Info & Opinion
April 25, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
Chicago-based but India-focused clinical trial management and site support organization Excel Life Sciences and Switzerland-based contract research organization (CRO) PFC Pharma Focus are launching PFC India, a full-service CRO specializing in clinical monitoring and data management services in India. The two will open an office for the new entity in New Delhi. PFC India will be a division of PFC Pharma. “PFC India will bring an unprecedented focus on quality data and good clinical practice to India, at a time when the FDA and the Drugs Controller General’s office of India is stepping up its compliance standards and pharmaceutical companies are requesting a high level of service, preferably from an experienced and established brand,” says Vijai Kumar, president and chief medical officer of Excel. A release on the new entity is here, and here's a recent article of ours in which an Excel exec tells us about the firm's operations in India.
Campbell Alliance, a pharma and biotech industry consulting firm, has appointed some industry veterans as executive VPs. They are Jon McGarity and David Lilley. McGarity has been in the business for 40 years, holding senior management positions at GlaxoSmithKline, Bristol Myers Squibb, and Novartis (Sandoz Pharmaceuticals). Lilley has been in the field for 30 years, in executive management roles at Johnson & Johnson, Quintiles Transnational and its divisions Innovex (sales) and NovaQuest (investments). "In this market environment, executive management teams at emerging and mid-size companies are experiencing unprecedented challenges in the areas of clinical development, partnering, financing, and commercialization,” says John Campbell, the firm's CEO. “Both Jon and David have decades of experience overcoming challenges of this nature.” A release on the appointments is here.
Deerfield Management, a health care-focused investment firm, is providing Arena Pharmaceuticals (NASDAQ: ARNA) with $100 million in funding through a credit facility. "This funding will put us in a stronger financial position as we complete the lorcaserin Phase III pivotal program and prepare its NDA submission while advancing our various partnering discussions for [weight management drug candidate] lorcaserin and our earlier-stage drug candidates,” says Jack Lief, Arena's president and CEO. During the next two years, Deerfield—already a significant Arena stockholder—may also provide the company $20 million more under the same terms. The release is here.
Another small firm has raised some funds as well. Generex Biotechnology (NASDAQ: GNBT), which focuses on treating metabolic diseases through the inner lining of the mouth, just netted $10.8 million via a direct offering of 17.2 million shares of its common stock to a group of accredited investors at .63 cents per share. Proceeds will be used to finance the company's efforts to get regulatory approval in the U.S., Canada, Mexico and the EU for Generex Oral-lyn oral insulin spray. This, along with other recent money-raising efforts, “will allow us to forge ahead with our regulatory approval processes, including the late-stage Phase III clinical trial of our flagship product,” says Anna Gluskin, Generex's president and CEO. The company announced earlier in the week that it had received five new patents in Canada, Australia, New Zealand, Brazil and Lebanon to provide additional protection for its compositions and methodologies for delivering drugs in buccal (lining of the mouth) applications. A release is here.
Pharma company UCB has partnered with PatientsLikeMe.com, an online community for people with life-changing conditions, to launch an epilepsy-focused patient community. The goal for UCB: to better understand the effectiveness of epilepsy drugs on the market. UCB, which focuses on the therapeutic areas of the central nervous system and immunology, says it would like to “collect, analyze and reflect information received from people with epilepsy, regardless of their diagnosis, prognosis or treatment regimen.” At the same time, it wants to develop a pharmacovigilance platform within the site that would automatically report adverse events directly to the FDA. The site is looking to hire a full-time pharmacovigilance manager. The online community is slated to launch in early 2010. Here is a release.