pharmaphorum

JANUARY 4, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), seeking approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). This reduces the timeframe for the MAA to be reviewed.

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Marketing Antibody FDA Approval Medicine 98

pharmaphorum

DECEMBER 4, 2020

Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC). The post J&J files lung cancer bispecific amivantamab for FDA approval appeared first on.

FDA Approval 93

FDA Approval Sales Antibody Marketing 93

pharmaphorum

FEBRUARY 8, 2022

The FDA has dropped a bomb on Eli Lilly’s marketing application for cancer immunotherapy sintilimab ahead of an advisory committee meeting due to take place on Thursday. Lilly has a long history of developing oncology products, but missed the boat when the market started to shift towards cancer immunotherapies a few years back.

Antibody 52

Antibody Licensing Licensing FDA Approval 52

Delveinsight

AUGUST 17, 2021

FDA’s Green Flag to Keytruda and Lenvima combination by Merck and Eisai for Advanced renal cell carcinoma (RCC). The FDA approved the combination of Keytruda and Lenvima produced by Merck and Eisai, as a first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Global President, Vaccines, Pfizer.

FDA Approval 98

FDA Approval Medicine Vaccination Vaccine 98

pharmaphorum

NOVEMBER 10, 2021

The agreement includes a sizeable $500 million upfront payment, reflecting that Nurtec ODT (rimegepant) is already FDA-approved for treating acute migraine with and without aura in adults, and for prevention of episodic migraine in patients who suffer less than 15 headache days per month.

Licensing 52

Licensing Licensing Drugs Sales 52

pharmaphorum

APRIL 23, 2021

The FDA has approved GlaxoSmithKline’s Jemperli (dostarlimab) immunotherapy, a drug acquired through its $5.1 With Jemperli , a PD-1 class drug, GSK is a latecomer to the immunotherapy party with a host of other competitors already on the market in various cancers.

FDA Approval 52

FDA Approval Marketing Drugs Licensing 52

XTalks

FEBRUARY 29, 2024

In a statement , the company said it will discontinue Aduhelm to focus efforts on its other amyloid beta-directed antibody Leqembi (lecanemab) for Alzheimer’s and focus on developing other new treatments. After its accelerated approval in January 2023, Leqembi received full US Food and Drug Administration (FDA) approval in July 2023.

Drugs 59

Drugs FDA Approval Antibody Life Science 59

The Pharma Data

MAY 7, 2021

BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (together with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

Licensing 52

Licensing Licensing Vaccination Vaccine 52

Pharmaceutical Technology

MARCH 6, 2023

New data for TopAlliance Biosciences/ Coherus Biosciences’ anti-PD-1 monoclonal antibody Tuoyi (toripalimab) in combination with chemotherapy suggest that it can become the next standard of care in the frontline setting. Tuoyi received marketing authorisation in China for six oncology indications, including NPC, in December 2018.

HR 130

HR FDA Approval Licensing Licensing 130

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S.

FDA Approval 52

FDA Approval Vaccination Vaccine Licensing 52

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. NEW YORK, Nov.

FDA Approval 52

FDA Approval Production Clinical Trials Clinical Trials 52

Pharmaceutical Technology

AUGUST 23, 2022

According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1, The companies have also commenced rolling submission for conditional marketing authorization from the European Medicines Agency (EMA) for this Omicron BA.4/BA.5-adapted

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Vaccination Vaccine Gene Therapy Protein 130

XTalks

APRIL 17, 2023

Monoclonal antibodies are gaining attention as alternative or additive treatments for atopic dermatitis. Lebrikizumab is a new and investigational monoclonal antibody designed to selectively inhibit IL-13. “In Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab outside of Europe.

Dermatology 97

Dermatology Antibody Clinical Trials Clinical Trials 97

XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

Drugs 52

Drugs FDA Approval Sales Vaccination 52

pharmaphorum

FEBRUARY 15, 2022

ImmunoGenAlmost four years after backing out of an antibody-drug conjugate (ADC) alliance with ImmunoGen, Eli Lilly has come back to the table with a new, wide-ranging deal worth up to $1.7 billion in exercise fees and milestone payments, as well as tiered royalties should any of the ADCs reach the market.

Antibody 52

Antibody Licensing Licensing Drugs 52

pharmaphorum

NOVEMBER 21, 2022

The US FDA approved the anti-CD3 antibody to delay the onset of stage 3 T1D in patients aged eight years and older who are currently diagnosed with stage 2 disease – a population estimated by Provention to be around 30,000 in the US. It also has an option on global marketing rights to the drug.

Drugs 116

Drugs Insulin FDA Approval Sales 116

Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

Development 161

Development Production Immune Response Licensing 161

The Pharma Data

JANUARY 12, 2021

million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential U.S. Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization.

Antibody 52

Antibody Production Manufacturing Clinical Trials 52

pharmaphorum

DECEMBER 23, 2021

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. Novartis resubmitted its marketing application in the US earlier this year, after swapping fill-and-finish production to one of its own facilities in Schaftenau, Austria.

Drugs 105

Drugs Sales Antibody FDA Approval 105

pharmaphorum

OCTOBER 27, 2022

The antibody – which targets granulocyte-macrophage colony-stimulating factor (GM-CSF) – did show efficacy in the ContRast-1 and ContRast-2 studies, working better than placebo at reducing symptoms of RA in patients who did not respond to conventional disease-modifying antirheumatic drugs (DMARDs), like methotrexate. Daprodustat backed.

