The Pharma Data

DECEMBER 13, 2020

RLY-1971 is a potent small molecule inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2). SHP2 is a critical signaling node and regulator that promotes cancer cell survival and growth through the RAS pathway, playing a key role in the way cancer cells develop resistance to targeted therapies. About RLY-1971.

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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

FEBRUARY 28, 2021

In other words, melatonin acts as a biological clock that regulates sleep. Melatonin, therefore, can be used to promote and regulate sleep (Wagner et al., 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. Can buy melatonin abroad?

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Drug Discovery World

AUGUST 21, 2023

Medications containing semaglutide such as Ozempic, licensed for diabetes, and Wegovy, for weight loss, are being studied to see if they can treat a range of different conditions, including addiction and dementia. It’s an exciting area,” he told The Guardian.

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Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. Even still, these approved drug products require a licensed healthcare provider’s prescription. What is the regulatory landscape of medical cannabis?

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XTalks

APRIL 26, 2021

It is the world’s first and only licensed malaria vaccine and also the first licensed for use against a human parasitic disease of any kind. The vaccine is protein-based and contains an adjuvant (MM), a component that helps generate a stronger immune response, that was developed by Novavax. Malaria Vaccine Phase II Trial.

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The Pharma Data

JANUARY 12, 2021

As a result of the Company’s successful collaboration with GlobalCo, the Company has chosen a clone of its CDX antibody that is ready for investigational new drug (“IND”) application-enabling studies, a significant step toward clinical trials. Market Abuse Regulation (MAR) Disclosure. ” About AML.

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Pfizer

APRIL 26, 2023

Our engineers created specially designed, temperature-controlled shipping containers (that we call “shippers”), which contain GPS temperature enabled trackers for continuous, real-time location and temperature monitoring and can maintain required temperature conditions for up to 10 days unopened. In the U.S.,

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The Pharma Data

JANUARY 10, 2021

Monjuvi (R) is a registered trademark of MorphoSys AG. Tremfya (R) is a registered trademark of Janssen Biotech, Inc. For more information, please contact: SOURCE: MorphoSys AG via EQS Newswire. View source version on accesswire.com: [link]. Source link.

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The Pharma Data

MARCH 14, 2021

This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. Furthermore, in clinical trials, even though the number of thrombotic events was small, these were lower in the vaccinated group.

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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). However, stakeholders should be aware that the leaked review contains no such analysis.

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The Pharma Data

SEPTEMBER 9, 2020

“We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”. “As The information contained in this release is as of September 7, 2020.

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The Pharma Data

JANUARY 26, 2021

As an Orphan Drug, Uttroside-B may benefit from a seven-year market exclusively following marketing approval, grant funding for clinical trials that contribute to marketing approval, protocol assistance, and tax credits. billion by 2027. About Q BioMed Inc. Q BioMed Inc. .

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The Pharma Data

NOVEMBER 24, 2020

. More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers. ” This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014).

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Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. For good clinical practice (GCP), refer to ICH E6 (R2) Section 5 and address all quality elements.

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The Pharma Data

NOVEMBER 27, 2020

This indication is approved under accelerated approval regulation based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. The FDA granted approval under the accelerated approval regulation.

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The Pharma Data

DECEMBER 20, 2020

Transcend is a research focused biotechnology company creating and clinically validating an evolving IP portfolio of novel molecules and drug delivery mechanisms for clinical trials and commercialization. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Sanofi, Empowering Life.

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The Pharma Data

OCTOBER 15, 2020

Researchers at MSK developed naxitamab and omburtamab, which are exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests related to the compounds and Y-mAbs. About Y-mAbs.

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The Pharma Data

MARCH 4, 2021

Under the 2017 collaboration agreement, Takeda received equity in Ovid and was eligible to receive up to $85 million in payments for regulatory milestones, including the initiation of Phase 3 clinical trials. You can identify forward-looking statements because they contain words such as “will,” “appears,” “believes” and “expects.”

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Empowering Life. www.sanofi.com.

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The Pharma Data

DECEMBER 14, 2020

Transcend is a research focused biotechnology company creating and clinically validating an evolving IP portfolio of novel molecules and drug delivery mechanisms for clinical trials and commercialization. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

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Pfizer

JANUARY 27, 2023

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. John’s Wort ( hypericum perforatum ) There are limited clinical data available for PAXLOVID.

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The Pharma Data

JANUARY 24, 2021

In clinical research, Cepharanthine exhibits multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic properties. Sairiyo is currently focused on advancing the clinical development of Cepharanthine to treat rare cancer diseases. PharmaDrug Inc.

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The Pharma Data

OCTOBER 19, 2020

Pneumococcal serotypes not in the currently licensed conjugate vaccine, such as 22F and 33F, are among the most common serotypes causing invasive pneumococcal disease in parts of the world, including the U.S., PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

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FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. As part of the Accelerated Approval, Oncopeptides was required to conduct “further adequate and well-controlled clinical trials to verify and describe clinical benefit.” That did not happen.

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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

AUGUST 3, 2021

Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. Novartis today announced that the U.S. SVP, Chief Medical Officer, Novartis Gene Therapies. “We

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The Pharma Data

AUGUST 30, 2021

In three clinical trials, patients taking Leqvio maintained LDL-C reduction throughout each six-month dosing interval 8,10. Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals, a leader in RNAi therapeutics. Disclaimer.

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The Pharma Data

NOVEMBER 2, 2020

We are grateful to the families who have participated in the clinical trials, the advocacy groups from around the world, and the study investigators, all who have been on this journey with us to deliver a treatment choice and contribute to further understanding achondroplasia medically and scientifically.” In the U.S.,

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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

JANUARY 13, 2021

Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. Source link.

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The Pharma Data

AUGUST 29, 2020

Novartis has obtained global rights to develop, manufacture and commercialize inclisiran under a license and collaboration agreement with Alnylam Pharmaceuticals. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995.

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The Pharma Data

JANUARY 15, 2021

Darzalex Faspro® is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials. About Darzalex Faspro® In August 2012, Janssen Biotech, Inc. Janssen Biotech, Inc.

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Pfizer

DECEMBER 13, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., For more information, please visit www.PAXLOVID.com. .

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The Pharma Data

OCTOBER 14, 2020

In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (?5% This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Adverse Reactions. Forward Looking Statement.

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Pfizer

DECEMBER 20, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., For more information, please visit www.PAXLOVID.com.

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