high-grade NMIBC patients.

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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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pharmaphorum

OCTOBER 28, 2020

Our goal is to ensure that Lilly antibody treatments are available to patients who need them, no matter where they live. “As As long as supply of neutralising antibodies is constrained, we believe the only way to ensure equitable access is for Lilly to contract directly with governments and pan-national philanthropic organisations. “As

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pharmaphorum

JULY 19, 2024

Less than two years after pulling multiple myeloma therapy Blenrep off most markets around the world, GSK has filed for approval of the drug in the EU once again, hoping to restore its blockbuster credentials.The remarkable renaissance for the BCMA-directed antibody-drug conjugate is supported by a pair of phase 3 trials that could not only support (..)

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World of DTC Marketing

APRIL 11, 2021

The CDC says “neither the recently authorized and recommended vaccines nor the other COVID-19 vaccines currently in clinical trials in the United States can cause you to test positive on viral tests , which are used to see if you have a current infection.? Plus, clinical trial settings aren’t always the same as real-world settings.

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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. month OS benefit compared to SOC chemotherapy in the DESTINY-Breast04 trial.

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Pharma Times

MAY 31, 2022

Antibody addresses high unmet medical need in rapidly growing kidney transplant market

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BioPharma Reporter

JULY 11, 2024

Amid a period of clinical holds and legal tangles, the US antibody specialist CytoDyn has reached a settlement to resolve legal disputes with its former contract research organization (CRO) Amarex Clinical Research.

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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. On choosing the candidate, the company will oversee the complete development, production and marketing.

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pharmaphorum

APRIL 9, 2021

The FDA says it has uncovered “deficiencies” in the marketing application for Provention Bio’s much-anticipated drug teplizumab for the prevention of type 1 diabetes (T1D) that could delay its review. The post Provention faces delay in FDA review of diabetes prevention antibody appeared first on.

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pharmaphorum

JULY 6, 2021

A peptide vaccine developed by Australia’s Imugene has reduced tumour size in around half of patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer in a phase 2 trial. ” The anti-HER2 market is advancing rapidly however, with a new generation of drugs coming through the industry pipeline.

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Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. Enhertu-treated subjects had a median overall survival (OS) of 23.4 months compared with 16.8

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Pharmaceutical Technology

AUGUST 12, 2022

The latest approval was based on the findings from the Phase II DESTINY-Lung02 clinical trial, which assessed the safety and efficacy of two doses of Enhertu in HER2 mutant metastatic NSCLC patients. . In the trial, 1.9% In the trial, 1.9% According to the interim efficacy data from a pre-specified patient cohort, a 5.4

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Pharmaceutical Technology

JUNE 29, 2022

The European Commission (EC) has granted marketing authorisation for Gilead Sciences’ subsidiary Kite’s CAR T-cell therapy, Yescarta (axicabtagene ciloleucel), to treat adults with relapsed or refractory follicular lymphoma (FL). . In the trial, 6% of the subjects had Grade ?3

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Pharmaceutical Technology

JANUARY 19, 2023

Acute myeloid leukemia (AML) is part of a market of blood malignancies that commercial cell therapies have not managed to penetrate yet. 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.

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pharmaphorum

FEBRUARY 25, 2021

The company announced a phase 1 trial is beginning of its nasal spray vaccine just as scientists in the UK said they are considering a similar approach. AZ already markets a nasal flu vaccine called FluMist, so the precedent is there, and the Oxford team is thinking of going down this route with its own research.

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Pharmaceutical Technology

JANUARY 27, 2023

All three treatments are monoclonal antibodies. While the occurrence and severity of side effects for Briumvi is comparable to other monoclonal antibodies available on the market, its approval still brings positive news for MS patients, due to its good efficacy in reducing disease progression.

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pharmaphorum

AUGUST 8, 2022

As we reported this morning, the deal gives Pfizer already-approved SCD therapy Oxbryta (voxelator) – which industry watchers reckon could see a dramatic uptick in sales with Pfizer’s marketing muscle – plus a phase 3 antibody candidate, a phase 1 follow-up to Oxbryta that could offer improved dosing.

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pharmaphorum

JANUARY 13, 2022

Preliminary data from an ongoing trial of AstraZeneca’s COVID-19 vaccine Vaxzevria has shown that a booster dose stimulates an increase in antibodies against Omicron, as well as other variants of the virus, including Alpha, Beta, Delta, and Gamma.

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Pharmaceutical Technology

MAY 19, 2023

Rinvoq is a major pillar in AbbVie’s plan to stem revenue drops once biosimilars to its behemoth Humira (adalimumab) enter the market on a sustained basis this year. AbbVie anticipates Rinvoq sales to exceed $7.5bn in 2025 and for the peak revenues from both drugs to exceed Humira’s peak sales by 2027.

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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.

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