XTalks

JULY 27, 2022

He showed the bottle label that seemed to indicate that it contains 444 servings of the product, at 60 calories per serving of about a tablespoon — a near mathematical impossibility. FDA-Approved? Shaw was recently fielding questions live on TikTok when someone asked her whether Pink Sauce was FDA-approved.

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Zokinvy for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company’s first FDA approval. PALO ALTO, Calif.,

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XTalks

NOVEMBER 9, 2023

Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDA approved Zepbound for chronic weight management in adults with obesity. Since its approval in May 2022, Mounjaro sales have hit $1.4

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pharmaphorum

NOVEMBER 1, 2021

Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML). Tasigna made sales of $1.56 Scemblix could beef up Novartis’ CML portfolio, which remains a big earner for the company.

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XTalks

MARCH 12, 2024

“This approval is an important milestone for people living with obesity and cardiovascular disease, as the SELECT data demonstrated that Wegovy has the potential to prolong lives by addressing some of the leading causes of preventable deaths by reducing the risks of cardiovascular events.” The drug remains on the FDA’s drug shortages list.

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XTalks

DECEMBER 5, 2022

The CBD prodrug will be going up against Jazz Pharma’s Epidiolex, the first FDA approved CBD drug formulation. Approved in 2018, Epidiolex is a CBD oral solution indicated for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, rare and severe forms of epilepsy, in patients two years of age and older.

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XTalks

JUNE 1, 2022

BONESUPPORT has recently received market authorization from the US Food and Drug Administration (FDA) for Cerament G, its bone graft with antibiotic elution. Xtalks learned more about BONESUPPORT and its first FDA-approved drug-device combination product Cerament G through an email interview with BONESUPPORT’s CEO Emil Billbäck.

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Delveinsight

OCTOBER 1, 2021

Myasthenia Gravis Approved Therapies. The current Myasthenia Gravis therapeutics market has many FDA-approved drugs for the treatment of Myasthenia Gravis. Some of the approved drugs are: Prograf (Tacrolimus). Prograf is available for oral administration in the form of capsules (tacrolimus capsules USP) containing 0.5

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XTalks

MAY 1, 2023

Qalsody contains tofersen, an antisense oligonucleotide that specifically targets the mRNA made from mutated SODI genes to prevent the formation of toxic SOD1 proteins. At its peak sales, Qalsody is expected to generate around $300 million for Biogen. How Does Qalsody Work?

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Camargo

DECEMBER 9, 2020

If you are facing an FDA remote review, Camargo can help design a comprehensive approach in order to avoid such pitfalls. Approval of the Month: Alnylam to Use Value-Based Agreements for Ultra-rare Disease Treatment. In November, the FDA ended its Unapproved Drug Initiative. Unapproved Drug Initiative Ends.

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Camargo

NOVEMBER 11, 2020

In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

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The Pharma Data

DECEMBER 28, 2020

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. However, not all forward-looking statements contain these words.

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The Pharma Data

JUNE 17, 2022

The adalimumab reference medicine (Humira ®* ) was first approved with an adalimumab concentration of 50 mg/mL. 2,3 In 2015, the EMA and US FDA approved Humira ® HCF, which contains adalimumab at a concentration of 100 mg/mL. Our ambition is to be the world’s leading and most valued generics company.

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XTalks

DECEMBER 20, 2023

Novo Nordisk’s GLP-1 weight loss-specific drug Wegovy (semaglutide) has been facing similar shortages, as it contains the same active ingredient as Ozempic. The ad followed GSK’s earlier campaign featuring Magic Johnson , aiming to raise awareness about RSV following Arexvy’s FDA approval in May 2023 for adults 60 years of age and older.

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The Pharma Data

APRIL 4, 2023

The adalimumab reference medicine (Humira ® *) was first approved with an adalimumab concentration of 50 mg/mL. 1 In 2015, the EMA and US FDA approved Humira ® HCF, which contains adalimumab at a concentration of 100 mg/mL. Our ambition is to be the world’s leading and most valued generics company.

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pharmaphorum

OCTOBER 2, 2020

It’s the same indication targeted by Janssen with another medicine that drew inspiration from an illegal recreational drug – Spravato is an FDA-approved nasal spray containing esketamine, an isomer of ketamine.

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The Pharma Data

APRIL 15, 2022

GSK will account for the transaction as a business combination and expects it to be accretive to adjusted EPS in 2024, the expected first full year of momelotinib’s sales. Patients were symptomatic and anaemic and had been previously treated with an FDA-approved JAK inhibitor.

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The Pharma Data

NOVEMBER 3, 2020

DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix’s first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. About DEXTENZA. Ocular Therapeutix, Inc.

