Symic Bio said yesterday that it raised $30 million in a Series B financing round, led by existing investors and HEDA Ventures. Funds from the round are slated to support the company’s clinical programs, including a drug designed to prevent peripheral vein graft failure, SB-030, and a therapy for pain management of osteoarthritis of the knee, […]
Pharmaceuticals
Anika touts Phase III data for Cingal knee therapy
Anika Therapeutics (NSDQ:ANIK) touted data today from a Phase III trial for its Cingal hyaluronic acid-corticosteroid combination viscosupplement as a treatment for osteoarthritis-related knee pain. The data showed that treatment with Cingal yielded better immediate and short-term pain relief compared to hyaluronic acid alone and better pain and stiffness relief through 26 weeks compared to saline. […]
Triple-combo inhaler for COPD wins recommendation for approval in EU
Chiesi Group said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended that the EMA approve its extra-fine triple combination inhaler for the treatment of chronic obstructive pulmonary disease. The Trimbow device combines an inhaled corticosteroid, a long-acting beta2-agonist and a long-acting muscarinic antagonist. The healthcare group said it is […]
EuroPCR Roundup: Bioresorbable stents show promise, but metallic drug-eluting stents remain standard
Updated to include a statement from an Abbott spokesperson. Abbott‘s (NYSE:ABT) bioresorbable scaffold has been plagued with a myriad of troubling data, including a study that showed that the device is associated with an increase in thrombosis and target lesion failure. In April, Abbott restricted use of the Absorb devices to clinical registry studies. In response […]
Updated: Quvium’s cough monitor boosts compliance by involving caregivers
When Steven Schmidt worked at Vertex Pharmaceuticals (NSDQ:VRTX), Eric Olson – the man who led the development of the 1st drug to treat the underlying causes of cystic fibrosis – asked Schmidt to look into ways that families could become more engaged with managing a patient’s condition. Olson pointed towards a publication that showed that […]
Sanofi’s insulin biosimilar wins EMA committee recommendation
Sanofi (NYSE:SNY) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended its insulin lispro biosimilar for approval. Insulin lispro Sanofi is a biosimilar of insulin lispro, a fast-acting insulin analog made using recombinant DNA technology. Sanofi’s biosimilar has the exact same amino acid sequence as its reference product. The positive opinion […]
Teva to cut 500 jobs after closing Hungary facility
Teva Pharmaceutical (NYSE:TEVA) is reportedly closing its sterile injectables plant in Godollo, Hungray and 500 workers could lose their jobs. The generics-maker is slated to close or sell the facility by the end of 2018. The plant stopped production last year after the FDA found an array of sterility issues that the agency said put […]
New FDA commish extends time for comments on off-label communication rules
Under the agency’s new commissioner, Dr. Scott Gottlieb, the FDA has reportedly extended the time for comments in its review of off-label communication rules. In the past, Gottlieb has advocated for off-label uses of medical products, arguing that doctors are adequately trained to make decisions in the best interest of their patients. The FDA maintains […]
Dr. Reddy’s liposomal doxorubicin wins FDA nod
Dr. Reddy’s Laboratories (NYSE:RDY) said today that the FDA approved its doxorubicin hydrochloride liposome injection for intravenous administration. The liposomal formulation is a therapeutic-equivalent generic version of the chemotherapeutic, Doxil. “This approval represents the 1st of its kind for Dr. Reddy’s in the complex depot injectables arena,” Alok Sonig, executive VP and head of the U.S. […]
Powering the next generation of ingestible drug delivery devices
Traditional implants in the gastrointestinal tract are meant to pass through a patient’s system, delivering a drug in short bursts or recording the health of a patient’s colon. But in recent years, scientists have sought after ultra-long lasting ingestible devices that can deliver drugs for several weeks in a patient’s GI tract. Lyndra, Inc., a start-up […]