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LAVA Therapeutics Receives FDA Orphan Drug Designation for LAVA-051 for the Treatment of Chronic Lymphocytic Leukemia

By Dr. Matthew Watson

UTRECHT, The Netherlands and PHILADELPHIA, Oct. 15, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (Nasdaq: LVTX), a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for the company’s CD1d targeted GammabodyTM, LAVA-051, for the treatment of chronic lymphocytic leukemia (CLL). CLL is a form of leukemia characterized by progressive accumulation of abnormal lymphocytes in the peripheral blood, bone marrow and lymphoid tissues.

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LAVA Therapeutics Receives FDA Orphan Drug Designation for LAVA-051 for the Treatment of Chronic Lymphocytic Leukemia

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Silence Announces Proposed Cancellation of Admission of its Ordinary Shares to Trading on AIM and Transition of its Primary Trading Venue to the…

By Dr. Matthew Watson

Silence Announces Proposed Cancellation of Admission of its Ordinary Shares to Trading on AIM and Transition of its Primary Trading Venue to the Nasdaq Global Market

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Tauriga Sciences Inc. Commences Development of Ashwagandha Infused Chewing Gum

By Dr. Matthew Watson

NEW YORK, NY, Oct. 15, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Tauriga Sciences, Inc. (OTCQB: TAUG) (“Tauriga” or the “Company”), a New York based diversified Life Sciences Company, today announced that it has commenced the development of a proprietary Ashwagandha extract infused supplement chewing gum.  This proposed product will incorporate the Company’s considerable expertise in developing proprietary chewing gums, as well as its unwavering commitment to innovation, while always adhering to the highest moral, safety, and quality standards.

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Apellis and Sobi Receive Positive CHMP Opinion for Aspaveli® (pegcetacoplan) for the Treatment of PNH

By Dr. Matthew Watson

WALTHAM, Mass. and STOCKHOLM, Sweden, Oct. 15, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the marketing authorization of Aspaveli® (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) who are anemic after treatment with a C5 inhibitor for at least three months. The positive opinion from the CHMP is now referred to the European Commission for an approval decision.

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Apellis and Sobi Receive Positive CHMP Opinion for Aspaveli® (pegcetacoplan) for the Treatment of PNH

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Ascendis Pharma A/S Announces U.S. Commercial Launch of SKYTROFA® (Lonapegsomatropin-tcgd), the First and Only FDA Approved Once-Weekly Treatment for…

By Dr. Matthew Watson

COPENHAGEN, Denmark, Oct. 15, 2021 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND), today announced the U.S. commercial launch of SKYTROFA (lonapegsomatropin-tcgd), its once-weekly treatment for the treatment of pediatric patients one year and older who weigh at least 11.5 kg (25.4 lb) and have growth failure due to inadequate secretion of endogenous growth hormone (GH). SKYTROFA (lonapegsomatropin-tcgd) is available by prescription and distributed through a network of specialty pharmacies across the United States.

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Ascendis Pharma A/S Announces U.S. Commercial Launch of SKYTROFA® (Lonapegsomatropin-tcgd), the First and Only FDA Approved Once-Weekly Treatment for...

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Generation Bio to Present at European Society of Gene and Cell Therapy 2021 Annual Virtual Congress

By Dr. Matthew Watson

CAMBRIDGE, Mass., Oct. 15, 2021 (GLOBE NEWSWIRE) -- Generation Bio Co. (Nasdaq: GBIO), a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, today announced an oral presentation at the European Society of Gene and Cell Therapy (ESGCT) Annual Virtual Congress taking place October 19-22. The presentation will highlight preclinical advances from the company’s retina therapeutic area.

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Albireo to Showcase New Data at AASLD The Liver Meeting® 2021

By Dr. Matthew Watson

– Seven abstracts accepted highlighting data in pediatric cholestatic and viral liver diseases –

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Vir Biotechnology Announces Multiple Abstracts Highlighting New Hepatitis B Data Accepted for Presentation at AASLD’s The Liver Meeting® 2021

By Dr. Matthew Watson

SAN FRANCISCO, Oct. 15, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that three abstracts highlighting data from its hepatitis B clinical program and one health outcomes research abstract have been accepted for oral and poster presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®, taking place virtually from November 12-15, 2021.

