The analysis of biopharma dealmaking trends by Clarivate Analytics at last year's J.P. Morgan Healthcare Conference (JPM) suggested the industry would continue to evolve rapidly as targeted therapies reshuffled the oncology space and other broad therapeutic areas – especially neuroscience and anti-infectives – faced clinical and financial headwinds. The challenge going forward, concluded Laura Vitez, commercial insights manager with Cortellis, and Jamie Munro, global practice leader, portfolio and licensing, both of Clarivate Analytics, was to generate value from deals in the face of rising costs for drug development, pushback on pricing and a shift in focus from M&A to other types of business development (BD). Read More
Eli Lilly and Co. CEO Dave Ricks called the $8 billion buyout of Loxo Oncology Inc. "completely in line with what we've been talking about all along," although it's a deal "bigger than we've done before. In this case, you have four either clinical or recently approved medicines in one package, which is a bit unique for us." The bundle comes with a platform that may prove more broadly useful, he pointed out during a conference call with investors. Read More
Favorable phase II data with N-methyl-D-aspartate (NMDA) receptor antagonist AXS-05 sent Axsome Therapeutics Inc.'s shares skyrocketing more than 200 percent on Monday, and offered new hope for an estimated 16 million major depressive disorder (MDD) patients in the U.S. Read More
Gene therapy has come a long way since the initial treatments of the early 1990s, but the insertion of genes can't help diseases with toxic gain-of-function mutations. Apic Bio Inc. is looking to overcome that limitation with its gene therapy platform, Thrive, which includes a second component expressing an miRNA to silence toxic gain-of-function mutations from a single vector. Read More
SAN FRANCISCO – For what J.P. Morgan analyst Cory Kasimov called "one of the most significant pre-conference announcements ever," the tradition-steeped J.P. Morgan Healthcare Conference broke form, just a little, turning an anticipated slide talk into a comfy fireside chat with Celgene Chairman and CEO Mark Alles and the chairman and CEO of Celgene acquirer Bristol-Myers Squibb Co., Giovanni Caforio, on Monday. With the typical Q&A session to follow canceled, runners poised to bolt from the back of the Westin St. Francis Hotel's Grand Ballroom sighed, just a little. Read More
SAN FRANCISCO - A restructured global immuno-oncology deal between Regeneron Pharmaceuticals Inc. and Sanofi SA means "we're now pretty much in control of our entire pipeline of oncology agents," Regeneron's founder and CEO, Len Schleifer, told attendees at the J.P. Morgan Healthcare Conference on Monday. (See BioWorld, Oct. 2, 2018.) Read More
Should a jury second-guess the FDA's decisions in rejecting changes to prescription drug labeling? And just how much proof is needed to establish "clear evidence" that the FDA would have rejected a new warning for a drug label? Read More
LONDON – It was double delight for Exscientia Ltd., as the artificial intelligence (AI) specialist sealed a CHF67 million (US$68.3 million) drug discovery deal with Roche Holding AG and announced the closing of a $26 million series B round. Read More
DUBLIN – On the basis that 11 percent of something is better than 100 percent of nothing, Vital Therapies Inc., is throwing in its lot with privately held German drug development firm Immunic AG in a reverse merger that is being encouraged with an additional investment of €26 million (US$29.7 million) from Immunic's shareholders. The deal will transform Planegg-Martinsried-based Immunic into a Nasdaq-listed company, and it is embracing its new identity by moving its headquarters from the Munich region to Boston. Read More
HONG KONG – South Korean biotech company Samsung Bioepis Co. Ltd. has entered a licensing agreement with China's 3Sbio Inc. to expand its biosimilars business to mainland China. The agreement covers multiple biosimilar candidates from the Incheon-based Samsung Bioepis, including SB-8, a biosimilar to blockbuster anti-VEGF antibody Avastin (bevacizumab, Genentech Inc./Roche Holding AG) that is undergoing phase III trials. Read More
The U.S. Patent and Trademark Office (PTO) said its examiners will review patent applications that include a judicial exception to eligibility by examining whether that exception "is integrated into a practical application" of that exception. An application that passes this test will not be reviewed to determine whether the exception embodies an inventive concept, a policy that should at the very least provide more predictability to patent holders in the life sciences. Read More
Stelexis Therapeutics LLC, of New York, said it closed a $43 million series A financing. The company's drug discovery platform identifies the earliest definable pre-cancerous stem and progenitor cells that lead to the formation of human primary and recurrent tumors for therapeutic intervention and relapse prevention. The funding will support the delivery of clinical trial data and the validation of its platform. Read More
The U.S. Supreme Court Monday declined to hear Gilead Sciences Inc. v. U.S., Ex Rel. Campie. The decision to deny cert is the end of the road for the whistleblower case, and it leaves standing a Ninth Circuit decision that the government's continued approval and payment for products after learning of alleged regulatory infractions doesn't foreclose False Claims Act allegations. Read More
4D Pharma plc, of Leeds, U.K., and the University of Texas MD Anderson Cancer Center inked a collaboration to evaluate 4D's Live Biotherapeutic oncology pipeline across a range of cancer settings. The deal initially will assess lead candidate MRx-0518 as a potential treatment for solid tumors. Financial terms were not disclosed. Read More
