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Wednesday, July 21, 2021

Anthem says COVID-19 costs could rise in coming quarters from variants

 U.S. health insurer Anthem on Wednesday warned of potentially higher COVID-19 costs in the second half of the year in the light of new coronavirus variants coupled with a slowing vaccination rate in the country.

The company's comments come after lower-than-expected medical costs helped it beat Wall Street estimates for second-quarter profit and raise its adjusted earnings forecast for the year by 40 cents.

Health insurers have been conservative in their 2021 outlooks as they expect fluctuations in medical costs due to the impact of virus variants and new outbreaks in some parts of the country, especially in areas with low vaccination rates.

"There's still a considerable amount of uncertainty surrounding COVID in the back half of the year and so we obviously want to maintain a prudent, if not cautious, posture," Anthem Chief Financial Officer John Gallina said.

The company backed its expectations of $600 million in COVID-19 costs in 2021.

Last week, larger rival UnitedHealth said it still expects a $1.80 per share hit to this year's profit due to COVID-19 treatment and testing costs, even as it raised full-year earnings target.

Health insurers seem to be adding in some additional earnings cushion for the second half by not raising by the full amount of the second-quarter beat, given the potential for medical costs to continue to rise, Stephens analyst Scott Fidel said.

Anthem on Wednesday became the latest large U.S. health insurer after UnitedHealth to say it was still watching out for additional guidance on Biogen Inc's newly approved $56,000 Alzheimer's drug Aduhelm.

The U.S. government's Medicare program and private health insurers, which sell Medicare Advantage plans for those over 65 years of age, will be bearing most of the drug's cost and delayed decision on its coverage could slow its uptake by patients.

https://www.marketscreener.com/quote/stock/BIOGEN-INC-4853/news/Biogen-Anthem-says-COVID-19-costs-could-rise-in-coming-quarters-from-variants-35907952/

BAYER AG Receives a Buy rating from Goldman Sachs

 In a research note published by Keyur Parekh, Goldman Sachs advises its customers to buy the stock. The target price is slightly upped from 74 to 76 EUR

https://www.marketscreener.com/quote/stock/BAYER-AG-436063/news/BAYER-AG-Receives-a-Buy-rating-from-Goldman-Sachs-35909824/

Lumos Pharma Shares Drop 12% After Treatment Period Extended

 Lumos Pharma Inc. shares were down 12% to $8.29 after the company said primary six-month data for its phase 2 OraGrowtH210 trial is expected in the second half of 2023.

With the new timeline, the biopharmaceutical company said the treatment period will be extended to 12 months.

The company said the pace of site initiation and enrollment of the trial has been slower than anticipated primarily due to Covid-19 restrictions. That impact has been particularly pronounced at international sites where faster patient enrollment was anticipated. The trial's primary outcome continues to be the preliminary validation of its predictive enrichment markers strategy.

Lumos said the Food and Drug Administration has now requested an extension of the Trial to 12 months. The planned protocol extension mirrors the first six months of the OraGrowtH211 long-term extension study. The FDA has placed the planned long-term extension study on partial clinical hold until additional efficacy data from the trial are available to be reviewed.

Wainwright & Co. lowered its price target on Lumos Pharma to $27 from $34 a share, while keeping a Buy rating on the shares.

https://www.marketscreener.com/quote/stock/LUMOS-PHARMA-INC-9420564/news/Lumas-Pharma-Shares-Drop-12-After-Treatment-Period-Extended-35913277/

Dicerna confirms beclesiran as one to watch

 After Vertex’s VX-864 crashed out in alpha-1 antitrypsin deficiency (AATD) earlier this year Arrowhead became the contender to watch – but early data from Dicerna today suggest that its rival RNAi project might also have legs. There are big caveats here: the release is thin on detail and concerns data in only 18 volunteers. But Dicerna’s belcesiran appears to produce dose-dependent declines in serum AAT, mutated forms of which build up in the liver and lungs of AATD sufferers, causing the rare inherited disease's severe complications. One subject in the 6mg/kg cohort registered a 91% decline, Dicerna said, adding that dosing had commenced at 12mg/kg. Perhaps the group feels the need to push harder to match the levels reported by Arrowhead with ARO-AAT, which sustained 78-97% reductions in mutated AAT over one year, data at Easl last month revealed. Belcesiran still needs to prove its worth in actual patients, and a phase 2 trial called Estrella has already started. But with Mereo’s MPH-966 the only other clinical AATD asset – phase 2 data are due by year end – Dicerna had good reasons to push on here.

Joining the AATD race: phase 1 data on belcesiran (DCR-A1AT)
 1mg/kg (n=6)3mg/kg (n=6)6mg/kg (n=4)12mg/kg (n=6)
Mean maximum serum AAT reductions from baseline50%69%80%?
Source: Dicerna press release.

https://www.evaluate.com/vantage/articles/news/snippets/dicerna-confirms-beclesiran-one-watch

Microsoft Azure joins AWS, Google Cloud as cloud platforms supporting NIH biomed research

 Though tech giants Microsoft, Amazon and Google typically vie against one another to become a collaborator’s sole cloud provider, they’ll be working in harmony for once to support the National Institutes of Health’s biomedical research work.

Several years after the NIH tapped Amazon Web Services and Google Cloud to provide cloud computing and storage services to the Science and Technology Research Infrastructure for Discovery, Experimentation and Sustainability, or STRIDES, initiative, Microsoft Azure has come aboard as well.

