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Home » Newsletters » BioWorld

BioWorld

June 21, 2018

View Archived Issues

Regulatory front

The FDA issued a statement Tuesday explaining the causes and progress being made toward resolving critical shortages of I.V. fluids, injectable opioid pain drugs and Mylan NV's Epipen (epinephrine) auto-injector.  Read More

Appointments and advancements

Atossa Genetics Inc., of Seattle, appointed Makarand (Mak) Jawadekar and Ajit Shetty to its strategic advisory board. Read More

Other news to note

Zosano Pharma Corp., of Fremont, Calif., disclosed the publication regarding Adhesive Dermally-Applied Microarray (ADAM) technology for the delivery of the migraine drug zolmitriptan in the Journal of Pharmaceutics. The test evaluated how different in vitro skin models influenced the absorption of zolmitriptan with ADAM.  Read More

Clinical data for June 20, 2018

Read More

Financings

Intiva Biopharma Inc., of Glendale, Colo., has filed to sell 2.46 million shares of common stock. According to its filing, it is developing drugs containing cannabinoids and/or terpenes for the treatment of various diseases. The company's shares trade on the OTCPink Market under the symbol NTVA. Read More

India considers new index for controlling drug prices

HONG KONG – The Indian government is considering new ways to regulate the prices of drugs, including the introduction of a new price index. Read More

Alzheimer's strategy takes center stage in Senate committee hearing

Politicians, scientists, health officials and advocates working to improve the lots of an estimated 5.7 million Americans living with Alzheimer's disease met in Washington Tuesday for a Senate Special Committee on Aging hearing on legislation promoting better management of the condition. If enacted, The Building Our Largest Dementia (BOLD) Infrastructure for Alzheimer's Act, first introduced late last year, would create a nationwide framework in which to implement Alzheimer's interventions focused on public health issues, such as increasing early detection and diagnosis, reducing risk, and preventing avoidable hospitalizations. With 35 co-sponsors, it's moving through the Senate Health Committee. Read More

TG, Novimmune aim to advance first anti-CD47 bispecific into the clinic

Fresh off presentations this month at the American Society of Clinical Oncology in Chicago and the European Hematology Association in Stockholm that confirmed continued progress in its late-stage pipeline, TG Therapeutics Inc. struck a deal to collaborate on the development and commercialization of a preclinical anti-CD47/anti-CD19 bispecific antibody discovered by Novimmune SA. The companies will jointly advance the fully human IgG1, known as TG-1801 (previously NI-1701), on a global basis with a focus on hematologic B-cell malignancies. Read More

MPM leads $75M series B as Iteos continues I-O work

LONDON – Immuno-oncology specialist Iteos Therapeutics SA has bounced back from Pfizer Inc.'s rebuff of its lead program, sealing a $75 million series B round that will enable the company to take forward two other compounds that aim to tweak the tumor microenvironment. Read More

Will price competition follow in the wake of incoming U.S. biosimilar wave?

Despite wishful predictions in the first years of the regulatory pathway, biosimilars have only lapped at the shoreline of the U.S. biologics market. But the tide is changing. Read More

Regulatory actions for June 20, 2018

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