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Agrochemicals
Kerala’s Native herb ‘Manathakkali’ (Solanum nigrum) Approved for Liver Cancer, Research gets US FDA Nod.
by adminby adminKEYPOINTS: ‘Manathakkali’ (Black nightshade or Solanum nigrum), a berry-bearing shrub found in the backyard, is traditionally known for its medicinal value. Two scientists at Rajiv Gandhi Centre for Biotechnology (RGCB) here …
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Active Pharmaceutical Ingredients (API)ibuprofenparacetamol
Hyloris announces FDA Acceptance Of New Drug Application for Maxigesic IV in Post-Operative Pain.
by adminby adminHyloris Pharmaceuticals SA, a speciality biopharma company committed to addressing unmet medical needs through reinventing existing medications, announces that the U.S. Food and Drug Administration (FDA) has accepted the …
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Pharma Science & Research
ICEBERG Study Demonstrates Improved Outcomes Of Esketamine Nasal Spray For Treatment-Resistant Depression
by adminby adminSUMMARY: Janssen’s ICEBERG study has demonstrated that Esketamine nasal spray (NS) has shown improved outcomes in an indirect treatment comparison with other real-world treatments for treatment-resistant depression (TRD). The ICEBERG …
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Active Pharmaceutical Ingredients (API)Covaxin
WHO grants Most-awaited Emergency Use Listing to Bharat Biotech’s Covaxin.
by adminby adminSUMMARY: WHO grant of EUL will ease international travel for those vaccinated with the Bharat Biotech`s Covaxin and the WHO clearance is a significant step in Covaxin being accepted by foreign …
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Agrochemicals
An Exciting Strategic Collaboration between Dunad Therapeutics and Novartis to Develop Next-generation Oral Targeted Protein Degrader Therapies.
by adminby adminKEYWORDS: Dunad Therapeutics, a biopharmaceutical company focusing on the development of next-generation targeted protein degradation therapies, announces that it has entered a strategic collaboration and licence agreement with Novartis to generate …
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A research project conducted by the Rajiv Gandhi Centre for Biotechnology (RGCB) here has found that the berry-bearing black nightshade shrub could be effective for treating the liver cancer. The …
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Agrochemicals
Agastya Agro Ltd, (Hyderabad) India and Primary BioAg Innovations, USA joined hands, entered an agreement for collaboration.
by adminby adminSUMMARY: Agastya Agro is in agreement with US-based Primary BioAg Innovations. Under the partnership, Primary BioAg Innovations will commercialize its product portfolio in India. In the future, PBI also intends …
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Dengue is an acute viral infection with potential fatal complications. Dengue fever was first referred as “water poison” associated with flying insects in a Chinese medical encyclopedia in 992 from …
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Active Pharmaceutical Ingredients (API)ATG-101Pharma Science & Research
Antengene Receives FDA Approval of IND for Phase 1 Trial of ATG-101 (PD-L1/4-1BB bispecific antibody) in Solid Tumors and Non-Hodgkin Lymphoma.
by adminby adminKEYPOINTS; Antengene Corporation Limited announced that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for ATG-101, a bi-specific monoclonal antibody in development as …
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Bharat Biotech
Australia has added Bharat Biotech’s Covaxin to the approved list of COVID vaccines.
by adminby adminKEYPOINTS: Australia’s medicines and medical devices regulator on Monday formally recognised India’s Covaxin, a vaccine against the coronavirus as the country’s border was reopened for the first time in nearly …
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Agrochemicals
Novavax partner of Serum Institute of India Receives Emergency Use Authorization for COVID-19 Vaccine (COVOVAX) in Indonesia.
by adminby adminKEYPOINTS: Novavax Inc and partner Serum Institute of India said on Monday they received emergency use authorization for their Covid-19 vaccine in Indonesia, making it the first approval anywhere in …
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Agro Science & ResearchAgrochemicalsAKVANO
Lipidor submits New Patent Application and Expands Collaboration with Cannassure using Lipidor’s AKVANO® Technology for Medicinal Cannabis Products.
by adminby adminKEYPOINTS: Lipidor submits a new patent application and expands collaboration with Cannassure using Lipitor’s innovative AKVANO technology for medicinal cannabis products AKVANO® is a novel proprietary drug delivery system. It …
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cortrophin
ANI Pharmaceuticals Announced the FDA Approval of Purified Cortrophin™ Gel for Multiple Indications Including Multiple Sclerosis, Rheumatoid Arthritis and Nephrotic Syndrome.
