Biotechnology News

covidvaccine 1117 17sep21 A U.S. Food and Drug Administration advisory panel voted against the approval of COVID-19 booster shots for most people, but recommended the use of a third dose in people over age 65. The independent advisory panel on Friday voted 18-0 in emergency approval for the Pfizer-BioNTech's COVID-19 vaccine...
Protagonist Therapeutics, Inc. (PTGX) announced Friday the receipt of a verbal communication from the U.S. Food and Drug Administration (FDA) that Protagonist's clinical studies for rusfertide, an investigational product candidate currently in development, have been placed on a clinical hold. Dosing...
Intellia Therapeutics, Inc. (NTLA) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted the investigational new drug (IND) application for NTLA-5001, the company's first wholly-owned ex vivo CRISPR genome editing candidate for the treatment of cancer. NTLA-5001 is an autologous...
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TCR2 Therapeutics Inc. (TCRR) announced positive interim results from the ongoing phase 1 portion of the gavo-cel phase 1/2 clinical trial for mesothelin-expressing solid tumors. The company is very encouraged by the progression free survival and overall survival observed among patients with refractory...
Amgen (AMGN) announced Thursday that combining LUMAKRAS (sotorasib) with Vectibix (panitumumab) demonstrated encouraging efficacy and safety in patients with KRAS G12C-Mutated colorectal cancer or CRC. Based on these results and the urgent need for new therapies, the company announced the initiation...
Leap Therapeutics, Inc. (LPTX), a biotechnology company focused on targeted and immuno-oncology therapeutics, announced Thursday updated positive data from the DisTinGuish Study of DKN-01 Plus Tislelizumab. The company noted that DKN-01 plus tislelizumab and chemotherapy demonstrated compelling activity...
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pfizer sep17

Drug major Pfizer has again expanded the earlier two recalls of its anti-smoking Drug Chantix (Varenicline) in the form of tablets, to now include all the lots, for the potential presence of nitrosamine impurity, N-Nitroso- varenicline, at or above the FDA interim acceptable intake limit (ADI), the U.S. Food and Drug Administration or FDA said in a statement.

kroger sep17

Kroger Co. is recalling its 16-ounce Kroger bagged kale product, produced by Baker Farms, citing the possible contamination with Listeria Monocytogenes, a deadly bacteria, the U.S. Food and Drug Administration said. The recall includes 16-ounce bags of Kroger branded Kale, with the UPC 11110-18170 with a best by date of 09-18-2021.

buurmafarms sep16

Willard, Ohio-based Buurma Farms Inc. is recalling 320 boxes of its Plain Parsley citing possible contamination with Shiga-toxin producing E.coli, the U.S. Food and Drug Administration said. The recall involves Buurma Plain (flat leaf) Parsley with a harvest date of August 30, 2021 from their Gregory, Michigan location.

sevirolifoods sep15

Seviroli Foods Inc. is recalling H-E-B Jumbo Stuffed Shells - 22 oz citing the potential presence of foreign material in product, the U.S. Foos and Drug Administration said. The Bellmawr, New Jersey-based company initiated the recall after H-E-B was notified of four customer complaints of metal presence in the product.

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Results Date Company Name Ticker Event Indication Outcome
Nov 2021 Inhibrx, Inc. INBX Additional data from phase I trial of INBRX-109 Conventional chondrosarcoma
Q4 2021 Windtree Therapeutics Inc. WINT Data from phase 2 global study of Istaroxime Early cardiogenic shock
Q4 2021 Cardiff Oncology, Inc. CRDF Data readout from phase II trial of Onvansertib in combination with abiraterone and prednisone Abiraterone-resistant metastatic castrate-resistant prostate cancer
Q4 2021 NextCure Inc NXTC Data from Phase 2 monotherapy trial of NC318 Non-small cell lung cancer (NSCLC) adenocarcinoma cohort
Early Q4 2021 Entasis Therapeutics Holdings Inc ETTX Topline data from phase III registration trial of SUL-DUR ( ATTACK) Patients with pneumonia and bloodstream infections caused by carbapenem-resistant Acinetobacter baumannii
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The company we are profiling today is KalVista Pharmaceuticals Inc. (KALV), which is developing a franchise of oral treatments for HAE - both on-demand and prophylactic HAE drugs.
Shares of Doximity Inc. (DOCS) touched an all-time high of $104.98 in intraday trading Friday (Sep.3, 2021) and that reflects a gain of nearly 155% in just 51 trading days. Given the rapid adoption of virtual and online care tools, Doximity, which now serves over 30% of all US physicians with its paid telehealth offering, is well worth watching.
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According to new research, it is possible to prepare the immunity system against certain proteins called neoantigens beforehand to increase the response of the T cells and shrink cancer cells before they mature. A study published in the Cell says, researchers from the MIT and Koch Institute for...
The highest single day COVID death toll in more than seven months was reported in the United States on Thursday. With 3,393 additional casualties reported, the total number of the pandemic victims in the country reached 670,027, as per the latest data from Johns Hopkins University.
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As August draws to a close, let us take a look back at some of the regulatory headlines from that eventful month and look forward to what September has in store.
As July comes to a close, it's time to look back on some of the month's most important news and look forward to what August has in store. In a recent town hall meeting, the US President Joe Biden stated that he expected the FDA to fully approve the COVID-19 vaccines as soon as late August or early September.
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Shares of Inhibrx Inc. (INBX) have lost more than 40% of their value from their all-time high of $50.97, recorded last December, and trade around $29.
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