Injector

Standard Motor Products Releases 118 Numbers in February Announcement

Retrieved on: 
Tuesday, February 27, 2024
Ignition, Kia Rio, Subaru, Electromagnetic coil, Standard, F-150, General Motors, Senior, Marketing, Subaru Outback, OE, Injector, ABS, Fuel injection, Growth, ICE, Catalog, Automatic parking, Wheel speed sensor, Control, Ford Transit, Mitsubishi Group, EGR, Ford, Mercedes-Benz, Jeep, Hyundai Palisade, Hyundai Santa Fe, SUV, Kia, Hyundai, Lexus, Automotive industry

NEW YORK, Feb. 27, 2024 /PRNewswire/ -- Standard Motor Products, Inc. (SMP®) is pleased to announce the introduction of 118 new part numbers in its February new number announcement. This recent release provides new coverage in 57 distinct product categories and 55 part numbers for 2023 and 2024 model-year vehicles.

Key Points: 
  • This recent release provides new coverage in 57 distinct product categories and 55 part numbers for 2023 and 2024 model-year vehicles.
  • Standard® introduced VVT Sprockets for Subaru, Hyundai and Kia vehicles through 2023 and VVT Solenoids for Mitsubishi vehicles through 2022.
  • Electronic vehicle safety systems become more complex with each passing year, and Standard® is committed to releasing new coverage in these high-tech categories.
  • When OE fails, technicians can trust Standard® for the highest-quality and best-performing parts available."

Apellis Announces Preliminary Fourth Quarter and Full Year 2023 U.S. Net Product Revenues

Retrieved on: 
Monday, January 8, 2024
Conference, Geographic atrophy, Injector, PNH, APLS, Webcast, Patient, Medicine, Paroxysmal nocturnal hemoglobinuria, Pharmaceutical industry

WALTHAM, Mass., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced preliminary U.S. net product revenues of approximately $138 million for the fourth quarter and approximately $366 million for the full year 2023 for SYFOVRE® (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration and for EMPAVELI® (pegcetacoplan) for adults with paroxysmal nocturnal hemoglobinuria (PNH).

Key Points: 
  • WALTHAM, Mass., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced preliminary U.S. net product revenues of approximately $138 million for the fourth quarter and approximately $366 million for the full year 2023 for SYFOVRE® (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration and for EMPAVELI® (pegcetacoplan) for adults with paroxysmal nocturnal hemoglobinuria (PNH).
  • Approximately $114 million and $275 million expected in preliminary U.S. net product revenues in the fourth quarter and full year 2023, respectively.i
    Approximately 62,000 doses (commercial and sample vials) distributed to physician practices in the fourth quarter; approximately 160,000 total doses have been distributed in 2023.
  • “Additionally, the high compliance observed with EMPAVELI speaks to the important impact of this medicine on patients’ lives.
  • The event will be available via a live webcast from the “Events and Presentations” page of the “Investors and Media” section of the company’s website .

Standard Motor Products Expands Gas Fuel Injection Program Offering

Retrieved on: 
Thursday, January 4, 2024
Civic, TBI, Kits, Gasoline, Hyundai Elantra, Altima, F-150, IATF, Hyundai, Direct injection, Nissan, Gasoline direct injection, RAV4, Insight, MFI, GDI, Jeep Grand Cherokee, Volkswagen, Fuel injection, Jeep, Intramuscular injection, OE, Infiniti Q60, Injector, Toyota

NEW YORK, Jan. 4, 2024 /PRNewswire/ -- Standard Motor Products, Inc. (SMP) continues to expand its aftermarket-leading Gasoline Fuel Injection program. With more than 2,100 part numbers, Standard® offers the most complete program in the industry, including everything needed for a complete repair.

Key Points: 
  • Standard's Gasoline Fuel Injection program features more than 2,100 parts, including GDI, MFI and TBI Injectors and related parts for the most complete program in the industry
    SMP-manufactured all-new Injectors are built in SMP's IATF 16949-certified Greenville, South Carolina facility
    NEW YORK, Jan. 4, 2024 /PRNewswire/ -- Standard Motor Products, Inc. (SMP) continues to expand its aftermarket-leading Gasoline Fuel Injection program.
  • Standard's complete Fuel Injection program features over 1,100 all-new, not remanufactured, Gasoline Direct Injection (GDI), Multi-Port Fuel Injection (MFI) and Throttle Body Injection (TBI) Injectors, as well as Fuel Injector Multi-Packs for a complete repair solution.
  • In addition to Injectors, the Standard® program also includes High-Pressure Fuel Pumps and Kits, Fuel Injector Rail Kits, Fuel Pressure Sensors, Fuel Feed Lines, Fuel Pressure Regulators, GDI Service Kits, Fuel Pressure Sensor Connectors, Camshaft Followers and more for a complete line of GDI components, with coverage for import and domestic vehicles through the 2023 model year.
  • All new Standard® Fuel Injection applications are listed in the eCatalog found at StandardBrand.com, and in electronic catalog providers.

