Administration terminates fed contract with fetal tissue firm

The Trump administration has ended a contract with a fetal tissue firm after receiving blowback from anti-abortion groups and Republican lawmakers.

The Department of Health and Human Services (HHS) canceled the $16,000 contract with Advanced Bioscience Resources because it was not “sufficiently assured” that the contract included appropriate protections and followed requirements for fetal tissue research, the agency said in a statement Monday evening.

HHS is also conducting an audit of all acquisitions involving human fetal tissue to “ensure conformity with procurement and human fetal tissue research laws and regulations,” the statement says.

The agency also said it would continue reviewing alternatives to human fetal tissue in HHS funded research “and will ensure that efforts to develop such alternatives are funded and accelerated.”

“In addition, HHS has initiated a comprehensive review of all research involving fetal tissue to ensure consistency with statutes and regulations governing such research, and to ensure the adequacy of procedures and oversight of this research in light of the serious regulatory, moral, and ethical considerations involved.”

The Food and Drug Administration, which is under HHS, contracted with Advanced Bioscience Resources in July to acquire fetal tissue to implant into mice for research purposes.

Republicans on Capitol Hill criticized the decision in a letter to FDA Commissioner Scott Gottlieb, writing that “unborn children are not commodities to be bought and sold.”

“The practice of conducting research using the body parts of children whose lives have been violently ended by abortion is abhorrent,” reads the Sept. 17 letter, signed by 85 House members.

“We urge you to cancel this contract immediately and utilize alternative, modern scientific techniques that do not contribute to the trafficking in baby body parts.”

Anti-abortion groups expressed shock and frustration that a “pro-life” administration would use federal funds on fetal tissue.

“We expect far better of our federal agencies – especially under the leadership of a courageous pro-life president – entrusted with the health of American citizens,” wrote 48 groups, led by the Susan B. Anthony List, in a statement earlier this month.

https://thehill.com/policy/healthcare/408199-trump-administration-terminates-contract-with-fetal-tissue-firm-after

MediciNova announces ‘positive’ FDA feedback on Phase 3 plan for ALS med

MediciNova announced it has received positive feedback from the FDA regarding MediciNova’s Phase 3 clinical development plan for MN-166 in amyotrophic lateral sclerosis. Key points from the FDA’s feedback include the following: If a single trial shows that MN-166 has a statistically significant benefit compared to placebo in a measure of functional activity, such as ALSFRS-R, an additional trial may not be necessary; In order to detect the maximal potential benefit of MN-166, FDA encouraged including a broad ALS population, with randomization that is stratified by baseline disease severity; no safety issues regarding MN-166 were raised by the FDA and the safety profile will be revisited once the pivotal results are available; given that the indication is for ALS, a rare disease, there may be flexibility in the requirements to support a marketing application. Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, “We are excited to receive the green light from FDA to proceed with Phase 3 development of MN-166 for ALS. We will finalize the study design according to FDA’s feedback.”
https://thefly.com/landingPageNews.php?id=2795497

Henry Schein Invests in 3 Dental Implant Businesses

Henry Schein, Inc. (Nasdaq: HSIC), the world’s largest provider of health care products and services to office-based dental, animal health, and medical practitioners, announced today three investments that will advance the Company’s dental implant business strategy.

Henry Schein will enhance its position in the premium implant segment through the acquisition of Intra-Lock, a provider of dental restoration solutions, including proprietary surface, connection, and biomaterial and small diameter implant technologies; expand into the lower-priced segment of the dental implant market through the planned acquisition of a majority interest in Medentis Medical, a dental implant manufacturer based in Germany; and strengthen its geographic footprint in Europe with the acquisition of a majority interest in Pro-Cam Implants B.V., CAMLOG’s exclusive distributor in the Netherlands.

Together, these acquisitions represent annual sales of approximately $45 million, will be neutral to the Company’s 2018 earnings per share, and are expected to be accretive thereafter. Financial terms were not disclosed.

