Drug delivery

Clearside Biomedical Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, March 12, 2024
Patient, G&A, BioCryst Pharmaceuticals, Eye, Drug delivery, Clinical trial, AAO, Extension, Webcast, Pharming, CPT, Safety, Disease, SPA, American Academy of Ophthalmology, Compass, Insurance, Diabetic retinopathy, Conference call, Aura, AMD, TKI, CLS, FDA, Administration, Conference, SCS, DME, American Academy, OASIS, Injection, Research and development, Axitinib, Pharmaceutical industry

ALPHARETTA, Ga., March 12, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today reported financial results for the fourth quarter and year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • License Revenue: License and other revenue for the fourth quarter of 2023 was $6.3 million, compared to $0.3 million for the fourth quarter of 2022.
  • Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2023 were $6.3 million, compared to $5.0 million for the fourth quarter of 2022.
  • General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2023 were $2.9 million, compared to $3.2 million for the fourth quarter of 2022.
  • Other Expense: Non-cash interest expense for the fourth quarter of 2023 was $2.3 million, compared to $2.0 million for the fourth quarter of 2022.

Kindeva Drug Delivery Welcomes Jennifer Riter, New Vice President of Analytical Services

Retrieved on: 
Monday, March 18, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Medical Devices, Chemicals, Plastics, Manufacturing, CDMO, Conference, Business, Drug delivery, University, Curriculum, Multimedia

Kindeva Drug Delivery (Kindeva), a global leader in drug-device combination products, today welcomes Jennifer Riter as Vice President of Analytical Services to head up the recently announced analytical services global business unit .

Key Points: 
  • Kindeva Drug Delivery (Kindeva), a global leader in drug-device combination products, today welcomes Jennifer Riter as Vice President of Analytical Services to head up the recently announced analytical services global business unit .
  • View the full release here: https://www.businesswire.com/news/home/20240318401921/en/
    Jennifer Riter joins Kindeva Drug Delivery as Vice President of Analytical Services to lead new analytical services business unit.
  • She brings specific leadership and expertise in analytical testing which includes extractables and leachables, container closure integrity and device/combination product performance, and particle analysis.
  • “Kindeva’s expertise in all areas of drug delivery and manufacturing is unmatched in the industry,” Riter said.

Kindeva Drug Delivery Launches New Analytical Services Global Business Unit

Retrieved on: 
Wednesday, January 31, 2024
Research, Medical Devices, Packaging, Chemicals, Plastics, Clinical Trials, Manufacturing, Biotechnology, Pharmaceutical, Health, Science, USP, Knowledge, CGMP, MD, Kindeva, ICH, Safety, CCI, Syringe, False vacuum decay, Drug delivery, Guideline, GMP, Fine chemical

Kindeva Drug Delivery (Kindeva), a global leader in drug-device combination products, announced the expansion of its analytical services capabilities — launching a new global business unit offering integrated and stand-alone analytical support to the wider pharmaceutical, biopharmaceutical, and medical device sector.

Key Points: 
  • Kindeva Drug Delivery (Kindeva), a global leader in drug-device combination products, announced the expansion of its analytical services capabilities — launching a new global business unit offering integrated and stand-alone analytical support to the wider pharmaceutical, biopharmaceutical, and medical device sector.
  • For more than half a century, Kindeva has developed significant knowledge, experience, and expertise working on inhaled, injectable, and transdermal drug delivery development programs and cGMP commercial supply.
  • Additionally, Kindeva has built deep expertise and capability in cGMP analytical services supporting its product development and supply partners.
  • In addition to increasing Kindeva’s global analytical footprint, Kindeva’s recently opened 32,000-square-foot state-of-the-art laboratories in Woodbury, Minnesota, will serve as the central hub for its expanded suite of stand-alone analytical services.

Kindeva Drug Delivery Acquires Summit Biosciences, a Specialized Nasal Drug Development and Manufacturing Organization

Retrieved on: 
Thursday, January 18, 2024
Medical Devices, Medical Supplies, Chemicals, Plastics, Manufacturing, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, European Medicines Agency, CGMP, Drug delivery, EMA, Food, Acquisition, Laboratory, FDA, Workforce, CDMO, Kirkland & Ellis, Pharmaceutical industry

Kindeva Drug Delivery (“Kindeva”), a global leader in drug-device combination products, announced today that it has acquired Summit Biosciences Inc. (“Summit”), an intranasal drug-delivery contract development and manufacturing organization (CDMO), from its founding family shareholders.

Key Points: 
  • Kindeva Drug Delivery (“Kindeva”), a global leader in drug-device combination products, announced today that it has acquired Summit Biosciences Inc. (“Summit”), an intranasal drug-delivery contract development and manufacturing organization (CDMO), from its founding family shareholders.
  • Established in 2009, Summit has an extensive track record of innovation in the unit dose nasal spray market.
  • “Nasal drug delivery is becoming a preferred dosage format for a growing number of indications, as it allows users to non-invasively administer medications in an acute or emergency setting,” said Kindeva CEO Milton Boyer .
  • “Summit brings a differentiated understanding of how to effectively formulate drugs for nasal delivery and the capability to manufacture them at commercial scale.

