COFEPRIS

Y-mAbs Reports Third Quarter 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Monday, November 13, 2023
International Society, Acquisition, Research, Cancer, Therapy, Interim, IND, Traction, Net, Patient, Investigational New Drug, HITS, COFEPRIS, Growth, Congress, GM-CSF, Adium, Physician, Radioimmunotherapy, Cryptocurrency, Pharmaceutical industry, Video game, Rare-earth element, Temozolomide, Irinotecan

During the third quarter ended September 30, 2023, approximately 63% of the vials sold in the U.S. were sold outside of Memorial Sloan Kettering Cancer Center (“MSK”), compared to 61% in the second quarter ended June 30, 2023.

Key Points: 
  • During the third quarter ended September 30, 2023, approximately 63% of the vials sold in the U.S. were sold outside of Memorial Sloan Kettering Cancer Center (“MSK”), compared to 61% in the second quarter ended June 30, 2023.
  • Cost of goods sold was $2.6 million and $2.5 million for the third quarter ended September 30, 2023 and 2022, respectively.
  • Research and development expenses were $15.4 million for the third quarter ended September 30, 2023, a reduction of 32% compared to $22.5 million for the third quarter ended September 30, 2022.
  • Selling, general, and administrative expenses were $10.2 million for the third quarter ended September 30, 2023, a reduction of 25% compared to $13.6 million for the third quarter ended September 30, 2022.

FMC Corporation granted preliminary injunction in Mexico against Rainbow for patent infringement

Retrieved on: 
Tuesday, August 15, 2023
Chlorantraniliprole, Private law, Intellectual property, Farmer, COFEPRIS, Research, Specialized court, Patent, Tribunal, FMC Corporation, Court, FMC, NYSE, Social media, Farm, Rainbow

FMC Corporation (NYSE: FMC), a leading global agricultural sciences company, announced the Mexican Federal Court of Administrative Justice, Specialized Court in Intellectual Property (Tribunal Federal de Justicia Administrativa, Sala Especializada en Materia de Propiedad Intelectual), granted FMC Corporation and FMC Agroquímica de México, S. de R. L. de C.V. a preliminary injunction against Rainbow Agro Sciences, S.A. De C.V. ("Rainbow") for patent infringement relating to the company seeking registration of chlorantraniliprole and chlorantraniliprole-containing products in Mexico.

Key Points: 
  • FMC Corporation (NYSE: FMC), a leading global agricultural sciences company, announced the Mexican Federal Court of Administrative Justice, Specialized Court in Intellectual Property (Tribunal Federal de Justicia Administrativa, Sala Especializada en Materia de Propiedad Intelectual), granted FMC Corporation and FMC Agroquímica de México, S. de R. L. de C.V. a preliminary injunction against Rainbow Agro Sciences, S.A. De C.V. ("Rainbow") for patent infringement relating to the company seeking registration of chlorantraniliprole and chlorantraniliprole-containing products in Mexico.
  • In addition, the preliminary injunction orders the Federal Committee for Protection from Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS) to prohibit the import and export of chlorantraniliprole technical from Rainbow in and out of Mexico and denies Rainbow any registration for formulated products that contain chlorantraniliprole.
  • "The principles decided by the Court are significant for future infringement actions and reinforce FMC's confidence in protecting and enforcing its patents around the world.
  • FMC Corporation invests heavily in research and development to bring the latest innovations to farms around the world.

M8 Pharmaceuticals obtains market authorization for Barlo® (Carragelose®) nasal spray in Mexico

Retrieved on: 
Tuesday, August 1, 2023
Allergy, Marketing, SARS-CoV-2, COFEPRIS, Cough, Patient, Patent, Map, OTC, News, Pharmaceutical industry

KORNEUBURG, Austria, Aug. 1, 2023 /PRNewswire/ -- M8 pharmaceuticals is pleased to announce the market approval of a Barlo® (Carragelose®) nasal spray in Mexico. In 2021, Marinomed announced a licence agreement with the Latin American based specialty biopharmaceutical company M8 pharmaceuticals for the distribution of Carragelose nasal sprays in Mexican and Brazilian markets. M8 is responsible for pursuing the local market authorization and marketing of the product in the region. The approval Barlo® (Carragelose®) nasal spray has now been granted in Mexico, which clears the way for a market launch. The product will be available under the trade name Barlo®, is envisaged for the next season. With a population of over 130 million, Mexico is Latin America's second largest OTC and Rx market. The Mexican consumer healthcare market is forecasted to keep growing at an annual rate of 8-10%, reaching 5 billion USD by 2035. With a share of 32%, cough, cold and allergy is the leading Mexican OTC segment and represents a significant sales potential for Carragelose products. 

Key Points: 
  • KORNEUBURG, Austria, Aug. 1, 2023 /PRNewswire/ -- M8 pharmaceuticals is pleased to announce the market approval of a Barlo® (Carragelose®) nasal spray in Mexico.
  • M8 is responsible for pursuing the local market authorization and marketing of the product in the region.
  • The approval Barlo® (Carragelose®) nasal spray has now been granted in Mexico, which clears the way for a market launch.
  • With a population of over 130 million, Mexico is Latin America's second largest OTC and Rx market.

EQS-News: Marinomed Biotech AG: M8 Pharmaceuticals obtains market authorization for Carragelose nasal spray in Mexico

Retrieved on: 
Thursday, July 27, 2023
Allergy, Marketing, SARS-CoV-2, COFEPRIS, Cough, Patent, Patient, VSE, OTC, Growth, Pharmaceutical industry

Korneuburg, Austria, 27 July 2023 – Marinomed Biotech AG (VSE:MARI) announced today the market approval of a Carragelose nasal spray in Mexico.

Key Points: 
  • Korneuburg, Austria, 27 July 2023 – Marinomed Biotech AG (VSE:MARI) announced today the market approval of a Carragelose nasal spray in Mexico.
  • In 2021, Marinomed disclosed a licence agreement with the Latin American based specialty pharmaceutical company M8 pharmaceuticals (formerly moksha8) for the distribution of Carragelose nasal sprays in Mexican and Brazilian markets.
  • M8 is responsible for pursuing the local market authorization and marketing of the product in the region.
  • The approval for the Carragelose nasal spray has now been granted in Mexico, which clears the way for a market launch.

 North American Specialty Hospital Provides Best Practices for Safe, Legal Procurement of Rx Medication Across Borders

Retrieved on: 
Monday, March 27, 2023
Health, FDA, Hospitals, Other Health, Managed Care, General Health, Pharmaceutical, Travel, Women in Science Hall of Fame (U.S. State Department), NASH, Commission, COFEPRIS, Pharmacy, Physician, Nursing, Pharmaceutical industry

North American Specialty Hospital (NASH), a pioneer and experienced provider of medical care and treatment outside the U.S., including Mexico and Canada, recommends four best practices for Americans to follow that ensure safe, legally sourced prescription medications from across borders.

Key Points: 
  • North American Specialty Hospital (NASH), a pioneer and experienced provider of medical care and treatment outside the U.S., including Mexico and Canada, recommends four best practices for Americans to follow that ensure safe, legally sourced prescription medications from across borders.
  • Given surging healthcare inflation and the rising cost of prescription drug prices, many US companies and their employees look to other countries for less expensive, affordable options.
  • “Given our years of experience with safely and legally providing Rx drugs to Americans, who are often directed by their employer to utilize our services, this guidance is timely and important,” says Michael Agostino , CEO, NASH.
  • “Our team of physicians, nurses and care coordinators both in the US and Mexico protects people from these issues and safeguards access to legitimate medications.

Mexican Government Grants XEBRA Brands the First Ever Cannabis Authorizations for the Cultivation, Processing, Production, and the National Commercialization of Cannabis Products

Retrieved on: 
Thursday, March 9, 2023
MD, Cannabis, Agriculture, Risk, Transport, Seed, COFEPRIS, Growth, Intellectual property, Bank, Hospital

All statements, other than statements of historical facts, are forward-looking information and statements.

Key Points: 
  • All statements, other than statements of historical facts, are forward-looking information and statements.
  • The words "aim", "believe", "expect", "anticipate", "contemplate", "target", "intends", "continue", "plans", "budget", "estimate", "may", "will", and similar expressions identify forward-looking information and statements.
  • Known and unknown factors could cause actual results to differ materially from those projected in the forward-looking statements.
  • Readers are cautioned that forward-looking statements are not guarantees of future performance and readers should not place undue reliance on such forward-looking statements.

Mexico Needs mpox Vaccine, Says AHF and Vaccine Advocates in The Lancet Letter

Retrieved on: 
Wednesday, March 8, 2023
LGBTQ+, AIDS, Health, Consumer, Infectious Diseases, Pharmaceutical, Science, Bangladesh Technical Education Board, Travel, Public sector, Federal Commission for the Protection against Sanitary Risk, Mpox, CDC, Ministry of Health (Saudi Arabia), Public health emergency of international concern, Infection, Vaccine, European Medicines Agency, MPOX, Ministry, Centers for Disease Control and Prevention, AIDS Healthcare Foundation, Risk, HIV, Disease, STI, AHF, WHO, Director general, Death, Public, NGO, COVID-19, Letter, Policy, Viral disease, Trade Wars, COFEPRIS, World Health Organization, Oregon Higher Education Coordinating Commission, SSA, Ministry of Health, Pharmaceutical industry, Medical device, EU, Lancet

The European Medicines Agency and the US FDA have also authorized the use of the vaccine.

Key Points: 
  • The European Medicines Agency and the US FDA have also authorized the use of the vaccine.
  • Among the authors of this study is the highest decision-maker in public health in Mexico, Dr. Hugo López-Gatell, Undersecretary of Health.
  • The letter was accepted and finally published by the same magazine in its correspondence section titled " MPOX vaccines are needed in Mexico ,” on March 6, 2023.
  • To learn more about AHF, please visit our website: www.aidshealth.org , find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare .

Xebra Provides Update on the Issuance of its Mexican Cannabis Authorizations and Announces Management Changes

Retrieved on: 
Thursday, January 26, 2023
Law of the United Kingdom, FSE, EBITDA, Mining, CFO, CSE, Corporation, THC, Transport, Sale, CBD, Cannabis, FDA, Risk, Growth, CBN, COFEPRIS, Supreme court, Seed, Acquisition, Agriculture, Supreme Court of Justice of the Nation, Multimedia, Prospectus, Drug, Mexican

VANCOUVER, BC, Jan. 26, 2023 /PRNewswire/ - Xebra Brands Ltd. ("Xebra") (CSE: XBRA) (OTCQB: XBRAF) (FSE: 9YC), a cannabis company, provides an update on the issuance of its Mexican cannabis authorizations and announces management changes.

Key Points: 
  • VANCOUVER, BC, Jan. 26, 2023 /PRNewswire/ - Xebra Brands Ltd. ("Xebra") (CSE: XBRA) (OTCQB: XBRAF) (FSE: 9YC), a cannabis company, provides an update on the issuance of its Mexican cannabis authorizations and announces management changes.
  • A Mexican court has granted the Mexican Health Regulatory Agency (the Mexican FDA equivalent) (the "COFEPRIS") another extension to the week of February 6th to fulfill the Supreme Court mandate to grant Xebra cannabis authorizations.
  • As Xebra has indicated in previous press releases, since the cannabis authorizations are without legal precedent in Mexico, guidance on approximate timing cannot be relied upon, and additional delays can be reasonably expected.
  • In addition, Xebra announces board and management changes.

Sofwave Gains Market Approval For SUPERB™ Non-Invasive Wrinkle Reduction and Lifting Technology in Mexico — the Second Largest Aesthetic Medical Market in Latin America

Retrieved on: 
Monday, January 23, 2023
TASE, Medicine, Food, Federal Commission for the Protection against Sanitary Risk, Food and Drug Administration, Safety, Hospital, Dermatology, Trade Wars, Physician, Medical tourism, Cellulite, SAN, COFEPRIS, Growth, Pharmaceutical industry, Health

SAN CLEMENTE, Calif., Jan. 23, 2023 (GLOBE NEWSWIRE) -- Sofwave Medical Ltd (“the Company”) (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices, today announced market approval for Sofwave’s™ SUPERB Technology in Mexico.

Key Points: 
  • SAN CLEMENTE, Calif., Jan. 23, 2023 (GLOBE NEWSWIRE) -- Sofwave Medical Ltd (“the Company”) (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices, today announced market approval for Sofwave’s™ SUPERB Technology in Mexico.
  • Approval was granted by Mexico’s Food and Drug Administration, the Federal Commission for the Protection from Sanitary Risks (COFEPRIS), a division of the Mexico’s Ministry of Health.
  • “The tailwinds associated with Mexico’s growing aesthetic medical device market which is growing at more than 8% annually is expected to benefit our anticipated brand launch.
  • Additionally, Sofwave has also recently received U.S. Food and Drug Administration clearance to expand SUPERB’s treatment indications to be used for the short-term improvement in the appearance of cellulite.

District Court Orders Mexican FDA to Grant Cannabis Authorizations to Xebra

Retrieved on: 
Tuesday, December 20, 2022
SA, Language, COFEPRIS, CSE, Risk, Transport, Growth, District court, Seed, FDA, CBD, THC, Supreme court, Prospectus, Agriculture, FSE, Multimedia, Cannabis, Xebra, Sale, Acquisition, EBITDA, Law of the United Kingdom, Drug, Mexican

On December 8, 2022, Xebra announced that the Mexican Health Regulatory Agency (the Mexican FDA equivalent) (the "COFEPRIS"), had formally notified Xebra's Mexican subsidiary, Desart MX, SA de CV ("Xebra Mexico"), with a resolution in which it claimed to have complied with the Supreme Court mandate to grant Xebra cannabis authorizations.

Key Points: 
  • On December 8, 2022, Xebra announced that the Mexican Health Regulatory Agency (the Mexican FDA equivalent) (the "COFEPRIS"), had formally notified Xebra's Mexican subsidiary, Desart MX, SA de CV ("Xebra Mexico"), with a resolution in which it claimed to have complied with the Supreme Court mandate to grant Xebra cannabis authorizations.
  • A District Court judge has now reviewed the COFEPRIS resolution and ruled in favor of Xebra Mexico, outright rejecting its scope and language as materially insufficient and upholding Xebra's irrefutable legal rights granted by the Supreme Court.
  • Thus, the judge ordered the COFEPRIS to issue the full and proper authorizations within 3 business days.
  • Due to many Mexican government offices closing during the holiday season, Xebra anticipates the process of issuing the authorizations to continue into January 2023.