Vertex, CRISPR Therapeutics Amend Collaboration Agreement

Vertex Pharmaceuticals Inc. and CRISPR Therapeutics amended their collaboration agreement for CTX001 in sickle cell disease and beta thalassemia.

CTX001 is an investigational gene editing therapy being developed as a potentially curative therapy for sickle cell disease and transfusion-dependent beta-thalassemia.

CRISPR Therapeutics shares were up 7% to $123.05 premarket.

Under the terms of the amended agreement, Vertex will lead global development, manufacturing and commercialization of CTX001 with support from CRISPR Therapeutics. Vertex will be responsible for 60% of program costs and will receive 60% of profits from future sales of CTX001 worldwide, representing a 10% increase in program economics compared to the previous agreement.

CRISPR will be responsible for 40% of costs and will receive 40% of profits. Additionally, CRISPR will receive a $900 million upfront payment, with potential for a $200 million payment upon the first regulatory approval of CTX001.

https://www.marketscreener.com/quote/stock/VERTEX-PHARMACEUTICALS-11321/news/Vertex-CRISPR-Therapeutics-Amend-Collaboration-Agreement-33014092/

J&J Tightens Ranges for Full-Year Guidance

 Johnson & Johnson on Tuesday narrowed its guidance ranges for its full-year profit and revenue results, leaving the midpoints of the guidance nearly unchanged.

The New Brunswick, N.J.-based pharmaceutical and healthcare company said it now estimates its full-year sales will be $90.6 billion to $91.6 billion, compared with a previous estimate of $90.5 billion to $91.7 billion. Analysts had been forecasting full-year revenue of $92.18 billion, according to FactSet.

Johnson & Johnson expects adjusted earnings per share for the full year of $9.42 a share to $9.57 a share. In January, it had forecast $9.40 a share to $9.60 a share. Analysts had been anticipating full-year adjusted earnings of $9.50 a share.

https://www.marketscreener.com/quote/stock/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-Tightens-Ranges-for-Full-Year-Guidance-33013166/

Abbott Drops on Mixed Results and Lagging Guidance

 Shares of Abbott Laboratories  (ABT) - Get Report dropped after the medical-device maker reported mixed first-quarter results and forecast full-year earnings that were below estimates. 

The Abbott Park, Ill., company earned an adjusted $1.32 a share, double the 65 cents a share of the year-earlier quarter. Revenue rose 35% to $10.46 billion.

Analysts surveyed by FactSet were expecting first-quarter earnings of $1.27 a share on revenue of $10.69 billion. 

All four of Abbott's major businesses ["achieved] strong growth," said Robert B. Ford, president and chief executive, in a statement. 

"We're particularly pleased with the growing momentum of several recently launched products and continue to forecast more than 35% earnings-per-share growth for the year."

For the year, Abbott forecast earnings of $5 a share, compared with the consensus estimate of $5.04. 

In December, Abbott said that its home coronavirus test had won emergency-use authorization from the Food and Drug Administration.

The company brought in $2.2 billion in the first quarter from COVID-19 testing sales, led by combined sales of $1.8 billion from Abbott's BinaxNow, Panbio and ID Now rapid-testing kits. 

The company said at the time that it would deliver and administer 30 million BinaxNow tests in the quarter with an additional 90 million expected to be used in the second quarter. 

https://www.thestreet.com/investing/abbott-drops-on-mixed-quarter-lagging-forecast

USDA Service Chooses 3M for Campylobacter Testing in Poultry

 3M Food Safety has been awarded a contract from the U.S. Department of Agriculture Food Safety and Inspection Service (USDA FSIS) for Campylobacter1 detection with the 3M™ Molecular Detection System. The award makes the 3M Molecular Detection System the primary method to be used by USDA FSIS for the detection of Campylobacter in poultry. 3M has begun working with USDA FSIS to initiate the transition process and the USDA FSIS will announce when the transition is complete for testing Campylobacter with the 3M system.

USDA FSIS previously named the 3M Molecular Detection System as the primary method for Salmonella2 and Listeria monocytogenes3 testing for meat, poultry and egg products.

For poultry processors, the 3M Molecular Detection System, which uses assays for both Campylobacter and Salmonella, is a complete solution that can be used in parallel to test both bacteria. 3M's system, utilizing a single protocol for both pathogens post-enrichment, allows processors to perform up to 96 tests of both pathogens in a single 60-minute run. In addition to the assay, 3M offers ready-to-use 3M™ Campylobacter Enrichment Broth, a simplified enrichment medium that requires addition of only sterile water, eliminating many steps in preparation of traditional media. To read more about poultry pathogen testing data, access a copy of the whitepaper at www.3M.com/PoultryPathogens.

