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The FDAapproved Truvada as the first PrEP treatment in July 2012, with Descovy receiving a nod for this use in October 2019. While both Descovy and Truvada contain emtricitabine, they feature different forms of the antiviral tenofovir. Truvada contains tenofovir disoproxil fumarate, whereas Descovy uses tenofovir alafenamide.
The new medicine, a pill called Krazati, was cleared to treat patients with advanced non-small cell lung cancer containing a specific type of KRAS alteration called G12C. The mutation is found in approximately 13% of lung tumors. Continue to STAT+ to read the full story…
That means it targets both the primary mutation in this form of NSCLC and the resistance mechanism at the same time, according to J&J, which has previously said it plans to expand use of the drug to “all EGFR-containing tumours”, challenging Tagrisso and other TKIs like AZ’s older Iressa (gefitinib) and Roche’s Tarceva (erlotinib).
The new federal rule on drug importation from Canada , drafted pursuant to Section 804 of the FDCA, does not allow for the importation of foreign versions of FDA-approved drugs. It only allows for the importation of FDA-approved drugs. Kesselheim called “ Reputation and Authority FDA and the Fight over U.S.
The sale of an illegally imported supplement being marketed as a weight-gain enhancer has been associated with cases of dizziness, cognitive impairment, and sedation, according to the US Food and Drug Administration (FDA).
The biotherapeutics market is rapidly growing, with 2021 seeing the highest-ever cell and gene therapy approval number. Early gene therapy methods were proposed in the 1970s, and the first approved gene therapy clinical research in the US began in 1990. The future of cell and gene therapies.
The top 15 diabetes drugs in 2023, according to 2022 sales data, reflect the current state of diabetes management and hint at the evolving needs and trends within this critical area of healthcare. Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics. mL subcutaneous solution (2 mg/1.5
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.
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.
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.
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.
FDAApproves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDAapproved. Related Articles: Danyelza (naxitamab-gqgk) FDAApproval History. NEW YORK, Nov. Source link.
Novartis has claimed FDAapproval 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.
Since Mounjaro’s May US Food and Drug Administration (FDA) approval, sales of the drug have skyrocketed beyond initial expectations owing to patient demand and a temporary shortage of Novo’s Ozempic. Sales of Ozempic were up by 28 percent in Q3 of 2022, driven by high demand for GLP-1-based diabetes treatments.
billion for its FDA-approved dry eye drug Xiidra during the Japanese pharma’s merger with Shire in 2019, outlining the sales potential in this market niche. The pipeline for dry eye disease drugs is beginning to heat up, with two biotechs announcing key developments, aiming to disrupt a market led by Allergan and Novartis.
FDAApproves 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 FDAapproval. PALO ALTO, Calif.,
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
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.
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).
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.
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.
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
The court ruled that AZ’s asserted claims in three of its patents protecting Symbicort, which is the mainstay of AZ’s respiratory diseases business unit with sales exceeding $2.7bn, are not invalid. Symbicort was first FDA-approved in 2006 as a treatment for asthma, followed by an extension to its label covering COPD in 2009.
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 FDAapproved, Lilly said they may expose patients to potentially serious health risks.
The CBD prodrug will be going up against Jazz Pharma’s Epidiolex, the first FDAapproved 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.
Its purpose is to stimulate the development of new drugs for rare pediatric diseases by offering additional incentives for obtaining FDAapproval of such products beyond the incentives offered by the ODD program.
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?
“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.
It is already indicated for active booster immunisation against tetanus, diphtheria, and pertussis in those aged 10 years and over and it has also previously been approved for use in pregnancy to protect the mother. Following childbirth, the placebo recipients were then vaccinated with Boostrix.
If passed, HR 8190 would allow insulin biosimilar products to receive automatic interchangeability upon FDAapproval. 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.
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 FDAapproved Zepbound for chronic weight management in adults with obesity. Since its approval in May 2022, Mounjaro sales have hit $1.4
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.
The collaboration with Bruker announced today will assess the suitability of the test as a professional-use in-vitro diagnostic (IVD) product for SARS-CoV-2 infection to run on Bruker’s MALDI-TOF instruments for sale in the UK and Europe. I look forward to updating the market when we have definitive clinical performance data.”.
Q1 2021 sales increase of 2.4% Specialty Care sales grew 15.3%, due to strong Dupixent ® performance (+45.6% General Medicines core assets grew 4.4%, while GBU sales were down 3.8%. Q1 2021 business EPS ( 1) growth at CER driven by efficiency and sales performance, supported by a one-time payment. IFRS net sales reported.
This year, Novartis’ deal-making in the area paid off when it received US FDAapproval 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
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).
The adalimumab reference medicine (Humira ®* ) was first approved with an adalimumab concentration of 50 mg/mL. 2,3 In 2015, the EMA and US FDAapproved 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.
DEXTENZA is FDAapproved 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.
The FDA’s assessment comes over two years after Daily Harvest’s French Lentil + Leek Crumbles product containing tara flour sickened nearly 400 people. The study found that none of the GRAS notices voluntarily submitted to the FDA for review followed the draft guidance. Related: Food Additive Ban?
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.
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.
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.
Unlike most other industries, in MedTech, AI is not confined to sales and operations ends of the value chain. In April 2018, the FDAapproved IDx ‘s AI-based diagnostic system for the autonomous detection of diabetic retinopathy, a disorder that can lead to blindness.
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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