Allogene Therapeutics Inc., a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, announced the pricing of an initial public offering of 18,000,000 shares of common stock at a price to the public of $18.00 per share.
Celgene Announces Phase 3 STYLE Study Of Otezla In Moderate-To-Severe Scalp Psoriasis Met Primary Endpoint
Celgene Corporation announced results from the phase 3 STYLE study, which showed that Otezla (apremilast) 30 mg twice daily achieved a highly statistically significant improvement in the primary endpoint of the Scalp Physician’s Global Assessment response at week 16 compared with placebo.
The FDA approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes for Genentech’s Xolair as an additional formulation for allergic asthma and chronic idiopathic urticaria.
Samsung Bioepis’ Biologics License Application for SB5 Adalimumab Biosimilar Candidate Accepted for U.S. FDA Review
Samsung Bioepis Co. Ltd. announced that the U.S. Food and Drug Administration accepted for review the company’s Biologics License Application under the 351(k) pathway for SB5, a biosimilar candidate referencing Humira (adalimumab).
Lyra Therapeutics Announces $29.5 Million Series B Financing to Advance Innovative Therapeutics for Ear, Nose and Throat Diseases
Lyra Therapeutics Inc., a clinical-stage biotechnology company developing medicines precisely designed to target ear, nose and throat (ENT) diseases, announced a $29.5 million Series B equity financing.
Morphic Therapeutic Announces $80 Million Financing to Advance Next-Generation Oral Integrin Therapeutics Through Clinical Proof of Concept
Morphic Therapeutic has completed a $80 million Series B financing to fund the biotechnology company’s two lead programs through clinical proof of concept, and to advance multiple other programs into the clinic.
FDA Issues Statement Reaffirming Positive Benefit-Risk Profile Of Nuplazid For Patients with Hallucinations, Delusions Associated With Parkinson’s Disease Psychosis
Acadia Pharmaceuticals Inc. announced that the FDA completed a postmarketing review and issued a clear statement reaffirming the positive benefit-risk profile of Nuplazid (pimavanserin) for patients with Parkinson’s disease psychosis.
Celltrion Signs ‘Incubation’ Agreement with Emory University for Development of New Drugs for Atherosclerosis
Celltrion Inc. signed an ‘Incubation’ agreement with Emory University in Atlanta to support the research and development of new drug candidates for atherosclerosis.
The U.S. FDA approved the New Drug Application of Xelpros 0.005% for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA), a Rare Form of Juvenile Arthritis
Roche Group member Genentech announced today that the U.S. FDA approved the subcutaneous formulation of Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.
Concentric Analgesics Inc. announced today that the clinical-stage biopharmaceutical company received Breakthrough Therapy designation from the U.S. Food and Drug Administration for CA-008 in post-surgical pain.
Checkmate Pharmaceuticals announced a clinical trial collaboration and supply agreement with the alliance between Merck KGaA and Pfizer Inc. to evaluate the TLR9 agonist CMP-001 in combination with the human anti-PD-L1 antibodyavelumab.
Abivax – a biotechnology company harnessing the immune system to develop a functional cure for HIV, as well as treatments for inflammatory/autoimmune diseases and cancer – today announced top-line results from its Phase 2a clinical trial, ABX464-101.
WPP announced the appointment of Mark Read as Chief Executive Officer and his appointment to the Board of WPP as an Executive Director with immediate effect.
Vertex and Genomics plc Establish Collaboration to Use Human Genetics and Data Science to Advance Discovery of Precision Medicines
Vertex Pharmaceuticals Incorporated and Genomics plc announced a three-year collaboration (extendable to five years) to use human genetics and machine learning to improve discovery of targets for precision medicines, and to advance understanding of the clinical impact of human genetic variation and patient stratification in diseases with significant unmet need.
bluebird bio and Gritstone Oncology Announce Strategic Collaboration to Develop Novel Cancer Cell Therapies
bluebird bio Inc. and Gritstone Oncology Inc. announced a collaboration to research, develop and commercialize products for the treatment of cancer using cell therapy.
The U.S. FDA approved an expanded label for Merck’s anti-PD-1 therapy Keytruda in combination with Alimta (pemetrexed) and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations, based on results of the KEYNOTE-189 trial.
FDA Accepts Priority Review Of ALXN1210 As Treatment For Patients With Paroxysmal Nocturnal Hemoglobinuria
Alexion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration accepted for review the company’s Biologics License Application for approval of ALXN1210, an investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal hemoglobinuria.
Sun Pharmaceutical Industries Ltd. received FDA approval for Cequa (cyclosporine ophthalmic solution) 0.09% to increase tear production in patients with keratoconjunctivitis sicca.
Gilead Sciences Inc. announced that Gregg Alton was appointed Chief Patient Officer, a newly created role that will facilitate access to the company’s medicines and increase focus on reaching patients. The company also announced that Diana Brainard, MD, was promoted to Senior Vice President, HIV and Emerging Viral Infections, and that Andrew Cheng, MD, PhD, Chief Medical Officer, decided to leave Gilead to pursue another opportunity.