CHMP has recommended that Baqsimi (glucagon), a non-injectable treatment for severe hypoglycemia, be granted marketing authorization in the EU.

The packaging solution works to protect drugs with a 3-Phase Activ-Polymer solution, a technology that is customized for the drug developer’s formulation, offers a broad spectrum of specific drug protection, and oxygen and odor scavenging.

The new device can inject a range of drugs of different viscosities up to 35cP and different fill volumes up to 1mL.

The goal of the investment is for the cures to be made available across the globe, including in sub-Saharan Africa’s low-resource communities.

The partners have developed a scalable, cost-effective purification process for adeno-associated viruses.

The CPhI Pharma Index points to Germany as having consolidated itself into a leading pharma industry.

Dr. Reddy’s, Sanofi, and Perrigo Company issued voluntary recalls of ranitidine in October 2019 because of N-Nitrosodimethylamine contamination.

The therapy received positive results in a randomized, double-blind, placebo-controlled clinical trial in 34 adults with proven celiac disease.

Under the agreement, gene and cell therapy companies can go directly to Aldevron for NTC’s technology without acquiring a license from NTC.

The transaction is set to be completed in the first quarter of 2020.

Through the agreement, Foamix will have access to $20 million of financing to fund the commercial launches of the topical treatments.

The transaction is anticipated to close by the end of 2019.

The company will debut its new brand name, ALPLApharma, and its new childproof closure, the CRC justONE, at CPhI Worldwide from Nov. 5–7 in Frankfurt, Germany.

The new location is the first step in the company’s plan to invest in the North American market over the next two years.

Bikash Chatterjee, president and chief science officer at Pharmtech Associates and Girish Malhotra, president of EPCOT International, touch upon how manufacturing could be revolutionized by new technologies if regulators evolve to prevent hindering future innovation.

The new location was established to ensure uninterrupted support for clients’ trials in both the United Kingdom and Europe if the UK leaves the European Union on Oct. 31, 2019, especially in the event of a no-deal Brexit.

Antimicrobial resistance is now the third leading cause of death in the US. As developers continue to leave an unprofitable market, legislation and new reimbursement models propose to stimulate development of new antibiotics.

The winners will be announced on Nov. 5, 2019 on the first day of CPhI Worldwide.

On Tuesday Nov. 5, 2019, Dr. Meinolf Brackhagen from DuPont Nutrition & Biosciences will discuss the current and future roles of excipient suppliers

During day two of CPhI Worldwide in Frankfurt, Germany, Informa Pharma Intelligence will host a roundtable discussion regarding recent and future mergers and acquisitions.

The agency announced it has approved 1171 generic drugs in fiscal year 2019.

The guidance document discusses the preparation and submitting of drug master files as well as FDA’s review process.

The guidance discuses waivers, refunds, and reductions of user fees under sections 735 and 736 of the FD&C Act.

A complete understanding of primary packaging physicochemical properties is necessary in the formulation and development of biologics.

Over a two-year period, FDA inspections at company facilities found repeat problems with quality systems including lack of written procedures, inadequate investigation of out-of-specification conditions and corrective and preventive action, and insufficient cleaning and cleaning validation.

Orgenesis has signed a co-development agreement with Accelix to integrate advanced optic technologies, cartridges, and software onto POCare platform.

Nonacus has revealed the launch of its new capture kit, ExomeCG, which has been designed to simplify molecular and cytogenomics data generation and interpretation.

Sarah Hardison, head of Regulatory and Pharmacovigilance Solutions, Clarivate Analytics, will regulatory tackle trends in her presentation on the World of Pharma Podium during the second day of CPhI Worldwide.