BioSpace News Archive

The moment you step on the job market, you’re selling yourself. Yes, you, the job seeker, are a “brand,” and each touchpoint you have with a potential new employer is an opportunity to “sell” that brand, that vision of your candidacy, the promise of yourself as a future team member and employer.

MorphoSys AG announces that it was informed that in its lawsuit against Janssen Biotech and Genmab A/S, the United States (U.S.) District Court of Delaware has ruled in a Court Order on January 25, 2019, that the asserted claims of three MorphoSys patents with U.S. Patent Numbers 8,263,746, 9,200,061 and 9,758,590 are invalid.

CAS DataLoggers Engineer Terry Nagy Solves a Unique Problem

The U.S. Food and Drug Administration issued a Complete Response Letter to the company in November, one month after an advisory committee rejected the drug. When the FDA issued the CRL, the regulatory agency requested additional clinical data on QT prolongation and indicated that the submitted safety database is not of adequate size for the proposed dosing.

Rentschler Biopharma SE announced the appointment of Dr. Christian Hunzinger (48) as the new Senior Vice President Project Management, effective from January 15, 2019.

Pfizer and Eli Lilly and Co. announced that their tanezumab hit two out of three co-primary endpoints in one dose and all three with a higher dose in patients with moderate-to-severe osteoarthritis (OA) pain in a Phase III trial.

Real-world evidence (RWE) or real-world data (RWD) relates to the collection of information about a drug’s safety and efficacy outside the structure of a clinical trial. Speaking yesterday, FDA Commissioner Scott Gottlieb laid out the FDA’s new framework for dealing with RWE and RWD.

The U.S. Senate Finance Committee and the House Oversight Committee started hearings on Tuesday, January 29, focused on dealing with high drug prices.

Karolinska Development’s portfolio company Umecrine Cognition announces overall results from a phase 2a study with the candidate drug GR3027 in patients with idiopathic hypersomnia.

Singapore Exchange-listed Singapore eDevelopment Limited wishes to announce that its U.S. biomedical subsidiary, Global BioLife Inc. has a product known as 3F Antimicrobial Fragrance which shows efficacy against tuberculosis.