Hikma Pharmaceuticals

Hikma announces US launch of COMBOGESIC® IV

Retrieved on: 
星期一, 二月 5, 2024
AFT, NSAID, Patient, Pain, Paracetamol, Pain management, Hikma Pharmaceuticals, Ibuprofen, Health, Hospital, Pharmaceutical industry

LONDON, Feb. 5, 2024 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces the launch of COMBOGESIC® IV (acetaminophen and ibuprofen) injection in the US.

Key Points: 
  • LONDON, Feb. 5, 2024 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces the launch of COMBOGESIC® IV (acetaminophen and ibuprofen) injection in the US.
  • COMBOGESIC® IV is an intravenous, opioid-free pain relief medicine that is a combination of 1,000 mg of acetaminophen and 300 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID).
  • In 2021, Hikma signed an exclusive license and distribution agreement with AFT Pharmaceuticals (AFT) for the commercialization of COMBOGESIC® IV in the US.
  • Under the trade name of MAXIGESIC® IV outside of the United States, COMBOGESIC® IV is licensed in over 100 countries and marketed in over 20 countries.

Hyloris announces U.S. FDA Approval of Maxigesic® IV

Retrieved on: 
星期三, 十月 18, 2023
Analgesic, Abbreviated New Drug Application, Paracetamol, IV, Hikma Pharmaceuticals, Hospital, EUR, New Drug Application, CET, USD, NDA, Brussels Stock Exchange, Pain, Pharmaceutical industry, AFT

The approval for the New Drug Application (NDA) is based on positive data from a Phase 3 program in which Maxigesic® IV demonstrated that it was well tolerated and offered faster onset of action and higher pain relief compared to Paracetamol IV (Acetaminophen IV) and Ibuprofen IV, as well as placebo.

Key Points: 
  • The approval for the New Drug Application (NDA) is based on positive data from a Phase 3 program in which Maxigesic® IV demonstrated that it was well tolerated and offered faster onset of action and higher pain relief compared to Paracetamol IV (Acetaminophen IV) and Ibuprofen IV, as well as placebo.
  • The superior analgesic effect of Maxigesic® IV was also supported by a range of secondary endpoints, including reduced opioid usage rates.
  • Under the terms of the development collaboration agreement between Hyloris and AFT, Hyloris is eligible to receive a share on any product-related revenues, such as license fees, royalties and milestone payments, received by AFT.
  • Following first U.S. sales, Hyloris will be entitled to a milestone payment of USD 2,1 million.

Hyloris Pharmaceuticals Reports 2023 Half-Year Results and provides Business Outlook

Retrieved on: 
星期三, 九月 6, 2023
US Foods, CET, IV, Hypophosphatemia, D, Lidocaine, Hospital, Heart, Collection, Atrial fibrillation, NDA, Allergic rhinitis, Acute coronary syndrome, CMO, Tranexamic acid, Progress, Cardiology, Aspirin, Disease, IC/BPS, Death, Rhinitis, Patient, ACS, Bone mineral, Patent, Blood, Brussels Stock Exchange, Risk, PDUFA, TXA, Growth, Metolazone, FDA, Hikma Pharmaceuticals, RTU, Allergen, Arrhythmia, Safety, Heparin, Dofetilide, Bookkeeping, Vaccine, Pharmaceutical industry, Health insurance, Fine chemical, AFT, Sotalol

A potential approval date for the US market was set for 17 October 2023 by the U.S. Food & Drug Administration.

Key Points: 
  • A potential approval date for the US market was set for 17 October 2023 by the U.S. Food & Drug Administration.
  • In January 2023, Hyloris in-licensed HY-088, a product candidate targeting hypophosphatemia, a serious condition causing patients to have low level of phosphate in the blood.
  • For Dofetilide IV, the results of the pivotal clinical study, allowing regulatory submission, are expected by the summer of 2024.
  • Hyloris aims to improve ease of administration and dosage control, and thus potentially improving clinical outcome.

