May 30

Notizia

Roche, Boehringer tout new idiopathic pulmonary fibrosis analyses to boost their rival medications

The idiopathic pulmonary fibrosis (IPF) market-share battle between Roche’s Esbriet and Boehringer Ingelheim’s Ofev hasn’t let up since the FDA green-lighted the medications in October 2014. And this week, both drugmakers upped the ante with positive new data for their contenders. At the American Thoracic Society’s annual meeting, Roche rolled out new analyses of phase 3 data showing that Esbriet, when compared with placebo, could cut the risk of death by 72% among patients with more serious lung function impairment, reduce patient-reported breathlessness among sufferers with moderate impairment and decrease the rate of respiratory-related hospitalizations among patients. Competitor Boehringer, though, had good news to report from new analyses of it own. Pooled phase 3 data showed that Ofev patients were, at 36.8%, twice as likely as those on placebo to experience an improvement—or experience no decline—in lung function, the German pharma said. Results also showed that Ofev didn’t increase the incidence of major adverse cardiovascular events among high-risk patients when compared with placebo. Both drug makers are looking for an edge in what so far has proved to be a competitive market race.

Trio of patients sue Pfizer, Bristol-Myers, claiming they soft-pedaled Eliquis bleeding risks

Just two weeks after convincing a judge in New York to toss a liability case over Eliquis bleeding risks, Pfizer and Bristol-Myers Squibb face three new suits in the same state over claims their big-selling anticoagulant ended up hurting patients. Filed this week in New York State court, the suits say Pfizer and BMS “negligently and fraudulently” represented their blockbuster med as “safe and effective for its indicated uses.” The companies “concealed their knowledge of Eliquis' defects” from prescribing physicians and the larger public, the lawsuits claim. After several months on Eliquis, the plaintiffs developed a variety of bleeding problems—bilateral subdural hemorrhages in one case, a subdural hematoma in another and postoperative bleeding, acute blood loss anemia and a hematoma in the third, according to the lawsuits. All of them required lengthy hospital stays. Pfizer and BMS “believe that the claims in these cases lack merit,” according to a Pfizer spokesperson.

New FDA commissioner Gottlieb unveils price-fighting strategies

During the campaign and since the U.S. presidential election, President Donald Trump has pledged to bring down drug costs and, in some cases, railed against the industry for its pricing. Now, his new FDA commissioner is laying out some approaches the agency will take to fight high prices. Importantly, the FDA can’t regulate drug prices, but it can implement measures aimed at deterring the types of price hikes that have made so many headlines over more than a year. At a U.S. House of Representatives budget hearing on Thursday, new FDA commissioner Scott Gottlieb said his agency will publish and regularly update a list of medications that are off patent and have no competition, work to improve generic review times and seek to “curtail gaming” of regulations by the industry that allows companies to extend patent monopolies. In his opening remarks at the budget hearing, Gottlieb said he’s working on a “drug competition action plan” that he will unveil soon. However, the new commissioner did offer a few strategies to lower costs.

EpicGenetics looks north to expand landmark fibromyalgia study

For four years, EpicGenetics has been selling its diagnostic for fibromyalgia in the U.S. Now it can list Canada among its international markets for the test. The company says approval and launch in Canada will help it push forward with an ambitious R&D program that is trying to decipher the underlying genetic basis for the chronic and painful condition, which affects millions of people worldwide. The Santa Monica, California, company made waves when its FM/a blood test for fibromyalgia secured a CLIA certification and became the first test available for fibromyalgia, which often goes undiagnosed because its symptoms can be so diverse. Aside from pain it can be accompanied by fatigue, sleep disturbances, muscle tenderness, headaches and depression, as well as problems with thinking and memory function.

 

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