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The Union Health Ministry has come up with draft New Drugs and Clinical Trials (Amendment) Rules, inserting provisions for “compassionate use” of any unapproved drug that is in the phase-III clinical trial, either in India or abroad, by importing or indigenous manufacturing.

The move is aimed at facilitating the availability of new drugs which are in Phase-III clinical trials (human trials) for severely-ill COVID-19 patients in the country.

According to a gazette notification of the draft rules published on June 5, a hospital or medical institution may import the new drug for “compassionate use for the treatment of patients suffering from a life-threatening disease or disease-causing serious permanent disability or disease requiring therapy for unmet medical need”, which has not been permitted in the country, but under Phase-III clinical trial in the country or abroad, by making an application to the Central Drug Regulator.

Also, if any hospital prescribes a new drug for the same purposes then they may be approved to be manufactured in limited quantity subject to provisions of the rules.

The manufacturer intending to manufacture a new drug will have to obtain the consent in writing from the patient to whom the medicine has been prescribed or his legal heirs and make an application to the Ethics Committee of the hospital or medical institution for obtaining its specific recommendation for the manufacture of such new drug.

After obtaining the recommendation of the Ethics Committee, the manufacturer shall make an application to obtain the permission, to the Central Licencing Authority for manufacturing the new drug for the purpose of compassionate use, the draft rules stated.

“The manufacturer to whom the permission is granted shall make use of the new drug only for the purposes specified in the permission and no part of it shall be sold in the market or supplied to any other person, agency, institution or place,” it stated.

The new draft rules will be applicable for 15 days during which people can send their objections and suggestions to be considered by the Central Government after which the final amended rules will be published in the Gazette of India.

The set of new rules have been inserted under section 96 which deals with filing an application, granting the license to the importer or manufacturer, conditions and suspension of such licenses among others.

For both manufacturing and importing, the licence shall remain valid for a period of one year from the date it has been issued.

If an importer or the manufacturer to whom the license is granted fails to comply with any provision of the Act and these rules, the Central Licencing Authority, may, after giving an opportunity of being heard, suspend or cancel the license for such period as considered appropriate either wholly or in respect of some of the substances to which the violation relates.

The quantity of any new drug manufactured or imported on the basis of permission granted shall not exceed one hundred average dosages per patient, the draft rules stated.

But in exceptional circumstances on the basis of the prescription of the medical officer and the recommendation of the Ethics Committee, the Central Licencing Authority may allow the manufacture of such new drug in larger quantity.

In both cases, for import or indigenous manufacturing, the application should have details including the rationale for the use of the new drug as compassionate use over the available therapeutic options, the criteria for patient selection with a description of the patient’s disease or condition and the method of administration of the drug, dose, and duration of therapy.

It should also mention the description of the manufacturing facility and a description of clinical procedures, laboratory tests, or other monitoring necessary to evaluate the effects of the drug and minimise its risks among others.

Several drugs across the country are in phase III clinical trials phase for COVID-19. Anti-viral drug Remdesivir, last week, was approved for “restricted emergency use” on severe COVID-19 patients.

Almac Clinical Technologies, a unit of UK-based contract development and manufacturing firm Almac Group, has introduced an advanced interactive response technology (IRT).

‘Simplify’ is designed to accelerate the study start-up process with higher efficiency and comes with an array of configurable functionality as standard.

Almac noted that Simplify was designed for trial sponsors and CROs in need of quick and efficient stand up critical eClinical infrastructure with minimal effort or oversight.

The IRT solution offers a hassle-free, straightforward approach for deploying leading IRT capabilities in half the time compared to traditional solutions.

Almac Clinical Technologies president and managing director Valarie Higgins said: “Simplify sets itself apart from other IRT alternatives by offering the flexibility to scale the scope of your solution to at any time.

“This means that unplanned, or unexpected, protocol changes that require custom solutions can be swiftly implemented without requiring a major redesign, and are guided by our expert team of biostatistical, integration, design and support consultants.

“We’re very proud of our longstanding reputation for developing novel solutions in direct response to the pain points we have observed in the industry.”

The IRT solution is powered by Almac IXRS 3 technology, which is known for its high performance and reliability.

According to Almac, the solution also provides improved experience and usability for the users at a significantly reduced cost.

In March last year, Almac unveiled a unified clinical trial supply solution to improve experience for sponsors.

Domestic medical devices industry is set to receive a booster dose as central government lays out plan to incentivise Indian players with at least ₹3,420 crore, over a period of five years. This incentive would be provided if they were to invest in their set-ups to produce key medical devices.