Enable Injections Enhances Board with Addition of Vickie Capps

Retrieved on: 
Tuesday, November 7, 2023
FDA, Certified Public Accountant, Enblend, San Diego State University, Injection, Injector, U.S. FDA, Therapy, DJO Global, Patient, Accounting, Management, Pharmaceutical industry, Enabling

CINCINNATI, Nov. 7, 2023 /PRNewswire/ -- Enable Injections, Inc. ("Enable"), a company developing and manufacturing the enFuse® platform of wearable drug delivery systems, is pleased to announce the appointment of Vickie Capps to the company's Board of Directors as the head of the audit committee.

Key Points: 
  • New director, Vickie Capps, brings comprehensive financial expertise and leadership experience to Enable Injections, serving as head of the audit committee.
  • CINCINNATI, Nov. 7, 2023 /PRNewswire/ -- Enable Injections, Inc. ("Enable"), a company developing and manufacturing the enFuse® platform of wearable drug delivery systems, is pleased to announce the appointment of Vickie Capps to the company's Board of Directors as the head of the audit committee.
  • New board director, Vickie Capps, brings comprehensive financial and leadership experience to Enable Injections.
  • "Vickie brings a wealth of experience and financial acumen to our Board at a pivotal stage for Enable Injections," said Mike Hooven, Chairman and CEO of Enable Injections.

Coherus BioSciences Reports Third Quarter 2023 Financial Results and Business Highlights

Retrieved on: 
Monday, November 6, 2023
Complete Response Letter, COGS, CCR8, FDA, Element, Research, Sale, IND, Food, PIN, Biologics license application, Medicare, SG, Cisplatin, Injector, Symantec Endpoint Protection, Surface, Conference, PD-1, GAAP, CHRS, Acquisition, HIV disease progression rates, Exercise, NPC, R, CRL, Adalimumab, Ranibizumab, Neoplasm, Risk, Webcast, Tumor microenvironment, Conference call, Investment, IL-27, BLA, Investigational New Drug, Rare-earth element, Video game, Pharmaceutical industry, Medical device, Online shopping, Q2

REDWOOD CITY, Calif., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today reported financial results for the quarter ended September 30, 2023, and recent business highlights:

Key Points: 
  • – Conference call today at 5:00 p.m. Eastern Time –
    REDWOOD CITY, Calif., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today reported financial results for the quarter ended September 30, 2023, and recent business highlights:
    CIMERLI® (ranibizumab-eqrn) net product sales increased in the third quarter 2023 to $40.0 million compared to $26.7 million in the second quarter.
  • UDENYCA® (pegfilgrastim-cbqv) net product sales increased in the third quarter 2023 to $33.0 million compared to $31.7 million in the second quarter.
  • Market share grew to 16.5% in the third quarter 2023, an increase of 4.3 market share percentage points compared to the prior quarter.
  • Coherus anticipates demand will continue to rise with significantly improved commercial and Medicare Advantage formulary coverage in the fourth quarter of 2023 and in 2024.

Apellis Pharmaceuticals Reports Third Quarter 2023 Financial Results

Retrieved on: 
Wednesday, November 1, 2023
FDA, Insurance, United Kingdom, CAD, PNH, Ophthalmology, Proteinuria, Injector, Congress, Workforce, European Medicines Agency, Research, R, Society, American Society of Nephrology, VALIANT, Growth, Clinical trial, American Academy, GA, Swedish Orphan Biovitrum, Recurrence, Webcast, ASN, U.S. FDA, Cold agglutinin disease, Travel, Safety, Patient, Administration, GALE, Lancet, APLS, Video game, Rare-earth element, Pharmaceutical industry, Clothing, Medical device, Beauty salon, OAKS, G&A, EU

Delivered approximately 37,000 commercial vials and 10,000 samples of SYFOVRE to physician practices in the third quarter 2023.

Key Points: 
  • Delivered approximately 37,000 commercial vials and 10,000 samples of SYFOVRE to physician practices in the third quarter 2023.
  • EMPAVELI for the treatment of PNH:
    Generated $23.9 million in EMPAVELI U.S. net product revenue in the third quarter 2023.
  • In August 2023, Apellis announced a corporate restructuring to drive growth of SYFOVRE and EMPAVELI, positioning Apellis for long-term success.
  • Apellis will host a conference call and webcast to discuss its third quarter 2023 financial results and business highlights today, November 1, 2023, at 8:00 a.m.

Enable Injections Receives First U.S. Food and Drug Administration (FDA) Approval

Retrieved on: 
Monday, October 2, 2023
Business development, Paroxysmal nocturnal hemoglobinuria, Injection, Patient, PNH, FDA, Injector, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry

CINCINNATI, Oct. 2, 2023 /PRNewswire/ -- Enable Injections, Inc. ("Enable") today announced that the U.S. Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse®) for the subcutaneous delivery of EMPAVELI® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. for adults with paroxysmal nocturnal hemoglobinuria (PNH). The EMPAVELI Injector is a compact, wearable injector designed to streamline the self-administration experience with minimal disruption to patients' daily lives.

