On February 18, 2020 NorthStar Medical Radioisotopes, LLC, a global innovator in the production and distribution of radioisotopes used for medical imaging, reported that the U.S. Food and Drug Administration (FDA) has approved the addition of two molybdenum-99 (Mo-99) filling lines at its facility in Columbia, Mo (Press release, NorthStar Medical Radiostopes, FEB 18, 2020, View Source [SID1234554454]). Addition of the filling lines is part of NorthStar’s ongoing expansion plans to increase production and capacity of domestic, non-uranium based Mo-99 for the U.S. healthcare system. Mo-99 is a medical radioisotope used to produce technetium-99m (Tc-99m), the most widely used diagnostic imaging radioisotope and of critical importance for patient healthcare. FDA approval of the filling lines was made through expedited review of a Prior Approval Supplement to the original RadioGenix System (technetium Tc 99m generator) New Drug Application, which was approved in 2018. The RadioGenix System is an innovative, high tech radioisotope separation platform for use in producing Tc-99m from non-uranium based Mo-99. Since commercial availability nearly 16 months ago, RadioGenix Systems have provided customers with reliable Tc-99m supply for tens of thousands of patients’ diagnostic imaging studies, despite ongoing shortages from suppliers using legacy, uranium-based production methods.

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NorthStar produces non-uranium based Mo-99 in collaboration with its manufacturing partner, the University of Missouri Research Reactor (MURR), in Columbia, Mo., using neutron capture technology. Natural Mo-98 is converted to Mo-99 at the MURR reactor and then processed into a radioactive Mo-99 solution. Filling lines at NorthStar’s facility on the MURR campus transfer the Mo-99 solution into tungsten-shielded containers called source vessels which are then shipped to radiopharmacies that have a RadioGenix System for use in producing Tc-99m used in combination with radiopharmaceutical kits and then injected into patients for diagnostic imaging studies.

"FDA’s expedited review and approval of the additional filling lines in our Columbia, Mo. facility means an immediate increase in Mo-99 production efficiencies in Columbia," said Stephen Merrick, President and Chief Executive Officer of NorthStar. "This is one component of our efforts to increase dependable, domestically produced radioisotope supply for the United States. We particularly wish to express appreciation to our manufacturing partner, MURR. We look forward to continuing to work with MURR in progressing production efforts for concentrated Mo-98 (cMo-98), which, pending licensures and approval, will dramatically increase Mo-99 production capacity and our ability to provide larger-sized source vessels for our customers. We also want to thank Von Gahlen, who designed, built and installed these state-of-the-art filling lines."

Mr. Merrick continued, "The expansion activities in Columbia run in parallel with NorthStar’s ongoing expansions in Beloit, Wis., where our Isotope Processing facility is nearing completion, and will augment processing at MURR. When approved, we will then have dual Mo-99 production hubs in Wisconsin and Missouri. In addition, construction of our Accelerator Production facility is underway, with the initial pair of electron beam accelerators being assembled in Belgium. We believe that all these efforts will further secure reliable, non-uranium based Mo-99 radioisotope supply for U.S. customers and patients."

About the RadioGenix System (Technetium Tc 99m Generator)
The RadioGenix System is an innovative, high tech separation platform that is approved for processing non-uranium/non-highly enriched uranium molybdenum-99 (Mo-99) for the production of the important medical radioisotope, technetium-99m (Tc-99m). Prior to availability of RadioGenix technology, the U.S. supply chain for Mo-99 has been subject to frequent and sometimes severe interruptions which negatively impact patient healthcare. Approved by the U.S. Food and Drug Administration in 2018, the RadioGenix System is the first and only on-site, automated isotope separation system of its kind for use with non-uranium/non-highly enriched uranium based Mo-99, designed to help alleviate shortage situations and expand domestic supply.