by adminby adminKEY POINTS: The U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) for Purified Cortrophin™ Gel (Repository Corticotrophin Injection USP) (Cortrophin Gel) for the …
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Agrochemicals
AstraZeneca has agreed to transfer its global rights for respiratory medicines Eklira (Aclidinium bromide) and Duaklir (Aclidinium bromide/formoterol) to Covis Pharma Group.
by adminby adminKEYPOINTS AstraZeneca has agreed to transfer its global rights to Eklira (Aclidinium bromide), known as Tudorza in the US, and Duaklir (Aclidinium bromide/formoterol) to Covis Pharma Group (Covis Pharma). Both …
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Agrochemicals
Pfizer-BioNTech became the First FDA Authorized COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age
by adminby adminKEYPOINTS FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age. Effectiveness: Immune responses of children 5 through 11 years of age were comparable …
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Agrochemicals
IMPACT Therapeutics Announced ATR Inhibitor IMP9064 IND Clearance by USFDA.
by adminby adminSUMMARY: Impact Therapeutics is a biopharmaceutical company, announced that its ATR inhibitor IMP9064 has received the IND clearance from the US Food and Drug Administration (FDA) for the phase I/II …
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Agrochemicals
Russians spurn their own country`s Sputnik-V jab and head west for vaccines.
by adminby adminSUMMARY: Sputnik-V was the world’s first registered COVID-19 vaccine, emerged in August 2020, but has not been approved by international health authorities. Russians also need to travel around the world, So they …
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Iptacopan
Novartis Pharmaceuticals UK awarded an Innovation Passport for Investigational Oral Therapy Iptacopan (LNP023)
by adminby adminSUMMARY: Iptacopan has been awarded the Innovation Passport for the treatment of C3 glomerulopathy (C3G) and is currently being investigated in a number of complement-driven renal diseases and one hematological …
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Agrochemicals
Union Health Minister expands Pneumococcal Conjugate Vaccine Under Universal Immunization Program.
by adminby adminSUMMARY: Union Minister for Health and Family Welfare, Dr Mansukh Mandaviya launched the nationwide expansion of Pneumococcal Conjugate Vaccine (PCV) under the Universal Immunization Programme (UIP) as a part of …
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Asciminib
FDA approves Novartis Scemblix® (Asciminib) for Certain Patients with Philadelphia Chromosome (Ph)–positive Chronic Myeloid Leukemia.
by adminby adminKeypoints: The FDA granted accelerated approval to Asciminib for the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia for 2 indications. Scemblix provides a much-needed and long-awaited new options …
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CabotegravirRilpivirine
European Commission Grants Decision for Vocabria (Cabotegravir) and Rekambys (Rilpivirine) injections to be initiated with or without an oral lead-in period for the long-acting treatment of HIV
by adminby adminSUMMARY: ViiV Healthcare announces the European Commission Decision for Vocabria (Cabotegravir) and Rekambys (Rilpivirine) injections to be initiated with or without an oral lead-in period for the long-acting treatment of …
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India
Indian Government Invited Stakeholders Opinion On New Draft Policy by 6 Nov,2021
by adminby adminThe Department of Pharmaceuticals (DoP) has come out with a draft policy to catalyse research and development (R&D) and innovation in pharmaceutical and medical devices sectors in India. DoP …
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Agrochemicals
FDA, NIH, and 15 Private Organizations have partnered to Increase Effective Gene Therapies for Rare Diseases.
by adminby adminSUMMARY: The U.S. Food and Drug Administration, the National Institutes of Health, 10 pharmaceutical companies and five non-profit organizations have partnered to accelerate the development of gene therapies for the …
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India
The New Policy Draft By Indian Government to Empower Pharma – MedTech Sector
by adminby adminIntroduction The Medical Device industry is highly capital intensive with a long gestation period and requires development and induction of new technologies. It also requires continuous training of health providers …
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Agrochemicals
The Union Health Minister Dr. Mansukh Mandaviya launches the Sixth Edition of The National Formulary of India (NFI).
by adminby adminSUMMARY: Union Health Minister Mansukh Mandaviya on Thursday launched the sixth edition of the National Formulary of India published by Indian Pharmacopoeia Commission (IPC) to promote rational use of medicines in …
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Pitolisant
Bioprojet’s Ozawade (Pitolisant) gets Approval for the Treatment of Excessive Daytime Sleepiness (EDS) associated with Obstructive Sleep Apnoea (OSA) in Adults.
