Pharmaceutical Technology

NOVEMBER 1, 2022

The European Commission (EC) has granted orphan medicinal product designation for Karyopharm Therapeutics and the Menarini Group’s Nexpovio (selinexor) to treat myelofibrosis (MF). The companies signed an exclusive licensing agreement in December 2021. The therapy is commercialised in the US as Xpovio.

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Protein FDA Approval Production Licensing 130

Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

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Scienmag

MARCH 28, 2021

Octaplas™ and fibryga® receive new product labeling following FDA’s approval of BLA supplements to update therapy research; FDA expands fibryga® indication to include treatment of children under 12 years of age Credit: Octapharma USA PARAMUS, N.J. March 29, 2021) – The U.S.

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Production FDA Approval Licensing Licensing 76

XTalks

DECEMBER 18, 2024

Trial data for both the pediatric and adult trials were published in The New England Journal of Medicine. Crenessity marks the third approved drug for Neurocrine. In 2018, the company also received approval for Orilissa (elagolix), which it licenses to AbbVie, for the treatment of endometriosis.

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Pharmaceutical Technology

MARCH 27, 2023

Iovance Bioterapeutics announced it has completed its rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for Lifileucel. Marc Hurlbert, CEO of the Melanoma Research Alliance (MRA) said he hopes for a quick FDA approval.

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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Pfizer and BioNTech also filed these data with the European Medicines Agency (EMA) and other regulatory authorities around the world.

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FDA Approval Vaccination Vaccine Clinical Trials 102

Pharmaceutical Technology

FEBRUARY 26, 2023

In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI. But the approval came through after an FDA Advisory Committee meeting. While Rebyota was the first to be approved, more could be coming up soon, says Gilbert.

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Bacteria Trials Research Medicine 278

Pharmaceutical Technology

MARCH 31, 2023

Brexafemme is a novel, approved anti-fungal medicine with a broad spectrum of activity against existing and emerging resistant strains of fungi. It will also receive an additional $15m in milestone payments, upon receipt of US FDA approval for an additional indication. The company will receive up to $245.5m

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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. After its approval, bluebird had set Zynteglo’s price at roughly EUR1.6 million ($1.8 million at the time). million price tag.

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Gene Therapy Gene FDA Approval Medicine 278

pharmaphorum

NOVEMBER 24, 2020

Alnylam’s Givlaari, FDA-approved a year ago for acute hepatic porphyria, costs $575,000 per year at full price in the US, although after discounts the figure is more likely to be in the region of $442,000 per year. Alnylam licensed inclisiran to The Medicines Company, which was bought last year by Novartis for $9.7

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Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

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Pharmaceutical Technology

AUGUST 23, 2022

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 5-adapted bivalent vaccine.

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Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine.

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

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pharmaphorum

SEPTEMBER 29, 2021

Amazon is advancing into healthcare on multiple fronts, launching its own pharmacy business for medicines delivery in the US last year, whilst also entering the health wearables market with its own Halo device, and bolstering the health-related capabilities of its Alexa virtual assistant.

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pharmaphorum

SEPTEMBER 15, 2021

If approved, linzagolix will be the only drug in the class with a dosing regimen intended for women with uterine fibroids who cannot or do not want to take hormone therapy, as well as options for those women happy to do so, according to ObsEva.

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Hormones Drugs FDA Approval Sales 98

Pharmaceutical Technology

SEPTEMBER 2, 2022

The rate of drug approvals could be on the rise. In a recent report, GlobalData revealed that the US Food and Drug Administration (FDA) approved 122 new drug applications (NDAs) and biologic license applications (BLAs) in 2021. This figure represents a 2.4% increase over the 2016–2020 period average.

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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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pharmaphorum

JANUARY 11, 2023

The partnership will build on Anima’s previous discovery and development collaborations with Eli Lilly in July 2018 and with Takeda in 2021, giving AbbVie exclusive rights to license and further develop and commercialise the programmes. Anima’s wholly owned pipeline programmes, meanwhile, are in fibrosis, oncology, and neuroscience.

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Protein Regulation FDA Approval Licensing 105

pharmaphorum

FEBRUARY 1, 2021

Novartis’ multiple sclerosis drug has been given the green light by the European Medicines Agency’s CHMP scientific committee, paving the way for a likely approval in the coming weeks.

