Digoxin

Draft revised consolidated 3-year work plan for the Methodology Working Party (MWP)

Retrieved on: 
수요일, 2월 14, 2024

Industry level .................................................................................................. 13

Key Points: 
    • Industry level .................................................................................................. 13

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 2/14

      1.

    • A reflection paper
      (RP) on the clinical pharmacology package for oligonucleotides is a prioritised activity in the MWP work

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 3/14

      plan, and it is envisaged that something similar may be needed for other emerging treatment
      modalities (e.g., peptides).

    • Guideline work led by other working parties
      ?

      Revision of the guideline on the requirements for clinical documentation for orally inhaled
      products (CPMP/EWP/4151/00 Rev.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 4/14

      The planned concept papers (CPs) will formulate problem statements for potential workshops and
      subsequent guidance documents will be informed and enriched by the outcome of discussions of
      workshops to be held in 2024.

    • Guideline work led by other working parties and committees
      ?

      Revision of Guidance on the investigation of medicinal products in the term and preterm
      neonate (EMEA/536810/2008).

    • There is a need for
      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 5/14

      new guidance in these areas to ensure these novel approaches meet the required evidentiary
      standards and facilitate their evaluation.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 6/14

      ?

      Revision of Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 7/14

      ?

      Provide appropriate support to the EU network for generic and hybrid medicines including
      product-specific requirements.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 8/14

      2.3.

    • ?

      Cross disciplinary work with Quality Working Party and other stakeholders on physiologically
      based biopharmaceutics modelling (PBBM).

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 9/14

      ?

      In order to support adequate evaluation of all methodology MWP will aim to facilitate an
      increase in presence and visibility in relevant committees of methodological expertise from
      across the EU network such as CHMP, PRAC, PDCO, CMD(h), ETF and CAT.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 10/14

      ?

      Product Specific Bioequivalence Guidelines (PSBGLs) (multiple) in liaison with CMD(h): for
      2024, azacitidine, budesonide (LALA GIT), trametinib, dabrafenib, paliperidone palmitate (3M
      depot) and melatonin have been prioritised as the next in series for drafting.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 11/14

      4.2.

    • ?

      Cross disciplinary work with Quality Working Party and other stakeholders on PBBM model
      assessment.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 12/14

      ?

      To deliver an improved access to raw data (e.g.

    • ?

      Propose regulatory research priorities for funders in across the activities of Methodology
      Working Party, including in the big data area.

    • ?

      Establish key communication points in national competent authorities and build a resource of
      key messages and communication materials on regulation and methodology.

    • The timing of workshops may need to be arranged according to the

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 13/14

      specific needs of the guidance ? either before the guidance is finalised to gather views and
      expertise; or once it is finalised for training purposes.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 14/14

Lexicon Pharmaceuticals Provides Business and Pipeline Update at 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
월요일, 1월 8, 2024

THE WOODLANDS, Texas, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives, today announced a business and pipeline update at the 42nd Annual J.P. Morgan Healthcare Conference taking place January 8-12, 2024.

Key Points: 
  • THE WOODLANDS, Texas, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives, today announced a business and pipeline update at the 42nd Annual J.P. Morgan Healthcare Conference taking place January 8-12, 2024.
  • “Lexicon achieved major advancements in 2023 in its business and pipeline of pharmaceutical innovations,” said Lonnel Coats, chief executive officer and director of Lexicon.
  • The company will also focus on ensuring a strong ongoing awareness of INPEFA in the medical community through medical publications and congress presence.
  • Company to Present at J.P. Morgan Healthcare Conference Thursday, January 11, 2024 at 10:30am PST (1:30pm ET)
    Lonnel Coats, Lexicon’s chief executive officer, will make a company presentation.

Teva Announces Approval of a Generic Version of Forteo® (teriparatide injection), in the U.S.

Retrieved on: 
금요일, 11월 17, 2023

Teva Pharmaceuticals Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the approval of a generic version of Forteo®1, in the United States.

