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Daiichi SankyoRegulatoryU.S FDA
FDA Grants Regular Approval to Fam-Trastuzumab Deruxtecan-Nxki(Enhertu) for Breast Cancer
by adminby adminSummary: Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either …
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Merger / Acquisition
Lilly Pumps $700M into Boston-Based RNA Therapeutics Facility
by adminby adminSummary: Eli Lilly and Company is investing $700 million to build a state-of-the-art facility in Boston’s seaport as part of plans to advance its RNA-based research and development activities. The …
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RegulatoryU.S FDA
Phathom Pharmaceuticals Announces FDA Approval of VOQUEZNA™ TRIPLE PAK™ (Vonoprazan, Amoxicillin, Clarithromycin) and VOQUEZNA™ DUAL PAK™ (Vonoprazan, Amoxicillin) for the Treatment of H. pylori Infection in Adults
by adminby adminSummary : The FDA approved two vonoprazan-based regimens, one with amoxicillin and clarithromycin (Voquezna Triple Pak) and one with amoxicillin (Voquezna Dual Pak), for the treatment of Helicobacter pylori (H. …
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Bristol Myers SquibbCompaniesMerck & CoMerger / Acquisition
BMS and Merck Buy Big Into Amphista’s Protein Degradation Platform with 2.3 Billion Collab
by adminby adminSummary : Bristol Myers Squibb and Merck KGaA are diving deeper into the protein degradation pool, with both inking partnerships with Amphista Therapeutics that together could bring in $2.3 billion for …
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RegulatoryU.S FDA
Supernus Announces FDA Approval of Qelbree®(Viloxazine) for the Treatment of ADHD in Adults
by adminby adminSummary : Qelbree (i.e. SPN-812) is a nonstimulant ADHD medication containing a serotonin norepinephrine modulating agent approved by the FDA to treat attention deficit hyperactivity disorder (ADHD or ADD) in patients 6 …
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Bristol Myers SquibbRegulatoryU.S FDA
BMS Scores FDA Approval for Novel HCM Treatment Camzyos (Mavacamten)
by adminby adminSummary : Camzyos (mavacamten), the first FDA-approved cardiac myosin inhibitor that directly addresses the root of obstructive hypertrophic cardiomyopathy, has been authorised by the US Food and Drug Administration (HCM). …
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CompaniesEuropeEurope Medicine Agency (EMA)Pfizer
Pfizer and Biohaven’s VYDURA® (Rimegepant) Granted First ever Marketing Authorization by European Commission for both Acute Treatment of Migraine and Prophylaxis of Episodic Migraine
by adminby adminSummary : Pfizer Inc. and Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced that the European Commission (EC) has granted marketing authorization for VYDURA® (rimegepant), a calcitonin gene-related peptide …
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EuropeEurope Medicine Agency (EMA)
Myovant Sciences Announces European Commission Approval for ORGOVYX® (Relugolix) for the Treatment of Advanced Hormone-Sensitive Prostate Cancer
by adminby adminSummary : ORGOVYX® is the first and only oral and rogend privation therapy for advanced hormone-sensitive prostate cancerin Europe Myovant expects to secure European commercialization partner ahead of anticipated launches ORGOVYX® blocks the …
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Summary : HYFTOR™ is the first topical treatment approved by the FDA for facial angiofibroma in individuals with tuberous sclerosis complex (TSC) 6 years and older Sirolimus is an mTOR inhibitor immunosuppressant …
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Summary : The Venus VivaTM will now make its American premiere, having already established itself as a pioneer in the worldwide medical aesthetics sector among cutting-edge plastic surgeons, dermatologists, and …
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Global MarketPatent LitigationPatents
FMC Corporation Wins Patent Infringement Case Against Udragon for Chlorantraniliprole
by adminby adminSummary : The Hangzhou Intermediate People’s Court in Zhejiang Province, China, awarded FMC a permanent injunction against Hangzhou Udragon Chemical Co., Ltd and Zhejiang Udragon Bioscience Co., Ltd, according to …
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Global MarketRegulatoryU.S FDA
Sol-Gel Technologies and Galderma’s EPSOLAY® Scores US FDA Approval
