FDA clears Boston Scientific single-use duodenoscope

The FDA grants 510(k) clearance to Boston Scientific’s (BSX +0.7%) EXALT Model D, a single-use duodenoscope (a hollow lighted tube for inspecting the small intestine) for use in endoscopic retrograde cholangiopancreatography procedures (aimed at diagnosing issues in the liver, gallbladder, bile ducts and pancreas).

The company says it is the first such single-use device available in the U.S. (other duodenoscopes are reusable which carries an infection risk if not cleaned thoroughly).

Limited commercial launch will commence next quarter.

https://seekingalpha.com/news/3526245-fda-clears-boston-scientific-single-use-duodenoscope

Eagle Pharma on go to launch Alimta alternative in early 2022

Eagle Pharmaceuticals (EGRX +2.5%) has settled all patent issues with Eli Lilly (LLY -0.3%) related to the latter’s chemo drug Alimta (pemetrexed for injection).

Under the terms of the settlement agreement, Eagle will be allowed to initially enter the U.S. market with its alternative offering, Pemfexy, on February 1, 2022 followed by full commercial launch on April 1, 2022.

https://seekingalpha.com/news/3526258-eagle-pharma-on-go-to-launch-alimta-alternative-in-early-2022

Monopar Therapeutics sets terms of downsized IPO

Monopar Therapeutics (MNPR) has filed a preliminary prospectus for an IPO of ~1.1M common shares at $8-10 per share.

Underwriters’ over-allotment will be an additional ~167K shares.

In September, it filed for an offering of ~4.4M shares at the same price range.

https://seekingalpha.com/news/3526260-monopar-therapeutics-sets-terms-of-downsized-ipo

FDA advisory committee backs Horizon’s teprotumumab

The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted 12-0 that the benefits of Horizon Therapeutics’ (NASDAQ:HZNP) teprotumumab outweigh the risks for the treatment of thyroid eye disease (TED).

The FDA’s action date is March 8, 2020.

Teprotumumab is a fully human monoclonal antibody that binds to (inhibits) a protein called insulin-like growth factor 1 receptor (IGF-1R). TED is a rare autoimmune disorder in which IGF-1R is overexpressed in the eye.

https://seekingalpha.com/news/3526261-fda-advisory-committee-backs-horizons-teprotumumab

Amarin shares halted pending news

Nasdaq has suspended trading in Amarin (AMRN +4.9%) pending the release of news. In this, probably the expected FDA nod for a CV benefit claim for Vascepa (icosapent ethyl). The agency’s action date is December 28.

https://seekingalpha.com/news/3526234-amarin-shares-halted-pending-news

FDA approves Tandem’s predictive insulin pump software

The U.S. Food and Drug Administration on Friday granted approval for Tandem Diabetes Care’s software program that uses readings from a continuous glucose monitor to predict and deliver corrective doses of insulin to patients using the company’s t:slim X2 insulin pump.

Tandem’s Control IQ algorithm is the first insulin dosing software approved under the FDA’s new “interoperability” approval pathway. This allows companies to develop components of so-called artificial pancreas systems that can be used with products sold by other companies that have gone through the same approval process.

“That’s a really big deal for the industry,” Tandem Chief Executive John Sheridan said in a phone interview.

https://www.reuters.com/article/us-tandem-diabetes/u-s-fda-approves-tandems-predictive-insulin-pump-software-idUSKBN1YH21P

SI-BONE: CIGNA Establishes Positive Coverage for MIS SI Joint Fusion

SI-BONE, Inc.,  (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, announced today that CIGNA has established a positive coverage policy for minimally invasive SI joint fusion.

The new policy specifies that coverage will be exclusive for FDA cleared implants that are placed across the SI joint and intended to promote bone fusion. This decision follows an extensive amount of published clinical evidence demonstrating the safety and effectiveness of the iFuse Implant System, including a recent publication of 5-year results from a long-term prospective study called LOIS (Long Term Outcomes from INSITE and SIFI).

Cigna is the fourth largest commercial health plan in the United States with 14.6 million members. Its new policy, available at this link: (https://cignaforhcp.cigna.com/public/content/pdf/coveragePolicies/medical/mm_0303_coveragepositioncriteria_lumbar_fusion_degenerative_conditions.pdf), became effective December 10, 2019.

“As a result of this positive coverage decision, CIGNA’s members will have access to the iFuse procedure when deemed medically necessary by their surgeons,” said Jeffrey Dunn, President, CEO and Chairman at SI-BONE. “CIGNA’s decision to cover MIS SI joint fusion is a significant milestone in the continuing adoption of this important treatment for patients with SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption.”

https://www.biospace.com/article/releases/si-bone-inc-announces-cigna-establishes-positive-coverage-for-mis-si-joint-fusion-using-the-ifuse-implant-systemnew-positive-coverage-policy-is-specific-for-fda-cleared-implants-placed-across-the-si-joint-and-intended-to-promote-bone-fusion/