Drugs
A study funded by Pharmaceutical Research and Manufacturers of America says that it is a misconception that manufacturers retain the vast majority of drug spending. In fact, the study says, despite absolute growth in brand medicine spending at the point of sale, which increased from $354 billion in 2015 to
Drugs
FDA says Appco Pharma and Denton Pharma (doing business as Northwind Pharmaceuticals) are recalling prescription ranitidine (Zantac) tablets because they may contain unacceptable levels of N-nitrosodimethylamine (NDMA). An agency recall notice says FDA has advised companies to recall ranitidine if testing shows NDMA levels above the acceptable daily intake
Drugs
Regeneron says results from the LUMINA-1 Phase 2 trial of its garetosmab in 44 patients with fibrodysplasia ossificans progressiva (FOP) showed about a 25% decrease in total bone lesions (new and existing) driven by a nearly 90% reduction in the formation of new lesions. A company statement says Regeneron
Drugs
FDA has approved a Blueprint Medicines NDA for Ayvakit (avapritinib) for treating adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) that have a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. Ayvakit is a kinase inhibitor, which blocks a type of enzyme called a kinase and helps
Drugs
Blueprint Medicines says it has begun a rolling NDA submission for pralsetinib after reporting top-line data from a pralsetinib study in patients with RET fusion-positive non-small cell lung cancer (NSCLC). The ongoing Phase 1/2 ARROW clinical trial showed a 61% objective response rate (ORR) and prolonged
Drugs
Two Recipharm staffers say a quality by design (QbD) approach to drug manufacturing “will become of greater importance as forward-thinking companies look to boost their production capabilities, reduce throughput times, and adopt more continuous manufacturing processes.” Writing in a Pharma Manufacturing online post, the authors say QbD “uses a
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) for treating patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Approval was based on data
Drugs
A Genetic Engineering and Biotechnology online post says that the CDER Emerging Technology Program is helping biotechnology and pharmaceutical companies innovate and still negotiate any regulatory steps as easily as possible. CDER Emerging Technology Team (ETT) director Sau Lee is quoted in the post as saying that the program employs
Drugs
Harvard Medical School researchers say policymakers should examine 25 high-cost drugs they studied to determine why generic or biosimilar versions are not yet on the market and how to take steps to facilitate entry for the benefit of patients and to reduce unnecessary Medicare spending. Writing online in the
Drugs
FDA has approved an Astellas Pharma supplemental NDA for Mycamine (micafungin for injection) for treating candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses without meningoencephalitis or ocular dissemination in pediatric patients younger than four months of age. Approval was based on data from 168 pediatric patients younger than four months
Drugs
ANDAs with citizen petitions had a significantly higher average number of approval days, according to a study by Auburn University researchers published online in Research in Social and Administrative Pharmacy. The article says the researchers looked at 289 ANDAs for 81 drugs submitted between the first quarter of 2008 and
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports FDA efforts to facilitate effective drug development, leveraging rapidly evolving scientific and technological advances to characterize the benefits and risks of a potential product and generate the data necessary to support product approval. Commenting on an FDA docket and
Drugs
An 8/12-8/16/19 FDA inspection at Apollo Health and Beauty Care, North York, Ontario, Canada, a contract manufacturer of over-the-counter drug products, including some labeled for use by children, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 12/23/
Drugs
A CDER report on new drug therapy approvals in 2019 shows that the Center used at least one expedited development and review method to speed approval for 60% of the 48 novel drugs approved in 2019. The report says that 17 of the drugs were designated for fast track approval,
Drugs
Commenting on an FDA 11/7/19 public meeting on opportunities and priorities for the CDER Office of New Drugs (OND) in promoting effective drug development programs, BioMarin says OND should support the practice of review teams and division directors who facilitate open, early, and frequent communication between review staff
Drugs
Emery Pharma, an FDA-registered and inspected laboratory, says the agency should issue a regulation, revise industry guidance, and request a recall and suspension of sales of Zantac (ranitidine) and take other steps in response to an Emery study showing that the ranitidine molecule may not be heat stable and,
Drugs
TransCelerate BioPharma says it appreciates the FDA vision for streamlining the IND safety reporting process through direct submission of IND safety reports to the FDA Adverse Event Reporting System (FAERS) and looks forward to implementation. In a draft guidance comment, the company says that during the 24-month transition period
Drugs
Teva is paying $54 million to resolve whistleblower allegations by two former company sales representatives that it used sham paid speaker programs to increase the use of its Copaxone and Azilect. Allegations in the complaint focused on a scheme to induce physicians to write prescriptions for Copaxone and Azilect by
Drugs
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Apollo Health and Beauty Care Ontario, Canada (12/23): FDA inspected the contract manufacturer of over-the-counter drug products and cited
Drugs
FDA has granted Precigen an orphan drug designation for PRGN-3006, a first-in-class investigational therapy for treating patients with relapsed or refractory acute myeloid leukemia (AML). PRGN-3006 uses Precigen’s UltraCAR-T therapeutic platform, which the company says “eliminates ex vivo expansion, reduces manufacturing time and provides
Drugs
FDA has issued ViiV Healthcare a complete response letter on its NDA for cabotegravir and rilpivirine, a long-acting regimen for treating HIV-1 infection in virologically suppressed adults. The letter cited chemistry manufacturing and controls (CMC) concerns as the reason for not approving the submission, the company says. “There
Drugs
FDA has approved a Novo Nordisk NDA for Fiasp (insulin aspart injection) 100 u/mL as a mealtime insulin option for children with diabetes. The company says Fiasp is the only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation. It is intended to be