Delveinsight

SEPTEMBER 28, 2021

Innovent, UNION Therapeutics Set to Advance Dermatology Market in China. Innovent Biologics and UNION therapeutics have announced a strategic and licensing collaboration to develop and commercialize Orismilast , a next-generation PDE4 inhibitor for inflammatory dermatology conditions in China.

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Drug Discovery World

MARCH 13, 2024

“Data from the FRONTIER 2 study showed that the skin clearance as seen by PASI 75 and higher-bar PASI 90 and 100 responses at 16 weeks was maintained at 52 weeks with no new safety signals across all JNJ-2113 treatment groups,” said Dr Laura Ferris, Professor of Dermatology, University of Pittsburgh.

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pharmaphorum

OCTOBER 5, 2022

Sanofi has added to its rare disease pipeline by licensing an antibody-RNA conjugate (ARC) for facioscapulohumeral muscular dystrophy (FSHD), a genetic muscle disorder, from US biotech miRecule. billion deal in 2018. The aim will be to identify promising candidates in areas of “unmet patient need.”

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pharmaphorum

JUNE 2, 2021

Amgen has made a play in a hot area of immunology R&D, paying $400 million upfront to claim rights to an OX40-targeting drug from Kyowa Kirin that is ready for phase 3 testing for atopic dermatitis or eczema. . Kyowa will co-promote the drug in the US if approved, with opt-in rights in some other countries as well.

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pharmaphorum

MAY 25, 2022

Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims could be a game-changer in the treatment of the skin disorder. The post Dermavant claims its first approval as FDA clears psoriasis drug appeared first on.

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The Pharma Data

APRIL 6, 2021

Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for baricitinib for the treatment of adults with moderate to severe atopic dermatitis (AD). The Prescription Drug User Fee Act (PDUFA) action date has been extended three months to early Q3 2021.

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Drug Discovery World

OCTOBER 7, 2022

The MHRA has granted marketing authorisation for Eli Lilly’s baricitinib (Olumiant), the first licensed JAK inhibitor for the treatment of severe alopecia areata in adult patients. . This is an important authorisation for patients as previously there has never been a licensed oral therapy for adults with severe alopecia areata.” .

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The Pharma Data

MARCH 27, 2022

Food and Drug Administration (FDA) granted priority review for OLUMIANT in severe AA as a potential first-in-disease medicine. associate professor of dermatology at Yale School of Medicine and lead author of these analyses. OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly.

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Drug Discovery World

SEPTEMBER 16, 2022

The study, published in The Lancet showed that the drug reduced skin itch and pain within two weeks, as well as improving patients’ sleep, and the quality of life of patients and their parents. The post First biologic therapy for young children with severe eczema appeared first on Drug Discovery World (DDW).

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Druggist

MARCH 17, 2021

Lymecycline is a drug, which belongs to a group of tetracycline antibiotics. Lymecycline is usually prescribed as a generic drug – lymecycline 408mg capsules or occasionally as a branded medication called Tetralysal 300 mg capsules. Both drugs are the same medicines. Why is lymecycline used in the treatment of acne?

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Bacteria Dermatology Doctors Doctor 59

The Pharma Data

AUGUST 16, 2021

Food and Drug Administration (FDA) has granted Fast Track designation to lebrikizumab for moderate-to-severe AD in adult and adolescent patients (aged 12 to less than 18 years of age and weighing at least 40 kg). . About Lilly in Dermatology. 1-4 The U.S. About Atopic Dermatitis. Skin-related diseases are more than skin deep.

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pharmaphorum

APRIL 26, 2021

UK biotech Avillion has reported positive mid-stage results with chronic psoriasis drug sonelokimab, which it is developing with Merck KGaA as an alternative to drugs like Novartis’ Cosentyx. . The drug is a nanobody, a molecule around one-tenth the size of a regular antibody derived from camelid species such as the llama.

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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.

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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). a wholly owned subsidiary of Kyowa Kirin Co.,

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The Pharma Data

AUGUST 17, 2021

An experienced leader in drug development who has led and grown Lilly’s oncology business over the past several years, White will be responsible for Lilly’s launched products and Phase 3 portfolio in pain and neurodegeneration, including the potential launch of donanemab for the treatment of Alzheimer’s disease.

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The Pharma Data

JUNE 7, 2022

With these data, Lilly plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lebrikizumab in AD in the second half of 2022, followed by submissions to other regulatory agencies around the world. Almirall S.A.’s ’s Chief Scientific Officer.

