India's Hetero gets emergency use nod to make Roche's COVID-19 drug

 

Indian drug developer Hetero said on Monday it has received emergency use approval from the country's health authorities to make a generic version of Roche Holding AG's COVID-19 drug.

Hetero expects to make the treatment, tocilizumab, available in India by the end of the month under the brand name Tocira. Tocilizumab has been facing a global shortage as the highly contagious COVID-19 Delta variant drives up cases in several countries.

COVID-19 cases in India have declined from levels hit during the second wave in April and May, although health experts believe that the country should brace for a third wave by October.

Roche's blockbuster arthritis drug, tocilizumab, cuts the risk of death among patients hospitalised with severe COVID-19 along with shortening the recovery time and reducing the need for mechanical ventilation.

Tocira will be made by Hetero's unit at its Hyderabad facility.

Hetero, which makes COVID-19 treatments like remdesivir and favipiravir, had also sought emergency approval for Merck's COVID-19 drug molnupiravir in July.

https://www.marketscreener.com/quote/stock/ROCHE-HOLDING-AG-9364975/news/Roche-India-s-Hetero-gets-emergency-use-nod-to-make-Roche-s-COVID-19-drug-36354210/

UK Minister Says Minors Can Get COVID Vaccine Jab Without Parental Consent

 COVID-19 Vaccine Deployment Minister Nadhim Zahawi told the Times radio that British teenagers would still be allowed to get a COVID-19 vaccination, even if their parents objected, as long as they consented to the jab.

Zahawi explained that thanks to its long history of carrying out school-related vaccinations, that the NHS is well-equipped to make these types of decisions. So long as the clinicians on hand determine that the teen is mentally competent to make a decision related to vaccination, then they would be free to move ahead and administer one, Zahawi explained.

He told Newton Dunn during the Sunday interview that “what you essentially do is make sure that the clinicians discuss this with the parents, with the teenager, and if they are then deemed to be able to make a decision that is competent, then that decision will go in the favor of what the teenager decides to do."

To try and draw Zahawi out, Dunn pushed for more clarification: "So to be clear, the teenager can override the lack of parental consent? If a teenager really wants a jab and is only 15, the parents say no, the teenager can have it?" to which Zahawi responded, "they would need to be competent to make that decision, with all of the information available."

Bizarrely, Zahawi appeared to contradict himself when he spoke to Sky News on Sunday and told them that children would require parental consent to get vaccinated no matter what.

Asked by Sky's Trevor Phillips whether he could "assure parents that if there is a decision to vaccinate 12 to 15-year-olds, it will require parental consent," Zahawi replied: "I can give that assurance, absolutely."

For context, On Friday (just two days before Zahawi's spate of interviews) the UK's Joint Committee on Vaccination and Immunization refused to recommend on Friday that healthy children between the ages of 12 and 15 be vaccinated against COVID-19, given they are considered extremely low risk, the government is still pushing for vaccination.

JCVI’s deputy chairman, Professor Anthony Harnden, noted on Saturday that "the health benefits from vaccinating well 12- to 15-year-olds" are only "marginally greater than the risks," and said that any decision should ultimately require "parents’ consent."

"Both the teenagers and the parents need to be involved in that choice," he argued.

On Friday, protesters stormed the London headquarters of the UK’s Medicines and Healthcare Products Regulatory Agency in protest of the government’s likely intention to vaccinate children under the age of 16.

https://www.zerohedge.com/geopolitical/uk-minister-says-minors-can-get-covid-vaccine-jab-without-parental-consent

China pharma companies may still get foreign IPO OKs

 China is planning to introduce new regulations that would ban several Chinese companies that handle sensitive user data from listing abroad, the Wall Street Journal reported on Friday, in a move that could be a severe blow to the ambitions of local internet companies who are planning to launch foreign initial public offerings (IPOs).

KEY FACTS

According to the WSJ report, the China Securities Regulatory Commission (CSRC) has informed some companies and their foreign investors that local internet giants who hold a large amount of user data will be prohibited from listing abroad.

As part of the rule change, the Chinese regulator will set up a mechanism that will require companies to obtain formal approval before moving ahead with a foreign IPO.

The approval process will be handled by a cross-ministry committee that will be set up in the coming months. 

The rules will specifically target companies planning foreign IPOs through units incorporated abroad, the report says.

The report also notes that companies with less sensitive data, such as pharmaceutical companies are still expected to receive a green light for foreign listings.

Reuters reported that the ban will also likely target companies that are seen as having “ideology issues,” without elaborating further.

TANGENT

The WSJ report—which was published less than an hour before markets closed in Hong Kong—hasn’t impacted the stocks of major Chinese internet giants like Baidu, Alibaba and Tencent. 

