The Dish’s Weekly News Wrap Up – April 4, 2014

This week’s headlines include, VC investments in biotech IPOs, regulators adopt more orphan drugs, FDA advisers back inhaled diabetes drugs, immunotherapies, new drugs for cholesterol treatment, FDA approves hemophilia B drug Alprolix, and GSK will improve vaccine access.

Cell Culture Events


“New Cholesterol Drugs Shown Effective in Studies,” The Wall Street Journal

“An experimental class of cholesterol-lowering drugs is emerging as the most promising new weapon against cardiovascular disease since the widely used medicines called statins first reached the market more than 25 years ago. In a flurry of studies presented over the weekend at the annual meeting of the American College of Cardiology, the drugs, known as PCSK9 inhibitors, were shown to reduce LDL cholesterol levels by half to two-thirds across several different patient groups. Elevated LDL or bad cholesterol is a key risk factor for heart attack and stroke.”

If you like this story, please see our blog titled Troubleshooting Media Development for Bioprocessing”

“Double for VC Investments in Q1, IPOs Hit a Grand Slam,” BioWorld

“Baseball parks are opening for business this week, but the biotech industry has already hit a grand slam with 26 biotechs raising $1.77 billion through initial public offerings (IPOs) on U.S. exchanges in the first quarter. The outstanding quarter follows a bunt single in the fourth quarter of last year with just eight biotechs going public on U.S. exchanges. All told there were 38 IPOs last year. It looks like we’ll surpass that number this year. There are still 18 companies tracked by BioWorld Snapshots with pending IPOs on U.S. exchanges. Let’s just hope this quarter is the start of a rally and not a sign that the manager is going to call in the relief pitcher to shut it down.”

If you like this story, please see our blog titled “Biologics Still on Top in Best Selling Drugs of 2013

“Deploying the Body’s Army,” The Scientist

“More than a century ago, American bone surgeon William Coley came across the case of Fred Stein, whose aggressive cheek sarcoma had disappeared after he suffered a Streptococcus pyogenes infection following surgery to remove part of the large tumor. Seven years later, Coley tracked Stein down and found him alive, with no evidence of cancer. Amazed, Coley speculated that the immune response to the bacterial infection had played an integral role in fighting the disease, and the doctor went on to inoculate more than 10 other patients suffering from inoperable tumors with Streptococcus bacteria. Sure enough, several of those who survived the infection—and one who did not—experienced tumor reduction.Coley subsequently developed and tested the effect of injecting dead bacteria into tumors, hoping to stimulate an immune response without risking fatal infection, and found that he was able to cause complete regression of cancer in some patients with sarcoma, a type of malignant tumor often arising from bone, muscle, or fat. Unfortunately, with the increasing use of radiation treatments and the advent of systemic chemotherapy, much of Coley’s work was abandoned by the time he died in 1936.”

If you like this story, please see our blog titled Paper or Plastic: A Study on Single-Use and Sustainability

“Amgen Drug Lowers Cholesterol up to 66 Percent in Pivotal Studies,” Reuters

“Amgen Inc’s drug from a high profile new class of experimental medicines lowered “bad” LDL cholesterol by 55 percent to 66 percent compared with a placebo in a trio of late-stage clinical trials, according to data presented on Saturday. Amgen had previously said the drug, evolocumab, met the main goals of five late-stage trials involving some 4,000 patients by significantly outperforming placebo or another cholesterol medicine in a variety of patient populations.”

If you like this story, please see our blog titled Flexible Facilities for Biopharmaceutical Manufacturing

“U.S. FDA Approves Biogen’s Hemophilia B Drug Alprolix,” Reuters

“Biogen Idec Inc has won U.S. approval for its long-acting hemophilia B treatment Alprolix, the U.S. Food and Drug Administration said on Friday. Hemophilia B is a rare, inherited disorder in which a person’s blood does not clot properly, potentially leading to prolonged bleeding and bruising. It affects about 4,000 people in the United States and 25,000 worldwide.”

If you like this story, please see our blog titled Choosing a Cell Culture Media Development Strategy for Biopharmaceutical Production

“Regulators Adopt More Orphan Drugs,” Nature

“Like a cancer cell, the definition of lymphoma has been dividing. Nearly 700,000 people in the United States have the disease, but over the past few decades, lymphoma has been sliced into several dozen subgroups on the basis of the type of immune cell that becomes cancerous. Drug companies have targeted these subtypes and have asked that they be counted as ‘orphan diseases’ — in the United States, this refers to diseases that have no cure and that affect fewer than 200,000 people, according to the definition given by the US Food and Drug Administration (FDA).”

If you like this story, please see our blog titled 2013 FDA New Drug Approvals

“GSK Will Tailor Vaccine Portfolio, Improve Access as Part of Wider Africa Initiative,” Fierce Vaccines

“GlaxoSmithKline ($GSK) has long been a leader in producing vaccines for Africa, but now it’s going one step further. The British pharma will tailor a portfolio of meds to address specific health needs on the continent and increase the registration of drugs and vaccines it already has, the company said this week. The drug giant’s commitment includes working with local partner Aspen Pharmacare to make its vaccines and other therapies available in places where they’re not already. It’s also continuing to develop products like its malaria vaccine that have the potential to make a social and economic impact. To achieve these goals, it’s creating an open R&D lab to study noncommunicable diseases and significantly bolstering its African manufacturing presence.”

If you like this story, please see our blog titled “Learning More About Your Cells by Employing Flow Cytometry and Cell Imaging Platforms – Troubleshooting Challenges

“U.S. FDA Advisers Back MannKind’s Inhaled Diabetes Drug,” Reuters

“U.S. health advisers on Tuesday recommended approval of MannKind Corp’s inhaled diabetes drug, and said the experimental treatment could help some patients, especially those wary of needles typically used with traditional insulin therapy. The Food and Drug Administration’s panel of outside advisers said that while the therapy, called Afrezza, did not appear as beneficial for adults with type 1 diabetes, it was clearly safe and effective for those with the more common type 2 form of the chronic disease.”

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