Policy & Regulation News

FDA Recommends New Asthma Rescue Treatment

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AstraZeneca and Avillion recently teamed up to develop PT027, an asthma rescue inhaler. PT027 is a pressurized metered-dose inhaler that delivers a fixed dose of two combined asthma medications,...

Novartis Is Losing Its Battle Against a Generic Drug for MS

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On Thursday of last week, the US Supreme Court (SCOTUS) allowed the launch of generic versions of Novartis’s Gilenya, siding with China’s HEC Pharm Co and other pharmaceutical companies...

How Federal and State Laws Have Hindered Access to OUD Treatment

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The opioid epidemic has persisted over the past few decades. Exacerbated by the pharmaceutical industry, this epidemic has left many struggling with opioid use disorder (OUD). Effective treatments for...

FDA Approved Psilocybin Investigational New Drug Application

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Psilocybin has become increasingly popular in pharmaceutical research to treat multiple neurological and mental health conditions. The FDA recently approved an investigational new drug (IND)...

US FDA Accelerated Approval for 48 Non-oncology Drugs

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The FDA approval process is multi-faceted and involves several aspects. One of these aspects is accelerated approval, which is meant to approve drugs to treat severe or fatal diseases. According to a...

Medications in the US Are More Widely Available than in Germany

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A retrospective cohort study was conducted using data from January 1, 2004, to December 31, 2018. The researchers reviewed information from the FDA and the European Medicines Agency (EMA) to determine...

FDA Approved the Use of Omnipod 5 for Children Over 2

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In January 2022, Omnipod 5 was first approved for anyone over six. Omnipod 5 is the first tubeless automated insulin delivery (AID) made available in the United States for a broad age range. Recently,...

FDA Approved AUVELITY for Major Depressive Disorder in Adults

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On August 19, 2022, the FDA approved AUVELITY — an oral medication manufactured by Axsome Therapeutics — for the treatment of major depressive disorder (MDD) in adults. This medication...

FDA Expands Emergency Use Authorization for Novavax COVID Vaccine in Kids

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As the COVID pandemic progresses and infection rates fluctuate, public health officials and organizations seek to provide more options to protect against illness. On August 19, Novavax announced that...

FDA Approves Cell-Based Gene Therapy for Patients with Beta Thalassemia

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On August 17, 2022, the FDA approved bluebird bio's Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy to treat patients with beta thalassemia who need regular red blood...

FDA Considers Dividing Monkeypox Vaccine Doses

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Monkeypox was declared a public health emergency by the WHO on Saturday, July 23, 2022. Since the rise of monkeypox rates, public health organizations have urged at-risk populations to seek...

Update on FDA Review and Enforcement of Non-Tobacco Nicotine Products

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On April 28, 2022, the FDA placed a total ban on all flavored nicotine products in an attempt to reduce the number of nicotine-related diseases and illnesses. Following previous FDA rulings to ban...

FDA Releases Drug Safety Communication regarding Cancer Drug, Copiktra

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On June 30, the FDA released a drug safety communication that warned against the risks associated with Copiktra. Copiktra, also called duvelisib, is a cancer drug used to treat relapsed or...

Antitrust Lawsuit against Generic Pharmaceutical Companies Is Amended

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A Pennsylvania Judge barred plaintiffs in an antitrust lawsuit from recouping substantial financial penalties in their case against a group of pharmaceutical companies. Judge Cynthia Rufe will not...

USPTF Updates Recommendations on Supplements to Prevent Cancer

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The Journal of the American Medical Association recently published an updated recommendation from the USTPF on using vitamins and supplements to prevent cardiovascular disease and cancer. The study...

FDA Expanded Approval of Skyrizi for Treatment of Crohn’s Disease

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The FDA recently approved Skyrizi as a treatment for moderate to severely active Crohn’s disease. Crohn’s disease is an inflammatory bowel disease (IBD) with many painful symptoms that can...

Could the Approval of Albrioza by Health Canada for ALS Impact the FDA Ruling?

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This week, Health Canada announced its approval of Albrioza (created by Amylyx Pharmaceuticals) for the treatment of ALS. It has been the only newly approved treatment for ALS since 2018. The drug is...

FDA Accepts Biologic Application for Keytruda Treatment of Lung Cancer

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The FDA recently accepted Merck’s Biologics License Application (BLA) for its cancer medication Keytruda. Promising results from interim clinical trial data indicated that Keytruda improved...

Bluebird Bio’s Rare Disease Gene Therapies Recommended for FDA Approval

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Last week, the FDA Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) voted 15 – 0, concluding that the benefits of bluebird bio’s gene therapy to treat cerebral...

US FDA Approves GSK’s Priorix Measles, Mumps, and Rubella Vaccine

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Earlier this month, the FDA approved GSK’s Priorix measles, mumps, and rubella (MMR) vaccine in the United States for individuals 12 months and older. MMR vaccines are recommended in a...