Clearside Biomedical Announces Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 13, 2023
Potential, Visual acuity, Patient, Research, American Medical Association, Targeted drug delivery, Conference, American Academy of Ophthalmology, R, Diabetes, Diabetic retinopathy, Webcast, Literature, American Academy, Administration, DME, G&A, Research and development, Physician, Paratriathlon, Retina, Drug delivery, Pharming, Eye, Intravitreal injection, BioCryst Pharmaceuticals, SCS, Edema, AAO, Melanoma, AURA, Solubility, Partnership, AMD, Clearside, Bausch & Lomb, OASIS, Axitinib, Plasma, Clinical trial, CLS, CPT, Conference call, UME, Injection, HIV disease progression rates, Pharmaceutical industry, Nursing, Video game

ALPHARETTA, Ga., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.

Key Points: 
  • ET -
    ALPHARETTA, Ga., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.
  • Other Income: Other income for the third quarter of 2023 was $0.4 million, compared to $0.2 million for the third quarter of 2022.
  • Other Expense: Non-cash interest expense for the third quarter of 2023 was $2.6 million, compared to $1.3 million in the third quarter of 2022.
  • Clearside’s management will host a webcast and conference call today at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update.

Kindeva Drug Delivery and Orbia Fluorinated Solutions (Koura) Announce Collaboration for Low GWP Propellant Conversion

Retrieved on: 
Tuesday, December 5, 2023
Other Manufacturing, Medical Devices, Medical Supplies, Chemicals, Plastics, Manufacturing, Other Health, Health, Pharmaceutical, General Health, Carbon, CDMO, Lung, DDL, Patient, Isocyanate, European, GWP, BMV, Pulmonary drug delivery, National Highway 152A (India), Partnership, Metered-dose inhaler, Drug delivery, Pharmaceutical industry, Engineered wood, Kindeva

Kindeva Drug Delivery (Kindeva), a leading global contract development and manufacturing organization (CDMO) focused on drug-device combination products, and Orbia Advance Corporation , S.A.B.

Key Points: 
  • Kindeva Drug Delivery (Kindeva), a leading global contract development and manufacturing organization (CDMO) focused on drug-device combination products, and Orbia Advance Corporation , S.A.B.
  • de C.V. (BMV: ORBIA*) Fluorinated Solutions business ( Koura ®), a global leader in the development, manufacture, and supply of fluoroproducts and technologies, announced today a co-development collaboration for the conversion from existing marketed pressurised Metered Dose Inhaler (pMDI) products to Koura’s more sustainable and environmentally-conscious medical propellant; HFA 152a, known as Zephex® 152a.
  • View the full release here: https://www.businesswire.com/news/home/20231205198764/en/
    This strategic collaboration will focus on accelerating the conversion of existing marketed pMDI inhaler products to low global warming potential (GWP) pMDIs utilizing Koura’s Zephex 152a platform with the objective of reducing respiratory healthcare carbon emissions while safeguarding patient choice.
  • This partnership aims to facilitate conversion of pMDI products to the lower GWP propellent 152a and progressing them through clinical development.

Insulet Reports Third Quarter 2023 Revenue Increase of 27% Year-Over-Year (25% Constant Currency1)

Retrieved on: 
Thursday, November 2, 2023
Other Consumer, Manufacturing, Women, Seniors, Teens, Parenting, Other Technology, Men, Children, Baby, Maternity, Family, Consumer, Consumer Electronics, Technology, LGBTQ+, General Health, Other Manufacturing, Health, Adjustment, FDA, European, MDC, IPad Air 2, IOS, Corporation, Safety, Drug delivery, Therapy, Pharmaceutical industry, Video game, Cryptocurrency, Health care

Third quarter 2023 revenue of $432.7 million, up 27.0%, or 25.1% in constant currency1, compared to $340.8 million in the prior year

Key Points: 
  • Third quarter 2023 revenue of $432.7 million, up 27.0%, or 25.1% in constant currency1, compared to $340.8 million in the prior year
    Total Omnipod revenue of $422.0 million, an increase of 29.4%, or 27.5% in constant currency
    U.S. Omnipod revenue of $320.6 million, an increase of 34.6%
    International Omnipod revenue of $101.4 million, an increase of 15.2%, or 8.0% in constant currency
    Drug Delivery revenue of $10.7 million, a decrease of 27.2%
    Gross margin of 67.8%, up 1,250 basis points, compared to gross margin of 55.3% in the prior year.
  • Operating income of $54.8 million, or 12.7% of revenue, up 1,180 basis points compared to operating income of $2.9 million, or 0.9% of revenue, in the prior year.
  • Adjusted operating income1 of $52.9 million, or 12.2% of revenue, up 60 basis points, excludes income of $1.9 million noted above.
  • Adjusted operating income in the prior year of $39.7 million, or 11.6% of revenue, excludes the charge of $36.8 million noted above.

