Boehringer Ingelheim, Twist Bioscience in Therapeutic Antibody Discovery Collaboration

 Twist Bioscience Corporation (NASDAQ:TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today announced a broad-based research collaboration with Boehringer Ingelheim International GmbH to use Twist’s proprietary antibody libraries to discover therapeutic antibodies against multiple targets provided by Boehringer Ingelheim.

"Boehringer Ingelheim believes Twist’s ability to generate potent, diverse therapeutic antibodies by mining its comprehensive libraries, combined with our extensive capabilities and experience in drug discovery and development, will enable us to deliver breakthrough opportunities to patients," said Clive R. Wood, Ph.D., Senior Corporate Vice President and Global Head of Discovery Research at Boehringer Ingelheim. "We look forward to working with Twist on molecular targets in a broad range of disease areas," added Wood.

Under the terms of the agreement, Twist Biopharma, a division of Twist, will utilize its "Library of Libraries," a panel of synthetic antibody phage display libraries derived only from sequences that exist in the human body, to identify potential therapeutic antibody candidates. Twist and Boehringer Ingelheim will work together to validate and optimize any resulting new antibody candidates, which could be researched against a range of therapeutic areas. Boehringer Ingelheim retains exclusive worldwide rights to develop and commercialize any therapeutic antibodies discovered as part of the collaboration.

Twist will receive an upfront payment for each program entry. In addition, Twist has the potential to earn up to a total of $710 million in success-based clinical, regulatory and commercial milestone payments for the multiple target discovery programs.

https://finance.yahoo.com/news/boehringer-ingelheim-twist-bioscience-enter-135600205.html

Merck KGaA lifts growth forecast for life science tools business

 Germany’s Merck KGaA on Thursday issued a more ambitious medium-term growth forecast for its Life Science unit, a supplier of materials and lab gear for the biotech industry.

Life Science division revenues are now expected to grow 7% to 10% per year, excluding the effect of currencies and acquisitions, significantly above market growth and up from a previous goal of 6% to 9%, the diversified company said.

In a statement on its capital markets day on Thursday, the family-controlled group added that it expects group sales to grow organically by more than 6% per year on average through 2025, driven by demand for the Life Science unit’s bioprocessing products, new pharmaceuticals and semiconductor chemicals.

https://kelo.com/2021/09/09/merck-kgaa-lifts-growth-forecast-for-life-science-tools-business/

Invacare Revised Financial Guidance

 Invacare Corporation (NYSE:IVC) ("Invacare" or the "company") will participate today in the 19th Annual Morgan Stanley Global Healthcare Conference with management available for 1x1 meetings with interested investors.

Third Quarter 2021 Update

Providing an update on the current business environment, Matt Monaghan, chairman, president and chief executive officer stated, "We are pleased to see increased customer activity as the world adapts to varying degrees of recovery from COVID-19. As we work to meet demand, the challenges related to labor, material and freight, which are affecting both our business and a wide variety of industries, are moderating our near-term outlook for revenue growth. We think it is prudent to update our investors on the measures we are taking to address these headwinds and on our sustained positive outlook for our business.

When we reconfirmed full-year guidance at the end of 2Q21, we had assumed an improvement in external factors which have not materialized as expected. These included moderation on cost and availability of freight and labor, which would have enabled us to capitalize on reducing backlog and generating higher revenue growth for the third quarter. In the short-term, we expect to maintain elevated levels of inventory and incur higher conversion costs. Management is working with customers on price increases as appropriate to defray significantly higher input costs; however, the benefit of those actions will not be realized until 4Q21."

As a result of these near-term challenges, the company anticipates third quarter 2021 results in the following ranges:

Third Quarter 2021 Guidance

• Constant currency net sales(a) of 0% to growth of 4% year-over-year.

• Adjusted EBITDA(b) in the range of $6 to $9 million; and,

• Free cash flow(c) usage of $4 to $7 million.

Fourth Quarter 2021 Update

Monaghan continued, "It is difficult to determine exactly when the pandemic-induced global supply chain turmoil will stabilize. However, we expect 4Q21 to improve sequentially from the third quarter, albeit more gradually than initially anticipated. Increases in our workforce at key locations to improve throughput, as well as an increase in the number of freight carriers to expedite order delivery, should reduce our currently elevated backlog, driving revenue growth and adjusted EBITDA improvement. We continue to take actions to repurpose our resources as necessary to focus on products with high demand. We expect cash flow will also improve materially compared to the third quarter, driven by improved profitability and reduced working capital. However, we anticipate inventory will remain elevated to mitigate continued supply chain challenges expected through year-end. During this period, we also expect higher receivables from increased sales."

https://finance.yahoo.com/news/invacare-corporation-provides-business-revised-113000425.html

FDA will reportedly seek more time to decide if Juul can keep selling e-cigs

 The Food and Drug Administration will reportedly seek more time before deciding if Juul can continue to sell its e-cigarettes in the United States, the Wall Street Journal reported Thursday.

A court mandate created a timeline for the agency to review vaping products, following years of pressure from politicians and public health groups to regulate the segment as strictly as other tobacco products.

The FDA did not immediately respond to a request for comment from CNBC.

