Monthly Archives: June 2020

For someone with a food or drug allergy, the risk of life-threatening anaphylactic shock lurks around every corner. A new Northwestern Medicine study shows there might be a pill that can be taken proactively to prevent mild to life-threatening anaphylaxis, no matter the cause.Anaphylaxis is a severe, potentially life-threatening systemic allergic reaction that can occur within seconds or minutes of exposure to an allergen. It occurs in about one in 50 Americans, though many believe the rate is higher (closer to one in 20), according to the Asthma and Allergy Foundation of America. If a persons blood pressure drops so low during anaphylaxis or their airway closes up enough that they cant get enough oxygen to their organs, they enter anaphylactic shock.

The study used three different BTK inhibitors, which blocked allergic reactions when tested on human mast cells in a test tube. Additionally, the study used one U.S. Food and Drug Administration-approved oral drug, which successfully reduced or prevented allergic reactions, including severe, life-threatening anaphylactic reactions, in a new humanized mouse model of anaphylaxis. The mouses organs contained transplanted human cells that, over several months, matured into human mast cells, the primary cells that react during allergic reactions.

This would be the first known treatment to prevent anaphylaxis other than avoiding the allergen. The findings could pave the way for future human clinical trials of such oral drugs to be used as a preventive treatment to avoid serious allergic reactions, said senior and corresponding author Dr. Bruce Bochner, the Samuel M. Feinberg Professor of Medicine at Northwestern University Feinberg School of Medicine.

This pill could quite literally be life-changing and life-saving, Bochner said. Imagine being able to take medication proactively to prevent a serious allergic reaction.

Additionally, Bochner said people who are at high risk of allergic exposures to life-saving antibiotics or people about to undergo oral food desensitization (gradually eating foods to build up a threshold to an allergic reaction) could take the pill as a preventive measure. If such drugs turn out to be safe and cheap enough for daily use, theoretically anyone with a serious allergy, including food allergies, could take it and be able to eat the foods theyve been strictly avoiding, Bochner said.

For now, Bochner said the drug would likely be used preventatively, not for emergencies, like an EpiPen, which injects epinephrine into someone experiencing an allergic reaction to reverse the symptoms. But he and his team are considering exploring whether this sort of medication could be reformulated to be added to the EpiPen to be injected along with the epinephrine to see if it would better stop or abort anaphylaxis after it has begun.

Inhibition of skin tests is a kind of a surrogate test for whether the drug is actually working, Bochner said. So, one future goal is to give this medication to food- or drug-allergic subjects, show by skin testing that their allergic sensitivity has been blocked by the drugs effect and then give them the food or drug, expecting they will have little or no reaction.

BTK inhibitors are currently on the market for approximately $500 per day as a successful and less-toxic alternative to chemotherapy for patients with blood cancers like chronic lymphocytic leukemia and mantle cell lymphoma. They are not yet approved for use in children, who are more likely to have food allergies.

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Food and Drug Allergy Anaphylaxis Could Be Prevented With a Pill - Technology Networks

Scientists have characterized the specific way SARS-CoV-2, which is the coronavirus that causes COVID-19, infects the nasal cavity to a great degree.

The new study published in the journal Cell suggests that the virus first tends to firmly establish itself in the nasal cavity, but it can then be aspirated into the lungs -- where it wreaks havoc and can lead to pneumonia.

Scientists at the UNC School of Medicine and the UNC Gillings School of Global Public Health believe their study supports the widespread wearing of masks as a way to prevent infection.

"If the nose is the dominant initial site from which lung infections are seeded, then the widespread use of masks to protect the nasal passages, as well as any therapeutic strategies that reduce virus in the nose, such as nasal irrigation or antiviral nasal sprays, could be beneficial," said study co-senior author Richard Boucher, a professor of medicine and director of the Marsico Lung Institute at the UNC School of Medicine, in a statement.

COVID-19 COULD BE SEASONAL ILLNESS THAT RETURNS AS HUMIDITY DECREASES, NEW STUDY SAYS

SARS-CoV-2 (red) infected ciliated cells in the COVID-19 patient's bronchi. (Takanori Asakura, PhD, UNC School of Medicine) (Takanori Asakura, PhD, UNC School of Medicine)

SARS-CoV-2, which first appeared in late 2019 in Wuhan, China and spread around the world, has now infected more than 6.4 million and killed 382,451. The U.S. accounts for almost one-third of the global infections and deaths.

