Regulation of tobacco by the U.S. Food and Drug Administration

LSL Pharma Group Announces Exclusive Distribution Agreement With Fera Pharmaceuticals to Alleviate Drug Shortage in U.S. Hospitals

Retrieved on: 
Wednesday, October 18, 2023
FDA, Food, Health, LSL, USP, Regulation of tobacco by the U.S. Food and Drug Administration, Hospital, Shijiazhuang Pharma Group, Pharmaceutical industry, Fera

BOUCHERVILLE, Québec, Oct. 18, 2023 (GLOBE NEWSWIRE) -- LSL Pharma Group Inc. (TSXV: LSL), (the “Company” or “LSL Pharma Group”), a Canadian integrated pharmaceutical company, announced today that it has entered into an exclusive agreement with Fera Pharmaceuticals, LLC (“Fera”), a U.S. specialty pharmaceutical company, to provide Erythromycin ophthalmic ointment USP (5mg/g) for the treatment of newborns in U.S. hospitals.

Key Points: 
  • BOUCHERVILLE, Québec, Oct. 18, 2023 (GLOBE NEWSWIRE) -- LSL Pharma Group Inc. (TSXV: LSL), (the “Company” or “LSL Pharma Group”), a Canadian integrated pharmaceutical company, announced today that it has entered into an exclusive agreement with Fera Pharmaceuticals, LLC (“Fera”), a U.S. specialty pharmaceutical company, to provide Erythromycin ophthalmic ointment USP (5mg/g) for the treatment of newborns in U.S. hospitals.
  • The agreement essentially focuses on fulfilling the need in the one-gram tube market.
  • Under the terms of the agreement, LSL Pharma Group, via its manufacturing subsidiary Steri-Med Pharma Inc. (“Steri-Med”), could initially supply up to 25% of the four million doses required annually in the U.S. hospital market.
  • “LSL Pharma Group is pleased to respond to this urgent healthcare need by making our eye medication readily available to the U.S. market,” stated François Roberge, President and Chief Executive Officer of LSL Pharma Group.

Avenacy Launches to Deliver Critical Medications

Retrieved on: 
Monday, October 23, 2023
Biotechnology, Hospitals, Health, Pharmaceutical, Managed Care, FDA, Food, Development, Conference, Entrepreneurship, Regulation of tobacco by the U.S. Food and Drug Administration, Sagent Pharmaceuticals, Drug development, Risk, Ecosystem, Partnership, Safety, Patient, Patient safety, Pharmaceutical industry

Avenacy, a specialty pharmaceutical company focused on developing, manufacturing, and delivering critical medications, today announced its launch.

Key Points: 
  • Avenacy, a specialty pharmaceutical company focused on developing, manufacturing, and delivering critical medications, today announced its launch.
  • Products will cover a range of critical medications used to treat patients in various medically-supervised settings, from acute care hospitals to outpatient clinics and physician offices.
  • Avenacy will also provide ready-to-use formulations of essential medications to help address dosing inaccuracies, enhance patient safety, and streamline efficiency – all with the ultimate goal of improving patient care.
  • “At Avenacy, we are advancing a partnership-driven business model that will enable us to be cost-efficient and nimble to market by focusing on product investment while minimizing manufacturing costs.

Philip Morris International Submits Applications to Commercialize IQOS ILUMA Tobacco Heating System to U.S. Food and Drug Administration

Retrieved on: 
Friday, October 20, 2023
FDA, Health, Retail, Tobacco, Convenience Store, Smoke, WalletHub, Sale, Philip Morris International, Altria Group, Inc. v. Good, Altria, NYSE, Food, Information, Life, Toxicology, Regulation of tobacco by the U.S. Food and Drug Administration, AMBER, Intellectual property, Acquisition, Research, Smoking, PMI, City, COVID-19, Marketing, Privacy, IQOS, Woman, Annual report, Heated tobacco product, ZYN, Dietary supplement, Medical device, Swedish Match

Philip Morris International Inc. (PMI) (NYSE: PM) on October 20 submitted Premarket Tobacco Product Applications (PMTAs) and Modified Risk Tobacco Product Applications (MRTPAs) for IQOS ILUMA heated tobacco products with the U.S. Food and Drug Administration (FDA).

Key Points: 
  • Philip Morris International Inc. (PMI) (NYSE: PM) on October 20 submitted Premarket Tobacco Product Applications (PMTAs) and Modified Risk Tobacco Product Applications (MRTPAs) for IQOS ILUMA heated tobacco products with the U.S. Food and Drug Administration (FDA).
  • A PMTA marketing order is required to commercialize any new tobacco product in the United States.
  • Internationally, IQOS ILUMA products have demonstrated how ground-breaking consumer-centric innovation can lead more adults to stop smoking.
  • The U.S. Food and Drug Administration has authorized versions of PMI’s IQOS Platform 1 devices and consumables and Swedish Match’s General snus as Modified Risk Tobacco Products.

