Rostec presents modernized robotic nurse

Concern Tecmash (part of Rostec) has presented the first sample of modernized Angel automated diagnostic and therapeutic system for human life support at the BIOTECHMED forum. The robot can perform new diagnostic functions, and it also became less heavy and more compact. 

The robotic nurse is to provide medical care during primary diagnostics, automated control over vital functions of an injured person, and to ensure invasive administration of prescribed drugs in accordance with a specific algorithm. Currently, the Angel diagnostic systems are already used by EMERCOM of Russia and several regional medical institutions.

Modernization of the system considerably increased Angel’s diagnostic capability. It will be able to record a synthesized 12-lead electrocardiogram and decipher it,  measure respiration characteristics, conduct non-invasive cardiac output monitoring, and add height, weight and sex of a patient and data from an electronic stethoscope. The complex can transfer all these data via telecommunication channels and select a mobile network operator with the strongest signal. The system became even more compact after the modernization.  Its weight was reduced from 22 kg to 8 kg.

Angel uses the data to diagnose traumatic and burn shock, intoxication, head injuries, radiation sickness, hemorrhagic shock, acute cerebrovascular accident, hypo- and hyperglycemic coma, acute respiratory distress syndrome (ARDS) of adults, bronchial asthma, arrhythmogenic disorders of cardiac functions, septic and cardiogenic shock, pulmonary thromboembolism, and acute coronary syndrome.

“High-tech developments used in healthcare, including Angel, ensure higher quality of medical care provided for the population, and its availability. Functions of the system combine the competences of several medical professionals specializing in relevant spheres, which is of critical importance when there is a lack of doctors. For instance,  during man-made disasters and in an emergency, in remote residential areas or when a patient is transported,” says Executive Director of Rostec Oleg Yevtushenko.

The BIOTECHMED forum is held in Gelendzhik from September 9 through September 11, 2018. It is a combination of an academic conference (in terms of giving experts an opportunity to exchange opinions) and a display area to provide for relevant and objective assessment of industry development prospects and making informed decisions. BIOTECHMED aims to make market participants interested in synergy to ensure transition to medicine of new generation and to form common understanding of problems, tasks and opportunities. The conference will be attended by more than 1,500 representatives of the business and academic community of Russia and other countries.

Concern Tecmash  was established in 2011. Concern Tecmash specializes in the development and production of ammunition supplies for the combat capabilities of the main strike forces of the Armed Forces. Highly effective modern weapons produced by Tecmash are used by the armed forces of more than 100 countries. Key activities of Tecmash include development and production of multiple launch rocket systems, small-caliber ammunition for ground forces, the Navy and the Air Force, engineer ammunition, aerial bombs, RPG, melee weapons, field and naval artillery, explosives, etc. Civilian products include fuel for the fuel and energy complex, industrial and medical coolers, agricultural machinery and concumer goods. Vladimir Lepin is Director General of Tecmash.

Rostec Corporation is a Russian corporation that was established in 2007 to facilitate the development, production and export of high-tech industrial products designed for civilian and military applications. The Corporation comprises over 700 organizations that are currently part of eleven holding companies operating in the military-industrial complex and four holding companies working in civilian industry, as well as over 80 directly managed organizations. Rostec’s portfolio includes well-known brands such as AVTOVAZ, KAMAZ, Concern Kalashnikov, Russian Helicopters, UralVagonZavod, etc. Rostec companies are located in 60 constituent entities of the Russian Federation and supply products to the markets of more than 100 countries. In 2017 the consolidated revenue of Rostec reached 1 trillion 589 billion rubles, while the consolidated net income and EBITDA amounted to 121 and 305 billion rubles respectively. In 2017 the average salary in the Corporation was 46,800 rubles. According to Rostec’s strategy, the main objective of the Corporation is to ensure that Russia has a technological advantage in highly competitive global markets. Rostec’s key objectives include the introduction of a new techno-economic paradigm and digitalization of Russian economy.​​

https://www.biospace.com/article/rostec-presents-modernized-robotic-nurse/

Recro Pharma Provides Regulatory Update for IV Meloxicam

Company Anticipates NDA Resubmission by the End of September 2018

Recro Pharma, Inc. (Nasdaq:REPH), a revenue generating specialty pharmaceutical company focused on therapeutics for the hospital and other acute care settings, today provided a regulatory update following receipt of the official meeting minutes from a July 2018 Type A meeting with the U.S. Food and Drug Administration (FDA)relating to a path forward for intravenous (IV) meloxicam, the Company’s lead product candidate for the management of moderate to severe pain.

