Author Archive

FDA Begins Enforcing Deadlines on Form 483 Responses

Maribel Rios PharmTech editorGot a Form 483? Then you’ve got 15 days. Starting today, FDA will enforce its program that calls for a more timely review of its Form 483 Inspectional Observations. Under this program, a company has 15 days to respond to the observations cited in the agency’s Form 483, before the agency decides whether to issue an official warning letter. The goal of this program is to optimize FDA’s already strained resources and to move firms to promptly correct noted violations. Read more »

Toward Personalized Diabetes Treatment

Maribel Rios PharmTech editorEfforts toward drug formulations that take into account genetic makeup will require a new examination of how disease develops in the body, thereby making it possible to connect biology with the chemical functions of a drug’s active ingredient. Read more »

More than a Salary Survey

Maribel Rios PharmTech editorOne of the traditional publications from PharmTech is its Annual Employment Survey, which has been published for more than 20 years. Every year more than 1200 pharmaceutical industry professionals worldwide participate in the survey, which provides information not only on salary and benefits, but also on the industry’s opinions about job security, regulatory impact, and the direction of the industry. These are the issues that provide a true, comprehensive picture of the work environment. Read more »

“Protein Factory” Secret Revealed

Maribel Rios PharmTech editorYesterday, I stumbled upon a list of someone’s opinion of the “top 10 accidental discoveries.” On the list were at least two drug products (take a guess before you research). Although I’m certain there are bound to be more accidental discoveries, I’m even more certain that most future discoveries will be deliberate, based on detailed knowledge of the systems under study.

For example, recent advances in therapeutic biologics have raised the need for a greater understanding of how the body fights infectious diseases at the most fundamental level. One of the most elusive parts of this understanding is the inner workings of ribosomes, those parts of the cell responsible for producing proteins. Read more »

The Nanoparticle Link in Process Understanding

Maribel Rios PharmTech editorPharmaceutical scientists are still just beginning to understand the working mechanisms of nano-sized particles in drug delivery. For formulators, one of the key challenges has been to design particles that increase bioavailability of the drug to specific targets but still have minimal side effects to the patient. For manufacturers, processing nanomedicines requires having to rethink traditional production operations. How do the unique properties of nano-sized particles affect the means in which they are handled, blended, mixed, coated, lyophilized? Read more »

Sustained Drug Delivery in a Cup

Maribel Rios PharmTech editorA formulation that can sustain the delivery of a drug and reduce the frequency of doses by itself contributes to improved patient compliance. But when sustained delivery of this formulation is coupled with organ-specific delivery by means of innovative combination products, the benefits to patients are even greater. Read more »

Proof: Diamonds Can Be Your Best Friend

Maribel Rios PharmTech editorAs if I needed another reason to believe diamonds can make a person feel better: Researchers at Northwestern University are using carbon-based nanodiamonds to slowly deliver and release tightly bound insulin (acting as a growth hormone to generate new skin cells) to a specific location to fight infection and heal wounds such as those from severe burns. Researchers also showed the insulin was virtually inactive while it was bound to the nanodiamonds, thereby preventing excess drug release. Read more »

Wyeth Says Yes to Pfizer Takeover

Maribel Rios PharmTech editorTo no one’s surprise, Wyeth shareholders approved yesterday the $68-billion merger agreement with Pfizer. The vote was overwhelming: 98% in favor. The final step is the approval by the Federal Trade Commission and international regulators. The mega deal, one in three this year (Merck and Schering Plough; and Roche and Genentech) emphasizes the bottom-line industry mantra: diversify to compete. Read more »

Cancer Drug Delivery on Homing Device

Maribel Rios PharmTech editor

Prostate cancer remains one of the most common cancers and the second-leading cause of cancer death in American men, according to the American Cancer Society. So far, treatments for prostate cancer include drugs that affect the entire body, instead of only cancer cells. Work by a team of researchers at Purdue University offers hope they have found a new method of not only finding and targeting these cancer cells, but also carry therapeutic drugs directly to the site of infection. Read more »

AAPS National Biotech Conference: Refocus on Science and QbD

Maribel Rios PharmTech editorInnovation, innovation, innovation .. and a call to focus on science and quality-by-design (QbD) principles. Such was much of the talk yesterday at this year’s AAPS National Biotechnology Conference in Seattle. Speakers discussed the tools the biotechnology industry will need for future innovation and how the industry must center on QbD principles, using lessons learned from small-molecule development and even nonregulated industries. Read more »

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