Subcutaneous

James Sherblom Appointed Board Chairman to Lead ReForm Biologics’ New Business Strategy

Retrieved on: 
Thursday, February 25, 2021
Medical devices, Human resources, Professional services, Biotechnology, Physical therapy, Health, General Health, Other Science, Science, Dosage forms, Injection, Medicine, Clinical medicine, Health sciences, Routes of administration, Subcutaneous injection, Intravenous therapy, Subcutaneous

As well, James (Jim) Sherblom has joined the board of directors of ReForm as chairman to lead the shift in strategy.

Key Points: 
  • As well, James (Jim) Sherblom has joined the board of directors of ReForm as chairman to lead the shift in strategy.
  • Under the strategy announced today, ReForm will develop a bio-innovative medicine pipeline to convert hospital-based intravenous dosing to subcutaneous injections on an outpatient basis.
  • ReForm will manage therapeutic viscosity to reduce injection volumes and fluid injection force, greatly enhancing many therapeutics, including pediatric applications.
  • I am delighted join the team at ReForm to help lead this revolution in better patient care and improved clinical outcomes.

Galderma Receives FDA Approval for Restylane® Defyne for Chin Augmentation

Retrieved on: 
Wednesday, February 3, 2021
Medical specialties, Surgery, Oral and maxillofacial surgery, Oral surgery, Clinical medicine, Glycosaminoglycans, Otorhinolaryngology, Restylane, Lidocaine, Chin, Lyft, Subcutaneous

For more information about Restylane Defyne for chin, visit RestylaneUSA.com.

Key Points: 
  • For more information about Restylane Defyne for chin, visit RestylaneUSA.com.
  • The FDA approval of Restylane Defyne for chin adds to Galderma's growing Restylane product portfolio.
  • The Restylane family of products are indicated for patients over the age of 21, and includes Restylane, Restylane-L, Restylane Lyft with Lidocaine, Restylane Silk, Restylane Refyne, Restylane Defyne and Restylane Kysse.
  • Restylane Defyne is also indicated for injection into the mid-to deep dermis (subcutaneous and/or supraperiosteal) for augmentation of the chin region to improve the chin profile in patients with mild to moderate chin retrusion.

Galderma Receives FDA Approval for Restylane® Defyne for Chin Augmentation

Retrieved on: 
Monday, February 1, 2021
Medical specialties, Surgery, Oral and maxillofacial surgery, Oral surgery, Clinical medicine, Glycosaminoglycans, Otorhinolaryngology, Restylane, Lidocaine, Chin, Lyft, Subcutaneous

For more information about Restylane Defyne for chin, visit RestylaneUSA.com.

Key Points: 
  • For more information about Restylane Defyne for chin, visit RestylaneUSA.com.
  • The FDA approval of Restylane Defyne for chin adds to Galderma's growing Restylane product portfolio.
  • The Restylane family of products are indicated for patients over the age of 21, and includes Restylane, Restylane-L, Restylane Lyft with Lidocaine, Restylane Silk, Restylane Refyne, Restylane Defyne and Restylane Kysse.
  • Restylane Defyne is also indicated for injection into the mid-to deep dermis (subcutaneous and/or supraperiosteal) for augmentation of the chin region to improve the chin profile in patients with mild to moderate chin retrusion.

Biogen Announces FDA Approval of PLEGRIDY® (peginterferon beta-1a) Intramuscular Administration for Multiple Sclerosis

Retrieved on: 
Monday, February 1, 2021
Clinical medicine, Multiple sclerosis, Health sciences, Medicine, Cytokines, Dosage forms, Routes of administration, Peginterferon beta-1a, Interferon beta-1a, Management of multiple sclerosis, Biogen, Subcutaneous

The new IM administration offers people living with relapsing MS the well-characterized efficacy and safety of PLEGRIDY with the potential for significantly reduced injection site reactions.

Key Points: 
  • The new IM administration offers people living with relapsing MS the well-characterized efficacy and safety of PLEGRIDY with the potential for significantly reduced injection site reactions.
  • This approval expands Biogens industry-leading portfolio of MS treatments, which also includes the subcutaneous (SC) administration of PLEGRIDY, and follows the European Commissions marketing authorization for the IM administration in December 2020.
  • A phase 1, open-label, crossover study to evaluate the bioequivalence of intramuscular and subcutaneous peginterferon beta-1a in healthy volunteers.
  • Poster presented at: Americas Committee for Treatment and Research in Multiple Sclerosis - 2020 Forum; 2020 Feb 27-29; West Palm Beach, Florida, USA.

RECORDATI: LICENSE OBTAINED FOR THE COMMERCIALIZATION OF ELIGARD IN EUROPE AND OTHER COUNTRIES

Retrieved on: 
Friday, January 29, 2021
Drugs, Pharmacology, Health sciences, Leuprorelin, Peptides, Transgender hormone therapy, Drug paraphernalia, Syringe, Injection, Subcutaneous, Acetate, Heroin

Milan, 29 January 2021 Recordati announces the closing of a License and Supply Agreement with Tolmar International Ltd, to commercialise Eligard (leuprorelin acetate), in Europe, Turkey, Russia and other countries.

Key Points: 
  • Milan, 29 January 2021 Recordati announces the closing of a License and Supply Agreement with Tolmar International Ltd, to commercialise Eligard (leuprorelin acetate), in Europe, Turkey, Russia and other countries.
  • The active ingredient of Eligard is leuprorelin acetate, a powder which is solubilized with a solvent for subcutaneous injection.
  • Eligard is available in three different dosages (for 1-month, 3-month and 6-month treatment, respectively) as a single kit containing two syringes.
  • The development of a new device to administer the product which is easier to handle is currently ongoing, following the request from EMA.

