CLINSQUARE: CLINICAL RESEARCH COURSES
Wednesday, December 25, 2024
CLINSQUARE: Clinical Rsearch Courses by LIFEPRONOW
Home Blog Page 143

The U.S. FDA is alertes safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)

admin
-
0
The U.S. FDA is alertes safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)

Jan 14, 2020: The U.S. FDA is alerting the public that results from a clinical trial assessing safety shows possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin).

The cause of the cancer is uncertain, and cannot concluded that lorcaserin contributes to the cancer risk.  Clinical trial results evaluation will communicate the final conclusions and recommendations when completed our review.

Health care professionals should believe if the benefits of taking lorcaserin are likely to exceed the potential risks when deciding whether to prescribe or continue patients on lorcaserin.

Lorcaserin is a prescription medicine approved by FDA in 2012 for use with a reduced-calorie diet and increased physical activity in order to help weight loss in adults who are stout or are overweight and have weight-related medical problems.

Lorcaserin  increases feelings of fullness so that less food is eaten, available as a tablet (Belviq) and an extended-release tablet (Belviq XR). https://www.fda.gov/drugs/drug-safety-and-availability/safety-clinical-trial-shows-possible-increased-risk-cancer-weight-loss-medicine-belviq-belviq-xr

Impact Factor

admin
-
0
Impact Factor

Since a long time, Impact factor (IF) has been used as a key indicator of importance of a journal in a particular field. The founder of Institute for Scientific Information, Eugene Garfield has introduced it.


Let’s define it:

“In any given year, the impact factor of a journal is the number of citations, received in that year, of articles published in that journal during the two preceding years, divided by the total number of “citable items” published in that journal during the two preceding years.”

Impact factor (IF) of any journal can be calculated only after completing the minimum of 3 years of publication. It means it cannot be calculated for new journal which has not completed the desired period.

Example: 2018 impact factor =A/B
Where A is the number of times articles published in 2017 and 2016 were cited by indexed journals during 2018. B is the total number of citable items like articles and reviews published by that journal in 2017 and 2016. The 2018 Impact factors are actually published in 2019.

In this case, Impact factor can be calculated once all of the 2018 publications have been processed by the indexing agency.

Significance and limitation of Impact factor:

  • Most frequent use of impact factor is in academic evaluation (in Universities and research institutes). It gives a general idea for public about prestige of journals.
  • It is quite useful in clarifying the significance of absolute (or total) citation frequencies.
  • It eliminates one important bias which tends to favor large journals over small ones, or frequently issued journals over less frequently issued ones. It also reduces the bias of selecting older journals over newer ones.
  • Inclusion of review articles or letters can influence a journal’s impact and its ranking in journal lists. Review articles generally are cited more commonly than typical research article thus impact factor may get increased.
  • Limitation of completion of 3 years of publication.

Agency which calculate the Impact factors:  Clarivate Analytics

This agency began to publish Journal Citation Reports (JCR)  in 1975 as part of the SCI (Science Citation Index) and the Social Sciences Citation Index (SSCI).

“The JCR provides quantitative tools for ranking, evaluating, categorizing, and comparing journals. Some of the journals listed in the JCR are not citing journals, but are cited-only journals. This is significant when comparing journals by impact factor because the self-citations from a cited-only journal are not included in its impact factor calculation (impact factor without self-citation).”

  • It is important to note that all journals are Not tracked in the JCR database. It means those journal do not have impact factor (IF)
  • Young or new journals has to wait until they have a record of citations before even being considered for inclusion
  • We cannot be 100 percent sure about scientific worth of an individual article or research by just looking the impact factor.    

References:
https://clarivate.com/essays/impact-factor/
https://www.elsevier.com/authors/journal-authors/measuring-a-journals-impact
http://mdanderson.libanswers.com/faq/26159
https://www.researchgate.net/publication/265392569_Journal_Impact_Factor_Its_Use_Significance_and_Limitations
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4150161/#ref2

Bristol-Myers Squibb Company announced U.S. FDA accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC)

admin
-
0
Bristol-Myers Squibb Company announced U.S. FDA accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC)

Jan 15, 2020: Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) with Yervoy (ipilimumab) for the first-line treatment of patients with the metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

The FDA has granted the application Priority Review with the Prescription Drug User Fee Act (PDUFA) aim date of May 15, 2020.This application is based on data from Part 1 of the Phase 3 CheckMate -227 trial evaluating Opdivo plus Yervoy vs. chemotherapy in patients with previously untreated NSCLC, in which the double immunotherapy combination demonstrated significant improvement in overall survival vs. chemotherapy alone. The safety profile of the Opdivo plus Yervoy was consistent with previously reported studies and no new safety signals were observed.

