In the face of hefty hep C competition from Gilead and AbbVie, can Daklinza profit from a set of niche uses?
Merck KGaA and Pfizer, playing catch-up among drug companies using the immune system to fight cancer, picked up the FDA's fast-track designation for their in-development therapy, designed to expedite its eventual review.
Specialty pharma OptiNose hopes to use a new up to $30 million in financing to get its OPN-375 in combination with its novel breath-powered device through the FDA. But the agency already demonstrated some skepticism around the device last year--it issued a complete response letter to OptiNose partner Avanir because of device errors and required further testing.
Big Pharma has been willing to pay hundreds of millions of dollars for a shortcut to FDA approval, buying up priority review vouchers created to incentivize new drugs for neglected diseases. But the agency seems less than enthusiastic about honoring its end of the bargain, with one top official expressing concerns about how the voucher program might harm the FDA's core mission.
Two weeks after reporting that its cancer vaccine spurred a positive response among a group of cervical cancer patients in a small clinical trial, Advaxis waited until after the market closed today to reveal that the FDA has placed the same cancer vaccine--axalimogene filolisbac (ADXS-HPV)--on a clinical hold, slamming the brakes on four studies.
China's MicroPort earned the FDA's most serious designation over a recall of devices used in hip joint replacement surgery after reports surfaced that showed the products could be endangering patients' lives.
Europe's Novocure has won an expanded indication for a 2011 FDA approval of its Optune to treat newly diagnosed glioblastoma in combination with temozolomide, a standard chemotherapy. The company has been on a roll of late, disclosing a CE mark for its second-generation version of Optune on Oct. 5 and pricing a $165 million IPO on Oct. 2.
Otsuka's antipsychotic franchise is facing more bad news, as Alkermes scored FDA approval for a long-acting injectable version of Abilify as it vies for a bigger spot in an increasingly crowded antipsychotic market.
Alkermes picked up FDA approval for a long-acting version of Otsuka's now-generic Abilify, planning to launch its injection as a treatment for schizophrenia.
Venture-backed Ark Biosciences has successfully completed a Phase I clinical trial of work on anti-respiratory syncytial virus (RSV) candidate AK0529, hitting a key milestone for the respiratory viral infection and viral hepatitis focused company.