pharmaphorum

AUGUST 11, 2020

Bayer is to buy UK-based KaNDy Therapeutics in a deal worth more than $800 million, adding the biotech’s menopause drug to its women’s health pipeline. At the beginning of this year, KaNDy completed a phase 2b trial of its first-in-class drug NT-814, showing activity against symptoms of the menopause such as hot flashes and night sweats.

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Pharmaceutical Technology

JULY 25, 2022

AstraZeneca and Daiichi Sankyo have received Priority Review for their supplemental Biologics License Application (sBLA) from the US Food and Drug Administration (FDA) of antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), to treat unresectable or metastatic HER2-low breast cancer in adults.

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BioTech 365

SEPTEMBER 4, 2020

– Prescription Drug User Fee Act (PDUFA) target action date of June 25, 2021 – – FDA indicated that it is currently not planning to hold an Advisory Committee Meeting – COPENHAGEN, Denmark, Sept. 04, 2020 (GLOBE NEWSWIRE) — Ascendis … Continue reading →

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pharmaphorum

AUGUST 16, 2022

On the same day as it reported encouraging new data for its cancer drug Trodelvy, Gilead Sciences has agreed a deal to buy rights to the drug in Asia held by Chinese drugmaker Everest Medicines. The new deal means that the licensing deal has been terminated, and the Chinese pharma is no longer on the hook for any remaining payments.

Licensing 52

Licensing Licensing Hormones Drugs 52

XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). Semaglutide acts as a glucagon-like peptide-1 (GLP-1) receptor agonist, mimicking the GLP-1 hormone released in the gastrointestinal tract after eating.

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pharmaphorum

MARCH 8, 2021

The cost-effectiveness agency is assessing use of Lynparza (olaparib) in patients with tumours that carry BRCA1 or BRCA2 mutations who have previously been treated with the hormone therapies abiraterone and enzalutamide but have relapsed.

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Drug Discovery World

APRIL 6, 2023

Men in England and Wales with advanced, incurable prostate cancer who have BRCA1/2 mutations in their tumours and who have seen their cancer progress despite hormone therapy will also have access to olaparib. NICE previously decided not to recommend the drug as a prostate cancer treatment due to the high cost of genetic testing.

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Delveinsight

JANUARY 5, 2021

Pfizer and OPKO Health: A step closer to FDA Nod for pediatric growth hormone deficiency (GHD) drug, Somatrogon. Pfizer and Opko had joined hands in 2014 to develop somatrogon , a pediatric growth hormone deficiency (GHD) drug. The drug has already received orphan drug designation in South Korea in October 2020.

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Hormones FDA Approval Trials Drugs 52

pharmaphorum

JULY 13, 2022

Merck & Co has added another clinical-stage drug to its oncology pipeline via a licensing agreement with Finland’s Orion for ODM-208, a prostate cancer candidate currently in phase 2 testing. It is rumoured to be near to announcing a $40 billion takeover bid for the biotech.

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pharmaphorum

JUNE 4, 2021

Presented as a late-breaker on the eve of the ASCO congress, VISION also revealed a 60% reduction in the risk of radiographic disease progression or death with the beta particle-emitting radioligand drug, the lead asset acquired as part of Novartis’ $2.1 The drug made $445 million in sales last year. months, compared to 3.4

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Hormones Licensing Licensing Drugs 73

pharmaphorum

FEBRUARY 21, 2022

AZ and Daiichi Sankyo are only releasing the top-line results for now, but said the drug demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) when compared to physicians’ choice of chemo – regardless of patients’ HER2 status.

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Pharmaceutical Technology

FEBRUARY 14, 2023

Alkaloids, natural dyes, drugs, proteins, and enzymes are some of the important classes of natural heterocyclic compounds essential for human life. The company filed heterocyclic composition patents in areas such as PAD4 inhibitors, factor Xa inhibitors, and nuclear hormone receptor modulators.

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pharmaphorum

MARCH 29, 2021

However, the CHMP said in its review that there are uncertainties about the benefits of Celltrion’s drug, including whether it can reduce the rate of hospitalisation in people with mild to moderate COVID-19. New drugs recommended. currently involved in driving a third wave infections in Europe.

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Antibody Hormones Medicine Licensing 78

The Pharma Data

NOVEMBER 24, 2020

25, 2020 /PRNewswire/ — RhoVac, a clinical stage company today announced that the American FDA has granted Fast Track Designation to the company’s drug candidate, RV001. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA. LUND, Sweden , Nov.

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Druggist

FEBRUARY 28, 2021

Melatonin is a hormone that is released at night by the pineal gland located in the brain. 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. Slenyto tablets have a specific licensed use. Can you get melatonin on Amazon.co.uk?

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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. GLP-1 is a hormone that is produced naturally in the brain and the gut in response to food ingestion.

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Clinical Trials Clinical Trials Trials Drugs 52

The Pharma Data

SEPTEMBER 15, 2020

The first of the two deals will focus on the development of Seattle Genetics’ LIV-1 inhibitor iadiratuzumab vedotin alone and in combination with MSD’s blockbuster immunotherapy drug Keytruda (pembrolizumab) as a treatment for triple-negative breast cancer, hormone receptor-positive breast cancer and other solid tumours which express LIV-1.

Genetics 52

Genetics Development Hormones Licensing 52

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. In April 2016, Janssen Biotech, Inc.

FDA Approval 52

FDA Approval Gene Hormones Licensing 52

Pfizer

JANUARY 27, 2023

The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. AUTHORIZED USE The U.S.

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Pfizer

AUGUST 15, 2022

The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. AUTHORIZED USE. anti-infectives). IMPORTANT SAFETY INFORMATION.

