Drugs
A 9th Circuit Court of Appeals three-judge panel has ruled that Physicians for Integrity in Medical Research has no standing to sue FDA over the agency’s decision not to revoke its approval of the chronic obstructive pulmonary disease drug roflumilast (AstraZeneca’s Daliresp). In its 2011 suit, the
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FDA has granted accelerated approval to Eli Lilly for its soft tissue sarcoma (STS) drug Lartruvo (olaratumab) and its use with chemotherapy drug doxorubicin in those who cannot be cured with radiation or surgery. Lartruvo is a platelet-derived growth factor (PDGF) receptor-alpha blocking antibody. “When stimulated, PDGF receptors
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FDA has approved Genentech’s Tecentriq (atezolizumab) for treating people with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities. Approval is based
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FDA has accepted an AstraZeneca NDA re-submission for sodium zirconium cyclosilicate (ZS-9), indicated for treating hyperkalemia (high potassium level in the blood serum). A complete response letter was sent in May to the company that identified observations cited during a pre-approval manufacturing inspection. The agency did not
Drugs
FDA has placed a clinical hold on a Regeneron Pharmaceuticals and Teva Pharmaceutical Industries Phase 2b clinical trial of fasinumab in patients with chronic low back pain. Fasinumab is an investigational Nerve Growth Factor (NGF) antibody in clinical development for osteoarthritis pain and chronic low back pain. The agency’s
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CDER’s Office of Drug Evaluation 1 has denied a PTC Therapeutics appeal of a 2/22 refuse-to-file letter issued by the Division of Neurological Products on an NDA for Translarna (ataluren) for treating nonsense mutation Duchenne muscular dystrophy (nmDMD). At the time, the agency said the submission
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Purdue Pharma is petitioning FDA to ensure that applications for approval of follow-on products citing its Butrans (buprenorphine) transdermal system as the reference-listed drug are supported by pharmacokinetic data establishing equivalent buprenorphine exposure over the entire seven-day dosing interval. “Absent such data,” the petition says, “there would
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Gilead says that under the terms of a recent federal court decision, FDA should grant its Stribild (cobicistat, elvitegravir, emtricitabine, tenofovir disoproxil fumarate) five-year new chemical entity (NCE) exclusivity and should extend that exclusivity to all subsequently approved drug products containing any of the new active moieties (elvitegravir and
Drugs
Since 2004, staff in FDA and the European Medicines Agency (EMA) have collaborated through groups, known as clusters, to help solve major challenges facing the agencies. An FDA Voice blog post says that clusters have focused on treatments for children, measures for developing and using biosimilars as cost-effective alternatives
Drugs
A 5/11-5/29/15 FDA inspection at U.S. Specialty Formulations, Bethlehem, PA, found multiple violations and activities that did not meet requirements under Section 503B of the Federal Food, Drug, and Cosmetic Act for drugs produced by an outsourcing facility to qualify for certain exemptions. A 9/
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Teva says it will respond 11/4 to an FDA Warning Letter about an inspection at the firm’s drug manufacturing facility in Godollo, Hungary, which has been closed since January. The company says in an SEC filing that the letter cites deficiencies in manufacturing operations and laboratory controls, and
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Virtus Pharmaceuticals has filed suit against FDA in middle Florida federal court seeking an order barring enforcement action against the company’s unapproved and allegedly grandfathered potassium chloride drug products. According to the company, after being marketed without an approved NDA for decades, two of Virtus’s competitors gained approval
Drugs
President Obama’s “Cancer Moonshot” initiative has released a task force report on implementation plans. One strategic goal, it says, is to catalyze new scientific breakthroughs by “fostering interdisciplinary approaches for elucidating the biological mechanisms underlying cancer onset and treatment; aligning research and care as a seamless and iterative process;
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Sandoz has petitioned FDA asking that it not approve generic copies of GlaxoSmithKline’s asthma inhaler Advair Diskus 100/50 (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder) unless ANDA submissions contain data from a pharmacokinetic (PK) bioequivalence study that is stricter than requirements outlined in an agency
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FDA reviewers are questioning clinical trial designs in a Serenity Pharmaceuticals NDA for SER120 (desmopressin nasal spray), which is proposed for treating adults with nocturia who awaken two or more times per night to urinate. The submission will be reviewed by the agency’s Bone, Reproductive and Urologic Drugs Advisory
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Omnicare has agreed to pay $28 million to resolve allegations that it solicited and received kickbacks from Abbott Laboratories in exchange for promoting the anti-epileptic drug Depakote for nursing home patients. In 2012, the government and Abbott entered into a $1.5 billion global civil and criminal resolution that
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FDA has announced a 10/21 public meeting to hear public comments on the recent proposed agreement to reauthorize the generic drug user fee program. The draft agreement will be finalized and delivered to Congress in January. One major change in the draft is that review performance goals will be
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FDA has released a guidance on “ANDA Submissions — Prior Approval Supplements Under GDUFA” that is intended to assist applicants preparing such submissions. The document describes the agency’s performance metric goals for reviewing these and clarifies how it will handle submissions that fall under user fee performance metric goals.
Drugs
FDA has told Egalet Corp. that it will not meet a previously announced 10/14 user fee review target date for the pain drug Arymo ER (morphine sulfate). The agency said the delay is centered on the product label, according to the company. “The FDA indicated that they need more
Drugs
FDA has accepted for review a Sunovion Pharmaceuticals NDA for SUN-101 (glycopyrrolate), a nebulized long-acting muscarinic antagonist delivered using PARI’s Pharma’s eFlow closed system nebulizer for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The agency has set
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Stakeholders are generally voicing support for two FDA draft guidances on compounded drug products that are essentially copies of a commercially available drug product. The Biotechnology Innovation Organization (BIO) says it strongly believes that the drug compounding provisions of the Drug Quality and Security Act did not change current law
Drugs
FDA has placed a clinical hold on an Aptose Biosciences Phase 1b clinical trial of APTO-253 in patients with hematologic cancers, requesting additional information. The agency is requesting the complete chemistry, manufacturing and control information for the final GMP drug substance and drug product intended for the clinic, according