Archive → March, 2012
C&EN senior business editor Melody Bomgardner dropped me a note yesterday about a new request for applications from NIH’s National Institute on Drug Abuse (NIDA) for small business grants.
Read the text below but here’s what I find interesting as a pharmacologist who plays well with chemists: the call for applications is not for analytical methods for designer drugs. Rather the announcement solicits novel methods for detecting some biochemical or pharmacological endpoint of these agents (a bioassay, in old-speak) that doesn’t require new method development every time a new structural analogue pops onto the market.
Here’s the text directly from NIDA – I can’t find an exact RFA to link to, however: (see update below)
A pharmacognosy colleague contacted me on Friday morning with word that the botanical drug development company Bionovo was closing its chemistry group.
Well, the news is actually worse as judging from this 8 pm Friday press release:
Bionovo, Inc. (OTC Link Platform: BNVI.PK) today announced that it will need to obtain substantial additional funding to achieve its objectives of internally developing drugs. The Company reduced its workforce by over 90%. The remaining management of the Company will receive reduced cash compensation until either adequate financing can be obtained or the Company is sold. The Company can not make any assurances about either of these events. As previously announced, management and the board of directors are continuing to explore strategic options for the Company. Management is currently reviewing the status of the ongoing clinical trial for Menerba.
The Company does not currently have adequate internal liquidity to meet its cash needs. If sufficient additional funds are not received in the near term, the Company may not be able to execute its business plan and may need to further curtail or cease operations.
Bionovo has been the rare superb example of a company that’s been trying to develop FDA-approvable drugs based on Chinese traditional medicine. Led by Isaac Cohen, a UCSF guest scientist and Doctoral of Oriental Medicine, and chief medical officer, Mary Tagliaferri, Bionovo took a hard, science-based approach to identifying herbal extracts for cancer and women’s health issues. Cohen and colleagues at UCSF and elsewhere examined Chinese herbal medicines for their biochemical and cellular effects based upon their traditional use.
Inhaled or oral?
Natural or synthetic?
Two interesting reports came across the interwebs over the last couple of days.
Earlier this week, the US Food and Drug Administration issued a warning letter (press release) to makers of Aeroshot brand of inhaled caffeine. No, it’s not an asthma medicine (although oral theophylline is). It’s billed as a non-caloric caffeine delivery system, 100 mg per hit. That’s roughly the amount in two 12 fl oz/355 mL cans of Mountain Dew or one gulp more than a 8.4 fl oz/250 mL can of Red Bull energy drink. However, the company claims that only 15-25 mg are delivered – perhaps half the amount in a Coca-Cola.
The FDA has concerns about the dual promotion of the product for swallowing and inhalation, the relative safety of inhaled caffeine, and the potential for children and adolescents to use the product in combination with alcohol. The company’s FAQ specifically notes that the product is not marketed for use in children. Readers will recall that Four Loko caffeinated alcohol drinks were withdrawn from the market in late 2010 and replaced with alcohol-only versions.
I’ve been rather quiet here as of late, Dear Reader. Between my new day job and trying to finish my book chapter on natural toxins while fighting an overall bout of writer’s block, these pages have been devoid of pixels.
But I couldn’t resist posting this news that came across my screen from various sources:
State Senator Nina Turner (D-Cleveland) announced legislation today that would protect men in Ohio from the risks of PDE-5 inhibitors, drugs commonly used to treat symptoms of impotence. Turner’s legislation would include provisions to document that the symptoms are not psychological in nature, and would guide men to make the right decision for their bodies. Physicians would be required to obtain a second opinion from a psychological professional to verify that a patient has a true medical malady before the medication could be prescribed.
“The men in our lives, including members of the General Assembly, generously devote time to fundamental female reproductive issues—the least we can do is return the favor,” Senator Turner said. “It is crucial that we take the appropriate steps to shelter vulnerable men from the potential side effects of these drugs.”
No, this is not from The Onion.
This is a press release from State Senator Turner’s website.
And the closer:
“We must advocate for the traditional family, protect the sanctity of procreation, and ensure that all men using PDE-5 inhibitors are healthy, stable, and educated about their options—including celibacy as a viable life choice. This legislation will do just that.”
The State Senator is my new hero.