ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry
Generics - User Fees (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 28, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Bonsity (Teriparatide Injection, for Subcutaneous Use) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - October 9, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Bonsity (teriparatide injection) to Treat Osteoporosis
SAN DIEGO, October 7, 2019— Pfenex Inc. (NYSE American: PFNX) announced today that the U.S. Food and Drug Administration (FDA) has approved the new drug application (“NDA”) for Bonsity (PF708) submitted under the 505(b)(2)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 7, 2019 Category: Drugs & Pharmacology Source Type: news

High-Dose Drug Combo Excels in Osteoporosis, but Cost a Barrier High-Dose Drug Combo Excels in Osteoporosis, but Cost a Barrier
The combination of high-dose teriparatide with denosumab could represent an ideal intervention for postmenopausal women with osteoporosis at very high risk of fracture; cost is a concern, however.Medscape Medical News (Source: Medscape Orthopaedics Headlines)
Source: Medscape Orthopaedics Headlines - August 29, 2019 Category: Orthopaedics Tags: Diabetes & Endocrinology News Source Type: news

Richter Launched Terrosa(R), its Biosimilar Teriparatide Across Europe
BUDAPEST, Hungary, Aug. 20, 2019 -- (Healthcare Sales & Marketing Network) -- Gedeon Richter Plc. ("Richter") today announced that it has launched its biosimilar teriparatide, Terrosa® in Europe. The product is approved in adults for the sam... Biopharmaceuticals, Product Launch Gedeon Richter, biosimilar, teriparatide, Terrosa, Forsteo, osteoporosis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 20, 2019 Category: Pharmaceuticals Source Type: news

Osteoporosis Dilemma: Denosumab or Teriparatide After Bisphosphonates Osteoporosis Dilemma: Denosumab or Teriparatide After Bisphosphonates
For osteoporosis patients on bisphosphonates for more than a year, switching to teriparatide rather than denosumab should be done with caution, especially for those at high risk of hip fracture, although denosumab has risks of its own, researchers say.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 22, 2019 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news

How Can Nanotechnologies Aid Implantable Drug-Delivery Systems?
Implantable technologies have come a long way over the years, and advancements in micro and nanotechnologies have helped device developers continue to push the envelope even further. Within the realm of drug delivery, advances in nanotechnologies have consistently improved patient outcomes by enabling sustained drug delivery to help treat chronic conditions. These scalable technologies have even offered localized drug delivery that can further improve bioavailability. While many of these technologies offer a variety of opportunities, we’re still eagerly awaiting to see the impact of these advancements onc...
Source: MDDI - November 29, 2018 Category: Medical Devices Authors: Kristopher Sturgis Tags: BIOMEDevice San Jose Implants Source Type: news

ASBMR: High-Dose Forteo Plus Prolia Increased BMD
(MedPage Today) -- Responses greater than what was seen with either drug alone in high-risk women (Source: MedPage Today Endocrinology)
Source: MedPage Today Endocrinology - October 2, 2018 Category: Endocrinology Source Type: news

Apidra (Insulin Glulisine [rDNA origin] Inj) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - July 20, 2018 Category: Drugs & Pharmacology Source Type: news

GlucaGen (Glucagon [rDNA origin]) for Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - July 17, 2018 Category: Drugs & Pharmacology Source Type: news

Fortical (Calcitonin-Salmon (rDNA origin)) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - May 2, 2018 Category: Drugs & Pharmacology Source Type: news

Zorbtive (Somatropin rDNA Origin for Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 28, 2017 Category: Drugs & Pharmacology Source Type: news

Teriparatide Bests Risedronate for Fracture Prevention in Severe Osteoporosis
Daily subcutaneous teriparatide prevents fractures more effectively than weekly oral risedronate, finds an international, industry-conducted study in the Lancet. Over 1300 postmenopausal women with... (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - November 13, 2017 Category: Primary Care Source Type: news

Mecasermin [rDNA origin] (Increlex) Injection (Updated - Resolved)
Drug Shortage (Source: FDA Drug Shortages)
Source: FDA Drug Shortages - November 6, 2017 Category: Drugs & Pharmacology Source Type: news

Zomacton (Somatropin (rDNA origin) for Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - October 30, 2017 Category: Drugs & Pharmacology Source Type: news

Switching From Bisphosphonates to Teriparatide May Improve BMD in Women With RA Switching From Bisphosphonates to Teriparatide May Improve BMD in Women With RA
Switching women with rheumatoid arthritis (RA) from oral bisphosphonates to teriparatide increases bone mineral density (BMD) and trabecular bone score, according to a new report.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 18, 2017 Category: Consumer Health News Tags: Medscape Today News Source Type: news

