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Monthly News Roundup - September 2017
Posted 3 weeks ago in Pharma Industry News
FDA Approves Lilly’s Verzenio: Targeted Breast Cancer Treatment Lilly’s Verzenio (abemaciclib), a CDK 4/6 inhibitor breast cancer treatment, has been FDA-approved. Verzenio is used in 2 patient populations: either with fulvestrant (Faslodex) in patients with HR-positive, HER2-negative advanced or metastatic breast cancer that progressed after endocrine therapy; or as monotherapy for patients who previously received endocrine therapy and chemotherapy. In combination with fulvestrant, the med...
Read moreFDA Improves Access to Reports of Adverse Drug Reactions
Posted 3 weeks ago in Pharma Industry News
September 28, 2017 -- The U.S. Food and Drug Administration today launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information. "Tools like the FDA Adverse Event Reporting System are critical to the FDA’s ability to help ensure the greatest level of transparency ...
Read moreFDA Approves First Continuous Glucose Monitoring System for Adults Not Requiring Blood Sample Calibration
Posted 3 weeks ago in Pharma Industry News
September 27, 2017 -- The U.S. Food and Drug Administration today approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using a blood sample from the fingertip (often referred to as a “fingerstick”). The system reduces the need for fingerstick testing by using a small sensor wire inserted below the skin’s surface that continuously measures and monit...
Read moreFDA Conducts Major Global Operation to Protect Consumers From Potentially Dangerous Prescription Drugs Sold Online
Posted 3 weeks ago in Pharma Industry News
September 25, 2017 -- The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics and injectable epinephrine products to American consumers. These actions were part of a major global operation that the FDA participated in to target illegal drugs being marketed online,...
Read moreTeva Announces Reintroduction of Generic Depo-Provera in the United States
Posted 4 weeks ago in Pharma Industry News
JERUSALEM--(BUSINESS WIRE)--Sep. 25, 2017-- Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) today announced the reintroduction of the generic equivalent to Depo-Provera1 Contraceptive Injection (medroxyprogesterone acetate injectable suspension, USP) 150 mg/mL, in the United States. Medroxyprogesterone acetate injectable suspension is a progestin indicated only for the prevention of pregnancy. “This reintroduction brings an additional product to a market that was previously lacking in o...
Read moreCriminal and Civil Actions Filed Against Aegerion Pharmaceuticals Inc.
Posted 4 weeks ago in Pharma Industry News
September 22, 2017 -- Today, Aegerion Pharmaceuticals Inc. agreed to plead guilty in the United States District Court for the District of Massachusetts to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) involving the introduction of misbranded Juxtapid (lomitapide) into interstate commerce. In connection with this agreement, the criminal information filed today charged that Juxtapid was misbranded because Aegerion failed to comply with the requirements of...
Read moreMonthly News Roundup - August 2017
Posted 7 weeks ago in Pharma Industry News
Kymriah from Novartis Approved as First U.S. CAR-T Cell Therapy History was made this month as the U.S. Food and Drug Administration (FDA) approved the first U.S. cell-based gene therapy known collectively as chimeric antigen receptor (CAR) T-cell therapy. Kymriah (tisagenlecleucel or CTL019) from Novartis was approved for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Kymriah is a...
Read moreFDA provides new tools for the development and proper evaluation of tests for detecting Zika virus infection
Posted 9 weeks ago in Pharma Industry News
August 17, 2017 -- As an additional measure in the fight against Zika virus, today the U.S. Food and Drug Administration announced that it has made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to detect recent Zika virus infection. “At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they w...
Read moreFDA Warns of Potential Contamination in Multiple Brands of Drugs, Dietary Supplements
Posted 10 weeks ago in Pharma Industry News
August 11, 2017 -- The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands, due to potential contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for severe patient infection. The drug and dietary supplement products made by PharmaTech include liquid...
Read moreMonthly News Roundup - July 2017
Posted 12 weeks ago in Pharma Industry News
FDA Approves Gilead’s Vosevi for Six Hepatitis C Genotypes The U.S. Food and Drug Administration (FDA) has approved Gilead’s Vosevi (sofosbuvir, velpatasvir and voxilaprevir) for retreatment of adults with chronic hepatitis C virus (HCV) of two types: either genotype 1, 2, 3, 4, 5, or 6 previously treated with an NS5A inhibitor regimen, or genotype 1a or 4 previously treated with a sofosbuvir regimen without an NS5A inhibitor. Vosevi, given once daily, is used in patients without cirrhosis or...
