Melanie Sena is community editor of Pharmaceutical Technology.

Melanie Sena

 has approved Entyvio (vedolizumab), an injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease.

The safety and effectiveness of Entyvio for ulcerative colitis was established in two clinical trials involving approximately 900 patients,  who had not responded adequately to corticosteroids, immunomodulators, or tumor necrosis factor blocker medications. Evaluations of patients included measures of stool frequency, rectal bleeding, endoscopic findings and a physician‘s overall assessment. Results showed that a greater percentage of participants treated with Entyvio compared to a placebo achieved and maintained clinical response, achieved and maintained clinical remission, achieved corticosteroid-free clinical remission, and as seen during endoscopy, had improved appearance of the colon. The same testing was conducted in three clinical trials with approximately 1500 patients with Crohn‘s disease. Results showed that a greater percentage of participants treated with Entyvio compared to a placebo achieved clinical response, achieved clinical remission, and achieved corticosteroid-free clinical remission.

The most common side effects in patients treated with Entyvio include headache, joint pain, nausea, and fever. The most serious risks associated with Entyvio include serious infections, hypersensitivity and infusion-related reactions, and hepatotoxicity. 

Entyvio is marketed by Deerfield, Ill.-based Takeda Pharmaceuticals.

Articles

FDA approves Entyvio, an injection to treat adult patients with moderate to severe ulcerative colitis and Crohn's disease.

FDA Approves Entyvio for Ulcerative Colitis and Crohn's Disease

Hangzhou Tigermed Consulting, a provider of outsourced clinical development services across China and the Asia Pacific, has entered a definitive agreement, subject to certain closing conditions and regulatory approval, to acquire a majority position in the ownership of 

Headquartered in Exton, PA, Frontage provides bioanalysis, preclinical and early phase clinical studies, drug development (CMC) services, and DMPK support for biopharmaceutical organizations. The company offers a range of services from discovery through late-stage clinical trials for new, generic, and consumer product development programs. Frontage also owns Frontage Lab (Shanghai) Co, Ltd.

Frontage will continue to operate independently. Song Li will remain CEO, and its current management team will remain in place after the transaction.
  
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Tigermed acquires Frontage Laboratories for $50.25 million.

Tigermed Acquires Frontage Laboratories

 Epanova, (omega-3-carboxylic acids) a treatment to help reduce triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500 mg/dL). Epanova is the first FDA-approved prescription omega-3 in free fatty acid form.

The FDA approval was based on data from a clinical development program that included positive results from the Phase III trial, which examined the efficacy of Epanova in lowering triglycerides and other key lipid parameters in patients with high triglycerides. The effect of Epanova on the risk of pancreatitis or on cardiovascular mortality and morbidity has not been determined.

AstraZeneca continues to assess the impact of lowering triglycerides and further evaluate the clinical profile of Epanova. Through a large-scale trial, AstraZeneca will evaluate the safety and efficacy of Epanova on cardiovascular outcomes in combination with statin therapy in patients with mixed dyslipidemia at increased risk of cardiovascular disease.  The company also plans to pursue the development of a fixed dose combination of Epanova with a statin and plans to file for regulatory approval in other markets for the severe hypertriglyceridemia indication.

AstraZeneca's Epanova is the first FDA-approved prescription omega-3 in free fatty acid form.

FDA Approves Omega-3 Therapy for High Triglycerides

 will acquire the consumer care business of Merck & Co., for $14.2 billion. This acquisition will make Bayer the second largest global supplier of non-prescription, OTC products, which will include Merck brands such as Claritin, Coppertone, and Dr. Scholl’s.

In a related transaction, Bayer has entered into a global co-development and co-commercialization agreement with Merck & Co., in the field of soluble guanylate cyclase (sGC) modulators, for which Merck & Co., will make an up-front payment to Bayer of $1 billion, with substantial additional sales milestone payments. The collaboration includes Adempas (Riociguat), which is already approved for the treatment of certain classifications of pulmonary hypertension and is being developed in additional life cycle indications, as well as vericiguat, an investigational compound that is currently being developed in two Phase IIb studies in worsening chronic heart failure.

Bayer and Merck & Co., will equally share costs and profits from the sGC modulators and implement a joint development and commercialization strategy. Bayer will lead the commercialization for Adempas in the Americas while Merck & Co., will lead the commercialization outside the Americas. For vericiguat and other potential investigational sGC modulators, Bayer will lead the commercialization outside the Americas while Merck & Co., will lead the commercialization in the Americas. Both companies will have the option to co-promote Adempas.

Merck & Co., will make payments to Bayer of up to $2.1 billion, comprising an up-front payment of $1 billion and sales milestone payments of up to $1.1 billion related to future collective sales of certain collaboration compounds including Adempas.

Bayer will acquire the consumer care business of Merck & Co., and enter a co-commercialization agreement in the field of sGC modulators.

Bayer to Increase Position in Consumer Care Business

reported its affiliate Janssen Pharmaceutical NV has entered into a collaboration with the Stiching International Dispensary Association (IDA), a procurement agent for the Stop TB Partnership’s Global Drug Facility (GDF), to facilitate access to the company’s anti-tuberculosis medicine. This public-private partnership was established by the newly formed Janssen Global Public Health, to help improve overall public health.

 More than 130 low- and middle-income countries outside of the US will now be able to obtain this new anti-tuberculosis medicine through the procurement processes of GDF and its agent, the IDA.  

Janssen Pharmaceutical collaborates with Stop TB Partnership's Global Drug Facility to increase access to anti-TB compound.

Janssen Pharmaceutical Collaborates with Stiching International Dispensary Association

 has been ranked No. 1 on Corporate Responsibility magazine’s 2014 list of the 100 Best Corporate Citizens, a benchmark for socially responsible investors and other stakeholders. Bristol-Myers Squibb has achieved the No. 1 ranking three times, including 2009 and 2012, and has ranked among the top 10 for the past six years.  

The 100 Best Corporate Citizens list ranks companies in the Russell 1000 using nearly 300 data points in seven categories: environment, climate change, employee relations, human rights, governance, finance, and philanthropy.  

Bristol-Myers Squibb is named No. 1 on 2014 Best Corporate Citizens List for the third time in six years.