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XTalks

JUNE 20, 2022

Alnylam Pharmaceuticals, a leading RNA interference (RNAi) therapeutics biopharmaceutical company, announced it received approval from the US Food and Drug Administration (FDA) for its RNAi therapeutic Amvuttra (vutrisiran) for the treatment of the polyneuropathy of hereditary transthyretin-mediated (ATTR) amyloidosis in adults.

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FDA Approval Protein Genetics RNA 98

Delveinsight

JANUARY 7, 2021

Ikena secures USD 120 Million to advance a growing pipeline of cancer drugs. Ikena Oncology has bagged USD 120 million to develop its expanding pipeline of cancer drugs. The newer side of the pipeline points targeted oncology drugs. Terns raises USD 87 Million for NASH drugs. IND-enabling studies are underway.

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RNA Clinical Trials Clinical Trials Bioavailability 52

Druggist

OCTOBER 8, 2020

Not only lansoprazole and omeprazole are the two most common PPI, but they are also one of the most popular prescribed drugs in the UK. PPIs are the most effective drug in stopping the production of stomach acid. Lansoprazole vs Omeprazole: common side effects PPIs, as a class of drugs, have some common side effects (SE).

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Pharmacy Drugs Production Medicine 98

Delveinsight

AUGUST 2, 2020

Cachexia is observed as a result of underlying diseases, including cancer, AIDS, tuberculosis, chronic heart failure, hormonal deficiency, and others. Phase II randomised, double-blind, placebo-controlled study demonstrated that the drug as well-tolerated and a higher dose even helped in gaining weight.

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Marketing Pharma Companies Development Hormones 94

XTalks

SEPTEMBER 17, 2020

Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. For example, studies of heart attack prevention medications use the surrogate endpoint of low-density lipoprotein cholesterol (LDL-C) to assess the effectiveness of new drugs. What Is a Surrogate Endpoint?

Trials 98

Trials Gene Hormones Clinical Trials 98

Pfizer

DECEMBER 20, 2022

FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets).

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Drugs Licensing Licensing Containment 69

The Pharma Data

JULY 22, 2021

“Building on Pfizer’s established leadership position in breast cancer science and CDK 4/6 inhibition, we are excited to work with Arvinas to maximize ARV-471, the first PROTAC for breast cancer with encouraging early clinical data and a potential novel hormonal therapy backbone for HR+ breast cancer,” said Jeff Settleman, Ph.D.,

Protein 52

Protein Development HR Hormones 52

The Pharma Data

AUGUST 17, 2021

This new indication follows an FDA priority review of the Biologics License Application and is based on the collective results from the dMMR endometrial cancer cohort A1 and the dMMR solid-tumour (non-endometrial cancer) cohort F of the ongoing GARNET trial. [vii] JEMPERLI was discovered by AnaptysBio and licensed to TESARO, Inc.,

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FDA Approval Antibody DNA Hormones 52

The Pharma Data

DECEMBER 9, 2020

Our focus on partnering to accelerate patient access to innovative medicines underscores our commitment to advancing breakthroughs in biomedicine such as antibody drug conjugates, cell therapy, RNAi and more, Ed Zhang, company co-founder, chief operating and business officer, said in a statement. “We

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In-Vivo In-Vitro Antibody Development 52

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. Drug Enforcement Administration. .” It was granted orphan drug designation for the treatment of narcolepsy in 2010. Drug Interactions. About WAKIX® (pitolisant) Tablets.

FDA Approval 52

FDA Approval Hormones Production Drugs 52

The Pharma Data

MARCH 25, 2022

Food and Drug Administration (FDA) has extended the review of the supplemental biologics license application (sBLA) for Reblozyl® (luspatercept-aamt) for the treatment of anemia in adults with non-transfusion-dependent (NTD) beta thalassemia to June 27, 2022. Bristol Myers Squibb (NYSE: BMY) today announced that the U.S.

Licensing 52

Licensing Licensing Drugs Medicine 52

Drug Discovery World

FEBRUARY 20, 2023

AstraZeneca’s Evusheld became the first antibody combination for pre-exposure prophylaxis (PrEP) against Covid-19 licensed in the UK. The approval was based on results from the PROpel Phase III trial, however, the drug was rejected by UK regulator NICE because it requires expensive genetic testing.

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Drug Trials Trials Clinical Trials Clinical Trials 52

pharmaphorum

SEPTEMBER 21, 2022

Takeda has decided that there is a future for its aurora kinase A inhibitor alisertib after it failed a phase 3 trial in lymphoma – but the company won’t be taking the drug forward itself. The post Takeda farms out cancer drug alisertib to Puma Biotech appeared first on.

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Drugs HR Licensing Licensing 64

The Pharma Data

FEBRUARY 25, 2021

and Eli Lilly and Company (NYSE: LLY) announced today a collaboration and licensing agreement to integrate Welldoc’s software into Lilly’s connected insulin solutions, currently in development. Food and Drug Administration (FDA) for use by adults with type 1 or type 2 diabetes. Welldoc, Inc., About Lilly Diabetes.

Insulin 40

Insulin Medicine Hormones Development 40

Pfizer

DECEMBER 13, 2022

In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID for patients who are at high risk of progression to severe disease from COVID-19. The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is in February 2023.

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Drugs Licensing Licensing Production 110

Pfizer

JANUARY 27, 2023

Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1‐800‐822‐7967 or report online to www.vaers.hhs.gov/reportevent.html. AUTHORIZED USE The U.S.

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Druggist

MAY 6, 2021

It is also one of the most prescribed drugs overall in the UK. As with other drugs, it is possible to experience side effects during the treament or medicine may not be suitable. Metformin can commonly cause gastrointestinal side effects and this very often leads to switching to another drug. Drug classification.

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Insulin Branding Drugs Licensing 98