Portage Biotech in Keytruda Collaboration With Merck

Portage Biotech has entered into a clinical trial collaboration agreement with Merck to evaluate Portage's next-generation adenosine antagonists in combination with Keytruda, Merck's anti-programmed death receptor-1 therapy, for patients with solid tumors.

The collaboration will explore Portage's adenosine 2A receptor antagonist, PORT-6, its adenosine 2B receptor antagonist, PORT-7, individually and together in combination with Keytruda in prostate, renal, head and neck, colorectal, endometrial, ovarian and non-small cell lung cancers.

Under the terms of the agreement, Merck will provide Keytruda for Portage Biotech's adaptive Phase 1a/1b trial, which plans to integrate proprietary biomarkers for selecting patients with high adenosine expression in order to identify those more likely to respond and have potential to benefit most from treatment.

https://www.morningstar.com/news/dow-jones/202309054202/portage-biotech-in-keytruda-collaboration-with-merck

Zai Lab ADR surges after Seagen, Genmab release cervical cancer treatment results

 Zai Lab Ltd.'s American depositary receipts (ZLAB) jumped 14% premarket on Tuesday after Seagen Inc. (SGEN) and Genmab A/S (GMAB.KO) announced that Tivdak, their treatment for cervical cancer, improved patients' overall survival in a late-stage study. Zai Lab is collaborating with the companies on a China extension study, which has been initiated and continues to enroll patients, Seagen and Genmab said in a release Monday. Zai Lab and Seagen late last year announced a collaboration for the development and commercialization of Tivdak in mainland China, Hong Kong, Macau, and Taiwan. The U.S. Food and Drug Administration in 2021 granted accelerated approval for Tivdak for treatment of adults with recurrent or metastatic cervical cancer. Zai Lab's ADR has dropped 15% in the year to date, while the S&P 500 has gained 17.6%

https://www.morningstar.com/news/marketwatch/2023090592/zai-lab-adr-surges-after-seagen-genmab-release-cervical-cancer-treatment-results

Novartis Confirms Sandoz Spin-Off Plans, Sets Oct. 4 Completion Date

 Novartis on Tuesday confirmed that it is pushing through with the spin-off of its generics and biosimilars division Sandoz, pending the final approval of its shareholders.

To secure approval, the Swiss pharma group will hold an extraordinary general meeting set for Sept. 15. If given the go-ahead, Novartis expects to complete Sandoz’s spin-off “on or around” Oct. 4, the company said in Tuesday’s announcement.

Novartis is also planning to list Sandoz on the SIX Swiss Exchange, with an American Depository Receipt (ADR) program in the U.S., for which the pharma group will likewise need to secure regulatory approvals.

Novartis first launched a strategic review of its generics unit in October 2021, when it announced that it was exploring options for the business moving forward—including a potential sale. At the time, Sandoz was seeing better volume sales figures but was struggling with decreasing drug prices in the U.S., which is its largest market.

The review of Sandoz was part of CEO Vas Narasimhan’s effort to streamline Novartis’ operations, which included the spin-off of its eye business Alcon and a sweeping realignment that is meant to help the company save $1 billion in operating costs by 2024. Under this strategic initiative, Novartis combined its oncology and pharmaceuticals units creating its Innovative Medicines division.

The restructuring also saw the departure of top company officials, including former oncology head Susanne Schaffert, and thousands of layoffs.

In July 2022, Novartis floated the idea of spinning Sandoz out into its own separate entity and finalized these plans a month later. At the time, a company spokesperson told BioSpace that the spin-off “would enable both businesses to focus on maximizing value creation for their shareholders.” It would also allow Novartis to focus on its five core therapeutic areas and strengthen its technology platforms.

Novartis’ Board of Directors in July 2023 unanimously endorsed the spin-off of Sandoz as a separate business entity, and if its shareholders approve the separation, they will receive one Sandoz share for every five Novartis shares they own, or one Sandoz ADR for every five Novartis ADRs.

Also in Tuesday’s announcement, Novartis posted Sandoz’s financial performance for the first half of 2023. During this period, the generics and biosimilars business made $4.8 billion in net sales to third parties, representing an 8% jump at constant currencies. Volume was again the driving force behind this increase, contributing 12 percentage points to its growth and offsetting the negative impacts of pricing.

