Drugs
Attorney Nathan Beaver (Foley & Lardner) says that FDA is unlikely to implement a biosimilar approval process laid out by the Federal Circuit Court of Appeals in Amgen v. Apotex. In an online National Law Review post, Beaver says that the court interpreted a provision in the Biologics Price Competition
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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
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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 Commenting on the agency’s draft guidance on SPAs, the association says it
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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
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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
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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,
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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
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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
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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,
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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
Drugs
FDA has issued Elite Pharmaceuticals a complete response letter (CRL) on its NDA for SequestOx (oxycodone hydrochloride and naltrexone hydrochloride), an investigational abuse-deterrent opioid candidate for managing moderate to severe acute pain where the use of an opioid analgesic is appropriate. The company says that FDA determined the NDA
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Ziopharm Oncology says a patient has died in an ongoing multicenter Phase 1 study involving gene therapy candidate Ad-RTS-hIL-12 plus orally administered veledimex in recurrent or progressive glioblastoma or grade 3 malignant glioma. “The patient death resulting from intracranial hemorrhage in the third cohort of this Phase
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FDA has placed two Lima & Pergher Brazilian drug manufacturing facilities on import alert, barring their products from entering the U.S. after an inspection detected significant GMP violations. The affected facilities are Lima & Pergher Industria, Comercio e Representacoes at 740 Airton Borges Da Silva Ave., Minas Gerais, and
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Despite a push by the White House to advance personalized medicine, this “new era of medicine” is many years away if it is ever to be truly realized, according to an article in the 7/19 MIT Technology Review. Research editor Mike Orcutt says the reasons for such pessimism are
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FDA says it will take 33% longer to review orphan drug designation requests due to the growing demand in new submissions. Previously, the agency worked within an internal goal to review 75% of designation requests within 90 days. Now, because of the sustained increase in designation requests over the past
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PharmaTech LLC (Davie, FL) is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium stool-softening solution distributed by Rugby Laboratories, Livonia, MI. The agency has confirmed the product has been contaminated with Burkholderia cepacia, a bacterium linked to infection outbreaks in five states. Symptoms include pneumonia,
Drugs
FDA has posted a revised International Council on Harmonization (ICH) guidance entitled “E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER)” that defines the recommended format and content of such reports and offers points to be considered in preparing and submitting them. The guidance revises, combines, and replaces two ICH guidances
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Astellas UK has been suspended as a member of the Association of the British Pharmaceutical Industry (ABPI), which is recognized by the UK government as the industry body negotiating on behalf of the branded pharmaceutical industry for statutory consultation requirements, including the pricing scheme for medicines in the UK. The
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Senators Dianne Feinstein (D-CA) and Chuck Grassley (R-IA), have co-introduced the Cannabidiol Research Expansion Act, a bill to support research initiatives on the potential benefits of substances like cannabidiol (CBD) that are derived from marijuana. “I strongly believe that more research into the potential medical benefits of