by adminby adminSUMMARY: EMA-approved medicine for excessive daytime sleepiness med Ozawade (Pitolisant) Pitolisant was developed after decades of research by Bioprojet co-founders Dr. Jeanne-Marie Lecomte and Prof. Jean-Charles Schwartz The European Medicines Agency (EMA) has approved …
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CompaniesNovartis
Novartis’s BLA has been accepted by US FDA & EMA for Kymriah (Tisagenlecleucel) to treat patients with relapsed or refractory follicular lymphoma.
by adminby adminNovartis says that the U.S. and European regulators have accepted its marketing applications for CAR-T cell therapy Kymriah (Tisagenlecleucel) as third-line therapy for adults with relapsed or refractory (r/r) follicular …
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Agrochemicals
New Collaboration between DNAe group holdings ltd and Innovate UK to Develop next-gen Diagnostic Platform for Early Cancer Detection.
by adminby adminSUMMARY: DNAe, alongside Imperial College London, has been awarded a UK Knowledge Transfer Partnership (KTP) by Innovate UK to collaborate on the early detection of recurrent breast cancer. The programme …
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Agro Science & Research
Argo Star Extends its Omnichannel presence Launches Mobile Application
by adminby adminOne of the major Agri-tech businesses, AgroStar, is expanding its omnichannel presence across numerous states in order to reach more farmers. Farmers’ difficulties of lack of access to high-quality …
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CompaniesPfizer
BioNTech Deal With Senegal, Rwanda to Make mRNA Vaccine in Mid 2022
by adminby adminSummary- BioNTech in bid to build manufacturing expertise in Africa Project seeks to avoid repeat of COVID-19 vaccine inequality Backed by EU Commission Manufacturing to begin with Mid 2022 BioNTech …
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Active Pharmaceutical Ingredients (API)Ataluren
ANVISA grants expanded Approval to PTC’s Translarna label to include Ambulatory Patients as young as 2 years old in Brazil.
by adminby adminKeypoints: PTC Therapeutics, Inc. announced that the Brazilian National Health Surveillance Agency has approved the expansion of the indication of Translarna (Ataluren) to include ambulatory children aged 2 to 5 …
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Intellectual Property (IP)Patents
Med-X, Inc. Receives Patent on Nature-Cide Insecticidal Soil Formulation
by adminby adminKeypoints Med-X, Inc. announced that the Company received Patent No. 11,147,266 B2 for its Nature-Cide Insecticidal Soil formulation. Med-X’s goal is to provide a pest-free environment without the use of …
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India is poised to be a $10 trillion economy by 2030. There also exist opportunities to enable and empower industries that have inherent powers to contribute to economy. One such …
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Cipla healthcare has launched Naselin antiviral nasal spray with Povidone Iodine that can offer the first line of defence against the COVID-causing SARS-CoV-2 virus. According to the company statement, the …
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Global MarketLaunch
Glenmark Pharmaceutical Launches First New Combination Drug for Type-2 Diabetes.
by adminby adminGlenmark Pharmaceuticals on Tuesday said it has launched a fixed-dose combination drug for the treatment of Type 2 diabetes in the country. It has introduced a fixed-dose combination of Remogliflozin …
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FDA approved Genentech’s Susvimo, a port delivery system with a customized formulation of Ranibizumab, the active ingredient in Lucentis. Now, the trick for Genentech and parent company Roche could be to …
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CompaniesMerck & Co
Merck’s Keytruda Gets EU Approval for Treatment of Triple-Negative Breast Cancer.
by adminby adminThe European Commission has cleared Keytruda (Pembrolizumab) in combination with chemotherapy as a first-line treatment for locally recurrent, unresectable or metastatic TNBC involving tumours with a PD-L1 expression score of …
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NPPA fixed the ceiling prices for 12 anti-diabetic generic medicines, including Glimepiride tablets, glucose injection and intermediate acting insulin solution. Drug price regulator National Pharmaceutical Pricing Authority (NPPA) on Monday …
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RegulatoryU.S FDA
U.S. Approved Bausch, Clearside XIPERE™ (Triamcinolone Acetonide )Injectable Suspension
by adminby adminBausch Health Companies Inc and Clearside Biomedical Inc said on Monday they received approval from the U.S. health regulator for their eye injection, giving patients access to a novel …
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Agro Science & Research
Tradecorp presents ‘Cash Coat’ seed cereals, a New Tool for Successful Plant Establishment.
