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Check Contract Manufacturers' GMP Compliance, US FDA Warns Eye Drop Firm, Lip Balm Provider

 

Request to recall eye drops should be fulfilled promptly and businesses providing lip balms as promotional products must verify contract manufacturers are compliant, recent FDA warnings states. Additional letters went to Jordanian firm about testing alcohol for methane and to a Chinese firm advised that compliance with China’s quality control standards isn’t sufficient.

Eye Drop Production Sterility Problems Bring Reason For US FDA Guidance Into Sharper Focus

 

Since FDA provided draft guidance on quality considerations for ophthalmic drugs, steady stream has continued of OTC brand recalls due to manufacturers’ failure to ensure sterility in production processes and purity of ingredients and other components.

Futura Strikes Deal To Commercialize Erectile Dysfunction Gel In Middle East

 
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UK R&D firm Futura Medical strikes third commercial agreement for its drug-free erectile dysfunction treatment MED3000, this time with Switzerland’s Labatec Pharma, which will take the drug-free gel to the Middle East. 

Hikma Prepares For Push Into MENA Oncology Biologics Market

 
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Having enjoyed some success in the Middle East and North Africa region with its Remsima infliximab biosimilar for autoimmune disorders, Hikma is lining up launches of both rituximab and trastuzumab into the region’s oncology arena.

MS Pharma Acquires Genepharm In Expansion Push

 
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MS Pharma, a leading generics company in the Middle East, has announced an agreement to acquire Greece-based Genepharm as part of an expansion drive into Europe and farther afield.

How Middle Eastern Markets Are Transforming Drug Reviews And Driving Competitiveness

 

The UAE, Jordan, Egypt and Saudi Arabia have all recently announced or implemented new verification/abridged regulatory pathways to improve access to medicines and free up resources.

FDA Posts Investigator In Singapore, But Trims Foreign Office List

 

FDA's Office of International Programs consolidates its China offices to "strategically focus its resources." FDA shifts away from primarily a domestic focus to global as drug criminal organizations spread globally

Celebrations at the 11th Annual Scrip Awards

What a year it has been for the pharma and biotech industries, and there was no better way to celebrate your achievements than at last night's 11th annual Scrip Awards in London.

Weekly Trademark Review July 28, 2015

OTC drug, personal care product and nutritional supplement trademark filings compiled by “The Tan Sheet” from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.

Weekly Trademark Review July 28, 2015

OTC drug, personal care product and nutritional supplement trademark filings compiled by “The Tan Sheet” from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.

Cynapsus up on PD results

 
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Patent 'superpowers' time limits upheld: biopharma implications

 
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While a 22 June US Supreme Court ruling that was peppered with Spider-Man puns may have provided some comic relief to legal watchers – although the loser in Kimble v Marvel likely didn't find much to laugh about – the case may help patent holders and those that enter into licensing rights deals, including biopharmaceutical makers, better understand and be more aware of a nearly half-century old case law rule.

Weekly Trademark Review May 12, 2015

OTC drug, personal care product and nutritional supplement trademark filings compiled by “The Tan Sheet” from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.

Glaxo/Novartis JV Wields ‘Power’ Brands, Switches To Spearhead Global Growth

 

Glaxo prioritizes seven “power” brands globally and also will invest in boosting sales of 12 “core” brands in its consumer JV with Novartis, says division head Emma Walmsley. The combination of the two firms’ consumer products puts the JV atop the OTC/wellness market in 36 countries.

Glaxo/Novartis JV Wields ‘Power’ Brands, Switches To Spearhead Global Growth

 

Glaxo prioritizes seven “power” brands globally and also will invest in boosting sales of 12 “core” brands in its consumer JV with Novartis, says division head Emma Walmsley. The combination of the two firms’ consumer products puts the JV atop the OTC/wellness market in 36 countries.

Postage Due: FDA Stamps Enforcement On Spiked Supplement Found In International Shipments

 

Most products identified in public notifications contain weight loss or ED drugs, but two contained fluoxetine, for treating depression, bulimia and obsessive-compulsive, panic and premenstrual dysphonic disorders. Using personal mail for commercial shipments is some importers only chance of getting products in the U.S.

Postage Due: FDA Stamps Enforcement On Spiked Supplement Found In International Shipments

 

Most products identified in public notifications contain weight loss or ED drugs, but two contained fluoxetine, for treating depression, bulimia and obsessive-compulsive, panic and premenstrual dysphonic disorders. Using personal mail for commercial shipments is some importers only chance of getting products in the U.S.

FDA Recalls For Nov. 12, 2014

Recalls reported by FDA for OTC drugs, nutritionals and personal care products.

FDA Recalls For Nov. 12, 2014

Recalls reported by FDA for OTC drugs, nutritionals and personal care products.

Hikma Should Revisit Investigations, FDA Warning Says

 
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Continued problems at a Portuguese plant have prompted the U.S. FDA to urge Hikma to make a global reassessment of its manufacturing processes.

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