GE Healthcare to Acquire BK Medical, Expanding into Surgical Visualization

 GE (NYSE:GE) has entered into an agreement to acquire BK Medical, a leader in advanced surgical visualization, from Altaris Capital Partners for a cash purchase price of $1.45 billion.

BK Medical is an innovator in global intraoperative imaging and surgical navigation, used to guide clinicians during minimally invasive and robotic surgeries and to visualize deep tissue during procedures in neuro and abdominal surgery, and in ultrasound urology. BK Medical is headquartered in Boston and Copenhagen with more than 650 employees and is delivering double-digit revenue growth.

GE Healthcare President and CEO Kieran Murphy said, "Ultrasound today forms an integral part of many care pathways, and BK Medical is a strategic and highly complementary addition to our growing and profitable Ultrasound business. This transaction helps GE Healthcare continue to expand beyond diagnostics into surgical and therapeutic interventions, simplifying decision-making for clinicians and equipping them with greater insights to deliver faster, more personalized care for their patients—representing another step toward delivering precision health."

BK Medical President and CEO Brooks West said, "We are immensely proud of the organization and of the life-changing technology that we have built at BK Medical, and look forward to our future as part of the GE Healthcare family. Combining our expertise in intraoperative imaging and surgical navigation with GE Healthcare’s many strengths and global presence will accelerate our mission to change the standard of care in surgical interventions. Our mission to help surgeons make critical decisions using active imaging aligns well with GE Healthcare’s mission to help physicians make more informed decisions and improve patient outcomes, and we are eager to begin this new chapter."

https://finance.yahoo.com/news/ge-healthcare-acquire-bk-medical-120800342.html

AstraZeneca invests in Imperial's self-amplifying RNA tech with eye on future drugs

 

AstraZeneca Plc on Thursday struck a deal with the firm behind Imperial College London's experimental COVID-19 vaccine to develop and sell drugs based on its self-amplifying RNA technology platform in other disease areas.

Under the deal, VaxEquity, a startup founded by Imperial vaccinologist Robin Shattock, could receive up to $195 million if certain milestones are met, in addition to royalties on approved drugs and equity investment from AstraZeneca and life sciences investor Morningside Ventures.

AstraZeneca already produces an adenoviral vector COVID-19 vaccine, and emphasised the potential of the self-amplifying RNA (saRNA) technology in novel therapeutic programmes beyond the coronavirus pandemic.

"This collaboration with VaxEquity adds a promising new platform to our drug discovery toolbox," said AstraZeneca research chief Mene Pangalos.

The technology works in a similar way to the messenger RNA (mRNA) vaccines made by Pfizer/BioNTech and Moderna.

However, a self-amplifying RNA vaccine not only encodes the instructions for the host cell to make a coronavirus protein, but makes lots of copies of the RNA containing those instructions, meaning doses can be smaller and cheaper.

"It's a bit like having a manufacturing facility, and instead of having one copy of the recipe, you have multiple copies that you can hand round to multiple production lines within the cell to produce more protein," Imperial's Shattock told Reuters. "So that's why it has that opportunity to use lower doses."

Imperial's COVID-19 vaccine is being retooled to produce a more consistent immune response with an eye on future coronavirus variants.

AstraZeneca, under the deal, has the option to collaborate on 26 drug targets for use against other therapeutic areas like cancers and rare genetic diseases.

"We believe self-amplifying RNA, once optimised, will allow us to target novel pathways not amenable to traditional drug discovery across our therapy areas of interest," Pangalos said.

U.S. companies Gritstone bio and Arcturus also are developing saRNA COVID-19 vaccines.

Shattock said safety data had been encouraging from initial trials of its COVID-19 vaccine, released in July ahead of peer review, and that Phase I results of its refined vaccine would be ready early next year.

"The reason we were slower was because we were coming from an academic setting," he said. "If we had this relationship (with AstraZeneca) at the beginning of 2020, we might have been faster."