TAKING ON THE OPIOID OVERDOSE EPIDEMIC IN NEW JERSEY

Retrieved on: 
星期四, 八月 3, 2023
State, Partnership, Hackensack Meridian Health, Drug overdose, Naloxone, Friends, United States drug overdose death rates and totals over time, South Carolina Opioid Overdose Prevention Bill, Dispensary, Naugle v. Philip Morris USA, Inc., Mortality, Heroin, Marketing, Opioid epidemic, Jersey Shore University Medical Center, CDC, Organization, Death, School, Addiction medicine, HMH, Take-home naloxone program, Harm Reduction Journal, Patient, Drug, Risk, Health, Hikma Pharmaceuticals, Hospital, Pharmaceutical industry, Silviculture, Fentanyl, Lancet

HACKENSACK, N.J., Aug. 3, 2023 /PRNewswire/ -- HIKMA Pharmaceuticals, Hackensack Meridian Health (HMH) and non-profit Dispensary of Hope are teaming up to pilot a Take-Home Naloxone Program to stem the tide of opioid overdose fatalities by delivering Kloxxado® (naloxone HCl) Nasal Spray 8 mg free of charge to patients at high risk of an opioid overdose. Kloxxado® contains naloxone, an opioid antagonist that can save the lives of patients who have overdosed with an opioid.1 All three organizations share a vision of providing affordable medication access, with a particular focus on communities and individuals who are most vulnerable.

Key Points: 
  • Hackensack Meridian Health, HIKMA Pharmaceuticals and Dispensary of Hope join forces to save lives from opioid overdose.
  • Opioid overdoses are preventable and tragic.
  • 2022, "Responding to the opioid crisis in North America and beyond: recommendations of the Stanford–Lancet Commission," The Lancet,  399:10324, p555-604
    3 Opioid Basics: Understanding the Opioid Epidemic.
  • CDC, https://www.cdc.gov/stopoverdose/fentanyl/index.html , Accessed 2022 1006
    6 Abdelal et al., 2022, "Real-world study of multiple naloxone administration for opioid overdose reversal among bystanders," Harm Reduction Journal, 19:49.

Octave Bioscience Closes $30M Extension to Series B Funding

Retrieved on: 
星期三, 七月 26, 2023
Medical Devices, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Sclerosis, Octave, Hikma Pharmaceuticals, Hope, Multiple sclerosis, Biomarker, MS, Venture, HIV disease progression rates, Patient, Physician, Blood, Series, Ecosystem, Pharmaceutical industry

Octave Bioscience, a leading precision care company focused on delivering a new standard of care for multiple sclerosis (MS) and other neurodegenerative diseases today announced the closing of a $30M extension to its Series B funding round.

Key Points: 
  • Octave Bioscience, a leading precision care company focused on delivering a new standard of care for multiple sclerosis (MS) and other neurodegenerative diseases today announced the closing of a $30M extension to its Series B funding round.
  • This funding will further accelerate commercialization efforts to bring Octave's multimodal solution to more multiple sclerosis patients.
  • Commercially launched in late 2022, Octave is in use in multiple MS Centers of Excellence, academic centers, and high-volume independent clinics across the country.
  • “By offering an end-to-end solution which optimizes and personalizes care, Octave is revolutionizing the way MS is treated and managed.

Hikma exceeds 150 injectable medicines in the US with launch of Dobutamine Injection, USP

Retrieved on: 
星期四, 六月 15, 2023
Hospital, Hikma Pharmaceuticals, Patient, USP, Pharmaceutical industry

LONDON, June 15, 2023 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, has launched Dobutamine Injection, USP, in a 250mg/20mL vial in the US.

Key Points: 
  • LONDON, June 15, 2023 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, has launched Dobutamine Injection, USP, in a 250mg/20mL vial in the US.
  • With this launch, Hikma's growing US portfolio of sterile injectable medicines now exceeds 150 products spanning a wide range of therapeutic areas and dosage forms.
  • "Our portfolio of more than 150 injectable medicines has expanded by more than 50 percent over the last three years1, driven by customer needs, an expansion of our capabilities and product offerings, and the continued recognition of Hikma as a reliable, high-quality supplier of sterile injectable medicines," said Riad Mishlawi, President, Injectables, Hikma.
  • In addition to its growing US portfolio, Hikma now markets approximately 30 sterile injectable medicines in Canada , with plans to launch up to 13 additional products this year.