Recro had requested this Type A meeting with the FDA to address a Complete Response Letter (CRL) it received from the FDA regarding the New Drug Application (NDA) for IV meloxicam. During the meeting, Recro discussed data from ad hoc analyses and selective secondary endpoints of Recro’s clinical trials which the FDA had highlighted in the CRL, as well as CMC related questions on extractable and leachable data provided in the NDA.  Based upon the discussion with the FDA as reflected in the official meeting minutes, Recro anticipates resubmitting the IV meloxicam NDA by the end of September. The NDA resubmission will incorporate revised language relating to the product label and, additional information relating to extractable and leachable items.

“We are pleased with the constructive nature of our interactions with the FDA regarding IV meloxicam, and we expect to resubmit the NDA for IV meloxicam by the end of September,” said Gerri Henwood, President and Chief Executive Officer of Recro. “We remain fully committed to IV meloxicam and to bringing this new non-opioid treatment option for the management of moderate to severe pain to the physicians and patients who need it.”

https://www.biospace.com/article/recro-pharma-provides-regulatory-update-for-iv-meloxicam/

Celltrion: FDA Panel to Meet on Proposed Biosimilar to Rituxan® (Rituximab)

Celltrion, Inc. (KRX:068270) today announced that the U.S. Food and Drug Administration (FDA) has scheduled the Biologics License Application (BLA) for CT-P10, a proposed monoclonal Antibody (mAb) biosimilar to Rituxan®¹ (rituximab), for discussion by the Oncologic Drugs Advisory Committee (ODAC) on October 10, 2018. Rituxan® is a Biogen and Genentech USA, Inc.’s rituximab product.

The ODAC reviews and evaluates data concerning the safety and effectiveness of investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA.

“We are fully committed to preparing for this advisory committee meeting and look forward to the discussion about CT-P10,” said Woosung Kee, Chief Executive Officer of Celltrion. “The development of biosimilars is of great importance in the field of oncology, and has the potential to enrich our therapeutic arsenal and to increase accessibility to therapies for patients at an affordable price.”

Celltrion and Teva Pharmaceutical Industries, Ltd. entered into an exclusive partnership to commercialize CT-P10 in the U.S. and Canada in October 2016.

¹ Rituxan® is a registered trademark of Biogen and Genentech USA, Inc.

https://www.biospace.com/article/releases/celltrion-announces-fda-oncologic-drugs-advisory-committee-meeting-schedule-for-proposed-biosimilar-to-rituxan-rituximab-/

Cushman & Wakefield: Life Sciences Drive Improved NJ Office Fundamentals

Sector Generates Significant Year-to-Date Leasing Volume – with More to Come

Even before Teva Pharmaceuticals USA Inc., represented by Cushman & Wakefield, signed a 345,000-square-foot commitment in Parsippany in July – marking the largest office lease year-to-date in Northern and Central New Jersey – the life sciences sector had emerged as a key driver in the state’s improving market fundamentals.

At mid-year, the Cushman & Wakefield research team had tracked more than 564,000 square feet in office activity involving life sciences tenants. “That impressive statistic represents 11.4 percent of the state’s total office leasing through the first six months of the year,” noted Jason Price, director of tri-state suburbs research for the commercial real estate services firm. “Add the Teva Pharmaceuticals transaction and other sizable office deals in the pipeline, and the influence of life sciences in 2018 will be even more marked by the end of the third quarter.”

Cushman & Wakefield’s Dan Johnsen represented Teva in its long-term lease at P3 Properties’ MCCBLUE (400 Interpace Parkway). JLL served as landlord broker in that blockbuster deal. “Companies within the life sciences sector, in particular pharmaceutical companies, are increasingly attracted to New Jersey due to its highway system and mass transit connectivity, EDA tax incentive programs and access to a highly educated workforce,” said Johnsen. Johnsen also represented Octapharma for its US Headquarters, where the firm signed a long-term lease for 64,000 square feet at 117 West Century Road in Paramus, where Cushman & Wakefield’s Marc Trevisan, David Sherman, David DeMatteis and Mark Zaziski served as landlord representative for Onyx Equities and Garrison Investments.

