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Wednesday, April 2, 2025

Biogen's BIIB080 Gets FDA Fast-Track Designation in Alzheimer's

 Biogen has won a U.S. Food and Drug Administration fast-track designation for its investigational BIIB080 therapy for the treatment of Alzheimer's disease.

Biogen on Wednesday said BIIB080 is the first tau-targeting antisense oligonucleotide therapy to enter clinical development for Alzheimer's disease and that it is currently being evaluated in a global phase 2 study in individuals in the early stages of the memory-robbing disease.

Abnormal accumulation of tau in the brain is a hallmark of Alzheimer's and is associated with neurodegeneration and cognitive decline.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Biogen in 2019 exercised a license option with Ionis Pharmaceuticals and obtained an exclusive royalty-bearing license to develop and commercialize BIIB080.

Cambridge, Mass., biotechnology company Biogen and Japan's Eisai are partners on Leqembi, which the FDA approved in 2023 for the treatment of Alzheimer's disease.

https://www.morningstar.com/news/dow-jones/202504023603/biogens-biib080-gets-fda-fast-track-designation-in-alzheimers-disease

Revvity Secures FDA Approval for Improved Automated Latent Tuberculosis Test

 FDA approves leading solution for latent tuberculosis diagnostics, advancing global effort to fight infectious diseases

Revvity, Inc. (NYSE: RVTY), today announced that the U.S. Food and Drug Administration (FDA) has approved the Auto-Pure 2400 liquid handling platform with the T-SPOT™.TB test. Initially launched outside the U.S. in 2024, this powerful combination allows laboratories to improve productivity while maintaining superior clinical performance in latent tuberculosis (TB) detection. This milestone marks a significant advancement in the fight against TB with a faster high-throughput solution delivering accurate diagnostic results to support timely treatment and containment in the U.S. as well as other locations around the world.

https://www.businesswire.com/news/home/20250402936376/en/Revvity-Secures-FDA-Approval-for-Improved-Automated-Latent-Tuberculosis-Test

BioMarin succeeds in trial for its metabolic disorder treatment

 BioMarin's trial for PALYNZIQ shows success in lowering blood Phe levels in adolescents with phenylketonuria.

https://seekingalpha.com/news/4428082-biomarin-succeeds-in-trial-for-its-metabolic-disorder-treatment

Oracle Cloud Users Urged to Take Action

 With Oracle not budging from its denial of a breach that a growing number of security experts believe occurred, some are urging the company's cloud customers to take immediate steps to verify if their data was compromised and to protect against any resulting misuse.

If the breach indeed occurred, the primary concerns include attackers leveraging stolen data to infiltrate cloud environments, escalating privileges to administrative control, and reusing credentials for lateral movement across affected organizations.

Cybersecurity Compliance Implications

Additionally, any exposure of personally identifiable information (PII) and passwords could trigger compliance requirements under statutes like the General Data Protection Regulation (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA) for covered organizations, Trustwave said in its take on the reported incident.

"This leak is a serious breach of identity and privilege-related security, underscoring the need for timely de-provisioning, password hygiene, and multi-factor authentication," Trustwave researchers Nikita Kazymirskyi and Karl Sigler wrote in a Trustwave blog post. "The exposure of [records,] especially with access tied to administrative groups, could serve as a direct entry point for ransomware deployment, data exfiltration, or long-term espionage."

News of the possible breach first surfaced on March 21 when CloudSEK reported seeing hacker "rose87168" attempting to sell around 6 million records allegedly obtained from Oracle's single sign-on (SSO) and Lightweight Directory Access Protocol (LDAP) systems in a cybercrime forum. CoudSEK identified the stolen data as including encrypted SSO passwords, Java KeyStore (JKS) files, key files, and enterprise manager JPS keys associated with over 140,000 Oracle cloud tenants, or customers.

The attacker appears to have exploited an unpatched vulnerability in Oracle Fusion Middleware (CVE-2021-35587) to compromise Oracle cloud's login and authentication system and steal the data, CloudSEK reported.

Convincing Breach Evidence?

