Putin orders mass coronavirus vaccinations in Russia from next week

 Russian President Vladimir Putin ordered officials on Wednesday to begin mass coronavirus inoculations next week and to open up the vaccination programme to all Russians.

Russia, which has the world’s fourth highest number of COVID-19 cases, started large-scale vaccinations last month.

The RDIF sovereign wealth fund has said 1.5 million Russians have already been inoculated with the Sputnik V vaccine.

“I ask you to start mass vaccinations of the entire population as early as next week,” Putin told officials at a government meeting by video link that was broadcast on state television.

Deputy Prime Minister Tatiana Golikova said authorities would be ready to broaden the programme from Monday.

Russia has imposed no broad lockdown during the second wave of infections that began in September and officials have said that targeted restrictions are enough to curb the virus.

Earlier on Wednesday, Russia reported 22,850 new COVID-19 cases in the previous 24 hours, pushing the national tally to almost 3.5 million since the pandemic began.

https://www.reuters.com/article/us-health-coronavirus-russia-putin/putin-orders-mass-coronavirus-vaccinations-in-russia-from-next-week-idUSKBN29I1JD

Danaher: Expects 38.5% Increase in 4Q Revenue, Raises Core Revenue Guidance

 Danaher Corp. said it expects its fourth-quarter revenue to rise about 38.5% from the prior year and raised its guidance for core revenue.

The life-sciences conglomerate on Wednesday said it expects core revenue including Cytiva to rise about 15% for the quarter. It previously expected the metric to grow in the low double-digit range.

Rainer Blair, the company's president and chief executive, will comment on financial performance Wednesday at the J.P. Morgan Healthcare Conference at 10:50 a.m. EST, Danaher said. It will report fourth-quarter and year-end results on Jan. 28.

https://www.marketscreener.com/quote/stock/DANAHER-CORPORATION-12295/news/Danaher-Expects-38-5-Increase-in-4Q-Revenue-Raises-Core-Revenue-Guidance-32185990/

African Union secures 270M COVID-19 vax doses from manufacturers

 The African Union has secured a provisional 270 million COVID-19 vaccine doses from manufacturers for member states to supplement the COVAX programme, South African President Cyril Ramaphosa said on Wednesday.

African nations are grappling with a second wave of the novel coronavirus, infections rising to at least 3.1 million and 74,600 deaths over the course of the pandemic, according to a Reuters tally.

The vaccines will be supplied by Pfizer, AstraZeneca , through the Serum Institute of India, and Johnson & Johnson, said Ramaphosa, who chairs the African Union.

He added that all 270 million doses would be made available this year, with at least 50 million available "for the crucial period of April to June 2021".

On financing, Ramaphosa said arrangements had been made with the African Export Import Bank (Afreximbank) to support member states who want access to the vaccines.

Afreximbank would, upon receipt of firm orders from member states, provide advance procurement commitment guarantees of up to $2 billion to the manufacturers.

"There is also close collaboration between the AU team and the World Bank to ensure that member states are able to access about $5 billion either to buy more vaccines or pay for delivery of vaccines committed on their behalf by Afreximbank," Ramaphosa said.

He added: "These endeavours aim to supplement the COVAX efforts, and to ensure that as many dosages of vaccine as possible become available throughout Africa as soon as possible."

Ramaphosa said while the COVAX initiative, co-led by the World Health Organization, was vital to Africa's response, the African Union was concerned that COVAX volumes to be released between February and June may not extend beyond the needs of frontline health care workers.

The COVAX facility aims to make available 2 billion doses of safe and effective COVID-19 vaccines by the end of 2021.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/African-Union-secures-270-million-COVID-19-vaccine-doses-from-manufacturers-32190127/

DOD funds help Akebia expand study of drug to prevent ARDS in COVID

 Researchers evaluating whether an investigational oral drug, vadadustat, can help prevent acute respiratory distress syndrome (ARDS) in COVID-19 patients were awarded $5.1 million in funding from the U.S. Department of Defense (DOD) to expand the Phase II clinical trial at The University of Texas Health Science Center at HoustonQ (UTHealth).

Vadadustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, or HIF-PHI, designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of HIF, which can lead to improved oxygen delivery to tissues. Stabilization of HIF can help to dampen alveolar inflammation, a key problem that patients with COVID-19-associated lung disease are facing when they develop ARDS. The drug is investigational in the U.S. but has been approved for use in Japan.