Novartis said Sandoz’s sales increase “was mainly driven by Europe, which benefited from strong volume growth driven by continued momentum from prior year launches, a strong cough and cold season and the Biosimilars business.” Looking ahead, Sandoz expects mid-single digit net sales growth for 2023 as well as for 2024 to 2028, according to Novartis.

https://www.biospace.com/article/novartis-confirms-sandoz-spin-off-plans-sets-oct-4-completion-date-/

Trump vows to end ‘madness’ of EV push

 Former President Trump is vowing to end the “madness” of the Biden administration’s push for electric vehicles — a likely appeal to voters in the swing state of Michigan.

In a pair of Truth Social posts Monday evening, Trump took aim at the electric vehicle industry and President Biden’s push for more electric vehicles. With this opposition to electric vehicles, Trump is likely trying to persuade Michigan voters to support him over Biden, who carried the swing state in 2020.

“The Great State of Michigan will not have an auto industry anymore if Crooked Joe Biden’s crazed concept of ‘all Electric Cars’ goes into effect,” he wrote in the Truth Social post. “CHINA WILL TAKE IT ALL, 100%. United Auto Workers, VOTE FOR TRUMP. Get your leaders to ENDORSE ME, I WILL KEEP ALL OF THESE GREAT JOBS, AND BRING IN MANY MORE. CHOICE IN SCHOOLS, AND CHOICE IN CARS!!!”

In 2021, Michigan was home to more than 175,000 auto manufacturing jobs, according to a report from nonprofit research center Mackinac Center for Public Policy. While that number is still higher than any other state, the report noted it’s also just 37 percent of the jobs Michigan had at its peak.

The Biden administration has pushed to boost electric car sales, with the Environmental Protection Agency (EPA) predicting that two-thirds of new car sales could be electric by 2032 under a new proposal released by the administration earlier this year. Just last week, the Energy Department announced plans to invest $12 billion into converting auto manufacturing facilities into plants for hybrid and electric vehicles.

Trump also took aim at Shawn Fain, the president of the United Auto Workers, for supporting the Biden administration’s latest investment into electric vehicles.

“Shawn Fain, the respected President of the United Auto Workers, cannot even think about allowing ALL ELECTRIC CARS — THEY WILL ALL BE MADE IN CHINA, and the Auto Industry in America will cease to exist!” Trump wrote in a separate Truth Social post.

“Vote for TRUMP, and I will stop this Madness, IMMEDIATELY!” he said. “Mexico & Canada LOVE Biden’s idiotic policy. SAVE MICHIGAN and the other Auto States. SAVE THE AMERICAN CONSUMER!!!”

The call-outs come as approximately 146,000 UAW members near a strike deadline when their contract ends Sept. 14 with three large U.S. automakers — General Motors, Stellantis and Ford.

Meanwhile, Fain calls their demands for a 46 percent pay raise, a 32-hour work week with 40 hours of pay and a restoration of traditional pensions “audacious.”

It is not the first time Trump has taken aim at the Biden administration’s push for electric vehicles to win over voters in Michigan. He has also touted the United States-Mexico-Canada Agreement (USMCA) he made in 2020, saying the deal created “tough new requirements to ensure more cars are made in American factories by American workers.”

“Biden is a catastrophe for Michigan and his environmental extremism is heartless and disloyal and horrible for the American worker, and you’re starting to see it,” Trump said in a keynote address to Oakland County Republicans in Michigan in June.

https://thehill.com/policy/energy-environment/4187159-trump-vows-to-end-madness-of-ev-push/

'CDC warns doctors to be on lookout for deadly flesh-eating bacteria'

 The Centers for Disease Control and Prevention (CDC) is warning doctors to be on the lookout for deadly flesh-eating bacteria that may be in waters of the Gulf of Mexico and East Coast.

The bacteria is known as Vibrio vulnificus or V. vuilnificus.

The CDC issued the health advisory last week to urge healthcare providers to consider it as the possible cause of infected wounds from people who have been in coastal waters.

The advisory said that the bacteria naturally live in coastal waters, and that V. vulnificus is primarily transmitted through open-wound contact. It also been transmitted in 10 percent of cases through eating raw or undercooked shellfish.

“V. vulnificus wound infections have a short incubation period and are characterized by necrotizing skin and soft tissue infection, with or without hemorrhagic bullae,” the CDC warned. “Many people with V. vulnificus wound infection require intensive care or surgical tissue removal.”

The CDC said that the heat wave and rising sea surface temperatures likely contributed to the growing range of infections and noted that fatal infections have been reported in New York, Connecticut and North Carolina.

