Guyana Situation Rapidly Deteriorates As Maduro Arrests Opposition, Military Drills With US

 Update (1600ET): The situation in Guayana is rapidly deteriorating, as Venezuelan President Nicolas Maduro has issued arrest warrants for opposition politicians who are challenging his move to annex oil-rich Essequibo.

As Charles Kennedy of OilPrice.com reports; Maduro has officially placed the disputed territory of oil-rich Essequibo under military jurisdiction, putting oil exploration and production operations of Exxon and Chevron at risk. 

Following a Sunday referendum, Venezuelan President Nicolas Maduro has declared the return of Essequibo, which represents some two-thirds of Guyana’s territory, to Venezuela. 

According to T&T News, Venezuela’s Prosecutor's Office has issued arrest warrants for a dozen opposition members, including former National Assembly head Juan Guaido and three members of staff of opposition presidential candidate Maria Corina Machado. The three are charged with conspiring against the Sunday referendum to annex Essequibo.

The recent temporary easing of U.S. oil sanctions on Venezuela were conditioned on the holding of free and fair elections in 2024.
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While the U.S. has offered Guyana “unwavering support for Guyana’s sovereignty”, there has been no concrete talk of reversing the easing of sanctions based on Maduro’s actions.

Exxon, which is targeting 1.2 million barrels per day of crude output from Guyana’s offshore Stabroek oil block by the end of 2027, has refrained from commenting on the developing situation, telling journalists earlier this week only that it believes “border issues are matters for governments and appropriate international organizations to address”.

In a comment shared with IBT on Wednesday, Chevron said: "Chevron has a long history and excellent record of being a partner of choice in the countries in which we have operations. We always aim to be, and we are a constructive presence in the countries where we operate."

A consortium controlled by ExxonMobil holds a 45% in the Stabroek block, with Chevron, which recently acquired Hess, holding a 30% stake and China’s CNOOC holding a 25% stake. 

On Tuesday, Maduro vowed to begin handing out exploration and extraction licenses “immediately” and ordered full compliance from foreign oil companies operating in the area. 

Both U.S. and Guyanese officials have shared their hopes for a peaceful resolution with Venezuela. Guyana's president, Irfaan Ali, told CBS News in a Tuesday interview that the country would prepare military assets with its allies to ready itself for "the worst case scenario," but said he hopes the conflict does not come to that.

"Our first line of defense is diplomacy," Ali told CBS News, adding that Guyana has reached out to leaders abroad, including in the U.S., India and Cuba, hoping that "they can encourage Venezuela to do what is right, and ensure that they do not act in a reckless or adventurous manner that could disrupt the peace within this zone." -CBS News

The Maduro administration, meanwhile, has blasted the drills as a "provocation."

"This unfortunate provocation by the United States in favor... of ExxonMobil in Guyana is another step in the wrong direction. We warn that we will not be diverted from our future actions for the recovery of the Essequibo," said Venezuelan Defense Minister Vladimir Padrino Lopez in a post to X.

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Meanwhile, the United States announced joint military drills in Guyana on Thursday.

"In collaboration with the Guyana Defense Force, the U.S. Southern Command will conduct flight operations within Guyana on December 7," the US Embassy in Guyana said in a statement, calling the flights part of "routine engagement and operations to enhance security partnership" between the US and Guyana and "to strengthen regional cooperation."

"The U.S. will continue its commitment as Guyana's trusted security partner and promoting regional cooperation and interoperability," the statement continued.

https://www.zerohedge.com/geopolitical/blinken-conveys-unwavering-support-guyana-after-venezuelas-maduro-proclaims-esequibo

Solid Biosciences Fast Tracked for Duchenne Gene Therapy

 Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that it has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for SGT-003, the company’s next-generation Duchenne muscular dystrophy (Duchenne) gene therapy candidate.

