XTalks

SEPTEMBER 28, 2023

a Texas-based pharmaceutical firm specializing in psychotropic drug development, revealed that its groundbreaking antidepressant, Exxua (gepirone extended release) for treating major depressive disorder (MDD), received US Food and Drug Administration (FDA) approval on September 22, 2023. Fabre Kramer Pharmaceuticals, Inc.,

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XTalks

MAY 17, 2024

The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products.

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XTalks

JANUARY 17, 2023

The US Food and Drug Administration (FDA) granted approval to AstraZeneca’s Airsupra (albuterol/budesonide), formerly known as PT027, for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of asthma attacks in individuals aged 18 years and older who have asthma.

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XTalks

JUNE 6, 2023

Posluma is now the first and only radiohybrid PSMA-targeted PET imaging agent to receive FDA approval. Posluma contains a radioactive imaging agent, fluorine-18 ( 18 F), that is designed to specifically bind to the PSMA over-expressed on prostate cancer cells. billion by 2030, according to a report by Global Market Insights.

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XTalks

AUGUST 18, 2020

Moreover, samples for the SalivaDirect test can be collected in any sterile container, and hence does not require any specific type of swab or collection vessel, making collection quick and easy. Last month, the FDA approved a pooled test for COVID-19 developed by Quest Diagnostics. And now it’s getting approval.

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XTalks

FEBRUARY 27, 2023

Chiesi Global Rare Diseases recently announced in a press release that Lamzede (velmanase alfa-tycv) received US Food and Drug Administration (FDA) approval for the treatment of non-neurological manifestations of alpha-mannosidosis in both adult and pediatric patients.

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XTalks

FEBRUARY 8, 2024

Diabetes remains a critical global challenge, affecting millions of lives and commanding significant attention from the medical, life sciences and pharmaceutical sectors. Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. mL subcutaneous solution (2 mg/1.5

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Pharma in Brief

JANUARY 7, 2024

On January 5, 2024, the US Food and Drug Administration ( FDA ) approved Florida’s proposal to import prescription drugs from Canada. This is the first approval of a Section 804 Importation Program ( SIP ) by the FDA. Biologics, controlled substances, and certain other drugs are not eligible for importation.

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Delveinsight

FEBRUARY 5, 2021

According to the CDC, in 2018, tobacco companies spent over USD 9 Billion in just promoting and marketing their cigars and cigarettes in the US. Fortunately, there exists FDA-approved therapies and drugs that double the success rates of quitting. Smoking Cessation: What are the drugs available in the market?

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XTalks

AUGUST 9, 2023

Xdemvy, specifically formulated as an ectoparasiticide (anti-parasitic) for Demodex blepharitis treatment, contains the active ingredient lotilaner, a member of the isoxazoline compound family. Xdemvy is set to hit the market by August 2023, with an estimated annual list price of $1,850. How Does Xdemvy Work?

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Drug Discovery World

AUGUST 9, 2023

The life sciences sector has seen significant M&A activity over the last few weeks. The new acquisition gives Biogen rights to Reata’s portfolio of products for neurological diseases, including the FDA-approved Skyclarys (omaveloxolone), the only approved treatment for Friedreich’s ataxia (FA) in the United States.

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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.

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XTalks

JUNE 1, 2022

BONESUPPORT received market authorization from the FDA for Cerament G, the first and only bone graft with antibiotic elution that is approved for the US market. BONESUPPORT has recently received market authorization from the US Food and Drug Administration (FDA) for Cerament G, its bone graft with antibiotic elution.

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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.

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pharmaphorum

APRIL 13, 2021

Dr Cindy Jacobs, chief medical officer of Achieve Life Sciences discusses the potential of cytisinicline therapy for smoking cessation. . This large number of e-cigarette users creates a significant market need for vaping cessation therapy. Dr Cindy Jacobs is president and chief medical officer of Achieve Life Sciences.

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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. Attendees will explore how Virtual Research Coordination (VRCC) can help with attracting a more diverse patient population, and more. How Does Qalsody Work?

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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. New partnership tests low-dose psilocybin.

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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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pharmaphorum

AUGUST 31, 2021

For the innovators and early adopters of the life sciences industry, engineering a regulatory-grade ECA can be daunting. Lastly, we look to our life science partners themselves, who have undoubtedly spearheaded ECAs for their own pipelines. It is true that RWD contains more potential bias as a result.

