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May 17, 2019

Welcome to FierceLifeSci Weekly Digest, your roundup of the biggest and most popular stories from each of our publications.

Featured Story

Teva starred in price-fixing scheme, but 19 other companies 'willingly' joined, attorneys general claim

In what could be "the largest cartel case in the history of the United States," 44 states sued 20 generics makers Friday for price fixing and personally named 15 of those companies' executives. And at the center of the scheme, the lawsuit claims, was Teva.

Top Stories Of The Week

Special Report—Biotech's top 10 money raisers of 2018

Private biotechs raised a record-breaking $16.8 billion in 2018, blowing past the record $12.1 billion set the previous year. Here are the top 10 fundraising rounds—which broke some records themselves—and together illustrate what's hot out there in the field.

ElevateBio uncloaks with $150M to build cell and gene therapy biotechs

ElevateBio seeks to address a bottleneck faced by cell and gene therapy developers: manufacturing. With $150 million in series A funding, the holding company will provide centralized R&D and manufacturing teams to its portfolio companies.

Medtronic withdraws from knee orthopedics while venturing deeper into titanium spine implants

Medtronic is walking away from the knee replacement work being done by Responsive Orthopedics, a startup it acquired in 2016 that had aimed to disrupt the market with lower-cost artificial joints and a bundled payment model, and making new inroads within its spine implant business with the acquisition of Titan Spine.

Boehringer buckles in AbbVie patent fight, saving Humira from biosims until 2023

Boehringer Ingelheim fought hard against AbbVie’s so-called patent thicket surrounding the world’s bestselling drug, Humira. But in the end, the German company ended up settling on a 2023 launch date, just like its fellow biosimilar makers.

Editor's Choice—Lawmakers weigh Part D out-of-pocket cap instead of rebate proposal: report

After HHS proposed eliminating drug rebates in Medicare and Medicaid, pharma cheered. But now, two officials from both major political parties have come up with a possible alternative, according to a BioCentury report.

Editor's Choice—Daiichi's leukemia drug falls amid FDA adcomm's trial concerns

Daiichi Sankyo went one for two in an FDA cancer advisory committee doubleheader Tuesday, with its prospective leukemia treatment getting struck out.

FDA tells ImmunoGen to run a second phase 3, sinking stock

The FDA has quashed ImmunoGen’s hopes of filing for approval of mirvetuximab soravtansine on the strength of a failed phase 3. FDA officials advised ImmunoGen a run a new phase 3 in patients with high folate receptor alpha-positive, platinum-resistant ovarian cancer before seeking approval.

Watch out, Dupixent. Pfizer's new JAK inhibitor could come after your eczema market

Pfizer’s FDA-approved JAK inhibitor Xeljanz is currently struggling with cardiovascular safety concerns. But another candidate in the family for which Pfizer has blockbuster hopes just slew a phase 3 in atopic dermatitis, teeing up a fight against Sanofi and Regeneron’s Dupixent.

Harvard-born diabetes startup Semma reports advances in turning stem cells into insulin producers

Semma Therapeutics has faced an obstacle with its process of turning undifferentiated pluripotent stem cells into insulin-producing pancreatic beta cells: Only 30% of the resulting cells turn out to be beta cells. Now, a Semma-Harvard University team has figured out how to boost the proportion of beta cells emerging from their process to 80%.

FDA finds testing issues at Torrent plant  

A year after Torrent Pharmaceuticals first began recalling tainted losartan products manufactured at its Indrad plant, the FDA paid a visit. It found a plant that often routinely reported products out of specification but frequently shipped them to the U.S. anyway.

Resources

[Executive Summary] Achieving a Successful Drug Product Tech Transfer

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What is agile competitive intelligence, and how can help healthcare researchers stay ahead of the curve?

[Whitepaper] Personalized Test for Treatment Prediction in Depression

Total Brain Announces Personalized Test for Treatment Prediction in Depression with 80% Accuracy.

[Whitepaper] Observed Impact of Medication Price Transparency on Patients and Practices

Prescription price transparency technology is here – but is it making a difference? Find out HERE.

[eBook] 2018 Weekly Compendium

The Biopharma industry is moving at lightning speed and it can be a challenge to keep pace. Here at Biotech Primer we spend hours each week researching, writing, and editing original content for the Biotech Primer WEEKLY with one goal in mind: to help everyone better understand the latest science and technology driving today’s healthcare industry.