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Wednesday, April 7, 2021

Sanofi Creates Unit to Increase Poor Countries' Access to Meds

 Sanofi said Wednesday that it has created a nonprofit unit aimed at increasing access to medicines in poor countries.

The French pharmaceutical company said the unit, called Sanofi Global Health, will administer medicines that the World Health Organization deems as essential to patients located in 40 lower-income countries.

It will provide medicines to treat, cure or prevent illnesses including cardiovascular diseases, diabetes, tuberculosis, malaria and cancer, it said.

Sanofi said the unit will also fund the training of healthcare professionals and the set up and development of sustainable care systems for people with chronic diseases.

Additionally, the company said it will donate 100,000 vials of medicine a year to patients who suffer from rare diseases and have no access to treatments.

https://www.marketscreener.com/quote/stock/SANOFI-4698/news/Sanofi-Creates-Unit-to-Increase-Poor-Countries-Access-to-Medicines-32902607/

EU regulator to probe ethical standards of Sputnik vaccine trials

 The EU drug regulator will begin investigations next week on whether clinical trials of Russia’s Sputnik V COVID-19 vaccine followed global clinical and scientific guidelines, the Financial Times reported on Wednesday.

The European Medicines Agency's probe comes as people familiar with the regulator's approval process told the FT here that Sputnik V trials had not been ethically run.

Kirill Dmitriev, head of Russia’s Direct Investment Fund, told the newspaper, “There was no pressure (on participants) and Sputnik V complied with all clinical practices”.

https://www.reuters.com/article/us-health-coronavirus-eu-sputnik/eu-regulator-to-probe-ethical-standards-of-sputnik-vaccine-trials-ft-idUSKBN2BU0BJ

India's Shilpa Medicare can make 100-200M doses of COVID-19 vaccine, says exec

 Indian drugmaker Shilpa Medicare Ltd has the capacity to manufacture 100-200 million doses of a protein-based vaccine for COVID-19, a company executive told Reuters on Wednesday.

India, the world’s largest vaccine producing nation, has been ramping up the production of COVID-19 vaccines and global firms including AstraZeneca, U.S.-based Novavax and Russia’s RDIF have signed manufacturing deals with local players.

RDIF, in particular, has already announced deals with six Indian companies to make more than half a billion doses of its Sputnik-V vaccine, including major drugmaker Dr Reddy’s Laboratories and several smaller firms.

Shilpa Medicare’s shares jumped as much as 10.4% on India’s National Stock Exchange following the news. They were last up 9.2%.

Both AstraZeneca’s vaccine and RDIF’s Sputnik-V are based on the protein-based recombinant technology, which combines the DNA from a virus with bacterial cells to produce proteins that are purified and used in a vaccine.

“For recombinant vaccines, anywhere between 100 and 200 million doses is a fair volume capacity (for Shilpa) ... depending on the vaccine type,” Vinay Konaje, managing director of Shilpa Biologicals, a unit of Shilpa Medicare, said in an interview.

Konaje declined to comment on whether Shilpa Medicare could partner with RDIF or any other vaccine developers for manufacturing COVID-19 shots.

Shilpa Medicare was among the Indian companies that could ink Sputnik-V manufacturing deals with RDIF, Fortune India reported here last week, citing unnamed industry officials.

Shilpa makes active pharmaceutical ingredients — the essential components of a drug — at facilities in the southern Indian state of Karnataka, as well as a plant in Austria.

Vaccines for COVID-19 can be manufactured at Shilpa’s facility at Dharwad, Karnataka, Konaje said.

Deaths from COVID-19 have crossed 3 million globally, while India is struggling to contain a second wave of the virus that has eclipsed the first.

India has also indicated it would prioritise local vaccine needs, and its foreign minister said last month India had told international buyers as much.

https://www.reuters.com/article/us-health-coronavirus-india-vaccine/exclusive-indias-shilpa-medicare-can-make-100-200-million-doses-of-covid-19-vaccine-says-exec-idUSKBN2BU0OG

EMA expects to hold AstraZeneca briefing on Wednesday afternoon

 The European Medicines Agency (EMA) expects to hold a briefing on the possible side effects of the AstraZeneca coronavirus vaccine on Wednesday at 1600 CET (1400 GMT).

Experts from the European drug authority have reviewed to what extent some cases of blood clotting in adults who had recently received the AstraZeneca vaccine may be linked to the injections.

https://www.reuters.com/article/us-health-coronavirus-eu-astrazeneca/ema-expects-to-hold-astrazeneca-briefing-on-wednesday-afternoon-idUSKBN2BU105

Brazil COVID-19 deaths on track to pass worst of U.S. wave

 Brazil’s brutal surge in COVID-19 deaths will soon surpass the worst of a record January wave in the United States, scientists forecast, with fatalities climbing for the first time above 4,000 in a day on Tuesday as the outbreak overwhelms hospitals

Brazil’s overall death toll trails only the U.S. outbreak, with nearly 337,000 killed, according to Health Ministry data, compared with more than 555,000 dead in the United States.

