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March 1 represents Self-Injury Awareness Day (SIAD), an international awareness day that is dedicated to learning about behaviors like “cutting” and other intentional methods of self-injury —raising awareness and providing …
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Zero Discrimination Day is an observance marked annually on March 1 by United Nations among other international organisations to promote equality and fairness before the law . The day was …
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RegulatoryU.S FDA
Expert: Newly Appointed FDA Commissioner Robert Califf Is Perfectly Positioned to Advance the FDA’s Accelerated Approval Pathway
by adminby adminSummary : Peter Pitts, a former FDA associate commissioner and president of the Center for Medicine in the Public Interest, discusses the implications of Robert Califf’s appointment to lead the …
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EuropePharma Science & Research
NICE recommends cenobamate for treatment of adult epilepsy patients in UK
by adminby adminSummary : NICE has issued a positive recommendation for Arvelle Therapeutics’ cenobamate (Ontozry), for the treatment of focal-onset seizures in adults with uncontrolled epilepsy in England and Wales. The Final …
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Summary : Vaccine pioneers expand presence throughout Europe with a view to leveraging technology The biotechnology company, Moderna, has announced plans to expand its commercial network across six additional countries …
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Global MarketPharma Science & Research
Scancell gains new facilities at The Oxford Science Park
by adminby adminSummary : British biotech company Scancell has expanded its research and development capabilities at one of the UK’s leading parks for science and technology companies – the Oxford Science Park …
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Summary : Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human …
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Sanofi Inc.
Late-breaking phase 3 data at 2022 AAAAI Annual Meeting show Dupixent® (dupilumab) significantly reduced itch and hives in patients with chronic spontaneous urticaria
by adminby adminSummary : Late-breaking phase 3 data at 2022 AAAAI Annual Meeting show Dupixent® (dupilumab) significantly reduced itch and hives in patients with chronic spontaneous urticaria In this Phase 3 trial, Dupixent added to standard-of-care antihistamines nearly doubled reduction in …
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Global Market
ADDING MULTIMEDIA Capri EGM Acquires R&D Build-to-Suit for National Resilience, a Biomanufacturing Company Contracted by the DOD, Harvard, and Moderna
by adminby adminSummary : Capri EGM, an investment company specializing in corporate build-to-suit and sale leaseback financing and the acquisition of income-generating life science, R&D, and logistics real estate, has funded and …
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RegulatoryU.S FDA
GC Pharma Receives Complete Response Letter From the U.S. FDA For ‘ALYGLO’
by adminby adminSummary : GC Pharma (KRX:006280) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to its Biologics License …
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Global Market
Syniverse Is First to Offer a Cloud-Native, Hyperscale Digital Communications and Messaging Platform for Enterprises: Syniverse’s Hyperscale Communications Platform
by adminby adminSummary : New Syniverse CPaaS Platform to Accelerate Enterprises’ Digital Transformation and Improve Customer Experience The Syniverse Hyperscale Communications Platform allows enterprises to easily elevate their digital transformation to feature …
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Covid DrugsGskSanofi Inc.
Data delivery: Sanofi and GSK seek authorisation for COVID-19 vaccine
by adminby adminSynopsis : Pharma giants take major stride as vaccine shows significant increase in neutralising antibodies Sanofi and GlaxoSmithKline (GSK) have announced that they will submit data from both their booster …
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Summary : The Committee for Medicinal Products for Human Use (CHMP) has provided an initial assessment of Valneva’s inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Following the company’s response, the European …
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CompaniesJapanMerck & CoOthers
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Approved in Japan for Radically Unresectable or Metastatic Renal Cell Carcinoma
by adminby adminSummary : MSD outside the United States and Canada, and Eisai today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the combination of KEYTRUDA, Merck’s …
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Summary : One of Eli Lilly’s diabetes drugs just scored another win with the U.S. Food and Drug Administration to expand its use in the heart failure population. Jardience will …
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AstraZenecaCovid DrugsRegulatoryU.S FDA
FDA Adjusts EUA Dosing On Evusheld To Fight Omicron
by adminby adminSummary: The U.S. Food and Drug Administration (FDA) has revised its emergency use authorization (EUA) for AstraZeneca’s Evusheld to a higher dose to be effective in the prevention of COVID-19. …
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AbbVieCompaniesGlobal MarketPharma Science & Research
AbbVie Makes Moves to Increase Profits in 2022
by adminby adminSummary : Chicago-based AbbVie has been making major decisions with company-wide impacts. The therapeutic company appears to be making changes that will benefit its bottom line. AbbVie recently reported its …
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Summary: The U.S. Food and Drug Administration has approved the use of Purdue Pharma’s candidate injectable treatment for partially or completely reversing opioid drug effects. Nalmefene hydrochloride injection comes as …