Officials in Department of Pharmaceuticals (DoP) said that the domestic manufacturing for cancer care and radiotherapy medical devices, radiology and imaging medical devices, anaesthetics and cardio-respiratory medical devices including catheters of this category meant for the heart and, renal care medical devices meant for kidneys, all implants including implantable electronic devices like cochlear implants meant for those with hearing impairment and pacemakers for the heart, will be given priority.

DoP ina notification proposed to pay a production linked incentive (PLI) of five per cent on incremental sales (over base year of 2019-20) of goods manufactured in India covered under target segments to eligible companies for a period of five years (2020-21 to 2025-26).

The notification states that on incremental investment of ₹180 crore over three years, with at least cumulative minimum ₹60 crore investment in first year. And then ₹120 crore in second year and eventual incremental sales of manufactured goods, say for instance, which are ₹120 crore in first year, reaching to ₹240 crore in the second, ₹360 crore in third year, ₹460 crore in the fourth year, reaching up to ₹560 crores in five years. DoP has proposed to dole out through reimbursements, an incentive of five per cent each year on that year’s incremental sales to the medical device companies.

According to data compiled by DoP, India’s medical device market stood at ₹50,026 crore for 2018-19 and is skewed in the favour imports which were to the tune of ₹43,365 crore, while exports were ₹16,300 crore. While both exports and imports grew at 25. 2 and 23.8 per cent as compared to 2017-19, and it is expected to touch ₹86,840 crore in 2021-22, officials said that there is a lack of level playing field in India versus the competing economies.

“India’s share is 1.6 per cent in global market, and it is among the top 20 medical devices market in Asia, and comes after Japan, China, South Korea. Still, Indian industry depends on imports up to an extent of 86 per cent and PLI scheme for medical devices is a financial incentive to boost domestic manufacturing and attract large investments in medical devices sector,” said a DoP official.

“Lack of adequate infrastructure, domestic supply chains, logistics, high cost of finance, limited availability of quality power supply, limited design capabilities, low focus on R&D, and skill development are the main roadblocks,” the official explained.

DOP would appoint a nodal agency to act as a Project Management Agency for appraising of applications and verification of eligibility of the company for support under the scheme. An empowered committee consisting of Secretaries of Pharmaceuticals, Commerce, DPIIT, Health and Director General of Foreign Trade will then consider the applications for approval and conduct periodic reviews of eligible companies.

When COVID-19 restrictions were put into place, many Bay Area residents mourned the sudden loss of the local restaurant scene. But for Julie Murphy, a public health librarian from Emeryville, a severe digestive disorder has long kept her from enjoying an evening out for dinner.

Her hopes for the future are pinned on a clinical trial she’s participating in that’s testing an aggressive new application of lovastatin, a drug traditionally used to treat high cholesterol. During a pandemic, however, that study looks very different.

The trial is hardly the only one affected. An analysis by this news organization of data on clinical trials from the National Institutes of Health found that the pandemic has led to the suspension of at least 60 trials and the disruption of hundreds of others in the greater Bay Area since March 1, stunting research into cancer, strokes, diabetes and other diseases.

“The impact has been profound,” said Harold Collard, associate vice chancellor of clinical research at UC San Francisco’s School of Medicine. “It has postponed, delayed or shut down a large percentage of our ongoing clinical research. It’s been an unprecedented time for us.”

Clinical trials play a critical role in medical research. They’re needed to prove that new drugs and therapies are safe and effective enough to be provided to patients. The trials are also often the only way for patients to gain access to promising medications and therapies. And even when participants only receive a placebo in “blind” studies, they still benefit from additional health care provided during the research.

In some instances, Collard said, trials are also considered part of standard care. Cancer patients, for example, often enroll in clinical trials so they can take experimental drugs at the same time they’re undergoing chemotherapy.

But with so much attention now shifting to coronavirus research, many hospitals lack the space, protective equipment and personnel to continue more exploratory and less urgent treatments and research. While some studies have simply ground to a halt rather than adapt their methods, others, like Murphy’s, have been significantly modified to allow research to continue.

At Stanford’s School of Medicine, no new treatment studies or clinical observation studies will be initiated aside from those related to COVID-19, according to spokeswoman Julie Greicius. Researchers are testing antiviral medications like remdesivir as well as interferon-lambda, a drug given to patients with mild COVID-19 cases to allow them to recover at home.

Similarly, UCSF has given priority to clinical trials with direct applications to the pandemic or those that deal with life-threatening illnesses.

But many researchers have chosen to suspend their trials because of the complications of accessing certain services during the pandemic.