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The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). Pfizer Inc. NYSE: PFE) today announced that the U.S.

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Druggist

DECEMBER 9, 2020

Skin itchiness caused by drugs. Clobetasone has a narrow licensed use. It contains a combination of miconazole (an antifungal drug) and hydrocortisone 1% (steroid). Dactacort has also antibacterial properties and is one of few over the counter creams licensed for bacterial infections. How is skin itch managed? Chickenpox.

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Olympian Clinical Research

AUGUST 19, 2022

Biologic drugs that are created from living cells and target a specific part of the immune system. The Benefits of Clinical Research for Pediatric Dermatology Conditions. These studies are done under the supervision of a licensed physician and are conducted with the safety of participants in mind.

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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. He has in depth Global Development Expertise (e.g. We are delighted to have Dr. Graham join the Tiziana team.

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The Pharma Data

NOVEMBER 4, 2020

Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., License and research and development revenue. .

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The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval for patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, based on data showing an ORR of 40 percent (95 percent CI, 29 – 51) and median duration of response of 11.1 Dermatologic Adverse Reactions 7. of patients.

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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.

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The Pharma Data

AUGUST 1, 2021

The approval by the Food and Drug Administration (FDA) was based on efficacy and safety data from the Saphnelo clinical development programme, including two TULIP Phase III trials and the MUSE Phase II trial. The option for Medarex to co-promote the product expired on its acquisition by Bristol-Myers Squibb (BMS) in 2009.

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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. [vii] JEMPERLI was discovered by AnaptysBio and licensed to TESARO, Inc.,

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XTalks

MAY 22, 2023

Allergan Aesthetics, an AbbVie company renowned for its development of leading aesthetics brands and products, recently announced the US Food and Drug Administration (FDA) approved their ground-breaking hyaluronic acid product, SkinVive by Juvéderm, for achieving remarkable skin smoothness.

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The Pharma Data

MAY 18, 2021

This business developed positively in the Europe/Middle East/Africa region and in Latin America, partly as a result of higher prices, whereas it shrank in North America, in part due to a license expiration. In the United States, the division benefited particularly from the launch of the cancer drug Nubeqa™. percent) due to competition.

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pharmaphorum

JUNE 8, 2021

Dermavant is in line to make some big payments to GlaxoSmithKline if its topical psoriasis drug tapinarof reaches the market, and it has just cut a deal to defray those costs. billion takeover of Constellation Pharma.

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XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. billion the drug generated in 2021. billion in 2022. billion, a 26.55

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The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. WAKEFIELD, Mass., in July 2019, who have recently initiated a Phase 1 study with their formulation.

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The Pharma Data

AUGUST 3, 2021

We expect that recovery in the dermatology segment will continue to progress over the coming quarters. In July, the FDA accepted the Biologics License Application and granted Priority Review for tezepelumab for the treatment of asthma. The FDA has assigned a Prescription Drug User Fee Act action date of December 19, 2021.

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The Pharma Data

JANUARY 24, 2021

The drug appears to inhibit IL-6, IL-1beta, TNF-alpha and other pro-inflammatory cytokines and chemokines. The drug did not differ statistically from placebo at 48 weeks on the prespecified co-primary endpoints on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 and the Clinical Dementia Rating Scale Sum of Boxes.

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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). 1 The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the first quarter of 2022.

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The Pharma Data

MARCH 4, 2021

Food and Drug Administration (FDA) for the treatment of AA. associate professor of Dermatology at Yale School of Medicine. AA is the second potential treatment indication in dermatology for baricitinib after AD. ” Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly.

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The Pharma Data

APRIL 26, 2021

COVID-19 negatively impacted demand, particularly: dermatology, ophthalmology, the breast cancer portfolio, Sandoz Retail and Anti-Infectives. billion declined, mainly due to the USD 650 million upfront payment to in-license tislelizumab from BeiGene. Adakveo sales reached USD 37 million. Free cash flow¹ of USD 1.6 Financials.

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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. A Phase 2 proof-of-concept study of Pfizer’s potential first-in-class pentavalent meningococcal vaccine candidate (Penta; MenABCWY).

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Delveinsight

AUGUST 13, 2020

In October 2019, GSK filed a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking an additional indication for Trelegy Ellipta for the treatment of asthma in adults. The drug is available for patients with COPD. for use in QVM149 (Worldwide excluding US).

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