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AgrochemicalsIndia
Medikabazaar Eyes to Achieve GMV of Around US$ 700 million in FY22
by adminby adminSummary : – Medikabazaar, an online B2B platform for medical supplies, is looking to achieve a gross merchandise value (GMV) of around US$700 million by March 2022 from US$400 million …
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RegulatoryU.S FDA
Roche COVID-19 At-Home Test Granted FDA Emergency Use Authorization to expand access to Rapid Self-Testing Solutions in the United States
by adminby adminSummary : Rapid test to support the American public’s fight against the COVID-19 pandemic, with availability to purchase over-the-counter (OTC) at pharmacies and retailers nationwide The COVID-19 At-Home Test uses …
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AgrochemicalsCompaniesGlobal MarketPharma Science & Research
Takeda’s Eohilia Suffers Another Set Back FDA rejection after Mysterious Delay
by adminby adminSynopsis: -The FDA recommended Takeda run an additional clinical study to resolve its questions around Eohilia, an oral suspension formulation of the corticosteroid budesonide, in eosinophilic esophagitis. (Takeda) – The …
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AgrochemicalsGlobal Market
Biogen, Eisai face Down Another Aduhelm Refusal—this Time from Japanese Regulators
by adminby adminSynopsis: After a special meeting, the Japanese drug reviewers ruled that existing data didn’t support an approval and are therefore seeking additional clinical data. Biogen and Eisai are now working …
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AgrochemicalsGlobal Market
PDS Biotech Reports An Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)
by adminby adminSynopsis: PDS Biotechnology Corporation (“PDS Biotechnology”) (Nasdaq: PDSB), a clinical-stage immuno-oncology company pioneering the development of novel multifunctional immunotherapeutic products, today announced that on June 28, 2019 the Compensation Committee …
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Summary : Minim, Inc. the creator of intelligent networking products under the Motorola brand, announced that Sean Doherty will be transitioning from his role as Chief Financial Officer to pursue …
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CompaniesNovartisRegulatoryU.S FDA
Novartis Cosentyx® Receives FDA Approval for the Treatment of Children and Adolescents with Enthesitis-Related Arthritis and Psoriatic Arthritis
by adminby adminSummary : -New approvals are based on JUNIPERA trial data showing Cosentyx® (secukinumab) demonstrated reduced flare risk versus placebo and improvement in disease activity observed over two years across both …
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Synopsis : – Slalom Launch Center to help Japanese organizations accelerate cloud transformation and modernize their technology services Amazon Web Services (AWS) and global consulting firm, Slalom, today announced …
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AgrochemicalsIndiaLaunch
BDR Pharma launches India’s First Generic Pazopanib to Treat Various Cancer .
by adminby adminSynopsis : Cabozantinib is used for the treatment of metastatic medullary thyroid cancer, advanced renal cell carcinoma and hepatocellular carcinoma, BDR Pharma said in a statement. Kidney cancers rank about …
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AgrochemicalsIndia
Government Approves PLI Scheme to Promote Domestic API Production.
by adminby adminSummary : The total outlay of the scheme as decided by the government is Rs.6,940 crore. The scheme will provide financial incentives for selected participants on incremental sales of 41 …
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AgrochemicalsGlobal MarketLaunch
BioRestorative Therapies Announces CRO Agreement with PRC Clinical for its BRTX-100 Phase 2 Clinical Trial to Treat Chronic Lumbar Disc Disease
by adminby adminSummary – BioRestorative Therapies, Inc. (the “Company” or “BioRestorative”) (NASDAQ:BRTX), a life sciences company focused on adult stem cell-based therapies, today announced it has entered into a Master Service Agreement …
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LaunchPharma Science & Research
MedMira Inc. Announces to Launch VYRA™ CoV2Flu Rapid Antigen Rapid Test
by adminby adminSummary – Launch of VYRA™ CoV2Flu Rapid Antigen Rapid Test (VYRA™ CoV2Flu). Based on MedMira’s proprietary technology, this 3-in-1 test is developed to distinguish between SARS-CoV-2 and Influenza A or …
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RegulatoryU.S FDA
FDA IND Application Clearance to Hepion Pharma for its CRV431 in the Treatment of Liver Cancer
by adminby adminSummary – New IND Expands Liver Disease Pipeline for CRV431 IND Clearance Allows CRV431 to Move Directly into Phase 2 for Hepatocellular Carcinoma Treatment New IND Provides for Complementary Therapeutic …
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AgrochemicalsIndia
Ocugen, Inc. Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
by adminby adminSynopsis : Company announced the Compensation Committee of the Board of Directors of Ocugen approved the grant of stock options to purchase an aggregate of 6,750 shares of its common …
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AgrochemicalsU.S. EPA
Bunker Hill Announces $50 Million Project Finance Package, Mine Purchase, and US EPA Settlement Agreement Amendment
by adminby adminHIGHLIGHTS $50 million term sheet executed with Sprott Private Resource Streaming and Royalty Corp (“SRSR”) outlining a proposed financing package to fund mine restart in stages: $8 million Royalty Convertible …
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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 …