"It's wonderful that we have COVID-19 vaccinations available now, but they won't directly help patients who are already sick in the hospital or who will become sick in the future," said Holger Eltzschig, MD, PhD, chair of the Department of Anesthesiology with McGovern Medical School at UTHealth. "In addition to vaccination, we direly need treatments to prevent ARDS, one of the deadliest complications of severe COVID-19. If we can arrest coronavirus infection at an earlier stage before the onset of lung complications that cause mortality, COVID-19 outcomes would be so much better." Eltzschig is also director of the UTHealth Center for Perioperative Medicine and the John P. and Kathrine G. McGovern Distinguished University Chair.

The award was given through the DOD's Peer Reviewed Medical Research Program as a COVID Clinical Trial Award. Only 4.2% of all applications submitted were awarded funding.

"This study could be critical for people in active duty with the armed forces as well as veterans," Eltzschig said. "COVID-19 has had a particular impact on the Navy, where personnel on vessels such as aircraft carriers are in close environments and are unable to socially distance. If an innovative oral investigative therapy could prevent ARDS, that would be wonderful. Also, our country's veterans tend to be older, have comorbidities, and are particularly suffering from dire consequences of COVID-19, so it would be fantastic to be able to help them as well."

Vadadustat, being developed by Akebia Therapeutics, Inc., recently completed its global Phase III clinical trial development for the treatment of anemia due to chronic kidney disease in patients on dialysis and not on dialysis, and Akebia expects to submit a New Drug Application (NDA) for vadadustat to the FDA for these indications as early as possible in 2021.

Previously published preclinical studies led by Eltzschig, showed HIF stabilization can protect lungs in mice with ARDS. His basic and translation science team in anesthesia is collaborating with the clinical team of Ben Bobrow, MD, chair of Emergency Medicine at McGovern Medical School, to move the idea from bench to bedside to see if it can help COVID-19 patients.

"Dr. Bobrow and his clinical team of nurses and researchers helped us build up the trial quickly. I've never seen a clinical trial go from just an idea in March to enrolling patients in four months. It's really remarkable and we couldn't have done it without Akebia, UTHealth's Center for Clinical and Translational Sciences, and the collaboration between Bobrow's clinical group with my translational group," Eltzschig said.

"So many people and departments at UTHealth, Memorial Hermann, and Harris Health have come together to bring this cutting-edge trial together faster than ever before to try to help people suffering from COVID-19 acute lung injury. Dr Eltzschig and I are inspired by the potential for this novel trial to make a major impact on COVID-19 patients," said Bobrow, who is the John P. and Katherine G. McGovern Distinguished Chair in emergency medicine. Bobrow and Eltzschig are attending physicians at Memorial Hermann-Texas Medical Center.

The randomized trial began enrolling patients at Memorial Hermann-Texas Medical Center in July. The DOD funding helped the trial expand to Memorial Hermann-Southwest Hospital, Memorial Hermann Greater Heights Hospital, and Memorial Hermann Memorial City Medical Center, as well as Harris Health's Lyndon B. Johnson Hospital. Currently, 75 patients have enrolled.

"It's unclear how long COVID-19 will be prevalent so it is critical to expand the single center trial to other sites," Eltzschig said.

###

The trial was initially funded by Akebia Therapeutics, Inc. and a donor grant to UTHealth's Center for Clinical and Translational Sciences.

Other McGovern Medical School faculty involved in the study include Elizabeth Jones, MD; Samuel Luber, MD; George Williams, MD; Paulina Sergot, MD; David Robinson, MD; Marie-Francoise Doursout, PhD; Misha Granado, MPH, MS; Misty Ottman, RN; Yanyu Wang, PhD; Xiaoyi Yuan, PhD; Tingting Mills, PhD; Boyun Kim, PhD; Christian Noval, RN; James Wang, BS; Marka Lyons, MS; Robert Suchting, PhD; Charles Green, PhD; Victor Guaregua, BS; Synthea Horton, MS; Seungwon Choi, MD; Nabras Abdulrahman, MS.

https://www.eurekalert.org/pub_releases/2021-01/uoth-dfh011321.php

Neuronetics Reports Prelim Q4, 2020 Financial Result

  Neuronetics, Inc., (NASDAQ: STIM), a commercial stage medical technology company focused on designing, developing and marketing products that improve the quality of life for patients who suffer from psychiatric disorders, today, in advance of the ICR/Westwicke Conference, announced certain preliminary unaudited fourth quarter and full year 2020 revenue results.