IND clearance by the FDA for SGT-003 was received in November 2023. The planned Phase 1/2 trial, SGT-003-101, is a first-in-human, open-label, multicenter trial to determine the safety and tolerability of SGT-003 in pediatric patients with DMD at a dose of 1E14vg/kg. SGT-003 will be administered as a one-time intravenous infusion to patients in two cohorts with a minimum of three patients each, with the potential for cohort expansion. Cohort 1 will study patients aged 4 to < 6 years of age with DMD. Long-term safety and efficacy will be evaluated for a total of 5 years following treatment.

https://www.globenewswire.com/news-release/2023/12/07/2792478/0/en/Solid-Biosciences-Receives-FDA-Fast-Track-Designation-for-Duchenne-Muscular-Dystrophy-Gene-Therapy-SGT-003.html

'Pharma Industry on Alert as Biden Administration Explores Patent Seizure Powers'

 The White House is endorsing a contentious power that permits the government to reclaim patents for specific high-cost medications. 

On Thursday, the administration is reportedly set to introduce a blueprint enabling the National Institutes of Health to more extensively exercise "march-in rights" – a policy enabling the seizure of patents from drug manufacturers whose products rely on research funded by the federal government. 

This framework will delineate instances when the agency might invoke this authority and advocate considering a drug's price in making such determinations, Politico noted, citing the sources.

The Biden administration has concluded that it holds the power to confiscate patents for specific high-priced medications, potentially paving the way for a more forceful federal approach to reduce drug costs. 

According to the sources, the administration is not planning to advocate the widespread use of march-in rights and doesn't intend to take immediate action against any particular drugs. 

Instead, the Commerce Department is set to unveil a new framework on Thursday outlining criteria for federal agencies to consider when contemplating march-in actions against costly drugs or other products supported by federal assistance.

Factors like product pricing and accessibility to the public will be emphasized in this framework.

This move is expected to encounter fierce opposition from pharmaceutical companies, which argue that government patent seizure is unlawful and could discourage new drug development. 

The Biden administration's move to lower drug prices has prompted a flurry of legal challenges. Eight lawsuits are winding their way through nationwide courts against the administration.

Some companies, including AstraZeneca Plc AZN, Bristol Myers Squibb & Co BMY, and Boehringer Ingelheim, said that they are willing to participate in the initial round of Medicare drug price negotiations despite having previously sued to halt the process. 

Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

https://www.benzinga.com/general/biotech/23/12/36130073/pharma-industry-on-alert-as-biden-administration-explores-patent-seizure-powers

FDA clears Becton's less-invasive blood collection device

 Becton Dickinson said on Thursday the U.S. Food and Drug Administration (FDA) cleared its finger-prick blood collection device that could provide a less-invasive option for some commonly ordered lab tests.

The device, BD MiniDraw Collection System, can help collect blood samples from a patient's finger through a trained healthcare professional without the need to do it from a vein, the company said

The clearances include blood collection for commonly ordered lab tests such as for lipid panel and tests to diagnose and monitor a variety of chronic conditions from hypertension to high cholesterol, it said. 

https://finance.yahoo.com/news/1-us-fda-clears-bectons-121749766.html

Oxford Biomedica growth targets, business update

 

• Current contracted value signed in 2023 of £124 million, an increase of 47% compared to £85 million in the year ending 31 December 2022 (excluding COVID-19 vaccine manufacturing)
• On track to achieve 2023 guidanceprovided at the Interim Results and reiteration of medium term guidance; growth supported by new orders recently signed across lentivirus, adeno-associated virus (AAV) and adenoviral vectors
• Progress towards multi-vector multi-site model with transfer of lentiviral vector capabilities to Bedford, Massachusetts site and acquisition of ABL Europe
• Recruitment of UK and US Site Heads with extensive CDMO experience to support move to site-based structure and strategic shift to a pure-play CDMO
• Significant progress in streamlining of operations to become a pure-play CDMO resulting in annualised cost-savings of c.£30 million

https://www.biospace.com/article/releases/oxford-biomedica-business-update/

Biomea Fusion Data from Ongoing Phase II Study of BMF-219 in Adults with Type 2 Diabetes

 BMF-219 is an investigational novel covalent menin inhibitor developed to regenerate insulin-producing beta cells with the aim to cure diabetes

