Koffler: Biden Is Turning Ukraine Into Another Afghanistan

 Former intelligence officer Rebekah Koffler told FOX Business Network's "Varney & Co." on Tuesday that the Biden administration does not have "achievable goals" in Ukraine and is turning the country into "another Afghanistan."

FOX BUSINESS HOST: Should NATO be giving more arms to Ukraine?

REBEKAH KOFFLER: Here's the $64,000 question, for what specific reason?

We have been providing billions of dollars worth of high-tech weaponry to Ukraine. Javelins, Stingers, now Patriot missiles, and even tanks. Right now there are deliberations within NATO to possibly provide F-16 warplanes, and the concern is obviously that the conflict, potentially will escalate out of control, dragging in the United States.

But no one has specified achievable goals. The goal that the Biden administration has stated is to evict the Russians completely from the entire Ukraine, including Crimea, and that is unachievable.

So this conflict has really exposed the Biden administration and the Pentagon's inability to plan ahead.

Ukrainians are being killed right now, between Russians and Ukrainians we now have a quarter of a million men -- and women, obviously, both civilians and military -- either injured or [killed], and the war is nowhere near the end.

FOX BUSINESS HOST: In fact, we're just starting to see the major offenses from the Russians. I read a lot about the town of Bakhmut, which seems to be a critical target for the Russians, and the Ukrainians are hanging on, but it's certainly starting to ramp up again, is it not?

REBEKAH KOFFLER: Oh, absolutely. My intelligence analysis tells me that Russia is unleashing a massive offensive across Ukraine, which is now concentrated on Bakhmut. Securing victory over Bakhmut would enable Russia to gain a foothold into the entire region of Donbas, which is the industrial heartland of Ukraine and Putin's key strategic goal at this stage of this war.

And so, unfortunately, Ukrainians are not receiving the weaponry that we have promised to them fast enough to defend themselves and so this is a deeply, deeply unfair fight.

Putin has mobilized an additional 315,000 troops, and 150,000 are in training camps, so this war is an endless war and it's turning into another Afghanistan. It's really time for the Pentagon to really sit down and think, "what is the ultimate goal?"

There's no strategy for victory. There's no exit strategy, and it's time to really be serious about what's going on. The conflict that is going to rip Europe apart if it doesn't stop very soon.

https://www.realclearpolitics.com/video/2023/02/14/koffler_biden_is_turning_ukraine_into_another_afghanistan.html

Merit Medical gets breakthrough tag on soft tissue cancer treatment

  Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, announced today the FDA has granted Breakthrough Device Designation for the SCOUT MD Surgical Guidance System.

The SCOUT MD is the latest step in Merit’s ongoing commitment and leadership in advancing oncology care. SCOUT MD expands Merit’s portfolio of products to optimize oncology for breast and other soft tissue cancers, which includes the SCOUT® Radar Localization system with new SCOUT® Mini Reflector and SCOUT Bx™ Delivery System, and the SAVI® Brachy System.

A first of its kind, the SCOUT MD localization system supports implantation of up to four unique reflector configurations. When implanted within abnormal breast or other soft tissue, the reflectors enable surgeons to pinpoint tumor location in multiple dimensions for more precise excision, minimizing trauma to healthy tissue and helping to reduce the likelihood of re-excision and the emotional and physical pain associated with a second surgery.

https://www.biospace.com/article/releases/merit-medical-receives-fda-breakthrough-device-designation-for-the-new-scout-md-surgical-guidance-systemnext-generation-system-helps-improve-surgical-precision-to-enhance-patient-care-in-breast-and-other-soft-tissue-cancer-treatment/

Capricor, Nippon Shinyaku Partner on Treatment of Duchenne Muscular Dystrophy in Japan

 Expands Partnership with Nippon Shinyaku to Japan to Leverage Deep Experience in Drug Development for Rare Diseases and Commercial DMD Franchise-

-Capricor to Receive an Upfront Payment of $12 Million, Additional Potential Milestone
Payments of up to $89 Million as well as Meaningful Double-Digit Percentage of Revenue Based on Product Sales-

Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, announced today that it has entered into a partnership with Nippon Shinyaku Co., Ltd., a Japanese pharmaceutical company listed on the TYO, for the exclusive commercialization and distribution in Japan of Capricor’s lead asset, CAP-1002, for the treatment of Duchenne muscular dystrophy (DMD), a rare neuromuscular disease with limited treatment options. This follows the exclusive Commercialization and Distribution Agreement entered into with Nippon Shinyaku in the United States in January 2022.

https://www.biospace.com/article/releases/capricor-therapeutics-and-nippon-shinyaku-enter-partnership-for-exclusive-commercialization-and-distribution-of-cap-1002-for-the-treatment-of-duchenne-muscular-dystrophy-in-japan/

Intelligent Bio Solutions files submission for Intelligent Fingerprinting Drug Screening

 513(g) submission will allow Intelligent Bio Solutions Inc. to determine the most suitable FDA regulatory pathway for its Intelligent Fingerprinting Drug Screening Cartridge, as the next step in its expansion strategy into the U.S. -

- Intelligent Fingerprinting Drug Screening Cartridge quickly detects the presence of four drugs and/or their metabolites from fingerprint sweat -

 Intelligent Bio Solutions Inc. ("Intelligent Bio Solutions" or the "Company") (Nasdaq: INBS), a life sciences company developing and delivering intelligent, non-invasive, real-time testing solutions, today announced that the Company has filed a 513(g) submission with the United States Food and Drug Administration (FDA) for its Intelligent Fingerprinting Drug Screening Cartridge. The submission will allow Intelligent Bio Solutions to determine the most suitable FDA regulatory pathway as part of the Company’s strategy for expansion into the U.S. market. 

https://www.biospace.com/article/releases/intelligent-bio-solutions-inc-files-fda-513-g-regulatory-submission-for-intelligent-fingerprinting-drug-screening-cartridge/

Seagen Mum on Merck Buyout Rumors as it Bats for Blockbuster with Adcetris

 Seagen did not address rumors of a buyout from Merck during its fourth-quarter and full-year financial report Wednesday.

