Medication

Global Cleanroom Lighting Market Forecast Report to 2029: Rising Adoption of Sensors and Automation in Cleanroom Lighting Solutions

Retrieved on: 
Tuesday, March 12, 2024
Automation, Growth, Biotechnology, Country, Medication, End user, Project delivery method, Electronics, Health care, Drink, Industrial, Safety, Cleanliness, LED, USD, Region, Government, Food, Personal protective equipment

The increased demand for energy-efficient cleanrooms is poised to be a significant driver of growth in the cleanroom lighting market.

Key Points: 
  • The increased demand for energy-efficient cleanrooms is poised to be a significant driver of growth in the cleanroom lighting market.
  • Cleanroom lighting, being an integral component of these controlled environments, is witnessing a surge in demand for energy-efficient solutions.
  • The cleanroom lighting market is witnessing a surge in focus on eco-friendly hardware solutions, fueled by rising environmental awareness and sustainability initiatives.
  • The heightened emphasis on these aspects by government authorities is positively influencing the adoption of advanced cleanroom technologies, particularly specialized lighting solutions.

ISPE Announces 2024 Facility of the Year Awards Submission Finalists

Retrieved on: 
Tuesday, March 12, 2024
Conference, Medication, International Society, Social impact, ISPE, Life, Supply chain, Creativity, Pharma, Pharmaceutical industry

NORTH BETHESDA, Md., March 12, 2024 /PRNewswire-PRWeb/ -- The International Society of Pharmaceutical Engineering (ISPE) is pleased to announce the 2024 Facility of the Year Awards (FOYA) submission finalists that met the rigorous qualifications and requirements of the FOYA program.

Key Points: 
  • The 2024 Facility of the Year Awards (FOYA) submission finalists are announced at the 2024 ISPE Aseptic Conference, taking place 12-13 March 2024 in Vienna, Austria, and virtually.
  • NORTH BETHESDA, Md., March 12, 2024 /PRNewswire-PRWeb/ -- The International Society of Pharmaceutical Engineering (ISPE) is pleased to announce the 2024 Facility of the Year Awards (FOYA) submission finalists that met the rigorous qualifications and requirements of the FOYA program.
  • FOYA is the premier global awards program recognizing innovation and creativity in manufacturing facilities that serve the regulated healthcare industry.
  • "The announcement of ISPE's FOYA submission finalists is step one to recognizing and celebrating innovation in pharmaceutical manufacturing plant design and qualification.

Press release - EU pharmaceutical policy: MEPs support comprehensive reform

Retrieved on: 
Wednesday, April 3, 2024
Health, ERA, Environment, Public health, EPP, Patient, Eras, Research, Food safety, S&D, Prescription, AMR, Commission, Parliament, European Medicines Agency, Council, HERA, Atmosphere, Water, Soil, Marketing, ECDC, Rapporteur, Medication, Pharmaceutical industry

MEPs adopted their proposals to revamp EU pharmaceutical legislation, to foster innovation and enhance the security of supply, accessibility and affordability of medicines.Committee on the Environment, Public Health and Food Safety Source : © European Union, 2024 - EP

Key Points: 


MEPs adopted their proposals to revamp EU pharmaceutical legislation, to foster innovation and enhance the security of supply, accessibility and affordability of medicines.Committee on the Environment, Public Health and Food Safety Source : © European Union, 2024 - EP

Procedural advice for orphan medicinal product designation: Guidance for sponsors

Retrieved on: 
Wednesday, April 3, 2024
Community, Reproduction, Letter, European Commission, European Communities, Inn, Patient, Agency, Translation, European Medicines Agency, Council, European, Deference, VSI, Marketing, Legislation, Certification, MHLW, Annex, European Economic Area, PDF, Public, Medication, Committee, Policy, Bibliography, EMA, CAT, COMP, SME, Language, Ministry, CHMP, Decision, Cisco Webex, Prevalence, Disease, Part, Classification, Regulation (European Union), Privacy, Commission, RTF, EEA, Sponsor, PMDA, FDA, Guideline, Diagnosis, Civil service commission, European Council, European Parliament, Recognition, Art, INN, Official Journal, Record, TEAMS, Mutual, Microsoft PowerPoint, ID, Pharmaceutical industry

Frequently asked questions ................................................................... 10

Key Points: 
    • Frequently asked questions ................................................................... 10

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 2/13

      1.

    • This Regulation lays down the procedure for
      the designation of medicinal products as orphan medicinal products and provides incentives for the
      development and placing on the market of designated orphan medicinal products.
    • The Regulation also
      establishes the Committee for Orphan Medicinal Products (COMP) within the European Medicines
      Agency (EMA), which is responsible for examining applications for orphan medicinal product
      designation.
    • As of 28 April 2000, the date this Regulation entered into force, sponsors have been able to
      submit applications for orphan medicinal product designation to the EMA.
    • Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 3/13

      2.

