Biotechnology News

The European Commission has approved Merck & Co. Inc.'s (MRK) anti-PD-1 therapy, Keytruda, in combination with chemotherapy for the first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumors express PD-L1 and who have not received prior chemotherapy...
Swiss drug major Roche (RHHBY) announced Friday the U.S. Food and Drug Administration approval of the VENTANA PD-L1 (SP263) Assay in non- small cell lung cancer or NSCLC as a companion diagnostic test for Tecentriq (atezolizumab). The company noted that the VENTANA PD-L1 Assay helps determine which...
The U.S. Centers for Disease Control and Prevention's or CDC Advisory Committee on Immunization Practices or ACIP voted Thursday to recommend the use of a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level for people aged 65 and older; people aged 18 to 64 who are at high risk of severe...
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Regeneron Pharmaceuticals Inc. (REGN) and Sanofi said that phase 3 results from a trial, which evaluated Dupixent or dupilumab in adults with uncontrolled prurigo nodularis, met its primary and all key secondary endpoints. The trial results showed that Dupixent significantly reduced itch at 12 weeks,...
Swiss drug major Roche (RHHBY) announced Friday the U.S. Food and Drug Administration approval of the VENTANA PD-L1 (SP263) Assay in non- small cell lung cancer or NSCLC as a companion diagnostic test for Tecentriq (atezolizumab). The company noted that the VENTANA PD-L1 Assay helps determine which...
Pfizer Inc. (PFE) and BioNTech SE (BNTX) said that results from a phase 3 randomized, controlled trial, which evaluated the efficacy and safety of a 30-µg booster dose of their COVID-19 vaccine in more than 10,000 individuals 16 years of age and older, showed a relative vaccine efficacy of 95.6% compared...
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smilinbobs oct22

Smilin' Bob's is recalling a limited amount of Smilin' Bob's Original Smoked Fish Dip products, due to undeclared egg, an allergen, the U.S. Food and Drug Administration said. The agency noted that certain Original Smoked Fish Dip was mistakenly packed in Smilin' Bob's Natural Smoked Fish Dip cups with a Original Smoked Fish Dip lid.

merck oct21

Merck & Co., Inc., known as MSD outside the U.S. and Canada, has recalled one lot of intravenous antibiotic Cubicin (daptomycin for injection) 500 mg for the potential presence of particulate matter identified as glass particles, the U.S. Food and Drug Administration or FDA said in a statement.

ivarssoupandsauce oct20

Mukilteo, Washington-based Ivar's Soup and Sauce Co. is recalling 14,968 sleeves of refrigerated Kettle Classic Clam Chowder With Uncured Bacon citing the possible presence of hard, sharp opaque plastic pieces, the U.S Foof and Drug Administration said. The products were sold exclusively at Costco stores.


Los Angeles, California- based Chocolate and the Chip is recalling various bakery products as it may contain undeclared allergens, including wheat, milk, soy, and tree nuts, the U.S. Food and Drug Administration said. The recall involves chocolate chip cookies, cookie bundt cakes and rice crispy treats. The affected cookies were packaged in uniform pairs in a clear resealable plastic package.

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Results Date Company Name Ticker Event Indication Outcome
2022 NovoCure NVCR Interim analysis from phase III trial to test the efficacy and safety of TTFields (PANOVA-3) Pancreatic adenocarcinoma
Q1 2022 Allena Pharmaceuticals, Inc. ALNA Interim data from phase III program of Reloxaliase (URIROX-2) Enteric hyperoxaluria
2022 Johnson & Johnson JNJ Completion of phase I/II clinical trial of M254 Idiopathic thrombocytopenic purpura (ITP)
1H 2022 STEALTH BIOTHERAPEUTICS CORP MITO Results from phase IIb study of Elamipretide (ReCLAIM-2) Geographic atrophy
1H 2022 ProQR Therapeutics PRQR Top-line data from phase II/III trial of Sepofarsen (QR-110) ( ILLUMINATE) Leber's congenital amaurosis 10
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Shares of Harmony Biosciences Holdings Inc. (HRMY) have gained 42% over the last three months to trade around $39. The company markets Wakix for the treatment of excessive daytime sleepiness in adults with narcolepsy. It is the first and only FDA approved non-scheduled treatment option for narcolepsy. The clinical utility of Wakix is also being explored beyond narcolepsy.
Shares of 4D Molecular Therapeutics Inc. (FDMT) have more than halved from their 52-week high of $54.98, recorded in March of this year, to trade around $26.
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The United States on Thursday reached an important milestone in its fight against the Covid-19 pandemic. The U.S. Government, which committed to donate 1.2 billion vaccine doses along with lifesaving assistance to countries in need to enhance their ability to get shots into arms, has so far donated and delivered 200 million COVID-19 vaccine doses to the rest of the world.
A group of doctors based in the UK has come up with a case study where an octogenarian woman suffering from lung cancer has seen tumor regression after using CBD oil. The doctors are looking at this case as a possible hypothesis that can be used for very important research on the effects of Cannabidiol...
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The FDA approved 3 novel drugs in the month of September, bringing the total number of novel drug approvals so far this year to 39. Let's take a look at the biotech stocks facing FDA decision in October.
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.
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Taysha Gene Therapies Inc. (TSHA), a pivotal-stage gene therapy company, has a couple of clinical, regulatory and preclinical milestones lined up for the remainder of this year. The company has 26 AAV-based gene therapies under development for the treatment of monogenic diseases of the central nervous system...
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