- Johnson & Johnson (NYSE:JNJ) unit The Janssen Pharmaceutical Companies has submitted a supplemental marketing application to the FDA seeking approval for six-month dosing of paliperidone palmitate. If approved, it will be the first and only long-acting injectable drug for schizophrenia with a twice-yearly regimen.
- The company markets paliperidone palmitate as Invega Sustenna (dosed monthly) and Invega Trinza (dosed every three months).
- https://seekingalpha.com/news/3629520-j-and-j-files-u-s-application-for-twice-yearly-dosing-of-schizophrenia-med
Monday, November 2, 2020
J&J files U.S. application for twice yearly dosing of schizophrenia med
Russian firm seeks to produce COVID-19 drug without patent
Russian drugmaker Pharmasyntez has asked the Kremlin for permission to produce a generic version of U.S. firm Gilead Sciences's GILD.O COVID-19 treatment remdesivir without а patent, the Vedomosti newspaper reported on Monday.
Siberia-based Pharmasyntez previously approached Gilead requesting a voluntary licence to produce and distribute the drug in Russia, the company’s director, Vikram Punia, had told Reuters this year.
But it was not able to produce the drug as it is protected by a patent and Gilead did not respond to a request for a voluntary licence, Vedomosti reported, citing a letter sent by Punia to several Russian ministries.
The Russian firm has completed a clinical trial of the generic drug, labelled Remdeform, on 300 patients across 23 Russian hospitals, a register entry showed.
Gilead granted such permission to manufacture its drug to producers in 127 countries. These were predominantly low-income countries or those with other significant obstacles to healthcare access, Gilead has said.
In his letter, Punia asked Russia’s government to activate a compulsory licensing process, Vedomosti reported, in which the government to grants licences to produce patented products in Russia without the permission of the patent holder, in the interests of national security and defence.
Sunday, November 1, 2020
Bharat Biotech plans to launch vaccine candidate in second quarter of 2021
India’s Bharat Biotech is planning to launch its COVID-19 vaccine candidate in the second quarter of 2021 if it gets approval from Indian regulatory authorities, a company executive said on Sunday.
The company, which has received initial approval from Drugs Controller General of India to conduct late-stage trials for its vaccine candidate COVAXIN said it plans to conduct recruitment and dosage for the Phase 3 trials in November.
The trial will be conducted in 25 sites in 10-12 states and will provide two doses each for the vaccine and placebo recipients, the company’s Executive Director Sai Prasad said.
The company, based in Hyderabad, is developing the vaccine in collaboration with the Indian Council of Medical Research. Bharat Biotech is also in talks with more than 10 countries that have shown an interest in its potential COVID-19 vaccine.
Guidelines for air passenger COVID-19 tests could set global reliability bar
A global aviation manual now under review by a UN body suggests global guidelines calling for the use of highly reliable tests when screening passengers to detect the novel coronavirus ahead of flights, three sources familiar with the matter said.
Carriers and airports are pushing for uniform global testing guidelines to waive strict quarantine requirements that are decimating travel, with airline trade group IATA forecasting a 66% decline in 2020 air traffic because of the pandemic.
Travel restrictions and the use of testing now vary globally. Certain airlines require passengers to obtain a negative test, even as some countries allow visitors in without quarantine, while others bar all non-essential foreigners.
The International Civil Aviation Organization (ICAO) Manual on Testing and Cross Border Risk Management Measures, expected in November, would offer voluntary technical guidance but not oblige countries to remove quarantines.
The manual is not expected to suggest specific tests, such as antigen or polymerase chain reaction (PCR), the sources said. Instead, it would recommend passengers be screened using a test with a sensitivity and specificity of 95% so there would be few false positives and negatives, the sources added.
Some rapid tests are less sensitive and therefore more likely to miss positive cases than PCR alternatives, although the accuracy gap has narrowed.
One of the sources said a range of tests, with reliability as low as around 80% to close to 100%, had initially been considered.
Another proposal is that passengers be tested up to 48 hours ahead of travel but not necessarily at the airport, the sources said. The sources declined to be identified as the discussions are confidential.
U.S. Federal Aviation Administration (FAA) Deputy Administrator Dan Elwell told Reuters on Wednesday that the manual would not be "heavy handed" or provide a prescription for testing. He did not confirm specific details about the manual.
"It's like 'look, if you are going to do pre-departure testing or arrival testing or quarantine, here's how we think you should do it,'" said Elwell, who heads an ICAO working group on issues like testing and quarantines.
ICAO said in an emailed statement the manual provides countries with a risk management framework for evaluating testing options and factors to consider, should a country elect to implement testing.
