The Pharma Data

AUGUST 17, 2020

In addition, Dragonfly will receive up to 24% royalties on worldwide net sales. In addition, Dragonfly has an ongoing Phase 1/2 clinical trial for patients with advanced solid tumors, which began in July 2020. The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Dragonfly received U.S.

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The Pharma Data

NOVEMBER 30, 2020

The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials. In addition, Sosei Heptares will be eligible to receive tiered royalties on net sales of products resulting from the collaboration. Vlad Coric , M.D.,

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Druggist

JANUARY 15, 2021

Firstly, I will list some common combination of drugs, which contain paracetamol, which may be used if standard paracetamol tablets or capsules. Paracetamol: licensed use and limit on the sale . Combination products containing paracetamol. Paracetamol – licensed use . Forms of paracetamol . nerve pains .

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Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. 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.

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Druggist

SEPTEMBER 15, 2020

Zovirax cream, marketed as Zovirax Cold Sore Cream, contains 5% of aciclovir. Zovirax cream for cold sores is licensed for the treatment of infections caused by Herpes simplex virus presented on lips or face in children and adults. Generic Zovirax cream for cold sores As previously mentioned, Zovirax cream contains 5% of aciclovir.

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The Pharma Data

NOVEMBER 2, 2020

(NASDAQ:ADIL; ADILW) , a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today provided an update on its landmark ONWARD Phase 3 pivotal trial. 40% of expected Trial patient screenings have been completed and the Trial is more than 25% enrolled relative to planned enrollment.

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pharmaphorum

DECEMBER 4, 2020

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).

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The Pharma Data

NOVEMBER 5, 2020

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

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XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. Qalsody contains tofersen, an antisense oligonucleotide that specifically targets the mRNA made from mutated SODI genes to prevent the formation of toxic SOD1 proteins.

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pharmaphorum

AUGUST 16, 2020

ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year. It will be provided on a no-profit basis while the pandemic is ongoing. Those deals cover 200 million doses of J&J’s Ad26.COV2.S

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Druggist

DECEMBER 9, 2020

Sale of some anti-itch creams is restricted to pharmacies only. Lotions: contain the least amount of oils and higher amounts of water with non-greasy consistency. Clobetasone has a narrow licensed use. It contains a combination of miconazole (an antifungal drug) and hydrocortisone 1% (steroid). Daktacort cream.

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Druggist

SEPTEMBER 30, 2020

Both products contain the same active ingredients regardless of whether they are prescribed or purchased over the counter: Each Buscopan tablets contains 10mg of hyoscine butylbromide. Each Colofac or mebeverine tablet contains 135mg of mebeverine hydrochloride. Both products contain the same drug – hyoscine butylbromide.

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Druggist

FEBRUARY 28, 2021

In the UK, licensed forms of melatonin are prescribed either for the management of insomnia in adults over 55 years of age or to help with jet lag. The licensed use of Circadin is as follows: the short-term treatment of insomnia characterised by the poor quality of sleep in patients aged 55 or over. 1,640 Reviews.

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The Pharma Data

JANUARY 13, 2021

Prior to joining Usona, Mr. Barrow served as Chief Operating Officer of Olatec Therapeutics where he oversaw the execution of numerous early- and late-stage clinical trials in the fields of analgesics, rheumatology, immunology and cardiovascular disease.

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e., futility analysis).

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The Pharma Data

NOVEMBER 23, 2020

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com. . . View original content to download multimedia: [link].

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Druggist

OCTOBER 21, 2020

Amorolfine 5% nail lacquer (brand name: Curanail 5% w/v Medicated Nail Lacquer) is available as general-sale medication, which can be purchased in most supermarkets and pharmacies. Additionally, oral antifungal tablets are not licensed for use in children. Amorolfine 5% nail lacquer is usually applied once or twice weekly.

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The Pharma Data

JANUARY 27, 2021

Based on these results, we will now move to identify the recommended Phase II dose for the Phase IIa part of the trial and look forward to further evaluating the exciting potential of BI-1206 to bring much needed innovation to lymphoma patients,” said Martin Welschof, Ph.D, (Nasdaq: CASI), a U.S. CEO of BioInvent.

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The Pharma Data

AUGUST 5, 2020

In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults.

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The Pharma Data

NOVEMBER 22, 2020

Omecamtiv mecarbil is an investigational cardiac myosin activator, developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF), and was recently studied in GALACTIC-HF, a positive Phase 3 cardiovascular outcomes clinical trial. Blum, Cytokinetics’ President and Chief Executive Officer.