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Covid DrugsGlobal MarketModernaPharma Science & Research
Moderna Projects COVID-19 Vaccine Sales at $19 Billion for 2022
by adminby adminSummary : Moderna only has a single marketed product, but it’s a blockbuster, for now at least. That product is the company’s mRNA vaccine against COVID-19, dubbed Spikevax. In today’s …
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Covid Drugs
US-Authorized COVID-19 Vaccines Generate More Than $30 Billion in 2021
by adminby adminSummary : The success of mRNA vaccines against COVID-19 has become a cash cow for Moderna, the Pfizer and BioNTech team and Johnson & Johnson. All three companies earned an …
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Pharma Science & Research
Research Collab Uncovers Underlying Mechanism for ALS and Dementia
by adminby adminSummary : For years, researchers interested in treating amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD) have struggled to understand why variants of the gene encoding protein UNC13A, critical for …
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Global MarketGsk
Medicago’s Plant-Based Vaccine Bolstered by GSK Adjuvant Wins First Approval
by adminby adminSummary : Canada’s Medicago scored a regulatory first after Health Canada approved its plant-based COVID-19 vaccine Covifenz that has been paired with GlaxoSmithKline’s pandemic adjuvant as a preventative treatment against …
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CompaniesPharma Science & ResearchTakeda
Takeda-Backed Biotech Grabs $24 Million for tRNA-Based Therapies
by adminby adminSummary : hC Bioscience, Inc., a company focused on discovering and developing tRNA-based therapies, announced that it has raised $24 million in Series A financing. The financing was led by …
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Global Market
LivaNova Announces First Patient Implanted in OSPREY Clinical Study for Patients Coping with Obstructive Sleep Apnea
by adminby adminSummary : LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology and innovation company, today announced the first patient implanted in the investigational device exemption (IDE) clinical study, “Treating Obstructive Sleep …
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CANbridge Pharmaceuticals Inc.CompaniesPharma Science & ResearchRegulatoryU.S FDA
CANbridge Announces Approval of CAN108 for Rare Liver Disease, Alagille Syndrome, Under the Early and Pilot Implementation Policy in Boao Lecheng International Medical Tourism Pilot Zone
by adminby adminSummary : CANbridge Pharmaceuticals, Inc. (“CANbridge”, stock code 1228.HK), a leading China-based global rare disease-focused biopharmaceutical company committed to the research, development and commercialization of transformative therapies, announced that CAN108 …
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Summary : Alejandro Antalich, Chief Executive Officer and Director of Biomind Labs, said: “We are pleased to have obtained our DTC eligibility, complementing our recent listing approval on the OTCQB …
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Merger / Acquisition
c-LEcta Announces That It Has Reached Agreement to Be Acquired by Kerry Group
by adminby adminSynopsis : Kerry Group acquires majority of the shares of c-LEcta GmbH. The previous management of c-LEcta remains on board. Acquisition promotes c-LEcta’s growth potential and allows access to new …
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Pharma Science & Research
American Oncology Network (AON) and VieCure Announce Strategic Collaboration to Accelerate Adoption of Precision Oncology and Personalized Cancer Care
by adminby adminSummary : Collaboration offers clinicians access to a state-of-the-art, cloud based oncology decision support platform that fully integrates the latest codified clinical content and generates patient specific treatment plans at …
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Global MarketLaunchRegulatory
Gunze Launches TENALEAF™ Absorbable Adhesion Barrier in Japan
by adminby adminSummary : Gunze Limited (Headquarters: Osaka, Japan, President: Toshiyasu Saguchi) [TOKYO: 3002] is pleased to announce that Gunze has obtained medical device approval to manufacture and sell TENALEAF™, the first …
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Global Market
Lysogene Provides Update on Efficacy, Safety and Timelines of the AAVance Phase 2/3 Clinical Trial with Gene Therapy LYS-SAF302 for the Treatment of MPSIIIA
by adminby adminSummary : Topline data of the main cohort of AAVance clinical trial expected in Q3 2022 Stabilization or decreased size of white matter abnormalities observed at injection points for all …
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Global MarketModerna
Moderna Cleared to Bring RSV Vaccine to Pivotal Phase III Trial
by adminby adminSummary : Moderna is poised to begin Phase III of its pivotal clinical trial for its candidate vaccine for respiratory syncytial virus (RSV) in adults ages 60 years and up. …
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AstraZenecaCompaniesGlobal MarketPharma Science & Research
AstraZeneca in the News: EMA Greenlights RSV Vaccine, Leif Johansson Departing
by adminby adminSummary : AstraZeneca and Sanofi secured accelerated authorization for respiratory syncytial virus (RSV) antibody nirsevimab from the European Medicines Agency. Nirsevimab was greenlit to prevent medically attended lower respiratory tract …
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Pharma Science & Research
Autoimmune diseases: discovery of central building block in immune cells
by adminby adminAutoimmune diseases are triggered when the immune system malfunctions and attacks the body’s own structures. Although there is not, as yet, any cure for such diseases, their progression can be …