Indication and Important Risk Information about the RadioGenix System and Sodium Pertechnetate Tc 99m Injection USP

INDICATION
The RadioGenix System is a technetium Tc-99m generator used to produce Sodium Pertechnetate Tc 99m Injection, USP. Sodium Pertechnetate Tc 99m Injection is a radioactive diagnostic agent and can be used in the preparation of FDA-approved diagnostic radiopharmaceuticals.

Sodium Pertechnetate Tc 99m Injection is also indicated in

Adults for Salivary Gland Imaging and Nasolacrimal Drainage System Imaging (dacryoscintigraphy).
Adults and pediatric patients for Thyroid Imaging and Vesicoureteral Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.
IMPORTANT RISK INFORMATION

Allergic reactions (skin rash, hives, or itching) including anaphylaxis have been reported following the administration of Sodium Pertechnetate Tc 99m Injection. Monitor all patients for hypersensitivity reactions.
Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer.
Discard the first eluate from every new Potassium Molybdate Mo-99 Source Vessel to minimize the risk of unintended radiation exposure from Rhenium Re-186.
Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 12 to 24 hours after Sodium Pertechnetate Tc 99m Injection administration.
Sodium Pertechnetate Tc 99m Injection should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.
Only use potassium molybdate Mo-99, processing reagents, saline and other supplies, including kits, provided by NorthStar Medical Radioisotopes. Do not administer Sodium Pertechnetate Tc 99m Injection after the 0.15 microCi of Mo-99/mCi of Tc-99m limit has been reached or when the 12 hour expiration time from elution is reached, whichever occurs earlier.

On February 18, 2020 Boston Scientific Corporation (NYSE: BSX) reported that it will participate in three upcoming investor conferences (Press release, Boston Scientific, FEB 18, 2020, View Source [SID1234554470]).

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On February 27, 2020, Susie Lisa, vice president, Investor Relations, will participate in a 25-minute question-and-answer session with the host analyst at the SVB Leerink 9th Annual Global Healthcare Conference in New York City. The session will begin at approximately 10:30 a.m. EST.

On March 3, 2020, Dan Brennan, executive vice president and chief financial officer, and Susie Lisa will participate in a 30-minute question-and-answer session with the host analyst at Cowen and Company’s 40th Annual Health Care Conference in Boston. The session will begin at approximately 10 a.m. EST.

On March 11, 2020, Mike Mahoney, chairman and chief executive officer, and Lauren Tengler, director, Investor Relations, will participate in a 25-minute question-and-answer session with the host analyst at the Barclays Global Healthcare Conference in Miami. The session will begin at approximately 8 a.m. EDT.

A live webcast and replay of the webcast for each event will be accessible at investors.bostonscientific.comView Source The replay will be available beginning approximately one hour following the completion of each event.

On February 18, 2020, Agenus Inc. (the "Company") reported that it has entered into an amendment (the "Amendment") with certain existing investors, pursuant to which the Company (Filing, 8-K, Agenus, FEB 18, 2020, View Source [SID1234554660]):

extended the maturity date of the $14.0 million senior subordinated promissory notes previously issued in 2015 (the "2015 Notes") by three years from February 20, 2020 to February 20, 2023;

extended the exercise period of the warrants to purchase 1,400,000 shares of the Company’s common stock previously issued in 2015 by three years from February 20, 2020 to February 20, 2023; and

issued new warrants to purchase 675,000 shares of the Company’s common stock with a term of five years and an exercise price of $4.48 per share, which represented a 20% premium over the 30-day average trailing closing price of the Company’s common stock (the "New Warrants").

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A brief description of the terms and conditions of the 2015 Notes can be found in Item 2.03 of the Current Report on Form 8-K filed by the Company with the Securities and Exchange Commission on February 26, 2015 and such brief description is incorporated by reference herein.

The securities issued in connection with the Amendment were issued in reliance on the exemption from registration provided by Section 4(2) of the Securities Act of 1933, as amended (the "Securities Act"). Neither the New Warrants nor the underlying shares of common stock have been registered under the Securities Act. Neither the New Warrants nor such underlying shares of common stock may be offered or sold in the United States absent registration or an applicable exemption from registration requirements. No commission or other remuneration was paid or given directly or indirectly for soliciting such issuance.

