Search Results for: COMBINATION PRODUCTS Device Development for
Articles
SPECIAL FEATURE - PFS & Parenteral Drug Delivery: Self-Injection is Very Much the “New Normal” May 2, 2022
Contributor Cindy H. Dubin showcases how leading CDMOs and drug delivery developers are responding to current market trends to create ergonomic technologies that are patient friendly, easy to use, reduce needle anxiety, and feature improved packaging materials.
ProMed Pharma Announces Preclinical Rat Study to Assess Pharmacokinetics of Novel Long-Acting Contraceptive Implant April 20, 2022
ProMed Pharma recently announce the initiation of preclinical evaluation of a novel fully resorbable contraceptive implant. The implant, developed in a project funded by the Bill & Melinda….
Halozyme to Acquire Antares Pharma to Create a Specialty Product & Drug Delivery Leader April 13, 2022
Halozyme Therapeutics, Inc. and Antares Pharma, Inc. recently announced the companies have entered into a definitive agreement pursuant to which Halozyme will acquire Antares for….
Gerresheimer Establishes Small Series Production in the US March 18, 2022
Pharma and medical technology specialist Gerresheimer has established small series production at its Technical Competence Center at its Peachtree City,...Viatris Announces Receipt of First FDA Approval for Generic Version of Symbicort Inhalation Aerosol in Partnership With Kindeva March 16, 2022
Viatris Inc. and Kindeva Drug Delivery L.P. recently announced Mylan Pharmaceuticals Inc., a Viatris subsidiary, has received approval from the US FDA...Eyenovia Concludes Type A Meeting With FDA Related to MydCombi NDA Resubmission February 8, 2022
Eyenovia, Inc. recently announced that the company successfully completed a Type A meeting with the US FDA related to the...SPECIAL FEATURE - Analytical Testing Trends in 2022 January 17, 2022
Contributor Cindy H. Dubin reports on the innovative technologies and techniques that several leading outsourcing providers currently offer for both small and large molecules.
Nemera to Build State-of-the-Art Manufacturing Facility in Poland to Serve More Customers & Patients November 17, 2021
Based in Szczecin, this facility extends Nemera’s manufacturing capabilities and will bring more drug delivery device solutions to patients. Following...BD Launches BD UltraSafe Plus™ 2.25-mL Passive Needle Guard Enabling Patient Ease of Use & Safety November 17, 2021
BD (Becton, Dickinson and Company) recently announced the launch of the BD UltraSafe Plus 2.250-mL Passive Needle Guard for use...Kymanox Adds Experienced Finance Leader to the Kymanox Executive Leadership Team November 15, 2021
Kymanox Corporation recently announced the addition of Tony Perry as Chief Financial Officer (CFO). Tony reports to CEO and Founder, Stephen...First Own Gerresheimer Autoinjector - Gerresheimer & Midas Pharma Announce Strategic Partnership November 8, 2021
Gerresheimer recently announced it has acquired the IP of a new generation cartridge-based autoinjector from Midas Pharma. This is the start of a strategic partnership. The joint project comprises the development and marketing of the new generation autoinjector…
Nemera Launches UniSpray, its Unidose System Primarily for Systemic-Acting Drug Administration October 27, 2021
Nemera has a proven track record in developing and manufacturing complex Ear Nose and Throat solutions. In line with clear growing market interest in unidose system coupled with promising advantages that nasal route could….
Pacira BioSciences to Acquire Flexion Therapeutics Further Expanding Leadership Position in Non-Opioid Pain Management October 12, 2021
Pacira BioSciences, Inc. and Flexion Therapeutics, Inc. recently announced a definitive agreement pursuant to which Pacira will acquire Flexion for...DRUG DELIVERY - CAPRO(TM): A New Advance in Polymeric Drug Delivery October 4, 2021
Bob Wieden and Chun Wang, PhD, discuss how significant challenges, coupled with the complexity and diversity of new pharmaceuticals, have fueled the development of a novel polymeric drug delivery platform that overcomes a great many bioavailability and delivery obstacles.
Aerami Therapeutics Announces Orphan Drug Designation for Imatinib for the Treatment of Pulmonary Arterial Hypertension August 31, 2021
Aerami Therapeutics, Inc. recently announced the US FDA has granted the company orphan drug designation for imatinib for treatment of...HOT MELT EXTRUSION - API Bioavailability: Suspending Hydrophobic Drugs in a Solid Solution August 26, 2021
Ameya Deshpande, MS, says for APIs that are compatible with HME, careful attention to the formulation quality attributes that include excipient selection, dosage form design, analytical testing, and stability are required to maximize the efficacy and quality of the final product.
Terumo Blood & Cell Technologies & PhotonPharma Inc. Announce Collaboration to Develop Novel Cancer Immunotherapy August 17, 2021
Terumo Blood and Cell Technologies and PhotonPharma Inc. recently announced they have established a memorandum of understanding (MOU) for collaboration to develop Innocell, a novel….
Pace Life Sciences Acquires Drug Delivery Experts, Expanding Capacity & Injectable Drug Product Services July 28, 2021
Pace Analytical Life Sciences, LLC, a subsidiary of Pace Analytical Services, LLC, a full-service contract development and manufacturing organization (CDMO), recently announced it has acquired Drug Delivery Experts, LLC (DDE)…..
Nemera & BIOMM Sign Partnership Agreement to Commercialize Reusable Insulin Pen in Brazil July 8, 2021
A pioneer in biotechnological medicines in Brazil, BIOMM is launching Nemera’s Advapen under the trade name Lifepen® for the administration of….
Nemera Breaks Ground in Brazil Through Milfra Acquisition June 23, 2021
Nemera recently announced it has entered into an agreement to acquire Milfra. Milfra, based in Jaguariuna, state of São Paulo,...WHITEPAPER - Addressing Regulatory Challenges for Ophthalmic Combination Products
Going forward, sponsors developing ophthalmic products formulated for delivery as eye drops must be prepared to pursue development programs that address the regulatory requirements for drug-device combination products. Partnering with a contract manufacturing organization (CMO) that has experience bringing such products to market is essential…..
