- Juno says two more patients die in leukemia drug trial (reuters.com)
Juno Therapeutics Inc said two more patients had died after suffering brain swelling during a trial of its experimental genetically engineered leukemia drug, bringing the total up to five...Juno said...it had voluntarily put the mid-stage study on hold and informed the U.S. Food and Drug Administration earlier this week...The company is still evaluating the cause of the deaths and has not yet decided whether it will continue developing the drug...JCAR015 is an experimental chimeric antigen receptor T-Cell therapy...The FDA, which had imposed a hold on the trial after the first three deaths, lifted it soon after Juno agreed to revert to its original drug regimen that excluded fludarabine...The elimination of fludarabine reduced toxicity but has not proved to be the only contributing factor...
- Trump should be good medicine for the pharmaceutical industry. Here’s why (statnews.com)
The holidays came early for the pharmaceutical industry this year...With Donald Trump elected to the White House and Republicans controlling Congress, the companies that make your medicines can expect a friendlier environment in which to operate. And investors quickly responded by boosting drug and biotech stocks…So what lies ahead? Here are a few predictions:
- FDA will stand for Faster Drug Approvals - Many Republicans would like to speed the Food and Drug Administration process for getting new medicines to patients.
- Drug makers will have more leeway on pricing - A big bet now is that the Trump administration will not be as aggressive in tackling prescription drug prices as a Clinton administration might have been.
- Friendly tax policies are on the way - Another key piece of the Trump plan is tax reform. Again, the Trump team is short on details, but one plan floating around is to allow companies to repatriate money parked overseas and pay taxes of only 10 percent or less, instead of 35 percent.
- AI Takes On Drug Safety (fortune.com)
IBM Watson Health tries to do what no pharma company has done: solve the drug-safety puzzle...Big Blue has found yet another business application for its precocious cognitive computing system. IBM Watson Health is collaborating with the biopharmaceutical company Celgene to develop a new platform for evaluating the safety of drugs—both before and after they hit the market—the two companies are announcing this morning. The new offering, "Watson for Patient Safety," will gobble up anonymized medical records, claims data, and millions of electronic submissions to the FDA about potential drug side effects (known as individual case safety reports) to see if it can learn about the hidden dangers of medicines before they become too costly...The problem is one of the toughest in drug development...
- Feds blame multistate B. cepacia outbreak on PharmaTech plant’s water system (fiercepharma.com)
After a months-long investigation, federal officials have nailed down the source of a Burkholderia cepacia outbreak that made its way into several states and infected dozens of patients...the Centers for Disease Control and Prevention and the FDA said they had detected the B. cepacia bacteria in the water system at Florida-based CMO PharmaTech. The company had produced 10 contaminated lots of constipation drug docusate sodium before 6 distributors shipped the meds around the country. In total, 60 people in 8 states became infected...The outbreak started in late June in ventilated cystic fibrosis patients. During the investigation, CDC officials said infections could be life-threatening in patients with compromised immune systems or lung conditions.
- Two biosimilars approved, but litigation delays launch (pharmacytoday.org)
FDA recently approved the first biosimilars for adalimumab (Humira—AbbVie) and etanercept (Enbrel—Amgen), known as adalimumab-atto (Amjevita—Amgen) and etanercept-szzs (Erelzi—Sandoz), respectively. These approvals came after unanimous votes of support by FDA’s Arthritis Advisory Committee in July. Unfortunately, the launch of both biosimilar products will be delayed because the manufacturers of the reference products are involved in litigation against biosimilar manufacturers for patent infringement...A recent meta-analysis...suggest these products have nearly identical pharmacokinetics, efficacy, and toxicity…Although the trials cited by this meta-analysis involved limited numbers of patients, there is no reason to suspect these biosimilars will not be nearly identical to their reference product...
