Here is a summary of key advances in biotechnology over the 24 hours.
(Biotechnology peaked at 52 weeks on January 14)
(Biotechnology reached a minimum of 52 weeks on 14 January)
DBV informs FDA about peanut allergy patches: a well-defined regulatory pathway
Feedback obtained from the FDA regarding possible resolutions proposed through DBV to FDA considerations related to the effect of patch adhesion and the need for patch modifications provide a well-defined regulatory pathway, the company said.
In order to verify consistency of efficacy knowledge between existing and modified patches, the FDA requested an evaluation comparing allergen absorption among patches in four- to 11-year-olds with peanut allergy. The FDA also conducts a well-controlled 6-month protective and adherence trial to evaluate the modified Viaskin Peanut patch in the target patient population.
Inventory rose 55. 61% to $5. 82 after hours.
Teva Pharmaceutical Industries Ltd (NYSE: TEVA) has announced the availability of a generic edition of NuvaRing 0. 120 mg / 0. 015 mg consistent with the day in the United States, indicated for use in women until pregnancy.
The company said it is expanding production of its COVID-19 Linea verification kit and pattern collection kits to meet the expected call from existing customers, its safeCircle service and due to increased interest in the verification kit following a recent FDA alert that met the check. as an EU-approved molecular diagnostic control that can potentially identify certain SARS-CoV-2 mutations.
Inventory rose 6. 62% to $9. 50 in pre-marketing on Friday.
Pfizer Inc. (NYSE: PFE) said the FDA approved the new application for a new drug for Xalkori for the treatment of paediatric patients over the age of 1 and young adults with recurrent or refractory giant mobile anaplastic lymphoma that is ALK positive. ALCL is a rare form of non-Hodgkin’s lymphoma and accounts for approximately 30% of LNH cases in other young people, and approximately 90% of ALCL cases in other young people are ALK positive, the company said.
AstraZeneca plc (NASDAQ: AZN) said its Imfinzi had been approved in the European Union and the United Kingdom for an additional dosing option, a steady dose of 1500 mg every 4 weeks in non-complex and irretectable mobile lung cancer in adults whose explicit PD-L1 tumors in at least 1% of tumor mobiles and whose disease did not progress after platinum-based chemorradiation.
The examination showed that biopsied lesions based on known genomic atypsy criteria through pla were related to melanoma enrichment nearly five times in patient samples with biopsies only based on visual evaluation criteria.
On Friday, in pre-marketing, inventory rose 3. 35% to $41.
Kadmon Holdings Inc (NASDAQ: KDMN) reacted to a presentation to the SEC indicating that the Point72 Asset Management hedge fund had 5. 3% in the company.
Inventory rose 5. 08% to $4. 97 after hours.
Operating out of hours, inventory 11. 16% to $28. 49.
Lantern Pharma Inc. (NASDAQ: LTRN) valued its public provision at $4. 286 million, which is not unusual consistent with $14 percentages consistent with the consistent percentage for gross revenue of $60 million. All non-unusual consistent percentages are presented through Lantern Pharma.
Inventory dropped 1. 79% to $14. 25 in pre-marketing on Friday.
AsCO Symposium Presentations on Gastrointestinal Cancer
Agios Pharmaceuticals Inc (NASDAQ: AGIO): Mature knowledge about the overall survival of the Tibsovo Phase 3 ClarIDHy exam in patients with mutant cholangiocarcinoma IDH1 treated in the past
Incyte Corporation (NASDAQ: INCY: Preliminary knowledge on protection and efficacy for a phase 1/2 trial comparing the arginase inhibitor INCB001158 plus chemotherapy in patients with complex bile duct cancer (the authorized asset through Calithera Biosciences Inc (NASDAQ: CALA))
AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO): AstraZeneca Imfinzi results in patients with first-line metastatic hepatocellular carcinoma
Zymeworks Inc (NYSE: ZYME): Effects of Zanidatamab Phase 1 in HER2-Expressing and HER2-Expressing Gastroesophageal Adenocarcinoma and After Presentation of Phase 2b Monotherapy Effects with Zanidatamab in Subjects with Metastatic Bile Duct Cancers or complexes amplified with HER22
Merus NV (NASDAQ: MRUS): Phase 1 knowledge of higher doses of MCLA-158 in metastatic colorectal cancer
Related Link: To the attention of biotechnology investors: Mark your calendar for the January dates of PDUFA