FDA progress/timeline --- agency transparency efforts in the US pharma industry

 

Article List

• FDA Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes
  March 26, 2020
• Federal register notice: New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication; Notice; Request for Comments
  June 26, 2019
• FDA-in-Brief: FDA seeks public feedback on new drug approval transparency efforts
  June 26, 2019
• FDA's Clinical Data Summary Pilot Program: Questions Frequently Asked by Industry
  May 2, 2018
• FDA Voice Blog: FDA’s New Pilot Program Aims for More Transparency about New Drug Approvals 
  March 19, 2018
• FDA Commissioner Scott Gottlieb, M.D., on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs 
  January 16, 2018

RE: 📉 Virtual Event Alert -- 22nd September thru 24th September 📉 Industry-leading Publications & Clinical Trial Transparency Conference w/Key Speakers -- Call John K. at 339-298-2112 📉 REGISTER NOW

 

A 'switch' that turns autoimmunity drugs into powerful anti-cancer machine

A 'switch' that turns autoimmunity drugs into powerful anti-cancer activity

From researchers at the University of Southampton (A UK Top 10 University) a team discovered a way to transform antibody drugs previously developed to treat autoimmunity into antibodies with powerful anti-cancer activity through a simple molecular 'switch'. Read more.

FDA Authorizes Gilead's Remdesivir for COVID-19

When I was tasked with writing the CSR shells for MERCK's Hepatitis C drug ZEPATIER® in the battle to go head to head with  Gilead Sciences' (NASDAQ:GILD  Harvoni I mused about putting a dart board at my desk with  the GILD ticker symbol in the center. Again with Seqirus/CSL Behring I find myself competing with GILD as we race to help provide health care practitioners (HCPs) with drug therapies.

That's all to say happy to see any pharma company making strides and was pleased the FDA  granted an Emergency Use Authorization (EUA) to )for Gilead Sciences' remdesivir. Remdesivir hasn't been formally approved to treat any disease, but the US government's action via the FDA authorizes HCPs to use it on a temporary basis  to treat hospitalized patients with severe COVID-19. Read the full article at the Motley Fool.

Online Virology Course for Lay People Brought to you by TEL AVIV UNIVERSITY

Viruses & How to Beat Them: Cells, Immunity, Vaccines

IsraelX - Virus101x

There are 160+ COVID-19 vaccines and drugs in development ....

Before you wade into the dizzying numbers of therapies start here to review a primer on immunity. What's below is taken from the UK patient.portal website. There is active and passive immunity:

Active immunity - offer protection by injecting VIRUS  (live or inactive) right into the individual
This is the stimulation of the immune mechanism to produce antibodies by giving an antigen as a vaccine. Such vaccines may be:

• Live attenuated viruses (rubella, measles, oral polio, mumps) or bacteria - bacillus Calmette-Guérin (BCG).
• Inactivated viruses (parenteral polio, hepatitis A) or parts of the bacterium or virus (pneumococcal vaccine, influenza).
• Inactivated bacterial toxins (diphtheria and tetanus).
• Genetically engineered (hepatitis B vaccine).

Passive Immunity - backdoor method -- offer protection via injecting immunoblogins or antibodies into the individual.  Immunoglobulins are glycoprotein molecules produced by plasma cells (white blood cells). They act as a critical part of the immune response by specifically recognizing and binding to particular antigens, such as bacteria or viruses, and aiding in their destruction.

This is achieved by giving immunoglobulins and the protection is immediate but lasts only a few weeks.

There are two types of immunoglobulins:

• Human normal immunoglobulin (HNIG) from pooled plasma. This contains antibodies to infections prevalent in the donor population. Some of these, such as that for hepatitis A, may be falling, ultimately affording less protection.
• Specific immunoglobulin for tetanus, varicella-zoster virus, rabies and hepatitis B. These are derived from pooled serum of convalescent patients.

READ MORE

CSL Executive VEEP: Leaders lead during uncertainty - there is no question that we are all experiencing the impact of COVID-19

CSL Behring and Takeda Pharmaceutical Company Limited are leading a joint effort with Biotest, BPL Group, LFB, and Octapharm to develop a potential plasma-derived therapy for treating COVID-19. The alliance started immediately with the investigational development of one, unbranded anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin medicine with the potential to treat individuals with serious complications from COVID-19.


“Leaders lead during uncertainty. There is no question that we are all experiencing the impact of COVID-19,” said Bill Mezzanotte, CSL Behring’s Executive Vice President and Head of Research and Development.Read more from B. Mezzanote.

FDA Approves Pandemic Flu Vaccine From SEQIRUS/CSL Behring

Medscape  reports that the FDA has approved Audenz, “the first and only adjuvanted, cell-based pandemic vaccine to provide active immunization against the influenza A virus H5N1 strain.” According to Medscape, “Influenza A (H5N1) monovalent vaccine, adjuvanted...is for use in individuals aged 6 months and older.” The vaccine is “designed to be rapidly deployed to help protect the US population and can be stockpiled for first responders in the event of a pandemic.”

  

Healio also covers the story.

Leading pharmaceutical companies and total global vaccine market share 2017 and 2024

The top ten pharmaceutical companies based on global vaccine revenue market share in 2017 and a projection for 2024 include companies like CSL Behring.

In 2017, GlaxoSmithKline (GSK) was the top pharmaceutical company and held about 24 percent of the global vaccine market by revenue. GSK is expected to maintain their position as the top company and even gain a small amount of the market until 2024. Pfizer is expected to account for some 16 percent of the global vaccine market by 2024, largely due to success with its pneumococcal vaccine, Prevnar 13. A vaccine often contains an agent that is made from a weakened form of a disease microbe, that is then used to stimulate the body's immune system to destroy and recognize the microorganism in case of later exposures.

Seqirus/CSL Behring is among the global leaders and has provided patient consumers new vaccines with these recent approvals: AUDENZ  the first and only adjuvanted, cell-based pandemic vaccine to provide active immunization against the influenza A virus H5N1 strain; FLUAD a seasonal vaccine in February 2020 in the US; and FLUCELVAX a seasonal vaccine for children and adults in Canada.

[READ MORE]

Global biotech leader CSL has formally offered to help governments around the world

(March 2020) -- To speed treatments, global biotech leader CSL is lend ingthe company’s expertise in science and manufacturing to address the recent coronavirus global pandemic.  The company is exploring development of a hyperimmune serum that could be derived from the blood plasma of people who have recovered from coronavirus. Once an adequate number of recovered patients is identified, it’s our hope that CSL could begin to collect their plasma and create a hyperimmune serum enriched with COV-19 antibodies to use as a therapy.

Though more research and testing is necessary, it’s believed that antibodies found in the plasma of now-healthy COVID-19 patients could potentially be used to boost the immune response of those who are struggling with the infection. By now it is well known that coronavirus causes mild flu-like symptoms in many, but others who are older than 60 or have additional medical conditions are at high risk of fatal complications.

[READ MORE]