Threshold Pharmaceutical announced initiation of the phase 1/2 trial evaluating TH-302

Threshold Pharmaceuticals announced that it has initiated the phase 1/2 dose escalation trial evaluating TH-302 in combination with sunitinib in patients with advanced renal cell carcinoma, gastrointestinal stromal tumor, and pancreatic neuoendocrine tumor. 

The trial plans to enroll 34 patients at Indiana University Goshen Cancer Center.  The primary objective of the dose escalation component is to establish the maximum tolerated dose and dose limiting toxicities of TH-302 in combination with sunitinib.  Twenty four subjects will be enrolled in the dose escalation portion of the study.

Once the maximum tolerated dose has been reached, the study will enroll

Acura got paid from Pfizer

Friday is payday... (at least in the US it is!)

Acura Pharmaceuticals announced that it has received $20M milestone payment from Pfizer ad the FDA approved Oxecta tablets CII on June 17, 2011.  The Oxecta tablet was developed

Avanir announced it has received paragraph IV certification notice

Avanir Pharmaceuticals announced that the Abbreviated New Drug Application for the generic version of Nuedexta or dextromethorphan hydrobromide and quinidine sulfate capsules was submitted on March 7, 2011 and received paragraph IV certification notices on  June 30, 2011.   (Doesn't Nuedexta just get its approval recently, like just last year? although both of the active ingredients are generics)

Avanir indicates that it is to vigorously enforce

Bausch & Lomb entered Pharmaceutical Business in India through partnership

Bausch & Lomb announced that it has launched a new pharmaceutical business in India after reaching a strategic agreement with Micro Labs who will be providing Bausch & Lomb high-quality manufacturing capabilities in this region.  The company plans to introduce new prescription and over-the-counter products targeting a wide range of eye diseases.

B&L also plans to establish dedicated sales and marketing teams in

Novartis announced positive results of the GLOW2 study

When Endo reported negative results of its phase III study, Novartis reported positive results of the phase III study using once-daily NVA237 against placebo and tiotropium in patients with COPD (chronic-obstructive pulmonary disease),

The phase III study (GLOW2) showed that NVA237 was superior

Endo reported disappointing results of the phase II study of axomadol

Endo Pharmaceutical reported rather a disappointing result of the phase II study evaluating axomadol against placebo as potential treatment of moderate to severe chronic low back pain.

The company reported that the results did not show that axomadol

Par Pharmaceuticals is to let go 100 employees of its Strativa Division

What will company do to increase profits besides increasing drug price or employing low-paid workforce?

Well, Par Pharmaceuticals announced that it is to let go approximately 100 employees currently working at Strativa (Par wholly-owned subsidiary) in

Sagent Pharmaceutical received US FDA approval to market Polymyxin B

Sagent Pharmaceuticals announced that it has received the FDA approval to market polymyxin B for injection available as 500,000 units in latex-free glass vial.

In 2010, it is estimated that the Us market for injectable polymyxin B was $8M.  Polymyxin B marketed by Sagent will feature the company's PreventIV measures packaging in addition to labeling that is designed to aid in the reduction of medication errors

Polymyxin B for Injection has been approved to

Valeant signed deal with Meda

I don't know what your reaction is like but here is mine! "What?" Another transfer?

Apparently, Xerese is quite hot!

Valeant annuounced that it has signed a license agreement with Meda to acquire North American rights to both Elidel (pimercolimus 1% cream) and Xerese (a combination of acyclovir and hydrocortisone cream 5%/1% cream that Meda has just recently acquired from Medivir - literally just a couple of days ago!)
Valeant has agreed to pay an initial payments of $76M and

A marketing authorization for aflibercept has been submitted to the Ministry of Health, Labour and Welfare of Japan

Bayer Healthcare and Regeneron announced that Bayer Yakuhin Ltd has submitted a marketing authorization application to the Ministry of Health, Labour and Welfare of Japan for VEGF Trap-Eye or aflibercept ophthalmic solution for the treatment of neovascular form of age-related macular degeneration (wet AMD). 

Included in the application are the results of the two phase III trials

Elite Pharmaceuticals signed commercial and manufacturing agreement with ThePharmaNetWork

Elite Pharmaceuticals announced that it has entered a commercial manufacturing and supply agreement with ThePharmaNetwork, LLC and Ascend Laboratories (ThePharmaNetwork's subsidiary).

Under the terms of the agreement, Elite Pharmaceuticals will manufacture and packaging

Meda acquired rights of Xerese from Medivir

Have you ever experienced cold sore? They are painful and often interfering with normal daily activities.  Maybe this is why Medivir's Xerese has been on fire recently.  After recenting signing an agreement with Daewoong, Medivir has entered into a commercial partnership with Meda transfering all rights of Xerese to Meda in the US, Canada and Mexico in return for a payment of $45M.  Meda has launched Xerese in February 2011 and Medivir has been receiving double digit royalty payment based on sale of Xerese in the US.

In addition, Meda now has US rights for Xerese to develop the compound for

Pfizer submitted the New Drug Application for axitinib

Pfizer announced that it has filed a New Drug Application for axitinib for the treatment of advanced renal cell carcinoma. 

The Marketing Authorization Application has been submitted and accepted for review in the EU.

