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Home » Newsletters » BioWorld

BioWorld

Nov. 25, 2019

View Archived Issues

Novartis barrels into PCSK9 inhibitor market with $9.7B bid for The Medicines Co.

DUBLIN – Novartis AG is making a $9.7 billion bet that the economics of an siRNA-based drug can better those of monoclonal antibodies and thus provide it with a dominant position in a major but still emerging cardiovascular drug market. The Basel, Switzerland-based pharma made an $85 per share offer for The Medicines Co., which has taken inclisiran, an siRNA-based inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9) to the brink of an approval in reducing the risk of a cardiovascular event – heart attack or stroke – in high-risk patients with cardiovascular disease or high levels of low-density lipoprotein cholesterol (LDL-C) who are inadequately controlled on current therapies. Read More

Adamis shares fall as FDA issues CRL for its high-dose naloxone candidate

Shares of San Diego-based Adamis Pharmaceuticals Corp. (NASDAQ:ADMP) fell 51% to close Monday at 62 cents after the FDA issued a complete response letter regarding its high-dose naloxone injection candidate, Zimhi, for the treatment of opioid overdose. The agency raised questions about chemistry, manufacturing and controls (CMC), but not the candidate's safety or efficacy, the company said. Read More

Cymabay’s PPAR-delta dawn darkens; seladelpar bound for NASH mansion in sky?

Due to the “dynamic nature of the situation,” officials of Cymabay Therapeutics Inc. declined to comment on the stoppage of work with PPAR-delta agonist seladelpar, but in a press release they pointed to “a series of investigative actions [that have begun in order] to better understand these findings.”   Read More

Mixed clinical results jolt La Jolla Pharma

La Jolla Pharmaceutical Co. discontinued its study LJ401-BT01 due to lack of efficacy and will reassess further development of LJPC-401 (synthetic human hepcidin) based on recent mixed clinical results. Read More
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‘PhASTer’ susceptibility testing could improve antibiotic use, trials

One necessary step to fend off a dystopian future of medical care without antibiotics is the development of new antibiotics. Another is improved deployment of existing ones, a feat which will take, among other things, better antibiotic susceptibility testing (AST).  Read More

Australian researchers create kidney tissue from iPS cells

MELBOURNE, Australia – Researchers at the Murdoch Children’s Research Institute in Melbourne are pushing the boundaries on creating kidney tissue from stem cells. Read More

Population-based cancer registries needed for treatment, prevention efforts

SINGAPORE – Population-based cancer registries were a frequent focus of discussion at the ESMO Asia Congress. Read More

Panelists urge better designs, more global focus for phase I trials

SINGAPORE – While a lot of focus is placed on phase III trials and the subsequent approvals, panelists during the ESMO Asia Congress pointed to the importance of designing the right kind of phase I trials, from reaching global populations to using appropriate endpoints. Read More

Quality of life and quality of studies take stage as Takeda reports solid NSCLC findings

SINGAPORE – Takeda Pharmaceutical Co. Ltd. presented new findings from its phase III ALTA-1L trial evaluating its Alunbrig (brigatinib) vs. crizotinib in adults with advanced anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer (NSCLC) who had not received a prior ALK inhibitor, showing Alunbrig reduced the risk of disease progression or death by 76% after more than two years of follow-up. Read More

Asuragen to develop CDx for Huntington’s disease gene therapies

Austin, Texas-based Asuragen Inc. is joining forces with Wave Life Sciences USA Inc., of Cambridge, Mass., to change the fatal trajectory of Huntington’s disease.  Read More

Appointments and advancements for Nov. 25, 2019

New hires and promotions in the biopharma industry. Read More

Financings for Nov. 25, 2019

Biopharmas raising money in public or private financings. Read More

In the clinic for Nov. 25, 2019

Clinical updates, including trial initiations, enrollment status and data readouts and publications. Read More

Other news to note for Nov. 25, 2019

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief. Read More

Regulatory actions for Nov. 25, 2019

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More

Regulatory front for Nov. 25, 2019

The latest global regulatory news, changes and updates affecting biopharma. Read More

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