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Monday, April 5, 2021

Cadila seeks nod to repurpose Hepatitis C drug for COVID-19 in India

 India’s Cadila Healthcare Ltd has sought approval from local regulators to use a Hepatitis C drug as a treatment for COVID-19 following promising interim results from a late-stage trial, the drugmaker said on Monday.

A single dose of the Hepatitis C drug when taken early could help COVID-19 patients recover faster and avoid complications seen in the advanced stages of the disease, Cadila said in a statement to stock exchanges.

About 91% of patients treated with the drug tested negative for COVID-19 in standard RT-PCR tests by day seven, compared to nearly 79% who were given the standard of care, the company said citing Phase-III clinical trial data.

The drug, known as Pegylated Interferon alpha-2b and branded as ‘PegiHep’ by Cadila, was originally approved for liver disease Hepatitis C and launched in India 10 years ago. It is being repurposed to treat COVID-19.

The news comes as daily coronavirus infections are surging to new highs in India, which has the world’s third-highest caseload after the United States and Brazil. India has so far reported close to 12.5 million infections and more than 164,000 deaths.

https://www.reuters.com/article/us-health-coronavirus-cadila-health/cadila-seeks-nod-to-repurpose-hepatitis-c-drug-for-covid-19-in-india-idUSKBN2BS05H

Singapore to accept COVID-19 digital travel pass from next month

 Singapore will next month accept visitors who use a mobile travel pass containing digital certificates for COVID-19 tests and vaccines, its aviation regulator said on Monday, becoming one of the first countries to adopt the initiative.

Singapore will accept the International Air Transport Association (IATA) mobile travel pass for pre-departure checks, where travelers can get clearance to fly to and enter Singapore by showing a smartphone application containing their data from accredited laboratories.

The pass was successfully tested by Singapore Airlines. More than 20 carriers, including Emirates, Qatar Airways and Malaysia Airlines, are also testing the pass.

“The success of our joint efforts will make IATA’s partnership with the government of Singapore a model for others to follow,” IATA director general Willie Walsh said in a statement.

Asian business hub Singapore, which has had relatively few coronavirus cases this year, has been a leader in developing and using technology during the pandemic and wants to be among the first countries to reopen to host international events.

Airlines are hoping more countries will approve digital passes on apps to allow travel to resume faster and avoid complications and delays at airports where multiple checks on documents are required.

Currently, travelers from most countries are required to take pre-departure COVID-19 swab tests within 72 hours of their flights in order to travel to Singapore, with results presented at airport check-in and on arrival.

https://www.reuters.com/article/us-health-coronavirus-singapore-travel/singapore-to-accept-covid-19-digital-travel-pass-from-next-month-idUSKBN2BS0UC

India's Panacea Biotec to produce 100 million Sputnik V doses annually

 Indian biotech firm Panacea Biotec Ltd has agreed to produce 100 million doses of Russia’s Sputnik V COVID-19 vaccine annually, the Russian Direct Investment Fund (RDIF), which markets the shot internationally, said on Monday.

RDIF did not say when production would begin.

https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-ind/indias-panacea-biotec-to-produce-100-million-sputnik-v-doses-annually-rdif-idUSKBN2BS0Z2

China reports biggest daily COVID-19 case jump in over 2 months

 China reported its biggest daily jump in new COVID-19 cases in more than two months, as a city on the border with Myanmar in southwestern Yunnan province accounted for all new local cases.

Ruili’s local government put residents in its urban area under home quarantine, launched a massive testing drive and began restricting people from leaving and entering the city from last week after reporting COVID-19 patients.

The city accounted for all of the 15 new local cases reported on April 4. The total number of new COVID-19 infections, including imported infections originating from overseas, stood at 32, marking the highest total since Jan. 31.

Genetic analysis of the cases discovered in Ruili suggest the new local infections stem from viruses imported from Myanmar, state media reported. Of the new patients reported in the city, 11 of them were identified as Myanmar citizens.

Ruili is a key transit point for Yunnan province, which has struggled to monitor its rugged 4,000 km (2,500-mile) border with Laos, Myanmar and Vietnam for illegal immigration amid a wave of unauthorised crossings last year by people seeking a haven from the pandemic.

On Monday evening, city authorities announced three high risk and six medium risk areas in Ruili as of 7pm local time (1100 GMT), reported state broadcaster CCTV.

CCTV also reported that Ruili would conduct a second testing drive round from April 6 onwards, and that residents who had visited Jiegaoyu City, a jade market in one of the high risk areas, between March 15 and 29 would need to be quarantined at home.

Local authorities have also began a vaccination drive in Ruili in a bid to contain COVID-19 and build up herd immunity in the city.

The number of new asymptomatic cases, which China does not classify as confirmed cases, stood at 18, matching the total from a day earlier.

The total number of confirmed COVID-19 cases in mainland China now stands at 90,305, while the death toll remains unchanged at 4,636.

https://www.reuters.com/article/us-health-coronavirus-china-cases/china-reports-biggest-daily-covid-19-case-jump-in-over-2-months-idUSKBN2BS00V

UK launches mass testing programme as economy reopens

 British Prime Minister Boris Johnson said on Monday everyone in England will be able to take a COVID-19 test twice a week in a new drive to track the pandemic as society reopens and the vaccine rollout continues at its rapid rate.