CheckMate -227 is a multi-part open-label Phase 3 trial that evaluates Opdivo-based regimens vs. platinum-doublet chemotherapy in patients with the first-line advanced non-small cell lung cancer across non-squamous and squamous tumor histologies. https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-accepts-priority-review-bris-1

Imago Receives Fast Track Designation from U.S. FDA for Bomedemstat for the Treatment of Essential Thrombocythemia

admin
-
0
Imago Receives Fast Track Designation from U.S. FDA for Bomedemstat for the Treatment of Essential Thrombocythemia

Jan 12, 2020: Imago BioSciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of bomedemstat (IMG-7289) for the treatment of essential thrombocythemia (ET), a bone marrow disease linked with high platelet counts and potentially catastrophic vascular complications.

Bomedemstat inhibits the enzyme LSD1 (lysine-specific demethylase 1), as a result preventing excess platelet and neutrophil production.

The FDA grants Fast Track designation in order to facilitate development and expedite the review of therapies with the potential to treat a severe condition where there is an unmet medical need.

A therapeutic that receives Fast Track designation can benefit from the early and frequent communication with agency, in addition to a rolling submission of the marketing application, with the objective of getting important new therapies to patients more speedily.

Bomedemstat is a small molecule that was discovered by Imago BioSciences, inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme essential for the production and normal function of megakaryocytes and for self-renewal of the malignant hematopoietic stem or progenitor cells.

Megakaryocytes are the primary producer of the platelets and cytokines that drive essential thrombocythemia pathogenesis.

http://www.imagobio.com/imago-receives-fast-track-designation-from-u-s-fda-for-bomedemstat-for-treatment-of-essential-thrombocythemia/

MorphoSys and Incyte Sign Global Collaboration and License Agreement for Tafasitamab development for the treatment of the B cell malignancies

admin
-
0
MorphoSys and Incyte Sign Global Collaboration and License Agreement for Tafasitamab development for the treatment of the B cell malignancies

Jan 13, 2020: MorphoSys AG and Incyte Corporation  announced that the companies have entered into a collaboration and license agreement to further develop and commercialise MorphoSys’ proprietary anti-CD19 antibody tafasitamab (MOR208) globally.

Tafasitamab is an Fc-engineered antibody against CD19 currently in clinical development for the treatment of the B cell malignancies.

Both will co-commercialise tafasitamab in the US, while Incyte has exclusive commercialisation rights outside of the US.In the US, MorphoSys and Incyte will co-commercialize tafasitamab, with the MorphoSys leading the commercialization strategy and booking all the revenues from sales of tafasitamab.

They will be collectively responsible for commercialization activities in the US and will share profits and losses on a 50:50 basis.

Outside the US, Incyte will have exclusive commercialization rights, and will lead the commercialisation strategy and book all revenues from sales of tafasitamab, paying MorphoSys royalties on ex-US net sales.

Additionally, the companies will share development costs associated with global and US-specific trials at a rate of 55% (Incyte) to 45% (MorphoSys); Incyte will cover over 100% of the potential development costs for trials that are specific to ex-U.S. countries.

Both parties have agreed to co-develop tafasitamab broadly in relapsed/refractory diffuse large B cell lymphoma (r/r DLBCL), frontline DLBCL as well as additional indications beyond the DLBCL, such as the follicular lymphoma (FL), marginal zone lymphoma (MZL) and chronic lymphocytic leukemia (CLL).

MorphoSys recently submitted a Biologics License Application (BLA) for tafasitamab, in combination with lenalidomide, to the US Food and Drug Administration (FDA) for the treatment of r/r DLBCL; the FDA decision regarding a probable approval is expected by mid-2020.

The submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in r/r DLBCL is planned for the mid-2020. https://www.morphosys.com/media-investors/media-center/morphosys-and-incyte-sign-global-collaboration-and-license-agreement

CytoDyn Files for Breakthrough Therapy Designation with the FDA for the Use of Leronlimab as an adjuvant therapy for the Treatment of Metastatic Triple-Negative Breast Cancer

admin
-
0
CytoDyn Files for Breakthrough Therapy Designation with the FDA for the Use of Leronlimab as an adjuvant therapy for the Treatment of Metastatic Triple-Negative Breast Cancer

Jan. 13, 2020:  CytoDyn Inc. announced that the Company has filed for Breakthrough Therapy designation (BTD) with the U.S. Food and Drug Administration (FDA) for the use of leronlimab as adjuvant therapy for the treatment of metastatic triple-negative breast cancer (mTNBC).

