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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 …
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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 …