Is the HCV Market Worth Additional Investment?

HCV

Over the past year, two products have significantly disrupted the hepatitis C (HCV) market. The breakthrough single and combination treatments from Gilead Sciences Inc. include Sovaldi® (sofosbuvir) and the more recently approved combination therapy Harvoni® (sofosbuvir/ledipasvir). These new treatments show a cure rate of greater than 90%, and are accompanied by staggering price tags. (more…)

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Reformating your CTD Information for your Brazilian Registration Dossier

CTD

In most countries, pharmaceutical legislations and regulatory requirements are well established and implemented to describe the marketing authorization (MA) procedures for medicinal products. The objective of the pharmaceutical companies is to identify ways and factors that impede the efficient registration of new medicinal products and their timely access to patients. To be able to submit a marketing authorization application (MAA) in all these countries, applicants need to know exactly in advance the pharmaceutical legislation (regulations, directives, and guidelines) and other regulatory requirements, in order to plan an efficient registration process. (more…)

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As Demographics Shift, Drugmakers Face Growing Chorus to Diversify Trials

clinical trials

After decades of foot-dragging, the FDA has put drugmakers on notice that greater inclusion in clinical trials – balanced gender enrollment, more cultural diversity and wider age spans – is coming. Hand-wringing, it appears, won’t halt the inevitable. Instead, the industry is facing the need to move proactively to design trials that more closely match the targeted populations for drug candidates. (more…)

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Renal Cell Carcinoma the Subject of New Report

Renal Cell Carcinoma

Renal cell carcinoma, a type of cancer originating in the renal parenchyma, is the most common form of kidney cancer affecting adult populations in Western countries. Closely linked to cigarette smoking and other lifestyle factors (overweight and obesity, hypertension and advanced kidney disease) that are increasingly prevalent worldwide, the incidence of renal cell carcinoma is increasing in a parallel fashion. It currently ranks as the seventh most common cancer in men and the ninth most common in women, with approximately 209,000 new cases diagnosed worldwide each year. Renal cell carcinoma is, furthermore, the most deadly of all urological cancers, with a disease-specific mortality rate of 30-40%. Worldwide, some 102,000 deaths from renal cell carcinoma are registered each year. (more…)

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Video: Avidbiotics Taps Nature to Tackle the Toughest Infectious Diseases

Avidbiotics

David Martin, CEO and Co-founder, Avidbiotics Corp. explained to BioWorld why heads are turning in the last year or two related to microbiome R&D. He also provided updates on the status of Avidbiotics’ two candidates for C. diff and E. coli. (more…)

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The Epic Failure to Achieve Diversity in Clinical Trials Persists

Diversity

Patients are astonished when they learn that the development of most drugs has, historically, not incorporated human differences into the design equation. How and why age, ethnicity, gender and race haven’t been woven into most clinical trial designs makes most people in the industry cringe because the issue is immensely complicated. And though there has been a lot of chatter in recent years about changing this – including updated regulatory guidances – achieving proper diversity in clinical trials is still just a goal. (more…)

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LCZ-696, a Novel Heart Failure Treatment Set to Become a Multi-Billion Dollar Blockbuster

LCZ-696

Novartis is on the way to revive its fortunes in the cardiovascular market. While its top-selling blood pressure pill Diovan (valsartan) is facing generic competition and its vasodilator serelaxin is having trouble gaining US and EU approval, the novel heart failure treatment LCZ-696 (valsartan plus sacubitril) is anticipated to become a multi-billion dollar blockbuster after the release of impressive outcomes data. LCZ-696 not only reduced cardiovascular death and first-time hospitalizations by a fifth over the widely used angiotensin-converting enzyme (ACE) inhibitor enalapril, which itself improves survival, but also reduced worsening of symptoms, the need for additional therapy and emergency room visits. LCZ-696 could become the drug of choice for heart failure once approved and some analysts have forecast sales of up to $10 billion. (more…)

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Expectation and Challenge for New Regulatory Framework of Regenerative Medicines

DIA

The Drug Information Association (DIA) of Japan hosted its 11th Annual Meeting from November 16-18 in the Tokyo Bay Area, where the futuristic culture is flowing. Over 800 attendees from worldwide regulatory agencies, pharmaceutical industries, and Japanese healthcare and academic organizations gathered for 3 days of presentations and discussions. Having succeeded to last year’s theme, “Revolutionary Drug Development,” this year the annual meeting focused on “Medical Innovation that Transcends Boundaries for Drug Development.” Among the 6-track sessions, 2 sessions discussed on regenerative medicines. (more…)

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Video: Lumena’s New Role in Shire and What’s Next for the Ex-CEO

lumena

Just a few weeks after Shire Pharmaceuticals agreed to acquire Lumena for an upfront payment of $260 million in cash, plus milestones, Lumena’s CEO and president Mike Grey chatted with BioWorld about how Lumena will be positioned within Shire. He also revealed what’s next for him since he’s out of a job. (more…)

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SICA and its Efforts for the Harmonization of Medicine Regulation

SICA

As outlined in the article Ways to Prosper in the Increasingly Competitive Global Pharmaceutical Market, market expansion is a critical strategy for sustaining growth in the increasingly competitive pharmaceutical market. Increasing regulatory hurdles in established markets represent a key challenge, which, combined with the potential for new patient populations in Emerging Markets, contributes to more pharmaceutical companies turning their attention towards new markets. (more…)

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