by adminby adminSummary: EPSOLAY (benzoyl peroxide, cream, 5%) utilizes Sol-Gel’s proprietary microencapsulation technology for the treatment of inflammatory lesions of rosacea and is patent protected until 2040 Galderma set to commercialize EPSOLAY in …
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Covid DrugsGileadRegulatoryU.S FDA
Gilead’s Veklury Becomes the First FDA-approved COVID-19 Treatment for Infants
by adminby adminSummary : The first treatment for COVID-19 in young children has been approved by the US Food and Drug Administration. In this situation, the FDA increased the use of Gilead …
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Merger / AcquisitionPiramal Group
Piramal Pharma To Acquire Hemmo Pharma For Rs 775 Cr
by adminby adminSummary : Piramal Enterprises said in a regulatory filing on Wednesday that its subsidiary Piramal Pharma Ltd has signed into a deal to acquire a 100 percent ownership in Hemmo …
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Alembic PharmaMerger / Acquisition
Alembic Pharma acquires 100% stake in Aleor Dermaceuticals
by adminby adminSummary : The company has acquired remaining 40 per cent stake from Orbicular Pharmaceutical Technologies, to have 100 per cent holding in Aleor, which has presence across cream, gel, ointment, …
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CompaniesIndiaMerger / AcquisitionNovartis
Dr. Reddy’s will Pay Rs 463 Crore for Novartis’ Cardiovascular Drug Cidmus (Valsartan +Sacubitril)
by adminby adminSummary Dr Reddy’s Laboratories, an Indian generic pharmaceutical company, has agreed to pay $61 million to Novartis AG for the cardiovascular brand Cidmus (approximately Rs 463 crore). This comes weeks …
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Summary : AbbVie has terminated its collaboration agreement with BioArctic in the development of alpha-synuclein antibodies for Parkinson’s disease and other movement disorders. BioArctic has already announced the news through …
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RegulatoryU.S FDA
Alymsys® (Bevacizumab-maly), a Biosimilar of Bevacizumab developed by mAbxience, has been Approved by the FDA.
by adminby adminSummary : ALYMSYS® was developed by mAbxience, a global biotech company with over a decade of experience in the development, manufacture, and commercialization of biopharmaceuticals. Bevacizumab-maly is a vascular endothelial growth …
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Amgen Inc.Merger / Acquisition
Amgen has bought Five Prime Therapeutics for $1.9 Billion
by adminby adminSummary : Five Prime’s lead asset, Bemarituzumab, is a first-in-class, Phase 3 ready anti-FGFR2b antibody with positive data from a randomized, placebo-controlled Phase 2 study in frontline advanced gastric or …
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Merger / Acquisition
Halozyme has agreed to Acquire Antares Pharma for $960 million.
by adminby adminSummary : Halozyme Therapeutics has announced a formal agreement to acquire all of Antares Pharma’s outstanding shares in a deal worth about $960 million in cash, or $5.60 per share. …
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CompaniesMerger / AcquisitionPfizer
Pfizer Acquire ReViral for $ 525 Millon and its Respiratory Syncytial Virus Therapeutic Candidates Sisunatovir
by adminby adminSynopsis : Under the terms of the agreement, Pfizer will acquire ReViral for a total consideration of up to $525 million, including upfront and development milestones. Pfizer Inc. and ReViral …
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Synopsis : GlaxoSmithKline plc and Sierra Oncology, Inc have announced that GSK will acquire Sierra Oncology, a California-based late-stage biopharmaceutical company focused on targeted therapies for the treatment of rare …
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Covid DrugsRegulatoryU.S FDA
The First COVID-19 Diagnostic Test Employing Breath Samples has been Approved by the US Food and Drug Administration.
by adminby adminSummary : Food and Drug Administration on Apr 14 issued an emergency use authorization It said is the first device that can detect COVID-19 in breath samples The InspectIR COVID-19 …
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BrazilPatents
INPI Publishes an Update on the Terms of Patent Protection for Pharmaceutical and Non-Pharmaceutical Claims.
