Drugs
FDA has granted Genentech a breakthrough therapy designation for Rituxan (rituximab) and its use for treating pemphigus vulgaris, a rare, serious and life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes. The company is currently enrolling patients in a Phase 3 study (PEMPHIX, NCT02383589), a
Drugs
Eli Lilly says it will invest $850 million in its U.S. operations in 2017 to expand its U.S. research laboratories, manufacturing sites, and general and administrative areas. “The investments are being driven by demand for Lilly products, as well as its robust pipeline of potential medicines in development
Drugs
FDA has approved a Shionogi Inc. and Purdue Pharma NDA for Symproic (naldemedine) 0.2 mg tablets, a once-daily oral peripherally-acting mu-opioid receptor antagonist for treating opioid-induced constipation in adult patients with chronic non-cancer pain. The companies say Symproic is currently a Schedule II controlled
Biologics
FDA has licensed eight Quotient Limited rare antisera blood typing reagent products that are intended for use in transfusion diagnostics, and formulated specifically for antigen phenotyping. The products are the most frequently used for special antigen testing by customers, and cover Fy [a ] and Fy [b ] ; S and s; Kell;
FDA Policy/General
FDA watchers are calling President Trump’s budget blueprint, which includes a doubling of user fees (see story), “dead on arrival,” according to an Alliance for a Stronger FDA analysis. During a 3/22 hearing, lawmakers expressed concern of the blueprint’s discussion on increasing user fees. “This Congressional reaction
Devices
Recent medical device reports are linking a superbug outbreak at a foreign health facility to a duodenoscope that Olympus modified last year in an move to reduce its risk of spreading bacteria between patients, according to a article by LA Times investigative reporter Melody Petersen. Five patients treated with the
Drugs
FDA has accepted for review a Symbiomix NDA for its lead investigational product candidate Solosec (secnidazole oral granules), an antibiotic designed to treat bacterial vaginosis (BV). The agency has granted a six-month priority-review designation with a user fee review target date of 9/17. The company described Solosec
Drugs
FDA has revised its Medication Guides list with one new guide and 21 updated documents. The new guide is for Orexigen’s Contrave (naltrexone HCl and bupropion HCl) ER. Updated guides are available for: GlaxoSmithKline’s Advair HFA (fluticasone propionate and salmeterol xinafoate), Atnahs’ Anaprox (naproxen sodium), Depomed’s Cambia
Drugs
A study in the Journal of the American Medical Association says that there is a correlation between increases in the number of men seeking and taking testosterone and televised direct-to-consumer ads for the drug. An online CardioBrief post says that although testosterone is approved only for men with
Drugs
FDA has given Cornerstone Pharmaceuticals a green light to conduct pivotal trials of its lead compound, CPI-613, in patients with acute myeloid leukemia (AML) and pancreatic cancer. CPI-613 is the company’s first-in-class anticancer compound from its proprietary Altered Energy Metabolism Directed platform. It is designed
Drugs
Sen. Bernie Sanders (I-VT) and Rep. Elijah Cummings (D-MD) have written to PTC Therapeutics CEO Stuart Peltz asking for information on the price the company plans to charge for Emflaza (deflazacort), used in treating Duchenne Muscular Dystrophy. PTC recently acquired rights to the drug from Marathon Pharmaceuticals, which
Devices
FDA has approved Alcon’s new AcrySof IQ ReSTOR +2.5 Multifocal Toric intraocular lens (IOL) with ActiveFocus design for uncompromised distance vision and presbyopia correction. The device is intended to give astigmatic cataract patients “quality distance vision and an increased range of vision to potentially reduce dependence on glasses,
Devices
AdvaMedDx says it is reviewing a discussion draft of the Diagnostic Accuracy and Innovation Act being circulated in the House by Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO). The trade group says it has “long supported a modernized, risk-based approach to FDA oversight of all diagnostic
Drugs
FDA has granted EMD Serono accelerated approval for Bavencio (avelumab) for treating adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy. The therapy works by targeting the PD-1/PD-L1 pathway (proteins found on the body’
Devices
FDA has approved a CeloNova Biosciences PMA for its COBRA PzF NanoCoated Coronary Stent System. The device, which is coated with a biocompatible proprietary nanothin polymer, requires a minimum 30-day dual antiplatelet therapy regimen after intervention, according to the company. The stent is designed to improve coronary luminal diameter
FDA Policy/General
Federal Register notice: CDRH has announced its 2017 Experiential Learning Program, a training component that is intended to provide Center staff with an opportunity to understand the policies, laboratory practices, patient perspective/input, quality system management, and other challenges that impact the device development life cycle. CDRH is inviting medical
Drugs
FDA has sent a Warning Letter to India’s USV Pvt Ltd for CGMP violations and data integrity problems at its Daman drug manufacturing facility. The Economic Times reports the letter also referenced similar CGMP violations at the firm’s other facilities. FDA acknowledged that USV is using a consultant
Drugs
Attorney James Beck (Reed Smith) says that if FDA ends its ban on truthful off-label promotion under incoming commissioner Scott Gottlieb, warnings that drug and medical device companies will face increased liability don’t ring true. Writing in an online blog post, Beck disputes assertions made in a 3/
Drugs
Former FDA commissioner Robert Califf is chairman of the board of the new People-Centered Research Foundation (PCRF) that he says has been created to sustain and expand a national network for clinical research that originated with funding from the Patient-Centered Outcomes Research Institute and studies conducted by the
Devices
FDA has approved a Medtronic PMA for the CoreValve Evolut PRO valve for treating severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery. The approval was based on 30-day clinical data that “showed high survival, low rates of stroke, minimal paravalvular
Drugs
The Combination Products Coalition says that while it agrees with many of the recommendations in an FDA draft guidance on comparative analyses and related comparative use human factor studies for a drug-device combination product submitted in an ANDA, it believes there should be several revisions. The coalition says it
Drugs
Acting on a request from Sens. Orrin Hatch (R-UT), Charles Grassley (R-IA), and Tom Cotton (R-AR), the Government Accountability Office (GAO) will look for possible abuses in FDA’s orphan drug program. Kaiser Health News reports that GAO will take the next few months to determine the