Drugs
As advancing science is fueling new discoveries, FDA needs help from academic scientists to review and approve new drug therapies because in-house talent is weak, according to a Nature editorial. To illustrate the challenges, the editorial points to a 7/12 FDA advisory committee panel that reviewed a Novartis
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FDA has issued Valeant Pharmaceuticals a complete response letter on its NDA for latanoprostene bunod ophthalmic solution, 0.024%, an investigative intraocular pressure-lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. The letter cites a GMP inspection at subsidiary Bausch + Lomb’s manufacturing facility
Drugs
New research by FDA and RTI International’s Center for Communication Science shows promising data on a new model for presenting risk information in broadcast direct-to-consumer (DTC) prescription drug ads. Designed to address how much information should be included in DTC major risk statements, the research found that
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FDA has approved a Teva Pharmaceutical Industries NDA for Qvar RediHaler (beclomethasone dipropionate HFA) inhalation aerosol, a breath-actuated inhaler for asthma maintenance treatment in patients aged four years and older. The inhaler is not indicated for relieving acute bronchospasm, the company says. The approval is supported by safety and
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FDA has issued Vernalis a complete response letter (CRL) on its NDA for CCP-08, an undisclosed extended-release product being developed for Vernalis by Tris Pharma for the U.S. prescription cough-cold market. A CRL was issued to Vernalis for another undisclosed product in April (see story). The
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FDA has tentatively approved a Perrigo ANDA for a generic version of Galderma Labs’ Mirvaso (brimonidine) topical gel 0.33%, indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older. Perrigo recently settled litigation with Galderma and Nestle Skin Health S.
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Eli Lilly says its investigational migraine drug lasmiditan met its primary endpoint in SPARTAN, a second Phase 3 study of the therapy. A greater percentage of patients treated with lasmiditan were migraine pain-free compared to placebo after two hours, it says. The results were statistically significant across all three
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FDA has granted Omeros an orphan drug designation for OMS721 for treating Immunoglobulin A (IgA) nephropathy. The human monoclonal antibody is designed to target mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system, according to the company. IgA nephropathy
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FDA is warning healthcare professionals about hypersensitivity reactions related to ImprimisRx’s curcumin (a component of the spice turmeric) compounded with polyethylene glycol 40 castor oil. An agency safety alert says that earlier a 30-year-old female patient experienced cardiac arrest after IV administration of the product. “Within minutes
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A Utah federal judge has entered a consent decree of permanent injunction against Isomeric Pharmacy Solutions (Salt Lake City), co-owners William O. Richardson and Rachael S. Cruz, and chief operating officer Jeffery D. Brown. The court action bars them from manufacturing, processing, packing, holding, or distributing drugs until they
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FDA has granted Applied Genetic Technologies an orphan drug designation for its unidentified gene therapy product candidate for treating X-linked retinitis pigmentosa (XLRP) caused by mutations in the RPGR gene. XLRP is an inherited condition that causes progressive vision loss, beginning with night blindness in young boys followed by
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Daiichi Sankyo says it will settle on behalf of its companies and Forest entities pending product liability litigation involving olmesartan products (Benicar, Benicar HCT, Azor, and Tribenzor). The suits, filed beginning in 1/2014, allege that the products cause sprue-like enteropathy and other severe gastro-intestinal symptoms, the company
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FDA has approved Jazz Pharmaceuticals’ Vyxeos, a fixed combination of daunorubicin and cytarabine, for treating adults with two types of acute myeloid leukemia (AML). The agency says in a news release that the two types are newly diagnosed therapy-related AML (t-AML) and AML with myelodysplasia-related changes (AML-
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FDA says that Rugby Laboratories is recalling all lots of its Diocto Liquid and Diocto Syrup (docusate sodium solutions) manufactured by PharmaTech due to a risk of product contamination with Burkholderia cepacia. An agency MedWatch notice says FDA informed Rugby that it received several adverse event reports of B. cepacia
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FDA’s Arthritis Advisory Committee has voted 12 to 1 against recommending approval of a Janssen Biotech BLA for Plivensia (sirukumab), citing safety concerns raised in an FDA briefing document released in advance of the meeting. Its major safety findings were related to immunosuppression consistent with other disease-modifying anti-
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Former Office of New Drugs director John Jenkins delayed his planned retirement last year because he was worried that his boss, CDER director Janet Woodcock, would step in as acting director and damage the new drugs review program. This revelation comes from a new email released under a Freedom of
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The Senate has voted 94-1 vote to pass an FDA user fee reauthorization bill to fund agency product reviews and related activities for the next five years. Senator Bernie Sanders (I-VT) was the lone vote against the measure. The House passed a similar bill earlier this summer. “The
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Former CDC director Thomas Frieden says that while randomized clinical trials have been considered the “gold standard” of medical research, they can have significant limitations, and other means of collecting and analyzing data can be better in some situations. Writing in The New England Journal of Medicine, Frieden says there
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FDA says it has updated its Risk Evaluation and Mitigation Strategy (REMS) Web site and structured product labeling (SPL) initiatives. The announcement says the updates are a result of feedback received from stakeholders who asked that the agency provide information on REMS programs in a more direct and user friendly
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Attorney General Jeff Sessions says the Justice Department is creating an Opioid Fraud and Abuse Detection Unit pilot program to use data to help combat the nation’s opioid crisis. Speaking at the Columbus Police Academy, Sessions said the new unit will focus specifically on opioid-related healthcare fraud using
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Coherus BioSciences has asked the Delaware federal court to delay the start of discovery in Biologics Price Competition and Innovation Act patent litigation with Amgen until after the court resolves a Coherus motion to dismiss Amgen’s suit against it. Attorneys with Patterson Belknap Webb & Tyler say in an
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FDA and TG Therapeutics have reached an agreement on a special protocol assessment (SPA) on the design of two Phase 3 clinical trials for TG-1101 (ublituximab), a glyco-engineered anti-CD20 monoclonal antibody for treating relapsing forms of multiple sclerosis (RMS). “The SPA provides agreement that the two Phase