logo

Biotechnology News

Share
Swiss drug maker Roche (RHHBY) announced Thursday that the U.S. Food and Drug Administration has issued an Emergency Use Authorisation or EUA for the Elecsys IL-6 test to help in identifying patients at high risk of severe inflammatory response. Roche noted that the test can support physicians, in...
Immuno-oncology company Agenus Inc. (AGEN) announced Tuesday the FDA's clearance of AgenTus' IND application for an allogeneic iNKT therapy. AgenT-797 was submitted by AgenTus Therapeutics, a subsidiary of Agenus. A clinical trial for the treatment of patients with COVID-19 is expected to commence...
Swiss drug maker Roche (RHHBY) announced Tuesday that the US Food and Drug Administration has approved Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) to treat the most common, aggressive form of liver cancer. The approval is for treatment of people with unresectable or metastatic...
Read More
recarbrio june05 Today's Daily Dose brings you news about Adamas Pharma's date with the FDA; Cyclerion's near-term catalysts; the pipeline progress of Mereo; FDA approval of Merck's combination antibiotic Recarbrio for a new indication; and the bidding war for Tetraphase.
whitehouse jun04 Today's Daily Dose brings you news about the finalists in 'Operation Warp Speed' COVID-19 vaccine program; FDA approval of Fitbit Flow ventilator for emergency use; an update on Cassava's phase IIb study of PTI-125 in patients with Alzheimer's disease and promising initial data from Kezar Life's MISSION trial.
pharma 032218 03jun20 Today's Daily Dose brings you news about Agenus' foray into COVID-19 drug development space; AMERI Holdings' progress in glioblastoma multiforme drug development; BrainStorm Cell's anticipated milestone related to its amyotrophic lateral sclerosis drug candidate; Citius Pharma's path forward for antibiotic lock solution; Novartis' revised FDA decision date and stock offerings of EvoFem and OraSure
Read More

metformin jun02

Following the recall of type 2 diabetes medication Metformin Hydrochloride Extended-Release (ER) by Apotex last week, the U.S. Food and Drug Administration or FDA has recommended more pharmaceutical companies, who are manufacturers of the drug formulation, to recall their products.

fda recall apotex 052920

Apotex Corp. recalled all lots of type 2 diabetes medication Metformin hydrochloride in the form of oral film-coated tablets for the potential presence of nitrosamine impurity, N-Nitrosodimethylamine (NDMA), above levels of the Acceptable Daily Intake Limit (ADI), the U.S. Food and Drug Administration or FDA said in a statement.

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.

Read More
Date Company Name Ticker Drug Event Outcome Details
11/30/2020 Y-mAbs Therapeutics, Inc. YMAB Danyelza (BLA) FDA decision on Danyelza for the treatment of patients with relapsed/refractory high-risk neuroblastoma
11/27/2020 RHYTHM PHARMACEUTICALS, INC. RYTM Setmelanotide (NDA) FDA decision on Setmelanotide for pro-opiomelanocortin deficiency obesity and leptin receptor deficiency obesity
11/25/2020 Revance Therapeutics, Inc. RVNC DAXI (BLA) FDA decision on DAXI in the treatment of moderate to severe glabellar (frown) lines
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
Read More
Results Date Company Name Ticker Event Indication Outcome
Late 2020 Caladrius Biosciences, Inc. CLBS Final results from phase II clinical trial of CLBS12 Critical limb ischemia
Late 2020 Catalyst Pharmaceutical Partners Inc. CPRX Top-line results from proof-of-concept phase III trial of Firdapse Ambulatory patients with spinal muscular atrophy (SMA) type 3
Late 2020 Acceleron Pharma, Inc XLRN Topline results from phase II study of Luspatercept (BEYOND) Non-transfusion-dependent beta-thalassemia
Late 2020 ABIVAX SA ABVX.PA Top-line data from phase IIb clinical trial of ABX464 (ABX464-103) Moderate to severe active ulcerative colitis
Late 2020 Mirum Pharmaceuticals Inc. MIRM Top-line data readout phase III trial of Maralixibat(MARCH-PFIC) Progressive Familial Intrahepatic Cholestasis in children
Read More
The IPO activity in the U.S. healthcare sector, which has been somewhat tepid in the last two months, is picking up pace . Let's take a look at the U.S. healthcare IPOs scheduled for tomorrow.
After winning FDA nod for Xpovio in the treatment of relapsed or refractory multiple myeloma, Karyopharm Therapeutics Inc. (KPTI) is now awaiting the FDA decision on the same drug for another indication - i.e., in relapsed/refractory diffuse large B-cell lymphoma.
Read More
Late-stage biotech company Novavax Inc. (NVAX) announced Friday that it has been awarded a contract by the U.S. Department of Defense or DoD to manufacture COVID-19 vaccine candidate NVX-CoV2373. Under the deal, the company would deliver 10 million doses to DoD in 2020 that could be used in Phase...
Canadian cannabis company Aurora Cannabis is selling its entire stake in Alcanna to an underwriting syndicate led by Cormark Securities Inc. Canada-based Alcanna is one of the largest private sector retailers of alcohol in North America and the largest in Canada by number of stores, operating 231...
Read More
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.
Read More
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.
Read More