Prostaglandin

Orphan designation: alprostadil Treatment of in solid organ transplantation, 16/08/2023 Positive

Retrieved on: 
Sunday, February 4, 2024

Key facts

Key Points: 
  • Key facts
    - Active substance
    - alprostadil
    - Intended use
    - Treatment of in solid organ transplantation
    - Orphan designation status
    - Positive
    - EU designation number
    - EU/3/23/2817
    - Date of designation
    - Sponsor
    Oresund Pharma ApS
    Patients' organisations
    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
    European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
    EMA list of opinions on orphan medicinal product designation
    EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:

Arachidonic Acid Market to increase by USD 114.82 million between 2023 to 2028; Rising awareness about preventative healthcare boosts the market - Technavio

Retrieved on: 
Thursday, December 7, 2023

NEW YORK, Dec. 7, 2023 /PRNewswire/ -- The arachidonic acid market size is expected to grow by USD 114.82 million from 2023 to 2028.

Key Points: 
  • NEW YORK, Dec. 7, 2023 /PRNewswire/ -- The arachidonic acid market size is expected to grow by USD 114.82 million from 2023 to 2028.
  • In addition, the growth momentum of the market will progress at a CAGR of  7.23% during the forecast period, according to Technavio.
  • Rising awareness about preventative healthcare is notably driving the arachidonic acid market.
  • However, factors such as the availability of substitutes for arachidonic acid may impede market growth.

Mesentech Doses First Patients with Investigational Drug MES1022 to Accelerate Healing of Bone Fractures

Retrieved on: 
Tuesday, September 26, 2023

Efficient drug delivery into bones remains a barrier in developing treatments for diseases of bone.

Key Points: 
  • Efficient drug delivery into bones remains a barrier in developing treatments for diseases of bone.
  • The bone is a complex, dynamic tissue with unique properties that make it a formidable challenge for drug efficient penetration.
  • The company successfully dosed the first patients via subcutaneous injection in a Phase 1 study evaluating MES1022, a bone-selective EP4 receptor agonist prodrug they are developing for bone regeneration, with the first application for accelerating healing of bone fractures.
  • “MES1022 is well-positioned to be the first therapy that mimics and enhances the natural processes the body uses to stimulate bone repair and healing.

Bausch + Lomb Launches LUMIFY EYE ILLUMINATIONS™ in the United States

Retrieved on: 
Tuesday, September 26, 2023

Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced the U.S. launch of LUMIFY EYE ILLUMINATIONS , a new line of hypoallergenic specialty eye care products scientifically developed to cleanse, nourish and brighten the sensitive eye area.

Key Points: 
  • Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced the U.S. launch of LUMIFY EYE ILLUMINATIONS , a new line of hypoallergenic specialty eye care products scientifically developed to cleanse, nourish and brighten the sensitive eye area.
  • “Many products contain chemicals or preservatives that can irritate the delicate area of and around the eye,” said John Ferris, executive vice president, Consumer, Bausch + Lomb.
  • LUMIFY EYE ILLUMINATIONS Hydra-Gel Brightening Eye Cream – a unique blend of optic brighteners and firming ingredients helps skin look brighter and smoother with a subtle glow.
  • “LUMIFY EYE ILLUMINATIONS was developed specifically for the sensitive eye area with extensive safety and performance testing.

Danco Statement on Filing of Cert Petition, September 8, 2023

Retrieved on: 
Friday, September 8, 2023

Danco remains confident in the safety and effectiveness of Mifeprex® under the 2023 REMS that currently governs its use.

Key Points: 
  • Danco remains confident in the safety and effectiveness of Mifeprex® under the 2023 REMS that currently governs its use.
  • The changes in 2016 and 2021—approved by FDA after careful analysis—have expanded the availability and use of Mifeprex®, providing crucial individual and public health benefits.
  • Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following MIFEPREX use.
  • The frequency of adverse reactions varies between studies and may be dependent on many factors including the patient population and gestational age.

Danco Statement on 5th Circuit Ruling, August 16, 2023

Retrieved on: 
Thursday, August 17, 2023

NEW YORK, Aug. 16, 2023 /PRNewswire/ -- The Fifth Circuit panel's decision is inconsistent with established Supreme Court principles governing standing and administrative law challenges.

Key Points: 
  • NEW YORK, Aug. 16, 2023 /PRNewswire/ -- The Fifth Circuit panel's decision is inconsistent with established Supreme Court principles governing standing and administrative law challenges.
  • Danco remains confident in the safety and effectiveness of Mifeprex® and committed to making the drug available as broadly as possible.
  • Danco will continue to be at the forefront of this fight, working closely with the reproductive rights community and pharmaceutical industry, as this case moves forward.
  • Over 5 million women have used Mifeprex® in the United States since its approval for the termination of early pregnancy in 2000.

Paracetamol versus ibuprofen – which works best and when?

Retrieved on: 
Monday, June 26, 2023

In most cases, pain and fever relief is as simple as a trip to your local supermarket for some paracetamol or ibuprofen.

Key Points: 
  • In most cases, pain and fever relief is as simple as a trip to your local supermarket for some paracetamol or ibuprofen.
  • Nurofen is the common brand name for ibuprofen, which is also sold under generic brand names.

