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Summary – Finning International Inc. (TSX: FTT) (“Finning”) today announced that, in connection with its previously announced normal course issuer bid (“NCIB”) to purchase up to 5,300,000 of its common …
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RegulatoryU.S FDA
Aquestive Therapeutics Receives Notification from FDA for the Company’s NDA for Libervant™ (diazepam) Buccal Film
by adminby adminSynopsis : Received notification to Review of the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for the treatment of breakthrough seizures and seizure clusters. Aquestive Therapeutics, Inc. , …
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RegulatoryU.S FDA
Intra-Cellular gets another FDA Nod for Caplyta, this time for Bipolar Disorder
by adminby adminSynopsis: CAPLYTA is the only FDA-approved treatment for depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults as monotherapy and as adjunctive therapy with lithium or …
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AgrochemicalsArgenx
Argenx Snags First US. FDA Approval With Vyvgart (efgartigimod alfa-fcab) win in Generalized Myasthenia Gravis
by adminby adminSynopsis: VYVGART is the first-and-only FDA-approved neonatal Fc receptor blocker 68% of anti-acetylcholine receptor (AChR) antibody positive gMG patients treated with VYVGART were responders (n=44/65) on the Myasthenia Gravis – …
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AgrochemicalsGlobal Market
BCI Pharma Collaborated with Mithra to Identify Novel Therapy for Endometriosis and Cancer in Women.
by adminby adminSynopsis : BCI Pharma and Mithra will start a collaboration to deliver new therapy for women! Mithra acquires the right relating to our development program on innovative inhibitors of CSF1R …
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Agrochemicals
Aptinyx Set in Motion Phase 2b Study of NYX-783 in Patients with Post-Traumatic Stress Disorder
by adminby adminSynopsis: Aptinyx Inc., a clinical-stage biopharmaceutical company, announced the initiation of a phase 2b study evaluating 50 mg QD of NYX-783 in 300 patients with post-traumatic stress disorder (PTSD). The …
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After skipping two years due to the Covid-19 pandemic, the pharmaceutical industry in Chennai is getting ready to host the seventh edition of the ‘Pharmac South’, a trade show and …
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Synopsis: Consultant uro-oncologist and robotic surgeon Abhay Kumar of Medica Superspecialty Hospital (MSH) said this robot-assisted surgery allowed a surgeon to go deeper inside the body because of refinement in …
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AgrochemicalsGlobal MarketIndia
Alembic Pharma under Pressure as USFDA Issues Form 483 to Gujarat Plant
by adminby adminSynopsis: Alembic Pharma share price fell over 4 percent in intraday trade on December 16 following reports that the US Food and Drug Administration (USFDA) issued a Form 483 to …
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Synopsis: UEFA is set to launch a video aimed at players featuring doctors explaining the benefits of vaccinations. Ceferin said the video featured only doctors explaining the benefits of the …
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Synopsis: The EMA’s human medicines committee has said it cannot approve Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, saying it was unconvinced by the data submitted for the drug. The …
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AgrochemicalsIndia
Serum Institute CEO Hails WHO’s Approval of Covovax for Emergency Use
by adminby adminSynopsis- India-made Covovax on Friday became the ninth Covid-19 vaccine to receive WHO’s emergency use listing approval, with manufacturer Serum Institute of India hailing the moment as another milestone. Serum …
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Summary : The company will invest up ₹6 crore for the 33% stake in the target firm Cipla on Wednesday announced that it has acquired 33% stake in renewable energy …
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Summary – The European Medicines Agency (EMA) has issued a list of about 100 regulatory science topics that need further research to close gaps and improve medicine development. The European Medicines …
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AgrochemicalsGlobal Market
Syngene International Extends Collaboration with Amgen Inc till 2026
by adminby adminSynopsis- Under the extended contract, the dedicated R&D center, ‘Syngene Amgen Research and Development Center’ (SARC), will continue to conduct drug discovery and development projects as part of Amgen’s global …
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CompaniesMerck & Co
European Commission Approves Merck’s Pneumococcal vaccine Vaxneuvance (Pneumococcal 15-Valent Conjugate Vaccine) for Individuals 18 Years of Age and Older
by adminby adminSynopsis : – The administration of the vaccine in accordance with the official recommendation can effectively prevent invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals aged 18 years …
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Synopsis- The provisional approval is for two doses of the paediatric Pfizer COVID-19 vaccine, given at least 21 days apart, the health ministry says in a statement New Zealand’s health …
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RegulatoryU.S FDAZydus Cadila
USFDA Grant Orphan Drug Designation to Zydus ZY19489 Antimalarial Compound.
