August 17, 2018

Pharmaceutical Trends for 2017: Biosimilars

Pharma Trends 2017:  Biosimilars

Frank Magliochetti Report

The FDA approved 56 new drugs in 2015 and, of these, 33 were specialty drugs and 23 were traditional. One was a biosimilar. Development, approval and acceptance of biosimilars may become an important trend in 2017.
The FDA is approving more specialty drugs than ever before and specialty medicines will likely face more competition in 2017. Increased FDA approval and frankmagliochetti-report-pharma-trends-biosimilarsdiscoveries of medications to treat orphan conditions and cancer will fuel competition. Biosimilars could overcome development hurdles and increase this competition even more.
Acceptance of biosimilars has been slow in the past. One of the reasons for the reluctance is that the development of biosimilars is different from that of generic drugs. Generic drugs for small molecules have a relative simple chemical structure that makes it easy to reproduce an identical chemical. It is more difficult to make a protein or peptide identical to the original biologic agent because of differences in the sugar residues attached to the protein, for example, or differences in the protein folding that make it unpredictable. This means that, even though a biosimilar has an identical peptide chain, it may not have an identical effect. These factors complicate the process of making biosimilars and increase the risk for problems.
Physician acceptance has been slow too but, as the cost of other medications rise, biosimilars will seem more attractive.
Approval of Biosimilars in 2015 and 2016
Biosimilars, which are products the FDA will approve with evidence that the medication up for approval is highly similar to an already-approved reference product, will probably continue to gain traction in 2017. The FDA has approved four biosimilars as of October 2016.
Zarxio is similar to Neupogen, according to an article published by Managed Healthcare Executive, except the biosimilar has a 15 percent lower list price. Both drugs treat low white blood cell counts associated with cancer and its treatment. The FDA approvedZarxio, made by Sandoz, in March 2015.
Inflectra is similar to Remicade to treat Crohn’s disease and ulcerative colitis. The FDA approved Inflectra in April 2016 but, due to litigation, the launch date is uncertain.
Erelzi, also made by Sandoz, is similar to Enbrel to treat arthritis. The FDA announced approval of Erelzi in August of 2016 and the expected launch date of biosimilar-frankmagliochetti-pharma-trends-2017February 2017 may be delayed.
Amjevita, by Amgen is similar to Humira and is for the treatment multiple inflammatory diseases. Amjevita became the fourth biosimilar drug to gain approval in September 2016. Launch date is set for March 2017 but may experience delays.
There are several biosimilars awaiting approval, including:
• Filgrastim by Grastofil, Apotex
• Pegfilgrastim by Apotex
• SB2 infliximab by Merck/Samsung Bioepis
• CHS‐1701 by Coherus Biosciences
• Epoetin alfa by Retacrit, Pfizer
The need for biosimilars will grow as the need for other drugs, especially cancer drugs and orphan drugs, increases. Doctors diagnose about 1.7 million cases of cancer each year, yet the death rate has fallen 23 percent since the early 1990s, partially due to new medications and treatments. The introduction of biosimilars could reduce cancer death rates even further.
Biosimilars may become one of the strongest trends in the pharmaceutical industry in upcoming years, as biosimilars have the potential to lower the cost for safe and effective treatments for a wider number of patients. Increased development of biosimilar cancer drugs is possible as some biopharmaceuticals lose patent protection.

Source
https://www.uspharmacist.com/article/record-number-of-fda-new-drug-approvals-in-2015
http://www.zarxio.com/index.jsp
http://managedhealthcareexecutive.modernmedicine.com/managed-healthcare-executive/news/five-specialty-pharmaceutical-trends-watch
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm436648.htm
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm
http://www.erelzi.com/
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm
http://pi.amgen.com/united_states/AMJEVITA/AMJEVITA_mg.pdf
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243.htm

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

frankmagliochetti_ParcaeCapital

Genome Editing – Progressing Trend

The Rush for Genome Editing

Frank Magliochetti Report

The Rush for Genome Editing

Gene-editing technology has sparked a frenzy of competitors fueled to develop the first of what may be thousands of treatments for genetic disorders.