Sales 97

Sales Antibody FDA Approval Trials 97

pharmaphorum

DECEMBER 21, 2021

The Swiss pharma group is paying BeiGene $300 million upfront for an option on ociperlimab, a TIGIT antibody in phase 3 testing for non-small cell lung cancer (NSCLC), with another $700 million on offer if that option is exercised before 2023. Novartis licensed rights to tislelizumab for $650 million upfront and up to $1.55

Drugs 98

Drugs Antibody Pharma Companies Development 98

XTalks

AUGUST 15, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced yesterday that the US Food and Drug Administration (FDA) has granted marketing authorization for its combination treatment Akeega for metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations. In April 2016, Janssen Biotech, Inc.

FDA Approval 52

FDA Approval Gene Hormones Licensing 52

The Pharma Data

DECEMBER 29, 2020

First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. futility analysis).

Antibody 52

Antibody Trials Production Clinical Trials 52

XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. Tegoprubart is an anti-CD40L antibody designed to inhibit the CD40 and CD11 costimulatory signaling pathways. The recommended dosage of Qalsody is 100 mg (15 mL) per administration.

FDA Approval 89

FDA Approval Gene Genetics Protein 89

The Pharma Data

JULY 29, 2021

First IL-5 therapy approved as an add-on treatment in the US for adults with chronic rhinosinusitis with nasal polyps to target eosinophilic inflammation Fourth indication for mepolizumab in the US for eosinophil-driven diseases. It is approved for paediatric use in SEA from ages six to 17 in Europe, the US and several other markets.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

Pharmaceutical Technology

NOVEMBER 9, 2022

An approval decision on the gene therapy, also known as EtranaDez, is expected by the end of this month. CSL Behring has a commercialisation and license agreement to develop EtranaDez. In the EU however, two years later, the European Commission awarded a conditional marketing authorisation for Roctavian. million ($1.5

Gene Therapy 278

Gene Therapy Gene FDA Approval Medicine 278

The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

Antibody 52

Antibody Medicine Production Trials 52

pharmaphorum

APRIL 6, 2022

The EU regulator has started a review of Novartis’ PD-1 inhibitor tislelizumab – licensed from Chinese biotech BeiGene – for oesophageal and lung cancers, ahead of an FDA decision on the drug due in July. FDA clears Vijoice for rare overgrowths.

Drugs 52

Drugs Licensing Licensing FDA Approval 52

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.

Drugs 52

Drugs FDA Approval Licensing Licensing 52

pharmaphorum

AUGUST 12, 2020

UK biotech Celleron Therapeutics has bought a licence to develop, manufacture and market emactuzumab, an unwanted drug from Roche’s pipeline that could be used in a rare tendon sheath cancer already targeted by Daiichi Sankyo.

Drugs 52

Drugs Licensing Licensing FDA Approval 52

pharmaphorum

APRIL 5, 2022

AstraZeneca’s take on the PCSK9 inhibitor – an antisense drug licensed from Ionis six years ago – has cleared a proof-of-concept trial in high-risk patients with high blood cholesterol, but it remains to be seen where it will fit into the increasingly busy category. billion in sales by 2027, ahead of Repatha at $2.2

Drugs 52

Drugs Antibody Sales FDA Approval 52

pharmaphorum

APRIL 10, 2022

Seagen claims Enhertu (trastuzumab deruxtecan) – an antibody-drug conjugate (ADC) targeting HER2 – infringes a patient it holds (No. 10,808,039) covering ADCs that include auristatin compounds coupled to an antibody via a linker molecule. billion licensing deal for the drug in 2019. That could be a sizeable sum.

Sales 52

Sales Antibody FDA Approval Drugs 52

pharmaphorum

MAY 24, 2021

Johnson & Johnson’s Janssen division has claimed a first approval in the US for its bispecific antibody Rybrevant as a treatment for EGFR-mutated non-small cell lung cancer (NSCLC). billion last year from its approved indications in EGFR-mutated NSCLC.

FDA Approval 52

FDA Approval Antibody Drugs Marketing 52

Delveinsight

AUGUST 2, 2020

The dynamics of the cancer cachexia market is expected to gain momentum as several companies are testing the waters, advancing cancer cachexia pipeline. NGM120 is a first-in-class antagonistic antibody, which binds glial cell-derived neurotrophic factor receptor alpha-like (GFRAL) and inhibits growth differentiation factor 15 (GDF15).

Marketing 94

Marketing Pharma Companies Development Hormones 94

The Pharma Data

OCTOBER 28, 2020

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Regeneron Pharmaceuticals, Inc. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron.

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

DECEMBER 5, 2020

NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences.

Antibody 40

Antibody Production Trials Medicine 40

Delveinsight

AUGUST 4, 2020

MorphoSys, Incyte gets an early FDA nod for Monjuvi, an alternative to CAR-T for B-cell malignancies. Not long ago, the companies inked an oncology pact to develop and commercialize MorphoSys’ anti-CD19 antibody Monjuvi jointly. Billion deal in a thirst to grow in the cancer market.

Cardiology 55

Cardiology Antibody FDA Approval Trials 55