Read moreFDA Clears First Neonatal Magnetic Resonance Imaging Device
Posted 13 weeks ago in Pharma Industry News
July 20, 2017 -- Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU). “Although we can use traditional MRI scanners to image neonates, taking babies outside of the neonatal intensive care unit to MRI suites presents great challenges,” said Vasum Peiris, M.D., M.P.H., chief medical officer for pediatrics and special populations at FDA’s Center for Devices an...
Read moreEndo Provides Update On Opana ER
Posted 15 weeks ago in Pharma Industry News
DUBLIN, July 6, 2017 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER (oxymorphone hydrochloride extended release) when used as intended, and notes that the Company has taken significant steps over the years to combat misuse and abuse. Nevertheless, after careful consideration and consultation with the FDA following the FDA's June 2017 withdrawal request, the Company has decided to voluntarily...
Read moreFDA Clears Expanded Use of Cooling Cap to Reduce Hair Loss During Chemotherapy
Posted 16 weeks ago in Pharma Industry News
July 3, 2017 -- Today, the U.S. Food and Drug Administration cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors. “We are pleased to expand the use of this product for cancer patients with solid tumors to potentially minimize chemotherapy-induced hair loss,” said Binita Ashar, M.D., director, Division of Surgical Devices, in the F...
Read moreMonthly News Roundup - June 2017
Posted 16 weeks ago in Pharma Industry News
New Fluoroquinolone Baxdela Approved for Certain Skin Infections Roughly 3 million patients are hospitalized each year in the U.S. with acute bacterial skin and skin structure infections (ABSSSIs), some of which may be difficult-to-treat and show antibiotic resistance. In response, the FDA has approved Baxdela (delafloxacin), an oral and intravenous (IV) fluoroquinolone antibiotic. Baxdela targets both gram-positive and gram-negative bacteria, including the serious pathogen MRSA...
Read moreFDA Allows Marketing of Test to Aid in the Detection of Certain Leukemias and Lymphomas
Posted 16 weeks ago in Pharma Industry News
June 29, 2017 -- The U.S. Food and Drug Administration today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN). “This represents a major step forward for the hematology-oncology community,” said Alberto Gutierrez, Ph....
Read moreFDA Unveils Plan to Eliminate Orphan Designation Backlog
Posted 16 weeks ago in Pharma Industry News
June 29, 2017 -- Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to eliminating the backlog within 90 days and responding to all new requests for designation within 90 days of receipt during his testimony bef...
Read moreFDA Tackles Drug Competition to Improve Patient Access
Posted 16 weeks ago in Pharma Industry News
June 27, 2017 -- Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented, for the first time, a new policy to expedite the review of generic drug applications where competition is limited. These actions are among the first taken under the...
Read moreSonar Products Ordered to Cease Operations, Stratus Pharmaceuticals Ordered to Cease Distributing Unapproved Drugs
Posted 18 weeks ago in Pharma Industry News
June 15, 2017 -- Today, U.S. District Judge Kathleen M. Williams for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Stratus Pharmaceuticals Inc. of Miami, Florida, Sonar Products Inc. of Carlstadt, New Jersey and two of the companies’ officers, Alberto Hoyo and Juan Carlos Billoch. According to the complaint filed with the consent decree, Stratus and Sonar routinely shipped unapproved, improperly labeled (misbranded), and s...
Read moreFDA Requests Removal of Opana ER for Risks Related to Abuse
Posted 19 weeks ago in Pharma Industry News
June 8, 2017 -- Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of...
Read moreFDA Approves First Generic Truvada for HIV Infection and Pre-Exposure Prophylaxis (PrEP)
Posted 19 weeks ago in Pharma Industry News
June 8, 2017 - The U.S. Food and Drug Administration has approved the first generic version of Truvada for the treatment of HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually-acquired HIV infection in adults at high risk. PrEP may be part of a comprehensive HIV prevention strategy that includes safer sex practices, such as consistent and correct condom use, regular HIV testing and risk...
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