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Vir Biotechnology Announces Multiple Abstracts Highlighting New Hepatitis B Data Accepted for Presentation at AASLD’s The Liver Meeting® 2021

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Gracell Biotechnologies to Participate in Two Upcoming Virtual Investor Conferences

By Dr. Matthew Watson

SUZHOU, China and PALO ALTO, Calif., Oct. 15, 2021 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (NASDAQ: GRCL) (“Gracell”), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that it will participate in the following upcoming virtual conferences:

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Unaware of Any Undisclosed Material Change

By Dr. Matthew Watson

TORONTO, Oct. 15, 2021 (GLOBE NEWSWIRE) -- At the request of the Investment Industry Regulatory Organization of Canada (IIROC), Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) wishes to confirm that the Company’s management is unaware of any undisclosed material change in the Company’s operations that would account for the recent increase in market activity.

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Celsion Corporation Announces Time of Oral Presentation at International Vaccines Congress

By Dr. Matthew Watson

Chief Science Officer Dr. Khursheed Anwer to Deliver Virtual Presentation Monday, October 18 at 7:30 a.m. Eastern Time

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PAOG Confirms Monday Marketing Launch Of First CBD Product Targeting $100 Billion Market

By Dr. Matthew Watson

Sandusky, OH, Oct. 15, 2021 (GLOBE NEWSWIRE) -- PAO Group, Inc. (OTC Pink: PAOG) today confirmed shipping its first CBD nutraceutical product to its distribution partner, North American Cannabis Holdings, Inc. (OTC Pink: USMJ).

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US FDA approves Roche’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer

By Dr. Matthew Watson

Basel, 15 October 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) as adjuvant treatment, following surgery and platinum-based chemotherapy, for adults with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumours express PD-L1?1%, as determined by an FDA-approved test.

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US FDA approves Roche’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer

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Santhera Announces First Half-Year 2021 Financial Results and Updates on Corporate Progress

By Dr. Matthew Watson

Ad hoc announcement pursuant to Art. 53 LR

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Genmab Announces that Janssen has Received Positive CHMP Opinion for RYBREVANT® (amivantamab) for Patients with Advanced Non-small Cell Lung Cancer…

By Dr. Matthew Watson

Media ReleaseCopenhagen, Denmark, October 15, 2021

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Genmab Announces that Janssen has Received Positive CHMP Opinion for RYBREVANT® (amivantamab) for Patients with Advanced Non-small Cell Lung Cancer...

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Nabriva Therapeutics to Present Data at CHEST Annual Meeting 2021

By Dr. Matthew Watson

DUBLIN, Ireland and FORT WASHINGTON, Pa., Oct. 15, 2021 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today, announced data presentation at CHEST 2021, the annual meeting of the American College of CHEST Physicians, which will be held virtually October 17-20.

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Chinook Therapeutics Announces Upcoming Data Presentations and Investor Conference Call During the American Society of Nephrology (ASN) Kidney Week…

By Dr. Matthew Watson

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Cabaletta Bio Announces Presentation of Preclinical Data Supporting PLA2R-CAART as a Potential Precision Therapy for Antigen-Specific B Cell Depletion…

By Dr. Matthew Watson

– Chimeric AutoAntibody Receptor (CAAR) T cells specifically recognized and eliminated anti-PLA2R antibody-expressing B cells in vitro –

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Cabaletta Bio Announces Presentation of Preclinical Data Supporting PLA2R-CAART as a Potential Precision Therapy for Antigen-Specific B Cell Depletion...

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Avadel Pharmaceuticals Announces Ongoing FDA Review of NDA for FT218 for Patients with Narcolepsy

By Dr. Matthew Watson

DUBLIN, Ireland, Oct. 15, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, announced today that the U.S. Food and Drug Administration (FDA) notified the company that the review of the New Drug Application (NDA) for FT218 is still ongoing, and action will likely not be taken in October. The FDA informed the company that there are no information requests at this time and a new target action date will be provided as soon as possible.

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Scientific Advisory Board Member Resigns Due to Conflict with Responsibilities with Important Public Sector Entity

By Dr. Matthew Watson

LOS ANGELES, Oct. 15, 2021 (GLOBE NEWSWIRE) -- (NASDAQ: ENOB) – Enochian BioSciences, a company focused on gene modified cellular and immune therapies for infectious diseases and cancer, announced that Dr. Peter Piot has resigned as Chairperson of the Respiratory Diseases Scientific Advisory Board due to important responsibilities advising a major governmental organization on COVID-19 that creates a conflict.

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