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-invests-in-Imperial-s-self-amplifying-RNA-technology-with-eye-on-future-drugs-36493476/

Valneva Continues Expansion of Trials of Inactivated COVID Vax Candidate

 

• Commences recruitment of Adolescents into Phase 3 trial “Cov-Compare”

• Enrolls participants in the Phase 1/2 Booster Trial

Valneva SE, (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today announced that it has commenced recruitment of adolescents in its pivotal Phase 3 Clinical Trial (VLA2001-301, “Cov-Compare”) for its inactivated COVID-19 vaccine candidate VLA2001 in the United Kingdom. Topline results from the pivotal Cov-Compare trial are expected early in the fourth quarter of 2021 and are intended to form the basis for potential regulatory approval in adults. The Company has also started to provide boosters to volunteers in its Phase 1/2 VLA2001-201 trial. This planned expansion of VLA2001 clinical trials will support future approval in further age groups, in addition to adults.

Recruitment of adolescents, aged 12 to 17 years, has commenced in the United Kingdom as part of Valneva’s pivotal Cov-Compare Phase 3 trial (VLA2001-301). An initial cohort of adolescents will be enrolled in an open label, non-randomized format. Subject to safety review, remaining participants will be randomized to receive two doses of either VLA2001 or a placebo 28 days apart, followed by a booster dose seven months after enrolling into the study. Approximately 660 participants will be recruited for this trial. Participants randomized to the placebo arm will have the opportunity to receive a course of VLA2001 following the initial safety assessment. A further expansion of the study to include volunteers younger than 12 years old is also envisaged, subject to data from the adolescent group.

Valneva has also commenced booster vaccinations as a continuation of the Phase 1/2 VLA2001-201 trial for which the Company reported positive topline data in April 20211. The booster shot will be provided to each volunteer six months after initial vaccination.

Valneva is conducting several clinical trials of VLA2001. In addition to Cov-Compare and VLA2001-201, VLA2001 is being evaluated in elderly volunteers in study VLA2001-304 in New Zealand as well as in a small, policy-led trial sponsored by University Hospital Southampton NHS Foundation Trust which is not part of Valneva’s regulatory package.

https://finance.yahoo.com/news/valneva-continues-expansion-clinical-trials-050000152.html

Solid Biosciences: 1.5-Year Data from Ongoing Duchenne Phase I/II Trial

 Data support continued functional benefit 1.5 years post treatment compared with natural history data; assessed by North Star Ambulatory Assessment (NSAA), 6-Minute Walk Test (6MWT) and Forced Vital Capacity (FVC) -

- Patient reported outcomes showed sustained improvements at 1.5 years compared to patient baseline and natural history data -

- No new drug-related safety findings for a period of up to 3.5 years -

https://finance.yahoo.com/news/solid-biosciences-reports-1-5-100000387.html

Sage Therapeutics started at Buy by Needham

 Target $84

https://finviz.com/quote.ashx?t=SAGE&ty=c&ta=1&p=d

Biogen started at Buy by Needham

 Target $400

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

Veritas, Elliott Consider $20 Billion-Plus Athenahealth Sale

 Veritas Capital and Elliott Investment Management are exploring options for Athenahealth Inc. including a sale or initial public offering, according to people familiar with the matter. 

Veritas and Elliott are aiming for the health information technology company to be valued at more than $20 billion in a transaction, said the people, who asked to not be identified because the matter isn’t public. 

The firms are working with Goldman Sachs Group Inc. and Evercore Inc. to help explore options for the company, the people said. The bankers have reached out to about a half dozen potential buyers to gauge their interest, one of the people said.

The two firms hope to complete a deal by the end of the first quarter, one of the people said. A final decision hasn’t been made, though, and the Veritas and Elliott could decide to keep Athenahealth, the people said.

Representatives for Athenahealth, Veritas, Elliott and Goldman Sachs declined to comment. A spokesperson for Evercore didn’t immediately respond to a request for comment.Veritas and Elliott agreed to buy Athenahealth for about $5.7 billion in 2018. After the deal closed, the company was combined with Virence Health, a health-care services company Veritas had acquired from General Electric Co.

Athenahealth helps doctors and hospitals collect money from health insurers and the government for services they provide. It processes $230 billion in bills a year, according to its website. It also has an electronic health records service that helps providers manage workflow and document patient visits, among other services.

Veritas is also considering an exit from another health technology portfolio company, Cotiviti, Bloomberg News reported in July. The firm hired advisers to help it explore an IPO of the health-care information and analytics company that could value it at more than $15 billion, the people said at the time. 

https://www.bloomberg.com/news/articles/2021-09-23/veritas-elliott-said-to-mull-20-billion-plus-athenahealth-sale