From science fiction of movies like Jurassic Park to the reality of GMO foods, the concept of customizing plants, animals and even human genomes has mesmerized our imagination and culture for decades. This obsession is not surprising considering the remarkable impact of genetic engineering on our lives, and the promise it may hold for our future.crispr-genome-editing-franlmagliochetti-report_northandoverma

Modifying the genes of an organism is no easy task. It’s not as simple as removing the parts you do not like with an eraser. It involves making changes at a molecular level that are both complex and challenging.

One concern among scientists is the modifications made in human germline cells – i.e. the sperm or the egg. These are genetic changes that would actually be passed on through generations and the fear is that there could be unexpected side effects. Couple that with the ethical concerns of people misusing this technology to intentionally modify the genome to make “designer babies” with enhanced characteristics. These are some real concerns that are causing scientists to pause and weigh the pros and cons of use of this technology.

More and more companies are racing to stay ahead of the trend and become the leaders in the field.

In Cambridge MA, Intellia Therapeutics Inc. has a 65,000 square foot build out underway, however, it is still planning to functioning while under construction.

Intellia is one of a trio of startups in the Cambridge area working locally in the biotech niche known as CRISPR-Cas9. The gene-editing technology was frank-magliochetti-report_intelliadiscovered just four years ago.

Drug development historically has been a slow process – it often takes more than a decade to bring a medicine from lab to marketplace. But that’s changing, thanks to new machines that can screen drug targets faster and an entrepreneurial environment that’s more akin to high-tech than Big Pharma.frankmagliochettireport_genome_editing

Intellia has high-profile collaboration deals with Swiss drug giant Novartis AG and Regeneron Pharmaceuticals Inc. of Tarrytown, N.Y. It raised $108 million in an initial public offering in May. Their scientists are working on gene-editing treatments for everything including the hepatitis B virus to a rare form of blindness. If all goes well, it could move its earliest drug candidates into clinical trials within 18 to 24 months.

Competitors for Intellia include Editas Medicine and Crispr Therapeutics Inc. both completed their own IPOs this year. There are more to come: all with the heightened interest of investors. These companies are in a race to develop the first treatment based on gene editing.

Genome editing is going to be a hot trend to watch in 2017 and for many years to come.

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

frankmagliochetti_ParcaeCapital

Handheld Medicine

Handheld Medicine: Doctors Connecting with Patients using Smartphones

Frank Magliochetti Report

Doctors are connecting with patients in an entirely new way – through smartphones.Mobile payments, apps, and digital advertising changed the way retailers work by providing new opportunities to attract new customers, build loyalty and improve sales. Now these same technologies that altered retail are revolutionizing the world of medicine. The use of smartphones and apps helps drive down costs, increases access to information, and fulfills the public’s desire for “anytime, anywhere” diagnosis, treatment and monitoring.

frankmagliochetti_doctormobilevideocallUntil now, the healthcare industry has underutilized smartphones, apps and even connected medical accessories. This is changing, as connectivity allows consumers to take control of their own care. The adoption of mobile health apps has doubled in only two years. The percentage of consumers with at least one medical, health or fitness app increased from 16 percent in 2013 to 32 percent in 2015, according to PWC.

Primary care practitioners and chronic disease managers are leading the way towards a new generation of telemedicine, and patients are eager to follow. Doctors in India set up patients with smart home monitoring kits that connect wireless to the company’s online platform. From there, patients can connect with a wide range of specialists, including dermatologists, cardiologists and fertility doctors who can conduct virtual examinations and prescribe medicine from remote locations.

Clinicians in the United States can now use their smartphones as digital otoscopes. A growing number of clinicians now send patients with chronic conditions home with connected pacemakers, glucose trackers, ECG monitors and other types of remote monitoring devices. Patients can turn their phones into precision digital scales for weighing out food or connect their bathroom scales to mobile app on their phones to track their weight. Symptom checkers, activity trackers, and on-demand e-visits are now available directly to consumers.