by adminby adminSummary: On February 8, 2022, the National Institute of Industrial Property (INPI) published a notice in Gazette 2666 detailing new rules for updating the patent term of applications that include …
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Patent LitigationPatents
Seagen Scores $41.8M in Enhertu Patent Case Against Daiichi Sankyo
by adminby adminSummary : A federal jury has awarded biotechnology company Seagen Inc. $41.8 million in a patent infringement lawsuit against Daiichi Sankyo Co. LTD for infringing on a patent developed by …
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Active Agrochemical IngredientSpirobudifenTiorantraniliprole
New Agrochemical Discovery Candidates – New ISO Published in 2022 – Spirobudifen (Tetronic acid Acaricide) & Tiorantraniliprole (Diamide insecticides)
by adminby adminNew Agrochemical Discovery Candidates – New ISO Published in 2022 Spirobudifen (Acaricide) & Tiorantraniliprole (Diamide insecticides) April 2022 BCPC – Compendium of Pesticide Common Names published new Agrochemical discovery acaricides …
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RegulatoryU.S FDA
First Generic of Symbicort (Budesonide and Formoterol Fumarate Dihydrate) Receives FDA Approval
by adminby adminSummary : The U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol to treat asthma in patients 6 years and older …
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BayerFluoxapiprolin
Australia to Approves Bayer’s Xivana Prime 20 SC Fungicide containing Fluoxapiproline
by adminby adminSummary : The Australian Pesticides and Veterinary Administration (APVMA) has proposed approval of Bayer CropScience Pvt Ltd’s fungicide Xivana Prime 20 SC, which contains 20 g/l of the new active …
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CompaniesIntellectual Property (IP)Patent LitigationPatentsSandoz
Sandoz and Teva Invalidate Patent and SPC of Blockbuster Apixaban
by adminby adminSummary : EP 1,427,415 was assigned to BMS and is set to expire on September 17, 2022. On May 19, 2026, the corresponding SPC (SPC/GB11/042) would expire. The patent claims …
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Global Market
The International PCT Patent Application for Inhalation Delivery of Multiple Psychedelic Molecules has been published by Cybin.
by adminby adminSummary : Cybin (Cybin or the Company), a biopharmaceutical company focused on bringing “Psychedelics to TherapeuticsTM,” announced today that the World Intellectual Property Organization (WIPO) has published an international patent …
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PatentsPharma Science & Research
Janssen Wins Darzalex Royalties Arbitration Battle Against Genmab
by adminby adminSummary : Janssen Pharmaceutical, a division of Johnson & Johnson, won an arbitrary victory against royalty choices arising from the licencing and marketing of daratumumab, an anti-CD38 monoclonal antibody therapy …
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Agro Science & ResearchUPL Ltd
UPL Launches UPLIFT Dual Action Fungicide In Australia for Wheat and Barley Crop
by adminby adminSummary : UPL an Agrochemical Pioneer launches UPLIFT Fungicide, the formulation of Azoxystrobin and Prothioconazole whose action will be on wheat and barley Crop . About UPLIFT Fungicide UPLIFT is …
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LaunchSWAL Corporation Limited
SWAL – Subsidiary of UPL Launch TRISHUK India’s First 3 Way Action Sugarcane Herbicide .
by adminby adminSummary : To solve the problems of sugar cane farmers, SWAL Corporation Limited (Part of UPL) launched Trishuk – a weed control solution. The innovative product is India’s first 3-way …
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NufarmTrifluralin
APVMA Approves Nufarm’s TriflurX (Trifluralin Herbicide) For Use on Oat Growers
by adminby adminSummary : The use of trifluralin in 2022 and beyond was secured for oat growers after Nufarm received registration of its herbicide TriflurX from the Australian Pesticides and Veterinary Medicines …
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KitoZymeU.S. EPA
KitoGreen, a Biopesticide Developed by KitoZyme, has received EPA Approval.
by adminby adminSummary : KitoZyme, the world’s first and largest producer of high-quality fungal chitosan, has received EPA certification for its KitoGreen products as biopesticides for a variety of applications and crops. …
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Mankind Pharma
Mankind Pharma Makes a Move into the Agri-Tech Sector Plans to Invest Rs 200 Crore.