Intra-Lock, Medentis Medical, and Pro-Cam Implants will complement Henry Schein’s existing solutions for implant-based tooth replacement, and strengthen the Company’s position in the global dental implant market. These acquisitions will broaden the Company’s geographic reach, add innovative technologies, enhance its manufacturing footprint, and further its commitment to serve the lower-priced segment of the implant market. Upon completion of the Medentis Medical acquisition, the Company will also be better positioned to address the growing needs of emerging markets.

“The dental implant category has become increasingly important, and we are committed to offering customers a wide array of the products and services associated with implant dentistry, thereby providing a complete solution for the benefit of the dental practice,” said Stanley M. Bergman, Chairman of the Board and Chief Executive Officer of Henry Schein. “We believe that with the investments we have made in CAMLOG, BioHorizons, and now Intra-Lock, Medentis Medical, and Pro-Cam Implants, we are well positioned to compete in the high growth global dental implant market. We welcome our new colleagues to Team Schein and look forward to continued success together.”

Intra-LockA U.S.-based dental implant manufacturing and sales company, Intra-Lock International and Intra-Lock Manufacturing is known for its OSSEAN® surface structure, which is engineered to increase host-to-implant biocompatibility and biomechanical response and is characterized by a surface topography that is similar at all levels of magnification. Intraspin PRF is a leading device for creating platelet-rich fibrin derived from the patient’s blood to enhance wound healing for implant site development.

Headquartered in Boca Raton, Fla. with its manufacturing facility in Vista, Calif., the Company has approximately 50 employees. Dr. Thierry Giorno, CEO and Director of Research & Development of Intra-Lock, will act as a consultant providing insights and strategic guidance to help accelerate the development of implants and new technologies for Henry Schein that will help dentists and improve oral health.

“As a member of the Henry Schein family, we see tremendous opportunities to continue our legacy of product innovation. We look forward to joining forces with the Henry Schein team to accelerate our growth and to develop and identify technologies that can be leveraged to create next-generation products for BioHorizons and CAMLOG product lines,” said Dr. Giorno.

Medentis MedicalBased in Bad Neuenahr-Ahrweiler and founded in 2001, Medentis Medical GmbH is a fast-growing provider of value-priced dental implants. A German manufacturer of high quality, lower-priced dental implants, the company sells its products in more than 40 countries and has 75 employees, including 10 telesales representatives.

Henry Schein will acquire a majority ownership interest in the company and Founder and CEO Alexander Scholz will continue to lead the business as Managing Director. Completion of the transaction is subject to regulatory approval, and is expected to close in the fourth quarter of 2018.

“With this new ownership position by Henry Schein, Medentis will accelerate several important, ongoing strategic initiatives including expanding our position in the fast-growing emerging markets,” commented Mr. Scholz. “My father ran a dental laboratory and I have spent my entire career in the dental industry, including serving as practice manager of an implant center in Cologne. As such, I fully appreciate the importance of quality products, value, and excellent customer service. I am delighted to be aligning Medentis with the global dental leader Henry Schein, and look forward to the many opportunities to advance the practice of dentistry.”

Pro-Cam ImplantsPro-Cam Implants B.V., CAMLOG’s exclusive distributor in the Netherlands, is one of the leading implant solution providers in the Netherlands.

Henry Schein has acquired a majority interest in Pro-Cam Implants, which is owned by Mike van Rooijen, who will continue to manage the business post-acquisition and will retain the remaining ownership in the company. Pro-Cam Implants will in the future also represent the BioHorizons implant lines and biomaterial portfolio.