Key Points: 
  • Teva Pharmaceuticals Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the approval of a generic version of Forteo®1, in the United States.
  • Currently, 1 in 12 generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
  • Teva’s generic equivalent of Forteo® (teriparatide injection) utilizes the Antares Pharma, Inc. multi-dose pen device.
  • Teriparatide injection can lessen the chance of broken bones (fractures) in the spine and other bones in postmenopausal women with osteoporosis.

Blame capitalism? Why hundreds of decades-old yet vital drugs are nearly impossible to find

Retrieved on: 
목요일, 7월 20, 2023

Past public ire over high drug prices has recently taken a back seat to a more insidious problem – no drugs at any price.

Key Points: 
  • Past public ire over high drug prices has recently taken a back seat to a more insidious problem – no drugs at any price.
  • Patients and their providers increasingly face limited or nonexistent supplies of drugs, many of which treat essential conditions such as cancer, heart disease and bacterial infections.
  • The American Society of Health System Pharmacists now lists over 300 active shortages, primarily of decades-old generic drugs no longer protected by patents.

A generic problem

    • The problem boils down to the nature of the pharmaceutical industry and how differently the markets for brand and generic drugs operate.
    • Perhaps the clearest indication of this is the fact that prices of brand drugs in the U.S. are among the highest in the developed world, while generic drug prices are among the lowest.
    • But once the patent expires, the drug becomes generic and any company is allowed to manufacture it.

Outsourced production creates more supply risks

    • One of the consequences of generics’ meager margins is that drug companies outsource production to lower-cost countries.
    • While overseas manufacturers often enjoy significant cost advantages over U.S. facilities, such as easy access to raw materials and lower labor costs, outsourcing production at such a scale raises a slew of issues that can hurt the supply.
    • The COVID-19 pandemic underscored the country’s reliance on foreign suppliers – and the risks this poses to U.S. consumers.
    • To ensure domestic supplies, the Indian government restricted the export of medications, disrupting the global supply chain.

Low profits hurt quality

    • Manufacturing drugs to consistently high quality standards requires constant testing and evaluation.
    • A company that sells a new, expensive, branded drug has a strong profit motive to keep quality and production high.
    • That’s often not the case for generic drug manufacturers, and this can result in shortages.
    • Thus, any hiccup in production or shutdown due to quality issues can affect the entire market.

Repatriating the drug supply

    • It is hard to quantify the impact of drug shortages on population health.
    • However, a recent survey of U.S. hospitals, pharmacists and other health care providers found that drug shortages led to increased medication errors, delayed administration of lifesaving therapies, inferior outcomes and patient deaths.
    • Whether this approach is feasible on a broader scale is uncertain, but, in my view, it’s a good first attempt to repatriate America’s drug supply.

Atea Pharmaceuticals Presents Favorable Drug Interaction Profile of Bemnifosbuvir in Phase 1 Studies at CROI 2023

Retrieved on: 
목요일, 2월 23, 2023

BOSTON, Feb. 23, 2023 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced that data from three Phase 1 studies suggest a favorable drug-drug interaction profile. No dosage adjustment is needed for CYP3A substrates or for drugs that are sensitive substrates of efflux and hepatic uptake transporters when co-administrated with bemnifosbuvir. CYP3A is an enzyme that metabolizes many classes of prescribed medicines and medicinal supplements, and efflux/hepatic uptake transporters regulate cellular trafficking of many drugs that are commonly prescribed to patients that are at high risk for severe COVID-19.

Key Points: 
  • BOSTON, Feb. 23, 2023 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced that data from three Phase 1 studies suggest a favorable drug-drug interaction profile.
  • No dosage adjustment is needed for CYP3A substrates or for drugs that are sensitive substrates of efflux and hepatic uptake transporters when co-administrated with bemnifosbuvir.
  • These results were presented at the Conference on Retroviruses and Opportunistic Infections (CROI), which took place February 19-22, 2023 in Seattle, Washington.
  • A single dose (simultaneous or staggered) of bemnifosbuvir 1100 mg administered with ROSU slightly increased the plasma exposure of ROSU.

BioCryst Announces Approval of ORLADEYO® (berotralstat) by the Israeli Ministry of Health

Retrieved on: 
월요일, 11월 28, 2022

With todays announcement, we look forward to working with our partner Neopharm to launch ORLADEYO in Israel.