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The Pharma Data

JULY 27, 2021

Amgen Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future.

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The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. REGN-COV2 was well tolerated in the trial. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S.

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The Pharma Data

MARCH 4, 2021

Ovid will receive an upfront payment of $196 million at closing and is eligible to receive up to an additional $660 million upon achieving development, regulatory and sales milestones. Together we generated positive Phase 2 ELEKTRA study data, and as a result, soticlestat is poised to enter two pivotal trials,” said Andy Plump, M.D.,

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The Pharma Data

OCTOBER 15, 2020

In addition, bone marrow clearance was observed with complete response in 7 of 9 patients, who had positive bone marrow at trial start. Researchers at MSK developed naxitamab and omburtamab, which are exclusively licensed by MSK to Y-mAbs. The median duration of response with long-term follow-up was 27 weeks. “We About Y-mAbs.

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Drug Discovery World

AUGUST 3, 2023

Even still, these approved drug products require a licensed healthcare provider’s prescription. Significantly, in January 2023, the FDA finalised a 2020 draft guidance outlining how sponsors and investigators can conduct clinical trials for certain drugs containing cannabis or cannabis-derived compounds without running afoul of federal law 2.

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The Pharma Data

JANUARY 24, 2021

1 Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials. PharmaDrug Inc.

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Drug Discovery World

MARCH 29, 2023

Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care). Will this be a viable solution? Clinical trials The draft outlines the requirement for clinical trials in children where a drug is approved in adults for a different disease.

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pharmaphorum

SEPTEMBER 18, 2020

AstraZeneca also wanted to endure shareholder value through global power and reach in sales and marketing, greater financial strategic flexibility and the creation of a stronger R&D platform for innovation-led growth. The merger of Astra and Zeneca aimed to improve the combined companies’ ability to deliver long term growth.

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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 REGN-COV2 trial in the COVID-19 outpatient setting met primary and key secondary endpoints. Third quarter 2020 EYLEA ® U.S. billion versus third quarter 2019. Total revenues (4). $.

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pharmaphorum

SEPTEMBER 8, 2022

Last year, the company signed two deals in quick succession, which saw it form a licensing deal worth $1.3 billion acquisition of Endocyte in 2018 , with estimations that sales could reach $600 million in this first indication alone. Big pharma has already noted its interest in the area, as seen in Novartis’ investments.

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The Pharma Data

DECEMBER 14, 2020

The Company anticipates using net proceeds from the offering to fund the continued development of ublituximab and umbralisib, the potential in-license, acquisition, development and commercialization of other pharmaceutical products, and for general corporate purposes. Morgan Securities LLC, Goldman Sachs & Co. LLC, Evercore Group L.L.C.,

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The Pharma Data

AUGUST 30, 2021

Overall, Leqvio was well-tolerated, with a safety profile similar to placebo and consistent with the overall pooled population from the combined trials 1 – 3. About the pooled post hoc analyses from Phase III ORION-9, -10 and -11 trials in patients with established cerebrovascular disease and patients with polyvascular disease.

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The Pharma Data

NOVEMBER 27, 2020

Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. On behalf of Y-mAbs, I want to thank all the patients and physicians who took part in our clinical trials and our scientific partner, Memorial Sloan Kettering, for helping us achieve this goal.”. “We

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The Pharma Data

JANUARY 4, 2021

About the Innate-Sanofi agreement: The Company has a research collaboration and licensing agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multispecific antibody formats engaging natural killer (NK) cells to kill tumor cells and secrete cytokines through the activating receptor NKp46.

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Druggist

DECEMBER 17, 2020

Without a doubt, codeine-containing products are one of the most commonly sold medicines in the UK. Restrictions on the supply of codeine-containing products. The main focus of this post is to introduce the most common over the counter codeine-containing products in the UK and review their codeine content.

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The Pharma Data

NOVEMBER 4, 2020

. Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. The THRIVE-AA1 Phase 3 trial is a randomized, double-blind, placebo-controlled clinical trial of CTP-543 to evaluate hair regrowth using the Severity of Alopecia Tool (SALT) after 24 weeks of dosing in approximately 700 adult patients with moderate to severe alopecia areata.

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FDA Law Blog

FEBRUARY 29, 2024

If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. That did not happen.

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