- More generics consolidation coming? Novartis deal rumors point up the industry’s troubles (fiercepharma.com)
If Novartis does snap up Amneal to beef up its own Sandoz unit, the deal will say as much about the state of the generics industry as it does about Novartis...True, Novartis is having trouble with its Alcon ophthalmology unit and it's been shopping for deals for some time. But generics companies have their own struggles, and building up by dealmaking is one way to combat them…Pricing pressures are putting a damper on sales and profits, and many analysts believe this pressure will only increase. The bigger generics makers are consolidating to become even bigger, because scale means better margins...Meanwhile, the FDA is under pressure to speed generics through the approval process, thanks to Mylan’s EpiPen pricing scandal and the attention it brought to copycat drugs with few-to-no generic competitors...the FDA is planning a renewal of the Generic Drug User Fee Act that would limit review time to 8 months...Look for the consolidation discussion to continue in generics, because the pricing problems, accelerating approvals and margin pressure aren’t going away anytime soon...
- FDA issues guidelines for female libido pills after learning some hard lessons (statnews.com)
After a two-year wait, the US Food and Drug Administration finally issued new guidance for companies that want to develop drugs to bolster female libidos. But the details suggest the agency has belatedly learned some hard-fought lessons following complaints that the controversial Addyi pill did not warrant approval last year...The 15-page draft guidance...offers a typical how-to for companies, but also points to certain steps that Sprout Pharmaceuticals did not follow as part of its Addyi marketing application...The drug, which is now sold by Valeant Pharmaceuticals, was approved despite debate over its safety and effectiveness, and the extent to which medicines should be used to treat female sexual dysfunction...the FDA is locking the barn door after the horse got out. So now, the agency is telling other companies to do some things that Sprout didn’t do...they’ve made it harder to get a drug approved but they have extended helping hands in numerous places...unless [a company] really looks hard for subgroups [of patients], the whole effort is hopeless...
- Homeopathic Medicines Will Carry Labels Saying They’re Unscientific (slate.com)
The Federal Trade Commission just cracked down on an unusual product that has long enjoyed exemption from regulation: homeopathic drugs. Available everywhere...homeopathic products are advertised as an effective way to treat a wide range of conditions...Americans spend over $3 billion a year on homeopathy, and the market appears to be growing steadily...companies selling these products have never been required to show they are effective at doing what they claim...the FTC announced its “enforcement policy statement” about homeopathic product labeling...the recommendations are pretty minimal...the agency produced a report that concluded customers were likely to be deceived by labels that did not carry the appropriate disclaimers, and therefore disclaimers stating that these products are untested will now be required. The requirement is not technically a law like…The rules require packaging to effectively communicate two key disclaimers:
- “There is no scientific evidence that the product works.”
- “The product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”
- Do links count? FDA to re-examine online drug ads (medcitynews.com)
It’s back to the drawing board for the FDA...After years of slow reaction to pharma marketing online, the agency announced this week a new research initiative to better understand how consumers process short-form posts and ads...the FDA is trying to determine whether links in tweets and Google ads can independently convey all the necessary information about product risk...Under current guidelines, drug companies are required to balance the information they provide in character-space-limited posts. That means for a typical 140-character tweet, at least 70 characters must be dedicated to explaining risks and side effects...Regulatory change could be good news for pharma marketers, who have for a long time sought clarity on what they can and cannot do...
- Pfizer’s Lyrica patent appeal fails in U.K., endangering bid to protect $5B med (fiercepharma.com)
Pfizer’s divide-and-conquer approach to Lyrica in the U.K. just hit a wall. The Court of Appeal upheld a ruling that struck down key patent claims on Lyrica and cleared Actavis’ generic of infringing it...The...case centered on a “carve-out” approval for Actavis’ Lyrica generic, a type of regulatory nod that branded drugmakers see as a threat...drugmakers want to prolong their monopoly access to patients, and they use follow-up patents to extend their protection past the time when IP coverage expires on the original compounds...some recent “skinny” regulatory nods--from the FDA as well as international regulatory agencies--that clear generics only for particular indications have complicated those efforts, because they give generics makers an entreé onto the market while so-called method-of-use patents remain in effect...The patent at issue in this case covered Lyrica’s use as a pain treatment; the patent on pregabalin itself, the active ingredient...had already expired. These days, Lyrica is used more often for pain than for its original indication as a seizure drug...The company hopes to now take its fight to the U.K. Supreme Court...Pfizer maintains its strong belief in the validity and importance...of the patent…