"This is a landmark study that reveals new and unexpected insights into the mechanisms that regulate disease progression and severity following SARS-CoV-2 infection," said Ralph Baric, a professor of epidemiology at the UNC Gillings School of Public Health. "In addition, we describe a new reverse genetic platform for SARS-CoV-2 allowing us to produce key indicator viruses that will support national vaccine efforts designed to control the spread and severity of this terrible disease."

SOME SCIENTISTS FEAR 'SUPERSPREADERS' MAY PROMPT NEW COVID-19 OUTBREAKS AS STATES REOPEN

Scientists were hoping to gain a stronger understanding of which cells in the airways the virus infects and how it gets into patients' lungs when they develop pneumonia.

Researchers used different isolates of SARS-CoV-2 to see how efficiently they could infect cultured cells from different parts of the human airway for one of the study's experiments. They discovered a pattern of continuous variation, or gradient, from a relatively high infectivity of SARS-CoV-2 in cells lining the nasal passages, to less infectivity in cells lining the throat and bronchia, to relatively low infectivity in lung cells.

The scientists also found that ACE2, the cell surface receptor that the virus uses to get into cells, was more abundant on nasal-lining cells and less abundant on the surface of lower airway cells. This difference could explain, at least in part, why upper airway nasal-lining cells were more susceptible to infection.

The hypothesis that aspiration of oral contents into the lung is a strong contributor to COVID-19 pneumonia is consistent with observations that people at higher risk for severe lung disease -- the elderly, obese, and diabetic -- are more prone to aspiration (the process of drawing breath), especially at night.

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New map of SARS-CoV-2 infection in nasal cavity provides more support for wearing masks, researchers say - Fox News

Global Stem Cell Banking Market: Overview

The demand within the global stem cell banking market is growing on account of advancements in the field of regenerative medicine. The medical fraternity has become extremely focused towards the development of artificial tissues that can infuse with the human body. Furthermore, medical analysis and testing has gathered momentum across biological laboratories and research institutes. Henceforth, it is integral to develop stem cell samples and repositories that hold relevance in modern-day research. The need for regenerative medicine emerges from the growing incidence of internal tissue rupture. Certain types of tissues do not recover for several years, and may even be damaged permanently. Therefore, the need for stem cell banking is expected to grow at a significant pace.

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In a custom report, TMR Research digs into the factors that have aided the growth of the global stem cell banking market. The global stem cell banking market can be segmented on the basis of bank size, application, and region. The commendable developments that have incepted across the US healthcare industry has given a thrust to the growth of the North America stem cell banking market.

Global Stem Cell Banking Market: Notable Developments

The need for improved regenerative medication and anatomy has played an integral role in driving fresh developments within the stem cell banking market.

Gallant has emerged as a notable market entity that has remained as the torchbearer of innovation within the global stem cell banking market. The company has recently launched stem cell banking for dogs, and has attracted the attention of the masses. As people become increasingly concerned about their pets, the new move by Gallant shall help the company in earning the trust of the consumers. Moreover, it can move several notches higher on the innovation index.

Cells4Life has also remained at the forefront of developments within the global stem cell banking market. After suffering backlash for its error in cord blood stem cell promotion, the company is expected to use effective public relation strategies to regain its value in the market.

Global Stem Cell Banking Market: Growth Drivers

Development of improved facilities for storage of stem cells has played an integral role in driving market demand. Furthermore, the unprecedented demand for improved analysis of regenerative medications has also created new opportunities within the global stem cell banking market. Medical research has attracted investments from global investors and stakeholders. The tremendous level of resilience shown by biological researchers to develop stem cell samples has aided market growth. Henceforth, the total volume of revenues within the global stem cell banking market is slated to multiply.