After Oracle denied that any such breach had occurred, the threat actor rose87168 shared a sample of 10,000 records allegedly taken from the breach, with CloudSEK, SOCRadar, and a few others. The records, according to the researchers who analyzed them, strongly pointed to a breach of Oracle's cloud environment. Others, including threat intelligence firm Hudson Rock, reported hearing directly from Oracle Cloud customers who recognized the leaked data as their own, adding further credibility to claims of a breach.

Trustwave analyzed a database sample with PII, a sample of LDAP records with PII, and a list companies allegedly affected by the breach. Its analysis showed the data to include markers that clearly identified accounts with elevated permissions and access to sensitive data, accounts that were active or inactive, accounts with admin access, and other contextual data that would allow an attacker to prioritize targets effectively. It found the list of affected companies to be made up of 128,466 unique domain names.

"If true, the scale of this breach is massive," Kazymirskyi and Sigler wrote. "For companies involved in such a breach, the consequences can be severe and multifaceted. Attackers can sell or exploit access to these networks for ransomware deployment, data theft, or espionage."

CloudSEK has provided a resource that organizations could use to verify if the reported breach affected them.

How to Protect Oracle Cloud Accounts

Liran Farazis, global enterprise security manager at Sygnia, recommends that organizations that find themselves on the list should take immediate measures to protect themselves.

The measures, which Sygnia documented in a recent blog post, include resetting all credentials in Oracle Cloud SSO, LDAP, or encrypted configuration files; invalidating existing sessions and tokens; and reviewing access logs, authentication records, and application behavior across Oracle Cloud components. "Reviewing this data helps identify unusual activity, such as failed login attempts, session anomalies, or unauthorized changes," Sygnia said. The vendor also recommends that potentially affected organizations rotate all cryptographic keys and secrets and implement continuous monitoring of the affected environment.

"While we cannot confirm exactly how the incident occurred, there is a strong basis to believe it did happen," Farazis says. He says the complexity associated with some of the mitigation measures will vary depending on the environment. "Some of the recommended mitigations can be challenging to implement and require careful planning and testing," Farazis adds. "The overall impact and urgency of these actions also depend on how many services and resources the organization has deployed in Oracle Cloud, as well as how those services are integrated into their broader environment."

Trustwave had similar advice for potentially affected organizations: Force password resets, enforce multifactor authentication for all systems, regenerate SSO/SAML/OIDC secrets, and audit and revoke dormant and unused accounts. The company suggests that organizations isolate and monitor critical systems, especially if the exposed credentials provided access to them.

Oracle did not immediately respond to a Dark Reading request for comment for this article. But in previous statements, the company has denied that any breach of its Oracle Cloud Infrastructure (OCI) has happened. "The published credentials," according to the company's last statement to Dark Reading, "are not for OCI. No OCI customers experienced a breach or lost any data."

However, some believe Oracle may be deliberately crafting narrow denials by referring specifically to OCI, potentially leaving room for breaches in other parts of its cloud ecosystem. In a March 31 post on Medium, security researcher Kevin Beaumont said the security incident appears to involve Oracle Cloud Classic, the older version of OCI. "Oracle are denying it on 'Oracle Cloud' by using this scope — but it's still Oracle cloud services that Oracle manage," Beaumont wrote.

"Oracle are attempting to wordsmith statements around Oracle Cloud and use very specific words to avoid responsibility," Beaumont said. "This is not okay. Oracle need to clearly, openly and publicly communicate what happened, how it impacts customers, and what they're doing about it."

https://www.darkreading.com/application-security/oracle-cloud-users-urged-take-action

Drugmakers Ask Trump for Staggered Tariffs

 With tariffs on medical products now seemingly inevitable, pharma companies are lobbying the Trump administration to implement them in a phased manner, giving the companies some breathing room to shift their manufacturing and absorb the financial impacts of these changes, according to an exclusive report from Reuters Tuesday .

Citing sources who requested anonymity, Reuters revealed that the largest pharma players now see President Donald Trump’s tariffs as unavoidable and have instead shifted their lobbying goals to securing an incremental implementation. Rather than a 25% levy out the gate, the companies are asking Trump for lower tariffs initially, building up to the full 25% over time, according to the sources.

