Amgen, AstraZeneca TEZSPIRE® approved for self-administration

 AstraZeneca and Amgen’s TEZSPIRE® (tezepelumab-ekko) has been approved in the US for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. TEZSPIRE is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.1

The approval by the US Food and Drug Administration (FDA) was based on results from the PATHFINDER clinical trial program, which included results from the PATH-BRIDGE Phase I trial and the PATH-HOME Phase III trial.2,3 The majority (92%) of healthcare providers, patients and caregivers were able to successfully administer TEZSPIRE both in the clinic and at home throughout the PATH-HOME trial.3 The improvements in asthma control and the safety profile of TEZSPIRE observed in the PATH-HOME trial were consistent with previous clinical trials.

https://finance.yahoo.com/news/tezspire-approved-self-administration-us-140000879.html

Hoenig: Fed 'talking tough, but words are not enough'

 Former FDIC Vice Chairman Thomas Hoenig joined "Mornings with Maria" on Thurdsay morning to discuss the January Federal Reserve meeting and rate hike. Hoenig claimed that the Federal Reserve and Jerome Powell's handling of the economy has led to a credibility problem. 

THOMAS HOENIG: The market is saying the Fed is done, so inflation's coming down, and now they're going to begin to think about lowering rates again by before the end of the year. The Fed is saying, no, we're just getting started and we want to make sure you understand that we're just getting started, and so we're going to keep rates up, and the discussions inside the Fed will be how long do we keep rates elevated? The market has led the Fed for over a decade and a half. That's why you have the market kind of pushing them to ease more quickly than they might otherwise. And the Fed has a credibility problem. So they're going to have to stick to their guns for a good part of this year, and I think we're going to have this difference going on through most, most of this year. 

 I think part of the problem is yesterday when the Fed raised only a quarter point, only a quarter point, it kind of confirmed what the market has already been thinking. Well, we're getting close. We're going to do this, and so the Fed has slowed down even more, and that signal is, I think, hurting the Fed's credibility. But we'll see. They're still talking tough, but words are not enough, and the market has to be convinced the Fed's now in charge again, which it hasn't been for some time. And I think that's going to be a major factor going forward whether or not they can believe the Fed, the leadership of the Fed.

https://www.foxbusiness.com/economy/former-fdic-chairman-says-federal-reserve-credibility-problem-still-talking-tough

Rockwell Med in 3-Year, Multi-Million Dollar Supply Agreement with Largest Non-Profit Dialysis Provider

 Rockwell Medical, Inc. (the "Company") (Nasdaq: RMTI), a commercial healthcare company focused on providing life-sustaining products for patients suffering from blood disorders and diseases associated with the kidney, announced that the Company signed a three-year, multi-million dollar per annum product purchase agreement with the largest non-profit dialysis provider in the United States. As part of the agreement, Rockwell Medical will be the preferred supplier of liquid and dry acid and bicarbonate concentrates to this non-profit dialysis provider's hemodialysis facilities located throughout the United States.

https://finance.yahoo.com/news/rockwell-medical-signs-three-multi-120000946.html

Biophytis: Positive Phase 2-3 COVA Study with Sarconeos (BIO101) in Severe COVID-19

 

• COVA study met primary end point with 44% significant reduction in the risk of respiratory failure or early death

• Filing for Early Access Programs to Sarconeos (BIO101) is being initated while preparing for Marketing Authorisation in Europe and the USA

https://finance.yahoo.com/news/biophytis-announces-positive-final-results-072000729.html

Tenax Allowed Patent Application Covering Use of IV Levosimendan in Pulmonary Hypertension

 

• Patent is expected to provide additional intellectual property protection until 2040

• Prevalence estimates indicate that PH-HFpEF affects over 1,500,000 patients in the U.S.

• There are currently no FDA approved treatments for PH-HFpEF

https://finance.yahoo.com/news/tenax-granted-notice-allowance-u-213100328.html

Merck fourth quarter tops expectations on strong COVID pill sales

 Merck & Co on Thursday reported higher-than-expected fourth-quarter earnings on strong sales of its COVID-19 antiviral pill molnupiravir in Asia.

The U.S. drugmaker said its sales in the quarter were $13.83 billion, up from $13.52 billion a year earlier. Analysts had expected sales of $13.67 billion, according to Refinitiv data.

Excluding items, Merck earned $1.62 a share, exceeding Wall Street expectations of $1.54 a share, according to Refinitiv.

Sales of molnupiravir were $825 million in the quarter, well over double analyst estimates of around $358 million.

Merck Chief Executive Rob Davis said the pandemic wave that moved through Asia in the fourth quarter drove sales of molnupiravir, which is sold under the brand name Lagevrio, particularly in Japan, South Korea and other areas of the Asia Pacific region.

"That really was the strength, and we've seen very good demand for Lagevrio in those markets," Davis said in an interview. "In Japan, we are a market leader."

The drug was not approved for use in China until Dec. 30, so sales there were not a factor in the fourth quarter.

The antiviral pills racked up sales of $5.2 billion in 2022, but the company expects sharply lower sales this year.

It forecast $1 billion in molnupiravir sales in 2023, mostly coming from Asian markets including China. Analysts had previously forecast around $825 million for 2023 molnupiravir sales.

Other makers of COVID-19 treatments also forecast lower 2023 sales. Pfizer reported sales of around $18.9 billion for its antiviral treatment Paxlovid in 2022 and forecast 2023 sales of around $8 billion.

Merck's blockbuster cancer immunotherapy Keytruda continues to grow, with fourth-quarter sales of $5.45 billion, up 19% from a year ago and roughly in line with analyst estimates.

The human papillomavirus (HPV) vaccine Gardasil had sales of $1.47 billion, slightly underperforming analyst expectations.

The drugmaker forecast adjusted 2023 earnings of $6.80 to $6.95 a share on sales of $57.2 billion to $58.7 billion. Analysts, on average, are estimating earnings of $7.36 on sales of $58.1 billion.

https://finance.yahoo.com/news/merck-fourth-quarter-tops-expectations-113131137.html

Quest Diagnostics Guides FY23 Adj. EPS In Line With Estimates

 While reporting financial results for the fourth quarter on Thursday, Quest Diagnostics Inc. (DGX) initiated its earnings, adjusted earnings and revenue guidance for the full-year 2023.

For fiscal 2023, the company now projects earnings in a range of $7.61 and $8.21 per share and adjusted earnings in a range of $8.40 and $9.00 per share on net revenues between $8.83 billion and $9.03 billion.

On average, 16 analysts polled by Thomson Reuters expect the company to report earnings of $8.69 per share on revenues of $9.13 billion for the year. Analysts' estimates typically exclude special items.

https://www.nasdaq.com/articles/quest-diagnostics-guides-fy23-adj.-eps-in-line-with-estimates-update