Quantum-Si Announces the Appointment of Jeff Keyes as Chief Financial Officer

Retrieved on: 
星期二, 五月 2, 2023
Genetics, Pharmaceutical, Health, Employment, Protein sequencing, Calendar, Multimedia, Washington University in St. Louis, Accounting, Bachelor of Arts, Acquisition, CFO, Growth, Hikma Pharmaceuticals, Inducement, Western Washington University, Disease, Management

Quantum-Si Incorporated (Nasdaq: QSI) (“Quantum-Si,” “QSI” or the “Company”), The Protein Sequencing Company™, today announced the appointment of Jeff Keyes as its new Chief Financial Officer, effective May 15, 2023.

Key Points: 
  • Quantum-Si Incorporated (Nasdaq: QSI) (“Quantum-Si,” “QSI” or the “Company”), The Protein Sequencing Company™, today announced the appointment of Jeff Keyes as its new Chief Financial Officer, effective May 15, 2023.
  • Mr. Keyes brings more than 25 years of experience in senior financial positions providing transformational leadership for emerging and evolving public and private companies.
  • View the full release here: https://www.businesswire.com/news/home/20230502005526/en/
    Quantum-Si- Incorporated The Protein Sequencing Company™, announced the appointment of Jeff Keyes as its new Chief Financial Officer, effective May 15, 2023.
  • Mr. Keyes brings more than 25 years of experience in senior financial positions providing transformational leadership for emerging and evolving public and private companies.

Hyloris announces potential registration date for Maxigesic® IV in the US

Retrieved on: 
星期二, 五月 2, 2023
US Foods, CET, IV, Food and Drug Administration, Prescription Drug User Fee Act, Brussels Stock Exchange, FDA, Hikma Pharmaceuticals, Glass, Pharmaceutical industry, AFT, PDUFA

Hyloris’ partner AFT Pharmaceuticals (“AFT”) submitted the additional data to the FDA on 17 April 2023.

Key Points: 
  • Hyloris’ partner AFT Pharmaceuticals (“AFT”) submitted the additional data to the FDA on 17 April 2023.
  • The Prescription Drug User Fee Act (PDUFA) goal date of 17 October 2023 set by the FDA confirms the anticipated review period of 6 months, and a potential registration of Maxigesic® IV for the US market before the end of 2023.
  • Sales could follow soon after, with an exclusive license and distribution agreement already signed between AFT and Hikma Pharmaceuticals (“Hikma”).
  • Under the terms of the development collaboration agreement between Hyloris and AFT, Hyloris is eligible to receive a share on any product-related revenues, such as license fees, royalties, milestone payments, received by AFT.

Hyloris announces submission of Maxigesic® IV packaging data requested by the US FDA

Retrieved on: 
星期二, 四月 18, 2023
IV, Symantec Endpoint Protection, Patient, Risk, Brussels Stock Exchange, FDA, Hikma Pharmaceuticals, Food, Pharmaceutical industry, AFT

The US regulatory body had requested this additional data while considering market approval for Maxigesic® IV, a novel, dual mode-of-action non-opioid pain treatment delivered through intravenous (IV) infusion.

Key Points: 
  • The US regulatory body had requested this additional data while considering market approval for Maxigesic® IV, a novel, dual mode-of-action non-opioid pain treatment delivered through intravenous (IV) infusion.
  • Importantly, the FDA did not report any issues related to the data generated during the clinical development program.
  • Assuming a positive assessment by the FDA, this implies potential registration of Maxigesic® IV for the US market before year end.
  • Maxigesic® IV holds the promise of becoming a valuable pain treatment option without the side effects and risk of addiction associated with opioids.”

FTC Approves Final Order Preserving Competition for Development and Marketing of Steroid Injectable Drug

Retrieved on: 
星期一, 十月 31, 2022
Blog, News, Social media, Commission, Complaint, Federal Trade Commission, Acquisition, TCA, FTC, LLC, Hikma Pharmaceuticals

Only Custopharm and a few other companies now make this drug.

Key Points: 
  • Only Custopharm and a few other companies now make this drug.
  • First announced in April 2022, the FTCs complaint alleged that with this acquisition, Hikma was likely to stop developing its own TCA product, threatening competition in the TCA market.
  • The consent order also requires Long Grove to maintain the competitive viability of the retained TCA assets going forward.
  • For the latest news and resources, follow the FTC on social media, subscribe to press releases and read our blog.