Commercialization of stem cell banks has emerged as matter of concern for the healthcare industry. However, this trend has also helped in easy storage and procurement of cells stored during the yester years of children. Presence of sound procedures to register at stem cell banks, and the safety offered by these entities, has generated fresh demand within the global market. New regional territories are opening to the idea of stem cell banking. Several factors are responsible for the growth of this trend. Primarily, improvements in stem cell banking can have favourable impact on the growth of the healthcare industry. Moreover, the opportunities for revenue generation associated with the development of functional stem cell banks has aided regional market growth.

The global stem cell banking market is segmented on the basis of:

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Stem Cell Banking Market Scope, Consumption and Opportunities Analysis 2018 2028 - Cole of Duty

First approvals for BRUKINSA in China and its first indication for relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma

BEIJING, China and CAMBRIDGE, Mass., June 03, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that its BTK inhibitor BRUKINSA (zanubrutinib) has received approval from the China National Medical Products Administration (NMPA) in two indications the treatment of adult patients with chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL) who have received at least one prior therapy, and the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Both new drug applications (NDAs) were previously granted priority review by the Center for Drug Evaluation (CDE) of the NMPA.

BRUKINSA received accelerated approval from the U.S. Food and Drug Administration (FDA) as a treatment for MCL in adult patients who have received at least one prior therapy in November 2019.

The concurrent approvals of BRUKINSA in R/R CLL/SLL and R/R MCL are a tribute to the collective expertise and hard work of the BeiGene team. With two product approvals covering four indications in China and one in the United States in merely seven months, we continue to focus on execution in advancing our broad portfolio, commented John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene.

Following in the footsteps of tislelizumab, BRUKINSA is the second BeiGene internally-developed drug approved in China, another significant expansion in our growing commercial portfolio. These approvals would not have been possible without the many clinicians and patients who participated in our trials and the support of the health authorities, commented Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. We look forward to launching BRUKINSA in China, a potentially best-in-class BTK inhibitor with extensive global data from nine Phase 3 or potentially registration-enabling studies including a head-to-head comparison trial that was recently presented at the American Society of Clinical Oncology Annual Meeting.

The NMPA Approval in R/R CLL/SLL

The NMPA approval of BRUKINSA in patients with R/R CLL/SLL is based on results from a single-arm pivotal Phase 2 trial conducted in 91 patients (82 with R/R CLL; nine with R/R SLL) in China (NCT03206918; BGB-3111-205). Clinical efficacy data in the BRUKINSA label in China, as assessed by independent review committee (IRC) per iwCLL 2008 criteria for CLL and Lugano Classification 2014 for SLL, include an overall response rate (ORR) of 62.6%, including a complete response (CR) rate of 3.3%, a partial response (PR) rate of 59.3%, and the PR with lymphocytosis (PR-L) rate was 22%.

The most common adverse reactions reported in the label in China (10%) were neutropenia (68.1%), thrombocytopenia (40.7%), hematuria (35.2%), purpura (34.1%), anemia (23.1%), leukopenia (18.7%), pneumonia (18.7%), upper respiratory tract infection (15.4%), hemorrhage (14.3%), and rash (12.1%). The incidence of Grade 3 adverse reactions was 69.2%. The incidence of serious adverse reactions was 19.8%, and the most common serious adverse reaction was pneumonia (11.0%).

The approval of BRUKINSA will provide an important treatment option for Chinese patients with relapsed/refractory CLL/SLL. In addition to BRUKINSAs significant anti-tumor activity evidenced by an ORR of more than 60%, the drug demonstrated a favorable safety and tolerability profile, commented Jianyong Li, M.D., Professor and Director of the Department of Hematology and Director of the Pukou CLL Center at the First Affiliated Hospital of Nanjing Medical University.

The NMPA Approval in R/R MCL

The NMPA approval of BRUKINSA in patients with R/R MCL is based on results from a single-arm pivotal Phase 2 trial conducted in 86 patients in China (NCT03206970; BGB-3111-206). Clinical efficacy data in the BRUKINSA label in China, as assessed by IRC per Lugano Classification 2014, include the ORR of 83.7%, including a CR rate of 68.6% and a partial response PR rate of 15.1%.