Sonya Borrero, a physician at the University of Pittsburgh School of Medicine, was heading a clinical trial with a hub in San Francisco. The study was aimed at testing the effectiveness of an online tool Borrero designed to provide reliable information to low-income women considering a tubal ligation. Even though the study didn’t require in-person visits, Borrero made the call in early March to postpone the trial when many hospitals began classifying the sterilization procedure as “nonessential.”

Noting that tubal ligations are the main method of contraception for women under 50 and are particularly popular with low-income families, Borrero said her decision was heartbreaking but unavoidable. “There’s been a major disruption to family planning services,” she said. And that’s “going to have long-lasting life impacts beyond the COVID pandemic.”

When the pandemic struck, Murphy was halfway through her clinical trial at Cedars-Sinai Medical Center in Los Angeles. She reluctantly boarded a flight for her last in-person visit on March 13, the same day President Donald Trump declared a nationwide state of emergency over the coronavirus.

“I was worried I wasn’t going to get a drug if I didn’t go for the appointment,” recalled Murphy, 54.

Ultimately, the trial’s researchers made sweeping changes that have allowed the study to continue. And they worked hard to make the process simple for her.

Her latest check-in took place in her own home, where she received equipment and medication by mail with detailed instructions on how to carry out each test herself. Her final appointment will be at an Oakland clinic.

“I performed the test, popped it in the box, walked it over to FedEx — and that was visit four,” she said. “I want to complete this because that’s one more person who will have helped get this drug to market.”

While the shift to virtual and remote methods has made it easier and cheaper for her to participate, she said, there is something lost in the transition: the comfort of speaking with a doctor face to face about potentially frightening medical issues.

“I would not trade my first visit because I got to speak to the expert and ask him all my weird questions,” Murphy said. “I got access to this valuable expertise that I don’t think would work if the whole thing was telehealth in the future.”

As states begin the slow, halting process of reopening, the hope is that most of the suspended trials will be able to resume in the next weeks and months, although some will likely need to start over entirely. Researchers are now deciding how to move forward.

“When we had to shut down, in some ways it was easier just because it was so much more black and white,” UCSF’s Collard said. “Opening up is a different story, and the timeline for that is really unclear.”

Patients currently enrolled in ongoing clinical trials for medical conditions other than COVID-19 report experiencing changes as a result of the pandemic such as telemedicine, study medication delivered to their homes, and the use of smartphone apps.

BOSTON (PRWEB) MAY 26, 2020

The recent public healthcare crisis has generated an increasing amount of attention on the topic of clinical research. In light of this, CISCRP conducted a brief survey among the public and patients in April 2020 to assess the impact of the pandemic on clinical research perceptions and experiences. The final report can be accessed here.

Five hundred diverse individuals in the United States and a few select countries in Europe (United Kingdom, France, Germany and Italy) completed the survey. Eighteen percent of the respondents have clinical trial experience. Of those who have participated in clinical research, more than half (56%) are currently enrolled in a clinical trial for COVID-19. Where appropriate, comparisons were made to the baseline 2019 Perceptions & Insights Study, a biennial large-scale global analysis of public and patient views of and experiences with clinical research to identify any notable differences.

Overall, awareness of clinical trials remains low – as 58% had not heard of a COVID-19 clinical research study recently.

“Interestingly, among the minority that had recently heard of a COVID-19 clinical research study in the recruitment phase, we learned that a higher proportion (40%) of Europeans are aware than Americans (34%),” said Annick de Bruin, Director, Research Services. “This contrasts with our larger baseline 2019 Perceptions & Insights Study where we found that North Americans are more likely to be aware of a current clinical trial in general than any other region. This may partially be due to the fact that the crisis evolved earlier in Europe.”

Misconceptions about the clinical research development process persist. Most (60%) think a treatment or vaccine for the virus will be developed in less than one year. Once developed, the majority (64%) think it will be less than a year before people can start receiving it.

Patients currently enrolled in ongoing clinical trials for conditions other than COVID-19 report experiencing changes as a result of the pandemic such as telemedicine, study medication delivered to their homes, and the use of smartphone apps. Twenty-six percent report a suspension of the clinical research study in which they were enrolled and 11% report a reduced number of in-person clinic visits.

Top motivators for participating in a COVID-19 clinical research study include altruistic reasons with 46% mentioning ‘to help others who are suffering’ and 46% mentioning ‘to advance science and the treatment of COVID-19.’ These motivations are in line with findings from the larger baseline 2019 Perceptions & Insights Study.