Fourth Quarter 2020

• Fourth quarter 2020 preliminary unaudited revenue between $15.0 and $15.5 million compared to previously issued guidance of $13.0 and $13.5 million. This represents a sequential increase of between 21% and 25% compared to third quarter 2020.

Full Year 2020

• Full year 2020 preliminary unaudited revenue between $48.7 and $49.2 million.

“During the quarter, we continued to see increased demand for NeuroStar Advanced Therapy systems, and we saw a strong uptick in treatment session revenues as compared to the third quarter despite the continued uncertainty related to COVID-19 and the busy holiday season,” said Keith J. Sullivan, President and Chief Executive Officer of Neuronetics. “One of my goals for 2020 was to build a strong foundation that will allow us to execute against our long-term strategy. As previously announced, we recently added twenty-two new field sales personnel who are now being trained with the expectation that they will be fully productive by the second quarter of 2021. We also received the results of our market research. The findings are being incorporated into our new marketing campaigns and support materials that are designed to increase awareness of NeuroStar Advanced Therapy for Mental Health as a non-drug treatment therapy for patients who suffer from depression. These new campaigns will be launched after our January National Sales Meeting.”

Total revenue for the fourth quarter of 2020 is expected to be in the range of approximately $15.0 to $15.5 million, representing a decrease of approximately 14% and 11%, respectively, when compared with $17.4 million for the fourth quarter of 2019 due to the impact of COVID-19.

Total revenue for the full year 2020 is expected to be in the range of approximately $48.7 to $49.2 million, representing a decrease of approximately 22% and 21%, respectively, when compared with $62.7 million for the full year 2019 due to the impact of COVID-19.

2021 Business Outlook
Looking ahead to full year 2021, the Company is expecting the recovery to continue and assuming the country doesn’t see a resurgence of COVID-19 that impacts our customers and patients, revenues should approach 2019 revenues.

Formal full year 2021 guidance will be provided when the Company reports fourth quarter and full year 2020 results.

https://www.biospace.com/article/releases/neuronetics-reports-preliminary-fourth-quarter-and-fiscal-year-2020-financial-results/

Will AZ's coronavirus vaccine turn profit this year? 'Too speculative' to predict

 After AstraZeneca pledged not to profit off its COVID-19 shot during the pandemic, a report emerged that the drugmaker might be ready to declare the pandemic over as soon as July. But according to EVP and biopharma president Ruud Dobber, it’s still “too speculative” to predict when the vaccine may start earning money.

“At this stage, I’m not going to speculate what exactly the data is,” Dobber said in an interview that aired Tuesday as part of Fierce JPM Week. The company is building a capacity of 3 billion doses for countries around the world, and it won’t be until after AZ delivers on its government supply deals that it might “feel open" to selling the vaccine commercially.

“We have just started in the first country vaccinating the people, so we still need to have hundreds of millions of people before we can think about it,” Dobber said, noting that the company would look to the World Health Organization as well as internal and external experts before making a determination.

“Let’s first deliver all the doses, let’s make sure people are getting vaccinated, and then we will decide at a certain stage when we are going to commercialize the vaccine,” he added.

Luckily for AstraZeneca, the company has plenty of other revenue sources, and it hopes to welcome even more of them in 2021. Dobber singled out lupus candidate anifrolumab, severe asthma prospect tezepelumab and anemia treatment roxadustat—which missed the chance to debut in 2020 when the FDA pushed back its December decision deadline—as its biggest products likely to hit the scene this year.

But if all goes well for AstraZeneca, the pharma giant could soon be bringing a lot more into the fold. In mid-December, it struck a $39 billion deal to buy rare disease specialist Alexion, an acquisition that will bring blockbuster Soliris and follow-up Ultomiris under AZ’s roof if it gets the go-ahead from regulators.

Those drugs could give the company a major boost as it weathers the pandemic, which has depressed diagnostic testing rates in oncology and, in turn, hurt sales of some of the company’s most important products. It’s also hit acute coronary syndrome treatment Brilinta particularly hard, because “even if you have pain in your chest, your willingness to go to the hospital is less at the moment."

COVID-19 has also hurt AstraZeneca in China, where the company “had a bit of a rough year,” as Dobber put it. The company saw a “sharp decline” in sales of asthma treatment Pulmicort as “parents were reluctant to go to the hospitals in China with their kids.”