Nutropin Depot (Somatropin (rDNA origin) for Inj) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 7, 2017 Category: Drugs & Pharmacology Source Type: news

Nutropin AQ (Somatropin (rDNA origin)) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 7, 2017 Category: Drugs & Pharmacology Source Type: news

Nutropin (Somatropin (rDNA origin) for Inj) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 7, 2017 Category: Drugs & Pharmacology Source Type: news

Tev-Tropin (Somatropin, rDNA Origin, for Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - July 3, 2017 Category: Drugs & Pharmacology Source Type: news

ICER review finds abaloparatide and teriparatide too costly
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - June 30, 2017 Category: Drugs & Pharmacology Source Type: news

Gattex (Teduglutide [rDNA origin] for Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - June 19, 2017 Category: Drugs & Pharmacology Source Type: news

Comparison of osteoporosis treatments for improving bone mineral density
After teriparatide, osteoporosis treatment with denosumab yields higher additional bone mineral density gain, compared with bisphosphonates, according to data presented at the European Congress of Endocrinology 2017.Medscape (Source: Society for Endocrinology)
Source: Society for Endocrinology - May 31, 2017 Category: Endocrinology Source Type: news

Denosumab Ups BMD More Than Bisphosphates After Teriparatide Denosumab Ups BMD More Than Bisphosphates After Teriparatide
Use of denosumab after stopping teriparatide yields a greater increase in bone-mineral density in postmenopausal women with severe osteoporosis than bisphosphonates, according to a retrospective analysis.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 25, 2017 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news

Bone Drug No Help in RA Erosions (CME/CE)
(MedPage Today) -- A year of treatment with teriparatide failed to repair damage (Source: MedPage Today Endocrinology)
Source: MedPage Today Endocrinology - May 25, 2017 Category: Endocrinology Source Type: news

Forteo (Teriparatide (rDNA origin) Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - May 22, 2017 Category: Drugs & Pharmacology Source Type: news

​FDA approves Radius Health osteoporosis drug, but adds cancer warning
The FDA on Friday approved an osteoporosis drug made by Waltham-based Radius Health, but added a so-called "black box" warning that the treatment had increased the risk of bone cancer in rats. Radius (Nasdaq: RDUS) is hoping that abaloparatide, which will be sold under the brand name Tymlos, will eventually take on Forteo, an osteoporosis treatment sold by Eli Lilly (NYSE: LLY) that generated $1.5 billion in sales last year. Forteo has the same warning, which states that the drug increa sed the risk… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 28, 2017 Category: Biotechnology Authors: Max Stendahl Source Type: news

​FDA approves Radius Health osteoporosis drug, but adds cancer warning
The FDA on Friday approved an osteoporosis drug made by Waltham-based Radius Health, but added a so-called "black box" warning that the treatment had increased the risk of bone cancer in rats. Radius (Nasdaq: RDUS) is hoping that abaloparatide, which will be sold under the brand name Tymlos, will eventually take on Forteo, an osteoporosis treatment sold by Eli Lilly (NYSE: LLY) that generated $1.5 billion in sales last year. Forteo has the same warning, which states that the drug increa sed the risk… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - April 28, 2017 Category: American Health Authors: Max Stendahl Source Type: news

Waltham-based Radius Health faces 3-month delay on drug approval
Radius Health suffered a setback Friday when the FDA delayed the potential approval of an osteoporosis drug that the Waltham biotech hopes will eventually take on Eli Lilly ’s $1.5 billion a year treatment Forteo. Radius (Nasdaq: RDUS) said in a statement Friday that the agency had moved its target approval date for the drug, called abaloparatide, from March 30 to June 30. According to Radius, regulators told the company on Thursday that they needed more time to rev iew additional information in… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - March 10, 2017 Category: Biotechnology Authors: Max Stendahl Source Type: news

NovoLog Mix 70/30 (Insulin Aspart Protamine and Insulin Aspart (rDNA origin)) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 2, 2017 Category: Drugs & Pharmacology Source Type: news

Glide raises $4m for phase I trial of solid-dose teriparatide
Glide Technologies said today that it raised £3.2 million, or $4.0 million USD, in a round of financing. A number of existing investors contributed to the round, according to the Oxford-based company. Glide plans to use the funds to finish phase I trials this year for its solid dose formulation of a parathyroid hormone, teriparatide. Get the full story at our sister site, Drug Delivery Business News. The post Glide raises $4m for phase I trial of solid-dose teriparatide appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 1, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Funding Roundup Pharmaceuticals Wall Street Beat Glide Technologies Source Type: news

