pharmaphorum

AUGUST 2, 2021

AstraZeneca has completed the resurrection of its anifrolumab drug for systemic lupus erythematosus (SLE) after claiming FDA approval for the drug as an add-on therapy for adults with the autoimmune disease. The post FDA approves AZ’s anifromulab, ending 10-year lupus drug drought appeared first on.

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XTalks

OCTOBER 27, 2021

Ranibizumab is an anti-angiogenic monoclonal antibody fragment that targets vascular endothelial growth factor A (VEGF A). Ranibizumab was developed by Genentech and is sold under the brand name Lucentis. It received FDA approval in 2018. It became the first ophthalmology biosimilar approved in the US.

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XTalks

NOVEMBER 1, 2024

Price of Ocrevus: $78,858 annually Why it sold so well: Ocrevus is a therapeutic monoclonal antibody that offers a unique scientific approach to treating MS. Why it sold so well: Botox is FDA-approved for the treatment of chronic migraines and that is currently the only chronic condition for which it has received approval.

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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.

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The Pharma Data

DECEMBER 17, 2020

MacroGenics, a biopharma company working to make cancer history with the development of innovative monoclonal antibody-based therapeutics, had its first product , MARGENZA , approved by the FDA on Wednesday. This will be the first branded proprietary product for Athenex, which will be launched in the U.S. Athenex, Inc.

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XTalks

JANUARY 25, 2021

Although TaiMed Biologics’ antibody drug Trogarzo is an intravenous formulation that is administered once every 14 days, it must be used in conjunction with other antiretroviral drugs. Cabenuva was actually expected to win FDA approval towards the end of 2019; however, manufacturing issues garnered rejection from the FDA at the time.

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XTalks

JANUARY 20, 2025

This strategic move transformed Actavis into one of the largest pharma companies globally, with a strong presence across branded, generic and over-the-counter (OTC) medicines. Following the merger, Actavis rebranded itself as Allergan, leveraging the strong recognition of Allergans brand.

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XTalks

APRIL 11, 2024

After backing from the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) last month, Johnson and Johnson (J&J) and Bristol Myers Squibb (BMS) scored FDA approvals for the use of their B-cell maturation antigen (BCMA)-targeting CAR T-cell therapies as earlier line treatment options for multiple myeloma.

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pharmaphorum

SEPTEMBER 2, 2022

German drugmaker Boehringer Ingelheim has its first regulatory approval for spesolimab, its antibody therapy for rare and life-threatening skin disorder generalised pustular psoriasis (GPP), in the US.

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pharmaphorum

DECEMBER 18, 2020

GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the first and only FDA-approved treatment for lupus nephritis. Benlysta binds and neutralises the B cell survival factor BAFF, while rituximab targets CD20, a protein found on the surface of B cells.

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pharmaphorum

OCTOBER 24, 2022

The CTLA4 inhibitor – now given the brand name Imjudo – is only the second drug in the class to be approved after Bristol-Myers Squibb’s well-established Yervoy (ipilimumab), which is used alongside BMS’ PD-1 inhibitor Opdivo (nivolumab) in several solid tumours, including HCC and lung, colorectal, skin, and kidney cancers.

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STAT News

NOVEMBER 18, 2022

The first therapy that delays the onset of type 1 diabetes received approval from the U.S. The monoclonal antibody teplizumab, which will be marketed under the brand name Tzield and is from ProventionBio and Sanofi, is given through intravenous infusion. Food and Drug Administration , CNN tells us. As of 2019, about 1.9

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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.

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XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

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XTalks

FEBRUARY 20, 2024

IgA nephropathy is an autoimmune condition characterized by the deposition of clusters of antibodies in the kidneys, resulting in inflammation and kidney impairment. These clusters, primarily comprised of IgA and other antibodies, harm the glomeruli, which are small blood vessels responsible for filtering blood in the kidneys.

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The Pharma Data

DECEMBER 30, 2020

billion acquisition of immuno-oncology company Forty Seven and its lead asset, magrolimab, a monoclonal antibody in the clinic for several cancers, including myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) and diffuse large B-cell lymphoma (DLBCL). It began in May with the $4.9 Magrolimab targets CD47.

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pharmaphorum

SEPTEMBER 21, 2021

AstraZeneca has unveiled plans to build a brand new manufacturing facility at a site in Ireland operated by its recent acquisition Alexion, providing employment for around 100 workers including scientists and engineers. “This significant investment will ensure the AstraZeneca supply network is fit for the future.”

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pharmaphorum

FEBRUARY 7, 2022

Sanofi has won FDA approval for its sutimlimab for cold agglutinin disease (CAD) at the second time of asking, becoming the first approved therapy for the rare blood disorder in the US. In CADENZA, sutimlimab met its combined objective of improving haemoglobin levels in the blood by at least 1.5

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pharmaphorum

MARCH 21, 2022

Bristol-Myers Squibb has won FDA approval for the first LAG-3 inhibitor drug ahead of its rivals in cancer immunotherapy including Merck & Co. Like PD-1, LAG-3 is a negative regulator of T cells, suppressing their activity against cancer cells, so when that brake is released the immune system can attack and kill tumours.

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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.