KEY BACKGROUND

The reported regulatory proposal comes on the backdrop of a concerted effort by the Chinese government to exert more control over the country’s major tech companies. Chinese authorities have targeted and punished several major tech companies in the country for anti-competitive practices and gathering large volumes of private user data. The new rules will allow Beijing to more closely control tech companies that use foreign units to raise capital abroad without explicitly needing Chinese regulatory approval. This loophole, which the new proposals seek to close, allowed Chinese taxi-hailing giant Didi to list on the New York Stock Exchange earlier this year.

WHAT TO WATCH FOR

The planned move by the CSRC comes at a time when the U.S. Securities and Exchange Commission (SEC) plans to increase scrutiny of Chinese-owned companies that are listed in the U.S. and those who are planning to launch a U.S. IPO. Last month, SEC Chairman Gary Gensler announced that the agencies will conduct “targeted additional reviews” of IPO filings for companies with significant China-based operations. Earlier this week, Gensler said the SEC will also order the more than 250 Chinese companies trading in U.S. markets to better inform investors about their political and regulatory risks. The SEC’s actions followed the fiasco around Didi’s U.S. IPO. The cab-hailing giant’s shares tanked last month following its IPO after Beijing announced it was scrutinizing the company and it would restrict it from adding any new users.

https://www.forbes.com/sites/siladityaray/2021/08/27/china-set-to-propose-ban-on-foreign-listing-for-firms-handling-sensitive-user-data-report-says/

Chinese shadow on Indian pharmaceutical industry

 In the last few years, the industry has come under China's shadow with the Chinese capturing nearly the entire supply chain

India is called the pharmacy of the world. It ranks fourth in the world in terms of value and third in terms of volume. India exports medicines to most of the countries and the share of Indian medicines in the US market is 34 percent.

We manufacture medicines for a range of diseases like malaria, common infections, vitamin deficiencies, diabetes, cancer, asthma, HIV, heart diseases.

However, for the last few years, the industry has come under China’s shadow with the latter nearly capturing the supply chain. Due to this, not only the health security of India’s 135 crore people could be at risk, it could even eclipse India’s ability to provide affordable medicine to the rest of the world.

Prior to 2000, there was a worldwide demand for Indian-made Active Pharmaceutical Ingredients (APIs). India was thriving in the field of basic chemicals, intermediate chemicals and APIs. After 2000, though, India continued to be the source of ready-made medicines for the world but the manufacturing of API and intermediates started slipping from India and went into the hands of China.

China created an unimaginable production capacity for intermediate chemicals and APIs and started dumping them in the world market including India at less than half the normal price. The Chinese Government was an active collaborator providing low-interest loans, long-term moratorium on debt repayment, credit guarantees by the Chinese insurance company Sinosure, proactive research and development support, export promotion incentives, marketing incentives, cheap electricity and community facilities, and deliberately lax pollution regulatory laws. Many provisions were against WTO rules.

This can be illustrated with the example of the price movements of 6-APA (6-Amino Penicillanic Acid, a derivative of Penicillin-G), the basic chemical building block for antibiotics, such as Ampicillin, Amoxicillin, Cloxacillin, Dicloxacillin, Flucloxacillin, Oxacillin among others. In 2005, India was completely self-sufficient for 6-APA as there were four manufacturers of Penicillin-G in India. Today, India, along with the world, has become 100 percent dependent on China for this input.

Until 2001, before the Chinese market aggression, 6-APA was sold for an average price of $22 per kilo. Between 2001 and 2007, the Chinese suppliers crashed the 6-APA prices by less than half to an average of US$9 per kilo. Indiancompanies were forced to stop production as they could not sustain the losses. As soon as Indian companies went out of production, China started increasing the prices of Penicillin-G and 6-APA. The price of 6-APA has since increased to a peak of USD 35 per kg.

China has thus established a monopoly in almost all types of Intermediates and APIs. It has a state-sponsored strategy where all Chinese suppliers come together to exploit the situation by significantly hiking the prices of products they export. For example, the price of ‘DBA’, the key input for anti-malarial drugs, went up by 47 percent, ‘Erythromycin TIOC’, key input for Azithromycin, increased by 44 percent and that of ‘Penicillin-G’ by 97 percent.

As a result, India faces a public health security crisis. If India is completely dependent on China for critical inputs, it is possible that our medical supplies could be jeopardised if China suddenly stops supplying these APIs.

China has already threatened to stop drug supplies to the US and concerns are being expressed in the US. India's National Security Advisor Ajit Doval had also warned that India’s dependence on China for APIs could be a serious national security threat.

The Government of India has recently announced Production Linked Incentives (PLI) plan to encourage API production in the country, under which an amount of Rs 12,000 crore has been allocated. But that alone will not suffice. To defeat China in the price war, the government will have to impose ‘Safeguard’ and ‘Anti-Dumping’ duties on all APIs.