by adminby adminSynopsis : Mankind Pharma is planning to invest up to Rs 200 crore in the first two to three years in the agri-tech sector. Mankind Agritech Pvt Ltd, a new …
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CompaniesMerger / AcquisitionNovartis
Sandoz Acquires Drug Delivery Device Firm Coalesce
by adminby adminSummary : Sandoz acquired the capabilities and assets of drug delivery device company, Coalesce, to further its existing portfolio of respiratory medicines and improve overall patient access. This acquisition will …
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Global MarketMerger / Acquisition
MGK, a subsidiary of Sumitomo – Procure DeBug Brands from Agro Logistic Systems
by adminby adminSummary MGK, a subsidiary of Sumitomo Chemical Company, purchased the DeBug brand of neem products from Agro Logistic Systems. The DeBug products add to MGK’s current botanical portfolio, which includes …
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Europe Medicine Agency (EMA)Regulatory
EMA establishes a Cancer Medicines Forum to optimize Cancer Treatments in Clinical practice
by adminby adminSummary EMA has launched the Cancer Medicines Forum (CMF) in collaboration with the European Organization for Research and Treatment of Cancer (EORTC). The forum, which brings together representatives from academic …
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Summary French agribusiness group InVivo has entered exclusive negotiations to merge its retail activities with 2MX Organic (2MX.PA), an acquisition vehicle backed by French telecoms billionaire Xavier Niel, the companies …
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437 RC meetingCIBRC - Indian Pesticide ApprovalsRC Meeting updates
INDIA CIBRC UPDATES – MINUTES OF THE 437th REGISTRATION COMMITTEE (RC) MEETING HELD ON 16.03.2022.
by adminby adminMINUTES OF THE 437th REGISTRATION COMMITTEE (RC) MEETING HELD ON 16.03.2022. The 437th meeting of the Registration Committee (RC) was held under the Chairmanship of Dr. S. K. Malhotra, Chairman, …
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Global Market
Indonesia, Malaysia agree their palm oil prices should not compete – Malaysia PM
by adminby adminSummary : Malaysia and Indonesia agreed that global prices of palm oil should be determined by the two biggest exporters and they should not compete, Prime Minister Ismail Sabri Yaakob …
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Synopsis : Biotalys (Euronext: BTLS), an Agricultural Technology (AgTech) company protecting crops and food with protein-based biocontrol solutions, is pleased to announce the appointment of Dr. Carlo Boutton as Chief …
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Clean Seed Capital Group Ltd.Global Market
With Canada West Harvest Centre taking on Saskatchewan distribution, Clean Seed Capital Group increases its Smart Seeder MaxTM dealer network.
by adminby adminSummary : Clean Seed Capital Group Ltd. (“Clean Seed” or the “Company”) (TSX-V: CSX) announced that it will promote the SMART Seeder MAXTM in collaboration with Canada West Harvest Centre …
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AscenzaLaunch
In Brazil, Ascenza’s multisite fungicide has been licenced for minor crops.
by adminby adminSummary : Cuprital 700, a protective multisite fungicide/bactericide, has been approved for use in fruits and vegetables, as well as large crops, by the company Ascenza Brasil, which is owned …
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India
Govt Plans to bring out “Climate-resilient” Natural Farming Programme in Tribal Districts
by adminby adminSummary : According to authorities, the Odisha government plans to launch a “climate-resilient” natural farming programme in tribal-dominated parts of five districts as a step toward sustainable agriculture. According to …
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Agro Science & ResearchGlobal Market
PepsiCo and N-Drip are partnering to bring water-conserving, yield-enhancing benefits to farmers in India
by adminby adminSynopsis : PepsiCo India and N-Drip, makers of an innovative gravity-driven micro-irrigation system, have announced a partnership ahead of World Water Day 2022 to help farmers in India adopt breakthrough …
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India
Dhanuka signs MoU with SKN Agricultural University for verification of new technology : India
by adminby adminSummary : On March 24, 2022, R G Agarwal, Chairman, Dhanuka Agritech Limited, and Dr J S Sandhu, Vice Chancellor, Sri Karan Narendra Agriculture University (SKNAU) Jobner signed a Memorandum …
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Agro Science & ResearchGlobal Market
AMVAC, BASF collaborate to develop Rhizo-Flo soybean inoculant solution
by adminby adminSummary : AMVAC® and BASF have announced a partnership to create Rhizo-Flo® granular soybean inoculant, which will be a welcome addition to the SIMPAS-applied SolutionsTM portfolio. Rhizo-Flo is a revolutionary …
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Synopsis Zulfikar, Director LULU group of Hypermarket declared that due to positive approach of Assam Government and APEDA, it is decided to start trials of sourcing Ginger from Assam, the …