For Bristol-Myers, A Victory And A Mystery

In a relief to investors, the combination of Opdivo and Yervoy extends survival in melanoma. More data being released this afternoon could yield answers to the question of why Opdivo did not show a benefit in previously untreated lung cancer.【阅读原文】

Astellas to buy GPCR specialist Ogeda for €500M upfront

Astellas has struck a deal to buy Ogeda for €500 million ($534 million) upfront. The takeover will give Astellas a potential nonhormonal treatment for menopausal hot flushes that cleared a phase 2a trial earlier this year.

Gosselies, Belgium-based Ogeda has accepted an offer of €500 million upfront and up to €300 million in clinical and regulatory milestones from Astellas. Ogeda, which until October was known as Euroscreen, landed the buyout bid on the strength of clinical data generated by its lead asset, NK3 receptor antagonist fezolinetant, also known as ESN364.【阅读全文】

Kite Presents Ongoing Response Rate in Plenary Session from its Pivotal CAR-T Trial of Axicabtagene Ciloleucel in Patients with Aggressive Non-Hodgkin Lymphoma at the 2017 American Association of Cancer Research Annual Meeting

Kite Pharma, Inc., (Nasdaq:KITE) today announced two plenary presentations of positive data from the primary analysis of ZUMA-1 for its lead CAR-T candidate, axicabtagene ciloleucel, in patients with refractory aggressive B-cell non-Hodgkin lymphoma (NHL) at the 2017 American Association of Cancer Research Annual Meeting in Washington, D.C. Both presentations were given by Frederick L. Locke, M.D., the ZUMA-1 Co-Lead Investigator, and Director of Research for the Immune Cell Therapy Program at Moffitt Cancer Center in Tampa, Florida.【阅读全文】

Patients with lung cancers responsive to immunotherapy drug beat standard odds of survival

More than seven years after the start of one of the first clinical trials of the immunotherapy drug nivolumab, researchers at the Johns Hopkins Kimmel Cancer Center report that the five-year survival estimate for a limited subset of people with advanced nonsmall cell lung cancer taking the drug is 16 percent, compared with a historical survival rate for that group of 1 to 4 percent.【阅读全文】

BeiGene Presents Phase IB Data on RAF Dimer Inhibitor BGB-283 at the 2017 American Association for Cancer Research Annual Meeting

BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today presented data from the Phase IB dose expansion study of RAF dimer inhibitor BGB-283 in patients with B-RAF or K-RAS/N-RAS mutated solid tumors in an oral presentation during a Clinical Trials Plenary Session at the 2017 American Association for Cancer Research (AACR) Annual Meeting in Washington, DC. BGB-283 is a novel inhibitor of RAF, in both its monomeric and dimeric forms, and has demonstrated activity in both B-RAF and K-RAS-mutated tumors in preclinical studies and in the Phase IA dose escalation portion of this Phase I study. In the Phase IB portion, BGB-283 has generally been well-tolerated at a dose of 30 mg once a day (QD) and has continued to show antitumor activity not only in subjects with B-RAF V600-mutated solid tumors, but also in subjects with K-RAS-mutated solid tumors.【阅读全文】

Bristol-Myers Squibb and Incyte to Advance the Combination of Opdivo (nivolumab) and Epacadostat into First-line Registrational Trials

Bristol-Myers Squibb Company (NYSE:BMY) and Incyte Corporation (Nasdaq:INCY) today announced the companies have agreed to advance their clinical development program evaluating the combination of epacadostat, Incyte’s investigational oral selective IDO1 enzyme inhibitor, with Opdivo (nivolumab), Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, into phase 3 registrational studies in first-line non-small cell lung cancer across the spectrum of PD-L1 expression and first-line head and neck cancer.【阅读全文】

Intrexon, ZIOPHARM and Merck KGaA, Darmstadt, Germany Advancing Next-Generation Non-Viral CAR-T Platform Empowered by Membrane-Bound IL-15 Under RheoSwitch Therapeutic System Control

