Chimerix Acquires Oncoceutics to Expand Pipeline with Late-Stage Oncology Program
January 08, 2021 06:00 ET | Source: Chimerix, Inc. Chimerix, Inc.
ONC201 Registrational Trial for Recurrent H3 K27M-mutant Glioma
Compelling Response Rates to Date; Defined Regulatory Path to Registration Pivotal Data Anticipated in 2021 to Support Potential Registration, Addressing an Estimated Market Opportunity of Greater than $500 Million
Management to Host Conference Call at 8:30 a.m. ET Today
DURHAM, N.C., Jan. 08, 2021 (GLOBE NEWSWIRE) Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that the Company has acquired Oncoceutics, Inc., a privately-held, clinical-stage biotechnology company developing imipridones, a novel class of compounds. Oncoceutics’ lead product candidate, ONC201, has been shown in clinical testing to selectively induce c
FDA slaps craft distilleries with fees for producing hand sanitizer at the onset of the COVID-19 pandemic Posted By Nina Rangel on Thu, Dec 31, 2020 at 12:03 PM click image Instagram / rangercreekwhiskey Craft distillers just can’t catch a break this year. Along with the hardships brought about by the pandemic such as the closure of their tasting rooms the Food and Drug Administration is now telling distilleries that produced hand sanitizer at the start of the pandemic that they ll need to pay a steep fee, the
The FDA is now informing the businesses that, due to a technical detail in recent pandemic relief legislation, they now owe the government more than $14,000, according to the newspaper.
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CytRx Corporation (OTCQB:CYTR) ( CytRx or the Company ), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today provided an update on the U.S. Food and Drug Administration s ( FDA ) review of Orphazyme A/S s (NASDAQ:ORPH) ( Orphazyme ) New Drug Application ( NDA ) for arimoclomol to treat Niemann-Pick Disease Type C ( NPC ). According to Orphazyme, the FDA has extended the review period with a standard extension of three months in order to complete the NDA review. The updated Prescription Drug User Fee Act ( PDUFA ) target action date is June 17, 2021.
Orphazyme disclosed that the FDA has confirmed that the NDA remains under Priority Review. The FDA grants Priority Review to applications for potential therapies that, if approved, could offer a significant improvement in safety or effectiveness, diagnosis, or prevention of serious conditions. Notably, the FDA has confirmed that the extensi
Protalix BioTherapeutics Issues 2020 Letter to Shareholders
USA - English
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CARMIEL, Israel, Dec. 30, 2020 /PRNewswire/ Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx
® plant cell-based protein expression system, today announced the following letter from its President and Chief Executive Officer, Dror Bashan, to its shareholders and the investment community.
Dear Protalix shareholders,
As we look forward to 2021 with great anticipation, I want to take a moment to reflect on our transformational accomplishments this past year, which has been unlike any we could have imagined. Together with our development and commercialization partner, Chiesi Global Rare Diseases, we submitted to the U.S. Food and Drug Administration (FDA) a Biologics License Application (BLA)
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Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for LORBRENA
® (lorlatinib) as a first-line treatment for people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). The sNDA is based on data from the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in April 2021.
LORBRENA is a third-generation ALK inhibitor specifically developed to inhibit the most common tumor mutations that drive resistance to current medications and to address brain metastases. Up to 40% of people with ALK-positive lung cancer present with brain metastases.