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FDA approves Elzonris for the treatment of a rare blood disease.


FDA recently approved the use of Elzonris (tagraxofusp-erzs) infusion for the treatment of BPDCN, blatic plasmacytoid dendritic cell neoplasm in pediatric patients two years and older and in adults [1]. A Breakthrough Therapy and Priority review designation has been granted to Elzonris. It has also received an Orphan Drug status which generates incentives to encourage and assist the development of rare disease drugs. The FDA approval was granted to Stemline Therapeutics.

BPDCN is a rare and aggressive form of rare disease that affects the blood and bone marrow in turn affecting various organs including the skin and lymph nodes. It can be presented as leukemia or can eventually evolve into acute leukemia. Men are more commonly affected by the disease especially those 60 years or older. The approval was based on data from studies in two cohorts of patients in a single-arm clinical trial. 13 patients with untreated BPDCN were included in the first trial cohort and seven of them (approximately 54%) achieved complete remission (CR) or achieved CR with a skin abnormality that is not a characteristic of the active disease (CRc). The second group contained 15 patients with refractory or relapsed BPDCN. One patients achieved Crc and one achieved CR. A boxed warning has been issued on the label for Elzonris to inform patients and health care professionals about the increased risk of capillary leak syndrome that could be life-threatening to patients in treatment. Some of the more common laboratory abnormalities were decrease in albumin, platelets, lymphocytes and calcium and increase in liver enzymes (ALT and AST) and levels of glucose. Some of the common side-effects observed in the clinical trials included fatigue, nausea, capillary leak syndrome (fluids and proteins leaking out into tiny blood vessels into surrounding tissues), fever, chills, swelling of legs and arms. Health care providers have been advised to monitor levels of liver enzymes and check for signs of intolerance to infusion. Pregnant women have been advised not to take Elzonris as it may cause harm to the fetus or newborn baby.


“Prior to today’s approval, there had been no FDA approved therapies for BPDCN. The standard of care has been intensive chemotherapy followed by bone marrow transplantation. Many patients with BPDCN are unable to tolerate this intensive therapy, so there is an urgent need for alternative treatment options,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

 

FDA announces the approval of a new treatment for adults with a life-threatening and rare blood disease.


FDA recently approved Ultomiris (ravulizumab) injection for adult patients with a rare and life-threatening blood disease called paroxysmal nocturnal hemoglobinuria (PNH) [2]. Ultomiris has received a Priority Review designation as well as an Orphan drug designation which will serve as an incentive for the development of drugs targeting such rare diseases. The approval was given to Alexion Pharmaceuticals.

Hemolysis (rupture or destruction of red blood cells) is the general outcome of the rare, acquired disorder, PNH. Patients with a missing protein, usually used to protect red blood cells from being destroyed, are the ones who are more prone to develop PNH. Certain stress conditions such as infections of physical exertions may lead to or trigger episodes of premature destruction of the red blood cells. Some of the symptoms associated with PNH include intermittent passage of dark colored urine, fatigue, kidney disease and associated pain, severe anemia and shortness of breath. PNH is usually diagnosed in young adulthood but can occur at any age. Ultomiris targets and prevents hemolysis by acting as a complement inhibitor. The approval was based on two clinical trials to determine the efficacy of Ultomiris. The first clinical trial included 246 treatment naïve patients, who had not been treated for PNH before and were randomized for treatment with Ultomiris or eculizumab. The results from this study were similar for both, i.e., patients did not receive any transfusion and had similar incidence of hemolysis as measured by the normalization of patient’s blood LDH levels. A second clinical trial was conducted that involved 195 patients with PNH who were stable after being treated with eculizumab for at least 6 months. There was a random selection of the patients to either continue eculizumab or to be treated with Ultomiris. The latter again showed similar effects as eculizumab based on hemolysis and no transfusions. Some of the common side-effects associated with the trials included upper respiratory infection and headache. A boxed warning has been issued for healthcare providers and patients about the risks of sepsis and meningococcal infections that could become fatal. Patients are expected to be immunized with meningococcal vaccine at least 2 weeks before the first dose of Ultomiris, unless delaying it overpowers the risk of developing the infection. Health care providers have been advised to consider recommendations from the most current Advisory Committee on Immunization Practices (ACIP) for patients with complement deficiencies related to meningococcal infections. Vaccination will not eliminate the chances of developing the infection and patients should be monitored for symptoms. Ultomiris is presently available only under a Risk Evaluation and Mitigation Strategy (REMS). A medication guide should be provided along with Ultomiris explaining the risks and providing necessary information about it.