While the United States "would like to get to a point where quarantine is not necessary," Elwell said, it would be difficult to create global guidelines for removing travel restrictions through testing since countries have individual concerns," he said.
"There are a lot of mixed feelings about quarantines."
UK's Nigel Farage set to relaunch Brexit Party as anti-lockdown party
Brexit Party leader Nigel Farage will relaunch the group as an anti-lockdown party called Reform UK in an attempt to fight anti-coronavirus measures imposed by Prime Minister Boris Johnson's government.
The new party will back a policy of focused protection from the coronavirus for only the most vulnerable, and allow the rest of the population to develop herd immunity, Farage and party Chairman Richard Tice wrote in an opinion piece in The Telegraph on Sunday.
Papers seeking the name change have been submitted to the Electoral Commission, they added.
The Brexit Party was set up in early 2019 by Farage, whose years of campaigning against membership of the European Union played a major part in delivering the 2016 referendum in which the UK voted to leave the bloc.
"We are showing the courage needed to take on consensus thinking and vested interests on Covid. But there are so many areas of public life that can be improved to benefit ordinary people. That is why we will campaign for Reform", Farage and Tice wrote.
"We want to be known as the party of Reform. The name reflects the ambition: Reform UK", they added.
The prime minister on Saturday ordered England back into a lockdown after the UK passed the milestone of 1 million COVID-19 cases and a second wave of infections threatened to overwhelm the health service.
The UK has the world's fifth-largest official death toll, after the United States, Brazil, India and Mexico, according to a Johns Hopkins University tally.
Brazilians protest mandatory COVID-19 immunization, Chinese vaccine
More than 300 Brazilians gathered on São Paulo's main commercial thoroughfare on Sunday to protest state Governor João Doria's support for mandatory COVID-19 immunization and testing the potential vaccine developed by China's Sinovac.
Doria has previously spoken in favor of making immunizations mandatory, once vaccines are available, sparking a spat with President Jair Bolsonaro who vows it will be voluntary. The Supreme Court's chief justice has said the court will ultimately decide on the issue.
A number of vaccines are obligatory in Brazil, including for example Hepatitis B which is given to newborns. Brazil has had great success with large vaccination campaigns in the past, eradicating polio in the 1980s for example.
In São Paulo, the Sinovac vaccine is being tested as part of phase III clinical trials with support from the Doria government.
Brazil's federal health ministry announced last month it would buy 46 million doses of the vaccine, contingent on regulatory approval, in a deal supported by state governors. But a day later right-wing President Jair Bolsonaro said that Brazil would not buy the vaccine.
Bolsonaro has bashed China intermittently since the campaign trail in 2018, over the Asian countries growing investments and influence in Brazil.
The protestors in São Paulo rallied in support of Bolsonaro, with one demonstrator holding a sign saying "We are not guinea pigs" and another in a mask that said "no vaccine." Many of the tightly packed protestors did not wear masks.
"We're against the authoritarian Chinese ambassador João Doria, who would now make the vaccine compulsory against our wishes," protestor Andre Petros said.
"This doesn't happen anywhere in the world, not even in China."
Brazil has the third-worst outbreak of coronavirus globally, with 5.5 million cases, after the United States and India, according to a Reuters tally.
Israel starts human trials on COVID-19 vaccine as schools slowly reopen
Israel began human trials on Sunday for its COVID-19 vaccine candidate which, if successful, could be ready for the general public by the end of next summer.
Eighty volunteers will initially take part in the trial that will be expanded to 960 people in December. Should those trials succeed a third stage with 30,000 volunteers is scheduled for April/May.
"We are in the final stretch," said Shmuel Shapira, Director General of the Israel Institute for Biological Research.
The institute, which is overseen by the Defense Ministry, began animal trials for its "BriLife" vaccine in March and announced a week ago it had received regulatory approval to take it to the next stage.
For a factbox on the many vaccine candidates in human trials worldwide, please click on
Shmuel Yitzhaki, head of the institute's biology division, told Reuters that if all goes well the vaccine could reach the general population by the end of next summer.
While the first batch of volunteers received the potential vaccine, around the country elementary students returned to school as a second nationwide lockdown comes to a gradual end.
Restrictions in Israel, with a population of 9 million, are being slowly lifted following a steady decline in the rate of daily infections.
First through fourth graders were the first to return to school on Sunday. Older kids are still learning from home.
The government also approved the reopening in stages of businesses and recreational activities.
The country reported 674 new cases on Friday - down from a peak of more than 9,000 several weeks ago. It has reported 2,541 deaths from the pandemic.
https://www.marketscreener.com/news/latest/Israel-starts-human-trials-on-COVID-19-vaccine-as-schools-slowly-reopen--31666532/
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