Drugs
Researchers say the FDA accelerated approval process has had generally positive results in speeding new drugs to patients, but it also has created financial issues for public insurers. Writing in a New England Journal of Medicine Perspective column, Walid Gellad and Arnold Kesselheim say that “at a time when medications
Drugs
Attorney James Beck (Reed Smith) says that based on FDA commissioner Scott Gottlieb’s previous agency and non-agency statements, he doubts “that FDA’s absolutist ban on truthful industry speech about off-label uses will continue much longer in its current form.” Writing in an online blog post, Beck
Drugs
Otsuka Pharmaceutical and Proteus Digital Health have resubmitted an NDA for a drug-device combination product using Abilify (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet. The companies are expecting a user fee review action in the fourth quarter. In 4/2016, FDA issued a complete response
Drugs
McNeil-PPC has reached a settlement with 43 state attorneys general to resolve allegations that the company distributed contaminated over-the-counter drugs and unlawfully promoted its products. Pennsylvania attorney general Josh Shapiro announced (includes link to settlement text) that the settlement would bring $1.4 million to his office
Drugs
The Association of Clinical Research Organizations has issued a policy statement detailing its opposition to legislation that would give terminally ill patients access to unapproved treatments, known as “right-to-try” bills. “As the organization representing the world’s leading clinical research organizations that each year conduct more than 7,
Drugs
FDA has accepted a Bristol-Myers Squibb supplemental BLA that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma (HCC) after prior sorafenib therapy. The agency has granted the submission a priority review and previously granted Opdivo orphan-drug designation for treating HCC. The user fee
Drugs
A Foundation for Research on Equal Opportunity white paper, “The Competition Prescription: A Market-Based Plan for Making Innovative Medicines Affordable,” says that increasing competition among drug companies is the surest way to lower drug prices. “Drug prices continue to grow at rates exceeding inflation and economic growth due to
Drugs
Writing in his first FDA Voice blog post as commissioner, Scott Gottlieb says his “highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction.” He writes that he e-mailed his agency colleagues to tell them of the first steps he plans
Drugs
A 2/13-2/17 FDA inspection at Changzho Jintan Qianyao Pharmaceutical Raw Materials Factory, Changzhou City, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API), according to a 5/11 Warning Letter. Specific deviations noted in the letter were: * failing to implement
Drugs
The Supreme Court has declined to hear an appeal filed by Jack and Peter DeCoster over their three-month prison sentences under the Park doctrine’s responsible corporate officer provisions. The jail term had been upheld by a 2-1 8th Circuit Court of Appeals decision, attorney Jennifer Thomas (Hyman,
Drugs
Stakeholders are commending FDA for a draft guidance on considerations in demonstrating interchangeability with a reference product and recommending additional items to be included in the document. Pharmaceutical Research and Manufacturers of America (PhRMA) says the guidance “provides welcome insights into FDA’s current thinking” and would benefit from several
Drugs
FDA has granted Merck accelerated approval for Keytruda (pembrolizumab) for treating patients whose cancers have a specific genetic feature (biomarker). “This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated,” an FDA
Drugs
FDA medical reviewers say the “totality of analytical data support the determination that Epoetin Hospira is highly similar to U.S.-licensed Epogen/Procrit notwithstanding minor differences in clinically inactive components.” That conclusion is included in a briefing document prepared for the 5/25 meeting of the Oncologic Drugs Advisory
Drugs
A 5/24 FDA Oncologic Drugs Advisory Committee plans to discuss agency concerns over “uncertainty in the magnitude of treatment effect due to unplanned” and multiple amendments to the clinical trial protocol involving Puma Biotech’s Nerlynx (neratinib) and its proposed indication for the extended adjuvant treatment of adult patients
Drugs
FDA is warning drug manufacturers of non-sterile, water-based drug products that there have been the subject of recent product recalls due to Burkholderia cepacia complex (BCC) contamination. “BCC and other water-borne opportunistic pathogens are among the contaminants that can be found in pharmaceutical water systems,” an agency
Drugs
FDA has expanded the approved use of Hoffman La Roche’s subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. Giant cell arteritis is a form of vasculitis and it causes the arteries to narrow or become irregular, impeding adequate blood flow. Approval was based on data from a
Drugs
Celgene says its Phase 3 RADIANCE trial met its primary endpoint in evaluating the efficacy and safety of ozanimod in patients with relapsing multiple sclerosis. The investigational oral, selective S1P 1 and 5 receptor modulator met the primary endpoint in reducing annualized relapse rate compared to weekly interferon (Avonex). The
Drugs
FDA has released a Form 483 after a January inspection cited significant GMP issues at Sancilio & Co.’s Riviera Beach, FL manufacturing facility. For example, FDA said laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that in-process
Drugs
Celgene says its Phase 3 RADIANCE trial met its primary endpoint in evaluating the efficacy and safety of ozanimod in patients with relapsing multiple sclerosis. The investigational oral, selective S1P 1 and 5 receptor modulator met the primary endpoint in reducing annualized relapse rate compared to weekly interferon (Avonex). The
Drugs
An ongoing FDA review of the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) has not identified adverse health effects from gadolinium retained in the brain. “All GBCAs may be associated with some gadolinium retention in the brain and other
Drugs
FDA has just released the FDA-483 form listing 10 observations from its 6/13-6/17/16 inspection at Sekisui Medical Co., Iwate, Japan. Deviations from CGMP regulations for active pharmaceutical ingredients noted on the form were: * failing to maintain and review all raw data; * failing to prevent unauthorized
Drugs
FDA has granted a breakthrough therapy designation to GlycoMimetics for GMI-1271 and its use in treating adult relapsed/refractory acute myeloid leukemia (AML). The E-selectin antagonist is currently being evaluated in the Phase 2 portion of a Phase 1/2 clinical trial in patients with AML. FDA previously