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19:50 EST 9th December 2018 | BioPortfolio

Common Technical Document: 2-Day Course (London, United Kingdom – December 4-5, 2019) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Common Technical Document” conference has been added to ResearchAndMarkets.com’s offering. This two-day course will provide you with a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets … Continue reading →

$CELG - Umer Raffat believes dividend being considered, and he likes it b/c will help assuage concerns about cash flows after generic Revlimid. Is dividend the answer to Celgene’s stock woes? Mgmt tried M&A, but investors don’t like the results, so fa

$CELG - Umer Raffat believes dividend being considered, and he likes it b/c will help assuage concerns about cash flows after generic Revlimid. Is dividend the answer to Celgene’s stock woes? Mgmt tried M&A, but investors don’t like the results, so far.

Generic Drugmaker to Sell Alternative to EpiPen Injectors

NewsSandoz will sell prefilled syringes with the same medicine, the hormone epinephrine, under the name Symjepi. The price will be $250 for two, without insurance.

Mallinckrodt Plans Spin-Off of Specialty Generics Business to Shareholders

NewsThe transaction is expected to create two companies — one focused on specialty brands, the other on niche specialty generic products and API manufacturing.

Way cleared in US for Suboxone and Zytiga generics

The US Court of Appeals is clearing the way for generics competitors to enter the market. The court has lifted an injunction on Dr Reddy’s Suboxone (buprenorphine/naloxone) generic and upheld a decision to invalidate Johnson & Johnson’s (J&J) patent on its blockbuster prostate cancer drug Zytiga (abiraterone).

Mallinckrodt splitting into 2 with generic spin-off plan

A spin-out generics maker based in St. Louis will keep the Mallinckrodt name in the company's plan to establish two independent, publicly traded pharmas.

Vitruvias Therapeutics Inc., Licenses Potassium Chloride ER ANDA (10 and 20 mEq) Capsules to Be Manufactured at Bora Pharmaceutical’s New Zhunan Facility in Taiwan

Vitruvias Therapeutics Inc., an Auburn, Alabama-based finished-dose generic drug development company, has agreed to license an approved Potassium Chloride Extended release ANDA. The product will be manufactured by Bora Pharmaceutical’s Zhunan site, which was recently acquired from Impax. This press release features multimedia. View the full release here: ...

Mylan Expands Gastroenterology Portfolio With Generic for Prevacid Tablets

NewsMylan's Lansoprazole delayed-release orally disintegrating tablets are approved to treat certain types of gastrointestinal ulcers.

Sol-Gel Technologies Announces Sixth Agreement for a Generic Product Candidate with Perrigo

NESS ZIONA, Israel, Dec. 04, 2018 (GLOBE NEWSWIRE) — Sol-Gel Technologies Ltd. (NASDAQ: SLGL) (“Sol-Gel” or the “Company”), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today … Continue reading →

Intalere’s Enhanced Generic Injectable Pharmaceutical Sourcing Strategy Brings Members More than 11% in Savings in 2018

Intalere, the healthcare industry leader in delivering optimal cost, quality and clinical outcomes, today announced its enhanced generic injectable pharmaceutical sourcing strategy, built around a highly dynamic real-time model, has helped to optimize market opportunities for members, driving more than 11 percent in members savings. ST. LOUIS (PRWEB) December 03, 2018 Intalere, the healthcare ind...

Patent litigation over Dr. Reddy’s Suboxone generic continues

The US Court of Appeals for the Federal Circuit removed the injunction against Dr. Reddyâs, which prevented the company from selling its Suboxone generic.

Vitruvias Therapeutics Inc., and Sunny Pharmtech Inc., Announce the FDA Approval of Generic Aminocaproic Acid 500 mg and 1000 mg Tablets

Sunny Pharmtech, Inc., a Taiwan-based API and finished-dose drug development company, and Vitruvius Therapeutics Inc., an Auburn, Alabama-based generic drug company announced today that their Abbreviated New Drug Application (“ANDA”) for Aminocaproic Acid Tablets 500 mg and 1000 mg tablets has received final approval from the U.S. Food and Drug Adminis...

Lupin launches generic nystatin, triamcinolone acetonide cream

FDA approves more generics in 2018 than any other year

The US Food and Drug Administration (FDA) approved 971 generics in 2018, more than in any previous year, according to the Activities Report of the Generic Drug Program (FY 2018).

Dr. Reddy’s launches generic chlorthalidone tablets

First generic EpiPen enters the market at half the cost

Tevaâs EpiPen generic will reach market at a cost of $300 per pack, which matches the price of Mylanâs own generic version.

Teva’s Generic Version of EpiPen Now Available in the United States

NewsLimited doses of the FDA-approved generic version of EpiPen will be available at a Wholesale Acquisition Cost of $300.

Antares’ Device Aids Teva’s Generic EpiPen Launch

The EpiPen and this generic equivalent are indicated for the emergency treatment of severe allergic reactions. The post Antares’ Device Aids Teva’s Generic EpiPen Launch appeared first on Investing News Network.

Perrigo launches generic Solaraze gel

J&J receives fresh blow to protect Zytiga against generic entry

US Court of Appeals knocked down J&Jâs efforts to block manufacturers producing generic versions of its product, Zytiga.

FDA approves Akorn’s generic Voltaren gel

Teva launches generic version of EpiPen auto-injector in US

Teva’s generic version of the EpiPen Jr (epinephrine injection, USP) Auto-Injector, 0.15 mg, and an additional supply of Teva’s generic version of the EpiPen (epinephrine injection, USP) auto-Injector, The post Teva launches generic version of EpiPen auto-injector in US appeared first on Compelo Medical Devices.

Teva begins selling generic EpiPen

The treatment for life-threatening allergies has been the flagship branded drug of Mylan, Teva's generic pharmaceutical rival.

Teva launches EpiPen generic at same price as Mylan's version

The copycat's entry could be a threat to Mylan, though limited supply may hamper the commercial impact. 

Antares Pharma Partner Teva Announces Commercial Availability of Generic Epipen

Antares Pharma (NASDAQ:ATRS) announced that Teva Pharmaceutical Industries generic EpiPen is now commercially available in limited quantities. As quoted in the press release: Teva’s generic EpiPen® was approved by the U.S. Food and Drug Administration (“FDA”) on August 16, 2018 and is indicated for emergency treatment of severe allergic reactions including those that are life threatening ...

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