“By joining forces with CAMLOG and BioHorizons, Pro-Cam Implants will have access to the resources and capital necessary to accelerate our growth in the highly competitive dental implant market. Working with Henry Schein’s platform in the Netherlands, we see enhanced business prospects and an opportunity to solidify market share gains in the future,” said Mr. van Rooijen.

https://www.marketscreener.com/HENRY-SCHEIN-9582/news/Henry-Schein-Strengthens-And-Expands-Its-Global-Dental-Implant-Business-With-Three-Investments-27313474/

Quest Diagnostics to Acquire U.S. Lab Services Business of Oxford Immunotec

Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, and Oxford Immunotec Global PLC (Nasdaq: OXFD), a global, high-growth diagnostics company, today announced the signing of a definitive agreement under which Quest will acquire the U.S. laboratory services business of Oxford Immunotec.

The acquisition, once completed, will include the T-SPOT^®.TB tuberculosis and the Accutix™ tick-borne disease testing services provided by Oxford Immunotec’s laboratories in Memphis, TN, and Norwood, MA. As part of the transaction, Oxford Immunotec will sell T-SPOT.TBtest kits and related accessories to Quest Diagnostics under the terms of a long-term supply agreement, which would be effective at closing of the acquisition. In addition, the parties expect to enter into a strategic collaboration agreement to drive continued growth of T-SPOT.TB testing in the U.S.

Quest Diagnostics intends to continue to offer QuantiFERON TB blood testing services to provide physicians choice in blood-based TB testing.

“This acquisition will extend our capabilities in infectious disease diagnostics, consistent with our strategy to accelerate growth by broadening access to diagnostic innovation,” said Steve Rusckowski, Chairman, President and CEO, Quest Diagnostics. “It will build on our momentum in tuberculosis services by enabling us to bring greater choice to physicians who seek innovative blood-based TB testing over traditional methods.”

“We are thrilled to be joining forces with Quest Diagnostics,” said Dr. Peter Wrighton-Smith, CEO, Oxford Immunotec. “As a result of this transaction, physicians and patients across the United States will benefit from significantly broader access to our T-SPOT.TB test.”

The transaction has been approved by the Boards of Directors of both companies, and is expected to be completed in the fourth quarter of 2018, subject to customary regulatory approvals. Shareholder approval will not be required for either company.

https://www.marketscreener.com/OXFORD-IMMUNOTEC-GLOBAL-P-14966054/news/Quest-Diagnostics-to-Acquire-U-S-Laboratory-Services-Business-of-Oxford-Immunotec-27314281/

Portola Gets FDA Orphan Drug Tag for Peripheral T-Cell Lymphoma Treatment

Portola Pharmaceuticals (Nasdaq: PTLA) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to cerdulatinib, an investigational, oral Syk/JAK inhibitor for the treatment of peripheral T-cell lymphoma (PTCL).

“We are pleased that the FDA has granted cerdulatinib Orphan Drug Designation, as it recognizes its potential to provide a significant clinical benefit to a group of patients with limited treatment options,” said John Curnutte, M.D., Ph.D., Portola’s interim co-president and head of research and development. “We look forward to presenting additional data from the Phase 2a trial at a scientific congress early next year and to continuing discussions with the FDA regarding next steps for the development of cerdulatinib, including the potential for an accelerated approval pathway.”

The FDA’s Office of Orphan Products Development grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the United States. Orphan Drug Designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA market application fees.

https://www.marketscreener.com/PORTOLA-PHARMACEUTICALS-I-13255910/news/Portola-Pharmaceuticals-Receives-FDA-Orphan-Drug-Designation-for-Cerdulatinib-an-Oral-Syk-JAK-Inhib-27316889/

UK’s BMI Healthcare reported close to £2 billion restructuring deal

Britain’s largest private healthcare group, BMI Healthcare, is nearing a 2 billion pounds restructuring deal that could cut millions of pounds from its annual rent bill, a person familiar with the matter said on Tuesday.

An announcement under which BMI’s rent bill will be cut by about 60 million pounds is likely to be made imminently, the source told Reuters.

