The highest biopharma story of the week includes the fast-moving area of lung most cancers, which, as we’ve written beforehand, has a number of key trials studying out in 2018.
An enormous domino fell this week: knowledge from a two-drug immunotherapy mixture developed by Bristol-Myers Squibb. However the outcomes, touted as constructive, left extra questions than solutions. First, Bristol modified the trial’s construction midstream. Second, it nonetheless hasn’t confirmed whether or not the mixture helps sufferers greater than its immunotherapy drug nivolumab (Opdivo) used alone. Extra outcomes are nonetheless to return.
Added up, the extremely anticipated knowledge led to a small inventory dip and many head-scratching. We’ll spherical up that story and the remainder of the week’s headlines beneath.
THIS WEEK IN DRUG COMBOS
—Bristol-Myers Squibb (NYSE: BMY) stated early knowledge from a lung most cancers examine validated “tumor mutation burden”—a measure of the genetic mutations on tumors—as a brand new approach to know which sufferers may benefit from its mixture of immunotherapies. However outdoors observers have been extra cautious, elevating questions on how the corporate is counting these tumor mutations.
—It was week of ups and downs for Gilead Sciences. Revenues proceed to dwindle for its hepatitis C franchise. However the FDA authorised bictegravir/emtricitabine/tenofovir (Biktarvy), a three-drug combo tablet for HIV important to Gilead’s future that Leerink’s Geoffrey Porges predicted may generate as a lot as $10 billion in peak annual gross sales. Rival GlaxoSmithKline (NYSE: GSK) promptly sued Gilead, claiming bictegravir infringes on a patent associated to GSK’s two-drug HIV tablet, dolutegravir/rilpivirine (Juluca).
—Celgene (NASDAQ: CELG) stated a three-drug routine of pomalidamide (Pomalyst), bortezomib (Velcade), and dexamethasome beat a bortezomib/dexamethasone combo in a Part three trial in sufferers with relapsed/refractory a number of myeloma.
—Two separate migraine drug races are underway: One to scale back the frequency of migraines, the opposite to take care of their signs higher. Allergan (NYSE: AGN) is testing its experimental tablet ubrogepant to deal with signs, and the drug this week cleared the primary of two Part three trials.
—In the meantime, within the migraine prevention race, Teva Pharmaceutical (NYSE: TEVA) stumbled. The FDA evaluate for its experimental drug fremanezumab could possibly be delayed by a 12 months on account of manufacturing points at a key provider. The company had been set to resolve on fremanezumab by June, a month after ruling on a rival drug from Amgen (NASDAQ: AMGN).
—Over within the startup world, Xoc Prescribed drugs, which goals to develop a migraine prevention tablet meant to leapfrog the medicine from Teva, Amgen, and others, raised a $30 million in Sequence A financing.
ON THE BELTWAY
—As Congress wrestled with new laws to offer terminally unwell sufferers extra entry to experimental medicine—doubtlessly with out FDA oversight—a gaggle of 38 affected person advocates and medical associations denounced the so-called “right to try” efforts.
—The brand new finances deal agreed to by Senate lawmakers this week would increase the Nationwide Institutes of Well being funding by $2 billion and add $6 billion to assist tackle the opioid disaster. Right here’s extra in Politico.
—Drug-price activist David Mitchell has fashioned a political group to again midterm election candidates who tackle excessive drug costs. He additionally co-authored a report within the journal Well being Affairs difficult the worth of Novartis’s cell remedy, Kymriah.
—EP Vantage reported that testing of Sarepta Therapeutics’s (NASDAQ: SRPT) experimental Duchenne muscular dystrophy drug golodirsen was halted within the U.Ok. final week on account of a doable security concern.
—Two separate research every delivered excellent news for prostate most cancers sufferers within the early levels of their illness—and superior an ongoing rivalry. Pfizer (NYSE: PFE) and Astellas launched constructive Part three knowledge for his or her prostate most cancers drug enzalutamide (Xtandi), and Johnson & Johnson (NYSE: JNJ) countered with outcomes from its experimental apalutamide (Erleada), acquired in J&J’s 2013 buyout of Aragon Prescribed drugs. Right here’s extra in FiercePharma.
