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. Sales have been modest to date – just £36 million in the third quarter – despite it being the first drug targeting BCMA to reach the market.

Marketing 105

Marketing Trials Antibody Clinical Trials 105

Pharmaceutical Technology

APRIL 13, 2023

Biogen opted into Denali’s Antibody Transport Vehicle (ATV): Amyloid beta programme (ATV: Aβ) as part of a binding agreement signed by the companies in 2020, to co-develop and co-commercialise Denali’s small molecule inhibitors of leucine-rich repeat kinase 2 (LRRK2) for Parkinson’s disease.

Licensing 130

Licensing Licensing Antibody Clinical Trials 130

Pharmaceutical Technology

MAY 19, 2023

In a January presentation, the company shared that approvals in additional indications would allow Rinvoq and Skyrizi, a monoclonal antibody, to gain peak share in the different markets, including inflammatory bowel disease. In patients with severe symptoms, a dosage of 30mg can be considered.

FDA Approval 264

FDA Approval Dermatology Sales Clinical Trials 264

World of DTC Marketing

APRIL 11, 2021

Both Pfizer and Moderna stand to make billions, and even though J&J said they would not make money on the first batch, they are already positioning yearly Covid Vaccine shots that could net them billions in sales. Antibody tests indicate you had a previous infection and that you may have some level of protection against the virus.

Vaccination 303

Vaccination Vaccine Clinical Trials Clinical Trials 303

pharmaphorum

OCTOBER 24, 2022

Novartis has chalked up another clinical trial win for its targeted factor B inhibitor iptacopan as it strives to position the drug as a patient-friendly, oral alternative to big-selling injectable rivals. The post Novartis’ oral drug iptacopan tops injectables in head-to-head PNH trial appeared first on.

Trials 79

Trials Drugs Antibody Sales 79

pharmaphorum

MARCH 15, 2022

Sanofi has agreed a deal with life sciences investor Blackstone to help fund clinical trials of a new formulation of Sarclisa for blood cancer multiple myeloma, accelerating its development. In return, it will get a royalty on sales if the new version gets approved.

Trials 93

Trials Sales Drug Delivery Antibody 93

pharmaphorum

OCTOBER 18, 2022

Gilead Sciences has made yet another rush into the oncology category, licensing a bispecific antibody from MacroGenics in development as a treatment for CD123-positive blood cancers, including acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS). Along with the signing fee, there is another $1.7 It brought in $4.7

Antibody 52

Antibody Sales Clinical Trials Clinical Trials 52

pharmaphorum

JUNE 23, 2021

GlaxoSmithKline’s pitch to shareholders kicked off this afternoon with an optimistic view of its late-stage pipeline – including some big sales predictions for products like its respiratory syncytial virus (RSV) vaccine and new blood cancer drug Blenrep. billion takeover of Tesaro in 2019. £1 mRNA ambitions.

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Sales Vaccination Vaccine Drugs 89

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. These two molecules are presently being analysed by the research and development (R&D) team of Sanofi, with one currently being evaluated in clinical trials.

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Development Engineer Clinical Trials Clinical Trials 264

Pharmaceutical Technology

AUGUST 16, 2022

According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Under the agreement, Horizon will hold an option for the acquisition of the ADX-914 programme, which is exercisable through a period after concluding the Phase II trials.

Development 130

Development Clinical Trials Clinical Trials FDA Approval 130

The Pharma Data

JANUARY 17, 2021

The treatment is based on the Grifols immunoglobulin Gamunex®-C, and contains anti-SARS-COV-2 polyclonal antibodies from plasma donors who have recovered from COVID-19. It could also be given to immunocompromised patients for whom the vaccination isn’t indicated. BARCELONA, Spain , Jan.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Containment 52

XTalks

DECEMBER 10, 2021

Biohaven Pharmaceuticals revealed positive top line results from a late-stage trial which show that its migraine medication Zavegepant provides “ultra-rapid” pain relief in just 15 minutes. Zavegepant is an antibody drug that prevents binding of the calcitonin gene-related peptide (CGRP) to the CGRP receptor.

