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Active Agrochemical IngredientAgrochemical Discovery Candidates (New ISO)Flusulfinam
NEW ISO HERBICIDE CANDIDATE PUBLISHED AUGUST 2022 – FLUSULFINAM FROM CHINESE PLAYER QINGDAO KINGAGROOT CHEMICAL
by adminby adminNew ISO Candidate Published August 2022 – Flusulfinam: New herbicide candidate from Qingdao Kingagroot Chemical Compound Co., Ltd., China Suflufenam (generic name: Flusulfinam; trade name: Daopurui®) is the latest generation …
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AstraZenecaRegulatoryU.S FDA
ENHERTU® Approved in the U.S. as the First HER2 Directed Therapy for Patients with HER2 Low Metastatic Breast Cancer
by adminby adminSynopsis: Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and increased overall survival by more than six months …
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Pharma Science & ResearchSanofi
Sanofi and Innovent Biologics Enter Strategic Collaboration
by adminby adminSanofi and Innovent Biologics have announced a collaboration that will bring innovative medicines to patients in China with difficult-to-treat cancers. Innovent is a biopharmaceutical company with strong clinical development capabilities …
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Marius PharmaceuticalsRegulatoryU.S FDA
Marius Pharmaceuticals Receives FDA Approval of KYZATREX™, an Oral Testosterone Replacement Therapy
by adminby adminSummary : Marius Pharmaceuticals, a patient-centric healthcare company, today announced the approval of KYZATREX™ (testosterone undecanoate) by the U.S. Food and Drug Administration (FDA). KYZATREX™ is an oral testosterone replacement …
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CompaniesGlobal MarketGsk
GSK Signs Agreement to Support Pandemic Preparedness in Europe
by adminby adminSummary: GSK plc (LSE/NYSE: GSK) announced it had signed a framework contract with the European Commission’s (EC) Health Emergency Preparedness and Response Authority (HERA) for the reservation of future production …
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Pharma Science & ResearchRegulatoryU.S FDA
FDA Grants Coherus’ CIMERLITM (Ranibizumab-eqrn) 12 Months of Interchangeability Exclusivity as the First and Only Interchangeable Biosimilar to Lucentis® for all Five Indications.
by adminby adminSynopsis : CIMERLI™ is Coherus’ third FDA-approved product and the first of four new product launches planned by the end of 2023 First CIMERLI™ product sales expected in October 2022 …
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Agro Science & Research
Iconovo Receives $883,800 Grant from the Bill & Melinda Gates Foundation
by adminby adminSummary: Iconovo has revealed that it has received a grant of $883,800 from the Bill & Melinda Gates Foundation to develop a low-cost device that can enable the delivery of …
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Global Market
MHRA Grants Marketing Authorisation for Global Blood Therapeutics’s Oxbryta (Voxelotor)
by adminby adminSummary: Voxelotor is the first medicine in Britain to directly inhibit sickle haemoglobin polymerisation Global Blood Therapeutics (GBT) has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has …
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AstraZenecaMerger / Acquisition
AstraZeneca to Acquire TeneoTwo and its Clinical-stage T-cell Engager TNB-486
by adminby adminSummary : AstraZeneca announced an agreement to acquire TeneoTwo, Inc. (TeneoTwo)i, including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluation in relapsed and refractory B-cell non-Hodgkin lymphoma. …
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BayerMerger / Acquisition
Bayer to Sell Men’s Health Product Nebido™ to Grünenthal for 500 Million Euro.
by adminby adminSummary : Bayer and Grünenthal have entered into a definitive agreement regarding the sale of Bayer’s men’s health product Nebido™ (testosterone undecanoate), for a purchase price totaling up to 500 …
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Boehringer IngelheimCompaniesGlobal MarketPharma Science & Research
Boehringer Ingelheim, Evotec and BioMérieux Launch Aurobac, a joint venture to fight Antimicrobial Resistance
by adminby adminSummary : Boehringer Ingelheim, a leading research-driven biopharmaceutical company, the life science company Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and bioMérieux, a world leader in …
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Active Agrochemical IngredientAgrochemical Discovery Candidates (New ISO)IptriazopyridNissan Chemical
New ISO Candidate July 2022 Update – Japanese Nissan Chemical: Iptriazopyrid – New Herbicide Candidate Published
by adminby adminJuly 20, 2022 – Japanese Nissan Chemical: Iptriazopyrid – New Herbicide Candidate Published. The Japanese player filed their international patent covering Iptriazopyrid in 2014, e.g. WO2014192936. The company also filed …
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RegulatoryU.S FDA
FDA Approved ZONISADE™ (Zonisamide Oral Suspension) of AZURITY PHARMACEUTICALS, INC.
