Drugs
BioMarin Pharmaceutical has agreed to sell for $125 million its Rare Pediatric Disease Priority Review Voucher (PRV) it was awarded by FDA in April when it received approval for Brineura, a new biological product for patients with late infantile neuronal ceroid lipofuscinosis type 2, a form of Batten disease. The
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DEVICES FDA has approved a Medtronic PMA for its Azure pacemakers with BlueSync technology. The devices are available in both single chamber and dual chamber models, and offer improved longevity, estimated at 13.7 years, according to the company. The new pacemakers also allow patients to have magnetic resonance imaging
Drugs
Harvard Medical School researchers say that in some situations, database studies may support supplemental applications for effectiveness for already approved drugs. Writing in JAMA Internal Medicine, the researchers describe their use of healthcare databases to replicate the study of Boehringer Ingelheim’s antihypertensive Micardis (telmisartan) for a supplemental indication to
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Janssen Biotech has submitted a supplemental BLA for Darzalex (daratumumab) and its expanded use in combination with bortezomib, melphalan and prednisone for treating patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation. Darzalex was first approved 11/2015 as a monotherapy for patients with multiple
Drugs
FDA has published a guidance, General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products, to assist those planning to develop and submit an ANDA for a generic version of a solid oral opioid drug product that references an opioid drug product with abuse-deterrent properties
Drugs
Cytokinetics has suspended its tirasemtiv drug development program after receiving disappointing data from the VITALITY-ALS Phase 3 clinical trial in patients with amyotrophic lateral sclerosis (ALS). The company says the study did not meet the primary endpoint of change from baseline in “slow vital capacity” (SVC) that was evaluated
Drugs
Federal Register notice: FDA has determined that Takeda’s Trintellix (vortioxetine hydrobromide) oral tablet, indicated for treating major depressive disorder, was not withdrawn due to safety or effectiveness concerns. The determination was in response to several citizen petition requests and will allow the agency to approve ANDAs referencing the product
Drugs
FDA has approved a ViiV Healthcare NDA for Juluca, the first complete treatment regimen containing two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1). Current HIV combination products include three or more drugs included in standard HIV treatment. “Limiting the number of drugs in any
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Pharmaceutical Research and Manufacturers of America (PhRMA) says it shares FDA’s efforts to help advance the benefit-risk related initiatives under PDUFA 5, but believes that additional guidance and clarity are needed on implementation of the benefit-risk framework to help ensure timely patient access to innovative biopharmaceuticals that
Drugs
Responding to an FDA request for comment on ensuring a balance between innovation and access in the Waxman-Hatch Act, the Biotechnology Innovation Organization (BIO) says there is an appropriate and necessary role for state laws in outlining the circumstances, authorities, and communication protocols for product substitution. “The designation of
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A 7/31-8/4 FDA inspection at Hubei Danjiangkou Danao Pharmaceutical Co., Hubei Province, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API), according to an 11/6 Warning Letter. Specific deviations cited were: * failing to demonstrate that the firm’s manufacturing process can
Drugs
Genentech has filed suit in Delaware federal court claiming that Pfizer will infringe or induce infringement of 40 Genentech patents on its breast cancer drug Herceptin (trastuzumab) by proceeding with its aBLA for a biosimilar to Herceptin. Genentech says Pfizer notified it 11/17 under the Biologics Price Competition and
Drugs
FDA has granted PellePharm a breakthrough therapy designation and orphan drug designation for topical patidegib for patients with basal cell carcinoma Nevus syndrome, a rare genetic disease also known as Gorlin Syndrome. The designations are based on data from a Phase 2 trial assessing the safety and efficacy of topical
Drugs
A new report from the White House’s Council of Economic Advisers estimates that the ongoing opioid crisis cost the U.S. $504 billion (2.8% of gross domestic product) in 2015 and led to over 33,000 American overdose deaths. Survey data indicate that 2.4 million Americans have
Drugs
FDA has approved a Kaléo supplemental NDA for AUVI-Q (epinephrine injection, USP) 0.1 mg, for treating life-threatening allergic reactions, including anaphylaxis, in infants and small children weighing 16.5 to 33 pounds who are at risk for or have a history of serious allergic reactions. The auto
Drugs
Congresswoman Rosa DeLauro (D-CT) has reintroduced a bill (HR 4385) that would amend the Food, Drug, and Cosmetic Act to restrict direct-to-consumer (DTC) drug advertising. The measure was referred to the House Committee on Energy and Commerce which will consider it before sending it to the House
Drugs
Federal Register notice: FDA is correcting an 11/3 Federal Register notice entitled “Controlled Correspondence Related to Generic Drug Development.” The document was published with an incorrect docket number. The correct Docket No. is FDA-2014-D-1167. To view the notice, click here.
Drugs
FDA’s Antimicrobial Drugs Advisory Committee has voted 9 to 6 against recommending approval for Bayer HealthCare Pharmaceuticals’ ciprofloxacin dry powder for inhalation for use in treating non-cystic fibrosis bronchiectasis. Panel members said they had concerns about inconsistent data, drug resistance and having met only one of four primary
Drugs
Pfizer subsidiary Greenstone has recalled multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets because the products have the potential to be super potent or sub potent. They were distributed nationwide to wholesalers/retailers from 11/2016 through 6/2017. “The use of this product in patients with uncontrolled diarrhea
Drugs
FDA commissioner Scott Gottlieb says the agency is taking steps to improve certain drug shortages at hospitals caused by hurricanes that devastated Puerto Rico this summer. Presumably, the agency is reacting to concerns raised late last week by the American Hospital Association, which urged the agency to intervene and “expedite
Drugs
By unanimous consent, the Senate agreed 11/16 to a House bill leaving to FDA decisions for battlefield drugs and medical devices. The House adopted HR 4374, introduced by Rep. Greg Walden (R-OR) the day before the Senate vote. The bill is intended to correct a provision adopted by
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FDA has approved Genentech’s Gazyva (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma (Stage II bulky, III or IV). Approval is based on results from the Phase 3 GALLIUM study, which showed superior progression-free survival