Antares Pharma Announces Full-Year 2021 Revenue Guidance of $175-200 Million

Retrieved on: 
Monday, January 11, 2021
Steroids, Androstanes, Organic compounds, Chemical compounds, Ketones, Testosterone enanthate, Teva Pharmaceuticals, Testosterone, Subcutaneous, Sumatriptan

EWING, N.J., Jan. 11, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the Company), a pharmaceutical technology company, today announced guidance for full-year 2021 and expects revenue to be in a range of $175 to $200 million, which assumes no significant disruptions to supply or operations due to the ongoing COVID-19 pandemic.

Key Points: 
  • EWING, N.J., Jan. 11, 2021 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the Company), a pharmaceutical technology company, today announced guidance for full-year 2021 and expects revenue to be in a range of $175 to $200 million, which assumes no significant disruptions to supply or operations due to the ongoing COVID-19 pandemic.
  • The Company also updated its guidance for full-year 2020 and expects revenue to be in a range of $145 to $150 million from $135 to $155 million.
  • Based on these achievements, we have narrowed our full-year 2020 revenue guidance.
  • Antares Pharmas FDA-approved products include XYOSTED (testosterone enanthate) injection, OTREXUP (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva.

Radius Health Announces Commercial Agreement with Paladin Labs for Abaloparatide in Canada

Retrieved on: 
Tuesday, January 5, 2021
Marvel Comics characters, Knight Therapeutics, Fictional characters, Paladin, Subcutaneous

Paladin Labs Inc. (Paladin), an operating company of Endo, will be responsible for all commercial activities related to abaloparatide.

Key Points: 
  • Paladin Labs Inc. (Paladin), an operating company of Endo, will be responsible for all commercial activities related to abaloparatide.
  • In accordance with the terms of the agreements, Paladin will license Radius abaloparatide subcutaneous injection, TYMLOS, and abaloparatide novel transdermal device (abaloparatide-TD) for the Canadian market.
  • Reaching an agreement with Paladin in Canada demonstrates both the interest in and opportunity to expand the global footprint of abaloparatide in select ex-U.S. markets.
  • Paladin is targeting to file a New Drug Submission (NDS) to Health Canada for TYMLOS by the first quarter of 2022.

Dicerna Announces Enrollment Completion of PHYOX™2 Pivotal Trial of Nedosiran for Treatment of Primary Hyperoxaluria

Retrieved on: 
Monday, January 4, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Genetics, Clinical trials, Kidney diseases, Medical specialties, Primary hyperoxaluria, Hyperoxaluria, Clinical medicine, Medicine, Oxalate, Ph2, Subcutaneous, Urinary system, Primary Hyperoxaluria (PH), Nedosiran, Dicerna Pharmaceuticals, Inc.

The PHYOX2 multicenter pivotal trial (NCT03847909) is designed to evaluate the efficacy and safety of nedosiran delivered as a once-monthly subcutaneous injection in participants aged six years and older who have PH1 or PH2.

Key Points: 
  • The PHYOX2 multicenter pivotal trial (NCT03847909) is designed to evaluate the efficacy and safety of nedosiran delivered as a once-monthly subcutaneous injection in participants aged six years and older who have PH1 or PH2.
  • The primary endpoint of the study is the percent change from baseline in 24-hour urinary oxalate excretion between Days 90 and 180.
  • Enrollment of 35 participants was completed in December 2020 and included participants across 11 countries, including the U.S., Japan and Europe.
  • Primary hyperoxaluria (PH) is a family of ultra-rare, life-threatening genetic disorders that initially manifest with complications in the kidneys.

Braeburn Announces Arbitration Determination that It Did Not Materially Breach Its License Agreement with Camurus AB

Retrieved on: 
Thursday, December 10, 2020
Camurus, Lund, Braeburn, Arbitration, Subcutaneous, Companies

PLYMOUTH MEETING, Pa., Dec. 10, 2020 /PRNewswire/ -- Braeburn announces that a tribunal appointed by the ICC International Court of Arbitration decided that Braeburn did not materially breach its license agreement with Camurus for the development and commercialization of an extended-release buprenorphine subcutaneous injection product.

Key Points: 
  • PLYMOUTH MEETING, Pa., Dec. 10, 2020 /PRNewswire/ -- Braeburn announces that a tribunal appointed by the ICC International Court of Arbitration decided that Braeburn did not materially breach its license agreement with Camurus for the development and commercialization of an extended-release buprenorphine subcutaneous injection product.
  • As a result of this decision, Braeburn retains all North American development and commercialization rights to the product as described in the license agreement, which remains in full effect.
  • This decision follows an arbitration hearing initiated by Braeburn in response to the issuance of a material breach notice from Camurus.
  • The decision, which is final as to all substantive bases alleged by Camurus, reserves a decision on the allocation of legal costs associated with the arbitration.

miRagen Reports Third Quarter 2020 Financial Results and Provides Corporate Updates

Retrieved on: 
Tuesday, November 10, 2020
Drugs, Sex hormones, Subcutaneous, Medroxyprogesterone acetate

Pending feedback from regulatory authorities, miRagen expects to initiate a Phase 2 clinical trial of VRDN-001 in TED in 2021.

Key Points: 
  • Pending feedback from regulatory authorities, miRagen expects to initiate a Phase 2 clinical trial of VRDN-001 in TED in 2021.
  • In parallel with the development of VRDN-001, miRagen is advancing VRDN-002 with the goal of developing a convenient, at-home subcutaneous injection product.
  • Research and Development Expenses: Research and development expenses were $3.1 million for the third quarter of 2020, compared to $9.0 million for the third quarter of 2019.
  • miRagen undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law.