Biotechnology News

Merck (MRK) reported FDA accelerated approval for KEYTRUDA as monotherapy for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The approval was based on pooled data from KEYNOTE-158...
British drug major AstraZeneca Plc (AZN.L, AZN) and Merck & Co., Inc. (MRK) announced Tuesday that the European Commission has approved Lynparza (olaparib) as a 1st-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer. Lynparza is the only PARP inhibitor approved in the EU...
Amgen (AMGN) and Allergan plc (AGN) said that the U.S. Food and Drug Administration approved Kanjinti or trastuzumab-anns for all approved indications of the reference product, Herceptin or trastuzumab for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing...
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pharmaup-jun17.jpg The following are some of Monday's top gainers in the pharma/biotech sector.
q2-april16.jpg We have two more weeks left in June, and for the second quarter to end. Listed below are a few biotech companies that are slated to report their clinical study results in the coming weeks, if they stick to their timeline.
pharmaup-jun12.jpg The following are some of today's top gainers in the pharma/biotech sector.
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The FDA has issued a safety alert regarding the use of fecal microbiota for transplantation, or FMT, following reports of two adults who received the investigational FMT developing invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E.coli).

The FDA has pulled up Scottsdale, Arizona-based R3 Stem Cell LLC for marketing unapproved stem cell products for treating serious health conditions.

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Date Company Name Ticker Drug Event Outcome Details
10/19/2019 Clearside Biomedical, Inc. CLSD XIPERE (NDA) FDA decision on XIPERE for Suprachoroidal Injection for macular edema associated with uveitis
10/14/2019 Flexion Therapeutics, Inc. FLXN ZILRETTA (sNDA) FDA decision on the repeat administration of ZILRETTA for patients with osteoarthritis knee pain
09/28/2019 Amarin Corp Plc AMRN Vascepa (sNDA) FDA decision on Vascepa to reduce residual cardiovascular risk in patients with statin-managed LDL-C cholesterol
09/27/2019 Intra-Cellular Therapies, Inc. ITCI Lumateperone (NDA) FDA decision on Lumateperone for the treatment of schizophrenia
09/15/2019 AVADEL PHARMACEUTICALS PLC AVDL AV001 (NDA) FDA decision on AV001 for Hospital product
09/13/2019 Aimmune Therapeutics Inc. AIMT AR101 (BLA) FDA panel to review AR101 for Peanut Allergy
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
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Results Date Company Name Ticker Event Indication Outcome
Late 2019 Zosano Pharma Corporation ZSAN NDA filing for M207 Migraine
Late 2019 Oragenics Inc. OGEN Top-line results from phase II clinical trial of AG013 Oral Mucositis
Late 2019 Avenue Therapeutics, Inc. ATXI Filing of NDA for intravenous Tramadol Bunionectomy surgery
Late 2019 Caladrius Biosciences, Inc. CLBS Results from phase I/II proof of concept study of CLBS14 Coronary microvascular dysfunction
Late 2019 CTI BioPharma Corp. CTIC Full top-line data from ongoing phase II study of Pacritinib (PAC203) Myelofibrosis
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The IPO activity in the U.S. pharma/biotech sector has had a strong showing so far this year, with 32 listings till the end of May. Although the first half of June witnessed no IPO activity in the healthcare sector, the second half is going to be busy, and 5 companies are making their public debut in the week ahead.
Shares of Verrica Pharmaceuticals Inc. (VRCA) are up 12 percent year-to-date while the iShares Nasdaq Biotechnology ETF (IBB), a bellwether of investor sentiment, has gained only 8 percent for the same period.
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China's drug enforcement body said that the legalization of marijuana in Canada and some U.S. states are a "new threat to China". According to CNN, Liu Yuejin, deputy director of China's National Narcotics Control Commission, reported a surge in drugs being smuggled into China over the past year, with the illegal packages primarily linked to North America.
A California court has ruled that prison inmates can legally possess marijuana in their cells, but they cannot not use it. Last week, the Third District Court of Appeal in Sacramento overturned the conviction of five prison inmates who were found with marijuana in their cells. In 2016, California voters legalized recreational possession of less than an ounce of marijuana.
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Everyone dreads catching a viral infection. The word "virus" has its origin in Latin, which means slimy liquid or poison, and it has been associated with a number of disease outbreaks, epidemic, and pandemic. Now, let's take a look at some of the viruses that are posing a constant threat to mankind.
Spinal muscular atrophy or SMA is a genetic disease affecting the part of the nervous system that controls voluntary muscle movement.
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Shares of MeiraGTx Holdings plc (MGTX), which touched a 52-week low of $7.98 on July 25, 2018, have since gained more than 150 percent.
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