• In a poster presentation on Thursday, Dec. 7th at 6:30pm and an oral presentation on Friday, Dec. 8th at 7:30pm, Biomea to present new preclinical and clinical data highlighting:
  • A sustained HbA1C reduction of ≥0.5% and ≥1.0% in 40% and 20% of patients, respectively, 22 weeks after the last dose from the 4-week BMF-219 treatment period from the initial two 100mg QD dose cohorts investigated in COVALENT-111
  • BMF-219 was generally well tolerated; there were no dose reductions, dose discontinuations, or severe or serious adverse events
  • BMF-219 displayed glucose-controlled beta cell proliferation in a preclinical ex-vivo human islet model, supported by on-target cell-cycle gene expression changes
  • The poster will present additional data on the reduction of A1c at Week 26, twenty-two weeks after last dose, change in C-peptide and Homa-B compared to baseline
• Biomea will kick-off the WCIRDC meeting by hosting a congress symposium titled, “BMF-219: An oral menin inhibitor in clinical development as a short-term treatment to address the root cause of diabetes, beta-cell dysfunction” on Thursday, December 7th at 7am PST.
• COVALENT-111 trial is ongoing and currently enrolling the expansion phase of the study. The company will share topline data from the escalation portion of COVALENT-111 at the conclusion of WCIRDC.

https://www.globenewswire.com/news-release/2023/12/07/2792616/0/en/Biomea-Fusion-to-Present-Long-Term-Follow-Up-Data-from-Ongoing-Phase-II-Study-COVALENT-111-of-BMF-219-in-Adults-with-Type-2-Diabetes-and-Results-from-Ex-Vivo-Human-Islet-Experiment.html

"$24 M From Foreign Nationals": House GOP Formalizes Biden Impeachment Probe, Releases Resolution Pre Planned Vote

 Ahead of next week's vote to formally move forward with the Biden impeachment inquiry, Rep. Kelly Armstrong (R-ND) has released a 14-page resolution that would authorize the investigation.

"Directing certain committees to continue their ongoing investigations as part of the existing House of Representatives inquiry into whether sufficient grounds exist for the House of Representatives to exercise its Constitutional power to impeach Joseph Biden, President of the United States of America, and for other purposes," reads the resolution, which is set for markup on Tuesday, Dec. 12, putting it on course for a Wednesday vote.

"It’s time for the House to take the next step in the Biden impeachment investigation and adopt an impeachment inquiry resolution. The White House and multiple witnesses have repeatedly refused to cooperate with the investigation and have rejected subpoenas. Despite this refusal, the investigation has uncovered alarming details that demand further scrutiny," said Armstrong in a statement.

"The Biden family and associates received more than $24 million from foreign nationals. Joe Biden received $200,000 from his brother, James Biden, the same day James received a $200,000 loan from a failing rural hospital operator. Joe Biden also received $40,000 in laundered Chinese money from his brother and sister-in-law. It’s become clear that the Biden family sold influence around the world using Joe Biden’s name as the product. An investigation in any jurisdiction around the country would move forward if it had these facts. A vote on an impeachment inquiry puts the House in the best position to prevail in court and uncover the truth," Armstrong continued.

The White House has argued that the GOP's ongoing impeachment inquiry is unconstitutional because it hasn't been formalized with said vote - an assessment that House Judiciary Chairman Jim Jordan vehemently disagreed with.

"Constitutionally, it’s not required. Speaker said we’re [in] an impeachment inquiry, [then] we’re in an impeachment inquiry," said Jordan. "But if you have a vote of the full House of Representatives and the majority say we’re in that official status as part of our overall oversight work or constitutional oversight duty that we have, it just helps us in court."

In anticipation of that vote, Democrats and the White House in recent days pointed to previous statements from swing-seat Republicans and moderates casting doubt on whether impeachment is warranted. 

They have also pointed to cries from Republicans when Trump’s impeachment began without taking a formal vote. 

But many of those same GOP members say that taking the step to authorize an inquiry is a much different question than a vote on actual impeachment articles. 

The House’s Judiciary, Oversight, and Ways and Means committees have for months investigated both what they have deemed the Biden family finances and a Justice Department investigation into Hunter Biden’s failure to pay taxes. -The Hill

Remember when Democrats impeached Trump for asking about obvious Biden corruption in Ukraine, and then again for 'instigating' the Jan. 6 riot which was riddled with feds?

Read the resolution below:

https://www.zerohedge.com/political/24-million-foreign-nationals-house-gop-formalizes-biden-impeachment-inquiry-releases