Pfizer also submitted the data from the phase III trial AXIS 1032 comparing axitinib

An Investigational Drug Candidate for Sleeping Sickiness of Anacor is to entered phase 1 trial

Anacor Pharmaceuticals, The Drugs for Neglected Diseases Initiative, and Scynexis announced that it has completed the pre-clinical studies for a drug candidate that has been developed for the treatment of human African trypanosomiasis (HAT) or often known as sleeping sickness.

The companies plan to initiate the phase 1 trial using the

An sNDA for Relistor has been submitted to the US FDA

Progenics announced that the supplemental new drug application has been submitted to the US FDA to request the use of Relistor (methylnaltrexone bromide) for the treatment of opioid-induced constipation in patients with chronic, non-cancer pain.

Relistor has been approved and commercialized

Gilead entered into an agreement with Tibotec

Gilead expands its relationship with Tibotec by entering into another agreement.

Gilead Sciences announced that it has signed a license agreement with Tibotec under which Tibotec is to develop and commercialize a new fixed-dose combination of cobicistat ( of Gilead) and Prezista (darunavir of Tibotec).

Cobicistat is an investigational product developed by Gilead as a pharmacoenhancing or boosting agent that works to increase a concentration of certain medication in the blood to allow for once-daily dosing.

Prezista has been approved in the US for the treatment of HIV-infected individuals

Immune Pharmaceuticals exercised its option to acquire bertilimumab from iCo

iCo therapeutics announced that Immune Pharmaceutical has exercised its rights to license bertilimumab in accordance to the agreement signed in December 2010.

Based on the terms of the agreement, Immune Pharmaceutical is to pay an upfront payment of $500,000 in cash.  It is also to require to issue 600,000 Immune shares and 200,000 Immune warrants to iCo therapeutics.

Immune Pharmaceuticals plans to develop bertilimumab for the treatment of eosinophilic inflammatory bowel disease and eosinophilic gastro-intestinal diseases.  Bertilimumab, acquired from

The FDA has authorized first clinical trial using Cell Sense reagent for imaging

Celsense announced that the US FDA has authorized the first clinical trial utilizing Cell Sense Reagent for in vivo imaging of a cell-based immunotherapy being studied in a phase I trial for colorectal cancer.

The study is being done at the University of Pittsburgh Cancer Institute.

The phase I trial is utilizing an autologous dendritic cell vaccine to treat

Cardium is to purchase Transdel's assets

Cardium therapeutics announced that it is to acquire Transdel Pharmaceuticals phase 3 topical analgesic and cosmeceutical business asset as Transdel filed for bankruptcy.  The acquisition is made in connection with the proposed asset purchase under Section 363 of Chapter 11 of the US Bankruptcy Code.  The acquisition will also include royalty-bearing license agreements for certain cosmeceutical products marketed by companies that utilize Transdel delivery technology.

Cardium is expected to make a payment of up to $4M including 1M of which will be paid when the Cardium successfully registers for Ketotransdel(TM) with the US FDA within 5 years of closing.  The payment is to  be made in the form of unregistered restricted shares of Cardium common stock priced at $.50 per share or if higher based on the price of Cardium's common stock on the closing date of the transaction.  The amount of stocks that is released when the registration of Ketotransdel is successful is to be based on the price of Cardium's stock on the date it is successfully registered if it is higher than 0.50 per share.

If Transdel accepted an alternative offer and terminated the asset purchase, Transdel is required to pay Cardium $500,000 break-up fee and other expenses and costs.

Transdel Pharmaceuticals:

The FDA accepted the NDA submitted by Columbia Lab for Prochieve

Watson Pharmaceuticals announced that the US FDA has accepted the New Drug Application submitted by Columbia Lab for Prochieve (R), a progresterone gel, for the reduction of risk of preterm birth in women with short uterine cervical length in mid-trimester of pregnancy.

Columbia has previously requested the application to be examined as a priority preview.  However, recent press release has indicated that it has voluntarily withdrawn the request.

The FDA has set the PDUFA date to be on Feb 26, 2012.

Under the terms of the Purchase and Collaboration Agreement, the acceptance for review of the NDA has triggered a $5M milestone payment from Watson.

The Application was submitted in April, 2011

The FDA Advisory Committee recommended the approval of Firazyr of Shire

Shire announced that the Pulmonary-Allergy Drugs Advisory Committee has recommended the approval of Firazyr or icatibant for the treatment of acute attacks of hereditary angioedema in patients who are 18 years and older. The committee recommended Firazyr to be self-administered.

The FDA is to decide whether to approve Firazyr on August 25, 2011.

The FDA advisory committee recommended the approval of Firazyr based on data from three double-blind, randomized, controlled phase III trials (FAST-1, FAST-2, and FAST-3) evaluating Firazyr in patients who have cutaneous, abdominal, and laryngeal attacks.  Thirty milligram of Firazyr was administered subcutaneously for acute attacks.

A phase IIIb EASSI study showed that Firazyr wa generally well-tolerated when it was self-administered for acute attacks of HAE,

Almost all patients experienced injection site reactions but they were generally transient and did not require medical intervention.  Other commonly observed adverse reactions were nausea, fever, dizziness, headache, and rash.