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January:

New Vaccine against Tuberculosis developed by GSK, shows positive results

During the 50th World Conference on Lung Health in Hyderabad, experts presented a vaccine developed by GlaxoSmithKline (GSK) against Tuberculosis (TB) showing positive study results in patients who took the vaccine.   

The vaccine known as M72 or AS01E was tested on 3,300 adults that are HIV negative and have latent Tuberculosis that could later develop into active TB.  

The test was done in 11 different parts of Kenya, South Africa, and Zambia and was conducted in partnership with the International AIDS Vaccine Initiative (IAVI).  

he study revealed that the new vaccine could minimize the number of people developing Tuberculosis by half, for those that received the vaccine.   

Findings of the study that was also highlighted by the reputable New England Journal of Medicine showed that the people who have received two doses of the vaccine, only 13 developed active TB.

This is contrary to those that received placebo treatment that resulted to over 20 of the people getting an active TB.   

Dr. Breuer, Chief Medical Officer of GSK vaccines quoted that “These results demonstrate that for the first time in the century, the global community has a new tool in helping protect against Tuberculosis”.   

The new vaccine is considered as one of the first few new vaccines developed against Tuberculosis.

At present, Bacille Calmette-Guerin (BCG) vaccine, which was developed way back in 1921, is given to guard people against TB.

However, the protection by BCG wears off after a few years thus, new vaccines must be developed to sustain protection against TB.   

Meeran, Director of Clinical Research at GSK said that GSK has relentlessly worked hard in ensuring positive study results since 1999 and has finally achieved efficiency in their efforts by the study’s recent promising results.   

(Source: The Economic Times, 2019)


February:

Dr. Reddy’s Laboratories acquires Wockhardt’s business in India for 259 million

Dr. Reddy’s Laboratories acquired some of Wockhardt’s branded generic business in India and other countries such as Nepal, Sri Lanka, Bhutan and Maldives for 259 million (USD).   

The business to be acquired consists of a portfolio of over 60 brands in different areas of therapy such as respiratory, neurology, VMS (Vitamins, Minerals & Supplements), dermatology, gastroenterology, pain, and vaccines. These will strengthen its acute therapeutic segment (ailments for cough, cold and some pains and more.)  

Analysts have said that this move aligns with Dr. Reddy’s Laboratories focused goal of growing its competitive presence in the Indian market, it has moved its place from the 16th to the 14th place, they aim to move up to the top 10 soon.  

Although Wockhardt is selling away some of the pillars of their company, Mr. Khorakiwala (Founder/Chairman) says that this move is in line with their company’s current strategic plan of shifting their business from acute therapeutics areas to chronic business-like anti-diabetes and CNS.

This intended sale will help strengthen Wockhardt’s balance sheets and will enable enough liquidity for investing in its new venture to grow in international operations and investments in Biosimilars for the US market and its other R&D developments.   

After the sale, Wockhardt will still continue to own its international operations in other countries through its subsidiaries.  

(Source: The Economic Times, 2020)


March:

National Technology University Singapore develops new high resolution medical device

Nanyang Technology University (NTU) scientists have developed its prototype of a handheld medical imaging device that enables the production of images of up to 1-2 micrometers.

This device helps in finding characteristics of the early signs of tumors in cells. With the new device, it can produce images of a higher resolution than X-Ray, Computed Tomography (CT) scan and Magnetic Resonance Imaging (MRI) machine.

This new imaging technology is known as Micro-Optical Coherence Tomography (OCT), it emits a spectrum of light between 700 to 950 nanometers, known as near-infrared light.   

This harmlessly penetrates human tissue and organs, and the device then measures the delay time of the ‘echo’ from its light waves as they strike different tissue structures, of which the information obtained is used to construct cross-section images of what is being scanned.  

The results are sent in real-time to a computer system running software developed at NTU, which assists in diagnosis by assembling the 2-D cross-section images into a three-dimensional picture and rendering different parts in color. 

This technology was developed for six years through joint research with teams from Harvard Medical School and the University of Alabama. Team lead, Professor Liu and his team continues to conduct in-depth research into OCT to further improve the medical device and extend collaboration in the healthcare industry.   

(Source: Bio Spectrum Asia, 2020) 


April:

Johnson & Johnson surges as they seize a $1 billion vaccine investment with the US government.

Johnson & Johnson said that they will begin on developing and manufacturing a new coronavirus vaccine with the U.S. government, after seizing over $1 billion deal with them.  

They would be working closely with Biomedical Advanced Research and Development Authority (BARDA), an arm of the U.S. Department of Health and Human Services to extensively develop the vaccine that they had been working on since January.  