“Over time that will become normal again, but when that is, it’s still a little bit unclear,” Dobber said. “Let’s hope that vaccination and the distribution of vaccines will continue to be good, and I really hope that will be the solution moving forward."

https://www.fiercepharma.com/pharma/fierce-jpm-week-will-az-s-covid-vaccine-turn-a-profit-year-it-s-too-speculative-to-predict

Bayer Continues Eying Potential Partnerships in Cell, Gene Therapy Space

 In December, life sciences giant Bayer launched a cell and gene therapy platform within its pharmaceutical division in order to become a leading company within a rapidly emerging and evolving field that offers the potential of life-saving therapies.

The launch of the C&GT Platform is supported by a number of collaborations and acquisitions the Germany-based company made over the past year, including the October acquisition of AskBio's AAV-based gene therapy pipeline, as well as its 2019 deal for BlueRock Therapeutics and that company’s induced pluripotent stem cells (iPSC) platform.

Also in December, the company partnered with Atara Biotherapeutics to develop off-the-shelf T-cell immunotherapies for high mesothelin-expressing tumors. While these are three companies considered key to the future of Bayer’s C&GT Platform, the company is not done fleshing out this new area. Marianne De Backer, Head of Business Development & Licensing in Bayer’s Pharmaceuticals Division, said the core pieces of the platform are in place, but noted there are other areas left to explore in the rapidly evolving space.

In an interview with BioSpace, De Backer outlined Bayer’s thought process for opening its purse strings and diving into the deep end of the cell and gene therapy space.

The roots of Bayer’s platform began in 2014, when the company stepped into the gene therapy space through a collaboration for hemophilia A with Dimension Therapeutics, which was later acquired by Ultragenyx in 2017. Although that never panned out as hoped, Bayer still saw significant potential in cell and gene therapy. De Backer said last year, the company decided it was time to heavily invest in this area.

“We analyzed where we wanted to play to become a leader in the field,” De Backer said from Germany. “There is an incredible unmet need in some diseases that can only be addressed through cell and gene therapies.”

As a result, the company settled on four areas of focus – iPSC, allogenic CAR-T, genome mutations and gene editing. In order to make a big impact in these areas, De Backer said it was important to find pioneers in the field and bring them into the fold. The company flexed its M&A muscle and has done precisely that with its three announced partnerships. Each of the companies met strict criteria that includes assets in clinical development, an industry-leading platform and in-house manufacturing capabilities.

“We have set the bar high. We wanted to come up with a deal that had pioneers in the field,” De Backer said.

She added she was incredibly happy to secure deals with these companies, noting that the core pieces are in place for the C&GT Platform. However, she said the company wants to strengthen its position in gene editing.

The platform is already bearing fruit. Last week, BlueRock announced the U.S. Food and Drug Administration cleared an Investigational New Drug application for a Phase I study of pluripotent stem cell-derived dopaminergic neurons in advanced Parkinson’s disease.

Although Bayer has been and will continue to seek out companies to acquire and forge strategic partnerships with, De Backer said part of the company’s strategy is to keep the companies at arm’s length, rather than fold them into Bayer’s own operations.

“We want them to focus on their science and make sure they keep their entrepreneurial culture,” De Backer said, describing the company as a “docking station” for its subsidiaries and partners.

Collaborative agreements will be a key for the company’s strategy in this space. De Backer said the past 10 months of the global pandemic has shown how important a cooperative landscape is to the development of promising new treatments. She touted the speed of vaccine development this past year and said that type of laser-like focus has proven drug development is prime for this kind of disruption.

“The silver lining of this pandemic has shown that we can do things differently,” De Backer said.

In addition to cell and gene therapy, De Backer said digital technology will also be a key focus for Bayer. Machine learning and artificial intelligence will bolster drug design programs and help spur that kind of innovation in drug discovery De Backer anticipates. An ongoing partnership with Recursion Pharmaceuticals is expected to lead to new development for fibrotic disease treatments.

De Backer said Recursion’s purpose-built artificial intelligence-guided drug discovery platform is the kind of tool Bayer hopes to harness to benefit patients across multiple indications. Despite all of the cutting-edge technologies now at in its arsenal, De Backer said the patients remain the company’s priority. It is the patient who they ultimately serve, she said.

https://www.biospace.com/article/bayer-continues-eying-potential-partnerships-in-cell-and-gene-therapy-space/