Key Points: 
  • CINCINNATI, Oct. 2, 2023 /PRNewswire/ -- Enable Injections, Inc. ("Enable") today announced that the U.S. Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse®) for the subcutaneous delivery of EMPAVELI® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. for adults with paroxysmal nocturnal hemoglobinuria (PNH).
  • The EMPAVELI Injector is a compact, wearable injector designed to streamline the self-administration experience with minimal disruption to patients' daily lives.
  • "The approval of the EMPAVELI Injector will enhance the patient experience of administering a large volume (20 mL) of subcutaneous therapy," said Michael D. Hooven, Enable Injections' Chairman and CEO.
  • "The EMPAVELI Injector is the first purely mechanical, large-volume, on-body subcutaneous drug delivery device," said Matthew Huddleston, Enable Injections' Chief Technology Officer and Executive Vice President of Business Development.

Enable Injections Receives First U.S. Food and Drug Administration (FDA) Approval

Retrieved on: 
Monday, October 2, 2023
Business development, Paroxysmal nocturnal hemoglobinuria, Injection, Patient, PNH, FDA, Injector, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry

CINCINNATI, Oct. 2, 2023 /PRNewswire/ -- Enable Injections, Inc. ("Enable") today announced that the U.S. Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse®) for the subcutaneous delivery of EMPAVELI® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. for adults with paroxysmal nocturnal hemoglobinuria (PNH). The EMPAVELI Injector is a compact, wearable injector designed to streamline the self-administration experience with minimal disruption to patients' daily lives.

Key Points: 
  • CINCINNATI, Oct. 2, 2023 /PRNewswire/ -- Enable Injections, Inc. ("Enable") today announced that the U.S. Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse®) for the subcutaneous delivery of EMPAVELI® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. for adults with paroxysmal nocturnal hemoglobinuria (PNH).
  • The EMPAVELI Injector is a compact, wearable injector designed to streamline the self-administration experience with minimal disruption to patients' daily lives.
  • "The approval of the EMPAVELI Injector will enhance the patient experience of administering a large volume (20 mL) of subcutaneous therapy," said Michael D. Hooven, Enable Injections' Chairman and CEO.
  • "The EMPAVELI Injector is the first purely mechanical, large-volume, on-body subcutaneous drug delivery device," said Matthew Huddleston, Enable Injections' Chief Technology Officer and Executive Vice President of Business Development.

Apellis Announces U.S. FDA Approval of the EMPAVELI® Injector, a Device to Streamline Self-Administration

Retrieved on: 
Monday, October 2, 2023
Transfer, Duke University, APLS, Paroxysmal nocturnal hemoglobinuria, Head, Medicine, Standard of care, Patient, PNH, FDA, Injector, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry

WALTHAM, Mass., Oct. 02, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the U.S. Food and Drug Administration (FDA) has approved the EMPAVELI® Injector. The EMPAVELI Injector is a compact, single-use, on-body device designed to enhance self-administration of EMPAVELI (pegcetacoplan), which is approved for adults with paroxysmal nocturnal hemoglobinuria (PNH).

Key Points: 
  • WALTHAM, Mass., Oct. 02, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the U.S. Food and Drug Administration (FDA) has approved the EMPAVELI® Injector.
  • The EMPAVELI Injector is a compact, single-use, on-body device designed to enhance self-administration of EMPAVELI (pegcetacoplan), which is approved for adults with paroxysmal nocturnal hemoglobinuria (PNH).
  • Now, we are further enhancing the patient experience with the approval of the EMPAVELI Injector, an innovative and first-of-its-kind, high-volume injector,” said Peter Hillmen, M.B.
  • “With the EMPAVELI Injector, patients can seamlessly integrate EMPAVELI treatment into their daily lives, whether that is at home or on the go.”

Coherus BioSciences Reports Second Quarter 2023 Financial Results and Business Highlights

Retrieved on: 
Wednesday, August 2, 2023
Exercise, OBI, COGS, Therapy, SG, Conference call, American Society of Clinical Oncology, OS, GAAP, Sale, Nasopharyngeal carcinoma, CHRS, PIN, Investigational New Drug, Acquisition, Patient, Investment, TIGIT, Webcast, Neoplasm, NPC, R, Research, FDA, Injector, Death, Adalimumab, Tumor microenvironment, Society, Conference, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Generic drug, Pharmaceutical industry, Online shopping, Cryptocurrency

REDWOOD CITY, Calif., Aug. 02, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS), today reported financial results for the quarter ended June 30, 2023, and recent business highlights:

Key Points: 
  • Coherus anticipates potential FDA approval and U.S. commercial launch of toripalimab in the second half of 2023.
  • Coherus launched YUSIMRY™, a Humira biosimilar, with a citrate-free and sting-free formulation delivered via a state-of-the-art autoinjector on July 3rd.
  • Coherus expects its 2023 net product revenue will exceed $275 million, including at least $100 million of CIMERLI® net revenue.
  • Coherus projects combined R&D and SG&A expenses for 2023 to be in the range of $315 to $335 million.