by adminby adminSynopsis- The ZY19489 is a novel antimalarial compound active against all current clinical strains of malaria-causing microorganisms ‘P. falciparum’ and ‘P. vivax’, including drug-resistant strains Pharmaceutical firm Zydus Cadila on …
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RegulatorySun PharmaU.S FDA
USFDA Approves Generic Amphotericin B Liposome for Injection Manufactured By Sun Pharma
by adminby adminSynopsis- Sun Pharmaceuticals Industries announced that one of its wholly-owned subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic Amphotericin B Liposome …
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Synopsis: The development has come at a time when the Omicron variant is making its presence felt in various states, with at least 33 cases being detected in the country …
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AgrochemicalsGlobal Market
Fujifilm to Expand US Biologics Manufacturing Capacity with $300M Texas outlay
by adminby adminSynopsis: In June, globe-trotting contract manufacturer Fujifilm Diosynth Biotechnologies unveiled an $850 million outlay to boost biologics capacity in the U.S. and the U.K. Earlier this month, the CDMO confirmed …
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Synopsis: Two districts, Mokokchung and Tuensang, were chosen for studying the feasibility of drone technology in delivery of medical supplies in Nagaland. To deliver COVID-19 vaccines to remote areas and …
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Synopsis – – Vineet Gupta joined Eli Lilly in 2010 as Marketing Director for India, followed by a role as Corporate Affairs & Pricing Reimbursement and Access (PRA) Director in …
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AgrochemicalsMorepen Laboratories Limited
Morepen gets USFDA nod for Anti-Allergy Fexofinadine Drug
by adminby adminSummary : Morepen Laboratories Limited has received USFDA approval for its anti-allergy drug fexofinadine hydrochloride Fexofinadine is most widely used, second generation antihistamine drug for the treatment of allergy symptoms …
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AgrochemicalsIndiaLupin Pharma
Lupin’s Goa Manufacturing Plant Receives EIR from US FDA
by adminby adminSummary – The USFDA had earlier issued seven observations after inspecting the Goa manufacturing facility in September. The Goa site is the major exporter of the products manufactured by Lupin. …
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AgrochemicalsGlobal Market
Glenmark’s arm Ichnos Sciences enters pact with Almirall Agreement for First-IN-Class IL-1RAP Antagonist Monoclonal Antibody.
by adminby adminSynopsis- Ichnos Sciences, Glenmark’s drug discovery subsidiary based in the US, on Tuesday said it has entered into an exclusive agreement with Spanish drugmaker Almirall to out-license its novel monoclonal …
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AgrochemicalsGlobal Market
Natco Pharma Put Forward to Acquire Dash Pharmaceuticals
by adminby adminSummary – This acquisition provides Natco with a front-end to engage with its customers directly in the USA which is the largest pharmaceutical market in the world. Natco Pharma on …
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Synopsis- MS Pharma has signed an exclusive licensing and supply agreement with Bioeq AG, Switzerland to commercialize the biosimilar candidate FYB201 (Ranibizumab) in the entire Middle East and North Africa …
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Agro Science & ResearchAgrochemicals
PM Modi To Address National Agro Summit With Focus On Natural Farming
by adminby adminSummary – The three-day National Summit on Agro and Food Processing with focus on natural farming will kick start from December 14. Prime Minister Narendra Modi will address virtually farmers …
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Summary – The U.S. drugmaker will pay $100 a share in an all-cash transaction for San Diego-based Arena, bringing assets in gastroenterology, dermatology and cardiology. Pfizer Inc. agreed to buy …
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Agro Science & ResearchTGAZydus Cadila
TGA Gives Clear Signal To Zydus nod to conduct Phase II clinical study in patients with CAPS – Aus
by adminby adminSynopsis- Zydus announced today that it has received permission to initiate the Phase II (a) clinical study of its NLRP3 inhibitor “ZYIL1” in patients with Cryopyrin- Associated Periodic Syndrome (CAPS) …
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AgrochemicalsIndiaIntellectual Property (IP)
Dehli HC invites Suggestions till 17 Dec to Finalizes Draft Rules Governing Patent Suits & Intellectual Property Rights Division Rules
by adminby adminSummary – The Delhi High Court has published the final drafts of ‘High Court of Delhi Rules Governing Patent Suits, 2021’ and ‘Delhi High Court Intellectual Property Rights Division Rules, …
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AgrochemicalsSanofi Inc.