The initiative was launched in 2018—with Google Cloud as its original cloud partner—to give biomedical researchers easier access not only to huge datasets from around the world but also to the processing tools needed to analyze such massive databases.

Now, researchers based at and funded by the NIH will be able to use Microsoft’s cloud resources to support their biomedical studies.


The NIH added a third cloud computing services provider to its roster because of the sheer amount of data available to its affiliated researchers. Microsoft Azure’s software is needed to kick up the horsepower to keep the STRIDES initiative moving toward its goal of improving efficiency and discovery in biomedical research, according to Andrea Norris, chief information officer of the NIH and director of the Center for Information Technology.

Since the launch of STRIDES, researchers have used Google and Amazon’s services to study more than 115 petabytes of cloud-hosted biomedical data, spanning more than 83 million hours’ worth of computational resources.

“The cloud can help democratize access to high-value research data and the most advanced analytical technologies for all researchers. Expanding our network of providers and access to the most advanced computational infrastructure, tools and services provides the agility and flexibility that researchers need to accelerate research discoveries,” Norris said in a statement.

Adding Microsoft Azure’s cloud computing power will help with storage of databases like the National Library of Medicine’s 43-petabyte Sequence Read Archive of genomic data, for example. Researchers will also be able to use Microsoft’s machine learning and other artificial intelligence tools to more rapidly comb through and draw out the most relevant insights from that data.

“We often risk losing the value of biomedical data because of the sheer volumes being generated and digitized around the world. By leveraging cloud and artificial intelligence capabilities, biomedical researchers are able to quickly identify and extract critical, lifesaving insights from this sea of information,” said Toni Townes-Whitley, president of Microsoft’s U.S. regulated industries business.


This year has already been a big one for Microsoft’s cloud-based forays into healthcare. Right off the bat, in January, the Big Tech company signed on as an equal partner in operating and developing the Terra biomedical research platform established by MIT and Harvard’s Broad Institute and Alphabet’s life sciences arm, Verily.

Just a few months later, Microsoft laid out plans to buy Nuance Communications, which develops speech recognition and conversational AI software. The $19.7 billion buyout will place Nuance in the shade underneath the Azure cloud, augmenting the capabilities of the Microsoft Cloud for Healthcare, which was unveiled in late 2020.

https://www.fiercebiotech.com/medtech/microsoft-azure-joins-aws-google-cloud-as-cloud-platforms-supporting-nih-biomedical

Novartis set to deliver 50 million CureVac COVID-19 vaccines this year

 Novartis is still helping CureVac make COVID-19 vaccines and could expand its capacity to assist other vaccine manufacturers as well, finance chief Harry Kirsch told reporters on Wednesday.

"We have started the production as planned. We are planning to deliver 50 million doses this year," Kirsch said of the CureVac deal when asked whether it could instead make its capacity free for others after CureVac said last month its COVID-19 jab was only 48% effective.

Swiss drugmaker Novartis also assists Pfizer and BioNTech in making COVID-19 vaccines and can ramp up output for them or others if needed, he said.

https://www.yahoo.com/news/novartis-set-deliver-50-million-063236668.html

Cassava Sciences to Present New Clinical Dataset at Alzheimer’s Association

 On Monday, July 26th, New Clinical Data for SavaDx to be Shared in

a Poster Presentation -

- On Thursday, July 29th, New Clinical Data for Simufilam to be Featured in a Podium Presentation -

Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today announced it will present two new clinical datasets for its product candidates at the 2021 Alzheimer’s Association International Conference (AAIC), which is being held in Denver, Co and virtually on July 26th through July 30th. Cassava Sciences’ investigational product candidates include simufilam, a drug treatment for Alzheimer’s disease, and SavaDx, a biomarker/diagnostic to detect Alzheimer’s disease with a simple blood test.

On Monday, July 26th, at approximately 10 am ET, scientists for Cassava Sciences will show a poster presentation at AAIC, titled “SavaDx, a Novel Plasma Biomarker to Detect Alzheimer’s Disease, Confirms Mechanism of Action of Simufilam”.

On Thursday, July 29th, at approximately 11 am ET, simufilam will be featured in a live podium presentation at AAIC, including a brief Q&A session. This oral presentation will announce results of an interim analysis on safety and cognition for the first 50 patients with Alzheimer’s disease to complete 9 months of open-label treatment. Scientists for Cassava Sciences will also present biomarker data analyzed from cerebrospinal fluid (CSF) collected from 25 study subjects at baseline and again after completing 6 months of open-label drug treatment, including:

  • Biomarkers of Alzheimer’s disease: amyloid beta42, total tau, P-tau181

  • Biomarkers of neurodegeneration: neurogranin, neurofilament light chain (NfL)

  • Biomarkers of neuroinflammation: YKL-40, sTREM2 and HMGB1

“Cassava Sciences’ contributions to AAIC showcase our efforts to develop innovative product candidates for people living with Alzheimer’s disease,” said Remi Barbier, President and CEO. “We are honored AAIC’s scientific committee has invited us to present the latest clinical dataset for simufilam in an oral presentation on Thursday, July 29th.”

Cassava Sciences expects to publicly release all AAIC materials contemporaneously with their scheduled date and time of presentation at AAIC. At those times, materials will be posted on the ‘Investors’ page of the Company’s website: https://www.CassavaSciences.com