“The approval of Ultomiris will change the way that patients with PNH are treated. Prior to this approval, the only approved therapy for PNH required treatment every two weeks, which can be burdensome for patients and their families. Ultomiris uses a novel formulation so patients only need treatment every eight weeks, without compromising efficacy,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

 

FDA approves the marketing of a diagnostic test to determine and measure the amount of nutrients present in breast milk.


FDA recently approved a new diagnostic test, Miris Human Milk Analyzer, to measure the amount of nutrients in breast milk [3]. The health care providers will be able to determine the concentration of fat, proteins, carbohydrates, total solids and energy by using the test. This is a very innovative invention since the diagnostic test is a first of its kind and will be extremely beneficial in managing the nutritional requirements of newborns and young infants who were delivered prematurely or who have other medical conditions. Miris AB received the marketing authorization from FDA. De Novo premarket review pathway, is a regulatory pathway for new devices of low-to-moderate-risk and the Miris Human Milk Analyzer was reviewed using this pathway. The FDA will also issue special controls to determine and provide for the reliability and accuracy of the tests to measure the nutritional composition of breast milk. This will ensure better regulation of the nutritional requirements of a new born or an infant. These special controls must be satisfied along with general controls for the test to be effective.

Breast milk composition is known to vary between individuals. Hence infants who are born prematurely or with certain health issues may have special nutritional needs. It is therefore very important to be informed about the breast milk composition so that any deficiencies or special needs can be met with. A knowledge about the macronutrient content will help parents and health care providers make informed decisions about the dietary needs of the infants. It is for this reason that the Human Milk Analyzer diagnostic test is a necessity. It uses infrared spectroscopy system to analyze the samples of human milk and gives a quantitative measurement of the corresponding protein, fat and carbohydrate content and an estimate of the total solids and energy content contained in milk. This is a prescription device that is supposed to be used only by trained health care professionals at clinical laboratories. The approval was made based on data submitted by the sponsor of 112 samples of human milk to determine the efficacy of the device. The samples were tested by the machine and compared to the expected values that were obtained by independent methods. Both generated similar results for each test. It was concluded that the Miris Human Milk Analyzer was effective in determining the levels of fat, carbohydrate and fat in human milk. These values may at times be influenced by medications that a nursing mother may be taking. Hence this factor needs to be kept in mind along with clinical assessments like weight and growth before developing a nutritional plan for newborns or infants.

Breast milk benefits

From Visually.

 

“Breast milk provides many health benefits to infants, and for many babies it can meet their early nutritional needs. But some infants — including those who may be born preterm or have certain health conditions — may need additional nutrients to support their optimal growth,” said Courtney Lias, Ph.D. director of the Division of Chemistry and Toxicology Devices in the FDA’s Center for Devices and Radiological Health. “For the first time, doctors have access to a test to help analyze the nutrients in breast milk. While this test is not for everyone, it has the potential to aid parents and healthcare providers, mainly in a hospital setting, in better assessing the nutrient needs of certain babies who are not growing as expected.”

 

FDA approves a treatment for the “off episodes” of patients with Parkinson’s disease.


FDA recently approved the use of INBRIJATM for the intermittent treatment of the “Off episodes” of patients with Parkinson’s disease and those treated with levodopa/carbidopa [4]. The standard oral baseline Parkinson’s treatment is the use of oral carbidopa/levodopa. Off episodes are referred to the return of Parkinson’s symptoms arising from reduction in levels of dopamine between the oral baseline treatment of carbidopa. The approval was given to Acorda Therapeutics.

