Bio Saga Blog - A Chronicle of Life Sciences & Informatics

President Barack Obama officially has launched the White House Cancer Moonshot Task Force, which will seek to address unnecessary regulatory barriers to developing new cancer treatments. Members of the task force — which will be chaired by Vice President Joe Biden — include the heads of the FDA, HHS, the National Cancer Institute and the National Institutes of Health.  The task force, funded by NIH, will present a report to the president before Dec. 31. Peter Pitts, president and founder of the Center for Medicine in the Public Interest and a former FDA associate commissioner, said the president should ask HHS to appoint an innovation czar to make the most of resources. Read the White House memorandum here: www.fdanews.com/01-29-16-MoonshotCuresMemo.pdf .

For Indian laboratories, the decision to implement  informatics applications that support compliance with 21 CFR Part 11 delivers multiple benefits. They are protecting their access to regulated markets in the US and other countries while implementing electronic processes and procedures that can reduce costs while enhancing their ability to deliver world class results.

The story of Sanofi-Aventis '  hostile bid for Genzyme Corp  continues,  Chief Executive Henri Termeer said he is willing to sell the company he built up over 25 years, but not for $69 a share.  In an interview with Reuters , Termeer said it was unlikely that French drugmaker Sanofi-Aventis SA would go hostile with its $18.5 billion bid and that the two sides had a good chance of coming to terms, though negotiations could last months. On Monday, the Cambridge, Massachusetts-based biotech company rejected Sanofi's bid of $69 a share. Sanofi has hinted it may take its offer directly to Genzyme shareholders if the company refuses to enter discussions based on its current offer.  Genzyme, in turn, is working its way through a manufacturing crisis that has lead to shortages of two of its biggest-selling products. Genzyme shares closed at $70.11 on Tuesday. Investors and industry analysts polled by Reuters have said a deal could be clinched at close to $78 per share....

The tables turn, it's 23andMe's turn to send a letter to FDA... Continuing the story  Reading Between Lines   slapped with cease and desist  letters . Direct-to-consumer genomics firm 23andMe has sent a letter to the heads of the US Food and Drug Administration and National Institutes of Health asking for a collaborative effort to develop guidelines for genetic testing. The firm  posted the letter  that it sent to FDA Commissioner Margaret Hamburg and NIH Director Francis Collins on its blog, The Spittoon, last night. 23andMe is one of several companies to be targeted recently by FDA, which  sent letters to several firms  saying that it believes the firms are selling unapproved diagnostic devices. The other firms that received letters were Knome, 23andMe, Decode Genetics, Navigenics, and Illumina, the last of which was cited for providing the tools that are used to provide genetic information to certain of the DTC genomics' customers. In the letter...

Sandoz has signed a definitive agreement to acquire Oriel Therapeutics, a privately held US pharmaceuticals company, gaining exclusive rights to a portfolio of generic drug candidates and related technologies targeting medicines in the inhalable respiratory drug market. Terms of the deal were not disclosed. The latter focuses on developing respiratory products with known pathways as generic alternatives to patented drugs for asthma and chronic obstructive pulmonary disease (COPD). The acquisition provides the former with three development projects targeting leading medicines in this field. Regulatory approvals of these medicines, if achieved, would enable the former to increase access to affordable, quality therapeutic alternatives for these increasingly prevalent diseases. Details of the latter's development programs, including anticipated timing of future regulatory submissions, are not disclosed for competitive reasons. The acquisition of the latter, which will be integrated as ...

Sandoz has signed a definitive agreement to acquire Oriel Therapeutics, a privately held US pharmaceuticals company, gaining exclusive rights to a portfolio of generic drug candidates and related technologies targeting medicines in the inhalable respiratory drug market. Terms of the deal were not disclosed. The latter focuses on developing respiratory products with known pathways as generic alternatives to patented drugs for asthma and chronic obstructive pulmonary disease (COPD). The acquisition provides the former with three development projects targeting leading medicines in this field. Regulatory approvals of these medicines, if achieved, would enable the former to increase access to affordable, quality therapeutic alternatives for these increasingly prevalent diseases. Details of the latter's development programs, including anticipated timing of future regulatory submissions, are not disclosed for competitive reasons. The acquisition of the latter, which will be integrated as ...

Qiagen has announced that two of its tests can be used to screen for the swine flu virus. Data analysis of the viral gene sequences showed that the artus Influenza LC RT PCR Kit and the Resplex II 2.0 Kit, can be used to detect whether or not Influenza A virus sequences are present in a sample, including the H1N1 subtype. If the sample proves positive, treatment with medication such as Tamiflu or Relenza can be prescribed, according to the recommendations given by the corresponding drug manufacturers. "We have compared the swine fever virus' sequence with our assays. The primers, which define the starting and end points of a genetic sequence that is amplified to make the target sequence visible, match 100 percent for the artus kit and almost 100 percent for the Resplex kit", said Dr Thomas Grewing, senior director, R&D. "We are now working closely with reference institutions to have both assays further re-validated and optimized based on clinical samples". B...

The US Food and Drug Administration issued a final guidance last week regarding investigational new drug applications for human gene therapy. Although gene therapy is still in the developmental stages, there is much hope for gene-based treatment and products. Because the therapy involves replacing a patient's faulty genetic material with normal genetic material,there is concern about safety in making sure replacement cells continue to function as they should. The guidance, therefore, focuses on the type of information that scientists need to consider and include in their documentation when studying these drugs and submitting them for FDA approval. Based on a draft guidance that was issued in November 2004 (69 FR 64958), the final document, Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) , provides information on what to include in an original IND. The document also applies to combinat...