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pharmaphorum

OCTOBER 3, 2022

Translarna was the first licensed treatment for DMD which addresses the loss of dystrophin. Translarna has had European approval for usage since 2014 and has also been available under terms similar to the MAA to DMD patients in Scotland since 2021. The post Translarna not approved by NICE for DMD on NHS appeared first on.

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Gene Therapy Gene FDA Approval DNA 98

Pharmacy Checkers

JANUARY 10, 2020

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. The exact same FDA-approved drugs are sold in America and other countries, but with different labels.

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The Pharma Data

AUGUST 19, 2021

today announced that the company’s Marketing Authorization Application (MAA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now under evaluation with the European Medicines Agency (EMA). Additional data from the CAPELLA study will be presented at a future scientific conference.

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XTalks

AUGUST 21, 2023

The FDA also issued a Rare Pediatric Disease Priority Review Voucher (PRV) to Ipsen that can be used for subsequent drug applications that would not qualify for a priority review. The FDA approval of Sohonos is a breakthrough for the US FOP community,” said Howard Mayer, head of R&D at Ipsen, in the company’s news release.

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Drugs FDA Approval Genetics Clinical Trials 98

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 added inclisiran to its pipeline after buying The Medicines Company – which had licensed the drug from Alnylam – for $9.7 It has a long way to go.

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Drugs Sales Antibody FDA Approval 105

XTalks

APRIL 17, 2023

These results are very promising for patients with atopic dermatitis,” said Jonathan Silverberg, MD, professor of dermatology at George Washington University School of Medicine & Health Sciences and co-investigator of the studies, in the company’s press release. Dupixent inhibits signaling of both IL-4 and IL-13.

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Dermatology Antibody Clinical Trials Clinical Trials 97

XTalks

JULY 19, 2024

Compounded GLP-1 medications, created by specialized pharmacies under a special US Food and Drug Administration (FDA) allowance due to ongoing shortage, have become increasingly popular for weight loss. Moreover, 15 percent of flagged ads offer the medication without the need of a prescription.

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Pharmacy Drugs Production Sales 104

Triage Cancer

AUGUST 18, 2020

Steven Joffe from the University of Pennsylvania’s Perelman School of Medicine found that the FDA approved 99% of all expanded access requests for almost 9,000 investigational drugs. To apply for Expanded Access: The patient consults with their licensed physician to make sure they have exhausted all other treatment options.

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pharmaphorum

SEPTEMBER 26, 2022

Astellas has won a reprieve in its attempt to stop Pfizer’s generic medicines unit Hospira launching a copycat version of its pharmacologic stress agent Lexiscan in the US – but only for a couple of weeks. AmphaStar and Glenmark Pharma also claimed FDA approval for versions of the drug earlier this year.

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Production FDA Approval Licensing Licensing 52

pharmaphorum

MARCH 16, 2022

Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca’s top-selling respiratory drug Symbicort, although launch plans remain uncertain for now. The post Update: FDA clears first generic of AZ’s blockbuster Symbicort appeared first on.

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pharmaphorum

APRIL 27, 2021

Since then, Merck KGaA and Pfizer have picked up a full FDA approval for their immunotherapy Bavencio (avelumab) as a first-line maintenance therapy for this type of cancer, and that could potentially raise the level of evidence needed to keep Keytruda and Tecentriq available to patients.

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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. Casirivimab and imdevimab injection is not FDA approved for any use.

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The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec.

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pharmaphorum

JANUARY 4, 2023

It looks like Astellas has been unsuccessful in its attempt to block Pfizer’s generic medicines unit Hospira from launching a copycat version of big-selling pharmacologic stress agent Lexiscan in the US. AmphaStar and Glenmark Pharma also claimed FDA approval for versions of the drug earlier this year.

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The Pharma Data

APRIL 14, 2021

Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. with Xolair since its initial approval in 2003. The Roche Group’s immunology medicines include: Actemra ® /RoActemra ® ?(tocilizumab)

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XTalks

FEBRUARY 29, 2024

After its accelerated approval in January 2023, Leqembi received full US Food and Drug Administration (FDA) approval in July 2023. The journey of Aduhelm from its accelerated approval and predicted blockbuster status to discontinuation has been fraught with controversy, debate and ultimately, disappointment.

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pharmaphorum

FEBRUARY 15, 2022

Mirvetuximab soravtansine showed efficacy in a phase 3 trial in ovarian cancer patients last November and is due to be filed for FDA approval in the coming weeks. Lilly is thought to be the first pharma company to sign up to use the new camptothecin payload platform.

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Antibody Licensing Licensing Drugs 52