The FDA has until Thursday to review roughly 6.5 million products from about 500 companies and decide if those products can continue to be sold. It said that it would fast track decisions on the market leaders, like Juul. The FDA has already denied about 55,000 applications from smaller players like JD Nova Group and Great American Vapes for their flavored vape products.

Juul has been the market leader in e-cigarettes since 2018, according to Euromonitor International. As of 2020, the company held 54.7% share of the $9.38 billion U.S. e-vapor market.

Marlboro owner Altria bought a 35% stake in the company for $12.8 billion in late 2018. However, Altria has slashed the value of the investment as Juul and the broader e-cigarette industry became embroiled in controversy. As of September 2020, Altria valued its stake at $1.6 billion, an eighth of its original investment, and Juul itself at under $5 billion.

https://www.cnbc.com/2021/09/09/fda-will-reportedly-seek-more-time-before-deciding-if-juul-can-keep-selling-its-e-cigarettes.html

Clyburn: 'You may not need $3.5 trillion to do what the president wants done'

 House Majority Whip James Clyburn (D-S.C.) said late Wednesday that $3.5 trillion may not be needed to achieve President Biden’s priorities, as Democrats continue to debate the price tag of their reconciliation spending plan.

“I think that there is a lot of room for people to sit down and negotiate. It may be, when you're sitting around the table, you may not need 3.5 trillion to do what the president wants done and what the current country needs done,” Clyburn told guest host Jim Acosta on CNN’s “The Situation Room.”

Clyburn’s comments come as Democrats have been engaged in an internal battle regarding the price tag of their sweeping reconciliation spending package, which includes a number of education, health care and climate change priorities.

Senate Democrats agreed last month on a $3.5 trillion price tag for the package, but some moderate members are now saying that figure is too high.

Sen. Joe Manchin (D-W.Va.) is warning the White House and congressional leaders that he will only support a package that has a $1 trillion price tag, or at most $1.5 trillion, Axios reported, setting the stage for a precarious situation in the upper chamber.

Democrats are planning to pass the spending package through reconciliation, allowing the party to dodge a Republican filibuster and approve the bill with a simple majority. That strategy, however, requires that all Democrats stay banded together in the evenly split Senate.

Clyburn during the CNN interview weighed in on Manchin’s reported opposition to the $3.5 trillion price tag.

“I think what has happened here is that the communication around this Build Back Better plan, which has a ceiling of 3.5 trillion, is just that a ceiling. No one has ever said that's an exact number or that's a floor. It's up to 3.5 trillion. Now, I see that Joe Manchin has mentioned a $1.5 trillion number. So, somewhere between 1.5 and 3.5, there is $2 trillion. Those $2 trillion are there,” he said.

Manchin, in addition to calling for a lower price tag, has also urged his Senate colleagues to “pause” deliberations on the package.

https://thehill.com/homenews/house/571452-clyburn-you-may-not-need-35-trillion-to-do-what-the-president-wants-done

Fauci: COVID-19 infections '10 times higher than needed to end pandemic'

 COVID-19 infection rates in the United States are ten times the rate they need to be in order for the pandemic to end, chief White House medical adviser Anthony Fauci told Axios in an interview published on Thursday.

"In a country of our size, you can't be hanging around and having 100,000 infections a day. You've got to get well below 10,000 before you start feeling comfortable," Fauci told Axios.

According to the Centers for Disease Control and Prevention (CDC), the seven-day moving average for cases is currently around 140,000.

With current infection rates as high as they are, Fauci said to Axios, "That's not even modestly good control ... which means it's a public health threat," adding that "we're still in pandemic mode."

Fauci added that when enough people have become vaccinated "you'll still get some people getting infected, but you're not going to have it as a public health threat."

As of Thursday, at least 73 percent of the U.S.'s eligible population has received at least one dose of a COVID-19 vaccine with 62.4 percent fully vaccinated. But just 53 percent of the country's total population is fully vaccinated.

Fauci, the country' leading expert on immunology, said that while available vaccines have been effective, not enough people are taking steps to protect against the delta variant.

He also warned that the longer the pandemic is allowed to rage on, the higher the chances are that a "monster variant" that is stronger than the vaccines will occur.

Immunology experts have repeatedly stated that as long as large groups of people continue to contract COVID-19 and harbor it in their systems, mutations like the delta and more recently identified mu variant will occur, increasing the chances of a vaccine-resistant strain occurring.

https://thehill.com/policy/healthcare/public-global-health/571468-fauci-covid-19-infections-10-times-higher-than-needed

Biden to announce vaccine requirement for all federal workers

 Biden on Thursday will announce a requirement that all federal workers be vaccinated against COVID-19, according to a source familiar with the plans.

The action goes a step further than what Biden announced earlier this summer, when federal workers had the option of being tested regularly instead of getting vaccinated.

The tightening vaccine requirement for federal workers comes as the Biden administration is stepping up its encouragement of vaccine mandates in the private sector as well.

Biden will announce the move as part of a speech later Thursday announcing a six-part plan to get the delta variant under control.

https://thehill.com/policy/healthcare/571469-biden-to-announce-vaccine-requirement-for-all-federal-workers