Drugs
Faced with a backlash over its $89,000 annual price for a decades-old steroidal drug that was recently approved for treating Duchenne muscular dystrophy, Marathon Pharmaceuticals says it has paused its “commercialization efforts” in order to meet with Duchenne community leaders to review their concerns and discuss all options.
Drugs
FDA has approved a Valeant Pharmaceuticals NDA for Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is intended for patients who are systemic therapy or phototherapy candidates who have failed to respond, or have stopped responding to other systemic therapies, an agency news release says. Brodalumab
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Public Citizen says that legislation introduced by Rep. Rosa DeLauro (D-CT) would close a “dangerous gap” in FDA authority by authorizing the agency to order emergency recalls of medications that present an imminent threat to the health of patients. In a statement, the advocacy group says that “most people
Drugs
FDA has expanded the approval for Boehringer Ingelheim Pharmaceuticals’ asthma medication Spiriva Respimat for the long-term, once-daily maintenance treatment of asthma in people age six and older. The agency approved the supplemental NDA under a priority review, and it also granted pediatric exclusivity for the product based on
Drugs
The Department of Justice says that a Massachusetts federal court sentenced a sales representative for multiple healthcare companies to three years of probation in connection with obstructing an investigation into kickbacks paid to medical professionals. The government says that Terrence Tackett of Florence, KY, pleaded guilty in 5/2016 to
Drugs
CDER director Janet Woodcock says that several years ago FDA became aware of a lack of an orderly process for biomarker development and set up its “qualification process.” Woodcock explains the process in a video included in the Center’s quarterly update “What’s New in Regulatory Science.” She says
Drugs
Drug company executives contacted by Reuters expressed anxiety about President Trump’s vow to roll back federal regulations at least 75%. They say they fear that a less robust FDA would make it harder to secure insurance coverage for pricey new medicines. The Biotechnology Industry Group told Reuters that in
Drugs
Richard Plotkin, who used experience with his grandson’s cancer diagnosis to become one of the nation’s leading advocates for children with cancer, says that the “right-to-try” legislation being considered by Congress should be rejected because it would leave patients without FDA protection. Writing in a blog
Drugs
Yale Law School professor Gregory Curfman and student Deborah Mazer say that while there are positive elements in the recently-approved 21st Century Cures Act, subtle changes to the approval procedures for new drugs and medical devices included in the law “could weaken FDA’s regulatory oversight as could a
Drugs
The CDER Exclusivity Board says that the scope of Daiichi Sankyo’sMorphaBond’s three-year exclusivity is labeling describing the expected reduction of abuse of single-entity extended-release morphine by the intranasal route of administration due to physiochemical properties. In a just-released determination, the board says the exclusivity
Drugs
FDA has exempted Evoke Pharma from having to perform a human factors validation study requirement prior to submitting an NDA on its late stage product Gimoti (metoclopramide nasal spray) for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Last year, FDA released a
Drugs
CDER is reminding industry that beginning 5/5 drug sponsors must submit applications for new drugs, generic drugs, biologics, biosimilars, and drug master files in the Electronic Common Technical Document (eCTD) format. Submissions in the eCTD format are intended to enhance the quality and efficiency of regulatory reviews. Such formatted
Drugs
Sens. Chuck Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) are asking new HHS secretary Tom Price to certify some Canadian drugs for importation into the U.S. under the 2003 Medicare Prescription Drug Improvement and Modernization Act. In a 2/14 letter, the senators say
Drugs
An 8/16-8/17/16 FDA inspection at Zhejiang Bangli Medical Products, Yongkang City, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 1/26 Warning Letter. The letter also indicates that the firm limited the agency’s inspection. Specific violations
Drugs
FDA Warning Letters issued in fiscal year (FY) 2016 fell by 15% compared with such letters issued in FY 2015, according to just-released enforcement statistics. Overall, there were 14,590 Warning Lettters issued in FY 2016, down about 2,600 from the 17,232 letters issued in 2015. The
Drugs
Former FDA commissioner Robert Califf says there are five things the Trump administration should be aware of if they try to speed drug approvals and reduce FDA regulations. Interviewed by Kaiser Health News, Califf said first that faster drug approvals don’t necessarily mean less expensive drugs. “What I’m
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CDER has issued a Manual of Policies and Procedures (MAPP) on good review management principles and practices for effective IND development and review. The MAPP is to assist Center review staff on good review management principles and practices for submissions during the IND phase of drug development, promote excellence in
Drugs
FDA has approved class labeling revisions about the risk of hepatitis B virus (HBV) in patients coinfected with hepatitis C virus (HCV) and hepatitis B virus. An agency notice says the labeling changes include: * test all patients for evidence of current or prior HBV infection before starting treatment with HCV
Drugs
A False Claims Act settlement last month (see earlier story) by Baxter Healthcare is being characterized as unusual because it was not an off-label promotion or kickback activity-related action typically seen in such settlements. “Instead the Baxter case was based on an allegation that Baxter manufactured products in
Drugs
Zosano Pharma says it is planning an NDA for its migraine drug M207 after reporting clinical trial (ZOTRIP) results where both co-primary endpoints of pain freedom and most bothersome symptom freedom at two hours were met. The placebo-controlled, dose-ranging trial compared three transdermal doses (1.0mg, 1.
Drugs
FDA has partially approved an Alcon citizen petition that asked the agency to require only in vivo bioequivalence testing for ANDAs that cite its Ciprodex (ciprofloxacin 0.3% and dexamethasone 0.1%) sterile otic suspension as the reference-listed drug. The petition said that a recently revised FDA draft guidance
Drugs
FDA has approved an updated label for Eli Lilly’s once-weekly Trulicity (dulaglutide) to include use in combination with basal insulin for adults with Type 2 diabetes. Trulicity is a once-weekly glucagon-like peptide-1 receptor agonist injectable prescription medicine designed to improve blood sugar (glucose) in adults