Cushman & Wakefield was also involved in other life sciences leasing transactions this year including Integra Life Sciences’ 166,791-square-foot headquarters lease at 1100 Campus Road in Princeton. Led by Cushman & Wakefield’s Robert Rudin, Marc Trevisan and David Sherman as well as a Boston-based team led by Rory Murray, that deal marked the state’s largest office lease of the second quarter. And in Morristown, Cushman & Wakefield’s Bill Brown, Jon Williams and Heather Polhamus represented Marcus Partners in Alvogen’s 84,000- square-foot lease at 44 Whippany Road.

While the volume of activity in 2018 is significant, the presence of life sciences in New Jersey is deeply rooted. The state houses more than 3,200 life sciences facilities (both office and R&D), employing approximately 117,000 people. The industry’s annual contribution to the state economy is estimated at $47.5 billion – 86.0 percent higher than the national average, noted Andrew Judd, Cushman & Wakefield’s New Jersey market leader.

“Thirteen of the top 20 global bio-pharma companies are headquartered in New Jersey,” Judd added. “These companies are attracted to the state by our skilled and talented labor pool, and 60-plus colleges that produce more than 20,000 life sciences graduates each year. In turn, the life sciences industry continues to fuel not only the New Jersey economy, but also the commercial real estate market. The state always has enjoyed the benefit of attracting tenants from diverse industries. While that remains unchanged, 2018 may well go down in recent history as the year of life sciences.”

At mid-year, the Cushman & Wakefield research team had recorded 3.8 million square feet of total office leasing activity in Northern and Central New Jersey, slightly ahead of last year’s pace. This helped push the state’s office vacancy rate lower, to 18.4 percent, and contributed to Class A average rents climbing by 5.6 percent year-over-year to $33.54 per square foot – a historic high.

https://www.biospace.com/article/cushman-and-wakefield-life-sciences-driving-improved-office-fundamentals-in-n-j-/

Doctor survey shows Allergan could be big player in wet-AMD: Deutsche Bank

Deutsche Bank analyst Gregg Gilbert says his survey of 30 ophthalmologists that treat wet age-related macular degeneration suggests Allergan could be a meaningful player in the market. Abicipar is one of Allergan’s most important pipeline assets, but the Street seems lukewarm on the drug, as evidenced by the stock reaction after the company reported Phase 3 results on July 19, Gilbert tells investors in a research note titled “Abicipar survey: Docs more bullish than Street.” He notes the doctors surveyed like the fixed 12 week dosing of abicipar and that despite the inflammation hurdle, they predict significant share for abicipar of their wet-AMD patients. Gilbert keeps a Buy rating on Allergan with a $210 price target.
https://thefly.com/landingPageNews.php?id=2789259

Siemens Healthineers announces first global installation of Acuson Sequoia

Siemens Healthineers has announced the first global installation of its newest ultrasound system, the Acuson Sequoia, at Baptist Health South Florida. With ten facilities and five “centers of excellence” in the South Florida region, Baptist Health South Florida purchased numerous Acuson Sequoia systems in order to enhance its imaging capabilities within the scope of gastroenterology, primary care, and bariatric specialties. With its powerful architecture and innovative features, the new Acuson Sequoia expands precision medicine by enabling high-resolution imaging that adapts to patients’ size and personal physical characteristics, contributing to more confident diagnosis. Siemens Healthineers built the entirely new Acuson Sequoia system to adapt to the “BioAcoustic Variations” of each patient, characteristics that include tissue density, stiffness, and absorption. With its new Deep Abdominal Transducer (DAX), a new high-powered architecture, and innovative updates to elastography and contrast-enhanced ultrasound, the new Acuson Sequoia produces penetration up to 40cm without image quality degradation often caused by attenuating echo signals, an industry first.
https://thefly.com/landingPageNews.php?id=2789283

Zogenix initiated at Northland

Zogenix initiated with an Outperform at Northland. analyst Carl Byrnes initiated Zogenix with an Outperform and $70 price target saying ZX008 is positioned to emerge as the 1st-line adjunctive therapy for patients with Dravet syndrome, achieving high market penetration. Byrnes is forecasting peak us US sales from the Dravet syndrome indication of $225M, with peak global sales for the indication at $500MM. Importantly, ZX008 has peak global sales potential greater than $2B, inclusive of other epileptic indications, the analyst wrote in a note to investors.
https://thefly.com/landingPageNews.php?id=2789281