Harmac

FDA grants accelerated approval for Sirturo for multi-drug resistant TB

Wednesday, January 2, 2013 03:13 PM

The FDA has granted accelerated approval to Janssen Therapeutics’ Sirturo (bedaquiline) tablets for the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) as part of combination therapy in adults. The accelerated approval is based on the surrogate endpoint of time to sputum culture conversion.

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JHP Pharmaceuticals acquired By Warburg Pincus

Wednesday, January 2, 2013 02:28 PM

JHP Pharmaceuticals, a Parsippany, N.J.-based specialty pharmaceutical focused on sterile injectable products, has been acquired by an affiliate of Warburg Pincus, a leading global private equity firm focused on growth investing, for $195 million on a debt-free, cash-free basis. JHP's current management team will continue to hold an interest in the company. Additional terms of the transaction were not disclosed.

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Perrigo acquires remaining stake in Cobrek Pharmaceuticals

Wednesday, January 2, 2013 12:18 PM

Perrigo, a global provider of healthcare products, has signed a definitive merger agreement with Cobrek Pharmaceuticals, a Chicago-based, privately held drug development company, and has acquired the company for approximately $45 million on a cash free and debt free basis.

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Teva signs new $3B syndicated revolving credit facility

Tuesday, December 18, 2012 02:23 PM

Teva Pharmaceutical Industries, a global pharmaceutical company, has entered into a new five-year, $3 billion unsecured revolving credit facility, which replaces its existing $2.5 billion credit facility.

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Takeda sells non-Colcrys URL Pharma to Sun Pharmaceutical

Tuesday, December 18, 2012 10:13 AM

Takeda Pharmaceuticals U.S.A. has entered into a definitive agreement to sell the non-Colcrys (colchicine, USP) URL Pharma generic business to Caraco Pharmaceutical Laboratories, a wholly-owned subsidiary of Sun Pharmaceutical Industries.

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Phenex, Janssen form research collaboration on autoimmune, inflammatory disorders

Monday, December 17, 2012 02:09 PM

Phenex Pharmaceuticals, a privately held drug discovery and development company based in Germany, has entered into an agreement with Janssen Biotech and its affiliates to jointly discover compounds that target the nuclear hormone receptor RORγT and may have utility in the treatment of chronic autoimmune and inflammatory disorders including rheumatoid arthritis, psoriasis and inflammatory bowel disease.

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Teva, Handok to establish business venture in Korean pharma market

Monday, December 17, 2012 01:41 PM

Teva Pharmaceutical Industries, an Israel-based pharmaceutical company, and Handok Pharmaceuticals, a pharmaceutical/healthcare company in Korea, have agreed to establish a business venture in South Korea, allowing Teva to gain entrance into the Korean pharmaceutical market, currently valued at approximately $14 billion.

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Isis, AZ form strategic alliance on RNA therapeutics for cancer

Wednesday, December 12, 2012 09:51 AM

Isis Pharmaceuticals of Carlsbad, Calif., and global biopharmaceutical company AstraZeneca have formed a strategic alliance for the discovery and development of novel generation antisense therapeutics against five cancer targets, which includes a license to develop and commercialize ISIS-STAT3Rx, a drug Isis is currently evaluating in an early clinical trial in patients with advanced lymphomas.

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Pernix Therapeutics to acquire Somaxon Pharmaceuticals

Wednesday, December 12, 2012 09:22 AM

Pernix Therapeutics, a specialty pharmaceutical company based in The Woodlands, Texas, has entered into a definitive merger agreement to acquire Somaxon Pharmaceuticals, a San Diego-based specialty pharmaceutical company, in a stock-for-stock transaction with a total equity value of $25 million.

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Biogen Idec, Isis collaborate on antisense programs for neurological disorders

Monday, December 10, 2012 11:54 AM

Weston, Mass.-based Biogen Idec and Isis Pharmaceuticals of Carlsbad, Calif., have entered into a global collaboration agreement to discover and develop antisense drugs against three undisclosed targets to treat neurological or neuromuscular disorders. Biogen Idec and Isis are already collaborating on antisense drugs to treat spinal muscular atrophy and myotonic dystrophy type 1 under previously established collaborations.

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CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

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The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

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December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

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