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RegulatoryU.S FDA
J&J, Legend Introduce New CAR-T Therapy to Multiple Myeloma Market
by adminby adminSummary : Johnson & Johnson’s partner, Legend Biotech, has been awarded U.S. Food and Drug Administration approval for its chimeric antigen receptor T-cell (CAR-T) therapy, Carvykti, for the treatment of …
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GileadRegulatoryU.S FDA
FDA Rejects Gilead’s Long-Acting HIV Drug Over Vial Issues
by adminby adminSummary : The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Gilead Sciences rejecting its New Drug Application (NDA) for lenacapavir. The NDA was under review …
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AbbVieCompaniesMerger / Acquisition
AbbVie Bolsters Neuro Platform with $1B Syndesi Buy
by adminby adminSummary : AbbVie has bolstered its neuropsychiatric and neurodegenerative portfolio with the acquisition of Belgium-based Syndesi Therapeutics in a deal valued at up to $1 billion. With an upfront payment …
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Global Market
Winners Announced in 16th Annual Stevie® Awards for Sales & Customer Servicef
by adminby adminWinners Announced in 16th Annual Stevie® Awards for Sales & Customer Service New Categories for 2022 Recognize Thought Leadership FAIRFAX, Va., March 01, 2022 (GLOBE NEWSWIRE) — Winners in the …
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Global MarketPharma Science & Research
SAB Biotherapeutics Announces Publication of Nonclinical Data Demonstrating SAB-185 Has High Potency for Effectively Neutralizing Circulating and Emerging SARS-CoV-2 Variants
by adminby adminSummary : – In the FDA-conducted study, SAB-185 consistently demonstrated high avidity and high potency for effectively neutralizing a broad range of SARS-CoV-2 strains and variants through Delta -SAB-185 additionally …
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Global Market
Bruker Releases CCS-Enabled TIMScore™ and TIMS DIA-NN 4D Proteomics Software
by adminby adminSummary : Bruker PaSER™ 2022 software now features TIMS DIA-NN processing for dia-PASEF® Innovative TIMScore for dda-PASEF and dia-PASEF libraries, combined with TIMS DIA-NN identifies ~9000 protein groups from 200 …
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Pharma Science & Research
MEI Pharma Announces Inducement Grant under Nasdaq Listing Rule 5635(c)(4)
by adminby adminSynopsis : MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today announced the grant of inducement stock options for an aggregate of …
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Pharma Science & Research
Booster critical as COVID-19 vaccine-induced antibodies wane in 6 months, don’t protect against omicron
by adminby adminSummary : A new study using serum from human blood samples suggests neutralizing antibody levels produced by two-dose mRNA vaccines against the original and early variants of the SARS-CoV-2 virus …
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Summary : As the COVID-19 pandemic continues to claim lives around the world, dairy scientists may have a surprising role to play. In a new report published in the Journal …
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Pharma Science & Research
Healthy gut microbiome improves success of cancer treatment
by adminby adminSummary : The largest study to date has confirmed the link between the gut microbiome and the response to cancer immunotherapy therapy for melanoma. The study is published today in …
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RegulatoryU.S FDA
Aquestive Therapeutics Presented Positive Topline Phase 1 Results for AQST-109 Epinephrine Oral Film at American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting
by adminby adminSummary : Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, presented …
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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 …