A roundup of developments and latest news from China (Dollar Tree), Germany (Bayer), India (Zydus Cadila), and the United States (Entera Bio, Torrent Pharma).

China

FDA Issues Warning Letter to Retailer Dollar Tree for GMP Violations for OTC Products

The US Food and Drug Administration has issued a Warning Letter to Greenbrier International, doing business as US-based retailer Dollar Tree, for receiving over-the-counter (OTC) drugs produced by foreign manufacturers found to have what the FDA termed as “serious violations of federal law.”

The Warning Letter outlines multiple violations of cGMP at contract manufacturers used to produce Dollar Tree’s Assured Brand OTC drugs as well as other drug products sold at retailer Dollar Tree and Family Dollar stores.

The Warning Letter details Dollar Tree’s receipt of adulterated drugs from manufacturers that received FDA Warning Letters in 2018. It also details the company’s use of contract manufacturers that received Warning Letters for similar issues between 2016 and 2019. The Warning Letters show a pattern of violations, such as not testing raw materials or finished drugs for pathogens and quality. Manufacturers that received these Warning Letters were placed on import alert, which is used to prevent potentially violative products from being imported into the US market. The FDA said it notified Dollar Tree of Warning Letters sent to these manufacturers at the time the Warning Letters were sent.

Source: FDA

Germany

Bayer, Dewpoint In $100-Million R&D License Pact for Cardio and Gynecological Diseases

Bayer and Dewpoint Therapeutics, a drug-discovery company specializing in biomolecular condensates, have agreed to a $100-million partnership option and research and license agreement to develop new treatments for cardiovascular and gynecological disease.

Under the agreement, Bayer would contribute up to $100 million. The partnership will leverage Dewpoint’s proprietary platform for biomolecular condensates and Bayer’s small-molecule compound library to develop new treatments for cardiovascular and gynecological diseases.

Under the agreement, Bayer will gain the option to exclusively license a specified number of novel therapeutics derived from the research activities. Bayer will contribute with its small- molecule compound library and research and development capabilities, including high- throughput screening and medicinal chemistry. As part of this partnership, Bayer and Dewpoint will broaden Dewpoint’s presence in Germany and foster local capabilities.

Many proteins act as part of complexes in biomolecular condensates, droplet-like membraneless organelles that form dynamically to carry out a wide variety of functions in cells. Condensates have historically been understudied because they are difficult to analyze with traditional drug-discovery methods such as protein crystallography and biochemical activity assays. A new wave of research into condensates could provide new insights into cellular function and disease.

Source: Beyer, Dewpoint Therapeutics

India

FDA Issues Warning Letter To Zydus Cadila

The US Food and Drug Administration has issued a Warning Letter to Zydus Cadila, an Ahmedabad, India-based pharmaceutical company, for GMP violations for finished pharmaceuticals at its formulation facility in Moraiya, India formulation facility. The inspection occurred from April 22 to May 3, 2019

The agency’s observations included inadequate cleaning procedure for non-dedicated equipment resulting in cross-contamination, inadequate investigations into failures during periodic qualification cycles, operators displaying poor aseptic practices during aseptic set-up and filling operations, and a deficient environmental and personnel monitoring program.

Zydus Cadila says it has taken multiple steps after the inspection to address the observations noted by the FDA. The company says it will continue to take all necessary steps to ensure that the FDA is satisfied with its remediation of the Moraiya facility. The company says the Warning Letter does not affect the existing business of the company in the US and that existing product supplies from the Moraiya facility will continue.

Source: Zydus Cadila, US Food and Drug Administration

United States

Entera Bio Establishes US Headquarters

Entera Bio, a product-focused biotechnology company specializing in the oral delivery of large molecules and biologic, has established a US headquarters in the Boston, Massachusetts area

Entera Bio Inc., Entera Bio’s wholly owned Delaware subsidiary, established its US headquarters in the Boston area (Wellesley, Massachusetts) to be centrally located near Boston’s biotechnology center and New York’s banking center. The company’s research and development operations will continue to be located in Jerusalem, Israel, where the company says that much of the company’s collaboration, clinical and CMC (chemistry, manufacturing and controls) efforts will expand to support anticipated growth.

In addition, Entera Bio has appointed Jonathan Lieber as its US-based Chief Financial Officer (CFO), responsible for all investor relations, finance and administration functions. He currently serves as a managing director of Danforth Advisors, and most recently served as CFO of Histogenics, a publicly traded cell therapy company. He additionally held the roles of CFO for Metamark Genetics and CFO and Treasurer of Repligen.

Source: Entera Bio

FDA Issues Warning Letter to Torrent Pharma for Its Pennsylvania Mfg Facility

The US Food and Drug Administration (FDA) has issued a Warning Letter to Torrent Pharma, an Ahmedabad, Gujarat, India-based pharmaceutical company, for GMP violations for finished pharmaceuticals at the company’s drug-manufacturing facility in Levittown, Pennsylvania following an FDA inspection from March 11 to April 9, 2019.

Torrent Pharma manufactures phenobarbital oral solution, USP and hydrocortisone acetate suppositories, 25 mg. The FDA said that these drugs are unapproved new drugs and are misbranded. In its Warning Letter, the FDA says it observed several violations, including producing drug products, such as rectal suppositories and oral solutions, using an inadequate water system and an inadequate investigation into failing microbiological results from the water system.

In addition to the observations from the inspection, the FDA said the phenobarbital oral solution, USP and hydrocortisone acetate suppositories, 25 mg are misbranded. A drug is considered misbranded if, among other things, it fails to bear adequate directions for its intended use. “Adequate directions” means directions under which a layman can use a drug safely and for the purpose for which it was intended. The FDA said that these two drugs are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners and are considered prescription drugs.

Source: US Food and Drug Administration