The Future of Smartphone Medicine

Moving towards mobile care will cause a dramatic shift in the needs of the healthcare community. Organizations will need assistance managing utilization, connecting healthcare providers working in remote locations, and overseeing the massive amount of data transferred and stored. There will be an increasing need to evaluate the security, privacy and risk associated with using these new tools.frankmagliochetti-report

Connected tools will create fresh links between healthcare and industries with which it rarely interacts, such as retail, hospitality and financial services. Connectivity will also generate more opportunities for healthcare providers and patients to plug in.

Healthcare providers can look forward to engaging in virtual medicine as more facilities build that technology into their long-term strategic plans. Virtual medicine allows health systems to move away from centralized brick-and-mortar locations towards decentralized partnerships and joint ventures to create “bedless” hospitals. Even with the limited smartphone medicine in use today, a growing share of clinicians can already deliver care remotely.

Patients are Eager to Participate

About 68 percent of adults in the United States have smartphones, according to Pew Research Center, which is up from just 35 percent in 2011. Tablet ownership is up to 45 percent.

aha_frankmagliochettiConsumer interest in telemedicine is growing as quickly as interest in smartphones. According to survey results provided by the American Hospital Association, 74 percent of U.S. consumers would be willing to use telehealth services and 30 percent already use computers or mobile devices to check for medical information. Seventy percent are comfortable communicating with their doctors via email, text or video rather than seeing them in person. More than three out of four patients believe that access to care is more important than human interaction with their healthcare providers.

Advanced hardware technology, the introduction of new apps and wireless links facilitates the move towards handheld medicine.

Sources:

http://www.pwc.com/us/en/health-industries/top-health-industry-issues/care-in-palm-of-hand.html

https://www.doctorkepaas.com/

http://www.medicalpracticeinsider.com/news/oto-converting-iphone-digital-otoscope

https://play.google.com/store/apps/details?id=rascsoft.precisionbalance&hl=en

http://weightgurus.com/http://www.pewinternet.org/2015/10/29/technology-device-ownership-2015/

http://www.aha.org/research/reports/tw/15jan-tw-telehealth.pdf

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

frankmagliochetti_ParcaeCapital

Combating Antibiotic Resistant Bacteria:

How the Fight is Progressing in 2016  

Frank Magliochetti Report

Bacteria that are resistant to common antibiotics have been around for some time. Unfortunately, they have frankmagliochetti_antibodiesbecome more widespread and more deadly than they were in times past. Following are some new major developments that may result in mankind either succumbing to antibiotic resistant bacteria or overcoming it altogether.

 

A New Danger

The civil war in Syria has nearly completely destroyed vital medical infrastructure. Thousands of doctors, nurses, medics, paramedics and other medical professionals have either been killed or have fled the country. Medical equipment is in short supply and operations are commonly conducted in caves or poorly lit basements. However, the war has brought about so many cases of antibiotic resistant bacteria that Newsweek has openly questioned whether or not the war may in fact spell the end of antibiotics altogether.

The root cause for this high level of antibiotic resistant bacteria are common the world over. Syrians, like many people around the world, used antibiotics far too freely in the past. However, the ongoing war has resulted in serious bacterial infections not seen outside of war zones. What is more, as Syrians travel in search of safety and shelter, the infections could potentially spread to others. Jordan, aware of the serious dangers that these infections may pose, has wisely implemented tight new controls on the use of Colistin to ensure that it is seldom used and thus remains effective against bacterial infections.

Another altogether different danger comes from the fact that a growing number of diseases are now becomingfrankmagliochettireport_worldhealthorganization more resistant to antibiotics than ever before. As the World Health Organization recently reported, cases of antibiotic resistant chlamydia, gonorrhea and syphilis are on the rise around the world. This has led the WHO to issue new guidelines specifying which antibiotics should and should not be used to combat these diseases. Serious fungal infections are also becoming resistant to antibiotics, a new trend that could have serious consequences for people with compromised immune systems.

New Answers

Thankfully, there are new answers on the horizon. German researchers at the University of Tubingen have recently been examining the human body to look for ways to combat infection. After analyzing bacteria found in the nose, they discovered a single gene that had the potential to help them create a completely new antibiotic. This antibiotic, currently known as lugdunin, has been tested on mice and the results show that it could effectively be used to treat both MRSA and Enterococcus infections.