Intrexon Corporation (NYSE:XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, ZIOPHARM Oncology (NASDAQ:ZIOP), a biopharmaceutical company focused on new immunotherapies, and Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced an update on the development of next-generation chimeric antigen receptor T cell (CAR-T) therapy for cancer as part of their strategic collaboration and license agreement.【阅读全文】

Jazz Pharmaceuticals Completes Rolling Submission of New Drug Application for Vyxeos (CPX-351), an Investigational Treatment for Acute Myeloid Leukemia

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the completion on March 31, 2017 of a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of Vyxeos™ (cytarabine and daunorubicin) liposome for injection, an investigational treatment for acute myeloid leukemia (AML), a rapidly progressing and life-threatening blood cancer. 1 The company has requested a priority review for the Vyxeos NDA, which, if granted, would accelerate the expected timing of the FDA's review.【阅读全文】

FDA hands over full approval to AZ’ Tagrisso

US regulators have issued a full approval for AstraZeneca’s lung cancer drug Tagrisso on the back of a strong progression-free survival (PFS) benefit observed in a late-stage trial.

The drug had already picked up an accelerated approval for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) whose disease has progressed on or after an EGFR tyrosine kinase inhibitor (TKI) therapy.【阅读全文】

Patent rulings knock Acorda and Forward

It was a bloody Friday for two biotechs that ended up on the wrong side of US patent court decisions. Verdicts handed down by the Patent Trial and Appeal Board (PTAB) mean that Acorda Therapeutics is on track to see generic competition for its multiple sclerosis drug Ampyra as early as next year. Separately, Forward Pharma could miss out on a substantial royalty stream owing to a negative decision on its claims on Biogen’s multiple sclerosis pill Tecfidera.【阅读全文】

Sucampo bags rare disease player Vtesse in $200M buyout agreement

Just a little more than two years after it was launched, the single-asset biotech Vtesse is being bought out by Sucampo for $200 million up front.

Vtesse spun out of the incubator Cydan with a Series A that eventually swelled to $42 million. The biotech used the cash to advance a human study into a new drug — which picked up a breakthrough drug designation — for rare cases of Niemann-Pick type C1 disease. And Rockville, MD-based Sucampo pledged backers a royalty stream on any marketing revenue.【阅读全文】

Lilly, Pfizer, et al. back Sanofi and Regeneron in PCSK9 patent appeal. AbbVie doesn't

Big Pharma is enthralled with the Amgen vs. Sanofi patent fight, and for good reason: Its outcome could affect their in-development meds—and farther up the pipeline, their decisions to advance candidates at all.

The reason: Amgen, which makes the cholesterol-fighting Repatha, is asserting an antibody patent that, if upheld, could give the California biotech the power to push Sanofi and Regeneron’s rival PCSK9 drug off the market. And it’s a type of patent that has the potential to allow Amgen—and other drugmakers in other fields—to stake out a claim to an entire class of therapies, or so Sanofi’s legal team said in a recent phone conference with reporters.【阅读全文】

Paratek shares shoot up as positive PhIII and a shot at FDA OK for its antibiotic fuel a market rally

Shares of Paratek shot up 30% $PRTK in after-market trading on Monday as investors reacted to the Boston biotech’s proclamation of a clean sweep for its pivotal test of its new antibiotic omadacycline. Execs said that their broad spectrum antibiotic hit its primary and secondary endpoints for the FDA as well as the co-primaries needed for the EMA in their second positive late-stage trial.【阅读全文】

#AACR17 roundup: Bristol-Myers, Merck KGaA and Pfizer in the spotlight, marking progress with checkpoints

Now that the first wave of PD-1 checkpoint inhibitors have been in use for awhile, we’re starting to see just how durable they can be for some patients. In an update on Opdivo at AACR, Bristol-Myers Squibb reports that they tracked a 5-year survival rate of 16% for patients with advanced cases of non-small cell lung cancer.

Based on historical data, Bristol-Myers says that patients in that category once could only expect a survival rate of less than 5%.【阅读全文】