Drugs
CDER director Janet Woodcock says “advanced manufacturing technologies” could reduce U.S. drug maker reliance on foreign-sourced active pharmaceutical ingredients (APIs) and thus “enable U.S.-based pharmaceutical manufacturing to regain its competitiveness with China and other foreign countries.” Testifying before a 10/30 House Energy and Commerce Subcommittee
Drugs
In a split vote, FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee has voted 9 to 7 to recommend that the agency remove from the market Amag Pharmaceuticals' accelerated-approval drug Makena (hydroxyprogesterone caproate injection) because a confirmatory trial failed to perform better than placebo to reduce the
Drugs
FDA has issued a guidance, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act, with the agency’s interim regulatory policy concerning compounding by outsourcing facilities registered under Section 503B of the Federal Food, Drug, and Cosmetic Act using bulk
Drugs
FDA has placed a partial hold on clinical trials for intrathecal administration of AVXS-101 following an AveXis communication to health authorities and clinical trial investigators based on findings from a small, AveXis-initiated pre-clinical study in which animal findings showed dorsal root ganglia mononuclear cell inflammation, sometimes accompanied
Drugs
FDA has approved a Biogen 505 (b)(2) NDA for Vumerity (diroximel fumarate) for treating relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The NDA included data from pharmacokinetic bridging studies comparing Vumerity and the company’s Tecfidera to establish
Drugs
A 3/19-4/5 FDA inspection at Petnet Solutions, Woburn, MA, found significant violations of current good manufacturing practice (CGMP) regulations for positron emission tomography (PET) drugs. A 10/17 Warning Letter says specific violations were: * the firm’s facilities are not adequate to ensure the prevention of contamination
Drugs
AstraZeneca has announced positive progression-free survival (PFS) results from the Phase 3 POSEIDON trial in previously-untreated Stage IV (metastatic) non-small cell lung cancer (NSCLC) for Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody, when added to chemotherapy. “The trial met a primary endpoint by showing a statistically
Drugs
FDA has issued a draft guidance, Providing Regulatory Submissions in Electronic Format: IND Safety Reports, describing the electronic format sponsors will be required to use when they electronically submit to FDA IND safety reports for serious and unexpected adverse reactions. The document implements the electronic submission requirements of Section 745A(
Drugs
An interagency drug shortage task force led by FDA has identified three root causes for drug shortages and “enduring solutions” to address such shortages. The report relies on information from stakeholders, published research, and economic analysis of market conditions affecting drug shortages, FDA says. The three root causes identified are:
Biologics
A Pew Trusts report, “FDA’s Framework for Regulating Regenerative Medicine Will Improve Oversight,” says the agency’s 2017 guidance documents that constitute its regulatory framework “marks an important step in the agency’s efforts to encourage the development of new therapies while also protecting patients from dangerous unapproved interventions.
Drugs
An Idaho district court has rejected the theory of “innovator liability” under which a branded drug manufacturer can be held liable for injuries caused by a generic version of its drug. A Washington Legal Foundation (WLF) Legal Pulse reports that the court ruled that plaintiffs could not sue Novartis for
Drugs
Reps. Frank Pallone (D-NJ) and Brett Guthrie (R-KY) have introduced H.R. 4866, the National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019. The bipartisan legislation would allow FDA to partner with universities across the country to designate them as National Centers of Excellence in Continuous
Drugs
FDA has accepted for review a Heron Therapeutics NDA resubmission for HTX-011, an investigational agent for managing postoperative pain. The agency has set a user fee review action date of 3/26/2020. The NDA was resubmitted based on feedback from an FDA/company meeting that sought clarity on
Drugs
FDA has released a draft guidance on “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics or Software.” A drug master file (DMF) is a voluntary submission that provides confidential detailed information about facilities, processes, or articles used in the manufacturing one or more human
Drugs
FDA has released a fact sheet to explain its “Accreditation Scheme For Conformity Assessment (ASCA) Pilot Program: Draft Guidance.” The sheet provides an abbreviated overview of the guidance and pilot program. The pilot is intended to take advantage of the growing acceptance of consensus standards in medical device reviews. It
Drugs
Allergan and its Forest Laboratories subsidiaries have settled for $750 million a lawsuit brought by direct purchasers of Alzheimer’s drug Namenda (memantine) that alleged Forest illegally delayed generic competition. The settlement does not recognize any wrongdoing and resolves litigation that was scheduled to go to trial this week. Plaintiffs
Drugs
FDA has approved a Melinta Therapeutics supplemental NDA for Baxdela (delafloxacin) for treating adult patients with community-acquired bacterial pneumonia caused by designated susceptible bacteria. Approval was based on data from a Phase 3 study that compared Baxdela to moxifloxacin. The study results demonstrated that Baxdela met all key primary
Drugs
FDA has authorized NuCana to begin a Phase 3 study (nutide:121) of the investigational drug Acelarin in combination with cisplatin for patients with previously untreated locally advanced or metastatic biliary tract cancer. The 828-patient study will randomize patients to receive either a combination of Acelarin plus cisplatin or
Drugs
Harvard Medical School researchers say that publicly supported research was central to the development of at least 25% of all new drugs approved by FDA between 2008 and 2017. Writing in the BMJ, the researchers say that the public support came either through direct contributions to drug development or through
Drugs
FDA acting commissioner Ned Sharpless says one of the agency’s focuses in 2019 has been to implement the Substance Use-Disorder that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) that passed 10/24/18. The bill gave the agency new authorities to advance efforts
Drugs
FDA says it is releasing a second liquid chromatography-mass spectrometry method for use in detecting and quantifying NDMA in ranitidine. The agency also announced two ranitidine recalls. An agency statement says FDA is using the new method to test potential NDMA-containing ranitidine samples. The method uses a more
Drugs
FDA acting commissioner Ned Sharpless and CDER director Janet Woodcock say the agency has taken steps to clarify its risk-based enforcement approach to drug products labeled as homeopathic. In a statement, Sharpless and Woodcock say FDA has revised its 2017 draft guidance to give additional information on the risk-