Scientists at the University of Melbourne have taken a different route albeit one that is no less effective. Their new genetically engineered peptide polymers (or SNAPPs as they are more commonly known) can tear down cell walls and kill bacteria rather than simply halt the growth of infection. The SNAPPs are not toxic and pose no risk to infected people but further research is needed to determine how well the treatment works and what worldeconomicforum_frankmagliochettidangers it could pose.

It is also encouraging to see that world leaders are taking the threat seriously. On September 21, the United Nations General Assembly will host an all day, high level meeting on the topic of drug-resistant bacteria. Earlier this year, the World Economic Forum called for more research into antibiotic resistant infections while the G7 noted that tackling such infections should be a priority. The G20 recently made a united commitment to working together to reduce such infections. While only time will tell if these and other efforts will be successful, there is hope that one day antibiotic resistant bacteria will no longer result in serious infections, amputations and deaths.

Source

http://www.newsweek.com/2016/09/23/bashar-al-assads-war-syria-could-spell-end-antibiotics-498035.html

http://www.who.int/mediacentre/news/releases/2016/antibiotics-sexual-infections/en/

http://www.smithsonianmag.com/smart-news/fungal-infections-are-getting-worse-they-become-drug-resistant-180960283/?no-ist

www.bbc.com/news/health-36910766

http://news.nationalgeographic.com/2016/09/in-first–united-nations-will-consider-antibiotic-resistance/

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

frankmagliochetti_ParcaeCapital

Drug Breakthrough for HSDD

Sprout Pharmaceuticals

Frank Magliochetti Report

Sex, specifically women’s sexuality, is often considered a topic that the public and the media tip toe around. For some time now, there has been demand for a addyi-frank-magliochetti-reportmedication that will serve a similar function as Viagra but for the female population that requires a libido boost. Since there are pharmaceutical drugs created that aid men having trouble with sexual activity which are widely advertised and accepted as a legitimate prescription, advocates for female sexual health have been discussing this inequality in healthcare and the possible solutions. Male sexual health medicines have been around for a significant amount of time, however, the female alternative is still in the beginning stages.

Given the current political and societal atmosphere women’s sexual health is a frequently debated topic. There have been numerous doctors frankmagliochettireport_addyand advocates for the past several years that have spoken out on behalf of the need for a drug that can aid the female population that suffers from various medical issues that make participating in sexual activity difficult or altogether impossible. With the rising demand for such a product pharmaceutical companies have been working on creating the solution. In August of 2015, the FDA finally approved a pill that was developed for such a purpose. This drug called Flibanserin is made by Sprout Pharmaceuticals and is sold under the brand name Addyi; given the pink coloration of the pills they have come to be known as the “little pink pill.”

Sprout Pharmaceuticals has made a great breakthrough with Addyi; not enough attention has been given to finding potential solutions for those suffering with HSDD.

Frank Magliochetti

Addyi is intended for use in premenopausal women suffering from a disorder known as Hypoactive Sexual Desire Disorder (HSDD), this disorder decreases women’s libido for no known reason and negatively impacts the lives of women suffering from HSDD. HSDD can negatively impact the affected women’s relationships and generate unneeded difficulty and stress, Addyi is intended to alleviate these issues by boosting the libido in women suffering from HSDD. Addyi, unlike the potential alternatives that are in the research stages. manages to aid women in the increasing of their libido without the use of hormones. Flibanserin is designed to balance the neurotransmitters in women’s brains in order to increase their libido. The neurotransmitters that are impacted frankmagliochettireport-addyi-sproutpharmaby this drug are dopamine, serotonin, and norepinephrine.  Addyi has been available for prescription since October of 2016. According to Sprout Pharmaceuticals it should be available through insurance companies and will cost anywhere from $30 to $75 whether the patient has insurance or does not have insurance. Addyi has shown that it has a few side effects such as sleepiness, faintness (loss of consciousness) and, low blood pressure.

