Skip to Content

Pharmaceutical Industry News

Monthly News Roundup - December 2017

Posted 2 weeks ago in Pharma Industry News

Luxturna Gene Therapy OK’d for Rare Form of Vision Loss A historic approval, Luxturna (voretigene neparvovec-rzyl) from Spark Therapeutics is the first directly administered gene therapy that targets a disease caused by specific gene mutations. In December the U.S. Food and Drug Administration (FDA) approved Luxturna, used in patients with biallelic RPE65-mediated inherited retinal disease (IRD), a form of vision loss that can lead to blindness. Luxturna is an adeno-associated viral (AAV) v...

Read more

FDA Permits Marketing of Device to Treat Diabetic Foot Ulcers

Posted 2 weeks ago in Pharma Industry News

Today, the Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers. “Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health. “The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases. Additional options for success...

Read more

FDA Clears Stereotactic Radiotherapy System for Use in Treating Breast Cancer

Posted 3 weeks ago in Pharma Industry News

December 22, 2017 -- Today, the U.S. Food and Drug Administration cleared a new noninvasive stereotactic radiotherapy system intended for use in treating cancer in breast tissue. “With today’s clearance, patients will have access to a treatment option that provides greater accuracy in delivering radiation therapy to breast tumors while saving surrounding breast tissue,” said Robert Ochs, Ph.D., acting deputy director for radiological health in the Office of In Vitro Diagnostics and Radio...

Read more

FDA Proposes New, Risk-Based Enforcement Priorities to Protect Consumers from Potentially Harmful, Unproven Homeopathic Drugs

Posted 4 weeks ago in Pharma Industry News

Today, the Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as h...

Read more

FDA Launches New Tool for Sharing Information That Allows Doctors to Better Manage Antibiotic Use

Posted 4 weeks ago in Pharma Industry News

Today the Food and Drug Administration is announcing a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to combat antimicrobial resistance. The agency created a website that will provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug. This approach is intended to aid health care professionals in making more informed prescribing...

Read more

FDA Warns Companies for Promoting Alternatives to Street Drugs

Posted 5 weeks ago in Pharma Industry News

December 12, 2017 -- The U.S. Food and Drug Administration today posted a warning letter to the marketers and distributors of Legal Lean Syrup, a drink, and Coco Loko, a “snortable” chocolate powder, for selling unapproved new drugs and misbranded drugs. The warning letter explains how the claims made in the promotional materials for Legal Lean Syrup and Coco Loko demonstrate that the products are intended to be used as alternatives to illicit street drugs and that the products, as labeled and ...

Read more

Monthly News Roundup - November 2017

Posted 6 weeks ago in Pharma Industry News

FDA Approves Juluca, a Novel 2-Drug Regimen for HIV-1 Infection In November, the U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Juluca (dolutegravir and rilpivirine), a single-tablet, two-drug regimen of dolutegravir (Tivicay) and rilpivirine (Edurant). Juluca is the first complete treatment regimen containing only two drugs, instead of three or more, for HIV maintenance. Juluca is used in certain adults with suppressed HIV-1 virus on a stable medication regimen for at l...

Read more

FDA Grants Marketing Authorization of the First Device for Use in Helping to Reduce the Symptoms of Opioid Withdrawal

Posted 8 weeks ago in Pharma Industry News

November 15, 2017 -- Today, the U.S. Food and Drug Administration granted a new indication to an electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal. “Given the scope of the epidemic of opioid addiction, we need to find innovative new ways to help those currently addicted live lives of sobriety with the assistance of medically assisted treatment. There are three approved drugs for helping treat opioid addiction. While we continue to pursue better m...

Read more

FDA Warns Companies Marketing Unproven Products, Derived From Marijuana, that Claim to Treat or Cure Cancer

Posted 10 weeks ago in Pharma Industry News

November 1, 2017 -- As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency today issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes. Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act, but also can put patients at risk as t...

Read more

Monthly News Roundup - October 2017

Posted 11 weeks ago in Pharma Industry News

Yescarta CAR T-Cell Therapy Approved for Lymphoma Novel chimeric antigen receptor T cell (CAR T) therapy allows patients with certain blood cancers -- but limited treatment options -- to achieve remission. The U.S. Food and Drug Administration (FDA) has cleared Kite Pharma/Gilead’s Yescarta (axicabtagene ciloleucel), the first CAR T-cell treatment for adults with large B-cell lymphoma after failing at least two other treatments. The patient’s T-cells, a white blood cell type, is genetically m...

Read more

Monthly News Roundup - September 2017

Posted 15 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 more

FDA Improves Access to Reports of Adverse Drug Reactions

Posted 15 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 more

FDA Approves First Continuous Glucose Monitoring System for Adults Not Requiring Blood Sample Calibration

Posted 16 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 more

FDA Conducts Major Global Operation to Protect Consumers From Potentially Dangerous Prescription Drugs Sold Online

Posted 16 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 more

Teva Announces Reintroduction of Generic Depo-Provera in the United States

Posted 16 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 more

Criminal and Civil Actions Filed Against Aegerion Pharmaceuticals Inc.

Posted 16 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 more

Monthly News Roundup - August 2017

Posted 19 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 more

FDA provides new tools for the development and proper evaluation of tests for detecting Zika virus infection

Posted 21 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 more

FDA Warns of Potential Contamination in Multiple Brands of Drugs, Dietary Supplements

Posted 22 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 more

Monthly News Roundup - July 2017

Posted 24 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 more
Older articles

Pharma Industry News Archive