by adminby adminSummary : The first and only FDA-approved zonisamide oral liquid formulation 100 mg/5 mL as adjunctive therapy for the treatment of partial seizures in adults and pediatric patients aged 16 …
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RegulatoryU.S FDA
The U.S. FDA has Approved Opzelura(Ruxolitinib) Cream by Incyte for the Treatment of Vitiligo.
by adminby adminSynopsis : Opzelura is the first and only FDA-approved product for repigmentation in nonsegmental vitiligo Phase 3 data supporting the approval show treatment with Opzelura resulted in improvements in facial …
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Summary : GSK plc announced it has completed the acquisition of Sierra Oncology, Inc. (Sierra Oncology), a California-based biopharmaceutical company focused on targeted therapies for the treatment of rare forms …
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Global MarketRegulatoryU.S FDA
Elite Pharmaceuticals Receives FDA Approval for Generic Sabril(R)
by adminby adminSummary : Elite Pharmaceuticals, Inc. (“Elite” or the “Company”) (OTCQB:ELTP), a specialty pharmaceutical company developing niche generic products, today announced that it received approval from the US Food and Drug …
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RegulatoryU.S FDA
The FDA Designated PT886 from Phanes Therapeutics as an Orphan Drug for the Treatment of Pancreatic Cancer.
by adminby adminSynopsis : The U.S. Food and Medication Administration (FDA) has designated PT886 as an orphan drug for the treatment of pancreatic cancer, according to Phanes Therapeutics, Inc. (Phanes), an up-and-coming …
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Global MarketRegulatoryU.S FDA
Beyond Air’s LungFit® PH Receives FDA Approval to Treat Term and Near-Term Neonates with Hypoxic Respiratory Failure
by adminby adminSummary : First and only nitric oxide generator and delivery system indicated for the treatment of termand near-term neonates with hypoxic respiratory failure that uses ambient air to provide unlimited, on-demand …
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IndiaPatent Litigation
Panacea Biotec Files Suit against Sanofi for Patent Infringement for EasySix Vaccine
by adminby adminSummary : Panacea Biotec on Monday said it has filed a suit before the Delhi High Court seeking to restrain Sanofi Healthcare India from marketing a fully liquid hexavalent vaccine. …
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Bristol Myers SquibbRegulatoryU.S FDA
U.S. FDA Approves Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi®(lisocabtagene maraleucel) for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy
by adminby adminSynopsis: In the pivotal Phase 3 TRANSFORM trial, single infusion of Breyanzi significantly outperformed the nearly 30-year standard of care with median event-free survival of 10.1 months vs. 2.3 months …
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Insecticide Resistance Action Committee (IRAC)Resistance Action Committee (RAC)
Insecticide Resistance Action Committee (IRAC) – Published New Mode of Action Classification – Now including Nematicides 2022
by adminby adminInsecticide Resistance Action Committee (IRAC) – Published New Mode of Action Classification – Now including Nematicides 2022 The Insecticide Resistance Action Committee published – Mode of Action (MOA) Classification Brochure …
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AdamaBrazilCombination ProductsGlobal MarketLaunch
ADAMA Launches Combination Herbicide Apresa (flumioxazine + S-metolachlor) in Brazil
by adminby adminSummary : Apresa, a premium pre-emergent herbicide for various crops with an exclusive combination of active chemicals (Flumioxazin + S-metolachlor), was introduced by ADAMA in Brazil. About Apresa Active Chemicals …
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CompaniesGlobal MarketMerck & CoRegulatoryU.S FDA
Merck Scores FDA Approval for Vaxneuvance ( Pneumococcal 15-valent conjugate vaccine) for Ages 6 Weeks through 17 Years
by adminby adminSummary : The FDA today approved the pneumococcal 15-valent conjugate vaccine for the prevention of invasive pneumococcal disease in infants and children. Clinical data supporting approval demonstrated non-inferior immune responses …
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AbbVieCompaniesRegulatoryU.S FDA
AbbVie’s Skyrizi (risakizumab-rzaa) Becomes First FDA-Approved IL-23 Inhibitor for Crohn’s Disease
by adminby adminSummary : Third approved indication for SKYRIZI (risankizumab-rzaa) is supported by safety and efficacy data from two induction and one maintenance clinical trials evaluating SKYRIZI in moderately to severely active …
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Active Agrochemical IngredientAgrochemical Discovery Candidates (New ISO)Pyriflubenzoxim
New ISO June 2022 Published – Pyriflubenzoxim Herbicide from Chinese Player Jiangsu Agrochem Laboratory
by adminby adminNew ISO June 2022 – Pyriflubenzoxim Herbicide from Chinese Player Jiangsu Agrochem Laboratory Pyriflubenzoxim is a new candidate in pyrimidinyl benzoate chemical class from Chinese Player Jiangsu Agrochem Laboratory Co., …
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Active Agrochemical IngredientAgrochemical Discovery Candidates (New ISO)Qingdao KingAgroot Chemical Compound
New ISO Published June 2022 – Flufenoximacil Herbicide from Chinese Player Qingdao KingAgroot Chemical Compound Ltd.