The gradual loss of certain dopamine-producing neurons in the brain leads to the classification of Parkinson’s disease as a progressive neurodegenerative disorder. The reduction in dopamine production leads to muscle stiffness, tremors and impaired movements. The Off periods set in with the progression of the disorder and are characterized by the return of the symptoms of the Parkinson’s disease despite the baseline therapy. Around 40 percent of people in the US experience Off periods. To combat this, INBRIJA is the first and only inhaled levodopa used for the intermittent treatment of Off episodes in patients with Parkinson’s treated with carbidopa/levodopa. INBRIJA uses Acorda’s innovative ARCUS platform for inhaled therapeutics. A Marketing Authorization Application (MAA) for INBRIJA was formally accepted in May 2018. The ARCUS Technology Platform facilitates the systemic delivery of medicines through the inhalation technique by converting the molecules into light, porous, dry powder thus allowing the use of higher doses. The approval was based on the data from a clinical program involving 900 patients with Parkinson’s on a carbidopa/levodopa regimen experiencing Off periods. SPANSM-PD was the Phase 3 pivotal efficacy trial. It was a 12-week, placebo controlled, randomized, double blind study evaluating the efficiency of INBRIJA in patients with Parkinson’s, experiencing Off periods. INBRIJA met the primary endpoint as patients showed a statistically significant improvement in motor function at week 12, measured by the Unified Parkinson’s Disease Rating Scale (UPDRS). The most common adverse effect exhibited during the SPAN-PD trial included discolored sputum, upper respiratory tract infection, cough and nausea. A second Phase-3 long-term, active-controlled open-labelled, randomized study assessing the tolerability and safety was conducted over one year. There was an average reduction in FEV1 (forced expiratory volume in 1 second) from the baseline for the INBRIJA and observational cohorts. Certain patients with COPD, asthma etc. in the last five years were excluded from the study. INBRIJA will be available through prescription in the first quarter of 2019.

Parkinson

by MountSinaiNYC.

From Visually.

 

“Today’s approval of INBRIJA marks a major milestone for both Acorda and the Parkinson’s community, for whom we are gratified to have developed this much needed therapy,” said Ron Cohen, M.D., Acorda President and CEO. “I’m delighted that INBRIJA has been approved and may be added to patients’ existing Parkinson’s medications for on-demand use, based on individual patient need,” said Burkhard Blank, M.D., Chief Medical Officer of Acorda. “We thank the FDA for a constructive dialogue throughout the development program and their partnership during the review cycle. We especially thank all those who volunteered for the INBRIJA clinical trials, without whose commitment new medications could not be developed. And we are grateful for the people living with Parkinson’s, their care partners, researchers, clinicians and advocacy groups, who have all collaborated with us to help achieve this milestone.” “Despite being on treatment, patients may experience OFF periods as Parkinson’s progresses, which can be disruptive.” “The Foundation provided funding for the early clinical development of INBRIJA because patients told us that OFF periods were one of their most serious issues. We knew we had to help address this unmet need, and this approval is a significant step forward for the community as it provides a new option to manage these gaps in symptom control,” said Todd Sherer, Ph.D., CEO, The Michael J. Fox Foundation.

 

FDA approves the Prior Approval Supplement for Portola’s commercial production of a bleeding antidote, Andexxa.


FDA recently announced the approval of the Prior Approval Supplement (PAS) for the large scale, second-generation Andexxa [5,6]. It is a bleeding antidote which is set for a broad commercial launch in the United States. Andexxa has already received an Orphan Drug status along with an FDA Breakthrough Therapy designation on May 3, 2018 under FDA’s Accelerated Approval Pathway. The approval was obtained by Portola Pharmaceuticals, Inc.