Johnson & Johnson’s spokesperson, Seema Kumar have said that they would be splitting the billion-dollar investment with BARDA 50 to 50 and announced its plans to commence building manufacturing capacity for a billion doses of the vaccine.

They expect to have the early doses ready for emergency use by early January of the following year.   

CEO of Johnson & Johnson, Alex Gorsky said that they are currently focused on conducting clinical trials to ensure that the vaccine works.  

Johnson & Johnson’s shares closed up 8% at $133.01 in New York, they planned to take a not-for-profit approach to the product saying it was too early to discuss the exact pricing of the potential vaccine and is focused on serving the immediate public health need.   

The company plans to start human trials before September and said it has two backup vaccines ready for development as well. 

(Source: Bloomberg, 2020)


May:

Celltrion Completes Test Candidate for COVID-19

Celltrion Group has recently announced that the company has successfully selected the most potent antibody candidates to neutralize SARS-CoV-2, the virus causing COVID-19. 

Through its partnership with Korea’s Centers for Disease Control and Prevention (KDCD), Celltrion was able to identify and secure over 300 various types of antibodies that bind together to the SARS-CoV-2 antigen.

Following the selection of antibody candidates that demonstrates high potency in neutralizing SARS-CoV-2, Celltrion will begin cell-line development. Once this is completed, Celltrion aims to roll out mass production of the therapeutic antibody, and, together with the KCDC, Celltrion will commence in conducting efficacy and toxicity testing in mice and non-human primates.

Celltrion’s research and development head, Ki-Sung Kwon said that Celltrion is utilizing all its resources and expertise to overcome this global health crisis and added that they are glad to have identified these antibodies sooner than expected. 

(Source: Business Wire, 2020)


June:

Thermo Fisher to enter cell therapy CDMO space with NJ facility

Thermo Fisher announced that it plans to open a cell therapy development and manufacturing collaboration center in Princeton as part of a $475 million investment in its biopharma capabilities.

Thermo Fisher first grew its contract development and manufacturing organization business firstly through its $7.2 billion acquisition of Patheon back in 2017 and its $1.7 billion Brammer Bio investment in 2019. 

President of Commercial Operations at Thermo Fisher said that this new center is designed to accelerate its cell therapy platforms. He added the concept is to build end-to-end cell manufacture workload solutions that can drive simplified processes with higher degrees of automaton while significantly reducing costs and improving the robustness and reliability of cell therapy GMP manufacture.

The new center is part of its plans to invest more than $475 million in new biopharma capabilities and capacity in 2020.

President of Thermo Fisher said that they have invested strategically to ensure that the supply-demand is met at all times. 

Chief Financial Officer, Stephen Williamson said that they expect net capital expenditures in the range of $1 billion to $1.1 billion as they invest more in capacity and capability expansions in its services and bioproduction businesses.

(Source: BioProcess International, 2020)


July:

FDA Approved Valneva’s Clinical Trials for its Chikungunya vaccine

A french vaccine producer, Valneva SE has recently announced that it has successfully been approved by the US Food and Drug Administration (FDA) to commence its Phase II Clinical Trials and licensure of its single shot Chikungunya vaccine, VLA1553.

Chikungunya is a mosquito-borne viral disease that was caused by the Togaviridae virus transmitted from Aedes mosquitoes, according to the World Health Organization.

This vaccine is a single dose, a live-attenuated candidate that is to provide immunization against the Chikungunya virus. It was granted Fast Track designation by the US FDA back in 2018.

Valvena SE said on 25th March that its Phase III pivotal trial will be subjected to a detailed protocol review, double-blinded, placebo-controlled, and multi-center study in almost 4,000 healthy adults.

Chief Medical Officer of Valvena, Wolfgang Bender says that they are excited to potentially have the vaccine available by the end of 2022, against the virus that threatens public health.

(Source: Precision Vaccinations, 2020)


August:

3 Big Drugmakers: Amgen, Takeda and AbbVie in Joint COVID-19 Study. 

Coming together to collaborate in tackling COVID-19, Amgen, Takeda, and AbbVie are conducting a joint clinical trial to see whether their products can improve outcomes for patients that are severely affected by the virus. 

The clinical trial will test Amgen’s psoriasis drug, Otezla, Takeda’s hereditary angioedema therapy Firazyr and AbbVie’s experimental nonalcoholic steatohepatitis drug cenicriviroc to see if it is able to reduce potentially life-threatening immune overreaction observed in some serious COVID-19 patients. The primary goal of the study is to improve at least 1 point on an 8-point World Health Organization ordinal COVID status scale for at least 48 hours for patients with severe COVID-19. 