The pink pill was previously submitted to the FDA sixty times for approval and the continued to require additional testing to be positive that the drug was safe, effective, and could not be misused to sexually assault someone. however, the FDA now believes that by the end of the year the pink pill will be as prominent as Viagra. The strides this development is making for women’s health are phenomenal. Addyi becoming even half as popular as Viagra will demonstrate the significant changes that have been made in the way that society views women’s sexual health and will change the entire conversation  in regards to sex. Women’s pleasure is no longer a nonexistent aspect of the equation in mainstream conversations about sexual health, this development has the potential to be as groundbreaking as when the birth control pill was first developed in the 1960s.

Related Stories:

Snapshot of Sprout Pharmaceuticals

http://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=182739307

Addyi general information

http://www.addyi.com/

What is HSDD?

http://www.everydayhealth.com/sexual-health/hypoactive-sexual-desire-disorder.aspx

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

frankmagliochetti_ParcaeCapital

Innovative Developments in Medical History

Preventative Vaccines:  Bexsero & Trumenba

Frank Magliochetti Report

One of the biggest public health epidemics occurred back in 2014; Ebola and Meningococcal B were responsible. These two diseases took 10,000 people in Sierra Leone, Guinea and Liberia. These three countries have weak health systems, which is the reason why they were unable to treat their people.

In order to fight this disease, which made its first appearance in 1976,  WHO (World Health Organization) had been trying to find a cure for many years. On August 8, 2015, WHO declared that Ebola and Meningococcal B is a disease of international concern and thus began the search for its vaccine. By late October, 2015 WHO had finally come up with two vaccines that were guaranteed to prevent Meningococcal B. Sadly; the cure for Ebola has not yet been found however, its vaccines trials are currently being conducted in Sierra Leone.who_frankmagliochettireport

Meningococcal B is caused by bacteria called “Neisseria Meningitidis”. Neisseria Meningitidis has five serogroups: B, C, Y, W and A. The most common serogroups that affect people in the US is B, C and Y.

Meningococcal B disease is not caught through the air. In fact, it is a diseasewhich is transmitted from one person to another in close physical contact. The disease commonly spreads faster in the family due to the exchange of fluids from daily contact. The disease is found at the back of the throat and later causes sepsis. Sepsis is transferred to the blood that infects the blood stream, which causes damage to the brain and spinal column. Meningococcal B often results in liver failure, vision loss, amputation of limbs and death.

bexsero-frankmagliochettireportThe two vaccines Bexsero and Trumenba specifically treat Meningococcal B and were approved by the FDA in October 2015. The trials for Bexsero were conducted in UK, Chile, Australia and Canada amongst 2,600 young adults and adolescents. The results were that the three infectious strains that cause Meningococcal were destroyed.

Another 5,000 participants in the trials conducted in the USA experienced headache, muscle and joint pain, chills, fatigue and diarrhea after receiving the vaccine. Whereas, 15,000 participants experienced less side effects. All in all, the FDA approved the vaccines because the side effects were not viewed aslong term or fatal.

An accelerated approval was used by the FDA to make this vaccine go public claiming that Meningococcal B is a life-threatening disease. The effectiveness of Bexsero was approved two months prior to the trials being conducted.

FDA recommends that the vaccine should be given to infants, children from the ages of ten till twenty three and people who have a weak immune system. It is recommended that more than one dosage should be given to people having serogroup B Meningococcal.

Anna Jaques, a non-profit Hospital in Newburyport, Massachusetts has taken extra measures and brought more doctors and experts on anna_jaques_hospitaltheir team to prepare themselves if a patient with Ebola or Meningococcal B comes to their door.

https://www.ajh.org/

Anna Jaques is a remarkable medical facility housed with some of the top health care professionals North of Boston.

Frank Magliochetti

With 2016 being the year of medical innovations, the vaccine for Meningococcal B has come as a godsend that will save millions of lives in rural areas where this disease is commonly found. The vaccines are set to be released worldwide by the end of the year.

