Formulation Development
Dipharma Announces FDA Acceptance of ANDA of Generic
Dipharma S.A. recently announced that the US Food and Drug Administration (FDA) accepted its nitisinone abbreviated new drug application (ANDA) for review. Nitisinone is a…
Attune Pharmaceuticals Announces $23-Million Financing
Attune Pharmaceuticals, Inc. recently announced the completion of a $23 million Series B financing. Venrock Healthcare Partners led the financing joined by new investor LifeSci…
Hovione Issues $50-Million Bond; Embarks on New Phase of Capital Expansion
Hovione recently announced it issued a bond of $50 million dollars maturing in 2033. The bond was arranged and subscribed by Banco BPI, S.A.
Q BioMed Technology Partner Mannin Research Enters Collaboration With McMaster University
Q BioMed Inc., a biotechnology acceleration company, recently announced its technology partner, Mannin Research, has initiated a collaboration with McMaster University of Ontario, Canada.
Orion Biotechnology Reports Positive Results for Preclinical Study
Orion Biotechnology Canada Ltd. recently announced preclinical data produced in collaboration with Charles River Laboratories, evaluating the efficacy of OB-002O (5P12-RANTES) in colorectal cancer. BALB/c…
Menlo Therapeutics Granted Breakthrough Therapy Designation
Menlo Therapeutics Inc. recently announced the US FDA has granted Breakthrough Therapy Designation for serlopitant for the treatment of pruritus associated with prurigo nodularis (PN).…
Auris Medical Provides Update on Intranasal Betahistine Programs
Auris Medical Holding AG, a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and CNS disorders, recently provided an…
First Patient Dosed in Phase 1 Clinical Trial Evaluating Neoepitopes Formulated in IMV’s DPX Delivery Platform
IMV Inc. recently announced that the first patient has been treated in the Phase 1 trial evaluating neoepitopes formulated in the company’s proprietary DPX delivery…
AMAG Pharmaceuticals Completes Acquisition of Perosphere
AMAG Pharmaceuticals, Inc. recently announced it has completed the previously announced acquisition of Perosphere Pharmaceuticals Inc., a private biopharmaceutical company. Through this acquisition, AMAG adds…
Zafgen Announces Positive Results for Phase 2 Clinical Trial
Zafgen, Inc. recently announced positive data for the second cohort of its Phase 2 clinical trial of ZGN-1061, designed to evaluate efficacy and safety in…
MilliporeSigma & Roche Renew Global Distribution Agreement
MilliporeSigma and Roche recently announced they have agreed to renew their current distribution agreement for the Biochemical Reagents and Kapa Biosystems product portfolios, as well as select qPCR & Nucleic Acid Purification products.
Bavarian Nordic Announces Exercise of $44-Million Option by BARDA
Bavarian Nordic A/S recently announced the US Biomedical Advanced Research and Development Authority (BARDA) have exercised another option under the ongoing contract for freeze-dried MVA-BN smallpox vaccine.
Lonza & Takeda Partner in Development & Manufacture of Cancer Treatment
Lonza recently announced another major milestone in its multiproduct partnership with Takeda.
Immutep Enters Into Clinical Trial Collaboration, Service, and Supply Agreement
Immutep Limited recently announce it has entered into a clinical trial collaboration agreement, a supply agreement, and a service agreement with CYTLIMIC Inc. for its…
Sublimity Therapeutics Receives IND Clearance
Sublimity Therapeutics recently announced that the company has received FDA clearance to proceed with its Phase 2b clinical trial of the company’s lead drug candidate,…
BioTime Enters Into Exclusive Agreement With Orbit Biomedical
BioTime, Inc. recently announced it has entered into a research and option agreement with Orbit Biomedical Limited. Orbit Biomedical, based in London, UK, and Ambler, PA,…
Lilly Announces Agreement to Acquire Loxo Oncology
Eli Lilly and Company and Loxo Oncology, Inc. recently announced a definitive agreement for Lilly to acquire Loxo Oncology for $235 per share in cash,…
Athenex Announces Completion of Target Enrollment in Phase III Study
Athenex, Inc. recently announced that target enrollment of 360 patients in the Oraxol Phase III clinical trial in metastatic breast cancer has been achieved on…
Vital Therapies & Immunic Therapeutics Announce Transaction to Create Leading Company
Vital Therapies, Inc. and Immunic AG recently announced they have entered into a definitive agreement under which Vital Therapies is expected to acquire all of the…
SPECIAL FEATURE - Outsourcing Analytical Testing: The Gateway to Drug Manufacturing
Contributor Cindy H. Dubin speaks with several leading analytical labs and CDMOs to review their technologies, services, and new strategies to operate in this ever-changing environment.