The most common adverse reactions (10%) reported in the label in China were neutropenia (47.7%), rash (32.6%), leukopenia (31.4%), thrombocytopenia (30.2%), and anemia (11.6%). The incidence of serious adverse reactions was 15.1%, and common serious adverse reactions (2%) included pneumonia (8.1%), hemorrhage (2.3%), and thrombocytopenia (2.3%).

BRUKINSA has shown promise in hematologic malignancies including in patients with relapsed/refractory MCL. With robust results including a 68.6% CR rate in the MCL trial, we are optimistic and excited about the clinical benefits BRUKINSA can bring to these patients, said Jun Zhu, M.D., Ph.D., Professor and Director of the Department of Internal Medicine and Lymphoma, Peking University Cancer Hospital.

The recommended dose of BRUKINSA in Chinese Package Insert is 160 mg twice daily taken orally with or without food. The dose may be adjusted for adverse reactions, and reduced for patients with severe hepatic impairment and certain drug interactions.

About Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are forms of non-Hodgkin lymphoma, a type of blood cancer, that arise from B lymphocytes. CLL and SLL are essentially the same disease, with the only difference being the location where the cancer primarily occurs.i When most of the cancer cells are located in the peripheral blood and the bone marrow, the disease is referred to as CLL, although the lymph nodes and spleen are often involved. When the cancer cells are located mostly in the lymph nodes, the disease is called SLL.ii According to epidemiological statistics, 88,200 patients are newly diagnosed with lymphoma each year in China, with NHL accounting for approximately 91%. Among all the NHL incidences, patients with B-cell NHL account for 66%, and CLL or SLL accounts for approximately 6.4% of all B-cell NHL incidences, indicating that the number of patients with CLL/SLL reaches approximately 3,390 in all patients (88,200) newly diagnosed with lymphoma each year.iii

About Mantle Cell Lymphoma

Lymphoma is a diverse group of cancers that originate from B-, T- or NK-cells. MCL is typically an aggressive form of non-Hodgkins lymphoma (NHL) that arises from B-cells originating in the mantle zone.iv According to epidemiological statistics, 88,200 patients are newly diagnosed with lymphoma each year in China, with NHL accounting for approximately 91%. Among all the NHL incidences, patients with B-cell NHL account for 66%, and MCL accounts for approximately 5% of B-cell NHL incidences, equivalent to over 2,600 newly diagnosed cases each year.v MCL usually has a poor prognosis, with a median survival of three to four years,vi and is often diagnosed at a later stage of disease.

About BRUKINSA (zanubrutinib)

BRUKINSA (zanubrutinib) is a small molecule inhibitor of Brutons tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad pivotal clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

BRUKINSA was granted accelerated approval by the U.S. FDA to treat adult patients with MCL who have received at least one prior therapy in November 2019. This accelerated approval is based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. BRUKINSA was granted approval in China for the treatment of MCL in adult patients who have received at least one prior therapy and CLL or SLL in adult patients who have received at least one prior therapy in May 2020.

BRUKINSA is not approved for use outside of the United States and China.

IMPORTANT U.S. SAFETY INFORMATION FOR BRUKINSA (ZANUBRUTINIB)

Warnings and Precautions

Hemorrhage

Fatal and serious hemorrhagic events have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher bleeding events including intracranial and gastrointestinal hemorrhage, hematuria and hemothorax have been reported in 2% of patients treated with BRUKINSA monotherapy. Bleeding events of any grade, including purpura and petechiae, occurred in 50% of patients treated with BRUKINSA monotherapy.

Bleeding events have occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Co-administration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.

Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections

Fatal and serious infections (including bacterial, viral, or fungal) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher infections occurred in 23% of patients treated with BRUKINSA monotherapy. The most common Grade 3 or higher infection was pneumonia. Infections due to hepatitis B virus (HBV) reactivation have occurred.

Consider prophylaxis for herpes simplex virus, pneumocystis jiroveci pneumonia and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately.

Cytopenias

Grade 3 or 4 cytopenias, including neutropenia (27%), thrombocytopenia (10%) and anemia (8%) based on laboratory measurements, were reported in patients treated with BRUKINSA monotherapy.

Monitor complete blood counts during treatment and treat using growth factor or transfusions, as needed.