Instead, the Washington-based biotech focused on upcoming label expansions and its promising pipeline.

For 2023, Seagen’s growth will depend greatly on its four approved products: Adcetris (brentuximab vedotin), Padcev (enfortumab vedotin-ejfv), Tukysa (tucatinib) and tivdak (tisotumab vedotin-tftv). For these, the company is anticipating several key data readouts or regulatory milestones this year, David Epstein, CEO, Seagen, said in an investor call.

“We are executing robust clinical development programs, including 10 potentially registrational studies for our approved products in areas of opportunity spanning multiple tumor types,” Epstein said.

In November 2022, Adcentris won FDA approval for pediatric Hodgkin lymphoma, expanding its label to include patients aged two years and above with high-risk disease.

A month later, the drug met its primary endpoint in a multi-part Phase II trial in classical Hodgkin lymphoma when combined with Bristol Myers Squibb’s Opdivo (nivolumab). This could pave the way for another label expansion for Adcetris.

Adcetris is now standard-of-care in front-line Hodgkin lymphoma, and following its most recent regulatory nod, is indicated for seven malignancies. Seagen expects Adcetris to hit blockbuster status in 2023, Epstein said.

The company also sees blockbuster potential in Padcev, its bladder cancer therapeutic, which it hopes to grow into a strong franchise in this space by expanding its utility into earlier stages of the disease, including muscle- and non-muscle-invasive forms of bladder cancer.

The FDA has granted priority review for Padcev’s accelerated approval application for the first-line treatment of metastatic bladder cancer, in combination with Merck’s Keytruda (pembrolizumab), in patients who are cisplatin-ineligible. with a target action date of Apr. 21, Epstein said.

Padcev is also approved for locally advanced or metastatic urothelial cancer, and Seagen is continuing to study the drug beyond bladder cancer.

Tukysa is a best-in-class tyrosine kinase inhibitor approved for HER2-positive metastatic breast and colorectal cancer. For the coming year, Seagen is gearing up for several product launches for Tukysa outside the U.S., Epstein said.

The FDA recently granted the treatment accelerated approval in patients with previously treated, RAS wild-type, HER2-positive metastatic colon cancer.

Seagen’s fourth major growth driver for 2023 is its newest commercial product Tivdak, a first-in-class antibody-drug conjugate (ADC) approved as a second-line treatment for metastatic cervical cancer. The company is seeking to expand Tivdak’s label to head and neck cancer.

Beyond these four approved products, Seagen is also advancing three promising ADC candidates to support its longer-term growth. These include disitamab vedotin for HER2+ metastatic urothelial cancer and other HER2-expressing solid tumors; SGN-B6A, which targets integrin beta-6; and SGN-B7H4V, which binds the B7-H4 immune checkpoint protein.

https://www.biospace.com/article/seagen-mum-on-merck-buyout-rumors-as-it-bats-for-blockbuster-with-adcetris/

Pfizer Reports Positive Data, Priority Review for Talzenna/Xtandi Combo

 Pfizer Inc. on Thursday said a Phase 3 study combining its breast-cancer drug Talzenna with its prostate-cancer drug Xtandi showed a 37% reduction in the risk of disease progression or death in men with metastatic castration-resistant prostate cancer compared with Xtandi plus placebo.

The New York drugmaker also said the U.S. Food and Drug Administration granted priority review to its application seeking approval of the combination for the treatment of men with the condition.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.

Pfizer, which is conducting a Phase 3 study of the combination in men with metastatic castration-sensitive prostate cancer, said it expects a decision from the agency sometime this year.

https://www.marketscreener.com/quote/stock/PFIZER-INC-23365019/news/Pfizer-Reports-Positive-Data-Priority-Review-for-Talzenna-Xtandi-Combo-43009209/

Labcorp reports 20% drop in COVID test sales in Q4

 Shares of Laboratory Corporation of America Holdings (LH) were down about 2.9% in premarket trading on Thursday after the diagnostics company reported lower-than-expected revenue in the fourth quarter of 2022. Labcorp had earnings of $76.4 million, or 86 cents per share, in the fourth quarter, down from $553.6 million, or $5.75 per share, in the same quarter in 2021. Adjusted earnings per share were $4.14, against a FactSet consensus of $3.87. Revenue came in at $3.67 billion for the quarter, down from $4.06 billion in the same three months of 2021, driven in part by a nearly 21% drop in sales of COVID-19 tests. The FactSet consensus was $3.86 billion. The company said it expects adjusted EPS of $16.00 to $18.00 in 2023. The FactSet consensus is $14.93. Labcorp's stock has declined 7.9% over the past year, while the broader S&P 500 is down 5.6%.

https://www.morningstar.com/news/marketwatch/20230216454/labcorp-reports-20-drop-in-covid-test-sales-in-q4