Manufacturing, Combination Drugs

Under a new pact, Genentech and PeptiDream will collaborate to discover and develop novel peptide-radioisotope drug conjugates.

API supplier Olon has started construction of a new manufacturing facility in Milan, Italy, which will be dedicated to production of cytotoxic payloads and linkers for ADCs.

ImmunoGen has formed a research collaboration with Oxford BioTherapeutics to develop novel antibody-drug conjugates for cancers with high unmet needs.

The author describes how to seize market opportunities while navigating the requirements of both drug therapies and delivery devices.

The two companies signed an exclusive collaboration agreement for the Aidaptus auto-injector.

Piramal Pharma Solutions plans to construct a multipurpose ADC manufacturing and aseptic fill/finish facility in Grangemouth, Scotland, and to upgrades its existing API manufacturing facility in Morpeth, England.

Experts share best practices in designing, manufacturing, and scaling up dry powder inhaler and metered dose inhaler drug–device combination products for inhalation drug delivery.

Trends affecting primary pharmaceutical packaging include the shift to more complex drug-device combination products.

The contraceptive is expected to receive new chemical entity designation from FDA, giving it patent protection beyond 2030. It will be launched in early 2021, pending FDA approval.

The company has expanded its high-potency API capability at its Riverview, MI, facility to serve the growing antibody drug conjugates market.

A simple, one-part DPI aims to make inhalation drug treatment more accessible and affordable.

API can be mixed with silicone and other polymers to create drug-delivery combination products.

Aptar now manufactures its child-resistant pump, designed to meet US CPC requirements, at its facility in Congers, New York.

Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.

The authors discuss regulatory and patent issues with combination products.

PMMI, The Association for Packaging and Processing Technologies, released a report on trends opportunities in packaging of pharmaceuticals and medical devices that predicts increased spending on capital equipment for processing and packaging.

Mylan CEO Heather Bresch appeared before the House Committee on Oversight and Government Reform on Sept. 21, 2016 to explain the company’s decision to increase the price of EpiPen more than 400%. The meeting comes after multiple members of Congress raised concerns about the price of the life-saving drug, which is used to treat anaphylaxis.

Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.

The new regulations aim to introduce greater consistency and uniformity in the assessment and approval of medical devices and in-vitro diagnostics across the European Union.

The agency has announced the creation of the Combination Products Policy Council to address issues related to combination products.

Curida entered into a partnership with René Bommer, PhD, founder and owner of pharmAccel Consulting.

The agency gives an update on the regulation of combination medical products.

Mark D. Kramer talks about combination products from a regulatory perspective and explains the implications of FDA's final rule on current GMP requirements for combination products.

Combination product design takes second prize in the National Collegiate Inventors and Innovators Alliance Biomedical Engineering contest.

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.

Fixed-dose combination drug therapies give rise to innovation in solid-dosage formulations and manufacturing.

Watson Laboratories has recalled two lots of hydrocodone bitartrate and acetaminophen tablets.

FDA Sets Limits for Acetaminophen in Prescription Combination Products

Abuse-deterrent combination drugs represent a niche area in formulation development.

The US Food and Drug Administration issued a proposed rule to clarify the current good manufacturing practice (CGMP) requirements applicable to combination products in the Sept. 23 Federal Register.