Both the COVID-19 special report, as well as the 2019 baseline reports are available free of charge on the CISCRP website under Research Services, https://www.ciscrp.org/services/research-services/ . CISCRP also presents the aggregate results of the Perceptions and Insights Study at industry conferences, company meetings, and other virtual and in-person forums. For a detailed, in-depth report with a facilitated virtual meeting or webinar, please contact Annick de Bruin at adebruin@ciscrp.org or call 617-725-2750 x400.

About CISCRP
The Center for Information and Study on Clinical Research Participation (CISCRP) is an internationally recognized non-profit organization dedicated to educating and informing the public and patients about clinical research. CISCRP works to raise awareness, enhance experiences, and strengthen communication and relationships among participants, research professionals and the public through various services and events. http://www.ciscrp.org

The company has submitted the proposal for required permission from the concerned authorities and the clinical trial will be conducted at Hamdard Institute of Medical Sciences and Research, New Delhi, Hamdard Laboratories said in a statement.

New Delhi: Health and wellness firm Hamdard Laboratories on Tuesday said it is planning to conduct clinical trial of its immunity booster medicines to assess their effectiveness against COVID-19. The company has submitted the proposal for required permission from the concerned authorities and the clinical trial will be conducted at Hamdard Institute of Medical Sciences and Research, New Delhi, Hamdard Laboratories said in a statement.

The Ministry of AYUSH has invited inputs from Ayush department, Hamdard Laboratories said.

The ministry’s task force is examining the proposals submitted by Ayush institutions. They will then be send to Indian Council of Medical Research (ICMR), which will register such clinical proposals and evaluate the outcome of studies for clinical efficacy of such products, it added.

“Currently, preventive measures are the only way to fight the coronavirus and having a strong immunity system is one of the ways to minimize the impact of the virus on the body,” Hamdard Laboratories (Medicine Division) Chairman Abdul Majeed said.

Hamdard Laboratories foresees that clinical trials of immunity boosting Unani medicines will further scientifically establish clinical evidence, he added.

“Our products are developed with natural formulae that combine the benefits of time tested herbs for strengthening of innate immunity which may be helpful in minimizing the impact of COVID-19 virus through development of specific antibodies,” Majeed said.

The company is hopeful that the trials will yield positive results and will help in fighting the COVID-19 pandemic, he added.

US biotech Novavax has begun a phase 1 study of its coronavirus vaccine, as the number in clinical development reached double figures. 

The World Health Organization has been keeping tabs on the various vaccines in development to treat the SARS-CoV-2 coronavirus, and at the latest count there are 10 in the clinic and more than a hundred in preclinical development. 

Maryland-based Novavax said it had enrolled the first participants in a phase 1/2 clinical trial of its coronavirus vaccine candidate. 

The vaccine, NVX-CoV2373, is a stable, prefusion protein mode using the company’s proprietary nanoparticle technology. 

It is boosted with Novavax’s proprietary Matrix-M adjuvant to enhance immune responses and stimulate production of neutralising antibodies.

The company expects immunogenicity and safety results from the phase 1 portion of the trial in July. 

The phase 1 portion is a randomised, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of NVX‑CoV2373, both adjuvanted with Matrix‑M and unadjuvanted.  

The trial is enrolling around 130 healthy participants 18 to 59 years of age at two sites in Australia. The protocol’s two-dose trial regimen assesses two dose sizes (5 and 25 micrograms) with Matrix‑M and without. 

The phase 2 portion is expected to be conducted in several countries including the US, and would assess immunity, safety and COVID‑19 disease reduction in a broader age range.  

According to Novavax this approach allows for rapid advancement of NVX‑CoV2373 during the pandemic. The trial is being supported by the recently announced funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI). 

CEPI kick-started the clinical trial with a $384 million investmentin Novavax earlier this month, following an initial $4 million invested in March.

The company has plans to produce up to 100 million vaccine doses by the end of this year, scaled up to more than a billion doses during 2021. 

Novavax and CEPI said they agree on the importance of “global equitable access” to vaccines produced from their partnership.  

Vaccines will be procured and distributed through global mechanisms now under discussion as part of the Access to COVID-19 Tools Accelerator, the international initiative launched by the World Health Organization and global leaders earlier this month. 

According to the WHO the most advanced vaccine is CanSino Biological and the Beijing Institute of Technology’as phase 2 candidate. 

An mRNA-based vaccine developed by Moderna and the US National Institute of Allergy and Infectious Diseases is cleared for phase 2 development. 