For Patients With Atypical Femur Fractures, Teriparatide Improves Bone Health For Patients With Atypical Femur Fractures, Teriparatide Improves Bone Health
Teriparatide may improve the bone health of patients with atypical femur fractures (AFFs) who've taken bisphosphonates, but doctors shouldn't depend on the drug to help heal the fractures, a new prospective study suggests.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 30, 2017 Category: Consumer Health News Tags: Orthopaedics News Source Type: news

New clinical trial to test drug combination to treat osteogenesis imperfecta
The University of Edinburgh will conduct a six-year trial of teriparatide and zoledronic acid combination to treat a condition called osteogenesis imperfecta (OI). (Source: Drug Development Technology)
Source: Drug Development Technology - January 18, 2017 Category: Pharmaceuticals Source Type: news

Increlex (Mecasermin [rDNA origin] Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 5, 2017 Category: Drugs & Pharmacology Source Type: news

Exubera (Insulin Human [rDNA origin]) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 5, 2017 Category: Drugs & Pharmacology Source Type: news

Serostim (Somatropin (rDNA origin)) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 15, 2016 Category: Drugs & Pharmacology Source Type: news

Genotropin (Somatropin [rDNA origin]) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 15, 2016 Category: Drugs & Pharmacology Source Type: news

Humatrope (Somatropin rDNA Origin) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 15, 2016 Category: Drugs & Pharmacology Source Type: news

Saxenda (Liraglutide [rDNA Origin]) Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 14, 2016 Category: Drugs & Pharmacology Source Type: news

EMA Okays LixiLan Plus Biosimilars for Osteoporosis and Diabetes EMA Okays LixiLan Plus Biosimilars for Osteoporosis and Diabetes
The EMA has given a green light to new diabetes medicines, including LixiLan and a new biosimilar version of insulin glargine, as well as two biosimilar versions of teriparatide for osteoporosis.International Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 11, 2016 Category: Consumer Health News Tags: Diabetes & Endocrinology News Alert Source Type: news

NovoLog (Insulin Aspart [rDNA origin] Inj) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 10, 2016 Category: Drugs & Pharmacology Source Type: news

Omnitrope (Somatropin [ rDNA origin] Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - October 31, 2016 Category: Drugs & Pharmacology Source Type: news

Calcitonin-salmon [rDNA origin] (Fortical) Nasal Spray (New - Discontinuation)
Updated Drug Shortage (Source: FDA Drug Shortages)
Source: FDA Drug Shortages - October 3, 2016 Category: Drugs & Pharmacology Source Type: news

Osteoporosis sufferers could benefit from new jab that can rebuild crumbly bones
In a clinical trial, four of 800 patients with osteoporosis had a spine fracture while taking new drug abaloparatide after 18 months compared with six taking a standard treatment, Forteo. (Source: the Mail online | Health)
Source: the Mail online | Health - September 19, 2016 Category: Consumer Health News Source Type: news

Novo Nordisk Inc. issues voluntary nationwide recall of six batches of GlucaGen ® HypoKit® (glucagon [rDNA origin] for injection) due to detached needles on the syringe in the kit
Novo Nordisk Inc. is recalling six batches of the GlucaGen ® HypoKit® in the U.S. due to two customer complaints from the UK and Portugal involving detached needles on the syringe with Sterile Water for Injection (SWFI). GlucaGen® HypoKit® is indicated for the treatment of severe hypoglycemia (low blood sugar) in patients with diabetes who are treated w ith insulin. A syringe with a detached needle cannot be used as prescribed. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 9, 2016 Category: Food Science Source Type: news

Injected Drug May Help Fight Osteoporosis in Women
Abaloparatide appears to reduce fractures better than the current drug Forteo, researchers say Source: HealthDay Related MedlinePlus Pages: Osteoporosis, Women's Health (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - August 17, 2016 Category: Consumer Health News Source Type: news

Injected Drug May Help Fight Osteoporosis in Women
Abaloparatide appears to reduce fractures better than the current drug Forteo, researchers say (Source: WebMD Health)
Source: WebMD Health - August 16, 2016 Category: Consumer Health News Source Type: news

Forteo (teriparatide)
Title: Forteo (teriparatide)Category: MedicationsCreated: 3/2/2005 12:00:00 AMLast Editorial Review: 8/8/2016 12:00:00 AM (Source: MedicineNet Womens Health General)
Source: MedicineNet Womens Health General - August 8, 2016 Category: OBGYN Source Type: news

Lantus (Insulin Glargine [rDNA origin] Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 1, 2016 Category: Drugs & Pharmacology Source Type: news

Romosozumab Tops Teriparatide in Phase 3 Osteoporosis Study Romosozumab Tops Teriparatide in Phase 3 Osteoporosis Study
Romosozumab, a novel investigational agent that both promotes bone formation and inhibits bone resorption, showed positive results at the hip and spine at 1 year. Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 2, 2016 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news