Biotechnology News

Biopharmaceutical company Cerecor Inc. (CERC) said Thursday it has received clearance from the U.S. Food and Drug Administration to proceed with a proof-of-concept clinical trial of its anti-LIGHT monoclonal antibody CERC-002 in patients with COVID-19 cytokine storm induced Acute Respiratory Distress...
Swiss drug maker Roche (RHHBY) announced Thursday that the European Medicines Agency or EMA has approved a new, shorter two-hour OCREVUS (ocrelizumab) infusion time, dosed twice yearly, for relapsing or primary progressive multiple sclerosis or MS. The approval is based on a positive opinion from...
intravenous 052720 The U.S. Food and Drug Administration granted approval for Artesunate for Injection 110 mg, powder and solvent for solution to biopharmaceutical company Amivas (US), LLC as the only FDA-approved drug now in the U.S. for the first-line treatment of severe malaria in adult and pediatric patients. It is also the first FDA-approved product that Amivas has introduced to their commercial portfolio.
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logos may28 Today's Daily Dose brings you news about NantKwest teaming up with ImmunityBio to accelerate the development of vaccines and therapeutics for COVID-19; Mersana's promising data in ovarian cancer and non-small cell lung adenocarcinoma trial and Arcus' 10-year partnership with Gilead, among others.
logos may27 Today's Daily Dose brings you news about Alnylam Pharma's regulatory catalyst in December; argenx' generalized myasthenia gravis trial data; Atara's multiple sclerosis trial data and stock offering; Merck's deals and collaboration to develop an effective response to the COVID-19 pandemic; Novavax' progress in a COVID-19 vaccine trial and Osmotica Pharma's near-term catalysts.
vaccines may26 As the companies race against time to develop antibiotics or vaccines against the novel coronavirus, here's what happened in the COVID-19 drug/vaccine development space in the week that went by.
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acellapharma may26

The U.S. Food and Drug Administration or FDA announced that Acella Pharmaceuticals, LLC recalled certain lots of hypothyroidism medication NP Thyroid in the form of tablets due to super potency. The company is recalling 13 lots of NP Thyroid that are packaged in 100 count bottles in strengths of 30 mg, 60 mg, and 90 mg, with expiration dates between June 20, 2020, and December 20, 2020.

biotabiosciences may21

Biota Biosciences recalled certain lots of pain suppressing medication Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin in the form of injectables as they were marketed without the approval of the U.S. Food and Drug Administration or FDA. Biota Biosciences is a supplier and contract manufacturer of wholesale, private label, and white label CBD Hemp Oil products.

cbdoil may18

Summitt Labs voluntarily recalled one lot of Kore Organic Watermelon CBD oil tincture to the consumer level after the product was found to contain high levels of lead. Ingestion of the oil tincture containing lead could result in high lead exposure and acute lead poisoning. The company issued the nationwide recall for Batch#730 Lot#K018 of the Kore organic watermelon CBD oil tincture.

ramarfoods may18

Ramar Foods is recalling one flavor of Peekaboo ice cream sold through Target stores in four states, citing possible presence of Listeria monocytogenes, the U.S. Food and Drug Administration said in a statement. The recall involves 14 ounce packages of Peekaboo branded Mint Chocolate Chip with Hidden Spinach Ice Cream product.

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Date Company Name Ticker Drug Event Outcome Details
11/24/2020 Liquidia Technologies Inc. LQDA LIQ861 (NDA) FDA decision on LIQ861 for the treatment of pulmonary arterial hypertension
11/23/2020 Roche Holding AG RHHBY Nnew formulation of Xofluza (NDA) FDA decision on Xofluza for the treatment of acute uncomplicated influenza in otherwise healthy children aged one to less than 12 years of age who have been symptomatic for no more than 48 hours
11/23/2020 Roche Holding AG RHHBY New formulation of Xofluza as one-dose granules for oral suspension (NDA) FDA decision on new formulation of Xofluza treat the flu (influenza) in people 12 years of age and older
11/23/2020 Roche Holding AG RHHBY Xofluza (sNDA) FDA decision on Xofluza for treatment of acute uncomplicated influenza in otherwise healthy children aged one to less than 12 years of age who have been symptomatic for no more than 48 hour
11/23/2020 Roche Holding AG RHHBY Xofluza (sNDA) FDA decision on Xofluza for post-exposure prophylaxis of influenza in people one year of age and older
11/16/2020 Bristol-Myers Squibb Co. BMY Lisocabtagene maraleucel (BLA) FDA decision on Lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies
11/15/2020 Alkermes plc ALKS ALKS 3831 (NDA) FDA decision on ALKS 3831 for the treatment of schizophrenia and for the treatment of bipolar I disorder
11/15/2020 Amgen Inc. AMGN KYPROLIS (sNDA) FDA decision on KYPROLIS in combination with dexamethasone and DARZALEX® (daratumumab) for patients with relapsed or refractory multiple myeloma
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Results Date Company Name Ticker Event Indication Outcome
2H 2020 Therapix Biosciences Ltd. TRPX Top line results from phase IIb, placebo-controlled 12-week clinical trial of THX-110 Tourette Syndrome TS
Q3 2020 Otonomy Inc. OTIC Top-line results from phase III trial of OTIVIDEX Ménière's disease
2H 2020 Aridis Pharmaceuticals Inc ARDS Interim data from phase III pivotal trial of AR-301 Acute pneumonia caused by S. aureus infection
2H 2020 CHIASMA, INC CHMA Top-line data from phase III clinical trial of octreotide capsules (MPOWERED) Adult patients with acromegaly
2H 2020 MyoKardia Inc MYOK Topline results from phase III study of Mavacamten (EXPLORER-HCM trial) Hypertrophic Cardiomyopathy Positive results announced on May 11, 2020
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Shares of Axcella Health Inc. (AXLA) have been dismally performing since their listing on the NASDAQ on May 9, 2019. The stock is down more than 70 percent over the last 1 year.
Irvine, California-based Inari Medical is slated to debut on the Nasdaq Global Select Market, under the symbol 'NARI', on May 22, 2020.
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The number of coronavirus deaths in the United States has topped the 100,000 mark nearly hundred days after the first COVID-19 infection in the country was reported in Washington. The death toll is around as many Americans who died from Covid-19 as from the accumulated number of US troops killed in Korea, Vietnam, Iraq and Afghanistan wars over decades. In a reverse trend, new coronavir
Cresco Labs Inc., a multi-state cannabis operator, said it has entered into agreements with Verdant Creations, LLC that will provide it the option to purchase four additional medical marijuana dispensaries in Ohio currently operated by Verdant. Cresco will pay $375,000 in cash and $500,000 of its...
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The FDA has been focusing mainly on COVID-19-related review since March. But that said, the regulatory decision on drugs proposed for rare tumors and life-threatening diseases has not been deferred. Now, let's take a look at the biotech stocks awaiting a regulatory decision in the month of June.
The ongoing COVID-19 pandemic has sickened over 3.25 million people and has killed 233,014 people, according to data from Johns Hopkins University.
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Shares of HOOKIPA Pharma Inc. (HOOK) are down 44 percent from their 52-week high of $14.38, recorded last April, and trade around $8.
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