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Bill Clinton, Pfizer, and Mylan announce new agreements to lower prices of antiretrovirals for HIV/AIDS in the developing world

President Bill Clinton announced two important and complementary agreements today to enable better, more affordable treatments for patients on second-line antiretroviral (ARV) therapy for HIV/AIDS in the developing world.

6 Aug 2009

Investigation urgently needed into treatment of mentally ill immigration detainees at California facility, editorial states

"Although the number of mentally ill immigration detainees" at the La Mesa, Calif.-based private psychiatric hospital Alvarado Parkway Institute "at any one time seems to range from as few as two to only five or so, their situation needs to be addressed quickly," a San Diego Tribune editorial states (San Diego Tribune, 5/19).

20 May 2009

Intradigm issued RNA interference (RNAi) patent covering potent siRNA sequence

Intradigm Corporation has announced the issuance of United States patent 7,534,878, titled "Composition and Methods of RNAi Therapeutics for Treatment of Cancer and Other Neovascularization Diseases."

19 May 2009

California mental health advocates raise concern over treatment of ICE detainees

The San Diego Tribune on Monday profiled the La Mesa, Calif.-based private psychiatric hospital Alvarado Parkway Institute. Some advocates say that the hospital is in a network of private hospitals that U.S. Immigration and Customs Enforcement uses to hold "severely" mentally ill detainees nationwide, often "out of reach of lawyers and even their families," the Tribune reports.

18 May 2009

Sinobiopharma announces Chinese approval of Perindopril

Sinobiopharma, Inc. has announced that it has received approval from the Chinese State Food and Drug Administration (SFDA) to manufacture and market its formulation of Perindopril, an anti-hypertension drug.

12 May 2009

FDA approves Benzyl alcohol lotion for head lice

The U.S. Food and Drug Administration has approved a new prescription medication for the treatment of head lice (Pediculosis capitis) infestation.

12 Apr 2009

Mylan's Matrix receives tentative FDA approval under PEPFAR for generic Truvada

Mylan Inc. has announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.2% controlling interest, has received the first tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg.

30 Mar 2009

Mylan's Matrix receives WHO approval for generic Lopinavir/Ritonavir tablets

Mylan Inc. has announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, received the first and only World Health Organization (WHO) approval for Lopinavir/Ritonavir Tablets, 200 mg/50 mg. Matrix's version of this product is heat-stable and affordable, making it practical for distribution and use in warm climates.

25 Feb 2009

Final FDA approval for generic version of antiretroviral Zerit capsules

Mylan Inc. has announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, received final approval from the U.S. Food and Drug Administration (FDA) on December 29, for its Abbreviated New Drug Application (ANDA) for Stavudine Capsules USP, 15 mg, 20 mg, 30 mg and 40 mg.

1 Jan 2009

NicOx signs agreement with DSM for the commercial manufacture of naproxcinod drug substance

NicOx S.A. has announced it has signed an agreement with DSM for the commercial manufacture and supply of naproxcinod drug substance (or API, active pharmaceutical ingredient).

3 Dec 2008

Mylan receives FDA approval for Fluoxetine capsules

Mylan Inc. has announced that its subsidiary, Mylan Pharmaceuticals Inc., received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fluoxetine Capsules USP, 10 mg and 20 mg.

18 Nov 2008

FDA seizes Heparin from Cincinnati manufacturer

As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government today seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio.

7 Nov 2008

Addex Parkinson's product progressing in early clinical trials

Addex Pharmaceuticals has announced that it has completed the first part of a two-part Phase I clinical trial to evaluate the newly developed modified release formulation of ADX48621. ADX48621 is scheduled to start a Phase IIa proof of concept study for the treatment of levodopa associated dyskinesia in Parkinson's disease during the first half of 2009.

15 Oct 2008

FDA warns Ranbaxy Labs and issues import alert

The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India.

16 Sep 2008

Mylan's Alphapharm victorious in Razadyne patent challenge

Mylan Inc. has announced that its subsidiary Alphapharm Pty Limited won a favorable decision in patent litigation against it and Barr Laboratories Inc. relating to Galantamine Tablets, USP, the generic version of Ortho-McNeil's Razadyne Tablets, 4 mg, 8 mg and 12 mg.

31 Aug 2008