Other News and information on Trumenba and Bexsero

Trumenba Offical Website:

http://www.trumenba.com/

Important Safety Information

  • Trumenba should not be given to anyone with a history of a severe allergic reaction after a previous dose of Trumenba
  • Individuals with weakened immune systems may have a reduced immune response
  • The most common adverse reactions were pain at the injection site, fatigue, headache, muscle pain, and chills
  • Data is not available on the safety and effectiveness of using Trumenba and other meningococcal group B vaccines interchangeably to complete the vaccination series
  • Tell your healthcare provider prior to the vaccination if you are pregnant, or plan to become pregnant
  • Ask your healthcare provider about the risks and benefits of Trumenba. Only a healthcare provider can decide if Trumenba is right for you or your child

 

trumenba-frankmagliochettireportIndication

  • Trumenba is a vaccine indicated for individuals 10 through 25 years of age for active immunization to prevent invasive disease caused by Neisseria meningitidisgroup B
  • Trumenba is approved based upon demonstrated immune response against four group B strains representative of prevalent strains in the US. The effectiveness of Trumenba against diverse group B strains has not been confirmed

Bexsero

Official Site

https://www.gsksource.com/pharma/content/gsk/source/us/en/brands/bexsero/pi/po.html?cc=3282D9F3E686&pid=

Important Safety Information

Indication

BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals 10 through 25 years of age.

Approval of BEXSERO is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the United States. The effectiveness of BEXSERO against diverse serogroup B strains has not been confirmed.Bexsero_logo_4C_temp_norDNA_bigger

  • BEXSERO is contraindicated in cases of hypersensitivity, including severe allergic reaction, to any component of the vaccine, or after a previous dose of BEXSERO
  • Appropriate observation and medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine
  • The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions in latex-sensitive individuals
  • Syncope (fainting) can occur in association with administration of BEXSERO. Ensure procedures are in place to avoid injury from falling associated with syncope
  • The most common solicited adverse reactions observed in clinical trials were pain at the injection site (≥83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%), induration (≥28%), nausea (≥18%), and arthralgia (≥13%)
  • Vaccination with BEXSERO may not provide protection against all meningococcal serogroup B strains
  • Vaccination with BEXSERO may not result in protection in all vaccine recipients

AAP issues meningococcal B vaccine ( Trumenba & Bexsero)  guidelines for adolescents
Trumenba and Bexsero have both been approved for the prevention of serogroup B meningococcal disease in individuals aged 10 through 25 years by the American Academy of Pediatrics Committee on Infectious Diseases.

Please Click the link below to read the entire post:

http://www.healio.com/internal-medicine/vaccination/news/online/%7B9d42e15b-0c08-477d-8b1e-f28a59c545ea%7D/aap-issues-meningococcal-b-vaccine-guidelines-for-adolescents

Pfizer heads back to school with Trumenba vaccination campaign

Please click the link below to read the entire post:

http://www.fiercepharma.com/marketing/pfizer-menb-vaccination-campaign-for-trumenba-gears-up-for-back-to-school

Teaching kids to share is usually a parental goal, but a new ad from Pfizer may have some parents rethinking the parameters.

The first campaign for meningococcal group B vaccine Trumenba highlights the dangers of MenB, which can be spread through habits common among teens–including kissing and sharing drinks and food.

The TV ad shows a mother in the hospital with her stricken son, asking “how did we get here?” The ad then goes back through events earlier in evening showing the son sharing food and drinks with several different friends at a party and kissing a girl.

“The campaign was designed to reach parents of teens and young adults during the summer and back-to-school season, when many parents are thinking about steps they can take to help protect their child’s health, including vaccination,” she said.

Trumenba is one of two vaccinations to protect against MenB, along with GlaxoSmithKline’s Bexsero. But last year, the CDC’s Advisory Committee for Immunization Practices (ACIP) stopped short of granting the pair universal recommendation. The vaccines are recommended for young adults ages 16 to 23, with a preferred age of 16 to 18, which means that doctors decide on an individual basis whether to vaccinate their patients against MenB.

watch the ad on iSpot.tv

https://www.ispot.tv/ad/ARCj/trumenba-meningitis-b

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

frankmagliochetti_ParcaeCapital

Genome Editing – CRISPR

Frank Magliochetti Report:   CRISPR

CRISPR trials just may be one the most important healthcare industry breakthroughs of this generation

Frank Magliochetti

Almost every year, a new disease is introduced in the world which affects the population of our country. It would be wrong to say that people living in rural areas may be more prone to catch diseases than those who are living in the city. The fact is that no matter where you live or how Frank-Magliochetti_crisprhard you try to protect yourself from the outside world, there are some in-house diseases that may catch up to you.