U.S. Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) filing to study the use of Alvesco in COVID-19

Study will evaluate the Safety and Efficacy of Alvesco in the Treatment of Non-hospitalized COVID-19 Patients Aged 12 and Above

LUXEMBOURG and ZUG, Switzerland, May 19, 2020 /PRNewswire/ — Covis Pharma Holdings S.a.r.l.. today announced the initiation of a Phase 3 clinical study to assess the safety and efficacy of its asthma drug Alvesco (ciclesonide) in non-hospitalized patients 12 years of age and older with symptomatic COVID-19. Patient recruitment for the multicenter, randomized, double-blind, placebo-controlled study of Alvesco is underway. The study is being initiated after FDA approval of the company’s IND filing for Alvesco for the treatment of COVID-19.

“There is promising scientific evidence that Alvesco, an inhaled glucocorticoid, may both reduce COVID-19 symptoms and suppress viral replication,” said Michael Blaiss, M.D., Clinical Professor of Pediatrics, Medical College of Georgia at Augusta University in Augusta, Georgia. “Evaluating Alvesco in this Phase 3 clinical trial is an important step towards determining its efficacy in treating individuals who have tested positive for the virus, and we are hopeful that it will become an important tool in the world’s response to this public health emergency.”

“We are committed to rapidly evaluating Alvesco as a potential treatment for this serious global health threat,” said Michael Porter, CEO of Covis. “Having received approval from the FDA for our study design and protocol, we are pleased to initiate this Phase 3 study. Should Alvesco show positive results in the study’s primary endpoint for reduction of patients with a hospital admission or mortality by day 30, we intend to file for approval of our drug in the U.S. for the treatment of COVID-19.”

Alvesco is a glucocorticoid indicated for the long-term treatment of asthma as maintenance therapy in adults and adolescents 12 years of age and older in the U.S. and over 6 years of age in Canada. It is currently under evaluation in clinical trials for the treatment of COVID-19 in countries such as Australia, Japan, South Korea, Sweden, the UK, and now the U.S. Covis is working with key stakeholders to make the appropriate supply of Alvesco available for these clinical investigations by supporting research efforts and donating Alvesco inhalers.

“Early scientific data suggest that the use of Alvesco may reduce symptoms in individuals with the novel coronavirus, potentially decreasing viral replication and therefore viral load,” said Aziza Johnson, Executive Vice President of Regulatory and Scientific Affairs at Covis. “Given the urgent need for treatment options, we are working with expediency to assess the efficacy of Alvesco against COVID-19 and believe this study will provide us with important data around the drug’s ability to reduce duration of clinical symptoms, as well as the severity of the disease.”

The Phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of Alvesco, a metered-dose inhaler, in non-hospitalized individuals with COVID-19 aged 12 and above. The study will enroll 400 patients at multiple clinical trial sites across the United States. Patients will be randomized in a 1:1 ratio to receive treatment with 320 µg of an Alvesco metered-dose inhaler twice daily plus standard supportive care, or to receive placebo plus standard supportive care. The primary efficacy endpoint is the percentage of patients with a hospital admission or death by day 30. Early results of the Phase 3 clinical study are expected to be released in late-August/early-September 2020.

There are currently no antiviral drugs approved by the FDA for COVID-19 with the exception of, Gilead’s Antiviral Remdesivir has received FDA Emergency Use Authorization for the treatment of COVID-19. According to the website of the Centers for Disease Control and Prevention (CDC), clinical management of COVID-19 includes prompt implementation of recommended infection prevention and control measures in healthcare settings and supportive management of complications. See CDC Clinical Guidance for COVID-19 for more information. The World Health Organization (WHO) advises that people of all ages can be infected by the new coronavirus (2019-nCoV). Older people, and people with pre-existing medical conditions (such as asthma, diabetes, heart disease) appear to be more vulnerable to becoming severely ill with the virus. WHO recommends people of all ages to take steps to protect themselves from the virus, for example by following good hand and respiratory hygiene.

About Alvesco
Alvesco (ciclesonide) Inhalation Aerosol is a glucocorticoid indicated for the long-term treatment of asthma as maintenance therapy in adults and adolescents 12 years of age and older in the U.S. and over 6 years of age in Canada. Alvesco Inhalation Aerosol is an inhaled glucocorticoid with a small particle size (1-2 μm) enabling it to reach areas of chronic inflammation in both the large and small airways. Alvesco is not indicated for the relief of acute bronchospasm. Alvesco is not indicated for children under 12 years of age in the U.S. or under the age of 6 in Canada. See full prescribing information at Alvesco.us.

About Covis Pharma 
Covis Pharma is headquartered in Luxembourg with operations in Zug, Switzerland and is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information is available at www.covispharma.com.