Where API firms are struggling for survival, funds may be allocated for upgradation of technology. The Government's support for the establishment of research and development facilities could be helpful. Easing environmental laws for API units and exemption from environmental laws may be appropriate strategy. Other incentives like reduction in import duty for testing equipment, allotment of land at cheaper rates, making it a pre-condition that Indian buyers of APIs and Intermediates are required to buy at least 50 per cent of their requirements from domestic manufacturers if those products are available from India, etc., could be some other steps to safeguard the national interest and possibly avoid an impending crisis.

https://www.dailypioneer.com/2021/columnists/chinese-shadow-on-indian-pharmaceutical-industry.html

Ping An, Alibaba, JD.com Healthcare Units Tumble As State Median Urges More Regulation

 Chinese online healthcare stocks plunged more than 10% after a state-run newspaper called for greater supervision of prescription drugs sold on the internet, sparking fears that the government is preparing to introduce new regulations. 

Ping An Healthcare and Technology, which operates the online health consultation app Ping An Good Doctor, saw its shares tumble 14.4% on Friday. The sharp drop wiped out $8.5 billion of the Shanghai-based firm’s market cap.

Shares of Alibaba Health Information Technology also fell nearly as much, dropping 13.3%, while JD Health International slid 14.4%. The drop brought the market cap of Alibaba Group and JD.com’s health units down $2.6 billion and almost $4 billion, respectively. 

Earlier the same day, the Communist Party’s main newspaper, People’s Daily, suggested that prescriptions filled by online healthcare platforms should be reviewed by professional clinical pharmacists. The commentary said some of the internet hospitals do not have a review system for their online prescriptions, while also lacking professional pharmacists, which has led to problems like “overprescriptions” and “distributing medicines before prescriptions are actually issued,” the paper said.

“Prescription drugs are exceptional, and we must strictly ensure medication safety,” People’s Daily wrote. “Whether the prescriptions come from a reliable source and whether their quality is guaranteed are a matter of medication safety concern.”

Ping An Healthcare, Alibaba Health and JD Health did not immediately respond to requests for comment.

China’s online healthcare sector had been experiencing a surge in sales as the pandemic boosted demand for remote consultations and medicine sales. Ping An Healthcare said it had attracted 72.6 million monthly active users in 2020, up 8.5% year-on-year. Alibaba Health said it recorded more than 280 million annual active users on its pharmaceutical platform and over 520 million users on its healthcare channel as of March. While JD Health said its annual active users increased to 89.8 million last year from 33.7 million in 2019 . 

The three companies all offer online healthcare services ranging from consultations, hospital referrals and appointments, as well as e-commerce platforms that sell medication and wellness products.

In recent years, China had lifted an earlier ban on the sale of prescription drugs online while seeking to promote the country’s digital healthcare sector as part of its drive to boost consumption and employment.  

https://www.forbes.com/sites/zinnialee/2021/08/20/ping-an-alibaba-jds-healthcare-units-tumble-as-state-media-calls-for-stepped-up-regulation/?sh=251986a21917

Identifying the risk factors for tooth loss

 One of the major causes of tooth loss is the inflammation and weakening of the supporting structures of the teeth caused by bacterial infection, a condition commonly known as "periodontitis." The oral cavity is home to a myriad of microorganisms, including bacteria that generally maintain a "symbiotic" (mutually beneficial) or neutral relationship with the host, but are also capable of initiating many diseases.

Aggregation of the bacterial community into "biofilms" is often associated with the development of infections, including periodontitis. With currently available treatment options often proving inadequate, there is a pressing need to understand the beginning and development of the disease better. Now, in a study published in International Journal of Environment and Public Health Research, a group of researchers led by Assistant Professor Naoki Toyama from Okayama University, Japan, reveal insightful findings that could provide new directions to the treatment strategies for periodontitis.

The physiology of an individual directly affects the development of infection. Genetic differences among hosts contribute to differences in susceptibility to specific pathogens and the chance of developing certain diseases. In their study, Dr. Toyama and colleagues focused on understanding the microbes associated with the presence of periodontitis and the host genetic factors that might facilitate the development of the conditions. Dr. Toyama explains the motivation behind their study, "Several studies on periodontitis have shown that the development of the disease is associated with the nature of the oral microbiome as well as with genetic 'polymorphism,' the most common type of genetic variation among people. However, there is no study that simultaneously assesses the importance of these two risk factors in developing the disease."

Accordingly, the team conducted a cross-sectional study in which they genotypically analyzed 14,539 participants and conducted saliva sampling of 385 individuals. They finally retained 22 individuals for statistical analysis, and based on their periodontal status, divided them into "periodontitis" and "control" groups.

