The Pharma Data

JANUARY 12, 2021

Virology, Respiratory, Dermatology, Allergy, & Rheumatology) in early & late stage Clinical Development and in Medical Affairs, with a strong track record for Developing and Accelerating Phase I–IV programs. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world.

Life Science 52

Life Science Antibody In-Vivo In-Vitro 52

The Pharma Data

AUGUST 16, 2021

Lebrikizumab is a novel monoclonal antibody (mAb) that binds soluble IL-13 with high affinity, has high bioavailability, a long half-life and blocks IL-13 signaling. associate professor of dermatology at George Washington University School of Medicine and Health Sciences in Washington, DC, and a principal investigator of the ADvocate 2 trial.

Dermatology 40

Dermatology Trials Bioavailability Medicine 40

pharmaphorum

JUNE 2, 2021

The deal gives Amgen rights to the KHK4083 antibody in all countries except Kyowa’s home market of Japan, and is back-loaded with potential milestone payments worth another $850 million plus royalties on sales. Kyowa will co-promote the drug in the US if approved, with opt-in rights in some other countries as well.

Drugs 52

Drugs Licensing Licensing Sales 52

The Pharma Data

JUNE 7, 2022

1-2 Lebrikizumab is a novel, monoclonal antibody (mAb) that binds to the interleukin-13 (IL-13) protein with high affinity to specifically prevent the formation of IL-13R?1/IL-4R? With these data, Lilly plans to submit a Biologics License Application (BLA) to the U.S. Almirall S.A.’s ’s Chief Scientific Officer.

Trials 40

Trials Clinical Trials Clinical Trials Medicine 40

pharmaphorum

APRIL 26, 2021

Merck licensed sonelokimab (M1095) from Ablynx in 2013, and four years later formed a partnership with Avillion to carry out phase 2 and 3 testing of the drug. The drug is a nanobody, a molecule around one-tenth the size of a regular antibody derived from camelid species such as the llama.

Antibody 52

Antibody Drugs Marketing Licensing 52

pharmaphorum

MAY 4, 2021

There’s a new biotech on the scene after MoonLake Immunotherapeutics launched on a mission to develop sonelokimab, a potential inflammatory diseases drug in-licensed from Germany’s Merck KGaA. MoonLake has swiftly in-licensed the drug discovered by Sanofi’s Ablynx unit, with plans to develop the drug targeting IL-17A and F.

Licensing 52

Licensing Licensing Dermatology Antibody 52

The Pharma Data

MARCH 15, 2022

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc.,

Trials 52

Trials Medicine Licensing Licensing 52

The Pharma Data

AUGUST 17, 2021

This new indication follows an FDA priority review of the Biologics License Application and is based on the collective results from the dMMR endometrial cancer cohort A1 and the dMMR solid-tumour (non-endometrial cancer) cohort F of the ongoing GARNET trial. [i] JEMPERLI was discovered by AnaptysBio and licensed to TESARO, Inc.,

FDA Approval 52

FDA Approval Antibody DNA Hormones 52

pharmaphorum

MAY 25, 2022

The main problem is that the market for psoriasis therapies is very crowded – so much so that Eli Lilly abandoned plans to launch its antibody therapy mirikizumab for the skin disease and is focusing instead on inflammatory bowel disease. It’s also in clinical testing for atopic dermatitis or eczema, with results due next year.

Drugs 52

Drugs FDA Approval Licensing Licensing 52

The Pharma Data

AUGUST 1, 2021

Saphnelo is a first-in-class type I interferon receptor antibody and the only new medicine in over a decade for patients with systemic lupus erythematosus . Financial considerations AstraZeneca acquired global rights to Saphnelo through an exclusive license and collaboration agreement with Medarex, Inc.

Trials 52

Trials Clinical Development Antibody Dermatology 52

The Pharma Data

NOVEMBER 8, 2020

Almirall strengthens its leadership in medical dermatology by reinforcing its management team in France and obtaining reimbursement in France of Ilumetri ® (tildrakizumab) for treating moderate to severe chronic plaque psoriasis in adults. Dermatology shows resilience in Europe and initial signs of recovery in the US.

Dermatology 52

Dermatology Sales Marketing Production 52

The Pharma Data

AUGUST 3, 2021

We expect that recovery in the dermatology segment will continue to progress over the coming quarters. For the remainder of the year, we expect continued growth from Kyprolis use in combination with CD38 antibodies. Looking forward, we are preparing for the anticipated approval of the mild-to-moderate psoriasis indication in the U.S.,

Sales 52

Sales Production Antibody Development 52

XTalks

AUGUST 2, 2023

2) Darzalex (daratumumab) Darzalex is a targeted monoclonal antibody that slows or stops the progression of multiple myeloma (a blood cancer) by binding to the CD38 protein on multiple myeloma cells. The monoclonal antibody targets CD20, a protein found on the surface of B lymphocytes (B cells). billion in 2022, a 32.44

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

JANUARY 24, 2021

All participants randomized to receive either 4,200 mg of bamlanivimab, Lilly’s neutralizing antibody, or placebo. oncolytic virus (VVcopTK-RR-) and engineered to encode both a Treg-depleting human recombinant anti-CTLA4 antibody and the human GM-CSF cytokine. The drug was licensed from Immutep Limited. Non-COVID-19-Related.

Trials 52

Trials Allergies In-Vitro Antibody 52

The Pharma Data

JULY 8, 2021

AstraZeneca’s Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from the US Food and Drug Administration (FDA). Tezepelumab is being developed by AstraZeneca in collaboration with Amgen.

Trials 52

Trials Medicine Sales Clinical Trials 52

The Pharma Data

SEPTEMBER 15, 2020

The results demonstrated that Penta immune responses were robust and noninferior to licensed meningococcal vaccines (MenB and MenACWY) in individuals 10-25 years of age, regardless of prior MenACWY exposure. Clinical Phase 1/2 study results demonstrated never before observed fold rises of RSV neutralizing antibodies; a fold rise of 15.2

Gene Therapy 52

Gene Therapy Vaccination Vaccine Trials 52

Delveinsight

AUGUST 13, 2020

SAR440340 History: Regeneron and Sanofi are currently studying REGN3500 in respiratory and dermatological diseases where inflammation is thought to play an underlying role. Regeneron and Sanofi Genzyme are worth mentioning here, as they are presenting key poster of their Phase II therapy REGN3500 in moderate-to-severe asthma patients.

Antibody 40

Antibody Medicine Trials Development 40