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In the News: October Regulatory and Development Updates

Camargo

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

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China Opens the Door to Personal Medicine Imports and Third-Party Online Platform Sales

Pharmacy Checkers

A new Chinese law (in effect as of December 1, 2019) makes third-party online platform medicine sales legal, appropriately ends a draconian definition of counterfeit drugs, and effectively decriminalizes personal drug importation, but with a lot of gray! Buying Drugs Online from Retail Platforms is Legal.

Sales 64
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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

In the case of Novartis’ antihypertensive drug Exforge (amlodipine and valsartan), retail pharmacies including CVS, Walgreens, and two other plaintiff groups accused Novartis and Endo International’s Par Pharmaceutical unit of forming an illegal “reverse payment” agreement to delay the launch of less expensive generic versions of the drug.

Doctors 242
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Pharming preps filing for rare disease drug leniolisib after trial win

pharmaphorum

The Netherlands biotech is developing leniolisib (formerly CDZ173) under license from Novartis for activated PI3K delta syndrome (APDS), an ultra-rare disease with no approved therapies that causes severe immune deficiency and a risk of blood cancers.

Trials 52
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Update: FDA clears first generic of AZ’s blockbuster Symbicort

pharmaphorum

Viatris’ generic of Symbicort (budesonide and formoterol fumarate dihydrate) – developed by Viatris in collaboration with 3M spin-off company Kindeva Drug Delivery and called Breyna – has been cleared for the same indications as the brand, namely maintenance treatment for asthma and chronic obstructive pulmonary disease (COPD).

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Buscopan vs Mebeverine | OTC IBS treatment

Druggist

Buscopan vs Mebeverine over the counter availability and age restrictions The table below summarises over the counter availability of both drugs and age restrictions associated with each brand. General sale medicines (GSL) can be sold in any retail outlets, commonly sold in supermarkets (e.g. Buy on Amazon Price incl.

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Investing In The U.S. Health System By Lowering Drug Prices, Reducing, Out-of-Pocket Costs and Improving the Medicare Benefit

Pharmacy Checkers

Our niche is comparative pricing and the proper credentialing of international online pharmacies, which process prescription drug orders filled by licensed pharmacies in several countries, require valid prescriptions, and do not ship controlled drugs into the U.S. sales prices. Methodology.