Drugs
Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen Auto-Injector, has expanded a recall of EpiPen (epinephrine injection, USP) and EpiPen Jr (epinephrine injection, USP) auto-injectors to include additional lots distributed in the U.S. and other markets. This recall is based on two
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Recent Warning Letters show that document control and data integrity (as well as complaint handling and corrective and preventive actions) remain key concerns of FDA investigators, according to an analysis by AssurX. “Today, FDA cGMPs and ISO standards require a document control system that demonstrates product safety and reliability,” the
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FDA has approved an Audentes Therapeutics IND for AT132, the company’s gene therapy product candidate to treat X-Linked Myotubular Myopathy (XLMTM). The IND covers the company’s plans to begin ASPIRO, a multicenter, multinational, open-label, ascending dose Phase 1/2 clinical study of AT132. Preliminary data from
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FDA has approved a Teva Pharmaceutical Industries NDA for Austedo (deutetrabenazine) tablets for treating chorea (uncontrollable muscular tremors) associated with Huntington’s disease. Approval was based on data from a Phase 3 multi-center trial conducted in 90 ambulatory patients with manifest chorea associated with Huntington’s. “Total Maximal Chorea
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Public Workshop on Engaging With CDER 03/31/2017 Federal Register notice. CDER announces a 5/12 public workshop on a “Roadmap for Engaging with FDA’s Center for Drug Evaluation and Research (CDER).” Comments Sought on Cell Tissue Product Info. Collection 03/31/2017 Federal Register notice: FDA seeks
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FDA has granted full approved to an AstraZeneca NDA for Tagrisso (osimertinib) 80mg once-daily tablets for treating patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer. In 2015, FDA gave accelerated approval to the therapy for those whose disease has progressed on
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FDA has approved a Pfizer supplemental NDA for Ibrance (palbociclib) that converts the previous accelerated approval to a regular approval based on the results from the confirmatory Phase 3 trial PALOMA-2. The approval also broadens the range of anti-hormonal therapy that may be administered with the therapy. IBRANCE
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FDA has accepted for priority review a Novartis BLA for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for use in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia. CAR-T therapies are manufactured for each individual
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FDA has granted Akari Therapeutics a fast track designation for Coversin for treating paroxysmal nocturnal hemoglobinuria (PNH) in patients who have polymorphisms conferring eculizumab resistance. Coversin is described by the company as a “second-generation complement inhibitor that acts on complement component-C5, preventing the release of C5a and the
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A group of Senate Democrats have introduced the Improving Access to Affordable Prescription Drugs Act that is intended to ensure drug companies put patients before profits and bring some much-needed relief to families and seniors on high drug costs. The lawmakers acted in the wake of Congressional Republicans’ failed
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FDA has released the FDA-483 issued following a 2/21-3/1 agency inspection at Cadila Healthcare, Himachal, Pradesh, India. Inspection observations made at the drug manufacturing facility included: * equipment used is the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations
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FDA researchers say that although drugs approved with a Boxed Warning or priority review are more likely to experience post-marketing safety events, other information provided during the FDA drug review that is easy to quantify is generally not associated with such post-marketing events. “It appears that these post-
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An online National Law Journal post says that a January FDA draft guidance on considerations in demonstrating interchangeability with a reference product outlines the nature and quality of the evidence biosimilar applicants should expect the agency to demand before making a finding of interchangeability for a biosimilar. “Because of the
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FDA has approved two Upsher-Smith Laboratories supplemental NDAs for Qudexy XR (topiramate) Extended-Release Capsules for use in preventing migraine headache in adults and adolescents 12 years of age and older. Topiramate is the active ingredient in Janssen Pharmaceuticals’ Topamax (topiramate) and is the molecule that neurologists prescribe most
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Pharmaceutical Research and Manufacturers of America (PhRMA) says that its members believe that additional dialog between FDA and industry is needed to resolve several fundamental issues before an agency draft guidance on submission of quality metrics data can move forward. “PhRMA respectfully requests that FDA pause its efforts to implement
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An FDA-483 issued at the conclusion of a 3/2-3/10 agency inspection at Alkem Laboratories, Pradesh, India, lists these observations: * failing to follow the written testing stability program; * master production and control records lack complete manufacturing and control instructions and special notations; and * failing to have written
Drugs
A Dr. Reddy’s oncology drug formulation manufacturing facility at Duvvada, Visakhapatnam, India, that was one of the facilities named in a 2015 Warning Letter, has been issued a 13-item Form-483. The February inspection cited the firm for failing to thoroughly review any unexplained discrepancy whether or not
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FDA has approved a Genentech NDA for Ocrevus (ocrelizumab) for treating adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). Approval for the intravenous infusion was based on data from two clinical trials in 1,656 participants treated for 96 weeks, according to an
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The Arizona legislature has approved the Free Speech in Medicine Act that authorizes drug and medical device companies to communicate truthful off-label treatment information to medical professionals. The bill was supported by the Goldwater Institute, which also has promoted state and federal “right-to-try” legislation. The institute reports
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FDA has issued Mylan a complete response letter on its ANDA for a generic copy of GlaxoSmithKline’s asthma therapy Advair Diskus (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder). Without providing any specifics on FDA’s concerns with the submission, Mylan said it is in the process
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The Parker Institute for Cancer Immunotherapy, Bristol-Myers Squibb and the Cancer Research Institute (CRI) have announced a multi-year clinical research collaboration to coordinate and begin clinical immuno-oncology studies across the Parker Institute and CRI networks. Under the agreement, Bristol-Myers Squibb will work closely with Parker Institute
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FDA’s Oncologic Drugs Advisory Committee has voted unanimously (11 to 0) that the benefit-risk ratio of rituximab/hyaluronidase for subcutaneous injection was favorable for treating certain blood cancers, which include: previously untreated follicular lymphoma, previously untreated diffuse large B-cell lymphoma, relapsed or refractory low grade or follicular