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XTalks

AUGUST 28, 2020

To help address the continued need for personal protective equipment (PPE) in the current COVID-19 pandemic, a group of entrepreneurs and PPE specialists have developed a modular full-face mask called Blanc; it is being marketed by their new company that goes by the same name. So while the Blanc 1.0

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Drug Discovery World

SEPTEMBER 28, 2023

In fact, the endometrial fluid contains peptides that may protect against a variety of fungi, bacteria, viruses, and other pathogens 4. For example, BIOHM, Daye, La Biome, Ombre and Thorne already market probiotics for general vaginal health. The influence of these microbiomes extends to children as well.

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XTalks

APRIL 25, 2024

BioVentrix markets the Revivent TC System in Europe but the device is currently only approved for investigational use in the US. The Barostim NEO System received FDA approval in 2019 for use in specific HFrEF patients who have exhausted other treatment options. The Carillon device, developed by Cardiac Dimensions Inc.

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XTalks

AUGUST 7, 2023

has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. Formerly known as VP-102, Ycanth is the first cantharidin formulation approved for this purpose. ’s berdazimer gel, containing 10.3

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Drug Discovery World

AUGUST 3, 2023

For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1. There is, however, one cannabis-derived drug product that the FDA has approved, which is Epidiolex (cannabidiol). There are five categories, each containing five cannabis scientists.

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XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Regulatory Approvals for CTC-Based Assays in Oncology. Table 1: Some examples of cfDNA-based assays that are approved by the US FDA.

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XTalks

APRIL 24, 2023

The Recent Increase in Cellular and Gene Therapy Product Approvals for Rare Diseases As of December 2022, the FDA’s Office of Tissue and Advanced Therapies (OTAT) has approved 27 cellular and gene therapy products. Last year, the FDA approved five novel cellular and gene therapy products with orphan drug designation.

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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

JANUARY 18, 2021

OKYO Pharma Limited (LSE: OKYO; OTCQB: EMMLF) is a life sciences and biotechnology company admitted to listing on the standard segment of the Official List of the UK Financial Conduct Authority and to trading on the main market for listed securities of London Stock Exchange plc. LONDON and BOSTON, Jan. Napoleone Ferrara.

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XTalks

NOVEMBER 9, 2022

Glucagon-like peptide-1 (GLP-1) receptor agonists are a newer class of diabetes drugs that have the potential to double as weight loss drugs, widening their lucrative market potentials. Novo’s obesity version of semaglutide (at a higher dose) is marketed as Wegovy and was approved in 2021. billion in 2021 to $61.6

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XTalks

SEPTEMBER 21, 2023

The company said it cannot “validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product.” Since the compounded versions of Mounjaro are not FDA approved, Lilly said they may expose patients to potentially serious health risks.

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XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. It contains the antiviral medications nirmatrelvir and ritonavir.

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XTalks

APRIL 29, 2022

Tirzepatide is a novel investigational obesity treatment that contains mimetics of two hormones that are involved in regulating appetite in a single peptide: a GIP (glucose-dependent insulinotropic polypeptide) receptor agonist and a GLP-1 (glucagon-like peptide-1) receptor agonist. percent and 22.5 percent, respectively, compared to placebo.

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XTalks

DECEMBER 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS) Augtyro (repotrectinib), marking a significant milestone for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC).

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XTalks

MAY 15, 2023

Chiesi Global Rare Diseases in collaboration with Protalix BioTherapeutics announced the US Food and Drug Administration (FDA) approval of their new medication Elfabrio (pegunigalsidase alfa-iwxj) for the treatment of Fabry disease. The administration of Elfabrio is performed by a healthcare professional. What is the Price of Elfabrio?

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FDA Law Blog

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. Banner Life Sciences LLC, 956 F.3d To that end, 35 U.S.C. § 156(c)(4) 3d 1351 (Fed.

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The Pharma Data

JANUARY 9, 2021

We are proud to be a leader in the growing public health threat market, enabled by our development and manufacturing expertise, successful public-private partnerships, and broad portfolio of products and CDMO services. “Operationally, we rapidly responded to our customers’ needs, and financially, we delivered record revenue and earnings.

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XTalks

APRIL 10, 2023

As the first OTC naloxone product approved by the FDA, Narcan is expected to be sold directly to consumers without a prescription as an emergency life-saving medication to reverse opioid overdose. Narcan nasal spray contains a single 4 mg dose of naloxone hydrochloride, which is administered intranasally.

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