by adminby adminJune 2022 – Qingdao KingAgroot Chemical Compound Co., Ltd. published a new ISO 1750 (provisionally approved) – Flufenoximacil Herbicide. The Flufenoximacil compound belongs to phenyluracil chemical class of herbicide. The …
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The British Big Pharma has launched an innovative rebranding, a tech-flavoured logo, and an impactful transformation for the future as GlaxoSmithKline turns GSK and eliminates its consumer unit. GSK has …
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RegulatoryU.S FDA
FDA Approves First Systemic Treatment Olumiant (Baricitinib) for Alopecia Areata
by adminby adminSummary : The U.S. Food and Drug Administration approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness and …
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RegulatorySetmelanotideU.S FDA
Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (Setmelanotide) for Use in Patients with Bardet-Biedl Syndrome
by adminby adminSummary : IMCIVREE now available for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to Bardet-Biedl syndrome . …
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Global MarketIntellectual Property (IP)Patents
Johnson & Johnson, Momenta Pharma File Patent Infringement Lawsuit Against Natco, Mylan in US for Glatiramer Acetate Injection.
by adminby adminSummary : Johnson & Johnson and Momenta Pharmaceuticals lawsuit alleges infringement of two old patents associated with 20mg/ml and 40mg/ml Glatiramer Acetate injection, Natco said in a regulatory filing. Glatiramer …
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RegulatoryU.S FDA
Alnylam Scores Another FDA Nod for Amvuttra (Vutrisiran) for the Treatment of Hereditary Transthyretin-Mediated Amyloidosis (hATTR)
by adminby adminSummary : Amvuttra (vutrisiran) from Alnylam Pharmaceuticals has been licenced by the US Food and Drug Administration for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy in adults. This …
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RegulatoryRocheU.S FDA
FDA Approves Roche’s Evrysdi for Use in Babies under Two Months with Spinal Muscular Atrophy (SMA)
by adminby adminSummary : Roche announced that the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under two months old with spinal muscular …
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Active Agrochemical IngredientFluchloraminopyrFluchloraminopyr-tefuryl
Fluchloraminopyr & Fluchloraminopyr-tefuryl- New Herbicide Candidate from Chinese Player Qingdao Kingagroot Chemical – ISO Published in June 2022
by adminby adminFluchloraminopyr & Fluchloraminopyr-tefuryl are new candidates in pyridine herbicides chemical class from Qingdao Kingagroot Chemical. Company has filed international patent covering Fluchloraminopyr and Fluchloraminopyr-tefuryl in 2020, wherein Fluchloraminopyr & Fluchloraminopyr-tefurylactive …
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Merger / Acquisition
GSK to Acquire Clinical-Stage Biopharmaceutical Company Affinivax, Inc. for 2.1 Billlon
by adminby adminSummary : GSK plc announced that it has entered into a definitive agreement to acquire Affinivax, Inc. (Affinivax), a clinical-stage biopharmaceutical company based in Cambridge, Boston, Massachusetts, for a $2.1 …
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Amgen Inc.RegulatoryU.S FDA
FDA Approves RIABNI™ (Rituximab-arrx), a Biosimilar to Rituxan® (Rituximab), for adults with moderate to severe Rheumatoid Arthritis
by adminby adminSummary : Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved RIABNI™ (rituximab-arrx), a biosimilar to Rituxan®, in combination with methotrexate for adults with moderate to …
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Global MarketRegulatorySanofi Inc.U.S FDA
FDA Approves Dupixent®(Dupilumab) as First Biologic Medicine for Children Aged 6 Months to 5 Years with Moderate-to-Severe Atopic Dermatitis
by adminby adminSummary : Children treated with Dupixent and topical corticosteroids (TCS) achieved clearer skin, experienced significantly improved overall disease severity and significantly reduced itch compared to TCS alone at week 16 …
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GskRegulatoryU.S FDA
GSK Announces US FDA Approval of Priorix For the Prevention of Measles, Mumps and Rubella .