Key Points: 
  • With todays announcement, we look forward to working with our partner Neopharm to launch ORLADEYO in Israel.
  • The approval of ORLADEYO is a major advancement for the HAE community in Israel.
  • The most frequently reported adverse reactions in patients receiving ORLADEYO compared with placebo were back pain and gastrointestinal reactions.
  • The gastrointestinal reactions generally occurred early after initiation of treatment with ORLADEYO, became less frequent with time and typically self-resolved.

Urovant Sciences® Announces Partnership with Thinx Inc. to Help Americans with Overactive Bladder This Travel Season

Retrieved on: 
월요일, 11월 14, 2022

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20221114005347/en/
    Urovant Sciences Announces Partnership with Thinx Inc. to Help Americans with Overactive Bladder This Travel Season (Graphic: Business Wire)
    November is Bladder Health Awareness Month and its also the start of holiday and winter travel.
  • To help people learn more about OAB and ways to manage symptoms, a free travel kit is available on TimeToGo.com.
  • Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily.
  • UROVANT, UROVANT SCIENCES, the UROVANT SCIENCES logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries.

BioCryst Presents Real-World Data Showing Rapid and Sustained HAE Attack Rate Reduction After Beginning ORLADEYO® (berotralstat), Regardless of Prior Prophylactic Therapy

Retrieved on: 
목요일, 11월 10, 2022

Every HAE patient has a unique experience with their therapy, and these data demonstrate that ORLADEYO can be a very effective treatment option for patients regardless of their reported prior attack rates or prophylactic therapy history.

Key Points: 
  • Every HAE patient has a unique experience with their therapy, and these data demonstrate that ORLADEYO can be a very effective treatment option for patients regardless of their reported prior attack rates or prophylactic therapy history.
  • Regardless of prior prophylaxis, a rapid reduction in median attack rates was observed early (1.67 attacks/month at baseline to a median attack rate of 0.33 attacks/month in days 1-90).
  • Upon initiating ORLADEYO treatment, the reduction in median attack rates from baseline over the 1360 days period was consistent for patients regardless of their prior prophylaxis therapy.
  • Regardless of baseline attack rate, patients reported a reduction in attack rates when treated with ORLADEYO.

Cytokinetics Presents New Data at the American Heart Association Scientific Sessions 2022

Retrieved on: 
월요일, 11월 7, 2022

SOUTH SAN FRANCISCO, Calif., Nov. 07, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data from two additional analyses from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), as well as an analysis of patients hospitalized for heart failure with reduced ejection fraction (HFrEF) from the Get With The Guidelines-Heart Failure Registry, were presented at the American Heart Association Scientific Sessions 2022 in Chicago, IL.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Nov. 07, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data from two additional analyses from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), as well as an analysis of patients hospitalized for heart failure with reduced ejection fraction (HFrEF) from the Get With The Guidelines-Heart Failure Registry, were presented at the American Heart Association Scientific Sessions 2022 in Chicago, IL.
  • Cytokinetics is readying for the potential commercialization of omecamtiv mecarbil, its cardiac muscle activator, following positive results from GALACTIC-HF, a large, international Phase 3 clinical trial in patients with heart failure.
  • Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act's Safe Harbor for forward-looking statements.
  • For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.

Urovant Sciences Announces Publication of Pharmacokinetic Data on GEMTESA® (Vibegron 75mg) Administered as an Intact or Crushed Tablet

Retrieved on: 
목요일, 10월 27, 2022

In the study, which involved healthy adults, GEMTESA was administered in a single 75-mg dose as an intact tablet vs. crushed and mixed with applesauce.

Key Points: 
  • In the study, which involved healthy adults, GEMTESA was administered in a single 75-mg dose as an intact tablet vs. crushed and mixed with applesauce.
  • All patients received one treatment with intact tablet and one with crushed tablet, mixed with applesauce.
  • Additional reported TEAEs experienced by 2 participants were constipation (crushed, 13.3%; intact 6.7%) and nausea (crushed 6.7%, intact 0%) .
  • UROVANT, UROVANT SCIENCES, the UROVANT SCIENCES logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries.