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medicine

Backlash after India grants permission for traditional medicine practitioners to perform surgery

The Indian government has formally granted permission for practitioners of Indian traditional medicine, known as Ayurveda, to perform surgeries, in a move that has provoked a strong reaction from doctors across the country.



a group of people standing in front of a crowd


© Provided by The Independent


Ayurveda is a traditional system of medicine practised across the Indian subcontinent which uses diet, herbal treatments, yogic breathing and other techniques for healing.

The controversial move now sanctions practitioners of the traditional system to perform a variety of general surgeries including ENT (ear nose and throat procedures), ophthalmological and dental procedures after training.

As per the new rules, training modules for surgical procedures will be added to the curriculum of Ayurvedic studies for the first time, the notification from the government said.

However, the decision has antagonised India’s biggest association of doctors, the Indian Medical Association (IMA) which described the move as equivalent to “corrupting the entire health system of the country”.

“Such mixing of the systems will be resisted at all costs,” it said in a statement. “All over India students and practitioners of modern medicine are agitated over this violation of mutual identity and respect.

“The CCIM [Central Council of Indian Medicine] should develop its own surgical disciplines from its own ancient texts… it should not claim the surgical disciplines of modern medicine as its own. Such a deviant practice is unbecoming of a statutory body,” IMA’s statement said.

Following the backlash, the government ministry of Ayush (Ayurveda, Yoga, Unani, Siddha and Homoeopathy) clarified on Sunday that “the notification is specific to 58 specified surgical procedures and doesn’t allow Shalya [general surgery] and Shalakya [Surgery for ear, nose, throat, head and eye] post-graduates to take up any other surgeries,” reported ANI.

People on social media also took a dig at the new rules and questioned the scientific rationale behind it.

One Twitter user wrote, “Make it compulsory for every central minister and BABU (government employees) to undergo surgery by Ayurveda MS people and you will see the law disappear.”

Another user said the government will next pass directive which “allows cobblers and tailors to give post-operative stitches, butchers to conduct throat surgeries and fish sellers to conduct a post-mortem.”

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medicine

Editas Medicine Reports Inducement Grants to New Chief Medical Officer

CAMBRIDGE, Mass., Nov. 10, 2020 (GLOBE NEWSWIRE) — Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, today announced the grant of inducement awards to the Company’s newly appointed Executive Vice President and Chief Medical Officer, Lisa Michaels, M.D. In connection with Dr. Michaels’ appointment, the Editas Medicine Board of Directors approved a stock option grant and a restricted stock unit award to Dr. Michaels as inducements material to Dr. Michaels entering into employment with Editas Medicine in accordance with Nasdaq Listing Rule 5635(c)(4).  The stock option provides for the purchase of up to 120,000 shares of Editas Medicine common stock at a price of $30.41 per share, the closing price per share of Editas Medicine common stock as reported by Nasdaq on the date of grant, and vests over four years, with 25 percent of the shares vesting on the first anniversary of Dr. Michaels’ employment start date, and the remainder vesting ratably at the end of each subsequent month thereafter, subject to Dr. Michaels’ continued service relationship with Editas Medicine through the applicable vesting dates. The restricted stock unit award is for 20,000 shares of Editas Medicine common stock and vests as to 25 percent of the shares on each one-year anniversary of Dr. Michaels’ employment start date until the fourth anniversary of Dr. Michaels’ employment start date, subject to Dr. Michaels’ continued service to Editas Medicine through the applicable vesting dates.

About Editas Medicine
As a leading genome editing company, Editas Medicine is focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cas12a (also known as Cpf1) genome editing systems into a robust pipeline of treatments for people living with serious diseases around the world. Editas Medicine aims to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases. For the latest information and scientific presentations, please visit www.editasmedicine.com.