The BTD filing is based on data as of the first patient in the Company’s mTNBC Phase 1b/2 trial and an additional single-patient trial under an emergency investigational new drug (IND) protocol evaluating leronlimab for the treatment of HER2+ metastatic, stage 4, breast cancer (MBC).

Data from the first patient in the Phase 1b/2 trial showed that the patient had no detectable circulating tumor cells (CTCs) or putative metastatic tumor cells in the peripheral blood and additional large reductions in CCR5 expression on cancer-associated cells at 11 weeks of treatment with the leronlimab.

This patient’s data also demonstrated tumor shrinkage of >20% after just a few weeks of treatment. The data from the patient under the emergency IND protocol with HER2+ metastatic, stage 4, MBC showed no sign of new metastatic spots in the liver, lung and brain during the treatment with leronlimab.


Breakthrough Therapy designation is a process designed to accelerate the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may display substantial improvement over available therapy on a clinically significant endpoint(s).


Triple-negative breast cancer (TNBC) is a type of breast cancer characterized by the absence of the three most common types of receptors in the cancer tumor known to fuel most breast cancer growth are estrogen receptors (ER), progesterone receptors (PR) and the hormone epidermal growth factor receptor 2 (HER-2) gene.

https://fda.einnews.com/pr_news/507047391/cytodyn-files-for-breakthrough-therapy-designation-with-the-fda-for-the-use-of-leronlimab-for-the-treatment-of-metastatic-triple-negative-breast

Ultragenyx and Kyowa Kirin Announce Submission of Supplemental Biologics License Application to U.S. FDA for Crysvita® (burosumab) for the treatment of Tumor-Induced Osteomalacia (TIO)

admin
-
0
Ultragenyx and Kyowa Kirin Announce Submission of Supplemental Biologics License Application to U.S. FDA for Crysvita® (burosumab) for the treatment of Tumor-Induced Osteomalacia (TIO)

Jan. 13, 2020: Ultragenyx Pharmaceutical Inc. and Kyowa Kirin Co., Ltd. announced that they submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) on December 18, 2019, for Crysvita® (burosumab) for the treatment of FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors (tumor-induced osteomalacia; TIO) that cannot be curatively resected or localized. The companies expect to hear back from FDA on submission acceptance and review designation in February 2020.

“Around half of patients suffering  with TIO have tumors that cannot be surgically removed, leaving them with no other current treatment options,” said Camille L. Bedrosian, M.D., Chief Medical Officer of Ultragenyx.

“We look forward to continuing to work closely with the FDA during the review process, with the goal of bringing Crysvita to patients with TIO in the U.S.”

The sBLA package includes data from the two single-arm Phase 2 studies, a 144-week study in 14 adult patients conducted by the Ultragenyx in the U.S. and an 88-week study in 13 adult patients conducted by the Kyowa Kirin in Japan and South Korea.

In both these studies, Crysvita was associated with increases in serum phosphorus and serum 1,25-dihydroxyvitamin D levels. Increased phosphate levels will led to improvements in osteomalacia, mobility and vitality also bone scans demonstrated in an increase in healed fractures and a decrease in new fractures during Crysvita treatment.

FDA also approved Crysvita for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients six months of age and older, and by Health Canada and Brazil’s National Health Surveillance Agency (ANVISA) for the treatment of XLH in the adult and pediatric patients one year of age and older.

Crysvita is approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) for the treatment of FGF23-related hypophosphatemic rickets and osteomalacia.

The medicine has received the European conditional marketing authorization for the treatment of XLH with radiographic evidence of bone disease in children 1 year of age and older and adolescents with the growing skeletons, and an application for the expanded use in adults with XLH is currently under review by the European Medicines Agency. https://fda.einnews.com/pr_news/507058520/ultragenyx-and-kyowa-kirin-announce-submission-of-supplemental-biologics-license-application-to-u-s-fda-for-crysvita-burosumab-for-tumor-induced

 

BioCryst to Provide Berotralstat and BCX9930 Program Updates at 38th Annual J.P. Morgan Healthcare Conference

admin
-
0
BioCryst to Provide Berotralstat and BCX9930 Program Updates at 38th Annual J.P. Morgan Healthcare Conference

Jan. 12, 2020:  BioCryst Pharmaceuticals, Inc. announced that the company will provide updates on berotralstat, an oral kallikrein inhibitor for hereditary angioedema (HAE), and BCX9930, an oral Factor D inhibitor for complement-mediated diseases, this week at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco.