In a note to investors on Sunday, analysts at Leerink Partners said that the risks from Trump’s tariffs are “underappreciated.” The added duties “would drive up US drug prices for consumers, because even if companies were to redomicile manufacturing, it will take years and cost more than ex-US manufacturing.”

Leerink reiterated these concerns in a subsequent note on Tuesday, warning that April 2 “will just be the start of the process.” Trump’s “Liberation Day” policies will likely prompt retaliation from other countries. “Retaliatory action could include reciprocal tariffs, suspension of [intellectual property] protections, and other actions,” according to the note.

Leerink’s key opinion leader estimates that pharma tariffs could be in the range of 18% to 30%.

Tariffs have become Trump’s policy move of choice since being sworn in earlier this year. In recent weeks, Trump has been alluding to April 2 as “Liberation Day,” when he plans to unveil a new sweeping set of duties against other countries. On Tuesday, CNN reported that these new tariffs could go into effect immediately—much sooner than most had expected.

It is yet unclear how aggressive the “Liberation Day” tariffs will be, though according to Reuters’ sources, Trump is unlikely to announce pharma-specific levies on Wednesday.

In anticipation of these tariffs, several Big Pharma companies have started the costly process of reshoring their manufacturing operations. Earlier this month, for instance, Johnson & Johnson unveiled a $55 billion package to boost its production and R&D capabilities in the U.S. A few weeks earlier, Eli Lilly announced a $27 billion commitment to increase its U.S. footprint with four new production plants, to be constructed over the next five years.

Pfizer has also said that it is ready to reshore its manufacturing operations should the need arise. Speaking at the 45th TD Cowen Annual Health Care Conference last month, CEO Albert Bourla said that the pharma is well-positioned to shift its production into the U.S. “if something happens.”

https://www.biospace.com/policy/drugmakers-ask-trump-for-staggered-tariffs-as-liberation-day-arrives

iCoreConnect faces potential asset auction by creditor

 In a recent development, iCoreConnect Inc., a Delaware-incorporated company specializing in prepackaged software services, disclosed a significant financial dispute with PIGI Solutions, LLC. The conflict revolves around a claim by PIGI alleging that iCoreConnect owes it approximately $2.43 million, encompassing principal, interest, legal fees, and costs. According to InvestingPro data, the company already carries a total debt of $11.98 million and maintains a concerning current ratio of 0.11, indicating potential liquidity challenges.

The notice, received by iCoreConnect on March 10, 2025, states PIGI’s intention to exercise its rights as a secured creditor to auction off virtually all of iCoreConnect’s personal property. This auction, as per PIGI’s assertion of rights under the Uniform Commercial Code, is scheduled to take place on or after May 9, 2025. The company’s stock has already suffered significantly, with InvestingPro data showing a 98.33% decline over the past year and currently trading at $0.40, near its 52-week low of $0.39.

iCoreConnect, however, is challenging both the claimed debt and PIGI’s entitlement to auction the company’s assets. While the company is actively engaged in negotiations with PIGI to settle the dispute and halt the planned auction, there is no guarantee that these efforts will prevent the auction from proceeding as scheduled.

The disclosure was made through a Form 8-K filing with the Securities and Exchange Commission by iCoreConnect, whose common stock is listed on The NASDAQ Stock Market LLC under the trading symbol ICCT. The information is based on a press release statement from the company, which is currently led by President and Chief Executive Officer Robert McDermott.

https://www.investing.com/news/sec-filings/icoreconnect-faces-potential-asset-auction-by-creditor-93CH-3950536

AngioDynamics ups 2025 guidance

 AngioDynamics, Inc. revised earnings guidance for the fiscal year 2025. The company now revises net sales to be in the range of $285 to $288 million, up from previously issued guidance of $282 to $288 million, representing growth between 5.3% to 6.4% over fiscal 2024 pro forma revenue of $270.7 million.

https://www.marketscreener.com/quote/stock/ANGIODYNAMICS-INC-8379/news/AngioDynamics-Inc-Revises-Earnings-Guidance-for-the-Fiscal-Year-2025-49508210/