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Tuesday, April 4, 2023

Veru: Positive Update on COVID-19 Program

 In the final report, sabizabulin significantly reduced key cytokines involved in Acute Respiratory Distress Syndrome (ARDS) in H1N1 influenza pulmonary inflammation murine ARDS model

Positive Phase 3 COVID-19 clinical study and preclinical influenza study further support the potential use of sabizabulin as a broad antiviral and anti-inflammatory agent for viral-induced ARDS

  • Expedited meeting granted by U.S. FDA in April 2023 for Phase 3 confirmatory study in hospitalized COVID-19 patients at high risk for ARDS

  • Veru plans Phase 3 clinical study in hospitalized influenza patients at high risk for ARDS

Phathom Plans for 2023 Erosive Esophagitis and H. pylori Commercial Launch

 

  • Favorable feedback following meeting with the U.S. Food and Drug Administration (FDA) allows for planned resubmission of erosive esophagitis new drug application (NDA) this quarter

  • Combined commercial launch of vonoprazan for erosive esophagitis and H. pylori indications expected Q4 2023, if approved

Germany Considers Banning ChatGPT Over Data Privacy Issues

 The decision by Italy's data protection authority to block access to Microsoft-backed OpenAI's ChatGPT last Friday, citing alleged privacy violations, may have kicked off a trend of European countries banning the AI chatbot. 

Reuters reports a spokesperson for the German Federal Data Protection Commissioner told the German-language business newspaper Handelsblatt that temporarily blocking the use of ChatGPT in Germany due to data security concerns could be possible. 

"In principle, such action is also possible in Germany," Ulrich Kelber said. He mentioned that data security issues could be subject to state jurisdiction but did not elaborate on immediate plans to ban ChatGPT.

Kelber said German officials requested further information from Italy on its ban. Officials in France and Ireland have already contacted Italy about their findings. 

"We are following up with the Italian regulator to understand the basis for their action and we will coordinate with all EU data protection authorities in relation to this matter," said a spokesperson for Ireland's Data Protection Commissioner. 

On Friday, the Italian National Authority for Personal Data Protection said ChatGPT violated the EU's General Data Protection Regulation in multiple ways, including unlawfully processing people's data and failing to prevent minors from accessing the AI chatbot. 

Calls to suspend new ChatGPT-4 have been increasing by the week. Last week, the tech ethics organization Center for Artificial Intelligence and Digital Policy filed a complaint with the Federal Trade Commission, asserting the new chatbot violates federal consumer protection law and asked for future chatbot releases to the public to be halted. 

The FTC complaint comes days after Elon Musk, Steve Wozniak, AI pioneer Yoshua Bengio and others signed an open letter calling for a six-month pause of new AI chatbots more powerful than ChatGPT-4. 

As of writing this, Italian users don't have access to ChatGPT. 

A European crackdown on AI chatbots is in progress. 

https://www.zerohedge.com/technology/germany-considers-banning-chatgpt-over-data-privacy-issues

Mainz Biomed Expands Corporate Health Program for ColoAlert

 Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that three German-based companies have selected ColoAlert®, the Company’s highly efficacious and easy-to-use screening test for colorectal cancer (CRC) into their respective corporate health programs.

https://finance.yahoo.com/news/mainz-biomed-expands-corporate-health-070100525.html

ANI gets FDA ok on cholesterol lowering generic

 ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Colestipol Hydrochloride Tablets USP, 1 g.

ANI’s Colestipol Hydrochloride Tablets are the generic version of the Reference Listed Drug (RLD) Colestid®. The current annual U.S. market for Colestipol Hydrochloride Tablets is approximately $81.3 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

https://finance.yahoo.com/news/ani-pharmaceuticals-announces-fda-approval-105000233.html

Pfizer, Merck trim prices in China for Paxlovid, molnupiravir

 Pfizer and Merck have slightly lowered the prices of their respective Paxlovid and molnupiravir COVID-19 treatments in China, local media reported on Tuesday citing pricing information published by the province of Jiangsu.

Pfizer cut the price of Paxlovid by about 100 yuan ($14.54) to 1,790 per box of 30 pills, while Merck trimmed the price of a 40-capsule bottle of its oral treatment molnupiravir by 74 yuan to 1,426 yuan, financial news outlet Yicai reported. The treatments are meant for high-risk people with mild to moderate symptoms of COVID-19.

