Biden's FDA pick clears key Senate hurdle

 Biden's nominee to lead the Food and Drug Administration (FDA) is headed towards a close confirmation vote after the Senate on Monday voted to shut down debate on his nomination.

The final confirmation vote on Robert Califf, which could come as early as Tuesday, is expected to be even closer than the 49-45 vote to invoke cloture. 

Five Republicans joined with Democrats to invoke cloture and end debate: Sens. Susan Collins (Maine), Lisa Murkowski (Alaska), Richard Burr (N.C.), Mitt Romney (Utah), and Roy Blunt (Mo.).

Prior to the vote, five Democrats had already spoken out against him; Sens. Joe Manchin (D-W.Va.), Sen. Bernie Sanders (I-Vt.), Ed Markey (D-Mass.), Maggie Hassan (D-N.H.) and Richard Blumenthal (D-Conn.) are expected to oppose Califf’s nomination.

Sen. Ben Ray Luján (D-N.M.) is absent after suffering a stroke, so if all Republicans who oppose Califf are present, Democrats will need one more vote in their favor to confirm.

Califf had slowly been picking up Democratic votes leading up to Monday by making individual pledges to lawmakers, including Sens. Dick Durbin (Ill.), the No. 2 Senate Democrat, Elizabeth Warren (Mass.), and Senate Finance Committee Chairman Ron Wyden (Ore.). 

Califf, a cardiologist and Duke University researcher, was confirmed to the same post by a vote of 89-4 in 2016 when he was nominated by former President Obama, but faced unexpected opposition this time.

The pushback appeared to catch the White House by surprise, and officials engaged in an intense behind-the scenes effort to shore up the votes for Califf, as conservatives tried to galvanize a handful of expected Democratic “no” votes and sink his confirmation. 

"At this critical moment we need a trusted hand to lead FDA," said Sen. Patty Murray (Wash.), the No. 3 Senate Democrat, on the floor just ahead of the vote. 

Manchin has been highly critical of Califf ever since Biden announced his nomination in the fall, both for his industry ties and because of FDA's role in the opioid crisis while Califf was at the helm.

Manchin also voted against Califf in 2016.

"Nothing that Dr. Califf has said or done leads me to believe he will operate FDA any differently than he did during his previous tenure," Manchin said on the floor. "I cannot for the life of me understand why this administration is so committed to asking each of us in the Senate to reconfirm a person who had the opportunity to make a difference, but showed us who he really was? Do not expect a different outcome if he is given another opportunity to lead the FDA." 

At the same time, Republicans are facing pressure from anti-abortion groups, which have mobilized against Califf. He gained just four GOP votes in a committee vote last month.

Anti-abortion groups in particular have been lobbying hard against Califf. The Susan B. Anthony List said it would “key vote” Califf’s nomination as a result of his work on the abortion drug mifepristone during the Obama administration.

https://thehill.com/policy/healthcare/594218-bidens-fda-pick-clears-key-senate-hurdle

Biofrontera to delist ADS from Nasdaq to reduce complexity and costs

 Biofrontera AG (the “Company”) (Nasdaq: BFRA; Frankfurt Stock Exchange: B8F), an international biopharmaceutical company, decided today its American Depositary Shares (“ADS”) should be delisted from the Nasdaq Capital Market (“Nasdaq”) and its reporting obligations with the Securities and Exchange Commission (“SEC”) should be deregistered and terminated. The main purpose of the delisting is to reduce complexity in financial reporting and administrative costs.

Biofrontera AG intends to maintain an amended ADS program on a Level I basis, which will allow investors to continue to hold their securities in the form of ADSs and trade the ADS on the U.S. over-the-counter (OTC) market. The ADSs will automatically transition to the new ADS program in connection with the delisting and will be traded under a new ticker to be designated.

Biofrontera AG’s ordinary shares will continue to trade in the Prime Standard at the Deutsche Börse under the symbol B8F. Holders of ADSs may choose to exchange their ADSs to holding ordinary shares listed on the Deutsche Börse.

Further details regarding the procedures will be announced later. The Company plans to submit a Form 25 relating to its ADSs on Nasdaq to the SEC on or about February 24, 2022 to initiate the delisting and expects the delisting to be become effective not less than ten days later.

https://finance.yahoo.com/news/biofrontera-ag-decides-delist-ads-190500929.html

ProQR cut to Neutral from Buy by Citi

 Target to $1.70 from $37

https://finviz.com/quote.ashx?t=PRQR

WHO Tracking 4 Omicron Subvariants

 The WHO indicated it is tracking four Omicron subvariants: BA.1, BA.1.1, BA.2 and BA.3. BA.2 has a growth advantage over BA.1, the variant responsible for the recent Omicron surge.

“For everybody [who is] out there watching this, what is important for you to know is that this virus continued to be dangerous,” said Dr. Maria Van Kerkhove, the COVID-19 technical lead of the WHO. “This virus transmits very efficiently between people, but there’s a lot that you can do.”

She emphasizes that the goal is not to prevent all transmissions, which is almost impossible. Van Kerkhove said, “But, we need to drive transmission down. Because, if we don’t, we will not only see more cases, more hospitalizations, more deaths, we will see more people suffering from post-COVID condition—Long COVID—and we will see more opportunities for variants to emerge.”

https://www.biospace.com/article/who-tracking-4-omicron-subvariants-and-more-covid-19-news/

Moleculin Biotech Annamycin Doublet Therapy Shows 68% Overall Survival In Animal Study

 Moleculin Biotech Inc 

MBRX -2.7%

 (Get Free Alerts for MBRX) has announced preliminary results supporting the successful conclusion of its second Phase 1 trial in Poland, evaluating Annamycin for relapsed and refractory acute myeloid leukemia (AML).

• Moleculin determined a dose of 240 mg/m2 as the Recommended Phase 2 Dose (RP2D), subject to final approval of the Safety Review Committee, and indicated no signs of cardiotoxicity. 
• Based on preclinical animal data, Annamycin in combination with Cytarabine demonstrated a 68% improvement in the median overall survival (OS) compared to Annamycin as a single agent and a 241% increase in OS compared to Cytarabine alone. 
• The Company plans to advance its AML clinical development program in a Phase 1/2 clinical trial in Europe, evaluating Annamycin/Cytarabine combo.
• The study is expected to begin in 1H 2022.
• Annamycin has demonstrated no cardiotoxicity to date, with an ORR of 60% in the last cohort for patients receiving a full course of Annamycin.

https://www.benzinga.com/general/biotech/22/02/25607167/moleculin-biotech-annamycin-doublet-therapy-shows-68-overall-survival-in-animal-study

Biden Declares 'Personal Freedom' Comes Second To COVID Mandates

 by Steve Watson via Summit News,

Joe Biden managed to cobble together a sentence during an interview with NBC’s Lester Holt over the weekend, declaring that his message to people who want COVID to be over is that their personal freedoms come second to his mandates.

“What’s your message to people who want desperately for [Covid] to be over and to be able to resume the lives they remember?” Holt asked Biden.

“If your exercising personal freedom puts someone else in jeopardy, their health in jeopardy, I don’t consider that freedom,” Biden sarcastically stated in response, before telling people who don’t want to continue wearing masks or getting jabs to “think of the children.”

Watch:

Someone should get the memo to Biden that it’s election season, and his unscientific mandates are not conducive to winning votes.

A CNN poll revealed Sunday that a majority of Democrats now don’t even want Biden as the nominee in 2024.

The survey noted that just 45 percent of Democrats and Democrat-leaning voters want Biden to run for reelection, with 51 percent saying they believe someone else should be the nominee.

In addition, the survey found that “While 70 percent of Democratic voters who strongly approve of the way he’s handling the job said they’d like to see him renominated, that drops to just 35 percent among Democrats who said they approve moderately.”

https://www.zerohedge.com/political/watch-biden-declares-personal-freedom-comes-second-covid-mandates

Pardes Biosciences Shares Early Data From COVID-19 Study

 Pardes Biosciences Inc's 

PRDS -2.95%

 (Get Free Alerts for PRDS) has presented interim data from its ongoing PBI-0451 Phase 1 trial in healthy adult volunteers at the Conference on Retroviruses and Opportunistic Infections (CROI) 2022. 

• The presentation shared details around the nonclinical profile of PBI-0451 and interim clinical safety, tolerability, and pharmacokinetics (PK) after single- and multiple ascending doses.
• PBI-0451 has been generally well tolerated over a >20-fold single- and >14-fold multiple-total daily dose range. 
• All treatment-emergent adverse events in the study reported through January 31 have been assessed as mild in severity and resolved without intervention.
• In a drug-drug interaction cohort, the pharmacokinetics of PBI-0451 was not substantially affected when co-administered with ritonavir.
• In multiple ascending dose cohorts, interim data showed that PBI-0451 twice-daily achieved and maintained PK exposures.
• The Company believes the candidate can provide potent antiviral activity against COVID-19 and emerging variants.
• Additional dose cohorts and PK evaluation in this ongoing Phase 1 study continue.
• The Company will inform dose selection for the upcoming PBI-0451 Phase 2/3 study anticipated to start mid-2022.

https://www.benzinga.com/general/biotech/22/02/25600319/pardes-biosciences-shares-early-data-from-covid-19-study