BioCentury | Mar 16, 2021
Product Development

March 16 COVID Quick Takes: FDA launches adverse events dashboard; plus Kintor, Boehringer, Apeiron, Moderna and more

FDA launched an FDA Adverse Event Reporting System (FAERS) public dashboard for COVID-19 drugs and biologics with emergency use authorization (EUA). The launch comes as EMA’s Pharmacovigilance Risk Assessment...
BioCentury | Jun 6, 2020
Product Development

June 5 Quick Takes: Merck, Tetraphase-Melinta, Apeiron, Neurasic, Jounce, Genmab-J&J

UCB buying Engage for $125M UCB S.A. (Euronext:UCB) acquired Engage Therapeutics Inc. Friday, gaining Staccato alprazolam, a drug-inhaler combo in Phase II testing for the rapid termination of epileptic seizures. Engage will receive $125 million...
BioCentury | Apr 3, 2020
Product Development

COVID-19 roundup: Amgen taps Adaptive as its antibody therapeutic partner; plus Alnylam-Vir’s siRNA targets, Ansun’s data and more

Amgen entered the race to develop an antibody-based COVID-19 therapy Thursday, partnering with Adaptive Biotechnologies to screen for neutralizing mAbs. The day also saw Alnylam and Vir name the first targets from their siRNA partnership...
BioCentury | Sep 21, 2018
Emerging Company Profile

Aprinoia tackles tau

...those targets, and then find therapies,” CEO Ming-Kuei Jang told BioCentury. The company’s lead diagnostic, APN-1607...
...the tau tracer technology from National Institutes for Quantum and Radiological Science and Technology, optimized APN-1607...
...that it is unclear why APN-1607 behaves differently than these other agents but added that APN-1607...
BioCentury | May 19, 2017
Company News

EC opens investigation into Aspen's EU pricing practices

...The European Commission began a formal investigation of Aspen Pharmacare Holdings Ltd. (JSE:APN) amid concerns that...
...that is committed to "fair and open" markets in the EU. Aspen Pharmacare Holdings Ltd. (JSE:APN...
BioCentury | May 11, 2017
Clinical News

EC approves EUSA's dinutuximab beta for high-risk neuroblastoma

EUSA Pharma Ltd. (Hemel Hempstead, U.K.) said the European Commission approved an MAA for dinutuximab beta (APN311) to treat high-risk neuroblastoma in patients ages ≥12 months. Last year, Apeiron Biologics AG (Vienna, Austria) granted EUSA...
BioCentury | Mar 31, 2017
Clinical News

Isqette regulatory update

EMA's CHMP recommended approval of an MAA from Apeiron for Isqette dinutuximab beta to treat high-risk neuroblastoma under EMA's exceptional circumstances clause. It is recommended in patients ages ≥12 months who achieved a partial response...
BioCentury | Mar 24, 2017
Company News

CHMP backs Orphan candidates, PD-1 mAbs

On Friday, EMA's CHMP recommended approval of several candidates, including Orphan disease therapies Isqette dinutuximab beta ( APN311 ) from Apeiron Biologics AG (Vienna, Austria) and Refixia nonacog beta pegol from Novo Nordisk A/S (CSE:NVO; NYSE:NVO). It...
BioCentury | Oct 10, 2016
Company News

Apeiron Biologics, EUSA Pharma deal

Apeiron granted EUSA exclusive, worldwide rights to commercialize pediatric neuroblastoma candidate Isqette dinutuximab beta ( APN311 ). The chimeric mAb against ganglioside GD2 (GD2) is under review in the EU. EUSA plans to submit a BLA...
BioCentury | Sep 19, 2016
Company News

GlaxoSmithKline, Aspen deal

...inquiries (see BioCentury, July 29, 2013). GlaxoSmithKline plc (LSE:GSK;NYSE:GSK), London, U.K. Aspen Pharmacare Holdings Ltd. (JSE:APN...
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