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FDA Announces Public Meeting on Generic Drugs
FDA Commissioner Scott Gottlieb announced the agency will hold a public meeting on drug competition as part of its Drug Competition Action Plan.
MA Governor Announces $500-Million Investment in Life-Science Industry
Charlie Baker announced a plan to invest up to $500 million in the MA life-science industry.
Sandoz Scores European Approval for Biosimilar Rituximab
The European Commission approved Rixathon for use in all indications of its reference medicine, MabThera.
BIO Releases Workforce Principles for the Biotechnology Industry
The organization released principles related to workforce development, diversity, and inclusion that it believes are key to the biotechnology industry.
Bio-Rad Launches Assay Kit for Zika, Dengue, and Chikungunya Detection
The RT-PCR kit can simultaneously screen samples for Zika, dengue, and chikungunya arbovirus RNAs.
Thermo Fisher Scientific Announces New Chromatography Technologies
The company announced its new ISQ EC Single Quadrupole mass spectrometer and the new range of Thermo Scientific MAbPac RP 1-mm columns.
MilliporeSigma Receives its First CRISPR Patent
The company was granted patent rights to the use of CRISPR in a genomic integration method for eukaryotic cells.
Agilent Adds Products to InfinityLab LC Series
The company added new products to its InfinityLab LC Series which will be showcased at HPLC 2017 in Prague.
Alvogen Recalls Clindamycin Injection Because of Sterility Problems
The company has voluntarily recalled Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level because of a lack of sterility assurance.
Hospira Recalls Sodium Bicarbonate
The company recalled a variety of products due to the potential of microbial contamination.
EMA Progresses on Brexit Plans
The agency’s management board discussed plans for the relocation of EMA at its June 2017 meeting.
Advanced Pharma Recalls Nitroglycerin Products
The company is voluntarily recalling all unexpired lots of nitroglycerin products produced at its Houston location for potency issues.
Basilea Announces Distribution Agreements with Pfizer and Avir Pharma Inc
Basilea Pharmaceutica International Ltd. entered into a distribution and license agreement with Pfizer and Avir Pharma Inc. to distribute Basilea’s antifungal treatments.
JSR Life Sciences to Acquire Selexis SA
Selexis will be integrated with KBI Biopharma, which was acquired by JSR Life Sciences in 2015.
Baxter and Dorizoe Agree to Develop More Than 20 Generic Injectables
The companies announced an agreement where Dorizoe will work with Baxter to develop more than 20 generic injectable products.
Congress Struggles to Address Drug Prices
Congressional measures lack the support to move forward.
SSB Integrates Automated Cell Culture Analyzer and Micro-Bioreactor
Sartorius Stedim Biotech combined the company’s ambr 15 bioreactor system with the Nova BioProfile FLEX2 cell culture analyzer for laboratory experiments.
FDA Warns Company Over Drug Listing Failures
The agency sent a warning letter to A-S Medication Solutions LLC after it found the company didn’t comply with drug listing file requirements.
Irvine Scientific Adds R&D Center in CA
The company added a 40,000-ft2 purpose-built R&D center at 17112 Armstrong Ave, Irvine, CA.
FDA to Hold Public Meeting on Opioids
FDA Commissioner Scott Gottlieb announced the July meeting as part of his commitment to address opioid abuse.
Rentschler Biotechnologie and Rentschler Fill Solutions Partner on Fill/Finish
The companies are partnering to provide new fill/finish facilities and solutions for biopharmaceutical products.
Compounding Facility Cited for Lack of Sterile Conditions
FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.
Waters Collaborates with IonSense
The companies are collaborating to interface the Waters Acquity QDa Mass Detector with the IonSense DART ionization source.
J&J Completes Acquisition of Actelion
The company said it expects to transaction to close on June 16, 2017.
Europe, Japan, and US Align on Antibiotics
The three regulatory agencies have agreed to data requirements for development of new antibiotics.
Supreme Court Rules in Amgen v. Sandoz
The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.
EMA to Evaluate Liver Problems Linked to Zinbryta
In its June meeting, the agency’s Pharmacovigilance Risk Assessment Committee discussed medicine safety reviews.
Lilly and KeyBioscience Join Forces on DACRAs
The companies will collaborate on the development of dual amylin calcitonin receptor agonists for patients with Type 2 diabetes.
Novartis Releases Interim Analysis of CAR-T Therapy
The company released an interim analysis from its JULIET study with CTL019.
FDA Asks Endo to Remove Opioid From Market
FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.