FDA Approval 98

FDA Approval Trials Drugs Sales 98

pharmaphorum

JANUARY 27, 2023

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. In fact, Evusheld is following the same trajectory as other COVID-19 antibodies.

Antibody 135

Antibody Sales Clinical Trials Clinical Trials 135

Pharmaceutical Technology

MAY 25, 2023

Yuflyma is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody. As a leading global biopharmaceutical company, we are leveraging our unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to expand the availability of high-quality biosimilars for US patients.”

FDA Approval 130

FDA Approval Packaging Packaging Clinical Trials 130

pharmaphorum

JANUARY 29, 2023

One of the Johnson & Johnson’s top clinical trial readouts for 2023 just generated results, which bode very well for the future prospects of multiple myeloma CAR-T Carvykti. The post Trial sets up earlier use of J&J’s Carvykti in myeloma appeared first on.

Trials 64

Trials Sales Antibody Clinical Trials 64

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.

Licensing 147

Licensing Licensing Sales Trials 147

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis). log 10 copies/mL for combined doses).

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

AUGUST 20, 2020

. Roche and Regeneron have joined forces in the fight against COVID-19 to develop, manufacture and distribute REGN-COV2, the latter’s investigational antiviral antibody combination, to people around the globe. Source link.

Antibody 52

Antibody Manufacturing Clinical Trials Clinical Trials 52

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.

Marketing 111

Marketing Sales Gene Editing Antibody 111

The Pharma Data

SEPTEMBER 17, 2020

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. The majority of current candidate vaccines aim to induce an antibody response against the spike protein. “As

Antibody 52

Antibody Vaccination Vaccine In-Vitro 52

Pharmaceutical Technology

JANUARY 19, 2023

While allogeneic hematopoietic stem cell transplants (HSCT) provide long-term benefit to a subset of AML patients, other cell therapy modalities such as natural killer (NK) cells or chimeric antigen receptor (CAR)-T cells have failed to show conclusive benefit in late-stage clinical trials.

Marketing 130

Marketing Gene Editing Production Sales 130

pharmaphorum

DECEMBER 23, 2020

AstraZeneca and Amgen looked on course to cruise to approval of their severe asthma drug tezepelumab with a pair of positive clinical trials, but the failure of a third threatens to derail the programme. billion in annual sales. The post AZ, Amgen’s asthma hope tezepelumab flunks phase 3 trial appeared first on.

Trials 52

Trials Clinical Trials Clinical Trials Antibody 52

Pharmaceutical Technology

JUNE 6, 2023

According to Globaldata, it is involved in 1 clinical trial, which is ongoing. Applying the drug’s phase transition success rate to remaining R&D costs and likelihood of approval (LoA) to sales related costs provides a risk-adjusted NPV model (rNPV). Buy the model here.

RNA 100

RNA Protein Antibody Vaccination 100

Delveinsight

JULY 28, 2020

AstraZeneca has inked an oncology deal with Daiichi Sankyo to jointly develop and commercialize an antibody-drug conjugate DS-1062 (trastuzumab deruxtecan), worldwide except in Japan. In return, AZ gets to be an equal shareholder of the profits on the sale of the drug conjugate. Daiichi holds exclusive rights to the drug in Japan.

Gene Therapy 52

Gene Therapy Trials Gene Vaccination 52

pharmaphorum

JULY 13, 2021

The Danish drugmaker is paying $100 million upfront for rights to antibody drug PRX004, which is heading for phase 2 trials in cardiomyopathy associated with ATTR amyloidosis, a life-threatening disease affecting the heart and nervous system. According to analysts at GlobalData – sales are set to rocket to $3.5 billion by 2025.

