Sun Pharmaceutical

e5 Pharma Launches Generic Form of Diazoxide; Approved by FDA

Retrieved on: 
Friday, December 20, 2019

e5 Pharma received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) using the Competitive Generic Therapy (CGT) Pathway.

Key Points: 
  • e5 Pharma received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) using the Competitive Generic Therapy (CGT) Pathway.
  • Chief Executive Officer of e5 Pharma, Bob Edwards, commented, "We are excited to launch our first generic drug designated as a competitive generic therapy.
  • e5 Pharma is a specialty pharmaceutical committed to the development and distribution of generic drugs.
  • Our focus is not necessarily on the development of new molecules, but instead on cost-reducing generic therapies and solutions.

FDA approves first generics of Gilenya

Retrieved on: 
Thursday, December 5, 2019

"Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.

Key Points: 
  • "Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.
  • The FDA has a longstanding commitment to increasing patient access to lower-cost, high-quality generic medicines."
  • MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body.
  • The FDA granted approvals of generic fingolimod applications to HEC Pharm Co. Limited, Biocon Limited and Sun Pharmaceutical Industries Limited.

Karo Pharma Divests Hydrokortison Trimb to Evolan Pharma

Retrieved on: 
Wednesday, November 27, 2019

This was part of the closing conditions for the acquisition of Trimb Holding AB ("Trimb"") in September 2019.

Key Points: 
  • This was part of the closing conditions for the acquisition of Trimb Holding AB ("Trimb"") in September 2019.
  • Karo Pharma has entered into an agreement to divest Hydrokortison Trimb and the intellectual property rights and assets relating thereto to Evolan Pharma AB ("Evolan"), a Swedish pharmaceutical company focused on product development, sales and marketing of pharmaceuticals.
  • The Competition Authority approved Evolan as the buyer of Hydrokortison Trimb on 27 November 2019.
  • The divestment of Hydrokortison Trimb to Evolan is expected to close on 29 November 2019.

MimiVax LLC and Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. announce exclusive licensing agreement on SurVaxM for glioblastoma treatment in China

Retrieved on: 
Monday, November 18, 2019

BUFFALO, N.Y. and SHANGHAI, Nov. 18, 2019 /PRNewswire/ -- MimiVax LLC and Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma Industrial) today announced the companies have entered into a China-exclusive licensing agreement for SurVaxM, a novel anti-cancer immunotherapy in the treatment of glioblastoma brain cancers.

Key Points: 
  • BUFFALO, N.Y. and SHANGHAI, Nov. 18, 2019 /PRNewswire/ -- MimiVax LLC and Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma Industrial) today announced the companies have entered into a China-exclusive licensing agreement for SurVaxM, a novel anti-cancer immunotherapy in the treatment of glioblastoma brain cancers.
  • Fosun Pharma Industrial is a wholly-owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co. Ltd (Fosun Pharma), a leading healthcare group in China with extensive healthcare business interests worldwide.
  • Fosun Pharma will work with MimiVax on the clinical, regulatory and commercial pathways necessary to bring SurVaxM to China.
  • Established in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"; stock code: 600196.SH, 02196.HK) is a leading healthcare group in the PRC.

Two Day Project Management for Pharma Professionals Course Specifically for the Bio/Pharma Industry: London, United Kingdom - December 9th-10th, 2019

Retrieved on: 
Tuesday, August 13, 2019

What is a Project / Project Management in the Bio/Pharma Industry?

Key Points: 

What is a Project / Project Management in the Bio/Pharma Industry?
Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Sun Pharma Launches Ready-to-Infuse INFUGEM in the U.S.

Retrieved on: 
Monday, April 8, 2019

INFUGEM is the only available gemcitabine formulation that does not require reconstitution and syringe withdrawal prior to intravenous administration.

Key Points: 
  • INFUGEM is the only available gemcitabine formulation that does not require reconstitution and syringe withdrawal prior to intravenous administration.
  • INFUGEM is an example of our focus at Sun Pharma, which is to improve provider and patient experiences by using high-tech delivery systems and/or novel formulations for gold-standard medicines, said Abhay Gandhi, CEO-North America, Sun Pharma.
  • Myelosuppression: Myelosuppression manifested by neutropenia, thrombocytopenia and anemia occurs with INFUGEM as a single agent, and the risks are increased when INFUGEM is combined with other cytotoxic drugs.
  • Advise females of reproductive potential to use effective contraception during treatment with INFUGEM and for 6 months after the final dose.

Cipher Pharmaceuticals Announces Amended Distribution and Supply Agreement for Absorica®

Retrieved on: 
Monday, July 30, 2018

MISSISSAUGA, ON, July 30, 2018 /CNW/ - Cipher Pharmaceuticals Inc. (TSX:CPH) ("Cipher" or "the Company") today announced that it has amended its distribution and supply agreement (the "Amendment") with Sun Pharmaceutical Industries, Inc. ("Sun") (previously Ranbaxy Laboratories Inc.) for Absorica, an innovative formulation of the active ingredient isotretinoin, which is used in the treatment of severe acne.

Key Points: 
  • MISSISSAUGA, ON, July 30, 2018 /CNW/ - Cipher Pharmaceuticals Inc. (TSX:CPH) ("Cipher" or "the Company") today announced that it has amended its distribution and supply agreement (the "Amendment") with Sun Pharmaceutical Industries, Inc. ("Sun") (previously Ranbaxy Laboratories Inc.) for Absorica, an innovative formulation of the active ingredient isotretinoin, which is used in the treatment of severe acne.
  • Under the original agreement, entered in August 2008, Cipher granted Sun the exclusive right to market, sell and distribute Absorica in the United States ("U.S.").
  • "This is a significant milestone for Cipher, providing the opportunity to maximize our total cumulative revenues from Absorica and other isotretinoin products.
  • Cipher (TSX:CPH) is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products.

DUSA Pharmaceuticals, Inc. Files Lawsuit Against Biofrontera Inc. for Patent Infringement, Trade Secret Misappropriation, and Tortious Interference

Retrieved on: 
Wednesday, July 11, 2018

DUSA Pharmaceuticals, Inc., ("DUSA") a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO), (Bloomberg: SUNP IN), (NSE: SUNPHARMA), (BSE: 524715) announced that DUSA has filed trade secret misappropriation and tortious interference claims in an ongoing patent infringement lawsuit against Biofrontera Inc., Biofrontera Bioscience GmbH, Biofrontera Pharma GmbH, and Biofrontera AG in the United States District Court for the District of Massachusetts.

Key Points: 
  • DUSA Pharmaceuticals, Inc., ("DUSA") a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO), (Bloomberg: SUNP IN), (NSE: SUNPHARMA), (BSE: 524715) announced that DUSA has filed trade secret misappropriation and tortious interference claims in an ongoing patent infringement lawsuit against Biofrontera Inc., Biofrontera Bioscience GmbH, Biofrontera Pharma GmbH, and Biofrontera AG in the United States District Court for the District of Massachusetts.
  • In its amended complaint, DUSA additionally alleges that the Biofrontera defendants misappropriated confidential and trade secret information from DUSA and improperly obtained confidential DUSA information from former DUSA employees to sell and market defendants' own products.
  • The lawsuit seeks an assessment of both damages and injunctive relief against the Biofrontera defendants.
  • The photodynamic therapy, pioneered by DUSA, combines a drug with a light source to treat disease conditions.