| Editor’s note: We will be taking a short publication break over the coming holidays. FierceLifeSci will return to your inboxes Jan. 3, 2020. It’s no secret the odds of bringing a drug all the way through clinical testing are pretty slim. As much as companies look to ensure they won’t trip before the finish line, there are still plenty of programs that miss the last hurdle—after millions or billions of dollars have been spent. This year’s top 15 list includes trials we’ve judged to have material consequences on their sponsors, and on their prospective patients—as well as one written-off medicine that’s staged a miraculous comeback. | |
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Featured Story This year’s top 15 list has been drawn up to include trials whose failure we judge to have had material consequences on their sponsors and the patients for whom the drugs are being developed. The catalog includes multiple trials for aggressive brain cancer, Alzheimer’s disease, nonalcoholic steatohepatitis and heart disease. Top Stories Of The Week Friday, December 13, 2019 Eli Lilly and Boehringer Ingelheim's SGLT2 diabetes med Jardiance is chasing at least one holy grail as a treatment for heart failure in patients with or without diabetes—a test AstraZeneca's rival med Farxiga recently aced. But in its first swing at Farxiga's lead, Jardiance whiffed. Monday, December 16, 2019 Novartis’ fevipiprant has failed another pair of phase 3 clinical trials, prompting the Swiss pharma to halt further development of the DP2 antagonist in asthma. The setback means Amgen, AstraZeneca and Novartis have now targeted DP2 without success, raising doubts about whether Gossamer Bio will fare better when it delivers data next year. Friday, December 13, 2019 In a high-stakes patent lawsuit between CAR-T companies Bristol-Myers Squibb and Gilead Sciences, BMS has come up with a victory. After a two-week trial, jurors in California ordered Gilead’s Kite Pharma to pay $752 million to BMS’ Juno Therapeutics and its partners, which sued in 2017 for patent infringement. Friday, December 13, 2019 The departure of Paul Biondi, who was named head of strategy and business development at Bristol-Myers Squibb after its merger with Celgene, is the latest surprise in what was already a challenging integration process for the company. Biondi presided over an extensive deal-making strategy that will continue to be important as BMS prioritizes oncology development. Monday, December 16, 2019 Gilead’s NASH pipeline took another hit as a pair of treatments failed to move the needle on liver scarring in a phase 2 study, both on their own and in combination. The Big Pharma is digesting the data with regulators to figure out what’s next for the programs. Friday, December 13, 2019 After being hit with an FDA rejection for Sarepta Therapeutics' second Duchenne muscular dystrophy drug back in the summer, it looked like a long road, tinged with more than a hint of political intrigue, for it to be approved. Tuesday, December 17, 2019 Here's a stat drugmakers would love to tout: With the cancer drug market exploding, oncologists rely on pharma's own sales reps for information. By a wide margin, in fact. Seventy-one percent of U.S. oncologists surveyed by Cardinal Health agreed sales reps play an important role in their education about new drugs—and, crucially, assistance in helping patients afford their meds. Monday, December 16, 2019 Georgetown University researchers have been studying Novartis’ cancer drug Tasigna as a potential treatment for Parkinson’s disease since 2013. Now, they're out with new research from a phase 2 trial showing that the drug boosts dopamine levels in the brain while also reducing levels of neurotoxic proteins, halting the decline of both motor and non-motor functioning. Monday, December 16, 2019 The FDA approved its first automatic insulin dosing system designed to deliver correction boluses as well as adjust background insulin levels, to help prevent bouts of high and low blood sugar in people with Type 1 diabetes. Monday, December 16, 2019 After years of criticism from the FDA, Sun’s Halol plant still can’t get through an FDA inspection without the agency finding some deficiency. In June, it was just one observation, but a just completed inspection ended with a Form 483 for Halol with significantly more. 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