"The 3M Molecular Detection System has proven to be a highly accurate and efficient tool for many food producers and contract labs globally," said Srini Raman, 3M Food Safety vice president.

https://www.prnewswire.com/news-releases/usda-food-safety-and-inspection-service-chooses-3m-for-campylobacter-testing-in-poultry-301271844.html

Aveanna launches IPO

 Aveanna Healthcare Holdings, a diversified home care platform that provides respiratory therapy products and services, has launched an initial public offering of about 38.2 million shares of its common stock at an anticipated initial public offering price of $16 to $18 per share. The company also intends to grant the underwriters a 30-day option to purchase up to an additional 5.7 million shares of its common stock. Aveanna has applied to list its common stock on the Nasdaq under the ricker symbol AVAH. Barclays, J.P. Morgan, BMO Capital Markets and Credit Suisse are acting as joint lead book-running managers, and BofA Securities, Deutsche Bank Securities, Jefferies, RBC Capital Markets and Truist Securities are acting as book-running managers for the proposed offering. Raymond James, Stephens Inc., Drexel Hamilton and Siebert Williams Shank are acting as co-managers for the proposed offering. Aveanna cares for patients and families in 25 states through a rapidly growing network of 200-plus branch offices. It offers respiratory therapy, enteral nutrition and medical supplies, as well as private-duty and home health and hospice services. The respiratory therapy products and services it provides include oxygen concentrators, CPAP devices and ventilators. 

http://www.hmenews.com/article/aveanna-launches-ipo

bluebird bio withdraws ZYNTEGLO from German market, reshapes workforce

 

bluebird bio, Inc. (Nasdaq: BLUE) announced today business and program updates across its severe genetic disease portfolio including a revised diagnosis for the previously reported case of myelodysplastic syndrome (MDS) in its Phase 1/2 study of LentiGlobin for sickle cell disease (SCD) (bb1111), the company’s decision to withdraw ZYNTEGLO™ (betibeglogene autotemcel, beti-cel) for transfusion-dependent β-thalassemia (TDT) from the German market and a targeted reshaping of its workforce intended to enable the company to advance its late-stage gene therapy programs.

The case of MDS reported in February in a patient from Group C of the Phase 1/2 HGB-206 study of LentiGlobin gene therapy for SCD has been further assessed following the review of results from additional tests. The treating investigator has concluded this is not a case of MDS and has revised the diagnosis to transfusion-dependent anemia. bluebird bio has reported this update to regulatory agencies and study investigators. The company continues to work with the treating investigator to determine the potential cause of this patient’s anemia.

Last month, the company reported that it is very unlikely the suspected unexpected serious adverse reaction (SUSAR) of acute myeloid leukemia (AML) reported in the HGB-206 study of LentiGlobin for SCD was related to the BB305 lentiviral vector (LVV). This assessment, along with the re-classification of the originally reported MDS case to transfusion-dependent anemia are important steps in bluebird bio’s path to seeking removal of the clinical hold on studies HGB-206 and HGB-210 of LentiGlobin for SCD. bluebird bio continues to work with regulators to resume its clinical studies in sickle cell disease as well as to remove the clinical hold for HGB-207 and HGB-212 clinical studies of beti-cel for β-thalassemia, with potential lift of all clinical holds in mid-2021.

In Europe, reimbursement negotiations in Germany did not result in a price for ZYNTEGLO that reflects the value of this one-time gene therapy with potential life-long benefit for people living with TDT. The price proposed by the German health authorities fails to recognize the severe burden of living with TDT or the innovation and benefit ZYNTEGLO brings to patients who are impacted every day, throughout their lives by this severe genetic disease.

bluebird bio continues with productive negotiations across countries in Europe and we plan to continue to provide updates on the negotiation processes in the second half of 2021.

In response to these and other events and shifts related to the business over the past year, bluebird bio plans to reduce and reshape its workforce, primarily in Europe. This reduction and reallocation of resources will allow the company to focus on priority European markets and streamline global operations going forward to ensure its ability to deliver gene therapies to patients based on bluebird bio’s current business plans.

https://finance.yahoo.com/news/bluebird-bio-provides-severe-genetic-113000039.html

LivaNova Gets FDA 510(k) OK for New In-Line Blood-Gas Monitoring System

 LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for B-Capta®, the new in-line, blood-gas monitoring system integrated into the market-leading S5® heart-lung machine (HLM). The system is designed to easily and accurately monitor arterial and venous blood gas parameters even during long and complex pediatric and adult cardiopulmonary bypass procedures. B-Capta, which received CE Mark in May 2020 and completed a successful limited commercial release in Europe, will now be available globally.

B-Capta’s innovative sensing technology provides accurate and continuous measurements that allow the perfusionist to quickly react to parameter changes. The system’s intuitive user interface reduces set-up time, aligning parameters to those of the hospital’s Laboratory Blood Gas Analyzer (ABL) and includes accurate oxygen partial pressure (pO2), a key measurement when performing Goal-Directed Perfusion (GDP).

"B-Capta significantly extends the in-line, blood-gas monitoring options available to our customers for continuous monitoring of key patient physiological parameters consistent with clinical guidelines during extracorporeal life support procedures," said Marco Dolci, LivaNova Senior Vice President, Global Operations and R&D. "Now integrated into our world-leading S5 HLM, the optical-based technology used for B-Capta provides accurate and reliable monitoring of patient blood gas parameters."

https://finance.yahoo.com/news/livanova-receives-fda-510-k-130000120.html