EMA Panel Backs Netarsudil for Elevated Intraocular Pressure

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorization for netarsudil ophthalmic solution 0.02% (Rhokiinsa; Aerie Pharmaceuticals) for the treatment of adults with glaucoma or ocular hypertension. The full indication is “reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension.” Netarsudil is a Rho kinase inhibitor …

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EMA Panel Backs Anesthetic Spray for Premature Ejaculation

At its September meeting, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended approval of a new treatment to address premature ejaculation in adult men. The product, called Senstend (Plethora Pharma Solutions Ltd), is a spray solution containing lidocaine and prilocaine. Lidocaine and prilocaine block the transmission of nerve impulses in the glans of …

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EMA Panel Backs Belimumab for Children With Lupus

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended extending the indication for intravenous (IV) belimumab (Benlysta, GlaxoSmithKline [Ireland] Limited) to include add-on therapy in children aged 5 years or older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity despite standard therapy. If the European Commission approves belimumab, this will …

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Too few pregnant women get exercise advice from doctors, study finds

(Reuters Health) – Only one in two pregnant women in an Australian survey said their healthcare practitioner had advised them about exercising, and more than half of these women had to raise the topic themselves, researchers found. Healthcare practitioners “are uniquely positioned” to advise women about exercise during pregnancy, the study team writes in the journal Women and Birth, but …

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EU Panel Votes to Expand Dulaglutide Indication Based on REWIND

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended updating the indication (and label) for dulaglutide (Trulicity, Lilly) to include results of the REWIND cardiovascular outcomes trial, which showed a 12% reduction in risk for major adverse cardiovascular events (MACE). The CHMP has recommended updating the dulaglutide indication to reflect “both glycemic control and the …

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MS Risk Nearly Doubles 15 Years Following Teen Concussion

STOCKHOLM — People who experience a concussion during adolescence are at significantly elevated risk for multiple sclerosis (MS) later in life, especially 15 years or more following their head trauma, a large retrospective study suggests. This risk for developing MS over time nearly doubled in this population compared with people without a history of concussion. “We also found a significantly …

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Adding Patiromer Allows More Spironolactone in Resistant HTN, CKD

PHILADELPHIA — Adding a potassium-sequestering agent to spironolactone in patients with treatment-resistant hypertension (HTN) and chronic kidney disease (CKD) may allow them to take more of the blood pressure (BP) med for a longer time, but with a lower risk for hyperkalemia, suggests a randomized trial. That was apparent in the study, called AMBER, regardless of whether the patients were …

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Warm freshwater can harbor dangerous parasite

People who swim in warm freshwater lakes, ponds and hot springs should do their best to avoid getting water up their nose because it could transmit a deadly parasite, a U.S. case report suggests. Typically, the infection occurs when water enters the nose, and the ameba migrates from the nose to the brain. It destroys brain tissue and causes brain …

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FDA OKs Packaging for OTC Loperamide to Help Stem Misuse, Abuse

In its ongoing effort to stem misuse and abuse of loperamide (Imodium, Johnson & Johnson), the US Food and Drug Administration (FDA) has approved changes to the packaging for brand-name, over-the-counter (OTC) tablet and capsule formulations of the opioid-based antidiarrheal medication. The changes to Imodium A-D, Imodium Multi-Symptom Relief, and Be Health Loperamide HCl Capsules limit each carton to no …

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Obesity, drinking and unhealthy diet add to gout risk

(Reuters Health) – Behavior changes could potentially reduce a large part of the risk for developing gout, a U.S. study suggests. Based on data from more than 14,000 people, researchers calculated how much factors like being overweight, following a diet that isn’t heart-healthy, drinking alcohol or taking water pills known as diuretics contribute to high levels of uric acid, known …

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Walmart to stop sales of e-cigarettes in U.S. stores: company memo

WASHINGTON (Reuters) – Walmart Inc (WMT.N) told staff on Friday it was discontinuing the sale of e-cigarettes and electronic nicotine delivery products at its U.S. stores. FILE PHOTO: Walmart’s logo is seen outside one of the stores in Chicago, Illinois, U.S., November 20, 2018. REUTERS/Kamil Krzaczynski In an internal memo seen by Reuters, the retailer said growing federal, state and …

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FDA Expands Indications for Pifeltro and Delstrigo for HIV

The US Food and Drug Administration (FDA) expanded the indications for two HIV drugs to include appropriate patients with HIV-1 who are virologically suppressed, according to a company news release. The indications were expanded for doravirine (Pifeltro, Merck) in combination with other antiretroviral agents and for doravirine/lamivudine/tenofovir disoproxil fumarate (Delstrigo, Merck) as a complete regimen. “Thanks to developments in HIV …

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New Drug Pricing Bill Allows Negotiation With Pharma

WASHINGTON — US House Speaker Nancy Pelosi (D-CA) is championing a bill to reduce drugs prices that would let Medicare negotiate directly with drugmakers on the prices of certain costly medicines, including insulin. Republicans long have objected to the idea of direct Medicare bargaining with drugmakers. Members of the two parties certainly will spar over this provision when a House …

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Trump Executive Order Aims to Speed Flu Vaccine Development

President Donald J. Trump has issued an executive order that aims to encourage development of seasonal and pandemic influenza vaccines that are more effective and can be made more quickly than current vaccines. The order also establishes a new task force charged with developing a solid plan to modernize US flu vaccine production, which has largely relied on a decades-old, …

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Walmart to stop sales of electronic cigarettes in its U.S. stores: company memo

FILE PHOTO: Walmart’s logo is seen outside one of the stores in Chicago, Illinois, U.S., November 20, 2018. REUTERS/Kamil Krzaczynski WASHINGTON (Reuters) – Walmart Inc (WMT.N) on Friday sent an internal memo to its staff saying the retailer will discontinue the sale of e-cigarettes and electronic nicotine delivery products at its U.S. stores. The retailer said growing federal, state and …

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Drug and medical suppliers say Brexit freight plans needed urgently

LONDON (Reuters) – Makers and suppliers of life-saving drugs and medical devices say they have still not been told by British authorities how their goods will be handled if the UK leaves the European Union without a deal at the end of October. FILE PHOTO: Illustration photo shows various medicine pills in their original packaging in Brussels, Belgium August 9, …

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FDA OKs ‘Game-Changer’ Oral GLP-1 Agonist for Type 2 Diabetes

The US Food and Drug Administration has approved oral semaglutide (Rybelsus, Novo Nordisk), 7 mg and 14 mg, for the treatment of type 2 diabetes in adults to improve glycemic control along with diet and exercise. The once-weekly injectable version of the long-acting glucagon-like peptide–1 (GLP-1) receptor agonist (Ozempic, Novo Nordisk) was approved in December 2017. “It’s going to be a …

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U.S. senators urge FDA to remove pod, cartridge-based e-cigarettes from market

WASHINGTON (Reuters) – A bipartisan group of U.S. senators on Friday urged federal regulators to immediately remove all pod and cartridge-based e-cigarettes from the market until it can be proven the products are safe. FILE PHOTO: A man uses a vape device in this illustration picture, September 19, 2019. REUTERS/Adnan Abisi/Illustration In a letter to Ned Sharpless, acting commissioner of …

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