But with Brazil’s healthcare system at the breaking point, the country could exceed total U.S. deaths, despite having a population two-thirds that of the United States, two experts told Reuters.

“It’s a nuclear reactor that has set off a chain reaction and is out of control. It’s a biological Fukushima,” said Miguel Nicolelis, a Brazilian doctor and professor at Duke University, who is closely tracking the virus.

On Tuesday, the Health Ministry reported another 4,195 COVID-19 deaths in the past 24 hours, well above the country’s prior single-day record. Brazil has set daily death records every week since late February, as a more contagious local variant and meager social distancing efforts fuel an uncontrolled outbreak.

With mass vaccinations curtailing the U.S. outbreak, Brazil has become the epicenter of the pandemic, contributing about one in four deaths per day globally, according to a Reuters analysis.

President Jair Bolsonaro has pushed back against mask-wearing and lockdowns that public health experts consider the best way to lessen virus transmission.

The country dragged its feet last year as the world raced to secure vaccines, slowing the launch of a national immunization program.

Despite the recent surge, Brazilian officials are insistent that the country can soon return to something resembling business as usual.

“We think that probably two, three months from now Brazil could be back to business,” Economy Minister Paulo Guedes said during an online event on Tuesday. “Of course, probably economic activity will take a drop but it will be much, much less than the drop we suffered last year ... and much, much shorter.”

Bolsonaro has responded to growing political pressure with a dramatic shakeup of a half dozen ministries, putting loyalists in key roles ahead of what may be a tough re-election campaign next year against his political nemesis.

While the president has shifted his tone on immunizations, touting vaccines he had recently disdained, the far-right former army captain continues to battle in the courts against state and municipal restrictions on economic activity.

With weak measures failing to combat contagion, Brazil’s COVID-19 cases and deaths are accumulating faster than ever.

Nicolelis and Christovam Barcellos, a researcher at Brazilian medical institute Fiocruz, are separately forecasting that Brazil could surpass the United States in both overall deaths and the record for average deaths per day.

As soon as next week, Brazil may break the record U.S. seven-day average for COVID-19 deaths, according to a model by the influential Institute for Health Metrics and Evaluation (IHME) at the University of Washington. The U.S. average for daily deaths peaked at 3,285 in January.

The IHME forecast does not currently extend beyond July 1, when it projects Brazil could reach 563,000 deaths, compared with 609,000 total U.S. fatalities expected by then.

https://www.reuters.com/article/us-health-coronavirus-brazil/a-biological-fukushima-brazil-covid-19-deaths-on-track-to-pass-worst-of-u-s-wave-idUSKBN2BT30P

TransMedics: Positive FDA Panel Vote for OCS Heart System

 Panel votes 12 to 5 that benefits of OCS Heart System outweigh risks

TransMedics Group, Inc. ("TransMedics") (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, announced today that after the review of TransMedics' clinical evidence from the OCS Heart EXPAND trial, the associated Continued Access Protocol ("CAP") results, as well as the OCS Heart PROCEED II trial, the Circulatory Systems Device Advisory Panel convened by the U.S. Food and Drug Administration ("FDA") has issued a favorable vote in support of approval of the OCS Heart System to the FDA's Office of Health Technology 2 (Cardiovascular Devices). The panel voted 12 to 5, with 1 abstaining, that the benefits of the OCS Heart System outweigh its risks. The panel voted 10 to 6, with 2 abstaining, that there is reasonable assurance that the OCS Heart System is effective. The panel voted 9 to 7, with 2 abstaining, that there is reasonable assurance of the OCS Heart System's safety.

https://finance.yahoo.com/news/transmedics-announces-positive-fda-advisory-022000627.html

FibroGen: FDA Panel to Review Roxadustat Application July 15

 FibroGen, Inc. (NASDAQ: FGEN) announced that the U.S. Food and Drug Administration (FDA) has informed the Company late today it has tentatively scheduled a Cardiovascular and Renal Drug Advisory Committee (CRDAC) on July 15, 2021 to review the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD) in both dialysis-dependent and non-dialysis-dependent patients.

The NDA submission was supported by positive results from a global Phase 3 program encompassing more than 8,000 patients. Roxadustat is approved and launched in China and Japan for the treatment of anemia of CKD in patients on dialysis and not on dialysis.

https://www.globenewswire.com/news-release/2021/04/06/2205454/33525/en/FibroGen-Announces-FDA-Advisory-Committee-to-Review-Roxadustat-New-Drug-Application-Tentatively-Scheduled-for-July-15-2021.html