The team found that the "β-diversity" of the microbes, which refers to the ratio between regional and local species diversity, was significantly different between the periodontitis and control groups. Furthermore, they attributed the presence of the bacteria species, P. gingivalis and the bacterial families, Lactobacillaceae and Desulfobulbaceae, to periodontitis. In contrast, they found no relation between genetic polymorphism and periodontitis. Taking these inferences into account, the team concluded that our oral microbiome affects the status of periodontitis more than our genes.

So, how do these findings influence current clinical practices? Dr. Toyama surmises, "The fact that the prevalence of periodontitis is associated with the members of the microbiome rather than the genetic identity of the individual would motivate clinicians to pay more attention to microbiome composition than to host factors in the routine work of periodontal examination, and design customized treatment strategy for periodontitis.''

These findings further reinforce the importance of regular tooth cleaning in keeping periodontitis at bay.

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Story Source:

Materials provided by Okayama University. Note: Content may be edited for style and length.

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Journal Reference:

1. Naoki Toyama, Daisuke Ekuni, Daisuke Matsui, Teruhide Koyama, Masahiro Nakatochi, Yukihide Momozawa, Michiaki Kubo, Manabu Morita. Comprehensive Analysis of Risk Factors for Periodontitis Focusing on the Saliva Microbiome and Polymorphism. International Journal of Environmental Research and Public Health, 2021; 18 (12): 6430 DOI: 10.3390/ijerph18126430

https://www.sciencedaily.com/releases/2021/09/210902125040.htm

U.S. Officials Rush to Reassure as Mu Variant Grabs International Headlines

 As cases of the Delta variant continue to raise concerns across the U.S., a new variant reaches a warning level for the World Health Organization.

The new coronavirus variant 'Mu' showed signs of possible resistance to vaccines, with the global health body designating it as a 'variant of interest' and said it is monitoring it closely.

The Mu variation is the fifth strain of the SARS-CoV-2 virus to be designated as a "variant of interest" by the World Health Organization. It is the latest variant to spark concern since the more contagious Delta variant, which has led to a fourth outbreak of the virus in the United States.

Dr. Anthony Fauci said at a press briefing on Thursday that the U.S. is closely monitoring the new coronavirus variant but that the strain doesn’t seem to pose an "immediate threat."

Fauci told reporters that Mu is “not at all even close to being dominant" and that it is not as prominent as Delta, which he said has a 99% dominance.

More than 98% of current U.S. Covid cases are caused by the Delta variant, which is highly transmissible and driving infections, hospitalizations and deaths nationwide.

The Mu variant has grabbed international headlines. Because of the high number of mutations, the WHO said the new variation may be impervious to immunological defenses and may even transmit more quickly than other versions.

The variant possesses genomic alterations that suggest current vaccines or monoclonal antibody treatments may not be as effective against it as they are against the original virus.

The UN agency clarified that more research is required to confirm whether the Mu variant will prove to be more infectious, lethal or vaccine-resistant.

Preliminary data demonstrates behavior parallels between Mu and the Beta variant when the latter first emerged in South Africa.

Fauci noted that the Mu variant can bypass certain antibodies produced by the vaccine, but added that there is no meaningful clinical data to show that it altogether eliminates the vaccine.

Also known as B.1.621, the Mu variant was first identified in Colombia in January 2021 and has since been confirmed in at least 39 countries. There have been sporadic reports of cases and some larger outbreaks in South America and Europe, the WHO said in its weekly bulletin on the pandemic.

Although global prevalence of the variant is currently below 0.1%, its prevalence in Colombia and Ecuador has consistently increased, where it accounts for approximately 39% and 13% of respective cases.

Reports on the variant’s prevalence should be “interpreted with due consideration” given the low sequencing capacity of most countries, the agency said.

According to the Centers for Disease Control and Prevention (CDC), the Mu variant is nowhere near as widespread in the United States as other Covid-19 strains.

Mu currently accounts for 0.2% of total cases in the United States. The only variant that represents more than 0.3% of the cases circulating in the country is the Delta variant, which represents 99.1% of all cases.

Per the GISAID open-source genome repository, more than 4,500 sequences (3,794 B.1.621 sequences and 856 B.1.621.1 sequences), genome sequences, and analyzed samples of the virus which were taken from patients were designated as Mu during the past 4 weeks.  

But Mu is not the only new variant that has attracted attention. Recently, according to a new pre-printed study by the South African National Institute of Communicable Diseases, scientists discovered another variant in South Africa and some other countries, called C.1.2, fearing it could be more infectious and adept at avoiding the vaccine.

While first detected in South Africa, C.1.2 has since been found in England, China, the Democratic Republic of the Congo, Mauritius, New Zealand, Portugal, and Switzerland.

While Alpha, Beta, Gamma and Delta are the four strains currently labeled 'variants of concern' by the CDC and the WHO, there are several other 'variants of interest' including Eta, Iota, Kappa and Lambda. 

https://www.biospace.com/article/u-s-officials-rush-to-reassure-as-mu-variant-garners-international-headlines/