Sanofi’s Isatuximab Added to RVd Boosts Response in Multiple Myeloma
by adminby adminSummary – A new drug recently introduced for use in the treatment of refractory/relapsed multiple myeloma looks like it will also find a role in the treatment of patients with …
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LIVA Miss Diva Universe 2021, Harnaaz Sandhu, representing India at the 70th Miss Universe 2021, has made it to the top 10! After wooing the judges in the preliminary competition, …
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Summary – Gland Pharma Limited has recently received a tentative approval from the United States Food and Drug Administration (USFDA) for Cangrelor for Injection, 50 mg/vial Single-Dose Vials. “Gland Pharma …
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Agro Science & ResearchAgrochemicalsIndia
APART Launch Competitive Funding Mechanism to Boost Agri sector : Assam
by adminby adminSynopsis- To support ecosystem/mechanisms in the agricultural domain of the state, APART has established the first of its kind initiative, the Assam AgriFin “Xamahar”. This fund has been conceptualised by …
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CompaniesPfizerPharma Science & Research
Swissmedic Approves Pfizer/ BioNTech Vaccine for Children Over 5
by adminby adminSummary: The clinical trial results show that the vaccine is safe and effective in this in this age group, it will thus be possible for children aged 5 years and …
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AgrochemicalsZydus Cadila
Zydus Cadila gets USFDA nod for Commercialisation Generic Schizophrenia drug Cariprazine
by adminby adminSynopsis – The company’s subsidiary has received tentative approval from the US Food and Drug Administration (USFDA) for Cariprazine capsules in the strengths of 1.5 mg, 3 mg and 4.5 …
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AstraZenecaPharma Science & Research
France HAS Approves AstraZeneca’s Evusheld for High-Risk Covid Cases
by adminby adminSummary – French health authorities have approved the use of an antibody treatment made by AstraZeneca for high-risk people who show resistance to vaccines against coronavirus. On Friday night, independent …
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AgrochemicalsIndia
Loop Health Collaborate with Marathwada Mitra Mandal’s IMERT, Pune to Provide Health Insurance to Entrepreneurs
by adminby adminSynopsis: Founded in 2018, Loop Health is a new age healthcare provider in India that combines high-quality primary care and insurance for employers. The startup enables businesses to help their …
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Agro Science & ResearchUK MHRA
Marksans Pharma Anti- Diarrheal Med Loperamide gets Clear Path by UK MHRA
by adminby adminSummary – Drug firm Marksans Pharma on Thursday said its subsidiary has received market authorisation from the UK health regulator for its anti-diarrhoea medication Loperamide capsules. Marksans Pharma yesterday said …
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Summary – The agreement is an addition to the investments made by B Medical Systems in India following a bilateral summit between the Prime Ministers of India and Luxembourg .. …
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Summary – Lupin Diagnostics, a 100 percent subsidiary of Lupin Limited, has set up a state-of-the-art 45,000 sq. ft National Reference Laboratory in Navi Mumbai to offer services to doctors, …
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Synopsis- Alembic said it has acquired preferred stock in RIGImmune amounting to a 19.97% post-money stake in the first closing of the series seed round that was completed recently. The …
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Synopsis – England’s National Institute for Health and Care Excellence (NICE) has given a thumbs up to Sobi’s paroxysmal nocturnal hemoglobinuria (PNH) drug Aspaveli. NICE issued its decision after setting …
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Agrochemicals
Dr Reddy’s Launches Drug to Treat High Blood Pressure, Heart Failure in US market
by adminby adminSynopsis Dr Reddy’s Valsartan Tablets are available in 40 mg in bottle count size of 30, and 80 mg, 160 mg and 320 mg tablets in bottle count sizes of …
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AstraZenecaCovid DrugsRegulatoryU.S FDA
FDA Approves AstraZeneca’s Evusheld becomes First Authorized COVID Antibody to Protect the Immunocompromised Before Exposure
by adminby adminSummary : With the FDA’s emergency use authorization today of AstraZeneca’s long-acting antibody cocktail, the roughly 2% of U.S. residents who are immunocompromised will have a treatment that provides protection …
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AstraZenecaIndia
AstraZeneca is in Contact with Indian Authorities to have Evusheld Approved.
by adminby adminSummary : The company also said studies are underway to provide information on the impact of the new Omicron variant on Evusheld, which is being developed with support from the …
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Biocon Pharmaceutical
Biocon Ties up with Tabuk Pharmaceuticals to Commercialise Medicines in Middle East
by adminby adminSynopsis: Under the terms of this agreement, Tabuk Pharmaceuticals will hold the marketing authorisation for select speciality products of Biocon and be responsible to register, importing, and promoting them in …
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AgrochemicalsNuvation Bio
Nuvation Bio Announces FDA Clearance to begin Clinical Trail of NUV-422 for Breast Cancer Treatment.
by adminby adminSummary – U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-422. It is a Cyclin-Dependent Kinase (CDK) 2/4/6 inhibitor, for the treatment …
