BioSpace News Archive

Drug Development

Russia Plans 40,000 Patient Study for Approved Coronavirus Vaccine

Following approval of its coronavirus vaccine, the first in the world, Russia plans to initiate a new study involving 40,000 people as the country looks to boost production and distribute the drug to patients in that country, as well as to patients in countries it has struck deals with.

August 21, 2020
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2 min read
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Alex Keown
Drug Development

Clinical Catch-Up: August 17-21

It was a relatively quiet week for clinical trial news. Here’s a look.

August 21, 2020
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5 min read
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Mark Terry
Business

Boehringer Ingelheim to Pay $379,000 to Settle Wage Discrimination Charges

Boehringer Ingelheim’s Animal Health USA division will reimburse $379,089 in back pay and interest to 75 female employees to resolve alleged wage discrimination at its St. Joseph, Missouri, facility.

August 21, 2020
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3 min read
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Alex Keown
Drug Development

Third Patient Dies in Audentes’ Gene Therapy Study for Neuromuscular Disease

The trial remains on clinical hold and continues to indefinitely delay the company’s plans to seek regulatory approval for the treatment.

August 21, 2020
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2 min read
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Alex Keown
FDA

FDA Greenlights Novartis’ Kesimpta for Multiple Sclerosis

The U.S. Food and Drug Administration (FDA) approved Novartis’ Kesimpta (ofatumumab) for relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

August 21, 2020
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2 min read
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Mark Terry
Drug Development

Pfizer and BioNTech Release Additional Early-Stage Data on COVID-19 Vaccine

Today’s data describes key safety and immunogenicity data from the U.S. Phase I study for BNT162b.

August 21, 2020
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3 min read
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Mark Terry
Policy

FDA Action Alert: PTC and Roche, Lipocine, Incyte and Morphosys, and BMS

August has been a busy month for the U.S. Food and Drug Administration. The final two weeks are marked by a number of PDUFA dates, although a few of those drugs have already been approved.

August 21, 2020
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3 min read
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Mark Terry
Auxolytic’s Nutrient-Based Shut-Off Switch Boosts Cell Therapy Safety Without Transgenes

The process, auxotrophy, uses the engineered inability of an organism to synthesize a compound required for its survival to allow physicians to turn off a gene therapy if serious side effects develop.

August 21, 2020
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4 min read
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Gail Dutton
Policy

Tiziana Granted a Patent on the Use of Milciclib in Combination with Tyrosine Kinase Inhibitors for Treatment of Hepatocellular Carcinoma and other Cancers

Tiziana Life Sciences plc announces that the United States Patent and Trademark Office has granted a patent on use of Milciclib in combination with tyrosine kinase inhibitors such as Sorafenib, Regorafenib and Lenvatinib for the treatment of hepatocellular carcinoma and other cancers in humans.

August 21, 2020
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6 min read
Pharm Country

RenalytixAI to Collaborate with AstraZeneca to Improve Outcomes for Patients with Chronic DiseaseParties to adopt multi-phase approach to develop precision medicine strategies to optimize treatment of cardiovascular, renal and metabolic disease

Renalytix AI plc, announced a collaboration with AstraZeneca to develop and launch precision medicine strategies for cardiovascular, renal and metabolic diseases.

August 21, 2020
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9 min read