“BioCryst is located for transformation in 2020 with the multiple global approvals and launches of the berotralstat, and PNH proof of the concept data with BCX9930.

The $100 million in additional capital we brought into the company in Q4 2019 provides a foundation for progress and value creation in 2020.”

As formerly announced, results from an ongoing three part Phase 1 trial of BCX9930 showed rapid, sustained and >95% suppression of the alternative pathway (AP) of the complement system at 100 mg every 12 hours, as calculated by the AP Wieslab® assay.

In two initial multiple ascending dose (MAD) assessment cohorts, healthy volunteers inward 50 mg or 100 mg of oral BCX9930 or placebo (each MAD cohort randomized 10:2) administered every 12 hours for seven days.

Healthy volunteers in the MAD cohorts were prophylactically dosed with broad-spectrum antibiotic, amoxicillin/clavulanate.  https://fda.einnews.com/pr_news/507012970/biocryst-to-provide-berotralstat-and-bcx9930-program-updates-at-38th-annual-j-p-morgan-healthcare-conference

FDA grants breakthrough device designation to Reflow Medical’s temporary spur stent system for the treatment of below-the-knee (BTK) peripheral artery disease

admin
-
0
FDA grants breakthrough device designation to Reflow Medical’s temporary spur stent system for the treatment of below-the-knee (BTK) peripheral artery disease

Jan 10, 2020: U.S. Food and Drug Administration (FDA) announced Reflow Medical’s Temporary Spur Stent System, a novel retrievable stent technology proposed for the treatment of below-the-knee (BTK) peripheral artery disease, designated for the Breakthrough Devices.

The Breakthrough Devices Program is designed in order to give patients and health care providers timely access to medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The program offers Reflow Medical the chance to interact with experts at the FDA throughout the premarket review phase, in order to help speed the development, assessment and review of the device.

The Temporary Spur Stent System is a novel combination device  that consist of a patented retrievable stent system having a series of radially expandable spikes designed to create multiple pathways in order to deliver antiproliferative drugs for increased uptake into the vessel wall and facilitate acute luminal gain, without leaving anything behind.

The device was developed in response to unmet clinical needs resulting in the high rates of restenosis and treatment challenges in patients with BTK disease. https://fda.einnews.com/article/506936937?lcf=8DWPqPuUsDVNDakfEIxsCA%3D%3D

Novartis ligelizumab (QGE031) more effective than Xolair®(omalizumab) at inhibiting immunoglobulin E pathway responsible for chronic spontaneous urticaria

admin
-
0
Novartis ligelizumab (QGE031) more effective than Xolair®(omalizumab) at inhibiting immunoglobulin E pathway responsible for chronic spontaneous urticaria

Jan 09, 2020: Novartis, a leader in immuno-dermatology, announced mechanistic study results showing ligelizumab is more efficient at inhibiting the major pathogenic IgE/FcεRI pathway in the chronic spontaneous urticaria (CSU), than current therapy. olair® (omalizumab).

Ligelizumab can bind to IgE with an 88-fold higher resemblance than Xolair. The data demonstrate ligelizumab and Xolair recognize and bind differently to IgE, with ligelizumab resulting in a considerably enhanced blockade of IgE/FcεRI signaling.

The data, published in The New England Journal of Medicine, shows an average complete response rate of 42% for 240 mg and 72 mg of ligelizumab at Week 12, compared with 26% for those taking 300 mg of Xolair. https://www.novartis.com/news/media-releases/novartis-ligelizumab-qge031-more-effective-xolair-inhibiting-immunoglobulin-e-pathway-responsible-chronic-spontaneous-urticaria

Bayer and Evotec form a new strategic alliance focusing on the treatment of polycystic ovary syndrome

admin
-
0
Bayer and Evotec form a new strategic alliance focusing on the treatment of polycystic ovary syndrome

Jan 09, 2020: Evotec SE and Bayer AG announced the expansion of their partnership in women’s health indications with a new five-year, multi-target collaboration to develop multiple clinical candidates for the treatment of polycystic ovary syndrome (“PCOS”).