Once such disease that can strike anyone at any time is cancer which arises through our genetics.   A disease that in some cases runs down from generation to generation which may strike no matter what we may do to help prevent it.  It is something we all dread.

A study conducted on genetic based cancer diseases was conducted in the US and finally was granted access for testing on humans on June 21st.   The NIH (National Institute of Health) gave the green light to start testing the CRISPR-Cas9 trial on humans so that help from T Cells could be enlisted to protect the body.

To understand the trial, first, one needs to understand what exactly CRISPR-Cas9 is. CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a drug derived from Streptococcus pyogenes, which enabled the researchers to make permanent mutations. This introduces double stranded healing breaks in cells to activate the repair pathways in a human body. They adapt immunity in certain archaea and bacteria, which allow organisms to invade and eliminate genetic material.

This disease was discovered in 1989 but until 2007 its symptoms were unknown. 2016 has brought new hope for people to live a healthy life. The trial will be funded by Sean Parker, a tech entrepreneur who has a $250 million dollar cancer treatment center; The Parker Institute for Cancer Immunotherapy.

There have been other trials conducted but the problem with them was that the T Cells, which were reintroduced to a person’s body were not that effective, however, they did kill the NY-ESO-1, the T Cells stopped proliferating and became less effective. crispr-magliochetti

There are many hospitals all over the world that are holding CRISPR trails. Some trials were started at the beginning of August while others are set to start in September.

Hospitals such as Massachusetts General Hospital located in Boston have been conducting tests on genome editing since 2013. This is one of the oldest hospitals in Boston and gets close to 100,000 patient visits per year. There are even chances that MGH affiliated laboratories will also conduct genome editing trials.

Many more hospitals based in Boston have announced that with proper funding, they will start genome editing trials in 2017. Since the trials are so expensive, scientists will pick patients who are immune to Cas9 enzyme.

The discovery and trials of CRISPR is one of the best advancements in medical history. Though the patients for the trial will be chosen in small numbers, people living in fear that their life may end after four or five years due to a genetic illness like Leukemia may now have new hope of living a healthy and happy life.

The content below was aggregated from a Boston Globe opinion piece by Jim Kozubek please click the link to head to the official site to read the rest of the post.

https://www.bostonglobe.com/ideas/2016/09/03/crispr-and-capitalists/uX8NuPsva5L2iNI2DCBArJ/story.html

CRISPR and the capitalists

CRISPER-CAS9 IS A method of manipulating DNA that is transforming medicine and science. It is both popular (“molecule of the year!”) and dangerous (researchers have received threats from GMO activists). It is also wildly lucrative.

The first clinical trial of these tiny molecular scissors may begin by the end of the year. Meanwhile, two camps, the Broad Institute — where I held affiliation for nearly three years — and University of California at Berkeley and researcher Emmanuelle Charpentier, are locked in a patent showdown that will play out in early 2017 with perhaps a billion dollars at stake.
Society treats science as a public trust by funding it through taxes, but perhaps it shouldn’t do so indefinitely. One of the subliminal things that the CRISPR-Cas9 legal showdown tells us is that academic-industry partnerships may one day be mature enough that science may begin to forgo its tax base.

In 1943, President Franklin D. Roosevelt directed his wartime chief of research, Vannevar Bush, to find a way to extend funding after the war. In a document with soaring language entitled “Science the Endless Frontier,” Bush laid out the argument for robust federal funding engines through the National Institutes of Health, the creation of the National Science Foundation, and what would become a briskly expanding network of research scientists throughout the United States.
Read More – CLICK HERE

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

frankmagliochetti_ParcaeCapital