Rather than each company operating its own trial, the collaborative study allows for multiple trial arms that can test several potential COVID-19 therapies simultaneously and modify protocols in real-time based on observed outcomes, thereby reducing the number of participants and time required to evaluate drugs. 

Drugs this way can proceed in the trial if early signs are positive. If the signal for improvement is strong, a drug may become the new standard of care, and without the trial stops, new therapies could be added onto the new backbone regimen as the trial moves forward. 

AbbVie, Amgen, and Takeda recently helped form the COVID R&D Alliance, a group of more than 20 biopharma companies working to accelerate the development of drugs against COVID-19 and related symptoms. The new study is a collaboration between the group, Quantum Leap Healthcare Collaborative, the designer of the adaptive platform, and the FDA. 

Each of the three companies is hopeful that their respective candidate might work as Otezla inhibits PDE4, which is thought to indirectly modulate the production of inflammatory molecules. Firazyr works in an acute HAE attack by inhibiting the receptor of inflammatory molecule bradykinin. Cenicriviroc is a blocker of chemokine receptors CCR2 and CCR5, which are also linked to acute respiratory distress syndrome in COVID-19. 

(Source: Fierce Pharma, 2020)


September:

Gensight Biologics seeks approval for its Lumevoq treatment for patients with vision loss caused by Leber Hereditary Optic Neuropathy.  

Gensight Biologics recently submitted a marketing authorization application for its lead gene therapy Lumevoq to the European Medicines Agency (EMA). They hope to obtain approval for Lumevoq to treat patients with vision loss due to Leber Hereditary Optic Neuropathy (LHON), caused by a mutation in the ND4 mitochondrial gene.

The company applied after seeing the results from the Phase I/IIa study and two Phase III efficacy studies, as well as long-term studies of the treatment. 

In the CLIN06 study, after two years post-treatment, patients experienced an average gain of +18.8 letters equivalent relative to the low point of their visual acuity in their Lumevoq treated eyes, compared to +17.3 letters equivalent in their treated eyes.

Three years after the one-time injection, the bilateral benefit was maintained with Lumevoq-treated eyes recording a mean improvement against patients’ equivalent relative to the low point of their visual acuity of +20.5 letters.

(Source: Pharma Times, 2020)


October:

Eli Lilly holds its clinical trials on its Monoclonal Antibody COVID-19 treatment. 

Eli Lilly said that they will be holding the clinical trial of its combination antibody treatment for COVID-19 due to safety reasons.

The clinical trial, evaluating Lilly’s investigational neutralizing antibody as a treatment for COVID-19 in hospitalized patients, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Eli Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.

Eli Lilly is currently testing a combination of two lab-engineered immune system proteins called monoclonal antibodies to treat severely ill patients with COVID-19.

The monoclonal antibody treatment is said to give the immune system a head start on fighting the virus. The antibodies were demonstrated to home in on the SARS-COV-2 virus, neutralize it, and infuse it.

(Source: CNN News, 2020)


November:

Oxford and AstraZeneca’s COVID-19 vaccine candidate shows 90% efficacy in clinical trials. 

The late-stage human trials for the COVID-19 vaccine candidate developed by Oxford University and AstraZeneca showed that the vaccine could be up to 90% effective.

The preliminary result showed that a lower dose appeared to be more effective. The volunteers were first given half a dose of the vaccine, followed by a full dose at least one month apart, efficacy was 90%. Whereas, when volunteers were given two full doses at least one month apart, efficacy was at 62%.

The combined analysis from both dosing regimens involving more than 11,000 volunteers resulted in an average efficacy of 70%.

Both companies said that more data will continue to accumulate and additional analysis will be conducted to improve the efficiency reading and establish the duration of immunization.

(Source: The Straits Times, 2020)


December:

Canadian Government Approves Pfizer – BioNTech COVID-19 Vaccines

On December 9, Canada has approved its first COVID-19 vaccines and will commence delivering and administering the first shots in the following week across the country. 

According to the plan, Canada is now in a good position to immunize 100 percent of the population in the year 2021. In a different table, the immunization could be completed by the end of September.

Canada has a firm order for 20 million doses of the Pfizer – BioNTech COVID-19 vaccine, which is enough to vaccinate 10 million people. The country also has an option to buy up to 56 million more of the vaccine. Pfizer will deliver its vaccine, which requires ultra-cold storage, to warehouses across the country.

According to federal guidelines, the first people to receive the vaccinations include some healthcare workers, long-term care residents and employees, the elderly and Indigenous populations.

(Source: Channel News Asia, 2020)