Yesterday, I reported the news that the US Pharmacopeial Convention (USP) released new standards for labels on prescription containers dispensed by pharmacists in the US. It seems that, despite the efforts of regulators, industry, and medical professionals, patients continue to misunderstand dosage instructions. Read more »
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Laboratories that offer stem-cell treatments have come under close scrutiny by FDA. Read more »
Pharmaceutical Technology and Patheon are partnering to provide you—our readers—with CMC advice from some of the leading formulation scientists and pharmaceutical manufacturing experts in the world. To get started, we need to know what plagues your CMC strategies and daily work. Email your questions directly to Editorial Director Angie Drakulich at firstname.lastname@example.org. (*Note: We will keep your name and company affiliation anonymous.)
Answers will be provided by the Patheon Certified Consultants team beginning in the January 2013 print and online editions of PharmTech. These experts have collectively brought more than 200 pharmaceutical products to market, including some of the world’s largest blockbusters.
• I have a BCS Class II compound for which amorphous solubility is easily sustained, but I can’t get the compound to rapidly dissolve. What are some solutions, particularly with respect to excipient selection?
• I have a compound that is non-ionizable and does not form a stable salt. Are co-crystals my best option and what are the key criteria in identifying a suitable co-crystal?
• I am having trouble maintaining product stability when scaling up a lyophilization process. What are the likely factors causing the problem?
PhRMA Senior Vice-President Matthew Bennett released a statement today on the state of the biopharmaceutical industry, in response to an analysis in the British Medical Journal. Bennett states that while the US may be lagging behind in spurring innovation programs, he believes the passage of the Prescription Drug User Fee Act (PDUFA) will improve the situation.
Here in Boston, the crowds are bustling at the BIO 2012 Convention and Exhibition. Today, BIO unveiled survey results that polled about 170 biotech industry leaders and 800 US voters, conducted by Hart Research and Public Opinion Strategies. Approximately 63% of biotech industry leaders said that they feel “very optimistic” about the future of biotech and its ability to develop new products that will meet global needs. A similar survey was conducted in 2007 showing that 79% of industry leaders were optimistic about biotech’s future. So there is a dip in optimism here, but considering the economic downturn of the past couple of years, such a change is not surprising. Read more »
House & Senate leaders aim to resolve the many differences by end of June.
Legislation to reauthorize Food and Drug Administration user fee programs sailed through the House and Senate last month, setting the stage for leading legislators to resolve their differences and agree on a compromise measure. Much of the work will be tackled by Committee staffers who have been laboring over the legislative details for months. The aim is to bring the House and Senate leaders together in about two weeks to hash out the final language. Read more »
The world of drug development is littered with early-phase failures: drugs that were shown to be safe in Phase I trials, but which failed to show efficacy later on. The failure of a drug at this early phase might not mean that there’s anything wrong with the compound. Rather, a failure might mean that the mechanism by which the drug acts was not of benefit in the disease against which it was tested. Read more »
Here at ExcipientFest 2012 in San Juan, excipient manufacturers and users are debating how to move foward surrounding the issue of atypical visible particles found in excipients. A speakers panel was held yesterday afternoon featuring Dale Carter, chair IPEC Americas; Cindy Buhse with FDA; Dave Schoneker of Colorcon and IPEC; and Ann Van Meter with Dow Wolff and IPEC. Read more »
Today in San Juan, at ExcipientFest 2012 in partnership with IPEC, Michael Beatrice of Abbott spoke about the seven deadly sins of quality management. Beatrice heads Quality at Abbott and used to serve as deputy director of CBER at FDA. The seven items to avoid, he notes are: bureacracy, tradition (just because you’ve always done something a certain way doesn’t make it right), excess (too many priorities), isolation (lack of communication among groups and with public), deafness (not listening to employees at all levels), and complacency. Read more »