Drugs
As reported by NBC News, Kaiser Health News says FDA’s approval of Janssen’s Spravato (esketamine) raises questions about “how drugmakers can take advantage of shortcuts in the FDA process with the agency’s blessing and maneuver through safety and efficacy reviews to bring a lucrative drug to market.
Drugs
An FDA inspection last month at Aurobindo Pharma’s Telangana, India manufacturing facility has led to a nine-observation Form 483. The inspection cited the firm’s quality control unit because its procedures and responsibilities are not in writing and fully followed. FDA also cited the firm for not retaining
Drugs
CDER’s Office of Compliance has set up a new compounding team with responsibility for the overall management of the agency’s drug compounding compliance program. According to an email from CDER director Janet Woodcock, Division of Compounded Drugs director Gail Bormel will lead the team and report directly to
Drugs
Provention Bio says that a recent study showed that a single 14-day course of PRV-031 (teplizumab) significantly delayed the onset and diagnosis of clinical Type 1 diabetes compared to placebo by a median of two years in children and adults considered to be at high risk. “During the
Drugs
FDA has posted a 3/14 Warning Letter to Pharmasol after conducting two 8/2018 facility inspections at South Easton, MA and Stoughton, MA, and citing significant GMP violations at both. At both facilities, FDA said, the firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch
Drugs
FDA has approved two new methods for administering GlaxoSmithKline’s Nucala (mepolizumab) — an autoinjector and a pre-filled safety syringe — for patients with severe eosinophilic asthma (SEA) or the rare disease eosinophilic granulomatosis with polyangiitis. This is the first anti-IL5 biologic to be licensed in the U.S. for
Drugs
The Federal Trade Commission (FTC) is implementing electronic filing to replace hard-copy submissions involving brand name and generic drug company agreements for antitrust reviews. Starting 6/17, such filings should be submitted to both the FTC at [email protected] and the Antitrust Division of the U.S. Department
Drugs
FDA has approved a PTC Therapeutics supplemental NDA for Emflaza (deflazacort) to expand its labeling to include patients with Duchenne muscular dystrophy (DMD) who are between two and five years of age. Emflaza was first approved 2/2017 for treating Duchenne in patients five years and older. An agency news
Drugs
Motif Bio says FDA is requiring an additional clinical trial before it can approve the company’s NDA for iclaprim, indicated for treating acute bacterial skin and skin structure infections. The agency expressed its position at a recent Type A meeting about a complete response letter that was issued in
Drugs
The Justice Department says Insys Therapeutics is settling separate civil and criminal investigations into illegal promotion of its Subsys opioid painkiller with a payment of $225 million. A department news release says the company will plead guilty to five counts of mail fraud and pay a $2 million fine and
Drugs
FDA has announced that later this month generic drug applicants will be able to submit pre-assigned ANDA number requests through CDER’s NextGen Portal. For sponsors already having a CDER NextGen Portal account, the account will be automatically updated with this pre-assigned ANDA number request functionality. To create
Drugs
FDA has published a draft guidance, Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment, to assist sponsors in the clinical development of drugs to treat nonalcoholic steatohepatitis (NASH) with compensated cirrhosis. The document contains the agency’s current recommendations on the important components of a drug development program for
Drugs
FDA is issuing a draft guidance, Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs, to recommend approaches that NDA and BLA clinical trial sponsors can take to broaden eligibility criteria, when scientifically and clinically appropriate, and increase enrollment of underrepresented populations in their trials.
Drugs
FDA has accepted a Celgene NDA for ozanimod, indicated for treating patients with relapsing forms of multiple sclerosis (RMS). The oral, sphingosine 1-phosphate (S1P) receptor modulator binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). The submission is based on data from the SUNBEAM and
Drugs
FDA has granted Palatin Technologies an orphan drug designation for PL-8177 for treating non-infectious intermediate, posterior, pan and chronic anterior uveitis. Non-infectious uveitis is a group of inflammatory diseases that produces swelling and destroys eye tissue and can result in vision loss, according to the company. PL-
Drugs
The Association for Accessible Medicines and its Biosimilars Council say they support FDA efforts to foster biosimilar competition in the interest of building a sustainable marketplace for those innovative medicines. Following an FDA 5/13 hearing on the future of insulin biosimilars, the association and council recommend that: * FDA has
Drugs
Tempus, a precision medicine technology company, says it is launching its Tempus Integrated Molecular Evaluation (TIME) trial, at scale, which aims to increase clinical trial enrollment and participation for cancer patients who are treated in academic and community settings. The company says TIME is a proprietary platform that aims to
Drugs
FDA has approved an Eli Lilly BLA for Emgality (galcanezumab-gnlm) solution for injection for treating episodic cluster headache in adults. The drug was first approved 9/2018 for preventing migraine headaches in adults. The new approval was based on data from a 106-patient placebo-controlled clinical trial. “The
Drugs
HHS says it will not further renew a contract with the University of California San Francisco (UCSF) for research involving human fetal tissue from elective abortions. A department statement says, “Promoting the dignity of human life from conception to natural death is one of the very top priorities of President
Drugs
The Washington Post reports that Pfizer researchers found in 2015 that its blockbuster rheumatoid arthritis drug Enbrel (etanercept) appeared to reduce the risk of Alzheimer’s disease. However, the newspaper says, the company made a decision during three years of internal review that Enbrel did not show promise for Alzheimer’
Biologics
Georgia State University law professor Yaniv Heled says a new FDA guidance explaining how drug manufacturers can develop follow-on biologics is a good step toward lowering drug costs, but may not be enough to make a real difference. Writing online for The Conversation, Heled explains why biologics are so
Drugs
Mallinckrodt (formerly Questcor Pharmaceuticals) says it expects to pay $15.4 million under an agreement in principle it has reached to resolve False Claims Act allegations that it used a foundation as a conduit to pay kickbacks in connection with its drug H.P. Acthar Gel from 2010 through 2014.