Prior Approval Supplement (PAS) is a document that needs to be submitted to list a major change prior to the distribution of a drug. A major change can be classified as anything that has the capacity to have an adverse effect on the strength, potency, purity of a drug which could eventually affect its safety and efficacy [7]. PAS paves way for the final marketing and distribution of the drug. Andexxa is recommended for patients as it is the first and only available antidote for patients treated with rivaroxaban or apixaban (used to prevent blood clots).  It is used when anticoagulation is not needed especially in cases where there could be uncontrolled bleeding thus becoming life-threatening. Andexxa is a recombinant modified human Factor Xa (FXa) protein. The Factor Xa inhibitors are very important these days to prevent and treat thromboembolic conditions such as pulmonary embolism, stroke and venous thromboembolism (VTE).  Their safety and efficacy profile have a much higher standard when compared to enoxaparin and warfarin. The increase in the importance is mainly due to a surge in the number of hospital admissions and deaths related to bleeding due to anticoagulation. Andexxa comes with a boxed warning of adverse life-threatening effects such as Ischemic event, arterial and venous thromboembolic events, cardiac arrests and sudden deaths. Hence, a constant monitoring for these events along with symptoms and signs that precede cardiac arrests must be maintained. Appropriate medications and anticoagulants should be administered as and when deemed medically appropriate. A study was conducted to determine the thromboembolic and ischemic risk in 185 patients who were subjected to Generation 1 product and 124 patients subjected to Generation 2 product. The patients were monitored for 30 days after the Andexxa infusion. Of the 86 patients who received Generation 1 drug and were re-anticoagulated before a thrombotic event, only 11 patients experienced these events. The most common adverse effect during the treatment with Andexxa included pneumonia and urinary tract infection. The drawback of Andexxa however is that it has not shown to be effective for the treatment of bleeding related to any FXa inhibitor other than rivaroxaban and apixaban.

Blood Clots Can Affect Anyone: Know the Risks and Symptoms

From Visually.

 

“It is clear from the response to the Andexxa Early Supply Program that there is significant need for a specific reversal agent that can address life-threatening bleeding associated with the use of the Factor Xa inhibitors apixaban and rivaroxaban,” said Scott Garland, Portola’s president and chief executive officer. “We are pleased to now be able to stock hospitals nationwide and serve all patients in the U.S. who could benefit from the potential life-saving impact of Andexxa.”

 

FDA approves the 6-in-1 (hexavalent) pediatric vaccine VAXELIS.


FDA recently approved VAXELISTM for use in children from 6 weeks through 4 years (i.e. before the 5th birthday) [8].  The vaccine is a combination of the following: Diphtheria and Tetanus toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Hemophilus b conjugate (meningococcal protein conjugate) and Hepatitis B (recombinant vaccine). The approval was given to a joint partnership (MCM) created in 1991 between Merck and the vaccine units of Sanofi. The vaccine is anticipated to be in the US market in 2020 as at present the companies are working towards maximizing the production of the vaccine for sustainable supply.

Vaccines Work

by Hyperakt.

From Visually.

 

The vaccine, VAXELIS, is supposed to be used for immunization against tetanus, diphtheria, hepatitis B, poliomyelitis, and disease caused due to Hemophilus influenzae type b. It contains antigens for H. influenzae type b and hepatitis B obtained from MSD and the remaining (diphtheria, tetanus, whooping cough) and poliomyelitis antigens obtained from SANOFI. It will be used as a 3-dose series consisting of a 0.5 ml intramuscular injection, administered at 2, 4 and 6 months of age. The point that needs to be noted here is that this 3-dose series will not constitute the primary immunization against pertussis (whooping cough) and an additional dose will be needed to complete the primary series. Since the vaccine is not yet commercially available, a large list of safety information has been published to update patients and healthcare providers. Like all other vaccines, VAXELIS may not be effective for all individuals. It has warnings against being administered to anyone with a history of progressive neurological disorder until the treatment has been stabilized or a regimen has been established. There are warnings against administration in anyone with a history of encephalopathy within 7 days of a pertussis containing vaccine that cannot be related to another identifiable cause. Those with a history of fever, hypotonic-hyporesponsive episode or persistent crying. The final decision of administering the vaccine depends on the individual infant’s medical history and status and by considering the benefits and the risks of the corresponding vaccine. The expected adverse reactions following the administration of the vaccine included pain at the injection site, irritability, crying, fever, decrease in appetite, vomiting and swelling at the injection site.

 

Valneva’s Lyme disease vaccine advances to the Phase 2 clinical trial stage.

Valneva SE, a biotech company specializing in the development and marketing of vaccines for infectious diseases, recently announced the advancement of their Lyme disease vaccine to the Phase 2 clinical trial stage. The candidate for the vaccine is called VLA15 [9]. The main aim of the Phase 2 trial is to determine the optimal dosage of the vaccine and to determine the schedule for the use in the Phase 3 efficacy study based on the safety and immunogenicity and safety data. In the Phase 2 developmental trial VLA15 will be tested at the highest dose used in Phase 1 along with a couple of higher doses. The company also wants to try out a 3-dose schedule.

