FDA Grants Breakthrough Device Designation for Dexcom Hospital CGM System

 

• Dexcom CGM to be evaluated for performance in the hospital and for the potential of more effective glycemic management and improved patient outcomes in the hospital setting

• Breakthrough Device Designation from the FDA is a critical milestone for in-patient Dexcom CGM use

• This designation provides a more efficient and streamlined review pathway so innovative Dexcom CGM technology can get to the hospital market faster

https://finance.yahoo.com/news/fda-grants-breakthrough-device-designation-210500678.html

Oak Street Health Gains After Reporting Q4 Earnings Miss, Revenue Beat

 Oak Street Health Inc (NYSE:OSH) reported its full-year earnings on Monday, sending its shares up 26.04% despite missing earnings per share estimates.

The care center reported unaudited results for the fourth quarter of 2021. Revenue surpassed expectations, coming in at $394.1 million, above analyst expectations of $386.65 million. On the other hand, the loss per share came in at 62 cents, missing projections for a per-share loss of 55 cents.

The company reported revenue of $1.43 billion for the full year, up 62% year over year.

"We reported a strong quarter with results favorable to the high end of guidance across metrics," said Mike Pykosz, Chief Executive Officer of Oak Street Health.

He added: "The quarter caps a year in which we advanced significantly on our journey to transform healthcare for older adults."

The company stated it was enthusiastic about its growth prospects. First-quarter revenue is predicted to be between $505 and $510 million, with full-year revenue forecast between $2.1 and $2.135 billion.

https://finance.yahoo.com/news/oak-street-health-gains-reporting-130636262.html

Gilead Hit By FDA Complete Response Letter For Lenacapavir In HIV Infection

 

• The FDA has issued a complete response letter (CRL) for Gilead Sciences Inc's 
  GILD -0.23%
   (Get Free Alerts for GILD) application for lenacapavir for heavily treated multi-drug resistant (MDR) HIV-1 infection.
• Lenacapavir is an investigational, long-acting HIV-1 capsid inhibitor.
• In the CRL, the FDA has cited Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir with the proposed container vial. 
• The FDA raised questions about vials made of borosilicate glass and their compatibility with the lenacapavir solution, resulting in a clinical hold for injectable lenacapavir.
• Gilead intends to provide FDA with a comprehensive plan and corresponding data to use a different vial type.
• The lenacapavir application was submitted to the FDA to treat heavily-treatment experienced people with multi-drug resistant HIV in June 2021 and selected for priority review. 

https://www.benzinga.com/general/biotech/22/03/25908224/gilead-hit-by-fda-complete-response-letter-for-lenacapavir-in-hiv-infection

Pfizer's Clostridioides Difficile Vaccine Fails To Prevent Infection

 

• Pfizer Inc 
  PFE -2.56%
   (Get Free Alerts for PFE) announced data from the CLOVER Phase 3 trial evaluating Clostridioides difficile vaccine candidate to prevent C. difficile infection (CDI).
• Initial analyses of two secondary endpoints indicated a highly favorable benefit in reducing CDI severity and 100% vaccine efficacy in preventing medically attended CDI.
• However, the trial did not meet its pre-specified primary endpoint of prevention of primary CDI. 
• Safety reviews indicated that the investigational vaccine was safe and well-tolerated.
• Vaccine efficacy under the primary endpoint was 31% following the third dose and 28.6% following the second dose for the C. difficile vaccine candidate. 
• For all CDI cases recorded 14 days post dose 3, vaccine efficacy 49%, 47%, and 31% up to 12 months, 24 months, and at the final analysis, respectively.
• Pfizer noted a highly favorable potential benefit in reducing the duration and severity of the disease. 
• None of the participants with CDI in the vaccine group required medical attention (including hospitalization) compared to 11 in the placebo group. 

https://www.benzinga.com/general/biotech/22/03/25905865/pfizers-clostridioides-difficile-vaccine-fails-to-prevent-c-difficile-infection

Lower Vascepa Volume Hits Amarin's Q4 Topline Growth

 Amarin Corp plc's 

AMRN -3.63%

 (Get Free Alerts for AMRN) Q4 FY21 sales decreased 13.6% Y/Y to $144.49 million, beating the consensus of $141.75 million.

