BioCorRx (OTC:BICX) said today that the FDA has granted the anti-addiction developer a pre-investigational new drug meeting, scheduled for Sept. 19. The Anaheim, Calif.-based company said it is slated to review the development and marketing plan for BICX101, an injectable, sustained-release formulation of naltrexone as a therapy for opioid addiction and alcohol use disorders. At […]
Regulatory/Compliance
UK watchdog accuses Merck of restricting biosimilar competition
Britain’s Competition and Markets Authority accused Merck‘s (NYSE:MRK) European unit, Merck Sharp & Dohme, of conducting an unfair discount scheme that it said was designed to restrict competition from biosimilar copies of the company’s drug, Remicade. Remicade is an antibody drug used to treat rheumatoid arthritis, ulcerative colitis and Chron’s disease. It was the 1st […]
Cerus lowers Intercept sales guidance after Fresenius Kabi supply snafu
Cerus (NSDQ:CERS) said today that it expects a U.S. supply shortage of Fresenius Kabi’s (NYSE:FMS) platelet additive solution will impact blood centers that use PAS to produce Intercept platelets. The pending shortage is due to “an unanticipated delay” in FDA approval of a plastic component used to manufacture the PAS container. The original component was discontinued […]
Proteus, Otsuka take another run at FDA approval for Abilify-smart pill combo
Otsuka Pharmaceutical (TYO:4578) and Proteus Digital Health said today that the FDA accepted its resubmitted new drug application for their “smart pill”. The drug-device product combines Abilify and a Proteus ingestible sensor in a single tablet. The FDA is slated to make a decision on the NDA resubmission in the 4th quarter this year. After the […]
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 […]
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 […]
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 […]
Navigating the regulatory and development pathways for drug-device products
David Lee began his path to CEO of Lumicell in 1999, when his wife was diagnosed with cancer. She passed away in 2003, while Lee was working in the semiconductor industry. He decided it was time for a career change. More than a decade later, Lee holds the corner office at a company that is […]
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. […]