West to Attend and Showcase Industry Leadership in Packaging and Containment at CPHI Worldwide Conference

Retrieved on: 
Monday, October 23, 2023
Sustainability, NYSE, West Pharmaceutical Services, WST, Vial, Control, Development, Containment, Drug delivery, Renewable energy, Fine chemical

EXTON, Pa., Oct. 23, 2023 /PRNewswire/ -- West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, today announced its participation at CPHI Worldwide in Barcelona, Spain to showcase its leadership and expertise on industry challenges and trends in packaging and containment.

Key Points: 
  • EXTON, Pa., Oct. 23, 2023 /PRNewswire/ -- West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, today announced its participation at CPHI Worldwide in Barcelona, Spain to showcase its leadership and expertise on industry challenges and trends in packaging and containment.
  • "West is applying its 100 years of innovation to address the changing containment and delivery needs of more complex molecules and combination products as well as more sustainable options for the industry," said Chris Ryan, Vice President, Containment and Glass Systems at West.
  • "At this year's CPHI, West will be sharing our guidance on Annex 1 EU GMP regulations and, as the exclusive distributor of Corning® Viridian™ Vials, we will be introducing this product that brings both performance and sustainability to the industry."
  • For more information about West, please visit our website: www.westpharma.com .

Kriya Announces Exclusive License and Collaboration Agreement with Everads to Advance Gene Therapies for Prevalent Diseases in Ophthalmology Including Geographic Atrophy

Retrieved on: 
Wednesday, September 27, 2023
Drug delivery, Retina, Injection, CR2, Pediatrics, IgG4-related ophthalmic disease, Sclera, Eye, Geographic atrophy, Quality of life, Intravitreal injection, Inflammation, AAV, Complement, RESEARCH, Administration, C3, Choroid, Stanford University School of Medicine, Patient, CR1, PARK, Entrepreneurship, FDA, Therapy, Emotional dysregulation, Disease, Pharmaceutical industry, Medical device, Vaccine, Ophthalmology, Kriyā, C5

PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., Sept. 27, 2023 (GLOBE NEWSWIRE) -- Kriya Therapeutics, Inc. ("Kriya"), a biopharmaceutical company developing gene therapies for conditions affecting millions of people around the world, has entered into an exclusive license, collaboration and supply agreement with Everads Therapy, Ltd (“Everads”) to advance Kriya’s portfolio of gene therapies for retinal diseases using Everads' suprachoroidal delivery device. Everads is a private biotech company that has developed a novel technology enabling targeted delivery of therapies to the retina via the suprachoroidal space, an anatomical compartment located between the sclera and choroid that traverses the circumference of the posterior segment of the eye. Suprachoroidal delivery is an emerging, non-surgical route of administration in ophthalmology. Specifically in delivery of gene therapy, this route of administration offers the potential to enhance the efficiency of gene therapy delivery to the retina while minimizing intraocular inflammation.

Key Points: 
  • Specifically in delivery of gene therapy, this route of administration offers the potential to enhance the efficiency of gene therapy delivery to the retina while minimizing intraocular inflammation.
  • The transaction enables Kriya’s access to Everads’ suprachoroidal delivery technology to deliver multiple prespecified gene therapy product candidates for several ophthalmic diseases, including those involving the complement cascade.
  • “I am quite optimistic and convinced that innovative therapies will continue to improve the lives of people with geographic atrophy and other serious ophthalmic diseases.
  • A gene therapy targeting the C3 and C5 pathways delivered by a suprachoroidal injection may be a significant improvement in the treatment of geographic atrophy.”

Kindeva Drug Delivery Appoints Brian Schubmehl as Chief Human Resources Officer

Retrieved on: 
Friday, September 15, 2023
Biotechnology, Pharmaceutical, Human Resources, Health, Packaging, Medical Devices, Professional Services, Manufacturing, HR, Workforce, Kindeva, CDMO, Acquisition, Drug delivery, Multimedia, Culture, Whirlpool Corporation, Management

Kindeva Drug Delivery (Kindeva), a premier global drug delivery device contract development and manufacturing organization (CDMO), announced that Brian Schubmehl has joined the company as Chief Human Resources Officer.

Key Points: 
  • Kindeva Drug Delivery (Kindeva), a premier global drug delivery device contract development and manufacturing organization (CDMO), announced that Brian Schubmehl has joined the company as Chief Human Resources Officer.
  • View the full release here: https://www.businesswire.com/news/home/20230915824136/en/
    Brian Schubmehl joins Kindeva Drug Delivery as Chief Human Resources Officer.
  • Before joining Kindeva, Brian was Vice President, Global Human Resources at Curia, where he steered expansion from 1,500 to 3,700 employees and developed key strategies that enabled organizational success.
  • “As Chief Human Resources Officer, his expertise and leadership will expand and safeguard Kindeva’s strengths as we continue to grow our organization as a global force in combination drug delivery.”