• The decline was driven primarily by the volume of Vascepa sales adversely impacted by the generic icosapent ethyl market entrants and the ongoing challenges of the COVID-19 pandemic.
• The cost of goods sold was $30.63 million, compared to $34.76 million. Amarin's overall gross margin on net product revenue was 79.2%, compared with 79.9% a year ago.
• SG&A expense was $92.36 million compared to $116.82 million in the prior year, primarily due to a decrease in marketing and direct-to-consumer promotions in 2021 due to the impact of COVID-19 and the company's focus on improving the profitability of operations.
• The decrease also includes reducing costs associated with the company's Go-To-Market strategy, resulting in decreased promotional initiatives, reduced travel, and decreased sales force.
• The company reported adjusted EPS of $0.06 compared to $0.04 a year ago and the consensus of $(0.02).
• Amarin held aggregate cash and investments of $489.1 million at the end of 2021.
• Guidance: Amid uncertainty related to the impact of COVID-19 and generic availability, Amarin is unable to provide 2022 revenue guidance.

https://www.benzinga.com/general/biotech/22/03/25897803/lower-vascepa-volume-hits-amarins-q4-topline-growth

CTI BioPharma's Bone Marrow Cancer Drug Scores FDA Approval

 

• The FDA approved CTI BioPharma Corp's 
  CTIC +63.16%
   (Get Free Alerts for CTIC) Vonjo (pacritinib) for treating adult patients with myelofibrosis, a type of bone marrow cancer with low blood platelets count.
• Pacritinib is a JAK inhibitor and will compete with Incyte Corporation's 
  INCY +0.59%
   (Get Free Alerts for INCY) Jakafi and Bristol Myers Squibb's Co 
  BMY -0.07%
   Inrebic, which were approved in 2011 and 2019, respectively for myelofibrosis.
• CTI BioPharma Chief Executive Officer Adam R. Craig said, "We are fully funded for commercial launch, following our debt and royalty transactions with DRI, and we look forward to providing VONJO to patients within 10 days."
• The Company said the drug was approved under priority, and the nod triggered a $60 million payment from DRI Healthcare Trust.
• The accelerated approval is based on efficacy results from the pivotal Phase 3 PERSIST-2 study. 
• Pacritinib 200 mg twice daily showed 29% of patients had a reduction in spleen volume of at least 35% compared to 3% of patients receiving the best available therapy, including Jakafi (ruxolitinib). 
• As part of the accelerated approval, CTI must describe a clinical benefit in a confirmatory trial. CTI plans to complete the PACIFICA trial to fulfill this post-approval requirement, with expected results in mid-2025.
• In November, the agency had delayed its decision for the drug by three months to review additional data previously submitted by the Company.

https://www.benzinga.com/general/biotech/22/03/25897717/cti-biopharmas-bone-marrow-cancer-drug-scores-fda-approval

FDA approves cancer therapy by J&J, partner Legend

 The U.S. health regulator has approved a therapy developed by Johnson & Johnson and its China-focused partner Legend Biotech Corp to treat a type of white blood cell cancer, the U.S. healthcare company said on Monday.

The Food and Drug Administration's decision paves the way for Legend's first approved product in the United States, at a time when the regulator has stepped up its scrutiny of drug trials conducted in China. The Legend-J&J therapy was tested initially in China, and then in the United States and Japan.

"This is the first of many cell therapies we plan to bring to patients as we continue advancing our pipeline across disease states," said Ying Huang, Legend's chief executive officer and chief financial officer.

The treatment, Carvykti/Cilta-cel, belongs to a class of drugs known as CAR-T therapies, or chimeric antigen receptor T-cell therapies.

CAR-T drugs work by harvesting a patient's own disease-fighting T-cells, genetically engineering them to target specific proteins on cancer cells, and replacing them to seek out and attack cancer.

Legend and J&J will sell the drug in Greater China at 70-30 split in profit, and in all other countries in a 50-50 split in profit. https://bit.ly/3C1cfns

A decision on the CAR-T therapy was initially expected to come by the end of November after it was given priority review six months earlier, but this was extended by three months to allow sufficient time to review information submitted by J&J following an FDA request.

Legend, which initiated the development, signed an agreement with Janssen Biotech Inc, an arm of J&J, in 2017, to jointly develop and commercialize the drug, with Legend getting $350 million in upfront payment.

Besides the United States, Carvykti/Cilta-cel is also being reviewed by health authorities in Japan and Europe. A Marketing Authorisation Application (MAA) for the therapy in China is yet to be filed. 

https://finance.yahoo.com/news/1-fda-approves-cancer-therapy-021427562.html