Johnson, who is expected to confirm plans to relaunch international travel and open sections of the economy later on Monday, said the new mass testing programme would break the chain of transmissions and spot cases without symptoms.

As much of Europe enters new lockdowns to tackle surging cases, Johnson has set out a staggered plan to ease restrictions in the coming months, a huge boost for one of the worst-hit countries during the pandemic.

“As we continue to make good progress on our vaccine programme and with our roadmap to cautiously easing restrictions underway, regular rapid testing is even more important to make sure those efforts are not wasted,” Johnson said in a statement.

Junior health minister Edward Argar said the tests would be sent to homes or businesses, or picked up from pharmacies or test centres. He said he was confident people would isolate.

“People are doing the right thing,” he told Sky News.

The increased testing will help health officials to track the pandemic as the country slowly reopens from a strict four-month lockdown.

Johnson is expected to confirm that all retail, outdoor hospitality and hairdressers can reopen on April 12 in England, while a traffic-light system for countries based on infection and vaccination levels will be used for international travel.

Vaccine passports are also being trial led for mass events.

Under the current plan international travel will not resume until May 17 at the earliest. The Financial Times said Johnson was not expected to set out a specific timeframe.

Scotland, Wales and Northern Ireland are following their own, similar paths out of a strict lockdown that was imposed at the beginning of this year.

Britain is able to pursue a recovery after it gave AstraZeneca and Pfizer shots to well over half the adult population. A reopening of schools in March has also not yet led to a spike in cases, despite increased testing.

https://www.reuters.com/article/us-health-coronavirus-britain/uks-johnson-launches-mass-testing-programme-as-economy-reopens-idUSKBN2BR0QW

Molecular Templates takes full rights from Takeda for biologic product

 Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), today announced that, following discussion with its co-development partner Takeda, MTEM will assume full rights to TAK-169 including taking control of clinical development from Takeda. In addition, MTEM announced the decision to discontinue development of MT-3724, MTEM’s only first-generation ETB. MTEM will focus on the clinical development of next-generation ETBs MT-5111, TAK-169, and MT-6402, as well as advancing next-generation preclinical ETB candidates against targets including CTLA-4, CD20, SLAMF-7 and CD45.

Takeda has communicated that its decision to turn over full rights of TAK-169, a second-generation ETB targeting CD38, was the result of Takeda’s ongoing portfolio prioritization. MTEM believes that TAK-169 is a potent molecule with a novel mechanism of action in multiple myeloma. It has demonstrated a favorable safety and efficacy profile in in vivo models and potency against daratumumab refractory patient samples. TAK-169 is in an ongoing Phase 1 study with dose escalation planned through six dose cohorts, in which the first patient was dosed in February 2020. To date, Takeda has enrolled and treated four subjects in the Phase 1 study. There have been no life-threatening toxicities, and no signs of capillary leak syndrome (CLS). The maximum tolerated dose (MTD) has not been reached, patient screening continues, and dose escalation is ongoing. One dose limiting toxicity (grade 2 myocarditis) was assessed in one subject. A mild elevation in Troponin I was noted in this subject after the third dose of TAK-169. No EKG or echocardiographic abnormalities and no clinical symptoms were noted. A stable elevation in high-sensitivity troponin was seen although no comparison to baseline was available as baseline levels were not required per protocol at the time. An independent radiologist and cardiologist reviewed the imaging in the case and concluded that there was weak to intermediate evidence of myocarditis. The subject had multiple pre-existing cardiac risk factors. No other cardiac adverse events were observed in any other subject. Pharmacokinetic and pharmacodynamic data of this first cohort have been in-line with predicted outcomes. MTEM looks forward to accelerating the full enrollment and completion of this safety and dose-finding study. MTEM’s manufacturing of TAK-169 has been qualified by Takeda and MTEM has sufficient TAK-169 drug supply to continue the Phase 1 study as planned. MTEM’s assumption of the full rights to TAK-169 is expected to result in cost savings in 2021 and MTEM’s guidance of cash runway into 2H23 is unchanged. Upon transfer of the full TAK-169 rights to MTEM, per the terms of the collaboration agreement, MTEM will owe Takeda low-single digit royalties on future net sales of TAK-169. MTEM anticipates that the transition of TAK-169 development from Takeda to MTEM will be conducted over the next 90 days.


Chembio Launches Diagnostic Tool to Differentiate COVID-19 and Flu

 Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced the commercial launch of an FDA Emergency Use Authorization-approved, in-licensed rapid point-of-care COVID-19/Flu A&B test, for use in decentralized and traditional testing settings. Product inventory is on-hand and immediately available for shipment to customers across the United States.

The rapid immunoassay test is approved for use in laboratories with a CLIA waiver license, produces results in 15 minutes and requires no instrumentation. The test simultaneously differentiates SARS-CoV-2 antigens and influenza Type A and Type B infections from a single swab.

https://finance.yahoo.com/news/chembio-announces-u-commercial-launch-213000838.html