CONTACT: Contacts: Media Cristi Barnett (617) 401-0113 [email protected] Investors Mark Mullikin (617) 401-9083 [email protected]m

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health

MHRA Grants HAE Patients Early Access to BioCryst’s Berotralstat in United Kingdom

RESEARCH TRIANGLE PARK, N.C., Oct. 30, 2020 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted oral, once-daily berotralstat a positive scientific opinion through the Early Access to Medicines Scheme (EAMS).

Under the EAMS, hereditary angioedema (HAE) patients in the UK aged 12 years and older can gain access to berotralstat for the routine prevention of recurrent attacks of HAE before the drug is granted marketing authorization by the European Commission (EC).

HAE is a serious, and potentially life-threatening, rare genetic illness characterised by periodic episodes of acute swelling of the skin, pharynx, larynx, gastrointestinal tract, genitals and/or extremities.

Medicines included in the EAMS are those that have a high unmet need, are intended to treat, diagnose or prevent seriously debilitating or life-threatening conditions where there are no adequate treatment options, and are likely to offer significant advantage over methods currently used in the UK. Under the scheme, the MHRA provides a scientific opinion on the benefit-risk balance of the medicine, based on the data available when the EAMS submission was made.

“There are many patients in the UK that don’t have a realistic option for effective HAE prophylaxis. The addition of berotralstat through the EAMS will bring a much needed option for HAE patients suffering with this debilitating disease,” said Dr. Sorena Kiani, Consultant Immunologist at Royal London Hospital, London.

“HAE patients around the world are waiting for an oral, once-daily therapy to prevent attacks and reduce their burden of therapy. With this decision by the MHRA, the wait for many HAE patients in the UK can end sooner,” said Jon Stonehouse, chief executive officer of BioCryst.

The European Medicines Agency (EMA) is reviewing the marketing authorisation application (MAA) for berotralstat under the centralized procedure. An opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected approximately 12 months from MAA validation, which the company announced on March 30, 2020.

About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including ORLADEYO(berotralstat), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.BioCryst.com.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements are identified by use of terms such as “expect,” “will,” and similar words, although

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health

American Brain Tumor Association Awards 11 Research Grants to Advance Brain Tumor Research

American Brain Tumor Association Awards 11 Research Grants to Advance Brain Tumor Research

PR Newswire

CHICAGO, Oct. 30, 2020

CHICAGO, Oct. 30, 2020 /PRNewswire/ — As the nation’s first nonprofit organization committed to funding brain tumor research and providing education and information across all tumor types, the American Brain Tumor Association (ABTA) persists in its mission, announcing today the investment of $368,000 towards 11 new research grants to foster innovation in diagnosis and treatment of brain tumors in adults and children.

American Brain Tumor Association
American Brain Tumor Association

The ABTA’s grant program plays an integral role in advancing the understanding and treatment of brain tumors. Dedicated to investing in early-stage investigators who have unique perspectives to drive the future of brain tumor science and treatment, the ABTA provides research grants to medical students, post-doctoral fellows, and early-career faculty. This investment is even more critical with the COVID-19 pandemic shifting research priorities and impacting government funding for brain tumor research.

“We are excited to continue our legacy of supporting innovative research and early-career researchers, especially during this challenging time. With almost $33 million invested to date, the ABTA is committed to funding the research that will one day lead to cures,” said Nicole Willmarth, Ph.D., chief mission officer, ABTA.

With the Southeastern Brain Tumor Foundation (SBTF) investing more than $100,000 to support three research projects, the ongoing partnership between the ABTA and SBTF exemplifies the strengths of the ABTA’s rigorous grant selection process and accelerates the research investments of both organizations.

“The vast potential of the new projects we fund and the incredible efforts by the researchers, renews my optimism that better treatments are on the horizon. Our collaborations with organizations, like SBTF, amplify our ability to achieve our common goal of improving outcomes for brain tumor patients,” said Nicole Willmarth.

This year’s slate of research investigates critical areas in neuro-oncology research including experimental therapeutics, the role of the immune system and immunotherapies, as well as factors that modify gene function in brain tumor cells.

The ABTA congratulates the 2020 grant recipients listed below. To learn more about the grant recipients and their research projects, visit https://www.abta.org/research/research-funding-impact/.

