21:28 , Jul 15, 2019 |  BC Extra  |  Politics & Policy

July 15 P&P Quick Takes: Senate bills for antibiotic de-linkage, germline editing; plus site inspections and PK guidance

Senators co-sponsor antibiotic de-linkage bill  Fourteen Democratic senators introduced legislation, the Affordable Medications Act ( S. 1801 ), that includes provisions to set aside $2 billion for an Antibiotics Innovation Incentive Fund that would grant...
01:48 , Jul 13, 2019 |  BioCentury  |  Product Development

Moving Beyond a Buzzword: How small- to mid-sized biotechs can adopt patient centricity in oncology trials

A major benefit of integrating the patient voice into clinical trials is the ability to speed enrollment, yet few companies take advantage of this due to the perception that it is too costly and time-consuming....
20:46 , Jun 13, 2019 |  BC Extra  |  Company News

Complex generic first to show ‘virtual’ bioequivalence with Certara’s modeling system

FDA's approval of an undisclosed complex generic via the ANDA pathway marks the first use of Certara's modeling systems, rather than clinical studies, to demonstrate bioequivalence. The Simcyp Simulator, a physiologically based pharmacokinetic (PBPK) modeling...
20:28 , Jun 12, 2019 |  BC Extra  |  Politics & Policy

Catalyst lawsuit challenges FDA's ability to bend the law to lower prices

FDA’s ability to bend the law to create competition for a drug is being challenged in federal court. The case, filed Tuesday by Catalyst against HHS and FDA, will test the agency’s ability to use...
03:07 , Jun 7, 2019 |  BC Innovations  |  Targets & Mechanisms

Following PARP, ATR axis next in line to expand synthetic lethal drug class

Promising ASCO readouts suggest targets in the ATR pathway are lining up behind PARP as the next drivers of “synthetic lethal” cancer killing. Biomarker and combination strategies presented at the American Society of Clinical Oncology...
02:43 , Jun 1, 2019 |  BioCentury  |  Product Development

ASCO 2019 abstracts show solid tumor race heating up among bispecifics and CAR Ts

While strong progress in CAR T therapies will again feature at this year’s ASCO meeting, bispecific antibodies are having a moment -- making more inroads into solid tumors than CAR Ts and branching out via...
22:54 , May 20, 2019 |  BC Extra  |  Company News

May 20 Company Quick Takes: LifeArc trades Keytruda royalties for $1.3B; plus Evotec-Just, Actelion-Owlstone, Genomind

LifeArc gets $1.3B for Keytruda royalties  U.K. medical research charity LifeArc sold an undisclosed portion of its royalties for Keytruda pembrolizumab to a subsidiary of the Canada Pension Plan Investment Board for $1.3 billion. LifeArc...
00:48 , May 17, 2019 |  BC Innovations  |  Tools & Techniques

Leaning on exosomes, model-informed drug development gets closer to tailoring doses to each patient

Model-informed drug development is poised to move into personalized dosing, with a little help from exosomes. An August FDA workshop aims to shed light on when and how to use these precision dosing models in...
19:53 , May 13, 2019 |  BC Extra  |  Company News

May 13 Company Quick Takes: PeptiDream/JCR, Grail, Lilly, Onconova/HanX, Regeneron

PeptiDream, JCR deal produces drug carriers for CNS delivery  The 2016 partnership between PeptiDream Inc. (Tokyo:4587) and JCR Pharmaceuticals Co. Ltd. (Tokyo:4552) has led to the development of constrained peptides that bind TFRC and are...
22:51 , May 7, 2019 |  BC Extra  |  Company News

Jacobus snags pediatric approval of rare autoimmune disease drug based on adult efficacy data

With the pediatric approval of Jacobus' Ruzurgi amifampridine to treat Lambert-Eaton myasthenic syndrome (LEMS) based on clinical data in adults, FDA could be signaling a shift towards greater acceptance of pediatric extrapolation. Last year, FDA...