—Roche’s Genentech group touted Part three knowledge for its immunotherapy drug atezolizumab (Tecentriq) mixed with bevacizumab (Avastin), additionally from Roche, in superior kidney most cancers.
—For the second time, Biogen’s (NASDAQ: BIIB) a number of sclerosis drug natalizumab (Tysabri) failed a Part 2 examine testing the drug in acute ischemic stroke victims.
—Amicus Therapeutics (NASDAQ: FOLD) launched further scientific trial knowledge displaying that sufferers with the uncommon muscle-wasting Pompe illness continued to enhance with therapy from the corporate’s drug.
AT THE INTERSECTION
—George Church’s Harvard College lab has spun out Nebula Genomics, which goals to assist folks them promote their genomic knowledge on to drug makers in transactions secured by blockchain know-how. The information comes quickly after San Diego’s Luna DNA, based by Illumina alumni, launched an analogous service.
—Andreessen Horowitz common associate Vijay Pande talked to Xconomy in regards to the rising function of synthetic intelligence within the life sciences.
—Sema4, the New York and Connecticut startup led by computational geneticist Eric Schadt, launched a diagnostic aiming to go properly past the standard exams hospitals run on new child infants to test for critical ailments.
—CNBC reported that Stephen Pal, recruited in 2016 to spice up Apple’s healthcare efforts, left the corporate late final 12 months. His LinkedIn web page lists him as an “independent entrepreneur.”
DEALS & RUMORS
—Theravance Biopharma (NASDAQ: TBPH) landed $100 million up entrance from Janssen Biotech in a partnership to develop a drug for inflammatory intestinal issues like ulcerative colitis and Crohn’s illness.
—Biotech billionaire Patrick Quickly-Shiong, already a stakeholder within the dad or mum firm of the Los Angeles Instances, reached a $500 million deal to purchase his hometown paper in addition to the San Diego Union-Tribune.
—Boston-based Pieris Prescribed drugs will get $30 million in a take care of Seattle Genetics (NASDAQ: SGEN) to develop a gaggle of most cancers immunotherapy medicine.
—Verastem (NASDAQ: VSTM) filed for FDA approval of duvelisib, a blood most cancers drug that has modified palms a number of occasions. Verastem purchased duvelisib from Inifinity Prescribed drugs in 2016.
—Juno Therapeutics (NASDAQ: JUNO) CEO Hans Bishop is in line for a greater than $270 million payday after Celgene (NASDAQ: CELG) acquires the Seattle firm. Safety filings present Bishop will obtain $205 million for his shares, plus $68 million for his inventory choices. He stands to realize extra from inventory tied to the corporate’s efficiency, and he’ll have his wage and well being advantages lined for 2 years.
—Nektar Therapeutics (NASDAQ: NKTR) is purchasing itself for a sale that might fetch $15 billion, Bloomberg reported, citing unnamed sources accustomed to the discussions. The San Francisco firm can also be contemplating choices that embody partnerships or licensing offers, Bloomberg stated.
MOVES & CUTS
—The Boston Enterprise Journal reported that Intarcia Therapeutics has reduce 60 jobs and ended two late-stage research of its implantable drug-delivery pump, ITCA 650.
—Intellia Therapeutics founding CEO Nessan Bermingham is rejoining Cambridge, MA-based Atlas Enterprise as a enterprise associate, and Genentech govt William Grossman has been named chief medical officer of Houston biotech Bellicum Prescribed drugs (NASDAQ: BLCM).
—San Diego biotech Arcturus Therapeutics (NASDAQ: ARCT) fired its CEO Joseph Payne final week. This week, Payne pushed again. His model of occasions was spelled out in a letter filed with the SEC.
Alex Lash and Frank Vinluan contributed to this report.
Ben Fidler is Xconomy’s Deputy Biotechnology Editor. You possibly can e-mail him at firstname.lastname@example.org Observe @benthefidler
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