Biotechnology News

Genentech, a member of the Roche Group (RHHBY), said that the U.S. Food and Drug Administration approved Tecentriq or atezolizumab, in combination with carboplatin and etoposide or chemotherapy, for the initial or first-line treatment of adults with extensive-stage small cell lung cancer or ES-SCLC. The...
British drug maker AstraZeneca Plc (AZN.L, AZN) announced Monday that US Food and Drug Administration has granted Orphan Drug Designation or ODD for saracatinib, a potential new medicine for the treatment of idiopathic pulmonary fibrosis or IPF. IPF is a type of lung disease that results in scarring...
Becton, Dickinson and Company (BDX) announced the U.S. FDA has granted premarket approval for the Venovo venous stent, the first stent indicated to treat iliofemoral venous occlusive disease, which is obstructed or narrowed blood flow specific to the iliac and femoral veins located near the groin. "The...
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pharma-daily-071918_15mar19.jpg Today's Daily Dose brings you news about the positive progress of Atossa Genetics' Oral Endoxifen as a post-mastectomy treatment for breast cancer; BioLife Solutions' stellar fourth-quarter financial results; BioPharmX Corp's anticipated milestones in 2019; revised FDA decision date of Karyopharm's Selinexor; and clinical trial catalysts of SCYNEXIS.
tickers-march11.jpg The clinical trial results of a drug company can impact its stock price depending upon the outcome - and more so if it is a small-/mid-cap biopharma stock. A keen understanding of the target timeline of the clinical trials will help trade biotech stocks with some margin of safety around the catalyst events.
pharma-022717_06mar19.jpg Today's Daily Dose brings you news about Invitae's secondary offering; BIOLASE's fourth-quarter financial results; Celgene's regulatory catalyst in September; and Endologix's reverse stock split, and the resignation of Scott Gottlieb as FDA Commissioner.
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Mount Olive, N.C. establishment Butterball, LLC is recalling approximately 78,164 pounds of raw ground turkey products that may be contaminated with Salmonella Schwarzengrund. The problem was discovered by FSIS and public health partners, who had been investigating a multistate outbreak of Salmonella Schwarzengrund illnesses involving 5 case-patients from 2 states.

There is an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of Pfizer Inc's (PFE) Xeljanz or Xeljanz XR is used in patients with rheumatoid arthritis, warns the FDA.


The FDA has added Boxed Warning to the label of gout medicine Uloric that highlights the increased risk of death with the drug.


The World Health Organization has warned consumers to be on vigil against fake versions of leukemia drug Iclusig sold in Europe and the Americas.

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Date Company Name Ticker Drug Event Outcome Details
09/03/2019 Celgene Corporation CELG Fedratinib (NDA) FDA decision on Fedratinib for myelofibrosis
09/02/2019 Roche Holding AG RHHBY Tecentriq (sBLA) FDA decision on Tecentriq plus chemotherapy in metastatic non-squamous non-small cell lung cancer
08/19/2019 Nabriva Therapeutics NBRV Lefamulin (NDA) FDA decision on oral and IV formulations of Lefamulin for bacterial pneumonia
07/06/2019 Karyopharm Therapeutics Inc. KPTI Selinexor (NDA) FDA decision on Selinexor for patients with refractory multiple myeloma
06/30/2019 Dova Pharmaceuticals, Inc. DOVA DOPTELET (sNDA) FDA decision on DOPTELET for chronic immune thrombocytopenia
06/26/2019 Regeneron Pharmaceuticals REGN Dupixent (sBLA) FDA decision on Dupixent for severe chronic rhinosinusitis with nasal polyps
06/21/2019 Agios Pharmaceuticals, Inc. AGIO TIBSOVO (sNDA) FDA decision on TIBSOVO for newly diagnosed acute myeloid leukemia with IDH1 mutation
06/10/2019 Merck & Co Inc. MRK KEYTRUDA (sBLA) FDA decision on KEYTRUDA as Monotherapy or in combination with Chemotherapy
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Results Date Company Name Ticker Event Indication Outcome
Jun 2019 Hancock Jaffe Laboratories, Inc. HJLI Results from pre-clinical feasibility study of CoreoGraft Coronary artery bypass surgery
Mid 2019 Conatus Pharmaceuticals Inc CNAT Results following extension period in ENCORE-PH trial Liver cirrhosis caused by nonalcoholic steatohepatitis (NASH), and severe portal hypertension
Mid 2019 Alnylam Pharmaceuticals Inc. ALNY Topline results from Phase III confirmatory trial of Inclisiran (ORION -9) Heterozygous familial hypercholesterolemia
Mid 2019 Alnylam Pharmaceuticals Inc. ALNY Top line results from Phase III confirmatory trial of Inclisiran in the U.S. (ORION-10) Reduce LDL-cholesterol in patients with atherosclerotic cardiovascular disease
Mid 2019 Alnylam Pharmaceuticals Inc. ALNY Top line results from phase III confirmatory trial of Inclisiran in the Europe (ORION-11) Reduce LDL-cholesterol in patients with atherosclerotic cardiovascular disease
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Shares of Ascendis Pharma A/S (ASND) closed yesterday's trading at an all-time high of $125.29, and that represents a gain of nearly 100% year-to-date.
Shares of Lantheus Holdings Inc. (LNTH) are up an impressive 53% year-to-date, way ahead of the iShares Nasdaq Biotechnology ETF (IBB) index, which has gained only 20% during the same period.
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Shares of Tilray Inc. rose more than 2 percent in after-hours trading on Monday after the Canadian marijuana company's fourth-quarter revenue more than tripled from the prior year and beat analysts' expectations. The company also said its strategic partnerships and acquisitions position it to accelerate global sales growth and drive long-term shareholder value.
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Alzheimer's is the 6th leading cause of death in the U.S., and there is no cure yet for this neurodegenerative disease. The available medications for Alzheimer's can only alleviate symptoms temporarily, and they don't work for everyone.
After a banner year in 2018, the novel drug approval is off to an uncharacteristically slow start this year. No novel drug was approved in January while three were approved in February.
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It's been a year since we started the column "This Day That Year" featuring some of the biotechs that have completed a year of listing. Here's a look back at the journey of those stocks so far and look ahead at some of what's in store for them.
Shares of BioXcel Therapeutics Inc. (BTAI) are down nearly 47% from their all-time high of $14.79 recorded on July 10, 2018.
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