Formulation Development
ABITEC Corporation Acquires Larodan AB Research-Grade Lipids
ABITEC Corporation, an ABF Ingredients company, announced today that it has acquired Larodan AB, a manufacturer and international marketer of state of the art, high-purity research grade lipids…..
Apellis Completes Enrollment in Phase 3 Study of Pegcetacoplan
Apellis Pharmaceuticals, Inc. recently announced the completion of enrollment in the global Phase 3 PRINCE study, which is evaluating pegcetacoplan (APL-2) in….
Sumitomo Dainippon Pharma Oncology Announces Its Formation Through Merger of Tolero & Boston Biomedical
Sumitomo Dainippon Pharma Oncology, Inc. was recently formed through the merger of Tolero Pharmaceuticals, Inc., and Boston Biomedical, Inc., two clinical-stage companies developing novel….
Lonza Expands Particle Engineering Assets to Advance Complex Molecules
Lonza reecently announced additional investments in its global particle engineering network for expanded capacity and specialized capabilities. Jet milling and spray dry processing for development…
Cambrex Increases Flexible Manufacturing Capacity
Cambrex, the leading small molecule company providing drug substance, drug product, and analytical services across the entire drug lifecycle, recently announced it is investing $3.6…
IM Therapeutics Announces First Patient Dosed in Phase 1 Study of its Lead Drug for Type 1 Diabetes
ImmunoMolecular Therapeutics, Inc. recently announced the dosing of the first patient in a Phase 1 study of IMT-002, an oral small molecule drug designed as a selective….
Timber Pharmaceuticals Announces All CONTROL Study Sites Open & Enrolling Patients With Moderate-to-Severe Congenital Ichthyosis
Timber Pharmaceuticals, Inc. recently announced that all 11 sites across the US and Australia participating in the Phase 2b CONTROL study evaluating TMB-001 (topical isotretinoin) are now….
Geron Receives Positive Opinion from the EMA Committee for Orphan Medicinal Products
Geron Corporation recently announced the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the company’s application for orphan…
MediciNova Announces Opening of IND for MN-166 for Prevention of Acute Respiratory Distress Syndrome in Patients With COVID-19
MediciNova, Inc. recently announced that the Investigational New Drug Application (IND) for MN-166 (ibudilast) for prevention of Acute Respiratory Distress Syndrome (ARDS) has been accepted…
Avadel Announces Sale of Hospital Sterile Injectable Drug Portfolio for $42 Million
Avadel Pharmaceuticals plc recently announced the sale of its portfolio of sterile injectable drugs used in the hospital setting, including three commercial products, Bloxiverz, Vazculep,…
2020 Respiratory Drug Development eBook – Inhaled Medications for Treating Unconventional Respiratory Diseases
This second annual Drug Development & Delivery Respiratory eBook focuses on a few companies that are taking inhalation devices to a new level in drug delivery.
Ajinomoto Bio-Pharma Services Introduces AJILITY Fast-Track Platform for Drug Product Manufacturing
Ajinomoto Bio-Pharma Services recently announce the launch of AJILITY, a flexible and agile drug product manufacturing platform, designed to advance….
Bioasis & Chiesi Group Announce Rare Diseases Strategic Alliance
Bioasis Technologies, Inc. and Chiesi Global Rare Diseases recently announced they have entered into a worldwide, exclusive licensing agreement for the….
FDA Approves First & Only Oral Somatostatin Analog for Acromegaly
Chiasma, Inc. recently announced the US FDA approved MYCAPSSA (octreotide) capsules for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment…
RedHill Biopharma Receives Approval for COVID-19 Phase 2/3 Study
RedHill Biopharma Ltd. recently announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the company’s Clinical Trial Authorization (CTA) application to commence a….
Artelo Biosciences Expands Stony Brook Commercial License Agreement for Development of Lead Cancer, Pain & Inflammation Compounds
Artelo Biosciences, Inc., a clinical stage biopharmaceutical company focused on the development of therapeutics that modulate the endocannabinoid system, today announced that it has expanded…
Intra-Cellular Therapies Announces Positive Top-line Results from Phase 1/2 Study
Intra-Cellular Therapies, Inc. recently announced topline results from Study ITI-214-104, a Phase 1/2 translational study of single ascending doses of ITI-214, a novel, selective phosphodiesterase-1…
Aptose Announces FDA Allowance of IND for Phase 1a/b Study
Aptose Biosciences Inc. recently announced the US FDA completed its review of the company’s Investigational New Drug (IND) application and has granted IND allowance for…
Oncology Venture Signs Agreement to Out-License Two Pipeline Assets
Oncology Venture A/S (OV) recently announced it has signed a definitive agreement out-licensing two clinical pipeline assets, LiPlaCis and 2X-111, to Smerud Medical Research International…
Novartis Announces MET inhibitor Approved in Japan for Advanced Non-Small Cell Lung Cancer With METex14
Novartis Pharma KK recently announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Tabrecta (capmatinib, formerly INC280), an oral MET inhibitor for…