by adminby adminKeypoints Tradecorp, a global benchmark in biostimulation and in the sustainable crop nutrition sector, their a mission is to feed the planet through healthy and safe solutions to create well-balanced, …
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UPL Ltd
UPL Ltd. Launches New ‘NPP’ Business Unit to Enhance Biosolutions Capacity for Sustainable Agriculture in Europe.
by adminby adminKeypoints UPL is the largest manufacturer and distributor of biosolutions worldwide. On 28 June 2021 UPL Ltd, a world leader in sustainable agriculture products and solutions, has announced the launch …
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Global Market
Neuland Donepezil Hydrocholoride Becomes the first API to get Certificate of Suitability (CEP)
by adminby adminNeuland announces that The European Directorate for the Quality of Medicines & HealthCare (EDQM) recently granted a Certificate of Suitability (CEP) for Neuland’s API, Donepezil Hydrochloride Monohydrate. Neuland is the first CEP …
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ChinaPharma Science & Research
Green Signal for Kintor Pharma, PD-L1/TGF-β dual-targeting antibody (GT90008) for Tumour Clinical Trail from China NMPA
by adminby adminKintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, announced that the clinical trial of PD-L1/TGF-β dual-targeting antibody (GT90008) for the treatment of …
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Global MarketPharma Science & Research
Himalayan caterpillar fungus possessing Anti- Cancer Activity Shows Potential and Promising Results in Phase 1 Clinical Trial
by adminby adminSynopsis- The chemotherapy has been developed from a molecule found in Himalayan caterpillar fungus and is still in the experimental testing stages. The Himalayan fungus has 40 times greater potency for …
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Launch
Approaching footsteps by Aptar Pharma and i2c Pharmaceutical Services toward new partnership for co-development and promoting Respitab
by adminby adminSynopsis- Aptar Pharma and i2c Pharmaceutical Services joins hand for co-develop and promote i2c’s pressurized metered dose inhaler (pMDI) technology, Respitab. Aptar Pharma, a global provider of drug …
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AgrochemicalsMefenoxam
Albaugh’s Anchor 3L ST (Metalaxyl-M) Fungicide Seed Treatment Launched in US Seed Treatment Market.
by adminby adminKeypoints Albaugh announced the EPA registration of Anchor™ 3L ST in multiple crop segments as a new fungicide seed treatment offer. Anchor™ 3L ST is a water-based fungicide formulation that …
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Active Pharmaceutical Ingredients (API)BictegravirEmtricitabineTenofovir Alafenamide
USFDA Approves Expanded Indication of Gilead’s Biktarvy for Treatment of HIV-1 in Pediatric Populations
by adminby adminKeypoints FDA Approves Low-Dose Tablet for HIV Treatment in Virologically Suppressed Children Weighing at Least 14 kg. Biktarvy Provides an Effective Treatment Option for a Diverse Range of People Living …
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Agro Science & ResearchAGXTEND
CNH Industrial launches Innovative Platform “AGXTEND” for Digital Agricultural Solutions in Brazil
by adminby adminCNH Industrial launched “AGXTEND” in Brazil, which is an innovative platform for digital agricultural solutions. AGXTEND™ develops and provides ground-breaking technologies that allow farmers to extend their efficiency and thereby …
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Active Pharmaceutical Ingredients (API)Chugai Pharmaceuticals and Oncolys BioPhamaCompaniesTelomelysin
Oncolys BioPharma and Chugai Pharmaceuticals agree to Terminate Exclusive License Agreement on Oncolytic Viral Immunotherapy, OBP-301(Telomelysin)
by adminby adminKeypoints: Chugai, Oncolys BioPharma agree to terminate exclusive license agreement on oncolytic viral immunotherapy, OBP-301 The effective date of the termination will be decided upon consultation with Oncolys, at the …
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Active Pharmaceutical Ingredients (API)Lenalidomide
Dr. Reddy’s Labs receives US FDA approval for Generic Revlimid (Lenalidomide).
by adminby adminKeypoints Dr. Reddy’s Laboratories said it has received approval from the US health regulator to market Lenalidomide capsules, used to treat multiple myeloma and myelodysplastic syndromes. Dr. Reddy’s Laboratories Ltd …