    • Objectives
      In examining an application for orphan medicinal product designation, the COMP will focus on
      determining whether the sponsor has established that the designation criteria are met, i.e.
    • To assist in the development of a policy on orphan medicinal products, an expert network will
      be built up by the Committee, with expert(s) identified as appropriate to be involved in the evaluation
      of applications for orphan medicinal product designation.
    • ?

      The complete application should include:

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 5/13

      Document

      Format

      General administrative and scientific information completed online via the portal.

    • Important:
      In preparing an application for orphan medicinal product designation, sponsors are requested to follow
      the Commission guideline (2022/C 440/02) on the format and content of applications for designation
      as orphan medicinal products.
    • Please refer to the Procedural advice on
      appeal procedure for Orphan Medicinal Product Designation (EMEA/2677/01 Rev.3).
    • The grounds for the

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 9/13

      appeal should be based only on the original information provided in the application for orphan
      designation.

    • ?

      The European Commission will enter the designated medicinal product in the Community Register
      of Orphan Medicinal Products.

    • General advice
      ?

      Full information on the procedure for orphan medicinal products designation is available on the
      EMA orphan designation website.

    • In accordance with Regulation (EC) No 141/2000 of 16 December 1999, the sponsor may submit an
      application for orphan medicinal product designation to the Agency at any stage of development of the

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 10/13

      medicinal product as long as the criteria for designation may be justified.

    • A request for orphan medicinal product designation may be made for
      a new orphan indication for an already authorised medicinal product.
    • Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 11/13

      Which are the sponsor?s options in case of negative outcome for orphan designation?

TOMI Expands SteraMist iHP Corporate Service Contracts and Clients

Retrieved on: 
Thursday, March 7, 2024
Hydrogen, DARPA, Acquisition, Pfizer, Hospital, Rocky, Restaurant, Hydrogen peroxide, Food safety, Disinfectant, Annual report, Health, Growth, Cell, Monroe Dunaway Anderson, Horsepower, Meat, University, School, Supervisor, Decontamination, MD Anderson Cancer Center, Police, Medication, Trust, Paint, Corporation, Partnership

FREDERICK, Md., March 07, 2024 (GLOBE NEWSWIRE) -- TOMI Environmental Solutions, Inc.® (“TOMI”) (NASDAQ: TOMZ), a global company specializing in disinfection and decontamination solutions, today announced an expansion in its SteraMist iHP Corporate Service contracts, reaffirming its position as a leading provider of decontamination services to corporate clients in the life sciences industry.

Key Points: 
  • FREDERICK, Md., March 07, 2024 (GLOBE NEWSWIRE) -- TOMI Environmental Solutions, Inc.® (“TOMI”) (NASDAQ: TOMZ), a global company specializing in disinfection and decontamination solutions, today announced an expansion in its SteraMist iHP Corporate Service contracts, reaffirming its position as a leading provider of decontamination services to corporate clients in the life sciences industry.
  • SteraMist iHP technology is becoming the standard decontamination technology in the life sciences sector and academic institutions with a broad spectrum of clients equipped with mobile systems, custom integrations, and service contracts.
  • In a notable development, Rising Pharmaceuticals has entered into an ongoing annual contract with TOMI’s SteraMist iHP Corporate Service following the acquisition of a building previously serviced by the team.
  • SteraMist iHP Corporate Service managed to decontaminate our entire facility quickly without causing harm to the infrastructure or our sensitive equipment.

Persica Pharmaceuticals completes recruitment into Modic Trial assessing efficacy of PP353, to treat chronic lower back pain

Retrieved on: 
Thursday, March 7, 2024
Modic, Safety, Disability, Pharmacokinetics, Patient, Pain, Medication, Psychotherapy, Low back pain, Genetically modified bacteria, Pharmaceutical industry

Persica Pharmaceuticals completes recruitment into Modic Trial assessing efficacy of PP353, to treat chronic lower back pain

Key Points: 
  • Persica Pharmaceuticals completes recruitment into Modic Trial assessing efficacy of PP353, to treat chronic lower back pain
    London, UK, 07 March 2024 – Persica Pharmaceuticals Ltd, a privately held, clinical stage pharmaceutical company developing an antibiotic formulation for intradiscal injection to treat Chronic Low Back Pain (CLBP) and disability associated with bone oedema (Modic 1), which is caused by bacterial infection, today announces the completion of enrolment of participants into its Phase 1b Modic Trial.
  • CLBP is a leading cause of disability with significant unmet medical need and contributes to the overuse of chronic opioid therapy.
  • The Modic Trial is a placebo-controlled randomised clinical trial assessing the safety and efficacy of PP353 as a treatment for patients with CLBP associated with Modic 1 changes.
  • Dr Steve Ruston, Chief Executive Officer of Persica Pharmaceuticals Ltd, said: “CLBP is a debilitating condition which affects millions of people.

