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FDA Releases New and Revised Product-Specific Generic Drug Guidance
The agency released several new and revised guidance documents regarding product-specific generic drug development.
Saneca Pharma Receives GMP Certification from Russian Regulator
Saneca has been granted approval to manufacture and supply multiple dosage forms to Russia.
Thermo Fisher Scientific to Acquire Patheon
Thermo Fisher will acquire Patheon for approximately $7.2 billion, including the assumption of approximately $2 billion of net debt.
Biogen Buys Stroke Treatment from Remedy for $120 Million
The company purchased Cirara from Remedy Pharmaceuticals for $120 million.
Catalent Biologics Collaborates with Therachon to Develop Novel Protein Therapy for Achondroplasia
Catalent has signed an agreement with Therachon to support preclinical and clinical development of TA-46, a novel protein being developed to treat achondroplasia.
Catalent to Manufacture Lexicon Pharmaceuticals' Orphan Drug Xermelo
Catalent has been working together with Lexicon to develop the drug formulation of Xermelo, which has now been approved by FDA for the treatment of carcinoid syndrome diarrhea.
EMA Approves First Electronic Lockout Device for Pain Management
Aptar Pharma’s e-Lockout device uses advanced electronic technology to limit the number of doses available during a 24-hour period, thereby ensuring safe patient compliance to Takeda’s pain-relieving nasal spray.
Patheon Completes Expansion at Greenville Facility
The company invested approximately $26 million to update its sterile pharmaceutical and development service suites.
Emergent BioSolutions Unveils Expanded Maryland Facility
The company held a ribbon cutting ceremony at its new Center for Innovation in Advanced Development and Manufacturing in Maryland.
Charter Medical, INCELL Announce Distribution Agreement
The partnership provides Charter Medical the exclusive rights to market, sell, and distribute INCELL media products on a global basis.
Cell Culture Media Polymer Designed for Lot-to-Lot Consistency
MilliporeSigma released a new surface-active nonionic polymer to ensure lot-to-lot consistency.
Pfizer and Sangamo Team Up on Hemophilia A Gene Therapy
The companies entered a license agreement that includes Sangamo’s SB-525, one of the company’s lead product candidates for the treatment of Hemophilia A.
FDA Warns Vikshara Trading & Investments Ltd
FDA sent a warning letter to the company in India for delaying and limiting an FDA inspection in addition to problems related to cGMP.
Modernizing Organic and Elemental Impurities Standards
At CPhI North America 2017, the US Pharmacopeial Convention will be discussing its upcoming revision and modernization of the standards for elemental and organic impurities.
Avantor Expands cGMP Product Portfolio
The company will display its expanded supply chain product portfolio at CPhI North America 2017.
CPhI North America Hosts Women’s Leadership Forum
The Women’s Leadership Forum includes a panel of female executives from the pharmaceutical and specialty chemicals market.
PhRMA Increases R&D Criteria for Member Companies
More stringent R&D investment requirements for PhRMA membership reduces the association ranks by 22 associate and member companies.
Aseptic Filling Machine for Vials for Fast Changeover
The Dara SX-310-PP/D aseptic filling, stoppering, and capping machine for vials features full servo-driven automation and a compact footprint.
Syrris Launches Titan System at CPhI North America/InformEx
The company will be releasing its Titan continuous process scale-up system at CPhI North America/InformEx 2017.
Halo Pharma Forms Pediatric Center of Excellence
The company has formed a Pediatric Center of Excellence in support of the development and manufacture of dosage forms for pediatric indications.
FDA Moves Forward on Mutual GMP Inspections with Europe
FDA hopes to better use global resources and avoid duplicate inspections of foreign facilities.
Oxford Genetics Licenses CRISPR Gene Editing Technology from ERS Genomics
Licensing agreement will expand Oxford Genetics bio-therapeutic discovery, design, and development service business.
Bosch Introduces Continuous OSD Manufacturing Platform
Bosch’s Xelum platform is designed for continuous production of oral solid-dosage forms.
CPhI Worldwide Experts Make Predictions for 2017
Industry experts forecast the changes to the pharma industry for 2017.
Comar Redesigns DoseGuard Valved Bottle Adapter
The new DoseGuard design is compatible with standard 20-mm containers.
CPhI Worldwide Announces 2017 Advisory Board
CPhI Worldwide announced new additions to its 2017 advisory board.
C.O. Truxton Expands Recall
The company is expanding their April 2017 voluntary recall of phenobarbital tablets.
EMA Finds Patient Involvement Beneficial
The agency released its report on pilot project to involve patients in the assessment of medicines.
Compounding Pharmacy Cited for Unlicensed Biologics
FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.
Gottlieb Faces Multiple Challenges at FDA
User fee reauthorizations, a hiring freeze, and opioid epidemic await the new FDA commissioner Scott Gottlieb.