The Lyme disease is transmitted to human beings by infected ticks and is caused by the Borrelia bacteria. Based on statistics from the US Center for Disease Control and Prevention (CDC), about 300,000 Americans are affected by the disease every year. It is one of the more common vector-borne illness in the Northern Hemisphere. Some of the most common symptoms of Lyme disease can go untreated as they are very often associated with less threatening diseases. Some of these symptoms include fever, fatigue, erythematous rash, mild stiffness in the neck etc. Without proper treatment these symptoms could lead to a major problem affecting the heart, joints and the nervous system. VLA15 is the only available vaccine for Lyme disease that is under clinical trial. It is a multivalent protein subunit vaccine that targets the outer surface protein A (OspA) of Borrelia. Thus, it is designed to provide protection against the majority of the Borrelia species. The vaccine generates antibodies that is supposed to prevent the bacteria from migrating from the ticks to humans. FDA used the Fast Track Designation in July 2017 to speed up the process as Lyme disease is becoming very common. Their decision was also supported by the favorable Phase 1 results that were released in March 2018. The vaccine was found to be immunogenic in all doses and formulations and showed a broad safety profile. As expected, the safety profile will be like the technologies used by other vaccines that have been approved for immunization purposes. People who have a history of Lyme disease or those above the age of 2 years living in an affected area or are planning to travel to one, are the ones who are most prone to develop the disease. Valneva has also enlisted the details of their planned Phase 2 trial. VLA15-201 will be the first of the two trials, it will be an observer-blind, randomized, placebo-controlled trial at different sites in the US and Europe. The studies will involve healthy adults between the ages of 18 and 65 years. Subjects who were previously exposed to Lyme disease and who have been cleared from the past infection, will also be enrolled. 120 subjects will initially be subjected to one of three dosage levels of VLA15 or placebo and the safety will be monitored by the Data Safety Monitoring Board. After this, 450 subjects will be given one of the two dose levels of VLA15 (180 people) or placebo (90 people), in the main study. VLA15 will be injected intramuscularly in 3 stages, at day 1, 29 and 57. There will be a constant monitoring for a year with the primary endpoint determination on Day 85.

Don’t Delay Lyme Disease Care

From Visually.

 

“Lyme disease cases in the U.S. have increased dramatically over the last 30 years or so, substantially increasing the costs for healthcare systems. The fear of contracting Lyme disease diminishes the quality of life of people of all ages. As the disease footprint widens, the need for a vaccine to prevent this significant unmet medical need increases. Valneva is doing everything possible, in consultation with FDA and EMA, to develop a safe and effective vaccine under the fast track designation,” said Wolfgang Bender, MD, PhD, Chief Medical Officer of Valneva.

 

Bristol-Myers Squibb will acquire Celgene to create a premier Biopharma company.


In one of the biggest mergers in recent times, Bristol-Myers Squibb announced that they will acquire Celgene Corporation to develop an innovative, premier Biopharma company [10]. Celgene Corporation is a biopharmaceutical company that focusses on the discovery and marketing of unique therapies for the treatment of inflammatory diseases and cancer using next-generation solutions in immune-oncology, homeostasis, protein homeostasis etc. Bristol-Myers Squibb is a global biopharmaceutical company which aims at discovering and developing innovative medicine against deadly diseases.

