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Bio Roundup: BCRA Fireworks, Shkreli Muzzled, Endo Pulls Drug & More

Xconomy National — 

The Fourth of July was this week, but members of Congress didn’t need to crane their necks skyward to see fireworks. Senators returned to their districts, where local news offered blistering headlines about the potential impact of the Republican plan to replace the Affordable Care Act.

Independence Day typically lets lawmakers mingle with constituents at picnics and parades, but few Republican senators took the opportunity to do so. Just four of the Senate’s 52 Republicans announced appearances at parades this year, the Washington Post reported. Behind the scenes, talks continued about amending the Better Care Reconciliation Act to win over on-the-fence Republicans. But those debates are stoking an internal party struggle.

Meanwhile, life science news did not stop for the holiday week. The securities fraud trial of Martin Shkreli began, and prosecutors sought a gag order on the “pharma bro” to keep his comments from reaching the jury. The short week also saw Celgene (NASDAQ: CELG) reach across the world to nab rights to a cancer drug, a halt to Merck (NYSE: MRK) cancer studies, and more. Let’s get to this week’s roundup.

A.I. IN HEALTHCARE

—As part of our ongoing series, Xconomy’s Bruce Bigelow asked how health and life science businesses can take advantage of artificial intelligence. His report focused on a debate among several people in the San Diego biotech community.

—GlaxoSmithKline (NYSE: GSK) became the latest big drug company to ink a deal with a small A.I. firm with the aim of using sophisticated data-crunching algorithms to speed up the drug discovery process. GSK’s $43 million deal is with Scottish firm Exscientia.

REGULATORY REVELATIONS

—Just before the long weekend, the U.S. Centers for Medicare and Medicaid Services published its annual tally of payments that doctors and hospitals receive from drug and device companies—everything from research grants to conference travel expenses. 2016’s total was $8.2 billion, slightly higher than the 2015 total. Regulatory Focus broke down some of the numbers. The transparency rule is part of the Affordable Care Act.

—Endo International (NASDAQ: ENDP) pulled its opioid painkiller oxymorphone hydrochloride (Opana ER) from the market. The decision came one month after the FDA asked the Dublin, Ireland-based company to withdraw the product, citing the risk of abuse.

—The FDA placed clinical holds on three Merck studies that are testing pembrolizumab (Keytruda) in multiple myeloma patients after a review of the data found more deaths in the study group compared to the control arm.

— Eli Lilly (NYSE: LLY) notched approvals for its rheumatoid arthritis drug baricitinib (Olumiant) in the UK and Japan. but the Indianapolis drug maker still awaits a meeting with the FDA after the U.S. regulator’s surprise rejection of the drug in April.

DEALS & DATA

—Summit, NJ, drugmaker Celgene struck a deal with BeiGene (NASDAQ: BGNS) to get rights to the China-based biotech’s lead immunotherapy candidate, as well as an equity stake in its new partner.

—Cambridge-based Acer Therapeutics aims to join the ranks of biotech companies going public via a reverse merger with The Woodlands, TX-based Opexa Therapeutics (NASDAQ: OPXA).

—Eli Lilly is pledging $52 million toward a research partnership with Purdue University that the drug giant hopes spawns innovations in injectable medications.

—Two groups of researchers reported positive Phase 1 data from a handful of skin-cancer patients taking personalized cancer vaccines. It’s the first evidence that an attack on what are known as “neoantigens”—markers on the tumor surface that aren’t present in the patients’ healthy cells—might be an effective weapon against cancer. The work is affiliated with the firms Neon Therapeutics and BioNTech and was published in the journal Nature.

—Bristol-Myers Squibb (NYSE: BMY) said Monday that nivolumab (Opdivo) bested ipilimumab (Yervoy) in a head-to-head Phase 3 study to keep melanoma from recurring after surgery. Both cancer immunotherapies are BMS products. The company announced the interim results, which came earlier than expected, but did not release data.

Alex Lash contributed to this report.

Photo by @yb_woodstock via a Creative Commons license.