by adminby adminSummary : US Food and Drug Administration (FDA) has approved Priorix (Measles, Mumps and Rubella Vaccine, Live) for active immunisation for the prevention of measles, mumps and rubella (MMR) in individuals 12 …
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Global Market
Halozyme Announces Commercial Launch of TLANDO™, an Oral Treatment for Testosterone Replacement Therapy
by adminby adminSynopsis : Halozyme (NASDAQ: HALO) (“Halozyme”) today announced the commercial launch of TLANDO™ (testosterone undecanoate), an oral treatment indicated for testosterone replacement therapy in adult males for conditions associated with …
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Summary: Lipocine Inc. , a clinical-stage biopharmaceutical company focused on developing innovative products for neuroendocrine and metabolic disorders, announced today that Antares Pharma, Inc. issued a press release announcing that …
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CompaniesSun Pharma
Sun Pharma Acquires Uractiv portfolio from Fiterman Pharma in Romania
by adminby adminSummary Indian multinational pharma company Sun Pharmaceutical on Friday announced that one of its subsidiaries, S.C. Terapia S.A, has acquired the Uractiv portfolio from Fiterman Pharma in Romania. The Uractiv …
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World Environment 2022: The World Environment Day is celebrated on June 5 of each year with the aim to mark the importance of nature and raise awareness for its protection. World …
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IndiaMerger / Acquisition
Dr. Reddy’s sells four Treatment Category Products to Torrent Pharma.
by adminby adminSummary : Torrent Pharmaceuticals, located in Ahmedabad, said on Thursday that it had agreed to buy four brands from Dr Reddy’s Laboratories Ltd. (DRL). Torrent’s presence in the therapeutic area …
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RegulatoryU.S FDA
TherapeuticsMD Receives U.S. Receives US Food and Drug Administration (FDA) Approval for the Supplemental New Drug Application (sNDA) for ANNOVERA
by adminby adminSummary : ANNOVERA is the only FDA-approved procedure-free, long-lasting, reversible birth control – -With this approval, the Company expects a significant reduction in its manufacturing batch rejections and an increase …
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CompaniesEli LillyRegulatoryU.S FDA
Eli Lilly Gets FDA Approval for Diabetic Drug Tirzepatide
by adminby adminSummary : The Food and Drug Administration (FDA) has approved a novel first-in-class drug to treat type 2 diabetes. The drug is called tirzepatide. It has a dual effect, lowering …
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Global MarketIndiaLaunch
Nichino India Introduces Insecticide ‘Orchestra’(Benzpyrimoxan) to Control Brown Plant Hopper in Rice
by adminby adminSummary : Nichino India, a subsidiary of the Japanese agrochemical company Nihon Nohyaku Co, has launched Orchestra to combat the rice Brown Plant Hopper, a pest that causes significant losses …
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439 RC meetingCIBRC - Indian Pesticide ApprovalsRC Meeting updates
INDIAN PESTICIDE APPROVALS UPDATES – MINUTES OF THE 439TH REGISTRATION COMMITTEE (RC) MEETING HELD ON 22.04.2022
by adminby adminINDIAN PESTICIDE APPROVALS UPDATES – MINUTES OF THE 439TH REGISTRATION COMMITTEE (RC) MEETING HELD ON 22.04.2022. The 439th meeting of the Registration Committee (RC) was held under the Chairmanship of …
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Merger / Acquisition
Marksans Pharma acquires Access Healthcare for Medical Products L.L.C , Dubai for Rs 27 cr
by adminby adminSummary: Marksans Pharma signed a share purchase agreement to acquire a 100% stake in Access Healthcare for Medical Products L.L.C, a Dubai-based front-marketing and promotion company for a cash consideration …
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Merger / Acquisition
Advanz Pharma Signs Acquisition Agreement for Intercept Pharmaceuticals
by adminby adminSummary: UK-headquartered pharma company, Advanz Pharma, has announced in a May 5, 2022 press release that it has signed an agreement with US biopharma company, Intercept Pharmaceuticals, to acquire most …
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Bayer
BASF Launches New Herbicide, “Vesnit Complete”(Combination of Topramezone & Atrazine) for Sugarcane & Corn Farmers
by adminby adminSummary : Vesnit Complete delivers effective and broad-spectrum control of post-emergent grasses & broadleaf weeds in Sugarcane. It has a convenient formulation for long-duration control & excellent crop safety. About …