Funds including Centerbridge and Och-Ziff Capital Management will inject about 50 million pounds of equity into the business, and maturity of about 2 billion of debt on the balance sheet of BMI and its property arm General Healthcare Group will be extended by six years, the source said.

Sky News had earlier reported about the deal on Tuesday.

Last year, South African private healthcare operator Netcare had made an all-share offer to buy out minority BMI Healthcare shareholders saying it was making the move because trading conditions “remained difficult” across the private healthcare market.

In March, Netcare drew a line under its ambitions in Britain saying it would exit the market due to difficult trading conditions.

Och-Ziff Capital Management and Centerbridge were not immediately available for comment.

BMI Healthcare operates 59 hospitals and clinics throughout the United Kingdom and had about 276,000 inpatient visits per year, according to its website.

https://www.marketscreener.com/NETCARE-LIMITED-1413397/news/Netcare-BMI-Healthcare-close-to-2-billion-restructuring-deal-source-27317048/

Global Settlement Resolves DOJ Probe Involving Community Health

Community Health Systems, Inc. CYH, -2.29% (“the Company”) announced today that it has reached a global resolution and settlement agreements ending the U.S. Department of Justice investigation into conduct by Health Management Associates, Inc. (“HMA”) and its affiliated entities reflected in qui tam lawsuits that were initiated and pending, and known to the Company, before HMA was acquired by merger in January 2014.

The settlement concludes the government’s investigations into whether HMA and its affiliated hospitals billed Medicare, Medicaid and TRICARE for certain inpatient admissions following emergency room visits between January 2008 and December 2012 that should have been billed as outpatient or observation cases. The settlement also resolves allegations of Stark and Anti-Kickback Act violations at certain HMA affiliated hospitals.

In reaching the settlement, the government noted that all conduct reviewed in its investigation pre-dated the HMA acquisition, and that following the acquisition, Community Health Systems engaged in remedial measures, including removing the HMA Board of Directors and senior executives and integrating the HMA affiliated hospitals into Community Health System’s existing compliance program.

The settlement includes a Non-Prosecution Agreement with HMA in which the government agreed not to bring criminal charges against HMA, as long as HMA and the Company abide by the provisions of the global settlement, and also includes a guilty plea to one count of conspiracy to commit healthcare fraud by Carlisle HMA, LLC (“Carlisle HMA”), the HMA affiliated entity that formerly operated Carlisle Regional Medical Center.

The global settlement includes a total payment of $262 million, which is expected to be paid in October 2018. As part of the accounting for the HMA acquisition by merger, the Company established a liability related to the legal claims underlying the contingent value right (“CVR”) that was issued to HMA shareholders as part of the merger consideration. This liability represented the Company’s best estimate of fair value of the potential future payments associated with the legal matters assumed in the HMA merger. This estimate has accordingly been updated over time as additional facts and circumstances have become known. Based on the settlement terms and calculation of any payment as defined in the CVR agreement, the Company anticipates that no distribution will be owed to CVR holders.

Under the terms of the global settlement, the Company’s existing corporate integrity agreement (CIA) has been amended and extended. The extension begins immediately and effectively adds two years to the existing CIA, with the amended CIA now running through 2021.

Commenting on the resolution of the government’s investigation into HMA, Wayne Smith, chairman and chief executive officer of Community Health Systems, Inc., said, “Since acquiring HMA in 2014, it has been our goal to resolve the government’s investigation into all of these allegations which occurred prior to the acquisition and which were already under investigation at the time of the transaction. We are pleased to have reached the settlement agreements so we can move forward now without the burden or distraction of ongoing litigation. As an organization, we are committed to doing our very best to always comply with the law in what is a very complex regulatory environment and to operate our business with integrity, ethical practices and high standards of conduct.”

https://www.marketwatch.com/press-release/global-settlement-resolves-us-department-of-justice-investigation-into-health-management-associates-inc-and-related-affiliates-2018-09-25