Amid increasing water temperatures and extreme weather events (e.g., heat waves, flooding, and severe storms) associated with climate change, people who are at increased risk for V. vulnificus infection should exercise caution when engaging in coastal water activities, the CDC said.

https://thehill.com/policy/healthcare/4187268-cdc-warns-doctors-to-be-on-lookout-for-deadly-flesh-eating-bacteria/

Why Is BioCardia Stock Plunging

 BioCardia Inc 

BCDA-22.1%+ Free Alerts

 shares are down after the company released interim efficacy results in the phase 3 pivotal CardiAMP cell therapy heart failure trial.

For the first tier, all-cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement at 12 months, there were 5.6% of CardiAMP treatment patients versus 5.3% for the control group (p = 0.42). 

24-month follow-up data showed a separation between groups, with 8.3% all-cause death, including cardiac death equivalents in the treatment group versus 13.2% in the control group (p = 0.94), corresponding to a 37% relative risk reduction for Tier 1 events compared to control patients on guideline-directed medical therapy (GDMT).

For the second-tier, non-fatal major adverse cardiac events (MACCE), excluding those deemed procedure-related occurring within the first seven days and defined as heart failure hospitalization, stroke, and myocardial infarction, 16.7% of the treatment group had MACCE compared to 15.8% of the control group (p=0.82). 

All available follow-up data for patients followed up to 24 months showed a 16.7% MACCE rate in the treatment group versus 23.6% in the control group (p=.76), corresponding to an 18% relative risk reduction for MACCE over GDMT.

For the third tier of change in the Six Minute Walk Test (6MWT) distance from baseline to 12 months, both CardiAMP treatment patients and control patients experienced a clinically meaningful improvement at 12 months, which was not statistically different. 

The treated group median 6MWT at 12M increased 36.1 with a standard deviation of ±70.8 meters, and the control group median 6MWT increased at 12M by 33.4 meters ± 74.8 meters (p =0.6). 

Results at 24 months showed the treatment group median improving 1.8 ± 76.1 meters and the control group median improving 17.4 ± 95.7 meters (p=0.33). 

The improvement in 6MWT at 12M for the control group was greater than was expected in this population.

Based on these measures at one-year follow-up, the 250-patient randomized controlled study is unlikely to meet its primary three-tiered Finkelstein-Schoenfeld (FS) efficacy endpoint.

https://www.benzinga.com/general/biotech/23/09/34233010/why-is-biocardia-stock-plunging-today

Oil Soars To New 2023 High After Saudis, Russia Surprise With Extended Production Cut

Just days after we said that Saudi Aramco floating to sell up to $50 billion in new stock meant that oil is about to soar much higher...

... moments ago oil exploded higher after first Saudi Arabia and moments later Russia surprised markets by announcing that the recently implemented production cuts would be extended through year-end, well beyond the 1 month that was widely expected by the market.

Just after 9am ET, Saudi Arabia said it would extend the voluntary cut of 1 million b/d of for another 3 months, from October until the end of December, well beyond the expectation of just 1 more month. Saudi press agency SPA notes that the voluntary cut decision will be reviewed monthly to consider deepening the cut or increasing production. The extension of cuts is meant to reinforce the precautionary efforts made by OPEO countries with the aim of supporting the stability of the oil market.

And then, literally seconds after the Saudi decision, Russian deputy PM Novak said Russia would also extend its reduction of oil exports until the end of the year, reducing its oil output by 300kb/d in voluntary cuts until December 2023.

Similar to the Saudis, Russia said that the decision to reduce oil production to be reviewed monthly to consider possibility of deepening reduction or increasing production depending on situation on the world market.

Following this announcement Brent Nov’23 lifted from USD 88.50 to above $90 for the first time in 2023, while WTI Oct’23 rose from USD 85.55/bbl to USD 87.00/bbl, also the highest price of the year, and about to crush the Fed's hopes for a decline in headline inflation.

Bottom line: we now know that a year and a half later, the OPEC+/BRIC+ reaction to Biden's weaponized dollar is weaponized oil; may the least hopeless man win.

As for Biden, we wish him the best of luck refilling the SPR now that oil is about to hit $100 and rise above the price where the senile president sold most of the US strategic oil.

https://www.zerohedge.com/markets/oil-soars-new-2023-high-after-saudis-russia-surprise-extended-expanded-production-cut