Gene Silencing 98

Gene Silencing Sales Gene Editing Clinical Trials 98

pharmaphorum

JANUARY 13, 2022

Sanofi has joined a growing list of drugmakers going after alpha-synuclein targeting drugs for Parkinson’s disease, licensing a bispecific antibody from South Korea’s ABL Bio in a deal that could be worth more than $1 billion. An AbbVie antibody called ABBV-0805 successfully cleared a phase 1 trial but seems to have been shelved.

Antibody 95

Antibody Drugs Protein Licensing 95

The Pharma Data

APRIL 12, 2023

Program uses Denali’s Antibody Transport Vehicle (ATV) technology to cross the blood-brain barrier (BBB) and aims to increase target engagement Biogen Inc. Nasdaq: DNLI) today announced that Biogen has exercised the option to license Denali’s Antibody Transport Vehicle (ATV): Amyloid beta program (ATV:Aβ).

Antibody 40

Antibody Development Engineer Licensing 40

The Pharma Data

AUGUST 18, 2020

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S.

Antibody 52

Antibody Clinical Trials Clinical Trials Manufacturing 52

pharmaphorum

DECEMBER 2, 2021

The UK medicines regulator has approved GlaxoSmithKline and Vir Biotech’s antibody for COVID-19, Xevudy, which has been shown to be effective against the new Omicron strain of SARS-CoV-2 in lab testing. The antibody was found to reduce the risk of hospitalisation and death by 79% in this patient group in a clinical trial.

Antibody 119

Antibody Regulation Clinical Trials Clinical Trials 119

The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. INDIANAPOLIS and THOUSAND OAKS, Calif. Reese , M.D.,

Antibody 52

Antibody Manufacturing Production Sales 52

pharmaphorum

OCTOBER 24, 2021

The green light comes on the back of the phase 3 ARCHWAY trial which showed that Susvimo was equivalent to monthly Lucentis injections at maintaining vision in patients over 40 weeks, with 98% of patients lasting six months before needing a refill. of patients in the clinical trial needed the additional dosing.

Sales 96

Sales Clinical Trials Clinical Trials Antibody 96

The Pharma Data

JANUARY 12, 2021

million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential U.S. Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021 , up to 1.25 TARRYTOWN, N.Y. , 12, 2021 /PRNewswire/ — . million doses.

Antibody 52

Antibody Production Manufacturing Clinical Trials 52

The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4

Antibody 40

Antibody Trials Production Clinical Trials 40

pharmaphorum

JANUARY 13, 2023

“I’m going to make a statement that could come back and bite me, but I think T-Cell therapies are going to be bigger than monoclonal antibodies,” AdaptImmune CEO Adrian Rawcliffe said at one session. Namely, who wants to be in a clinical trial for a drug that’s already in the market? The big difference?

Clinical Trials 98

Clinical Trials Clinical Trials Gene Therapy Trials 98

Pharmaceutical Technology

JUNE 6, 2023

XB-002 is a monoclonal antibody conjugated commercialized by Exelixis, with a leading Phase I program in Esophageal Squamous Cell Carcinoma (ESCC). According to Globaldata, it is involved in 1 clinical trial, which is ongoing. The drug candidate is a second generation antibody drug conjugate.

Antibody 100

Antibody Development Clinical Trials Clinical Trials 100

pharmaphorum

NOVEMBER 18, 2022

The US regulator has approved the anti-CD3 antibody as Tzield to delay the onset of stage 3 T1D in people eight years and older who currently have stage 2 disease, which according to the FDA “may provide patients with months to years without the burdens of disease.”

Drugs 52

Drugs FDA Approval Insulin Clinical Trials 52

pharmaphorum

JUNE 18, 2021

Japan’s Eisai has hit the jackpot with its first ever antibody-drug conjugate (ADC) drug candidate, attracting a licensing deal from Bristol-Myers Squibb that could top out at more than $3.1 antibody with cell-killing drug eribulin – sold on its own by Eisai as Halaven.

Antibody 98

Antibody Licensing Licensing Sales 98