Shortening Drug Approval Times Is A Rallying Cry For Administration. But It Was Already Happening.
Programs that were put into place before the Trump administration have been cutting times by sometimes more than a year. In other pharmaceutical news: problems with AstraZeneca's blockbuster drug; the Food and Drug Administration requests that a pharma company recall a product that may cause liver injury; sexual harassment allegations involving the founder of biotech's largest hedge fund, and more.
Los Angeles Times:
FDA's Program To Speed Up Drug Approval Shaved Nearly A Year Off The Process
Speeding the pace at which potentially lifesaving drugs are brought to market was a rallying cry for Donald Trump as a candidate, and is a stated priority of his Food and Drug Administration commissioner, Dr. Scott Gottlieb. But a new study finds that programs already in place were routinely shortening the drug development process by close to a year, and sometimes much more. (Healy, 12/5)
A Deadly Drug Cocktail Shines A Light On An AstraZeneca Blockbuster
AstraZeneca has paid more than $1 billion in settlements over side effects and marketing of Seroquel, once one of the world’s best-selling drugs. The company hasn’t admitted any wrongdoing. Zayas claims that AstraZeneca targeted pain clinics and addiction centers to sell Seroquel as it battled for share in a competitive market for such drugs. Salespeople were directed to call on clinic doctors and paid bonuses based on sales to the facilities, she alleges in the suit, which seeks reimbursement for costs to government health programs and fines. (Hopkins, 12/6)
FDA Urges Maker To Recall Limbrel After Liver And Lung Injury Reports
The Food and Drug Administration has asked Primus Pharmaceuticals to recall a product touted to address “the metabolic processes associated with osteoarthritis” but that the agency says comes with a risk of liver injury and a lung condition. Primus markets the product, Limbrel, as a “medical food” — a distinct regulatory category — but this week, the FDA said it considers Limbrel to be an unapproved drug. The FDA cannot require the company to recall Limbrel. (Joseph, 12/5)
Finance Titan Sam Isaly Harassed Women For Years, Former Employees Said
The founder of biotech’s largest and most powerful hedge fund has for years perpetuated a toxic culture of sexual harassment, former employees told STAT, routinely subjecting young female assistants to pornography in the workplace, lewd jokes, and pervasive sexist comments. Five people who once worked at investing giant OrbiMed Advisors said Sam Isaly, the firm’s 72-year-old managing partner, kept a set of breast implants on his desk, palpating them like stress balls during idle conversation. He wantonly demeaned and verbally abused female employees, they said. (Garde, 12/5)
A Cambridge Biotech Is Challenging Its Workers To Better Understand The Limits Facing Patients With A Rare Disorder
Biotech companies developing drugs for rare diseases often invite patients to visit so workers can put a human face on illnesses that could be viewed as abstract scientific puzzles. Akcea Therapeutics is taking that idea further — it wants staffers to get a taste of life with a super-rare metabolic disorder. An actual taste. (Saltzman, 12/5)
These Companies Want To Transform Our Gut Bugs Into Drugs. How Close Are They To Market?
Now doctors at that same hospital system can order the sludge themselves — in no less than three different formulations — from a nonprofit stool bank. There are clinical trials on using fecal transplants to treat everything from bacterial infections to ulcerative colitis to obesity. And last week, a new study in the Journal of the American Medical Association found that when treating recurrent Clostridium difficile infections, other people’s waste works just as well if it’s delivered by pill or by colonoscopy. (Boodman, 12/6)