The acquisition of Celgene by Bristol-Myers Squibb, will involve a cash and stock transaction with an equity value close to $74 billion. The Celgene stakeholders will receive 1.0 Bristol-Myers Squibb share and $50.00 in cash for each share of Celgene. Along with this the stakeholders of the former will also have one tradeable Contingent Value Right (CVR) effective for each of its share. This will entitle them to receive a payment for future regulatory milestones. The decision has been made based on agreement of the Board of Directors of both the companies. The stock and cash consideration to be obtained by the Celgene stakeholders at closing in is supposed to be $102.43 Celgene share along with one CVR. At the end, the Celgene stakeholders are expected to own 31 percent of the company whereas the Bristol-Myers Squibb shareholders are expected to own 69 percent. The acquisition is expected to result in both strategic and financial benefits for both the companies. The combination will create the number one cardiovascular franchise by Eliquis, it will result in leading franchise in both hematology malignancies and solid tumors and will establish a top five immunology and inflammation franchise led by Orencia and Otezla. Just by combining the companies, they are looking at more than $1 billion in annual sales with nine products and potential growth in immunology, oncology, cardiovascular diseases and inflammation. The new innovative combined company will have six near-term product launches, four in hematology, luspatercept, liso-cel (JCAR017), bb2121 and fedratinib and two in immunology and inflammation, TYK2 and ozanimod. Just these will have the potential to generated $15 billion in revenue.

“For more than 30 years, Celgene’s commitment to leading innovation has allowed us to deliver life-changing treatments to patients in areas of high unmet need. Combining with Bristol-Myers Squibb, we are delivering immediate and substantial value to Celgene shareholders and providing them meaningful participation in the long-term growth opportunities created by the combined company,” said Mark Alles, Chairman and Chief Executive Officer of Celgene. “Our employees should be incredibly proud of what we have accomplished together and excited for the opportunities ahead of us as we join with Bristol-Myers Squibb, where we can further advance our mission for patients. We look forward to working with the Bristol-Myers Squibb team as we bring our two companies together.”

“Together with Celgene, we are creating an innovative biopharma leader, with leading franchises and a deep and broad pipeline that will drive sustainable growth and deliver new options for patients across a range of serious diseases,” said Giovanni Caforio, M.D., Chairman and Chief Executive Officer of Bristol-Myers Squibb. “As a combined entity, we will enhance our leadership positions across our portfolio, including in cancer and immunology and inflammation. We will also benefit from an expanded early- and late-stage pipeline that includes six expected near-term product launches. Together, our pipeline holds significant promise for patients, allowing us to accelerate new options through a broader range of cutting-edge technologies and discovery platforms. We are impressed by what Celgene has accomplished for patients, and we look forward to welcoming Celgene employees to Bristol-Myers Squibb. Our new company will continue the strong patient focus that is core to both companies’ missions, creating a shared organization with a goal of discovering, developing and delivering innovative medicines for patients with serious diseases. We are confident we will drive value for shareholders and create opportunities for employees.

 

GlaxoSmithKline and Pfizer have announced a collaboration to generate a premier global healthcare company.


GSK and Pfizer recently announced that they have entered into an agreement to develop a premier global consumer healthcare company with iconic brands [11][12]. This major alliance between two of the biggest names in the biopharmaceutical industry is expected to be the largest global consumer healthcare business. Based on the decision taken unanimously by the Board of Directors for both the companies, Pfizer will contribute its consumer healthcare business to the already existing consumer healthcare business of GlaxoSmithKline. The global sales for the year 2017 for the combined company were estimated to be $12.7 billion.

Based on the agreement, the new collaboration venture with combined sales of approximately $12.7 billion will result in a new-world leading alliance. Pfizer is estimated to have an equity interest of 32 percent whereas GSK will have the majority control with 68 percent. Right after the alliance, GSK intends to separate the venture as an independent company via demerger of its equity interest to its shareholders and a listing of the Consumer Healthcare business on the UK equity market. The sole right to decide whether to initiate a separation, will be on GSK along with a listing for a period of five years from closing of the transaction. They may also sell their part of the stake in a contemporaneous IPO. In the case of separation and listing during the first five years after closing, Pfizer will retain the choice of either participating in the sale of its equity interest in a contemporaneous IPO or through the distribution of its equity interest in the joint venture to its shareholders. The alliance is expected to be a category leader in pain relief, vitamin and mineral supplements, skin health, oral healthcare. GSK Consumer Healthcare will be the name used for the global operation of the joint venture. Emma Walmsley, CEO, GSK, will be the chair of the new venture. Brian McNamara, current CEO GSK Consumer Healthcare, will be the CEO of the joint venture and Tobias Hestler, current CFO GSK Consumer Healthcare will be the CFO.