Different blocking actions

    • While ibuprofen and paracetamol can be taken for similar reasons (pain relief) each works in a slightly different way.
    • Ibuprofen is a non-steroidal anti-inflammatory drug, which means it acts by blocking the enzymes that produce a group of chemicals called prostaglandins.
    • Like ibuprofen, it is thought to act by blocking the enzymes that produce prostaglandins, although through a different mechanism to ibuprofen.

Is one drug better than the other?

    • Because they each provide pain relief in different ways, paracetamol can be better at treating some types of pain, while ibuprofen is better at treating other types.
    • But be wary of packaging that claims a medication is useful for targeting pain associated with a specific condition as these claims are not true.
    • Paracetamol does not reduce inflammation but it is a better choice when fever is associated with the pain, like when you have a cold or flu.

What about taking both or ‘piggybacking’ them at intervals?

    • If one pathway does not completely control the pain then it can be useful to target the other one.
    • Combination products that contain both paracetamol and ibuprofen in a single tablet include Nuromol and Maxigesic.
    • This keeps the levels of the medication in the body more constant and helps to provide more steady pain relief.
    • Read more:
      Take care with paracetamol when pregnant — but don't let pain or fever go unchecked

How do the side effects compare?

    • These can manifest as nausea, indigestion, bleeding in the stomach, and diarrhoea.
    • For this reason, people with a history of bleeding or ulcers in the gut should not take ibuprofen.
    • However, you need to be careful when using these medicines to make sure you don’t use more than is recommended.
    • Read more:
      The TGA is considering paracetamol restrictions due to poisonings – but what does that mean for consumers?

Both work, both need to be used safely

    • Always read the label so you know exactly what products you are using and how much.
    • Only take the recommended dose, and if you need to, write down the time you take each dose.
    • Your pharmacist or doctor can also advise on the best medicine for your pain and fever and how to use the selected medicine safely.

SCOTUS Issues Stay

Retrieved on: 
Saturday, April 22, 2023

NEW YORK, April 21, 2023 /PRNewswire/ -- We at Danco are gratified the Supreme Court has granted a stay, which keeps the approval of Mifeprex intact without any changes. This stay is an important step in maintaining access to medication abortion during the litigation. Danco stands by the well-established safety profile of Mifeprex and FDA's repeated and careful review of the data and literature in approving the drug and modifying the conditions under which it is available. We remain committed to working with healthcare providers, patients and state and federal governments to keep Mifeprex available and accessible.

Key Points: 
  • This stay is an important step in maintaining access to medication abortion during the litigation.
  • Danco: Gratified the Supreme Court has granted a stay, which keeps the approval of Mifeprex intact without changes.
  • Over 5 million women have used Mifeprex® in the United States since its approval for the termination of early pregnancy in 2000.
  • Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following MIFEPREX use.

-SCOTUS Issues Administrative Stay-

Retrieved on: 
Saturday, April 15, 2023

NEW YORK, April 14, 2023 /PRNewswire/ -- This afternoon, the US Supreme Court issued an administrative stay of the April 7 order from Judge Matthew Kacsmaryk of the US District Court for the Northern District of Texas.  This administrative stay, which runs until midnight on April 19, is a temporary measure that contemplates the Court ruling by then on applications from Danco and the federal government for a broader stay. 

Key Points: 
  • The administrative stay issued today stops Judge Kacsmaryk's order for the time necessary for the Supreme Court to rule on the requests for a full stay.
  • The administrative stay means that the approved status of Mifeprex remains unchanged, including the 2023 revisions to the REMS that allow for dispensing from certified pharmacies and by mail.
  • "It is temporary, but we look forward to the careful consideration we know the Court will give to these important issues.
  • "  Because of the Court's administrative stay, Mifeprex remains approved for use through 70 days' gestation and with the dosing regimen approved in 2016.

Statement In Response To Texas Ruling Upending FDA Approval of Mifeprex®

Retrieved on: 
Saturday, April 8, 2023

 NEW YORK, April 7, 2023 /PRNewswire/ -- Danco Laboratories strongly disagrees with unprecedented preliminary injunction issued by US District Judge Matthew Kacsmaryk in The Alliance for Hippocratic Medicine, et al., v. U.S. Food and Drug Administration, et al. The lawsuit seeks to overturn FDA's two-plus-decade old approval of Mifeprex and its approval of a generic version of the drug mifepristone. The ruling states that the court is "staying" the 2000 approval of Mifeprex and all subsequent challenged actions related to that approval for the duration of the lawsuit. The ruling is set to take effect in seven days, during which time the Defendants will seek a stay from the US Court of Appeals for the Fifth Circuit. 

Key Points: 
  • The lawsuit seeks to overturn FDA's two-plus-decade old approval of Mifeprex and its approval of a generic version of the drug mifepristone.
  • The ruling states that the court is "staying" the 2000 approval of Mifeprex and all subsequent challenged actions related to that approval for the duration of the lawsuit.
  • Danco is appealing this ruling and feels strongly that the rule of law should prevail in this case, which would result in a reversal of this ruling.
  • Over 5 million women have used Mifeprex® in the United States since its approval for the termination of early pregnancy in 2000.