Basic Research Fellowships are two-year, $100,000 grants awarded to post-doctoral fellows who are mentored by established and nationally-recognized experts in the neuro-oncology field.

  • Emily Darrow, Ph.D., St. Jude Children’s Research Hospital

  • Tyler Miller, M.D., Ph.D., Massachusetts General Hospital

Discovery Grants are one-year, $50,000 grants supporting cutting-edge, innovative approaches that have the potential to change current diagnostic or treatment standards of care for either adult or pediatric brain tumors.

  • Munjal Acharya, Ph.D., University of California, Irvine

  • Lan Hoang-Minh, Ph.D., University of Florida

  • Gary Kohanbash, Ph.D., Children’s Hospital of Pittsburgh

Medical Student Summer Fellowships are $3,000 grants awarded to medical students to conduct brain tumor research projects under the guidance of neuro-oncology experts. Through these grants, the ABTA seeks to encourage physician-scientists to enter and remain in the brain tumor field.

  • Hasan Alrefai, B.S., University of Alabama at

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health

FDA Grants 510(k) Clearance for Abiomed’s Innovative Cardiopulmonary Support Technology

The United States Food and Drug Administration (FDA) has granted Abiomed (NASDAQ: ABMD) a 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system called the Abiomed Breethe OXY-1 System™.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201026005299/en/

The Abiomed Breethe OXY-1 System has received 510(k) clearance from the United States FDA (Photo: Buisness Wire)

The ECMO system provides cardiopulmonary bypass support for patients whose lungs can no longer provide sufficient end organ oxygenation. The 510(k) clearance is to pump, oxygenate, and remove carbon dioxide from blood during cardiopulmonary bypass for up to six hours. The system can help provide oxygenation to patients suffering from cardiogenic shock or respiratory failure such as ARDS, H1N1, SARS, or COVID-19. When used with the Impella heart pump it can unload the heart and oxygenate the body, a combination therapy known as ECpella.

Abiomed’s Breethe technology is a novel, easy-to-use cardiopulmonary bypass system that is designed for mobility. The components of the system are designed to reduce the overall equipment footprint, support patient ambulation, and provide an intuitive interface for health care providers to setup and manage. The integrated pump lung unit is engineered with volute spiral technology for uniform blood flow with minimal stagnation and advanced gas exchange technology that allows for full therapy with reduced oxygen requirements.

“As a leader in technology and innovation, the Breethe system is a natural addition to Abiomed’s existing product portfolio,” said Michael R. Minogue, Abiomed’s Chairman, President and Chief Executive Officer. “This ECMO technology will allow us to support new patient populations, such as COVID-19 patients and others who need lung support, and provide combination ECpella therapy to Impella patients who need oxygenation. Furthermore, we will advance the field of native lung recovery and improve patient outcomes by collecting critical research data and developing and teaching best practices.”

“Abiomed has a long-established track record of bringing to market improved options to support physicians with innovative technology like Breethe, which is designed to provide advanced respiratory and cardiac support,” said Bartley Griffith, MD, the Hales Distinguished Professor of Surgery at University of Maryland, School of Medicine. “Abiomed is committed to advancing heart and lung therapies to help improve patient care and ultimately outcomes.”

“The clinical community has long been in need of innovation compared to traditional extracorporeal circulation therapy,” said Dr. Zachary Kon, cardiothoracic surgeon at New York University. “The Breethe system is a breakthrough technology because it supports transition from bed to ambulation via system portability. This system has the potential to revolutionize the way we think about extracorporeal life support therapy and can improve patient care.”

To help health care providers achieve the best possible outcomes, the Breethe system will be supported 24 hours a day, 7 days a week by Abiomed’s experienced field-based, in-hospital clinical team and on-call team from the Clinical Support Center.

This ECMO technology adds to Abiomed’s innovative portfolio focused on native heart and lung recovery. For many patients in cardiogenic shock, Abiomed now provides the treatment

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