FDA approves AbbVie's HCV regimen
FDA approved Viekira Pak from AbbVie Inc. (NYSE:ABBV) with or without ribavirin to treat HCV genotype 1 infection in patients with and without compensated cirrhosis. AbbVie set the WAC for the three direct-acting-antivral (3-DAA) treatment regimen at $83,319 for a 12-week course.
FDA approves Cubist's Zerbaxa
FDA approved Zerbaxa ceftolozane/tazobactam from Cubist Pharmaceuticals Inc. (NASDAQ:CBST) to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
FDA approves AstraZeneca's Lynparza
FDA granted accelerated approval to Lynparza olaparib from AstraZeneca plc (LSE:AZN; NYSE:AZN) as monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated advanced ovarian cancer, as detected by an FDA-approved test, who have been treated with three or more prior lines of chemotherapy.
Lilly does second deal for Adocia's fast insulin
Adocia S.A. (Euronext:ADOC) rose EUR 10.16 (37%) to EUR 37.40 after granting Eli Lilly and Co. (NYSE:LLY) exclusive, worldwide rights to BioChaperone Lispro to treat Type I and Type II diabetes.
Gilead, Ono in Btk inhibitor deal
Ono Pharmaceutical Co. Ltd. (Tokyo:4528) granted Gilead Sciences Inc. (NASDAQ:GILD) exclusive rights to develop and commercialize ONO-4059 outside of Japan, South Korea, Taiwan, China and countries in the Association of Southeast Asian Nations (ASEAN), where Ono retains development and commercialization rights. Ono will receive an undisclosed upfront payment and is eligible for milestones.
CHMP gives conditional nod to Chiesi's Holoclar
EMA's CHMP recommended conditional marketing authorization for Holoclar from Chiesi Farmaceutici S.p.A. (Parma, Italy) to treat adults with moderate to severe limbal stem cell deficiency (LSCD) due to physical or chemical burns to the eyes.
CHMP puts Orexigen on first-to-market path in EU
Orexigen Therapeutics Inc. (NASDAQ: OREX) stands to be first to market with a new obesity drug in Europe as EMA's CHMP adopted a positive opinion for Mysimba naltrexone/bupropion as an adjunct to reduced-calorie diet and increased physical activity for the management of weight in adults who are obese or are overweight with weight-related co-morbidities.
CHMP recommends Newron's safinamide for PD
EMA's CHMP recommended marketing authorization of safinamide from Newron Pharmaceuticals S.p.A. (SIX:NWRN) and partner Zambon Co. S.p.A. (Bresso, Italy) as add-on therapy to a stable dose of a dopamine agonist for patients with early PD, and as add-on therapy to levodopa alone or in combination with other treatments in patients with mid- to late-stage PD.
FDA strikes twice for Cerus
Three days after FDA approved the Intercept Blood System for plasma, Cerus Corp. (NASDAQ:CERS) announced the agency approved the company's Intercept system for platelets. Cerus shares rose $0.25 to $6.41 on Friday; they have gained 34% since Tuesday's close, before the plasma system approval was announced.
Roche down on Phase III setbacks
Roche (SIX:ROG; OTCQX:RHHBY) fell CHF18.30 to CHF270.40 on Friday after reporting disappointing data from a Phase III trial of breast cancer drug Kadcyla ado-trastuzumab emtansine and discontinuing a Phase III study of gantenerumab to treat prodromal Alzheimer's disease (AD).
Juno gains 46% in first trading day
Juno Therapeutics Inc. (NASDAQ:JUNO) gained $11 (46%) to $35 on Friday, its first day of trading, after raising $264.6 million through the sale of 11 million shares at $24 in its IPO. The cancer immunotherapy developer finished the day with a market cap of $2.7 billion (see BioCentury Extra, Dec. 18).
Sage Kelly resigned as managing director and global head of healthcare investment banking at Jefferies & Co. Inc.
POLITICS & POLICY
First Amendment, patient engagement on CDER's list
In a memo outlining priorities for FDA's Center for Drug Evaluation and Research, center director Janet Woodcock disclosed an initiative to "rapidly re-evaluate our regulation of drug advertising and promotion in light of current jurisprudence around the First Amendment."
Dunn permanent successor to Katz at FDA neurology division
William Dunn has been promoted to director of FDA's Division of Neurology Products (DNP) from acting director. He takes over the permanent role that had not been filled since longtime division director Russell Katz announced in January 2013 that he planned to retire.