Second Primary Malignancies

Second primary malignancies, including non-skin carcinoma, have occurred in 9% of patients treated with BRUKINSA monotherapy. The most frequent second primary malignancy was skin cancer (basal cell carcinoma and squamous cell carcinoma of skin), reported in 6% of patients. Advise patients to use sun protection.

Cardiac Arrhythmias

Atrial fibrillation and atrial flutter have occurred in 2% of patients treated with BRUKINSA monotherapy. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher events were reported in 0.6% of patients treated with BRUKINSA monotherapy. Monitor signs and symptoms for atrial fibrillation and atrial flutter and manage as appropriate.

Embryo-Fetal Toxicity

Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for at least 1 week after the last dose. Advise men to avoid fathering a child during treatment and for at least 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Adverse Reactions

The most common adverse reactions in > 10% of patients who received BRUKINSA were neutrophil count decreased (53%), platelet count decreased (39%), upper respiratory tract infection (38%), white blood cell count decreased (30%), hemoglobin decreased (29%), rash (25%), bruising (23%), diarrhea (20%), cough (20%), musculoskeletal pain (19%), pneumonia (18%), urinary tract infection (13%), hematuria (12%), fatigue (11%), constipation (11%), and hemorrhage (10%). The most frequent serious adverse reactions were pneumonia (11%) and hemorrhage (5%).

Of the 118 patients with MCL treated with BRUKINSA, 8 (7%) patients discontinued treatment due to adverse reactions in the trials. The most frequent adverse reaction leading to treatment discontinuation was pneumonia (3.4%). One (0.8%) patient experienced an adverse reaction leading to dose reduction (hepatitis B).

Drug Interactions

CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily.

CYP3A Inducers: Avoid coadministration with moderate or strong CYP3A inducers.

Specific Populations

Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.

INDICATION

BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Please see full U.S. Prescribing Information at beigene.com/PDF/BRUKINSAUSPI.pdf and Patient Information at beigene.com/PDF/BRUKINSAUSPPI.pdf

About the Zanubrutinib Clinical Trial Program

Clinical trials of zanubrutinib include:

About BeiGene

BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide. Our 3,800+ employees in China, the United States, Australia, and Europe are committed to expediting the development of a diverse pipeline of novel therapeutics for cancer. We currently market two internally-discovered oncology products: BTK inhibitor BRUKINSA (zanubrutinib) in the United States, and anti-PD-1 antibody tislelizumab in China. We also market or plan to market in China additional oncology products licensed from Amgen Inc., Celgene Logistics Srl, a Bristol Myers Squibb (BMS) company, and EUSA Pharma. To learn more about BeiGene, please visit http://www.beigene.com and follow us on Twitter at @BeiGeneUSA.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGenes plans and expectations for the commercialization of BRUKINSA, the potential implications of clinical data for patients, and BeiGenes further advancement of, and anticipated clinical development, regulatory milestones and commercialization of BRUKINSA and its other products and product candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGenes limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; the impact of the COVID-19 pandemic on the Companys clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled Risk Factors in BeiGenes most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

Investor Contact Media Contact

Craig West Liza Heapes or Vivian Ni

+1 857-302-5189 + 1 857-302-7596

ir@beigene.com media@beigene.com

__________________________i Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Fact Sheet, Lymphoma Research Foundation. Accessed at: https://www.lymphoma.org/wp-content/uploads/2018/04/LRF_FACTSHEET_CLL_SLL.pdf

ii Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Lymphoma Research Foundation. Accessed at: https://www.lymphoma.org/aboutlymphoma/cll/

iii Chen W, Zheng R , Baade P D , et al. Cancer statistics in China, 2015[J]. CA: A Cancer Journal for Clinicians, 2016, 66(2):115-132.

iv https://www.lls.org/sites/default/files/file_assets/mantlecelllymphoma.pdf

v Li, et al. Journal of Diagnostics Concepts & Practice, 2012,11(2): 111-115

vi Philip J. Bierman, James O. Armitage, in Goldman's Cecil Medicine (Twenty Fourth Edition), 2012.

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BeiGene Announces the Approval of BRUKINSA (Zanubrutinib) in China for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small...