Pharma News

It is well known that pharma companies are ready to chip on shoulders with rival companies in any regulatory or marketing disputes. Recently pfizer has took a dig against Amgen, Johnson & Johnson and Genentech for allegedly distribiting false and misleading information about use of biosimilars in the U.S. Pfizer filed citizen petition and requested FDA that they should issue guidance to ensure truthful and non-misleading communications by sponsors concerning the safety and effectiveness of biosimilars, including interchangeable biologics.

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Ensuring that food is safe and truthfully labeled is one of our fundamental responsibilities at the U.S. Food and Drug Administration. Consumers deserve accurate information about the food they eat and how it can affect their health and nutrition. That’s why Congress entrusted the FDA to serve as the nation’s expert on food safety and labeling and to craft predictable, uniform federal requirements on matters within our jurisdiction. Consistent with that authority, we work to provide the best advice possible to Americans about the foods they eat based on the most recent scientific information, taking into account the food’s benefits in addition to any potential health risks.

The U.S. Food and Drug Administration announced it has warned four more online networks, operating a total of 21 websites, illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol. The warning letters issued by the FDA to each of the networks state that they must immediately stop illegally selling these products to American consumers.

Children react differently to medicines than adults, which is why it is important that medicines are properly studied and demonstrated to be safe and effective for minors.

The task force  set up by European Union (EU) regulators to better address potential problems with medicines’ supply and to avoid shortage. Improving the availability of human and veterinary medicines authorised in the EU is a key concern.  The task force will develop and coordinate actions for better prevention, identification, management of and communication on issues that can affect the availability of medicines, in order to improve continuity of supply of human and veterinary medicines across Europe.

Adverum Biotechnologies, Inc a clinical-stage gene therapy company targeting unmet medical needs in serious rare and ocular diseases, today announced its Investigational New Drug (IND) application is active for the planned multi-center, open-label, Phase 1, dose-escalation study of ADVM-022, a novel gene therapy candidate for the treatment of wet age-related macular degeneration (wAMD).

Nebula Genomics announced that it has raised $4.3M million in seed financing with participation from 10 leading venture capital firms. The funds will support the company’s mission to usher in the era of personal genome sequencing by creating a trusted, secure, and decentralized marketplace for genomic data. The company also has forged a partnership with Veritas Genetics, the leading whole genome sequencing and interpretation company, that will connect the Nebula marketplace to Veritas’ Arvados open-source software platform.

KaNDy Therapeutics, a clinical-stage Women’s Health company, today announces it has successfully closed a Series C financing round, raising £25 million from new US investor Longitude Capital, and existing internationally recognised life sciences investors Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed.

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle because of customer complaints that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL).

The U.S. Food and Drug Administration  approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye).