pharmaphorum

DECEMBER 23, 2022

The FDA has given a green light to Roche’s CD20xCD3 bispecific antibody Lunsumio as a treatment for relapsed or refractory follicular lymphoma, following the lead of the European Commission which cleared the drug in June. Some analysts agree, pitching peak sales at $2 billion or more.

Antibody 97

Antibody Sales Drugs Trials 97

Pharmaceutical Technology

MARCH 10, 2023

Pharmaceutical and biotechnology industries widely use freeze-drying systems to protect vaccines, antibodies, antibiotics such as penicillin, blood plasma, proteins, enzymes, hormones, viruses, and bacteria from heat and minimise their biological activity. The process eliminates the disadvantages of conventional drying methods or freezing.

Manufacturing 147

Manufacturing Production Containment Antibody 147

BioPharma Reporter

MARCH 14, 2023

The expanded antibody-drug conjugate (ADC) collaboration includes up to $2.2bn in total potential payments plus tiered royalties on net sales.

Sales 52

Sales Antibody Drugs Regulation 52

pharmaphorum

OCTOBER 24, 2022

The study enrolled patients who were still experiencing residual anaemia despite prior treatment with anti-C5 antibodies, making them fatigued and in some cases needing transfusions to prop up red blood cell levels. Analysts at Jefferies have previously said that iptacopan could hit $3.6 “Practice-changing” Shreeram Aradhye.

Trials 78

Trials Drugs Antibody Sales 78

XTalks

FEBRUARY 5, 2024

The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research. Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. Price of Revlimid: A supply of 28 oral 2.5 mg capsules is $24,576.

FDA Approval 101

FDA Approval Drugs Sales Development 101

pharmaphorum

NOVEMBER 22, 2022

GSK had great expectations for Blenrep, which was approved in 2020 for multiple myeloma patients who have received at least four prior therapies – including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

Marketing 104

Marketing Trials Antibody Clinical Trials 104

pharmaphorum

AUGUST 15, 2022

At this year’s ASCO congress, the Trop2-targeting antibody-drug conjugate (ADC) was found to improve progression-free survival significantly in in patients with hormone receptor-positive, HER2-negative metastatic breast cancer who received multiple lines of prior treatment.

HR 77

HR Hormones Sales Antibody 77

pharmaphorum

JULY 29, 2021

The FDA has started a priority review of Roche’s bispecific antibody faricimab for two major causes of blindness, preparing for a market showdown with Bayer and Regeneron’s market-leading Eylea. Beovu launched in October 2019 in the US with sales predictions of $2.5 billion in sales for Roche last year and $1.9

Drugs 98

Drugs Sales Marketing Antibody 98

pharmaphorum

DECEMBER 23, 2021

The US regulator issued Novartis with a complete response letter (CRL) for inclisiran a year ago, citing “unresolved facility inspection-related conditions” at a third-party manufacturing site run by Corden Pharma near Milan, Italy. It will be launched in the US in January, said Novartis. It has a long way to go.

Drugs 104

Drugs Sales Antibody FDA Approval 104

pharmaphorum

JULY 25, 2022

AstraZeneca and Daiichi Sankyo will hear back from the FDA before the end of 2022 on their license application for Enhertu in HER2-low breast cancer – an indication which could drive the drug into multibillion-dollar sales territory.

Sales 57

Sales Regulation Licensing Licensing 57

Drug Discovery World

NOVEMBER 13, 2023

Ahead of protein and antibody engineering conference PEGS Europe 2024 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting. Hiroki Shirai, PhD, Coordinator, RIKEN Center for Computational Science, on: ‘Applying deep learning anomaly detection to antibody structures’.

Protein 59

Protein Antibody Engineer Scientist 59

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. and around the world.

Antibody 52

Antibody Clinical Trials Clinical Trials Manufacturing 52

pharmaphorum

JANUARY 29, 2023

The EU regulator’s Committee for Medicinal Products for Human Use (CHMP) said it will “assess the impact of these findings on the balance of benefits and risks of Adakveo” and the impact on its conditional approval, which was granted in 2020.

Genotype 52

Genotype Trials Antibody Regulation 52

pharmaphorum

DECEMBER 29, 2021

Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. It continues to grow strongly with Sanofi reporting a 53% rise in sales to more than $4.1 billion in the same year. billion in 2020. billion in 2020.

Sales 109

Sales Dermatology Marketing Allergies 109

pharmaphorum

APRIL 19, 2022

The US regulator has kicked off a priority review of Enhertu (trastuzumab deruxtecan) as a treatment for NSCLC with HER2 mutations after prior systemic therapy, setting up a decision in the third quarter of this year. billion licensing deal for the drug in 2019. That was more than double the amount made in the previous year.

Sales 104

Sales Licensing Licensing Drugs 104

pharmaphorum

MARCH 28, 2022

GlaxoSmithKline and Vir’s Xevudy has become the latest COVID-19 antibody therapy to have its use restricted by the FDA as a result of waning activity against new variants of the virus. 2, and would be sharing these data with regulators around the world. 2 subvariant of Omicron. Previously, when the original BA.1

Antibody 52

Antibody Immune Response Regulation Sales 52

pharmaphorum

MAY 31, 2022

The US regulator has granted Dupixent (dupilumab) a six-month priority review in PN and is due to deliver a verdict by 30 September, offering patients hope of a first-approved therapy for the highly-debilitating disease. billion) a year and some analysts predicting levels could go as high as $12.5

Sales 113

Sales Drugs Antibody Regulation 113

pharmaphorum

AUGUST 19, 2020

The success of AbbVie’s Humira (adalimumab), which peaked at almost $20 billion in sales in 2018, demonstrates the potential of inflammatory diseases drugs to make mega-bucks. per share is expected to close in the second half of 2020, subject to clearance by US antitrust regulators. The transaction valuing Momenta at $52.50

Antibody 104

Antibody Drugs Sales Protein 104

XTalks

FEBRUARY 5, 2024

The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research. Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. Price of Revlimid: A supply of 28 oral 2.5 mg capsules is $24,576.

FDA Approval 52

FDA Approval Drugs Sales Development 52

pharmaphorum

AUGUST 26, 2022

The US biotech claimed conditional marketing approval from the European Commission for Roctavian (valoctocogene roxaparvovec) as a treatment for adults with severe haemophilia A, who don’t have a history of developing the antibodies that inhibit the activity of blood-clotting protein Factor VIII.

Gene Therapy 109

Gene Therapy Gene Antibody Marketing 109

pharmaphorum

JULY 22, 2021

Aduhelm’s accelerated approval using clearance of amyloid plaques as a surrogate marker for efficacy has been driving that speculation , with Jefferies predicting an expedited review for the drug earlier this month and sales of up to $6 billion if approved. “Let’s keep fingers crossed,” he said. billion ($17.2

Drugs 52

Drugs Sales Antibody Regulation 52

pharmaphorum

AUGUST 4, 2021

Bristol-Myers Squibb’s HDAC inhibitor Istodax has been on the US market for a decade as a treatment for peripheral T-cell lymphoma (PTCL), but will now be withdrawn from sale after a failed phase 3 trial. The latter got an accelerated okay for newly-diagnosed patients in combination with chemotherapy in 2018.

FDA Approval 98

FDA Approval Trials Sales Marketing 98

pharmaphorum

JANUARY 24, 2022

The regulator said that Veklury could be provided to eligible patients “at skilled nursing facilities, home healthcare settings and outpatient facilities such as infusion centres.” ” It would have to be delivered as a daily intravenous infusion in these outpatient setting over three days.

Nurses 97

Nurses Sales Antibody Regulation 97

pharmaphorum

MARCH 9, 2022

Sanofi and Sobi’s haemophilia partnership has been under competitive pressure from new therapies like Roche’s antibody Hemlibra, so the two companies are hoping a new long-acting drug candidate can revitalise the franchise. Sanofi recorded a $2 billion charge in 2019 that it said was largely down to pressure on its drug.

Sales 98

Sales Protein Gene Therapy Regulation 98

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. billion in pharmaceutical sales from 2021. In contrast, several drugs experienced sale declines, such as Remicade (infliximab), an old immunology medication that continues to decline due to the rise of biosimilars since 2016.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

pharmaphorum

JULY 6, 2021

The US regulator issued Novartis with a complete response letter (CRL) for inclisiran in December, citing “unresolved facility inspection-related conditions” at a third-party manufacturing site run by Corden Pharma near Milan, Italy. Analysts at EvaluatePharma have suggested it could make $2 billion a year in 2026.

RNA 104

RNA Manufacturing Sales Marketing 104

pharmaphorum

AUGUST 15, 2022

The new version – dubbed Spikevax Bivalent Original/Omicron – has been given conditional authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) based on phase 2/3 trial data, which showed it was better at stimulating neutralising antibodies against BA.1 1 candidate to regulators in Europe last month.

Vaccination 109

Vaccination Vaccine Antibody Regulation 109

pharmaphorum

OCTOBER 30, 2022

The ODAC agreed with the regulator’s assessment, leaving Y-mAbs waiting for the FDA’s decision on the license application for omburtamab – due by 30 November – with very little hope of a positive outcome. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.

Trials 52

Trials Drugs Antibody Clinical Trials 52

pharmaphorum

JULY 7, 2021

The complete response letter (CRL) for teplizumab as a treatment to delay clinical type 1 diabetes in at-risk individuals reiterates the FDA’s concerns around the pharmacokinetics (PK) data for the antibody.

Drugs 98

Drugs Insulin Contract Manufacturing Antibody 98

Delveinsight

OCTOBER 1, 2021

This disease is associated with antibodies directed against the acetylcholine receptor, muscle-specific kinase (MUSK), lipoprotein-related protein 4 (LRP4), or agrin in the postsynaptic membrane at the neuromuscular junction. The latter are Anti-Acetylcholine Receptor (AChR) antibody-positive. It was first launched in Japan in 2011.

Marketing 85

Marketing Antibody Drugs Sales 85

pharmaphorum

SEPTEMBER 14, 2020

US-based Merck, known as MSD outside North America, will globally develop and market Seattle’s investigational antibody-drug conjugate (ladiratuzumab vedotin). MSD will be responsible for ex-US filings including Europe and will record sales outside the US, Europe, and Canada.

Genetics 52

Genetics Development Drugs Sales 52

pharmaphorum

JULY 21, 2021

Novartis has revealed that the FDA has accepted its resubmission for cholesterol-lowering drug Leqvio – rejected unexpectedly by the US regulator last year – and has set a new action date of 1 January 2022. Meanwhile, sales of gene therapy Zolgensma for spinal muscular atrophy shot up more than 50% to $315 million.

Sales 52

Sales Gene Therapy RNA Production 52

pharmaphorum

JUNE 9, 2022

mRNA-1273.214 stimulated almost twice the neutralising antibody levels against the Omicron strain than Spikevax , with a significantly higher response also seen against other variants of concern, one month after administration, according to the company. It has predicted sales of COVID-19 vaccines will be around $21 billion this year.

Vaccination 104

Vaccination Vaccine Containment Clinical Trials 104

pharmaphorum

APRIL 30, 2021

The company posted Q1 product sales of $7.26bn, ahead of consensus forecasts of around $6.84 Oncology continues to be AZ’s strong suit with sales of cancer med Tagrisso increasing by a reported 17% to $1.15 billion, with total revenues up 15% compared with last year’s Q1 to $7.3bn.

Sales 70

Sales Vaccination Vaccine Antibody 70

pharmaphorum

FEBRUARY 13, 2022

Eli Lilly has been granted an emergency use authorisation from the FDA for bebtelovimab, its second COVID-19 antibody drug and a rival to GlaxoSmithKline and Vir Biotech’s fast-growing Xevudy. Lilly recorded more than $2.2 Meanwhile, Regeneron made $6.2 billion from REGEN-COV during 2021.

Drugs 52

Drugs Antibody Sales Regulation 52

pharmaphorum

JANUARY 9, 2023

The US regulator has granted accelerated approval to anti-amyloid therapy Leqembi (lecanemab) with a fairly broad label to treat patients in the mild cognitive impairment or mild dementia stage of disease who have confirmed presence of amyloid pathology.

Drugs 98

Drugs Sales Clinical Trials Clinical Trials 98

pharmaphorum

APRIL 20, 2021

Novartis has secured backing from NICE for its relapsing multiple sclerosis (RMS) therapy Kesimpta in the UK, just two weeks after the drug was approved by the national drugs regulator. . billion in sales in 2028. billion by 2028. While it requires a clinic visit, Ocrevus only has to be administered twice a year.

Sales 109

Sales Medicine Drugs Marketing 109