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Camargo

MARCH 25, 2021

Its purpose is to stimulate the development of new drugs for rare pediatric diseases by offering additional incentives for obtaining FDA approval of such products beyond the incentives offered by the ODD program.

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The Pharma Data

DECEMBER 16, 2020

Aurinia will receive tiered royalties ranging from 10 to 20 percent (dependent on achievement of sale milestones) on net sales upon commercialization, along with additional milestone payments based on the attainment of certain annual sales by Otsuka. and has the potential to receive up to $50 million U.S. based in Japan.

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The Pharma Data

JANUARY 7, 2021

The Company also has granted to the underwriters a 30-day option to purchase up to an additional 2,100,000 shares of common stock at the Public Offering Price to cover over-allotments in the sales of the securities, if any. 333-233978), previously filed with the U.S. About Cerecor Inc. Forward-Looking Statements.

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XTalks

MARCH 15, 2023

FDA-approved ADHD-specific non-stimulants are a relatively newer class of medication designed to treat ADHD that have much fewer side effects than stimulants. Strattera’s active ingredient is the SNRI atomoxetine hydrochloride while Qelbree contains viloxazine hydrochloride, a serotonin-norepinephrine modulating agent (also a SNRI).

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The Pharma Data

MAY 15, 2021

You can rest assured that it does not contain any dangerous stimulants or toxins, and more importantly, they are not habit forming. The product is made here, in the USA, in our FDA approved and GMP certified facility, under sterile, strict and precise standards. CLICKBANK® is a registered trademark of Click Sales, Inc.,

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The Pharma Data

DECEMBER 15, 2020

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state or jurisdiction.

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Delveinsight

DECEMBER 7, 2020

Unlike most other industries, in MedTech, AI is not confined to sales and operations ends of the value chain. In April 2018, the FDA approved IDx ‘s AI-based diagnostic system for the autonomous detection of diabetic retinopathy, a disorder that can lead to blindness.

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FDA Law Blog

JANUARY 11, 2022

In accordance with the statutory “section viii” provision, FDA approved Hikma’s generic product referencing Vascepa in May 2020 omitting information pertaining to the patented CV indication. The procedural background of Amarin v. Hikma (unlike that of GSK v.

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FDA Law Blog

JANUARY 11, 2022

In accordance with the statutory “section viii” provision, FDA approved Hikma’s generic product referencing Vascepa in May 2020 omitting information pertaining to the patented CV indication. The procedural background of Amarin v. Hikma (unlike that of GSK v.

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The Pharma Data

JANUARY 24, 2021

This press release contains “forward-looking information” within the meaning of applicable securities legislation. Forward-looking information contained in this press release is expressly qualified by this cautionary statement. Accordingly, readers should not place undue reliance on forward-looking information.

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pharmaphorum

SEPTEMBER 8, 2022

This year, Novartis’ deal-making in the area paid off when it received US FDA approval for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for previously-treated patients with PSMA-positive metastatic castration-resistant prostate cancer. The drug was added to Novartis’ portfolio through a $2.1

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The Pharma Data

DECEMBER 4, 2021

.” With nearly 550 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market, and holds the leading position in first-to-file opportunities, with approximately 100 pending first-to-files in the U.S. Epiduo® Forte Gel had annual sales of $253 million in the U.S.,

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XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. billion in 2022, a 23.43

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pharmaphorum

JANUARY 28, 2021

If passed, HR 8190 would allow insulin biosimilar products to receive automatic interchangeability upon FDA approval. The PDPRA is slated for Senate review in 2021; it is aimed at lowering the cost of drugs for patients and contains several provisions that would impact biosimilars.

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Delveinsight

DECEMBER 13, 2020

In July 2017, the US FDA approved sofosbuvir/velpatasvir/voxilaprevir? Vosevi) to treat adult chronic hepatitis C of all genotypes previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor. in January 2019.

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The Pharma Data

NOVEMBER 5, 2020

net sales increased 11% to $1.32 Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07 FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus).

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pharmaphorum

JANUARY 5, 2022

Oral agents will be a useful adjunct, but vaccination will remain the primary lever to contain the pandemic, with innovations in COVID-19 vaccines appearing in 2022. Aduhelm’s Q3/2021 sales were $300k; investors will expect strong ramp-up in H1/2022. CNS’s moment of truth. Other competitors, including Roche’s gantenerumab, may follow.

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The Pharma Data

MAY 16, 2021

Every capsule is made here, in the USA, in our FDA approved and GMP certified facility, under sterile, strict and precise standards. You can rest assured that they do not contain any dangerous stimulants or toxins, and more importantly, they are not habit forming. CLICKBANK® is a registered trademark of Click Sales, Inc.,

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FDA Law Blog

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

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