“Eighteen months ago, I set out clear priorities and a capital allocation framework for GSK to improve our long-term competitive performance and to strengthen our ability to bring new breakthrough medicines and better healthcare products to people around the world. We have improved our operating performance and have set out a new approach to R&D. We have also started to reshape the Group’s portfolio through prioritisation of R&D programmes, acquisitions such as that proposed with the oncology biopharmaceutical company, TESARO, the minority buy-out of the consumer healthcare business and a series of non-core product divestments. The transaction we have announced today is a unique opportunity to accelerate this work. Through the combination of GSK and Pfizer’s consumer healthcare businesses we will create substantial further value for shareholders. At the same time, incremental cashflows and visibility of the intended separation will help support GSK’s future capital planning and further investment in our pharmaceuticals pipeline,” said Emma Walmsley, Chief Executive Officer, GSK. “The combination of these leading businesses with distinct regional and category strengths will be more sustainable and broader in scope than either company individually, said Albert Bourla, Chief Operating Officer and incoming Chief Executive Officer, Pfizer. “We believe that this joint venture is a great opportunity to ensure the future success of Pfizer Consumer Healthcare while unlocking meaningful after-tax value for Pfizer shareholders.

Reference:

  1. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629020.htm.
  2. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629022.htm.
  3. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629089.htm.
  4. http://ir.acorda.com/investors/investor-news/investor-news-details/2018/Acorda-Therapeutics-Announces-FDA-Approval-of-INBRIJA-levodopa-inhalation-powder/default.aspx.
  5. http://investors.portola.com/phoenix.zhtml?c=198136&p=irol-newsArticle&ID=2381753.
  6. https://www.fiercepharma.com/manufacturing/portola-wins-fda-approval-for-commercial-production-bleeding-antidote-andexxa.
  7. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm077097.pdf.
  8. http://hugin.info/152918/R/2230064/876179.pdf.
  9. https://globenewswire.com/news-release/2018/12/17/1667601/0/en/VALNEVA-Initiates-Phase-2-Clinical-Development-For-Its-Lyme-Disease-Vaccine-Candidate.html.
  10. https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-acquire-celgene-create-premier-innovative.
  11. https://www.gsk.com/en-gb/media/press-releases/glaxosmithkline-plc-and-pfizer-inc-to-form-new-world-leading-consumer-healthcare-joint-venture/.
  12. https://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_glaxosmithkline_announce_joint_venture_to_create_a_premier_global_consumer_healthcare_company.

 

About the Author:

Esha Sehanobish

She is presently a Postdoctoral research fellow at Albert Einstein college of medicine, NY and works on characterization of enzymes that could act as potential therapeutic targets against tuberculosis. She is an enzymologist with a doctoral degree from the University of Central Florida in 2016. She loves using her communication skills to raise awareness about the importance of science in general by using social media. When she is not doing “science”, she loves designing and painting as a way of expressing ones thoughts through graphics and color.

Editor and Blog Design

Abhi Dey

Abhi graduated from the Molecular Biophysics Unit of IISc (Bangalore, India) in 2011. As a Biomedical Scientist, he has worked with all three life-forms in his 13-year research career, viz., particulate, unicellular and multicellular. He is currently an Assistant Scientist at Emory University (Atlanta, GA) studying mechanisms of tumor recurrence in kids with brain tumors. As a postdoctoral fellow, he was the recipient of two Young Investigator Awards from Alex Lemonade Stand Foundation (Philadelphia, PA) and Rockland Immunochemicals. His current research has been funded by Northwestern Mutual Foundation (Milwaukee, WI), CURE Childhood Cancer Foundation (Atlanta, GA) and American Association for Cancer Research (AACR).  When he is not on the bench you will find him spending time with his family or exploring the world through traveling and blogging.

Cover image: (Cell Image Library) Description: “Colorized scanning electron micrograph of partially dried red blood cells clotted on the cotton fibres of a gauze wound dressing. Image was collected at low vacuum to avoid charging of cotton fibres.”

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The contents of Club SciWri are the copyright of Ph.D. Career Support Group for STEM PhDs (A US Non-Profit 501(c)3, PhDCSG is an initiative of the alumni of the Indian Institute of Science, Bangalore. The primary aim of this group is to build a NETWORK among scientists, engineers, and entrepreneurs).

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