On February 18, 2020 Cancer Research UK reported that a genetic study has found evidence to suggest that women who take statins in the long term could be less likely to develop ovarian cancer (Press release, Cancer Research UK, FEB 18, 2020, View Source [SID1234554423]).

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"Our findings open up the possibility of repurposing a cheap drug to help prevent ovarian cancer – especially in women who are at a higher risk." – Professor Richard Martin
The same result was also found in women who carry the BRCA1/2 gene fault. Having the BRCA1/2 fault puts women at a higher risk of ovarian cancer than the general population*.

The research published in JAMA studied genes and the extent to which they inhibit the enzyme HMG-CoA reductase – which is responsible for regulating cholesterol in the body – and is the exact enzyme targeted by statin drugs to reduce cholesterol.

While the study suggests that statins could lower ovarian cancer risk, more research needs to be done specifically looking at their use and impact on women’s risk of developing the disease.

The researchers based at the University of Bristol looked at 63,347 women between the ages of 20 and 100 years old, of whom 22,406 had ovarian cancer. They also looked at an additional 31,448 women who carried the BRCA1/2 fault, of whom 3,887 had ovarian cancer. The study used an approach called Mendelian randomization, which involves analysing the genetic data from thousands of people.

Statins may protect against the development of ovarian cancer because they’ve been shown to induce apoptosis – one of the body’s ways of getting rid of old, faulty or infected cells – and to stop tumours from growing in laboratory studies. Another line of thought is that statins lower circulating cholesterol, which helps regulate cell growth, though this research suggests that lower circulating cholesterol was not the method by which statins may reduce ovarian cancer risk.

The findings suggest that long-term statin use could be associated with an estimated 40% reduction in ovarian cancer risk in the general population, although the estimate comes from looking at gene variation rather than statins themselves, and the exact mechanism by which these genes are associated with lower ovarian cancer risk is unclear.

Ovarian cancer is the 6th most common cancer in women in the UK. There are around 7,400 cases each year**, and out of those with a known stage at diagnosis, almost 6 in 10 are diagnosed at a late stage***. Around 4,100 women die from the disease every year in the UK.

There is no test that reliably picks up ovarian cancer at an early stage, so chemoprevention could be an important approach to saving lives.

Professor Richard Martin, from the University of Bristol, said: "Our findings open up the possibility of repurposing a cheap drug to help prevent ovarian cancer – especially in women who are at a higher risk. It’s incredibly interesting that women whose bodies naturally inhibit the enzyme targeted by statins have a lower risk of ovarian cancer, but we don’t recommend anyone rushes to take statins specifically to reduce ovarian cancer risk because of this study.

"It’s a promising result and I hope it sparks more research and trials into statins to demonstrate conclusively whether or not there’s a benefit."

Dr Rachel Orritt, Cancer Research UK’s health information manager, said: "This study is a great first step to finding out if statins could play a role in lowering ovarian cancer risk, and justifies future research into this area.

"But there’s not yet enough evidence to know if statins themselves could reduce the risk of developing ovarian cancer safely. And it’s important to remember that the risk of developing ovarian cancer depends on many things including age, genetics and environmental factors. Speak to your doctor first if you have any concerns about your risk."

On February 18, 2020 Synlogic (Nasdaq: SYBX) announced today that Aoife Brennan, M.B., B.Ch., Synlogic’s president and chief executive officer, will participate in the following upcoming investor conferences (Press release, Synlogic, FEB 18, 2020, View Source [SID1234554439]):

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9th Annual SVB Leerink Global Healthcare Conference on Tuesday, February 25 at 1:00 pm ET in New York
Cowen 40th Annual Health Care Conference on Monday, March 2 at 2:10 pm ET in Boston
Live webcasts of the presentations can be accessed under "Event Calendar" in the Investors & Media section of the Company’s website. Archived webcast recordings will be available on the Synlogic website for approximately 30 days after each event.