PepGen Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Wednesday, March 6, 2024
CONNECT, SAD, Research, Dystrophin, Clinical trial, Food, DMD, Common, DM1, Safety, Health care, Patient, MHRA, Disease, Three Months, Male, IND, Enrollment, PGN, U.K, MBNL1, CTA, Medication, Pharmaceutical industry

BOSTON, March 06, 2024 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today reported financial results for the fourth quarter and full year ended December 31, 2023, and highlighted recent corporate developments.

Key Points: 
  • “With important data readouts expected from our two lead programs, 2024 has the potential to be a transformational year for PepGen.
  • People with myotonic dystrophy type 1 (DM1) currently have no approved treatment options that target the root cause of the disease.
  • Financial Results for the Three Months and Twelve Months ended December 31, 2023
    Cash and cash equivalents were $110.4 million as of December 31, 2023.
  • Net loss was $78.6 million for the year ended December 31, 2023, compared to $69.1 million for the same period in 2022.

Increasing Incidence of Pancreatic Cancer Leading to a $6.85 Billion Dollar Market Size for New Treatments

Retrieved on: 
Tuesday, March 5, 2024
MRK, Hospital, News, FOLFIRINOX, Growth, AbbVie, PR, Neutrophil, Poster, Diagnosis, Pancreatic cancer, HBV, Incidence, Cancer, TME, Hepatology, Interleukin, Therapy, Prostate cancer, Liver, Immune system, Partnership, Merck & Co., AIO, PSMA, Inflammation, Safety, TILS, GPCR, Tumor microenvironment, Research, Medication, PALM, ABBV, Merck, Macrophage, Blood, FDA, TSX, Food, Ageing, Pembrolizumab, Pancreatic Cancer Action Network, Government, Prevalence, Ocean Biomedical, LAVA, PDAC, Patient, MHRA, Disease, ONC, PEI, Pharmaceutical industry

Thus, an increase in the geriatric population is one factor driving the pancreatic cancer treatment market growth.

Key Points: 
  • Thus, an increase in the geriatric population is one factor driving the pancreatic cancer treatment market growth.
  • The incidence is significantly higher in the geriatric population above 65 years of age compared to other types of cancers.
  • A report from Fortune Business Insights said that: “the pancreatic cancer treatment market size is projected to grow to USD 6.85 billion by 2029, exhibiting a CAGR of 15.7% during 2022-2029.
  • Companies engaged in manufacturing cancer drugs have increased their focus on R&D activities to develop new drugs for pancreatic cancer treatment.

Zentalis Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Friday, March 1, 2024
Therapy, SAN, Compensated emancipation, Medication, Employment, Cancer, Pharmaceutical industry

The stock options were granted under the Zentalis Pharmaceuticals, Inc. 2022 Employment Inducement Incentive Award Plan (2022 Inducement Plan) as an inducement material to each such individual’s entering into employment with Zentalis in accordance with Nasdaq Listing Rule 5635(c)(4).

Key Points: 
  • The stock options were granted under the Zentalis Pharmaceuticals, Inc. 2022 Employment Inducement Incentive Award Plan (2022 Inducement Plan) as an inducement material to each such individual’s entering into employment with Zentalis in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The 2022 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Zentalis, or following a bona fide period of non-employment, as an inducement material to each such individual’s entering into employment with Zentalis, pursuant to Nasdaq Listing Rule 5635(c)(4).
  • The stock options have an exercise price of $15.28 per share, which is equal to the closing price of Zentalis’ common stock on The Nasdaq Global Market on the date of grant.
  • Vesting of the stock options is subject to the employee’s continued service to Zentalis on each vesting date.

Codexis Reports Fourth Quarter and Fiscal Year 2023 Financial Results

Retrieved on: 
Wednesday, February 28, 2024
Therapy, Alnylam Pharmaceuticals, Senior, Enzyme, (glutamate—ammonia-ligase) adenylyltransferase, Doctor of Philosophy, Gene editing, Biotechnology, Roche, Pharmaceutical manufacturing, SAB, Telephone, McGill University, Phosphorylation, Research and development, Growth, DNA, ECO, RNA, Medication, Food, Nucleotide, Element, Administration, Exocrine pancreatic insufficiency, Central Waqf Council, Protein, Net, Small RNA, MBBS, RNA interference, Masad Damha, Video game

REDWOOD CITY, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company, today announced financial results for the fourth quarter and fiscal year ended December 31, 2023, and provided a business update.

Key Points: 
  • Including enzyme sales related to PAXLOVID™, total revenues were $26.6 million in fourth quarter 2023 compared to $30.4 million in fourth quarter 2022.
  • Including enzyme sales related to PAXLOVID™, product revenues were $18.1 million in fourth quarter 2023 compared to $23.3 million in fourth quarter 2022.
  • Product gross margin, excluding enzyme sales related to PAXLOVID™, was 71% for fourth quarter 2023 compared to 44% in fourth quarter 2022.
  • Including enzyme sales related to PAXLOVID™, product gross margin for fourth quarter 2023 was 84% compared to 64% in fourth quarter 2022.