Kirby McInerney LLP Reminds Investors That a Class Action Lawsuit Has Been Filed on Behalf of Kenvue Inc. (KVUE) Investors and Encourages Investors to Contact the Firm Before December 8, 2023

Retrieved on: 
Friday, October 20, 2023
Class Action Lawsuit, Professional Services, Legal, NYSE, Food, KVUE, News, Court, Regulation of tobacco by the U.S. Food and Drug Administration, Phenylephrine, Prospectus, Risk, District court, Douglas v. U.S. District Court ex rel Talk America, Kirby, Johnson & Johnson, Security (finance), Pharmaceutical industry, IPO

Investors have until December 8, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Key Points: 
  • Investors have until December 8, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • On November 12, 2021, Johnson & Johnson announced the creation of Kenvue as a wholly owned consumer health subsidiary.
  • On May 3, 2022, Johnson & Johnson and Kenvue jointly announced that the price of Kenvue’s IPO would be $22 per share.
  • Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation.

Daiichi Sankyo and Merck Announce Global Development and Commercialization Collaboration for Three Daiichi Sankyo DXd ADCs

Retrieved on: 
Friday, October 20, 2023
Research, FDA, Clinical Trials, Stem Cells, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, MSD, TKI, DXD, NSCLC, SCLC, Cleavage, NYSE, ESMO, Food, Breakthrough therapy, Congress, MRK, European Society for Medical Oncology, Conference, GAAP, Regulation of tobacco by the U.S. Food and Drug Administration, HIV disease progression rates, Journal, Trastuzumab deruxtecan, ADC, Daiichi Sankyo, EPS, TSE, Spacecraft, American Journal of Clinical Oncology, Lung cancer, Cancer, Patient, BLA, Fine chemical, Pharmaceutical industry, Merck, Limited

The companies will jointly develop and potentially commercialize these ADC candidates worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights.

Key Points: 
  • The companies will jointly develop and potentially commercialize these ADC candidates worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights.
  • Merck also will pay Daiichi Sankyo up to an additional $5.5 billion for each DXd ADC contingent upon the achievement of certain sales milestones.
  • If Merck opts out of patritumab deruxtecan and/or raludotatug deruxtecan, the upfront payments already paid will be retained by Daiichi Sankyo and rights related to such DXd ADCs will be returned to Daiichi Sankyo.
  • The collaboration is expected to contribute to enhancing the corporate and shareholder value of Daiichi Sankyo over the medium to long term.

NJOY Brings Sweeping Litigation Against Illicit Disposable Vapor Manufacturers

Retrieved on: 
Thursday, October 19, 2023
Public Policy, Government, Other Manufacturing, Tobacco, Other Policy Issues, Consumer Electronics, Technology, Manufacturing, Retail, NJOY, FDA, AB InBev, Complaint, Sale, Helix, Horizon, Food, ABI, United States Customs Service, Regulation of tobacco by the U.S. Food and Drug Administration, Research, PM, Philip Morris USA Inc. v. Williams, Marlboro, City, District court, Marketing, EB, John Middleton Co., Central District, Smoker, Education Act, Investment, General counsel, Lanham Act, Heated tobacco product, MST, Defendant, Cronos, Altria

Altria Group, Inc. (Altria) announces today its operating company NJOY, LLC (NJOY) has filed sweeping litigation against 34 foreign and domestic manufacturers, distributors and online retailers of illicit disposable e-vapor products that are unlawfully marketed and sold in the State of California and elsewhere.

Key Points: 
  • Altria Group, Inc. (Altria) announces today its operating company NJOY, LLC (NJOY) has filed sweeping litigation against 34 foreign and domestic manufacturers, distributors and online retailers of illicit disposable e-vapor products that are unlawfully marketed and sold in the State of California and elsewhere.
  • The suit seeks a nation-wide injunction against the import, marketing and sale of these illicit products and significant compensatory and punitive damages.
  • “Today there are two markets – one for those who play by the rules and one for those who flagrantly ignore them.
  • NJOY may add additional manufacturers, distributors and retailers to this complaint and will consider further litigation activity.

THINK Surgical's TMINI System Receives FDA Special 510(k) Clearance for Use With Additional Implants

Retrieved on: 
Monday, October 23, 2023
FDA, Food, BKS, Regulation of tobacco by the U.S. Food and Drug Administration, Surgeon, Patient, Medical device

FREMONT, Calif., Oct. 23, 2023 /PRNewswire/ -- THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINI™ Miniature Robotic System has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with implants from three additional implant manufacturers.

Key Points: 
  • FREMONT, Calif., Oct. 23, 2023 /PRNewswire/ -- THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINI™ Miniature Robotic System has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with implants from three additional implant manufacturers.
  • The TMINI system includes a wireless robotic handpiece that assists surgeons in performing total knee replacement and first received 510(k) clearance from the U.S. FDA in April 2023 for use with an implant from a single implant manufacturer.
  • "We are excited to expand the number of implant modules supported by the TMINI system, allowing more customers and patients access to robotic assisted technology for knee replacement."
  • "We are currently working on adding more implant modules to the TMINI System to continue our mission of an open implant library."

U.S. Food and Drug Administration Approves BioMarin's VOXZOGO® (vosoritide) for Children Under 5 Years with Achondroplasia

Retrieved on: 
Friday, October 20, 2023
FDA, Ageing, Mutation, Food, CHMP, European Commission, Committee, Physician, Endocrinology, Genetics, European Directive on Traditional Herbal Medicinal Products, FGFR3, Epiphysis, European Medicines Agency, Regulation of tobacco by the U.S. Food and Drug Administration, Committee for Medicinal Products for Human Use, Achondroplasia, Endocrine Society, Civil service commission, Medicine, Shanda, Emory University, EMA, New Drug Application, Safety, European Society for Paediatric Oncology, Patient, BioMarin Pharmaceutical, Child, Hypochondroplasia, Pharmaceutical industry, Vaccine

SAN RAFAEL, Calif., Oct. 20, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for VOXZOGO® (vosoritide) to increase linear growth in pediatric patients with achondroplasia with open epiphyses (growth plates). This indication is approved under accelerated approval based on an improvement in annualized growth velocity. Previously, VOXZOGO was indicated for children who were 5 years of age and older. This expanded indication now includes children of all ages with open growth plates.

Key Points: 
  • "We are pleased that VOXZOGO is now available for children of all ages with achondroplasia," said Hank Fuchs, M.D., president of Worldwide Research and Development at BioMarin.
  • "We are grateful for the collaboration of the achondroplasia community, physicians, and the children and their families who have played a crucial role in advancing this clinical program.
  • The overall safety profile of VOXZOGO in children under 5 years of age was similar to that seen in older children.
  • While similar to achondroplasia, people with hypochondroplasia typically present with milder disproportionality and less severe short stature compared to achondroplasia.

RegCell Appoints Experienced Life Science Executive and Entrepreneur Michael McCullar, Ph.D., MBA, as its New Chief Executive Officer

Retrieved on: 
Thursday, October 19, 2023
Osaka University, FDA, Immune tolerance, Food, Biotechnology, Business development, Acquisition, MBA, Regulation of tobacco by the U.S. Food and Drug Administration, Research, Otsuka Pharmaceutical, Supergene, Syndrome, Drug development, Senior, U.S. Department of Defense Strategy for Operating in Cyberspace, Technical advisor, Immune system, Business, Sumitomo Pharma, Kyoto University, Patient, Astex Pharmaceuticals, Toxic epidermal necrolysis, Pharmaceutical industry, Vaccine, Regulatory T cell, Decitabine

"I am honored to join this remarkable team at an exciting time for RegCell as we prepare to enter the clinical stage and to support the company's mission to discover innovative treatments for autoimmune diseases," said Dr. Michael McCullar, Chief Executive Officer of RegCell.

Key Points: 
  • "I am honored to join this remarkable team at an exciting time for RegCell as we prepare to enter the clinical stage and to support the company's mission to discover innovative treatments for autoimmune diseases," said Dr. Michael McCullar, Chief Executive Officer of RegCell.
  • "In an era where the increasingly aging population is facing an escalating burden of autoimmune disorders, Treg-based cellular therapies are opening the doors to exciting new treatment possibilities.
  • Dr. McCullar has a wealth of experience in the biotech and pharmaceutical industries, spanning more than two decades.
  • Dr. McCullar has held several high-level executive positions at SuperGen, showcasing his commitment and upward career path within the company.

Data From Two Studies Demonstrating Positive Financial Impact of INPEFA® (Sotagliflozin) to be Presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 National Meeting

Retrieved on: 
Tuesday, October 17, 2023
Nexus, Food, Expo Hall, T2D, Standard of care, QALY, Risk, Hospital, Orlando World Center Marriott, Death, Mortality, AMCP, Academy of Managed Care Pharmacy, HF, FDA, ED, Heart failure, Quality-adjusted life year, National meetings of the Workers' Party of Korea, Cypress, Life imprisonment, Pharmacy, Regulation of tobacco by the U.S. Food and Drug Administration, SOC, Patient, Health insurance, Pharmaceutical industry

THE WOODLANDS, Texas, Oct. 17, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today highlighted upcoming presentations of two studies demonstrating positive financial impact of INPEFA® (sotagliflozin) at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 National Meeting, October 16-19, 2023, at the Orlando World Center Marriott, Expo Hall, Cypress 1 and 2, Orlando, Florida.

Key Points: 
  • The budget impact was modeled as the change in medical and pharmacy costs from using sotagliflozin in addition to the standard of care (SoC) compared with the SoC alone among U.S. patients hospitalized with heart failure (HF).
  • Costs included pharmacy, inpatient, emergency department visits, and other medical and adverse event costs.
  • Amongst treated patients on sotagliflozin, commercial payers incurred increased pharmacy costs of $7,276 per patient per year as compared to patients on SoC alone.
  • Clinical outcomes of interest were hospital readmissions, emergency department (ED) visits, and all-cause deaths after an HF hospitalization.