Jiangsu authorities published the pricing information on Friday and the new prices took effect from Saturday.

Pfizer and Merck did not immediately respond to requests for comment.

The moves come after China adjusted its medical insurance coverage policy for COVID-19 treatments as a massive wave of cases that hit the country following the abrupt lifting of its zero-COVID policy in early December recedes.

Previously, under a temporary policy China enacted for COVID-19 treatments, insured patients only needed to pay 10% of the price for Paxlvoid and Merck. That policy expired on March 31, meaning they now need to pay full price.

Paxlovid was among the most sought-after remedies during the height of China's infection wave, with boxes of the treatment changing hands for as much as 50,000 yuan via underground channels, according to local media reports and social media posts.

China earlier this year said that talks with Pfizer on whether to include Paxlvoid in an update to its list of medicines covered by basic medical insurance schemes failed as authorities and the company were unable to agree on the price.

https://news.yahoo.com/pfizer-merck-trim-prices-china-094416159.html

Is my bank safe from failing? Warning signs of financial trouble

 A spate of bank failures in March may have more Americans on edge wondering just how safe their money actually is.

The stunning implosion of Silicon Valley Bank and Signature Bank ignited fears over a broader financial system meltdown and the threat of a domino effect among other mid-sized regional banks.

While the panic has begun to subside in recent days, experts suggest that risks remain.

"It’s very hard to predict the solvency or failure in any bank in the banking system," Ben Johnston, chief operating officer of financing company Kapitus, told FOX Business. "However, I do believe that if [interest] rates continue to rise, some of the problems that ailed SVB and Signature may continue to materialize in other institutions."

Small businesses are especially vulnerable to the financial panic, particularly with regional banks at the epicenter of the crisis. Businesses with fewer than 99 employees tend to make up the bulk of business customers at regional banks, community banks and credit unions. 

There are several ways for small businesses and other bank customers to assess the health of their financial institution.

Typically, smaller banks that are publicly traded are required to publish annual reports about their finances on Form 10-K and quarterly reports on Form 10-Q. Those documents can be found on the Securities and Exchange Commission's (SEC) website.

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"Among other things, the 10-K and 10-Q offer a detailed picture of a company’s business, the risks it faces, and the operating and financial results for the fiscal year or quarter, as applicable," the SEC said of the forms.

Reading financial data online can often be complicated and confusing for individuals who are not financial analysts by trade, however, Johnston noted.

He suggested that customers ask to speak to the branch manager of their local bank and ask them specifically how financially sound the bank is and how confident they are in its health.

Customers should also inquire about what percentage of the bank's deposit holders hold more than $250,000 – the maximum amount insured by the FDIC.

"What has triggered some of the bank problems at SVB and Signature have been when customers held large amounts of deposits with those banks and then withdrew those deposits quickly for fear the bank may fail and [that] the FDIC may not cover those deposits," Johnston said.

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Finally, customers should consider asking the branch manager about how the bank invests its money, including how much is held in securities, Treasuries, structure products and non-local investments.

"If you see that a local bank is making risky investments in opportunities that you are skeptical of, that might be a bank you’d want to avoid," he said.

SVB largely catered to tech companies, venture capital firms and high net-worth individuals who were pulling cash at a rapid pace as the once red-hot tech sector cooled. When the bank announced it was trying to raise capital from investors and that it would take a $1.3 billion loss on long-term securities that had tumbled in value amid higher interest rates, depositors panicked and a bank run ensued.

Within days, U.S. regulators took extraordinary steps to contain the fallout from the bank's collapse and shore up wavering confidence in the financial system, including protecting all deposits at the two institutions — even those holding funds that exceeded the FDIC's $250,000 insurance limit.

The Fed also launched a new emergency backstop for lenders to help them meet deposit withdrawals under favorable terms.

"The comforting thing is, depositors are insured up to $250,000 through the FDIC, and after Signature and SVB closed, the FDIC and the Fed guaranteed all deposits at those banks," Johnston said. "And so the expectation, at least for the foreseeable future, is that deposits above $250,000 across the banking system will be backstopped by the U.S. government."

https://www.foxbusiness.com/economy/bank-safe-failing-warning-signs-financial-trouble