Drugs
The Federal Circuit Court of Appeals has upheld a district court ruling that parties may rely on extrinsic evidence when establishing a claim element’s function under the doctrine of equivalents. Attorney Karalena Guerrieri (Winston & Strawn) writes in an online post that the decision came in a case brought
Drugs
The Generic Pharmaceutical Association (GPhA) says that special protocol assessments (SPAs) are an important mechanism for developing biosimilars as they allow sponsors to engage with FDA and discuss the adequacy and acceptability of a proposed study design. Commenting on the agency’s draft guidance on SPAs, the association says it
Drugs
FDA approved 7/19 eight generic copies (see approval letters below) of AstraZeneca’s cholesterol-lowering Crestor (rosuvastatin), the same day it rejected the company’s citizen petition seeking a delay on ANDA final approvals (see earlier story). The petition sought a block on any rosuvastatin ANDAs that contained a
Biologics
Amgen and Allergan have announced results from a Phase 3 study evaluating the efficacy and safety of their biosimilar candidate ABP 980 compared with Genentech’s Herceptin (trastuzumab) in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer. “The results ruled out inferiority compared to
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Acts,” has been submitted to the Office of Management and Budget for review and
FDA Policy/General
Federal Register Notice: The FDA commissioner is renewing the Science Board to the FDA for an additional two years beyond the charter expiration date. The new charter will be in effect until 6/26/18. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a draft revised guidance for industry entitled General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals. It is intended to inform sponsors of the scientific data and/or information that may provide an acceptable basis
Drugs
EG Lifesciences says that companies should have a site inspection readiness team on hand and ready to take action whenever FDA inspectors arrive for an announced or unannounced visit. Once inspectors arrive, a recent online post says, companies should use the following checklist for key logistical considerations: * be sure that
Devices
FDA has cleared a Medtronic 510(k) for the CD Horizon Fenestrated Screw Set, a cement-augmented pedicle screw which can be used for patients diagnosed with advanced stage tumors involving the thoracic and lumbar spine. The device is intended for use at spinal levels where structural integrity is not
Biologics
FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee has voted 18 to 0 to recommend approval of a Valeant BLA for Siliq (brodalumab) injection for treating plaque psoriasis. Fourteen panel members recommended that risk management options for “suicide ideation and behavior” outside of the approved labeling be implemented if approved.
Drugs
The Alliance for Patient Access (AfPA) says that the 7/12-13 hearings of the FDA Arthritis Advisory Committee showed the need for more policy guidance on biosimilars. “Participants and even committee members expressed concerns about unfinished regulatory policy and the need to prioritize patient safety,” the group says in
Drugs
Montrium, a consulting company, says that technology and computerized systems have changed the way that lifesciences companies do business. Such a transition has been accompanied by an additional expectation of complying with various regulations, it says. A white paper focuses on FDA’s legal requirements for electronic records and signatures,
Drugs
FDA has denied an AstraZeneca citizen petition seeking to block the approval of generic copies of its blockbuster cholesterol-lowering Crestor (rosuvastatin calcium) if they are considered with a labeling “carve-out” that omits marketing exclusivity-protected pediatric labeling. The company also lost its bid to gain a temporary restraining
Devices
Despite objections from congressional Republicans, FDA is moving ahead with plans to finalize guidelines for regulation of laboratory-developed tests by the end of this year, according to the online political Web site The Hill. The report says that Republicans on the House Energy and Commerce and Appropriations committees warned
Devices
The former chief executive officer and vice president of sales at medical device company Acclarent have been acquitted by a Boston jury involving felony charges that the two illegally marketed a medical device for off-label uses. While cleared of the felony charges, the jury did find the two guilty
Drugs
FDA has approved a Valeant Pharmaceuticals and Progenics Pharmaceuticals NDA for Relistor (methylnaltrexone bromide) tablets for treating opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Relistor subcutaneous injection (12 mg and 8 mg) was approved in 2008 for treating OIC in adults with advanced illness who are
Drugs
Attorney Mark Schwartz (Hyman, Phelps & McNamara) says that FDA has been working for more than a decade to reach an agreement with the European Union that would allow for regulatory bodies to avoid duplication of their surveillance activities and lower the overall costs of their respective programs. Writing in
Drugs
A Health Affairs blog post urges FDA to publish guidance on off-label promotion in the wake of recent First Amendment court cases that have questioned the agency’s authority to regulate off-label information. “Given the competing interests of patient health, access to information, drug safety, and the financial
Drugs
Researchers from FDA and RTI International say that two recent direct-to-consumer advertising studies showed that consumers’ understanding of FDA approvals and its authority were mixed. “Many consumers were not familiar with the use of composite scores in a medical context or in advertising and, in the first study,
Devices
FDA has sent Palm Harbor, FL-based Oscor Inc. a Warning Letter after an inspection cited GMP deficiencies involving the manufacturing of introducer catheters (Adelante Magnum) and a neuromodulator for obesity (Maestro Rechargeable System). According to the letter, Oscor failed to develop, conduct, control, and monitor production processes to ensure
Biologics
Novartis says its Sandoz drug unit has received a complete response letter from FDA for a biosimilar pegfilgrastim candidate (Amgen’s Neulasta). “We are working with the agency to address remaining questions,” the company briefly said in a 7/19 financial report. Sandoz reported 11/2015 that FDA had accepted
Drugs
FDA has cited a GlaxoSmithKline active pharmaceutical ingredient manufacturing facility in the UK after an inspection a year ago raised cross-contamination concerns. A just-released 6/30 Warning Letter says GSK failed to have appropriate procedures in place to prevent cross-contamination from a dedicated penicillin manufacturing area to