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RegulatoryU.S FDAVertex
Vertex Announces U.S. FDA Approval for ORKAMBI® (lumacaftor/ivacaftor) in Children With Cystic Fibrosis Ages 12 to 24 months
Summary: Orkambi was first approved in 2015 in the US and is now available in more than 30 countries. Vertex Pharmaceuticals Incorporated announced the US Food and Drug Administration (FDA) …
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Boehringer IngelheimRegulatoryU.S FDA
Boehringer’s Spevigo (spesolimab) Bags First FDA Approval for Rare Skin Disease, for Generalized Pustular Psoriasis (GPP)
Synopsis: German drugmaker Boehringer Ingelheim has its first regulatory approval for spesolimab, its antibody therapy for rare and life-threatening skin disorder generalised pustular psoriasis (GPP), in the US. The FDA …
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RegulatorySanofi Inc.U.S FDA
XenpozymeTM (Olipudase alfa-rpcp) Approved by FDA as First Disease-Specific Treatment for Acid Sphingomyelinase Deficiency, a Rare Genetic Disease to Sanofi
Summary: XenpozymeTM (olipudase alfa-rpcp) approved by FDA as first disease-specific treatment for ASMD (non-CNS manifestations) Xenpozyme is the first approved medication to treat symptoms that are not related to the central nervous system in patients with …
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Highlights: ICAR-Indian Institute of Spices Research, Kozhikode, has signed an agreement with Bayer Crop Science Limited, Thane for capacity building, development of plant protection schedule and nematode management programmes. The …
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Merger / Acquisition
Alcon Expands Foothold in Eye Sector with $770 Million Aerie Pharmaceuticals Purchase
In order to gain access to Aerie Pharmaceuticals’ open-angle glaucoma and ocular hypertension medications, Alcon announced that it will acquire the company for around $770 million. As part of the …
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RegulatoryU.S FDA
Incyte Announces FDA Approval of Pemazyre® (Pemigatinib) as the First and Only Targeted Treatment for Myeloid/Lymphoid Neoplasms (MLNs) with FGFR1 Rearrangement
Synopsis : This marks the second indication for Pemazyre, which received accelerated FDA approval in 2020 for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast …
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CompaniesCovid DrugsIntellectual Property (IP)Pfizer
Pfizer and BioNTech are being Sued by Moderna for Patent Infringement over Covid Drug mRNA Technology Platform.
Summary: Complaints to be filed in both United States and Germany alleging that Pfizer and BioNTech’s COVID-19 vaccine Comirnaty® unlawfully infringes patents Moderna filed between 2010 and 2016 Moderna not …
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RegulatoryU.S FDA
Axsome Therapeutics Auvelity(dextromethorphan HBr -bupropion HCl) Becomes the First FDA-Approved Oral NMDA for Major Depression
Summary: The FDA has approved Axsome Therapeutics’ Auvelity for major depressive disorder (MDD) in adults, making it the first and only oral N-methyl D-aspartate (NMDA) receptor antagonist approved for this …
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Active Agrochemical IngredientAgrochemical Discovery Candidates (New ISO)Syngenta
NEW ISO INSECTICIDE CANDIDATE PUBLISHED AUGUST 2022 – FLUPYROXYSTROBIN FROM SYNGENTA PARTICIPATIONS AG
NEW ISO INSECTICIDE CANDIDATE PUBLISHED AUGUST 2022 – FLUPYROXYSTROBIN FROM SYNGENTA PARTICIPATIONS AG Flupyroxystrobin compound is covered in European Patent EP242081B1, which was assigned to Imperial Chemical Industries PLC, and …
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Global MarketRegulatoryU.S FDA
Genentech Announces FDA Approval of Xofluza(Baloxavir Marboxil) to Treat Influenza in Children Aged Five and Older
Summary: Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved for children as young as five years of age The FDA also …
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Summary : Through the acquisition of Global Blood Therapeutics, Pfizer aims to enhance its presence in rare haematology and particularly sickle cell disease (SCD). Under the terms of the transaction, …
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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
New 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
Synopsis: 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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Sanofi 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
Summary : 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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Summary: 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.
Synopsis : 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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Summary: 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)
Summary: 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
Summary : 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.
Summary : 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
Summary : 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
July 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.
Summary : 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.
Synopsis : 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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Summary : 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.
Synopsis : 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
Summary : 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
Summary : 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
Synopsis: 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
Insecticide 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
Summary : 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
Summary : 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
Summary : 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
New 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.
June 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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Summary : 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
Summary : 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.
Summary : 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)
Summary : 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)
Summary : 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
Fluchloraminopyr & 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
Summary : 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
Summary : 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
Summary : 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 .
Summary : 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
Synopsis : 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 …