As per  the terms of the agreement, both companies will contribute drug targets and a comprehensive set of high-quality technology platforms to jointly develop innovative treatment options. The strategic alliance will also have access to the targets from the recently formed partnership between Celmatix and Evotec.

Celmatix is the world leader in big data-driven target discovery that focuses on fertility and women’s health. “PCOS is a common, underdiagnosed and undertreated disease among women, with several serious co-morbidities.”

Evotec will receive € 6.5 m direct payment and € 10 m research payments over five years.

In addition, Evotec might be eligible in order  to receive pre-clinical, clinical and sales milestones of potentially over € 330 m as well as royalties up to low double-digit percentages of net sales.

In 2012, Bayer and Evotec entered their first strategic five-year, multi-target alliance. The collaboration was productively completed resulting in three clinical and one pre-clinical drug candidate currently advancing during development for the treatment of endometriosis.

A second research alliance was initiated in 2016 to develop multiple clinical candidates for the treatment of kidney diseases. https://www.evotec.com/en/invest/news–announcements/p/bayer-and-evotec-form-new-strategic-alliance-focusing-on-polycystic-ovary-syndrome-5893

Approval pathways of Fixed dose combination (FDC) in India

admin
-
0
Approval pathways of Fixed dose combination (FDC) in India

Fixed dose combination (FDC) approval process is a little different from the drug approval process in India.
FDC can be divided into 5 major parts:
Category 1: FDC  which are not marketed in India and one or more active ingredient(s) is a new drug not approved in India.

It may be further divided into two parts:
Sub Category I: One of the ingredients of the FDC is an Investigational New Drug (IND). 

Sub Category II: One or more of the active ingredients of the FDC is a New Drug not approved individually in India but they are approved in other countries. 

In simplest terms we can say that, at least one active ingredients of proposed FDC should not be approved in India.

Category  2:
FDC which is not marketed in India but the active ingredients are approved/ marketed individually and there is possibility of  PK/PD interactions among ingredients if given as FDC.

It can be divided into three parts:
Sub Category I: FDC which is approved in other countries

Sub Category II: FDC, which is not marketed anywhere but individual active ingredients used concomitantly.

Sub Category III: FDC, which is not marketed and individual active ingredients are not used concomitantly
In simplest terms, all the active ingredients of FDC should be approved individually in India.
Category 3 :  FDC which are marketed in India but some changes are sought.

Category 4: FDC which are Only for convenience (no significant changes from clinical point of view)

Category 5: Approvals of a FDC already approved in the country.
Documents needs to be submitted as per proposed FDC category, Indication and nature of drugs etc.

Requirements of Clinical and Non Clinical Data

  • If the Fixed dose combination is not marketed in India, and one or more of its active ingredients are not approved in any country:  In this case first applicants for each proposed FDCs must conduct a full, four-phase clinical trial.
  • If the FDC is marketed in other countries. In this case only the Phase III clinical trial (‘bridging studies’) is needed.
  • If  active ingredients of FDCs are approved and marketed in India and FDC is approved in other countries, then regulatory authority asks for in vitro studies.
  • If FDC is not marketed in any other country but has a history of concomitant use in India; then only ‘adequate evidence’ of their safe and effective concomitant use may be necessary for approval ( if published data is not available).
  • If applicant is seeking minor changes for the FDCs marketed in India, then regulatory authority asks for in vitro studies. BA/BE study is necessary if regulatory authority is not satisfied with the claim.

 The same guidelines are applicable to FDCs which are combined only to bring convenience, and whose individual ingredients have been in concomitant clinical use.

Follow the link for List of approved FDCs (Fixed Dose Combinations) Approved by DCG (I) Since 1961 Till February, 2013:http://www.cdsco.nic.in/Approved%20FDCs%20by%20DCG(I).pdf

References: https://journals.sagepub.com/doi/full/10.1177/0971721818762931
http://www.globalresearchonline.net/journalcontents/v13-2/004.pdf
https://www.jbsoweb.com/admin/php/uploads/298_pdf.pdf https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI1MQ==

1...142143144...156Page 143 of 156

EDITOR PICKS

POPULAR POSTS

POPULAR CATEGORY

ABOUT US

LifeProNow provides guidance and high quality contents to help job seekers to get their dream Job. All the contents are written by experienced folks and peer reviewed by experts.

Contact us: [email protected]

FOLLOW US

© LifeProNow | All Rights Reserved