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pharmaphorum

APRIL 6, 2022

There are already several PD-1/PD-L1 inhibitors on the market, and if approved tislelizumab will come up against Merck & Co’s dominant Keytruda (pembrolizumab) and others in the NSCLC indications, as well as Keytruda and Bristol-Myers Squibb’s Opdivo in oesophageal cancer. FDA clears Vijoice for rare overgrowths.

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Delveinsight

SEPTEMBER 8, 2021

Hydroxychloroquine and BENLYSTA are the FDA-approved therapies for SLE treatment. With the approval of these therapies, the outlook for SLE patients improved from a 4-year survival rate of ~50% in 1950 to a 15-year survival rate of ~85% by 2013. It is sold under the brand name Plaquenil and is available only by prescription.

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XTalks

MAY 25, 2021

Biosimilar and interchangeable products can expand treatment options and lower drug and healthcare costs by offering a cheaper alternative with the same effectiveness; essentially a non-branded version of a biologic such as monoclonal antibodies, proteins and vaccines. million in 2019, according to Fortune Business Insights.

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The Pharma Data

MAY 5, 2021

India approves Roche/Regeneron antibody cocktail to treat COVID-19 ( Reuters ). Adagio offers first peek at Covid-19 antibody data, with preventative numbers that may rival mRNA vaccines ( Endpoints ). CureVac says well on track to request vaccine approval as planned ( Reuters ) ( NYT ).

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The Pharma Data

FEBRUARY 23, 2022

Food and Drug Administration (FDA) approved TicoVac™ 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. induces protective antibodies against the three most prevalent subtypes of the TBEV circulating globally.

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XTalks

MAY 31, 2023

Another noteworthy candidate from Acelyrin’s pipeline is lonigutamab, an anti-IGF-1R monoclonal antibody administered via subcutaneous delivery. If tecarfarin receives FDA approval, the company anticipates annual revenues of approximately $1 billion in the US market.

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The Pharma Data

NOVEMBER 8, 2021

Topiramate is one of the most commonly prescribed medications in migraine prevention with an estimated 600,000 new-to-brand prescriptions written in the U.S. “HER-MES is the first study that directly compared the therapeutic effects of an antibody and a small molecule in migraine prevention,” said Uwe Reuter, M.D.,

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The Pharma Data

DECEMBER 13, 2020

Although we are disappointed by the delay in timing to bring omidubicel to patients after a potential FDA approval, we are encouraged by the FDA’s reaction to our Phase 3 data as the pivotal trial of omidubicel achieved pre-specified primary and secondary endpoints. chief executive officer of Gamida Cell.

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The Pharma Data

OCTOBER 15, 2020

On the clinical side, cell and gene therapies must find places where small molecules, antibodies or other traditional approaches may not be the best option. For dry AMD, there’s nothing approved by the FDA. As with dry AMD, there is no FDA-approved therapy. “We

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Delveinsight

AUGUST 17, 2020

Metoclopramide , sold under the brand name Reglan , is the first and only FDA-approved therapy for the treatment of Diabetic Gastroparesis. However, the drug is not FDA-approved but is available in some European countries. FDA for a phase 2b study in diabetic kidney disease (DKD).

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XTalks

AUGUST 30, 2022

Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies. Biogen’s nusinersen (brand name Spinraza) is an antisense oligonucleotide (ASO) therapy that is administered directly into the CNS by intrathecal injection through lumbar puncture.

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The Pharma Data

AUGUST 3, 2021

New-to-brand prescription (NBRx) volumes grew 10% year-over-year, even as patient visits to dermatologists remained 15% below pre-pandemic levels. For the remainder of the year, we expect continued growth from Kyprolis use in combination with CD38 antibodies. In the U.S., Cost of Sales margin increased 1.6 Tax Rate increased 5.6

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The Pharma Data

OCTOBER 23, 2020

Remdesivir gets full FDA approval to treat COVID. Remdesivir’s full approval Thursday by the FDA comes after the agency granted it emergency use authorization last spring. is selling the drug under the brand name Veklury. It is given intravenously to hospitalized patients.

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The Pharma Data

OCTOBER 24, 2020

Remdesivir gets full FDA approval to treat COVID-19. Remdesivir’s full approval Thursday by the U.S. is selling the drug under the brand name Veklury. Food and Drug Administration comes after the agency granted it emergency use authorization last spring. It is given intravenously to hospitalized patients.

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The Pharma Data

APRIL 27, 2021

due to COVID related stocking in Q1 2020 and low demand for cough and cold brands in Europe. Dupixent ® total prescriptions (TRx) increased 51% ( year-over-year ) and new-to-brand prescriptions (NBRx) grew 16% despite fewer in-person physician visits which remain below the pre-COVID level. Sarclisa ® is already approved in the U.S

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Delveinsight

AUGUST 13, 2020

Approval History: In September 2017, FF/UMEC/VI was approved in the US under the brand name Trelegy Ellipta for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Trelegy Ellipta is not indicated for relief of acute bronchospasm or for the treatment of asthma.

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The Pharma Data

JUNE 18, 2021

The BTK protein sends important signals that tell B cells to mature and produce antibodies. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. The full U.S.

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