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Summary – Takeda and Code Biotherapeutics announced a collaboration agreement to leverage the latter’s proprietary targeted 3DNA® non-viral genetic medicine delivery platform for the design and development of gene therapies …
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Summary : Colombia became the latest country in Latin America to expand access to abortion Monday as the nation’s Constitutional Court voted to legalize the procedure until the 24th week …
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Summary : Hong Kong will test its entire population for COVID-19 in March, the city’s leader said Tuesday, as the city grapples with its worst outbreak driven by the omicron …
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Summary – Of course, Xiaomi is not far behind, they too have similar offerings (and they have smart shoes) and the latest in the line is their Performance T-Shirt. Xiaomi’s …
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Covid DrugsWHO
EU countries agree to admit travellers vaccinated with WHO-approved Covid shots
by adminby adminSummary : European Union countries agreed on Tuesday to open their borders to travellers from outside the bloc who have had shots against COVID-19 authorised by the World Health Organization, …
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GskLaunch
GSK announces independent Consumer Healthcare company is to be called Haleon
by adminby adminSynopsis : GlaxoSmithKline plc (GSK) today announced that the new company, to result from the proposed demerger of Consumer Healthcare from GSK in mid-2022, will be called Haleon. Haleon will …
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Summary : A new study shows why certain NK cells are activated when encountering a cell infected with SARS-CoV-2. The infected cells contain a peptide from the virus that triggers …
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Global MarketMerger / Acquisition
Tesis Biosciences Acquires Genome Explorations to Accelerate Clinical Research and Product Development for Chronic Disease Cures
by adminby adminSynopsis: Tesis Biosciences, the leader in targeted genetic sequencing, has acquired Genome Explorations, a premier research institution providing global genomic profiling and molecular diagnostics services. The acquisition, which aligns with …
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EuropeModerna
Moderna Announces Plan to Expand Commercial Footprint in Europe Across Six Additional Countries
by adminby adminSynopsis : Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced plans to expand its commercial network across six additional countries in Europe. Moderna plans to …
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CompaniesEli Lilly
ImmunoGen Announces a Global, Multi-Target License Agreement of its Novel Camptothecin ADC Platform to Lilly for Up to $1.7 Billion
by adminby adminSynopsis : ImmunoGen Inc., a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, announced a global, multi-year definitive licensing agreement whereby it granted Eli …
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Global MarketPharma Science & Research
Recipharm expands its advanced therapy medicinal products (ATMPs) offering into Virotherapies with the acquisition of Vibalogics
by adminby adminSummary : Recipharm, a global contract development and manufacturing organisation (CDMO), is continuing to build its service offerings in new biologic modalities through the acquisition of Vibalogics, a virotherapy CDMO …
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Global MarketMerger / Acquisition
Recipharm acquires Arranta Bio, a CDMO leader in advanced therapy medicinal products (ATMPs), to expand its biologics offering in the US
by adminby adminSynopsis : Recipharm, a leading global contract development and manufacturing organisation (CDMO), announced the acquisition of Arranta Bio, a prominent advanced therapy CDMO. Under the stewardship of Mark Bamforth and …
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BioNTechCompaniesGlobal MarketPharma Science & Research
BioNTech and Medigene announce global collaboration to advance T cell receptor immunotherapies against cancer
by adminby adminSummary – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Medigene AG (FSE: MDG1, Prime Standard, “Medigene”), a clinical-stage immuno-oncology company focusing on the development of T cell immunotherapies, today announced that …
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BayerPharma Science & Research
Bayer delivers on medical innovation fueling transformation of pharma business
by adminby adminSummary : At its annual Pharma Media Day 2022, Bayer presented the latest developments in the ongoing transformation of its pharmaceuticals business, which is aimed at delivering long-term, sustainable business …
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Pharma Science & Research
Alexion and UK patient advocacy groups launch video campaign
by adminby adminSummary : Rare Disease Day has inspired a pioneering video to support patients living with rare conditions Alexion Pharma UK has launched a new video titled–‘Reforming Rare Diseases: Making the …
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CompaniesGlobal MarketNovartis
Syncona announces sale of portfolio company to Novartis
by adminby adminSynopsis : Syncona – a company focused on founding, building and funding global leaders in life science – has announced the sale of its portfolio company, Gyroscope Therapeutics Holdings plc. …
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Global MarketIndiaRegulatoryU.S FDA
Covaxin gets nod for human clinical trials in the US
by adminby adminSummary : After a long wait, Bharat Biotech’s Covaxin has finally got the nod from the US Food and Drug Administration (USFDA) to conduct clinical trials in humans for its …