Drugs
Attorneys from McDermitt Will & Emery say that in 2019 the CDER Office of Prescription Drug Promotion (OPDP) issued a total of six untitled letters and three Warning Letters, a slight increase over the 2018 total. Writing in their firm’s review of the year 2019 for FDA, they say
Drugs
FDA has approved a Lannett Co. NDA for cocaine hydrochloride nasal solution 4% (40 mg/mL), the company’s first branded local anesthetic product indicated for the introduction of local anesthesia in the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults. The 505(
Drugs
The FDA Anesthetic and Analgesic Drug Products Advisory Committee will discuss 1/16 Durect Corp.’s 10/2019 response to a 2/12/14 FDA complete response letter for its Posimir (bupivacaine extended-release solution) with a proposed indication for administration into a surgical incision to produce post-surgical analgesia.
Drugs
Republican leaders of the House Energy and Commerce Committee say they are reopening their 8/2018 inquiry into three opioid manufacturers — Insys, Mallinckrodt, and Purdue — to obtain additional information from the companies. In 2018, the companies were asked to provide information about their actions related to the spread of the
Drugs
A new FDA safety alert says that results from a clinical trial assessing safety of Eisai’s weight-loss drugs Belviq and Belviq XR (lorcaserin) show a possible increased cancer risk. The alert says that the cancer cause is “uncertain” and that the agency cannot conclude that lorcaserin contributes to
Drugs
FDA has placed a partial clinical hold on Innate Pharma’s TELLOMAK Phase 2 trial that is evaluating lacutamab’s efficacy and safety in patients with advanced T-cell lymphomas. The company says it has been in ongoing discussions with regulatory authorities about GMP deficiencies at its manufacturing subcontractor site
Drugs
Harvard Medical School researchers say that while the FDA approval and regulation processes for drugs have evolved and increased in complexity over the last four decades as special programs have been added and the use of surrogate measures has been encouraged, the changes have not led to a reduction in
Drugs
A Science investigative report says that FDA and the National Institutes of Health (NIH) are doing little or nothing to enforce a 2007 law and its 2017 final rule requiring recording of most clinical trial results in a federal database so doctors and patients can see whether new treatments are
Drugs
A 5/13-6/3/19 FDA inspection at the Health Pharma drug manufacturing facility in Rahway, NJ, found significant violations of current good manufacturing practice (CGMP) regulations. A 12/18/19 Warning Letter says specific violations were: * failure of the firm’s quality control unit to exercise its responsibility
Drugs
A 7/1-7/5 FDA inspection at Huaian Zongheng Bio-Tech Co., Huaian, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 1/9 Warning Letter says specific violations were: * failing to have for each batch of drug product appropriate laboratory determination of
Drugs
Vifor Pharma, which manufactures a number of complex drugs to treat iron deficiency, is asking FDA “to take critical steps regarding the approval and therapeutic equivalence of safe and effective follow-on harder-to-copy complex drugs.” Specifically, the firm’s petition says, FDA should make clear to its stakeholders
Drugs
FDA has denied an 11/1/19 petition filed by Arent Fox asking that the agency deny approval of an NDA for Neurelis’ Valtoco (diazepam nasal spray) until additional clinical studies are conducted. The agency approved the NDA 1/10 contemporaneously with the petition denial. The petition had asked that
Drugs
Former FDA principal deputy commissioner Joshua Sharfstein says there are four things FDA and Congress should do to enhance the benefits and value and reduce the inefficiency and risks of the U.S. system of drug approval. Sharfstein’s ideas appear in a JAMA editorial accompanying a research article discussing
Drugs
CDER director Janet Woodcock says enhancing postmarket safety initiatives and modernizing the Center’s new drugs regulatory program are two of the top priorities for 2020. “Maintaining our robust postmarket surveillance and risk evaluation programs is critical for identifying new adverse events that did not appear during the product development
Drugs
Taro Pharmaceuticals has recalled one lot of epilepsy/bipolar drug lamotrigine 100 mg tablets after it was found to have been cross-contaminated with a small amount of another drug substance (enalapril maleate) that was used to manufacture another product at the same facility. Enalapril Maleate is indicated for hypertension
Drugs
FDA has accepted for review a Chiasma NDA resubmission for Mycapssa (octreotide) capsules for the maintenance treatment of adults with acromegaly. According to Chiasma, acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, which leads to significant health problems and early death if
Drugs
FDA has accepted for priority review an AstraZeneca supplemental NDA for Lynparza (olaparib) in combination with bevacizumab (Genentech’s Avastin) for the maintenance treatment of women with advanced ovarian cancer whose disease has shown a complete or partial response to first-line treatment with platinum-based chemotherapy and bevacizumab. The
Drugs
Evotec has entered into a definitive agreement with Aptuit under which Evotec will acquire all operational business of Aptuit for $ 300 million that will expand Evotec’s role as a leading player in integrated outsourced drug discovery and development solutions. LabCorp has agreed to purchase private contract research organization (CRO)
Drugs
FDA has issued SCA Pharmaceuticals (Little Rock, AR) a six-observation Form 483 after a November inspection cited GMP issues at the drug outsourcing facility. For example, the agency said that each batch of drug product required to be free of objectionable microorganisms is not subjected to appropriate laboratory testing.
Drugs
The Coalition to Preserve Access to Pharmacogenomics (PGx) Information has petitioned FDA urging it to stop enforcement actions against genetic tests that claim to predict a patient’s response to specific medications. Over the past year, the agency has warned several companies about claims made for specific genetic tests. It
Drugs
Alnylam Pharmaceuticals has begun a rolling submission of its NDA for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase for treating primary hyperoxaluria Type 1 (PH1). Specifically, the company submitted non-clinical components and it expects to submit the remaining components later this year 2020. Alnylam also says it has
Drugs
Researchers from the University of Michigan and Harvard Medical School say that Reckitt Benckiser earned at least $1 billion in extra profits by exploiting various FDA regulatory procedures to impede the entry of generic competitors and maintain elevated prices for its Suboxone (buprenorphine), used to treat opioid use disorder. Writing